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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 10-Q
 
    QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the quarterly period ended September 30, 2020
Or
         TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the transition period from              to             .
 
Commission File Number 001-35726
 
Radius Health, Inc.
(Exact name of registrant as specified in its charter)
Delaware 80-0145732
(State or other jurisdiction of (IRS Employer
Incorporation or organization) Identification Number)
 
950 Winter Street
Waltham, Massachusetts 02451
(Address of Principal Executive Offices and Zip Code)
 
(617) 551-4000
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.0001 par value per shareRDUSThe Nasdaq Global Market
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes   No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).  Yes   No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filerAccelerated filer 
  
Non-accelerated filer Smaller reporting company 
Emerging growth company 


Table of Contents
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes   No

Number of shares of the registrant’s Common Stock, $0.0001 par value per share, outstanding as of November 2, 2020: 46,547,387 shares


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RADIUS HEALTH, INC.
FORM 10-Q
FOR THE QUARTER ENDED SEPTEMBER 30, 2020
TABLE OF CONTENTS
 
   
 
 
 
 7
 
   
   
   


Table of Contents
PART I— FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
Radius Health, Inc.
Condensed Consolidated Balance Sheets
(Unaudited, in thousands, except share and per share amounts)
September 30,
2020
December 31,
2019
 (unaudited) 
ASSETS  
Current assets:  
Cash and cash equivalents$81,830 $69,886 
Restricted cash567 567 
Marketable securities43,873 91,015 
Accounts receivable, net21,175 23,289 
Inventory7,506 5,323 
Prepaid expenses11,346 12,131 
Other current assets17,078 846 
Total current assets183,375 203,057 
Property and equipment, net1,276 2,293 
Intangible assets5,984 6,583 
Right of use assets - operating leases4,832 6,704 
Other assets484 514 
Total assets$195,951 $219,151 
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)  
Current liabilities:  
Accounts payable$15,767 $6,030 
Accrued expenses and other current liabilities63,662 53,030 
Operating lease liability, current2,229 2,198 
Total current liabilities81,658 61,258 
Convertible notes payable208,902 195,591 
Term loan9,941  
Operating lease liability, long term4,031 4,581 
Total liabilities304,532 261,430 
Commitments and contingencies
Stockholders’ equity (deficit):  
Common stock, 0.0001 par value; 200,000,000 shares authorized, 46,548,201 shares and 46,189,870 shares issued and outstanding at September 30, 2020 and December 31, 2019
5 5 
Additional paid-in-capital1,215,769 1,194,327 
Accumulated other comprehensive income82 3 
Accumulated deficit(1,324,437)(1,236,614)
Total stockholders’ equity (deficit)(108,581)(42,279)
Total liabilities and stockholders’ equity (deficit)$195,951 $219,151 
See accompanying notes to unaudited condensed consolidated financial statements.


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Radius Health, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited, in thousands, except share and per share amounts)
Three Months Ended
September 30,
Nine Months Ended
September 30,
 2020201920202019
REVENUES:
Product revenue, net$50,412 $46,766 $148,448 $117,652 
License revenue27,414  27,414  
Total revenue$77,826 $46,766 $175,862 $117,652 
OPERATING EXPENSES:  
Cost of sales - product3,839 3,971 11,771 10,809 
Cost of sales - intangible amortization200 200 599 599 
Research and development, net of amounts reimbursable (a)39,450 31,791 123,340 82,230 
Selling, general and administrative33,692 35,617 108,356 116,918 
Income (Loss) from operations645 (24,813)(68,204)(92,904)
OTHER INCOME (EXPENSE):    
Other (expense) income(87)59 (144)21 
Interest expense(7,069)(6,298)(20,747)(18,500)
Interest income222 1,008 1,272 3,105 
NET LOSS$(6,289)$(30,044)$(87,823)$(108,278)
OTHER COMPREHENSIVE LOSS:    
Unrealized (loss) gain from available-for-sale debt securities(26)66 79 776 
COMPREHENSIVE LOSS$(6,315)$(29,978)$(87,744)$(107,502)
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS - BASIC AND DILUTED (Note 8)$(6,289)$(30,044)$(87,823)$(108,278)
LOSS PER SHARE:    
Basic and diluted$(0.14)$(0.65)$(1.89)$(2.36)
WEIGHTED AVERAGE SHARES:    
Basic and diluted46,493,126 46,141,217 46,395,124 45,975,691 
(a) Amounts reimbursable for the three and nine months ended September 30, 2020 were $15.4 million and $0 for the three and nine months ended September 30, 2019.

See accompanying notes to unaudited condensed consolidated financial statements.


5

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Radius Health, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited, in thousands)
Nine Months Ended
September 30,
 20202019
CASH FLOWS USED IN OPERATING ACTIVITIES:  
Net loss$(87,823)$(108,278)
Adjustments to reconcile net loss to net cash used in operating activities:  
Depreciation and amortization1,616 1,785 
Amortization of premium/discount on marketable securities, net237 (246)
Amortization of debt discount and debt issuance costs13,313 11,638 
Impairment loss on operating lease right of use assets1,510 339 
Stock-based compensation19,821 16,911 
Loss on property and equipment disposals 201 
Changes in operating assets and liabilities:  
Inventory(2,183)1,299 
Accounts receivable, net2,114 (4,770)
Prepaid expenses785 (1,359)
Other current assets(16,232)344 
Operating lease right of use assets1,472 1,507 
Other long-term assets30 132 
Accounts payable9,737 382 
Accrued expenses and other current liabilities10,632 6,879 
Lease liability, operating leases(1,629)(1,704)
Other non-current liabilities (71)
Net cash used in operating activities(46,600)(75,011)
CASH FLOWS PROVIDED BY INVESTING ACTIVITIES:  
Purchases of marketable securities(39,916)(36,589)
Sales and maturities of marketable securities86,900 135,500 
Net cash provided by investing activities46,984 98,911 
CASH FLOWS PROVIDED BY FINANCING ACTIVITIES:  
Proceeds from exercise of stock options and warrant exercises 3,869 
Proceeds from issuance of term loan10,000  
Payment of debt issuance costs(61) 
Proceeds from issuance of shares under employee stock purchase plan1,621 1,840 
Net cash provided by financing activities11,560 5,709 
NET INCREASE IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH11,944 29,609 
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT BEGINNING OF PERIOD70,453 59,881 
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT END OF PERIOD$82,397 $89,490 
SUPPLEMENTAL DISCLOSURES:  
Cash paid for interest$9,658 $9,150 
Cash paid for amounts included in the measurement of operating lease liabilities$1,932 $2,068 
Right of use assets obtained in exchange for operating lease liability$1,110 $8,289 
See accompanying notes to unaudited condensed consolidated financial statements.

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Radius Health, Inc.
Condensed Consolidated Statements of Stockholders’ Equity (Deficit)
(Unaudited, in thousands, except share and per share amounts)
 Stockholders’ Equity (Deficit)
 Common StockAdditional Paid-In Capital 
Accumulated Other
Comprehensive Income
(Loss)
 Accumulated
Deficit
Total Stockholders’ Equity (Deficit)
 SharesAmountAmount Amount AmountAmount
Balance at June 30, 201946,125,197 $5 $1,181,761 $(45)$(1,181,855)$(134)
Net loss(30,044)(30,044)
Unrealized gain from available-for-sale securities66 66 
Share-based compensation expense related to share-based awards for employee stock purchase plan20 20 
Issuance of common stock upon purchase by employee stock purchase plan47,973 813 813 
Share-based compensation expense5,029 5,029 
Balance at September 30, 201946,173,170 $5 $1,187,623 $21 $(1,211,899)$(24,250)
Balance at June 30, 202046,448,491 $5 $1,208,616 $108 $(1,318,148)$(109,419)
Net loss(6,289)(6,289)
Unrealized loss from available-for-sale securities(26)(26)
Vesting of restricted shares39,650  
Issuance of common stock upon purchase by employee stock purchase plan60,060 631 631 
Share-based compensation expense6,522 6,522 
Balance at September 30, 202046,548,201 $5 $1,215,769 $82 $(1,324,437)$(108,581)
See accompanying notes to unaudited condensed consolidated financial statements.






























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Radius Health, Inc.
Condensed Consolidated Statements of Stockholders’ Equity (Deficit)
(Unaudited, in thousands, except share and per share amounts)
Stockholders’ Equity (Deficit)
Common StockAdditional Paid-In CapitalAccumulated Other
Comprehensive Income
(Loss)
Accumulated
Deficit
Total Stockholders’ Equity (Deficit)
SharesAmountAmountAmountAmountAmount
Balance at December 31, 201845,563,693 $5 $1,165,003 $(755)$(1,103,621)$60,632 
Net loss(108,278)(108,278)
Unrealized gain from available-for-sale securities776 776 
Vesting of restricted shares75,331  
Exercise of options341,337 2,869 2,869 
Exercise of warrants81,104 1,000 1,000 
Share-based compensation expense related to share-based awards for employee stock purchase plan456 456 
Issuance of common stock upon purchase by employee stock purchase plan111,705 1,840 1,840 
Share-based compensation expense16,455 16,455 
Balance at September 30, 201946,173,170 $5 $1,187,623 $21 $(1,211,899)$(24,250)
Balance at December 31, 201946,189,870 $5 $1,194,327 $3 $(1,236,614)$(42,279)
Net loss(87,823)(87,823)
Unrealized gain from available-for-sale securities7979 
Vesting of restricted shares242,974  
Issuance of common stock upon purchase by employee stock purchase plan115,357 1,621 1,621 
Share-based compensation expense19,821 19,821 
Balance at September 30, 202046,548,201 $5 $1,215,769 $82 $(1,324,437)$(108,581)
See accompanying notes to unaudited condensed consolidated financial statements.
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Radius Health, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Organization
Radius Health, Inc. (“Radius” or the “Company”) is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics. In April 2017, the Company’s first commercial product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapies. In July 2017, the Company entered into a license and development agreement with Teijin Limited (“Teijin”) for abaloparatide for subcutaneous injection (“abaloparatide-SC”) in Japan, under which the Company received an upfront payment and is entitled to receive milestone payments upon the achievement of certain regulatory and sales milestones, and a fixed low double-digit royalty based on net sales of abaloparatide-SC in Japan during the royalty term. In January 2019, the European Commission adopted a decision refusing approval of the Company’s European Marketing Authorisation Application (“MAA”) for abaloparatide-SC. The Company is developing an abaloparatide transdermal patch, or abaloparatide-patch, for potential use in the treatment of postmenopausal women with osteoporosis. In connection with its strategic plans to focus on bone health and targeted endocrine diseases, in July 2020 the Company entered into a license agreement with Berlin-Chemie AG, a company of the Menarini Group (“Berlin-Chemie”), under which the Company granted Berlin-Chemie an exclusive license to develop and commercialize products containing elacestrant (RAD1901), a selective estrogen receptor degrader (“SERD”), worldwide. Elacestrant is being developed for potential use in the treatment of hormone receptor-positive breast cancer. Further, the Company completed its divestment of its oncology program with the sale of RAD140, an internally discovered non-steroidal selective androgen receptor modulator (“SARM”) the Company was developing for potential use in the treatment of hormone receptor-positive breast cancer, to Ellipses Pharma in September 2020.
The Company is subject to the risks associated with biopharmaceutical companies with a limited operating history, including dependence on key individuals, a developing business model, the necessity of securing regulatory approvals to market its investigational product candidates, market acceptance of the Company’s investigational product candidates following receipt of regulatory approval, competition for its investigational product candidates following receipt of regulatory approval, and the continued ability to obtain adequate financing to fund the Company’s future operations, inclusive of the impacts from the coronavirus disease 2019 (“COVID-19”) pandemic. The Company has incurred losses and expects to continue to incur additional losses for the foreseeable future. As of September 30, 2020, the Company had an accumulated deficit of $1,324.4 million, and total cash, cash equivalents, and marketable securities of $125.7 million.
The ongoing global COVID-19 pandemic has resulted in significant governmental measures being implemented to control the spread of the virus and while the Company cannot predict their scope and severity, these developments and measures have had an effect on the Company’s business, results of operations and financial condition and may adversely affect its business, results of operations and financial condition in the future. The Company is closely monitoring the impact of the COVID-19 pandemic on all aspects of its business and is taking steps to minimize its impact on its business. However, the full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, including sales, expenses, reserves and allowances, manufacturing, clinical trials, research and development costs and employee-related amounts, will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the outbreak, new information that may emerge concerning the severity of COVID-19 pandemic or the effectiveness of actions taken to contain the pandemic or minimize its impact, among others. Furthermore, if the Company or any of the third parties with whom it engages were to experience additional or prolonged shutdowns or other business disruptions, the Company’s ability to conduct its business in the manner and on the timelines presently planned could be materially or negatively affected, which could have a material adverse impact on its business, results of operations and financial condition.
Based upon its cash, cash equivalents, and marketable securities balance as of September 30, 2020, the Company believes that, prior to the consideration of revenue from the potential future sales of any of its investigational product candidates that may receive regulatory approval or proceeds from partnering and/or collaboration activities, it has sufficient capital as well as access to other capital discussed in Note 7, “Term Loan and Credit Facility” to fund its development plans, U.S. commercial scale-up and other operational activities, for at least one year from the date of this filing. The Company expects to finance the future development costs of its clinical product portfolio with its existing cash and cash equivalents, and marketable securities, or through strategic financing opportunities that could include, but are not limited to collaboration or partnership agreements, future offerings of its equity, or the incurrence of debt. However, there is no guarantee that any of these strategic or financing opportunities will be executed or executed on favorable terms, and some could be dilutive to existing stockholders. If the Company fails to obtain additional future capital, it may be unable to complete its clinical trials and obtain approval of certain investigational product candidates from the FDA or foreign regulatory authorities.
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2. Basis of Presentation and Significant Accounting Policies
Basis of Presentation—The accompanying unaudited condensed consolidated financial statements and the related disclosures of the Company have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01. Accordingly, they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included.
When preparing financial statements in conformity with U.S. GAAP, the Company must make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expenses and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the nine months ended September 30, 2020 are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2020. Subsequent events have been evaluated up to the date of issuance of these financial statements. These interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes, which are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 (“2019 Form 10-K”), filed with the Securities and Exchange Commission (“SEC”) on February 27, 2020.
Significant Accounting Policies—The significant accounting policies identified in the Company’s 2019 Form 10-K that require the Company to make estimates and assumptions include: revenue recognition, inventory obsolescence, long-lived assets and intangible assets, accounting for stock-based compensation, contingencies, tax valuation reserves, fair value measures, and accrued expenses. There were no changes to significant accounting policies during the nine months ended September 30, 2020, except for the adoption of the Accounting Standards Updates (“ASU”) issued by the Financial Accounting Standards Board (“FASB”) detailed below.
Accounting Standards Updates—Recently Adopted—In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). Certain amendments thereto were also issued by the FASB. ASU 2016-13 and the related amendments require that credit losses be reported using an expected losses model, representing the entity’s current estimate of credit losses expected to be incurred. The previous accounting guidance, as applied by the Company through December 31, 2019, was based on an incurred losses model. The standard replaces the incurred loss impairment methodology under current U.S. GAAP with a methodology that reflects expected credit losses and requires the use of a forward-looking expected credit loss model for accounts receivables, loans, and other financial instruments. For available-for-sale debt securities with unrealized losses, ASU 2016-13 and the related amendments now requires allowances to be recorded instead of reducing the amortized cost of the investment. These amendments under ASU 2016-13 are effective for interim and annual fiscal periods beginning after December 15, 2019. The Company adopted ASU 2016-13 as of January 1, 2020 and it did not have a material impact on the Company’s condensed consolidated financial statements.
In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement - Disclosure Framework - Changes to the Disclosure Requirement for Fair Value Measurement, or (“ASU 2018-13”). The amendments in ASU 2018-13 modify the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement, based on the concepts in the Concepts Statement, including the consideration of costs and benefits. The amendments under ASU 2018-13 are effective for interim and annual fiscal periods beginning after December 15, 2019, with early adoption permitted. The Company adopted ASU 2018-13 on January 1, 2020 and it did not have a material impact on the Company’s condensed consolidated financial statements.
In August 2018, the FASB issued ASU 2018-15, Intangible-Goodwill and Other Internal-Use Software (Subtopic 350-40) (“ASU 2018-15”). ASU 2018-15 updates guidance regarding accounting for a cloud computing arrangement that is a service contract. The amendments under ASU 2018-15 are effective for interim and annual fiscal periods beginning after December 15, 2019, with early adoption permitted. The Company adopted ASU 2018-15 on January 1, 2020 and it did not have a material impact on the Company’s condensed consolidated financial statements.
Other - In March 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was signed into law and provides an estimated $2.2 trillion to fight the COVID-19 pandemic and stimulate the economy. The business tax provisions of the CARES Act include temporary changes to income and non-income-based tax laws. Some of the key income tax provisions include eliminating the 80% of taxable income limitations by allowing corporate entities to fully utilize net operating loss (“NOL”) carryforwards to offset taxable income in 2018, 2019, or 2020 and reinstating it for tax years after 2020; allowing NOLs generated in 2018, 2019, or 2020 to be carried back five years; increasing the net interest expense deduction limit to 50% of adjusted taxable income from 30% for the 2019 and 2020 tax years; allowing taxpayers with alternative minimum tax credits to claim a refund for the entire amount of the credit instead of recovering the credit through refunds over a period of years, as required by the 2017 Tax Cut and Jobs Act; and allowing entities to deduct more of their charitable cash contributions made
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during calendar year 2020 by increasing the taxable income limitation to 25% from 10%. Companies are required to account for these provisions in the period that includes the March 2020 enactment date (i.e., the first quarter for calendar year-end entities). The Company has assessed the impact of these provisions and they are not material to the Company’s condensed consolidated financial statements or related disclosures. Measures of the CARES Act not related to income-based taxes include allowing an employer to pay its share of Social Security payroll taxes that would otherwise be due from the date of enactment through December 31, 2020 over the following two years and allowing eligible employers subject to closure due to the COVID-19 pandemic to receive a 50% credit on qualified wages against their employment taxes each quarter, with any excess credits eligible for refunds. These measures of the CARES Act are also not material to the Company’s condensed consolidated financial statements as the Company did not apply for any credit during the period.
Accounting Standards Updates, Recently Issued—In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes (“ASU 2019-12”). ASU 2019-12 eliminates certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interest period and the recognition of deferred tax liabilities for outside basis differences, and also clarifies and simplifies other aspects of the accounting for income taxes. The amendments under ASU 2010-12 are effective for interim and annual fiscal periods beginning after December 15, 2020, with early adoption permitted. The Company is currently evaluating the effects the adoption of ASU 2019-12 will have on its consolidated financial statements and related disclosures.
In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”). The guidance simplifies the complexity associated with applying U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. More specifically, the amendments focus on the guidance for convertible instruments and derivative scope exception for contracts in an entity’s own equity. ASU 2020-06 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company is currently in the process of determining the effect that the adoption will have on its condensed consolidated financial statements and related disclosures.
3. Marketable Securities
Available-for-sale marketable securities and cash and cash equivalents as of September 30, 2020 and December 31, 2019 consisted of the following (in thousands):
 September 30, 2020
 Amortized Cost ValueGross 
Unrealized 
Gains
Gross 
Unrealized 
Losses
Fair Value
Cash and cash equivalents:    
Cash$55,796 $— $— $55,796 
Money market funds26,034 — — 26,034 
Total$81,830 $— $— $81,830 
Marketable securities:    
Domestic corporate debt securities$38,822 $91 $(3)$38,910 
Domestic corporate commercial paper4,968  (5)4,963 
Total$43,790 $91 $(8)$43,873 
 
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 December 31, 2019
 Amortized Cost ValueGross 
Unrealized 
Gains
Gross 
Unrealized 
Losses
Fair Value
Cash and cash equivalents:    
Cash$34,726 $— $— $34,726 
Money market funds35,160 — — 35,160 
Total$69,886 $— $— $69,886 
Marketable securities:    
Domestic corporate debt securities$41,229 $3 $(3)$41,229 
Domestic corporate commercial paper24,900 5  24,905 
Agency bonds12,391 1 (3)12,389 
US treasury bonds12,492   12,492 
Total$91,012 $9 $(6)$91,015 
The Company reviews marketable securities whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time. We evaluate whether the decline in fair value has resulted from credit losses or other factors. In making this assessment, we consider the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and adverse conditions specifically related to the security, among other factors. If this assessment indicates that a credit loss exists, the present value of cash flows expected to be collected from the security are compared to the amortized cost basis of the security. If the present value of cash flows expected to be collected is less than the amortized cost basis, a credit loss exists and an allowance for credit losses is recorded for the credit loss on the condensed consolidated balance sheet, limited by the amount that the fair value is less than the amortized cost basis. Any impairment that is not related to credit is recognized in other comprehensive income.
Changes in the allowance for credit losses are recorded as a provision for (or reversal of) credit loss expense on the condensed consolidated statement of operations. Losses are charged against the allowance when the Company believes the uncollectability of an available-for-sale debt security is confirmed or when either of the criteria regarding intent or requirement to sell is met. The unrealized losses at September 30, 2020 and December 31, 2019 are attributable to changes in interest rates and the Company does not believe any unrealized losses represent credit losses.
As of September 30, 2020 and December 31, 2019, the Company had 2 and 8 available-for-sale debt securities in an unrealized loss position, respectively, for which an allowance for credit losses has not been recorded. The following table summarizes such investments by major security type and length of time in a continuous unrealized loss position as of September 30, 2020 (in thousands).
Less than 12 Months12 months or longerTotal
Fair valueUnrealized lossesFair valueUnrealized lossesFair valueUnrealized losses
Available-for-sale debt securities
Domestic corporate debt securities$4,621 $(3)  $4,621 $(3)
Domestic corporate commercial paper4,964 (5)  4,964 (5)
Total available-for-sale debt securities$9,585 $(8)  $9,585 $(8)
4. Fair Value Measurements
The Company determines the fair value of its financial instruments based upon the fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Below are the three levels of inputs that may be used to measure fair value:
Level 1—Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
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Level 2—Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
Transfers into or out of any hierarchy level are recognized at the end of the reporting period in which the transfers occurred. There were no material transfers between any levels during the nine months ended September 30, 2020. There were no material transfers between any levels during 2019.
The following table summarizes the financial instruments measured at fair value on a recurring basis in the Company’s accompanying condensed consolidated balance sheets as of September 30, 2020 and December 31, 2019 (in thousands):
 As of September 30, 2020
 Level 1Level 2Level 3Total
Assets    
Cash and cash equivalents:    
Cash$55,796 $ $ $55,796 
Money market funds (1)26,034   26,034 
Total$81,830 $ $ $81,830 
Marketable Securities    
Domestic corporate debt securities (2)$ $38,910 $ $38,910 
Domestic corporate commercial paper (2) 4,963  4,963 
Total$ $43,873 $ $43,873 
 
 As of December 31, 2019
 Level 1Level 2Level 3Total
Assets    
Cash and cash equivalents:    
Cash$34,726 $ $ $34,726 
Money market funds (1)35,160   35,160 
Total$69,886 $ $ $69,886 
Marketable Securities    
Domestic corporate debt securities (2)$ $41,229 $ $41,229 
Domestic corporate commercial paper (2) 24,905  24,905 
Agency bonds (2) 12,389  12,389 
US treasury bonds (2)$ $12,492 $ $12,492 
Total$ $91,015 $ $91,015 
(1)                           Fair value is based upon quoted market prices.
(2)                           Fair value is based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant assumptions are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. Inputs are obtained from various sources, including market participants, dealers and brokers.
As of September 30, 2020, the carrying amounts of the cash and cash equivalents, restricted cash, accounts receivable, prepaid expenses, other current assets, accounts payable, accrued expenses, long-term debt and operating lease liabilities approximated their estimated fair values.
5. Inventory
Inventory consisted of the following as of September 30, 2020 and December 31, 2019 (in thousands):
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September 30,
2020
December 31,
2019
Raw materials$4,475 $4,093 
Work in process1,299  
Finished goods1,732 1,230 
Total inventories$7,506 $5,323 
Finished goods manufactured by the Company have a 36-month shelf life from date of manufacture.
6. Convertible Notes Payable
On August 14, 2017, in a registered underwritten public offering, the Company issued $300.0 million aggregate principal amount of 3% Convertible Senior Notes due September 1, 2024 (the “Convertible Notes”). In addition, on September 12, 2017, the Company issued an additional $5.0 million principal amount of Convertible Notes pursuant to the exercise of an over-allotment option granted to the underwriters in the offering. In accordance with accounting guidance for debt with conversion and other options, the Company separately accounted for the liability component (the “Liability Component”) and embedded conversion option (the “Equity Component”) of the Convertible Notes by allocating the proceeds between the Liability Component and the Equity Component, due to the Company’s ability to settle the Convertible Notes in cash, common stock or a combination of cash and common stock, at its option. In connection with the issuance of the Convertible Notes, the Company incurred approximately $9.4 million of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees, and allocated these costs to the Liability and Equity Components based on the allocation of the proceeds. Of the total $9.4 million of debt issuance costs, $4.3 million was allocated to the Equity Component and recorded as a reduction to additional paid-in capital and $5.1 million was allocated to the Liability Component and is now recorded as a reduction of the Convertible Notes in the Company’s condensed consolidated balance sheet. The portion allocated to the Liability Component is amortized to interest expense using the effective interest method over seven years.
The Convertible Notes are senior unsecured obligations of the Company and bear interest at a rate of 3.00% per annum, payable semi-annually in arrears on March 1 and September 1. Upon conversion, the Convertible Notes will be convertible into cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s election. The Convertible Notes will be subject to redemption at the Company’s option, under certain restrictions as noted below, on or after September 1, 2021, in whole or in part, if the conditions described below are satisfied. The redemption of the Convertible Notes may also be subject to certain restrictions included in Note 7, “Term Loan and Credit Facility”. The Convertible Notes will mature on September 1, 2024, unless earlier converted, redeemed or repurchased in accordance with their terms. Subject to satisfaction of certain conditions and during the periods described below, the Convertible Notes may be converted at an initial conversion rate of 20.4891 shares of common stock per $1,000 principal amount of the Convertible Notes (equivalent to an initial conversion price of approximately $48.81 per share of common stock).
Holders of the Convertible Notes may convert all or any portion of their notes, in multiples of $1,000 principal amount, at their option at any time prior to the close of business on the business day immediately preceding June 1, 2024 only under the following circumstances:
(1)if the last reported sale price of the Company’s common stock for at least 20 trading days (whether consecutive or not) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day;
(2)during the five-business day period after any five-consecutive trading day period (the “measurement period”) in which the “trading price” per $1,000 principal amount of the Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day;
(3)if the Company calls the Convertible Notes for redemption, until the close of business on the business day immediately preceding the redemption date; or
(4)upon the occurrence of specified corporate events.
As of September 30, 2020, none of the above circumstances had occurred and, as such, the Convertible Notes were not convertible.
Prior to September 1, 2021, the Company may not redeem the Convertible Notes. On or after September 1, 2021, the Company may redeem for cash all or part of the Convertible Notes if the last reported sale price of the Company’s common stock equals or exceeds 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30-
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consecutive trading day period ending within five trading days prior to the date on which the Company provides notice of the redemption. The redemption price will be the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. In addition, calling any Convertible Note for redemption will constitute a make-whole fundamental change with respect to that Convertible Note, in which case the conversion rate applicable to the conversion of that Convertible Note, if it is converted in connection with the redemption, will be increased in certain circumstances.
The initial carrying amount of the Liability Component of $166.3 million was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The allocation was performed in a manner that reflected the Company’s non-convertible debt borrowing rate for similar debt. The Equity Component of the Convertible Notes of $138.7 million was recognized as a debt discount and represents the difference between the proceeds from the issuance of the Convertible Notes of $305.0 million and the fair value of the Liability of the Convertible Notes of approximately $166.3 million on their respective dates of issuance. The excess of the principal amount of the Liability Component over its carrying amount (the “Debt Discount”) is amortized to interest expense using the effective interest method over seven years. The Equity Component is not remeasured as long as it continues to meet the conditions for equity classification. In connection with issuance of the Convertible Notes, the Company also incurred certain offering costs directly attributable to the offering. Such costs are deferred and amortized over the term of the debt to interest expense using the effective interest method.
The outstanding balances of the Convertible Notes as of September 30, 2020 consisted of the following (in thousands):
2024 Convertible Notes
Liability component:
Principal$305,000 
Less: debt discount and issuance costs, net(96,098)
Net carrying amount$208,902 
Equity component:$134,450 
The Company determined the expected life of the Convertible Notes was equal to their seven-year term. The effective interest rate on the Liability Components of the Convertible Notes for the period from the date of issuance through September 30, 2020 was 13.04%. As of September 30, 2020, the “if-converted value” did not exceed the remaining principal amount of the Convertible Notes. The fair value of the Convertible Notes are based on data from readily available pricing sources which utilize market observable inputs and other characteristics for similar types of instruments, and, therefore, the Convertible Notes are classified within Level 2 in the fair value hierarchy. The fair value of the Convertible Notes, which differs from their carrying value, is influenced by interest rates, the Company’s stock price and stock price volatility. The estimated fair value of the Convertible Notes as of September 30, 2020 was approximately $250.8 million.
The following table sets forth total interest expense recognized related to the Convertible Notes during the three and nine months ended September 30, 2020 and 2019 (in thousands):
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020201920202019
Contractual interest expense$2,288 $2,288 $6,863 $6,863 
Amortization of debt discount4,421 3,865 12,830 11,216 
Amortization of debt issuance costs165 145 480 421 
Total interest expense$6,874 $6,298 $20,173 $18,500 
Future minimum payments on the Company’s long-term debt as of September 30, 2020 are as follows (in thousands):
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Years ended December 31,
Future Minimum Payments
2020$ 
20219,150 
20229,150 
20239,150 
2024314,150 
Total minimum payments
$341,600 
Less: interest
(36,600)
Less: unamortized discount
(96,098)
Less: current portion
 
Long Term Debt
$208,902 
7. Term Loan and Credit Facility
On January 10, 2020, the Company and Radius Pharmaceuticals, Inc., a wholly-owned subsidiary of the Company (collectively, the “Borrowers”), entered into a (i) Credit and Security Agreement, as amended (Term Loan) (the “Term Credit Agreement”) with MidCap Financial Trust, in its capacity as administrative agent (the “Agent”) and as a lender, and the financial institutions or other entities from time to time parties thereto and (ii) Credit and Security Agreement (Revolving Loan) (the “Revolving Credit Agreement,” together with the Term Credit Agreement, the “Credit Agreements”), with the Agent, and the financial institutions or other entities from time to time parties thereto.
The Credit Agreements consist of a secured term loan facility (the “Term Facility”) in an aggregate amount of $55.0 million, which will be made available to the Borrowers under the following four tranches: (i) Tranche 1 - $10.0 million, available at closing; (ii) Tranche 2 - $15.0 million, available no earlier than June 25, 2020, but no later than December 31, 2020; (iii) Tranche 3 - $15.0 million, available no later than December 31, 2021, subject to the Company’s satisfaction of certain conditions described in the Term Credit Agreement; and (iv) Tranche 4 - $15.0 million, available no later than December 31, 2021, subject to the Company’s satisfaction of certain conditions described in the Term Credit Agreement.
The Credit Agreements also consist of a secured revolving credit facility (the “Revolving Facility”, together with the Term Facility, the “Facilities”) under which the Borrowers may borrow up to $20.0 million, the availability of which is determined based on a borrowing base as follows: (i) up to 85% of the net collectible value of the Borrowers’ domestic accounts receivable due from eligible direct and third-party payors, plus (ii) up to 40% of the Borrowers’ domestic eligible inventory, provided that the availability from eligible inventory may not exceed 20% of the total availability at any time. The Borrowers also have the right, subject to certain customary conditions, to increase the Revolving Facility by $20.0 million.
The Facilities have a maturity date of June 1, 2024. The Borrowers guarantee their obligations under the Credit Agreements. The obligations are secured by first priority liens on substantially all of the assets of the Borrowers, including, with certain exceptions, all of the capital stock of the Borrowers’ subsidiaries. On July 23, 2020, the Company entered into a Partial Release and Acknowledgement Agreement (the “Release Agreement”) with the Agent pursuant to which the Agent agreed to release the security interest on certain assets of the Company that are licensed to Berlin-Chemie AG pursuant to the license agreement between the Company and Berlin-Chemie AG.
The proceeds of the Term Facility may be used for (i) transaction fees in connection with the transactions contemplated by the Credit Agreements, (ii) the payment in full on the closing date of certain existing debt, and (iii) working capital needs and general corporate purposes of the Borrowers and their subsidiaries. The proceeds of the Revolving Facility may be used for (i) transaction fees in connection with the transactions contemplated by the Credit Agreements and (ii) working capital needs and general corporate purposes of the Borrowers and their subsidiaries.
Borrowings under the Term Facility will bear interest through maturity at a variable rate based upon the LIBOR rate plus 5.75%, subject to a LIBOR floor of 2.00%. Borrowings under the Revolving Facility will bear interest through maturity at a variable rate based upon the LIBOR rate plus 3.50%, subject to a LIBOR floor of 2.00%.
Subject to the terms and conditions set forth in the Credit Agreements, the Borrowers may be required to make certain mandatory prepayments prior to maturity.
The Credit Agreements contain affirmative and negative covenants customarily applicable to senior secured credit facilities, including covenants that, among other things, will limit or restrict the ability of the Borrowers, subject to negotiated exceptions, to incur additional indebtedness and additional liens on their assets, engage in mergers or acquisitions or dispose of assets, pay dividends or make other distributions, voluntarily prepay other indebtedness as noted above in Note 6, “Convertible Notes Payable,” enter into transactions with affiliated persons, make investments, and change the nature of their businesses. The
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Credit Agreements also contain customary events of default, including subject to thresholds and grace periods, among others, payment default, covenant default, cross default to other material indebtedness, and judgment default. In addition, the Credit Agreements require the Borrowers to maintain a minimum level of net revenue, or in the case where the Borrowers fail to maintain a minimum level of net revenue, certain levels of market capitalization and unrestricted cash. As of September 30, 2020, the Company was not in violation of any covenants contained in the Credit Agreements.
As of September 30, 2020, the Company had received net proceeds of approximately $9.8 million from the Term Loan, net of fees and expenses of $0.2 million. The estimated fair value of the Term Facility as of September 30, 2020 was approximately $8.2 million. The outstanding balance of the Term Loan as of September 30, 2020 was (in thousands):
Term loan
Principal$10,000 
Less: debt issuance costs, net(59)
Net carrying amount$9,941 
The following table sets forth total interest expense recognized related to the Term Facility during the three and nine months ended September 30, 2020 (in thousands):
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020201920202019
Contractual interest expense$198 $ $573 $ 
Amortization of debt discount1  2  
Total interest expense$199 $ $575 $ 
Future minimum payments on the Term Facility as of September 30, 2020 are as follows (in thousands):
Years ended December 31,
Future Minimum Payments
2020$196 
2021786 
2022786 
20237,044 
20243,611 
Total minimum payments
$12,423 
Less: interest
(2,423)
Less: unamortized issuance costs
(59)
Less: current portion
 
Long Term Debt
$9,941 

8. Net Loss Per Share
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Basic and diluted net loss per share for the periods set forth below is calculated as follows (in thousands, except share and per share amounts):
Three Months Ended
September 30,
Nine Months Ended
September 30,
 2020201920202019
Numerator:    
Net loss$(6,289)$(30,044)$(87,823)$(108,278)
Denominator:    
Weighted-average number of common shares used in loss per share - basic and diluted46,493,126 46,141,217 46,395,124 45,975,691 
Loss per share - basic and diluted$(0.14)$(0.65)$(1.89)$(2.36)
The following potentially dilutive securities, prior to the use of the treasury stock method, have been excluded from the computation of diluted weighted-average shares outstanding, as they would be anti-dilutive. For the three and nine months ended September 30, 2020 and 2019, respectively, all of the Company’s options to purchase common stock and restricted stock units outstanding were assumed to be anti-dilutive as earnings attributable to common stockholders was in a loss position.
Three and Nine Months Ended September 30,
 20202019
Options to purchase common stock5,868,348 4,860,997 
Restricted stock units686,069 655,723 
Performance units70,000 79,000 
The Company has the option to settle the conversion obligation for the Convertible Notes in cash, shares or any combination of the two. As the Convertible Notes are not convertible as of September 30, 2020, they are not participating securities and they will not have an impact on the calculation of basic earnings or loss per share. Based on the Company’s net loss position, there is no impact on the calculation of dilutive loss per share during the three and nine-month periods ended September 30, 2020 and 2019, respectively.
9. Product Revenue Reserves and Allowances
To date, the Company’s only source of product revenue has been from the U.S. sales of TYMLOS, which it began shipping to customers in May 2017. The following table summarizes activity in each of the product revenue allowance and reserve categories for the nine months ended September 30, 2020 and 2019 (in thousands):
Chargebacks, Discounts, and FeesGovernment and other rebatesReturnsTotal
Ending balance at December 31, 2018$3,198 $7,620 $411 $11,229 
Provision related to sales in the current year21,203 44,426 698 66,327 
Adjustments related to prior period sales(27)697  670 
Credits and payments made(19,759)(34,190)(575)(54,524)
Ending balance at September 30, 20194,615 18,553 534 23,702 
Ending balance at December 31, 2019$5,739 $17,280 $1,583 $24,602 
Provision related to sales in the current year16,123 57,120 2,030 75,273 
Adjustments related to prior period sales(107)(1,570) (1,677)
Credits and payments made(20,011)(50,717)(893)(71,621)
Ending balance at September 30, 2020$1,744 $22,113 $2,720 $26,577 
Chargebacks, discounts, fees, and returns are recorded as reductions of trade receivables, net on the condensed consolidated balance sheets. Government and other rebates are recorded as a component of accrued expenses and other current liabilities on the condensed consolidated balance sheets.
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To date, the Company has no bad debt write-offs and the Company does not currently have credit issues with any customers. There were no credit losses associated with the Company’s trade receivables as of September 30, 2020 and 2019.
10. License Revenue and Reimbursable Expenses
General
The Company has generated revenue from contracts with customers, which include upfront payments for licenses.
Berlin-Chemie
On July 23, 2020, the Company entered into a license agreement (“License Agreement”) with Berlin-Chemie under which the Company granted Berlin-Chemie an exclusive license to develop and commercialize products containing elacestrant (RAD1901) worldwide.
The Company and Berlin-Chemie simultaneously entered into a Transition Services Agreement (the “TSA”), pursuant to which the Company agreed to perform certain services for Berlin-Chemie related to the EMERALD Phase 3 monotherapy study until the earlier of the completion of the contemplated services or the filing with the FDA of a New Drug Application for elacestrant. Pursuant to the TSA, Berlin-Chemie agreed to reimburse the Company for all out-of-pocket and full-time employee costs in performing the services, for total estimated reimbursements of $111.5 million. The Company will continue to incur research and development expenses in support of scale up costs under the TSA.
Pursuant to the terms of the License Agreement, Berlin-Chemie made a nonrefundable initial license fee payment to the Company of $30.0 million in July 2020. The Company is also eligible to receive up to $20.0 million in development and regulatory milestone payments and up to $300.0 million in sales milestone payments, with such payments contingent on the achievement of specified milestones with respect to the licensed products. The Company is also eligible to receive tiered royalties on sales of licensed products at percentages ranging from low to mid-teens, subject to certain reductions. Royalties on net sales will be payable on a product-by-product and country-by-country basis until the latest of the expiration date of the last to expire of the relevant patent rights, the expiration of regulatory exclusivity, or ten years from such first commercial sale.
The License Agreement will continue on a licensed product-by-licensed product and country-by-country basis until the last to expire royalty term. Either party may terminate the License Agreement for an uncured material breach by the other party or upon the bankruptcy or insolvency of the other party. The Company may terminate the License Agreement for certain patent challenges or if no development, manufacture or commercialization activity occurs in any given 24-month period. Berlin-Chemie may terminate the License Agreement at its discretion for any reason by delivering 180 days’ prior written notice to the Company; provided that such termination will not be effective prior to the third anniversary of the effective date.
The Company determined that the License Agreement and TSA should be combined and evaluated as a single arrangement as they were executed on the same date and negotiated as a package. The arrangement with Berlin-Chemie provides for the transfer of the following goods or services: (i) license, (ii) know-how, (iii) regulatory filings, (iv) inventory, (v) transition services, including certain clinical, manufacturing, regulatory and other services associated with the Phase 3 EMERALD monotherapy study, and (vi) participation in various joint committees.
Management applied the guidance in ASC 606 to identify all distinct goods and services within the arrangement to assess whether there is a unit of account that should be accounted for under ASC 606. Management evaluated all of the promised goods or services within the contract and determined which of those were separate performance obligations. The Company determined that the license granted, at arrangement inception, should be combined with the know-how and regulatory filings as they are not capable of being distinct (the “License”). The Company also concluded that the license rights, know-how, and regulatory filings are capable of being distinct from the supply of inventory, as Berlin-Chemie would be able to benefit from the inventory on its own or with other resources that are readily available, and capable of being distinct from the transition services and participation in joint committees as these are research and development services that can typically be performed by other third parties.
The License is an element of the arrangement that is subject to the revenue recognition accounting guidance, as the performance obligation is an output of the Company’s ordinary activities in exchange for consideration. Conversely, the transition services, the participation on joint committees, and transfer of inventory are elements of the arrangements that are outside the scope of the revenue recognition guidance, as the Company is providing goods and services that are not an output of the Company’s ordinary activities.
The transaction price at inception is comprised of fixed consideration of $30.0 million. The $30.0 million upfront fee, which represents the fixed consideration in the transaction price, was allocated to the License and the supply of inventory, on a relative standalone selling price basis. The Company estimated the standalone selling price for the license by applying a risk adjusted, net present value, estimate of future potential cash flows approach and determined the standalone selling price for the inventory
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using a cost approach. Accordingly, the Company has allocated $27.4 million to the license and $2.6 million to the inventory. The Company concluded that the reimbursements for the research and development transition services and participation in the joint steering committees was commensurate with the standalone selling prices of the services, and as such, will be attributed to those services. The reimbursements for these services will be recorded as a reduction of the related research and development expenses as the expenses are incurred.
Under the Berlin-Chemie agreements, the Company is eligible to receive various development and regulatory, and sales milestones. There is uncertainty that the events to obtain the development and regulatory milestones will be achieved. The Company has thus determined that all such milestones will be constrained until it is deemed probable that a significant revenue reversal will not occur. Additional transaction price recognized in future periods related to milestone payments and royalties will be allocated solely to the License.
Sales milestones and sales-based royalties were also excluded from the transaction price as the license is deemed to be the predominant item to which the sales milestones and sales-based royalties relate. The Company will recognize such revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
During the three and nine months ended September 30, 2020, the Company recognized $27.4 million of license revenue, as it had satisfied its promises under the performance obligation for the license, including the transfer of know-how and regulatory filings, by transferring them at a point in time during the quarter. During the three and nine months ended September 30, 2020, the Company recorded $15.4 million as a reduction of research and development expenses for reimbursement of transition services performed under the TSA.
11. Commitments and Contingencies
Litigation
From time to time, the Company may become subject to legal proceedings and claims which arise in the ordinary course of its business. The Company records a liability in its condensed consolidated financial statements for these matters when a loss is known or considered probable and the amount can be reasonably estimated. The Company reviews these estimates each accounting period as additional information is known and adjusts the loss provision when appropriate. If a matter is both probable to result in a liability and the amounts of loss can be reasonably estimated, the Company estimates and discloses the possible loss or range of loss to the extent necessary to make the condensed consolidated financial statements not misleading. If the loss is not probable or cannot be reasonably estimated, a liability is not recorded in its consolidated financial statements.
As of September 30, 2020, the Company was not party to any significant litigation.
Manufacturing Agreements
In June 2016, the Company entered into a Supply Agreement with Ypsomed AG (“Ypsomed”), as amended, pursuant to which Ypsomed agreed to supply commercial and clinical supplies of a disposable pen injection device customized for subcutaneous injection of abaloparatide. The Company has agreed to purchase a minimum number of devices at prices per device that decrease with an increase in quantity supplied. In addition, the Company has agreed to make milestone payments for Ypsomed’s capital developments in connection with the initiation of the commercial supply of the device and to pay a one-time capacity fee. All costs and payments under the agreement are delineated in Swiss Francs. The agreement had an initial term of three years, which began on June 1, 2017, after which it automatically renewed for a two-year term. Following its current term, the agreement automatically renews for additional two-year terms unless either party terminates the agreement upon 18 months’ notice prior to the end of the then-current term. For the two-year term beginning May 2020, the Company is required to purchase a minimum number of batches for CHF 1.9 million (approximately $2.1 million).
In June 2016, the Company entered into a Commercial Supply Agreement with Vetter Pharma International GmbH (“Vetter”), as amended, pursuant to which Vetter agreed to formulate the finished abaloparatide-SC drug product containing abaloparatide active pharmaceutical ingredient fill cartridges with the drug product, assemble the pen delivery device, and package the pen for commercial distribution. The Company agreed to purchase the cartridges and pens in specified batch sizes at a price per unit. For labeling and packaging services, the Company agreed to pay a per unit price dependent upon the number of pens loaded with cartridges that are labeled and packaged. These prices are subject to an annual price adjustment. The agreement has an initial term of five years, which began on January 1, 2016, after which, it automatically renews for two-year terms unless either party notifies the other party two years before the end of the then-current term that it does not intend to renew.
In July 2016, the Company entered into a Manufacturing Services Agreement with Polypeptide Laboratories Holding AB (“PPL”), as amended, as successor-in-interest to Lonza Group Ltd., pursuant to which PPL agreed to manufacture the commercial and clinical supplies of abaloparatide API. The Company agreed to purchase the API in batches at a price per gram
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in euros, subject to an annual increase by PPL. The agreement has an initial term of six years, which began on June 28, 2016, after which, it automatically renews for three-year terms unless either party provides notice of non-renewal 24 months before the end of the then-current term. The Company was required to purchase a minimum number of batches annually, equal to approximately €2.9 million (approximately $3.4 million) per year, subject to any annual price adjustments, during the initial term, except in calendar years 2019 and 2020. The Company was not subject to the minimum purchase requirement in 2019 and is not in 2020.
Related Party Transactions
Since December 2019, an immediate family member of Jessica Hopfield (a member of the Company’s Board of Directors) has been an executive officer of one of the Company’s customers, AmerisourceBergen Corporation (“ABC”). The activities with ABC and its affiliates are in the ordinary course of business and were primarily for commercial distribution of TYMLOS and service fees. As of September 30, 2020, the Company recognized net revenues of approximately $23.7 million in connection with product sales of TYMLOS and paid ABC and its affiliates approximately $2.0 million for services under various commercial and services agreements. In addition, no accounts receivable were recorded within the Company’s consolidated balance sheets as of September 30, 2020.
12. Income Taxes
The Company did not record a federal or state income tax provision or benefit for each of the nine months ended September 30, 2020 and 2019 due to the expected loss before income taxes to be incurred for the years ended December 31, 2020 and 2019, as well as the Company’s continued maintenance of a full valuation allowance against its net deferred tax assets.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Cautionary Statement
This Quarterly Report on Form 10-Q, including in the sections titled “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and including the information incorporated by reference herein, contains, in addition to historical information, forward-looking statements. We may, in some cases, use words such as “project,” “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “continue,” “should,” “would,” “could,” “potentially,” “will,” “may” or similar words and expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements in this Quarterly Report on Form 10-Q may include, among other things, statements about: 
our expectations regarding commercialization of TYMLOS in the U.S., including our market access coverage expectations, and our ability to successfully commercialize TYMLOS in the U.S.;
the therapeutic benefits and effectiveness of TYMLOS and our investigational product candidates and the potential indications and market opportunities therefor;
our ability to obtain U.S. and foreign regulatory approval for our investigational product candidates, including supplemental regulatory approvals for TYMLOS, and the timing thereof;
our ability to compete with other companies that are or may be developing or selling products that are competitive with TYMLOS or our investigational product candidates;
anticipated trends and challenges in the U.S. and other markets in which TYMLOS may compete and in other potential markets in which we may compete;
the direct and indirect impact of the COVID-19 pandemic on our business and operations, including sales, expenses, supply chain, manufacturing, research and development costs, clinical trials and employees;
the impact of the COVID-19 pandemic and related downturn of the U.S. and global economies;
our plans with respect to collaborations and licenses related to the development, manufacture or sale of TYMLOS and our investigational product candidates, including our out-license of elacestrant and our sale of RAD140;
our expectations and the performance of RAD140 following the sale to Ellipses Pharma, including the percentage of sales that we may be entitled to;
the performance and experience of our licensee, Berlin-Chemie AG, a company of the Menarini Group, to successfully develop and, if approved, commercialize elacestrant worldwide under the terms and conditions of our license agreement;
our plans with respect to expanding our product portfolio;
our expectations regarding the timing of our regulatory submissions;
our expectations for our Phase 3 studies of abaloparatide-SC for men, and abaloparatide transdermal patch (abaloparatide-patch) or our other clinical trials, as well as the Phase 3 study of elacestrant, including projected costs, study designs or the timing for initiation, recruitment, completion, or reporting top-line data;
the progress of, timing of and amount of expenses associated with our research, development and commercialization activities;
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the safety profile and related adverse events of TYMLOS and our investigational product candidates;
the ability of our investigational product candidates to meet existing or future regulatory standards;
our expectations regarding federal, state and foreign regulatory requirements;
the success of our clinical studies for our investigational product candidates;
our expectations as to future financial performance, expense levels, future payment obligations and liquidity sources;
our ability to attract, motivate, and retain key personnel; and
other factors discussed elsewhere in this Quarterly Report on Form 10-Q.
The outcome of the events described in these forward-looking statements is subject to known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from the results anticipated by these forward-looking statements. These important factors include our financial performance, the uncertainties inherent in the early stages of commercializing any new pharmaceutical product or the initiation, execution and completion of clinical trials, uncertainties surrounding the timing of availability of data from our clinical trials, ongoing discussions with and actions by regulatory authorities, our ability to attract and retain customers, our development activities and those other factors we discuss under the caption “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q and in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019 and in “Item 1A. Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. You should read these factors and the other cautionary statements made in this Quarterly Report on Form 10-Q as being applicable to all related forward-looking statements wherever they appear in this Quarterly Report on Form 10-Q. These important factors are not exhaustive and other sections of this Quarterly Report on Form 10-Q may include additional factors which could adversely impact our business and financial performance.
You should read the following discussion of our financial condition and results of operations in conjunction with our financial statements and related notes set forth in this report. Unless the context otherwise requires, “we,” “our,” “us,” “Radius,” “Company,” and similar expressions used in this Management’s Discussion and Analysis of Financial Condition and Results of Operations section refer to Radius Health, Inc. and our consolidated entities.
Executive Overview
We are a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics.
In April 2017, our first commercial product, TYMLOS (abaloparatide) injection, was approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In May 2017, we commenced U.S. commercial sales of TYMLOS and as of October 1, 2020, TYMLOS was available and covered for approximately 279 million U.S. insured lives, representing approximately 99% of U.S. commercial and 83% of Medicare Part D insured lives. In July 2017, we entered into a license and development agreement with Teijin Limited (“Teijin”) for abaloparatide for subcutaneous injection (“abaloparatide-SC”) in Japan. Under this agreement, we received an upfront payment and are entitled to receive milestone payments upon the achievement of certain regulatory and sales milestones, and a fixed low double-digit royalty based on net sales of abaloparatide-SC in Japan during the royalty term. In March 2018, we initiated our Phase 3 ATOM study of abaloparatide-SC in men with osteoporosis which, if successful, will form the basis of a supplemental New Drug Application (“NDA”) seeking to expand the use of TYMLOS to treat men with osteoporosis at high risk for fracture. We completed patient enrollment in September 2020 and expect to report top-line data from the study in the second half of 2021. In October 2018, the FDA approved a labeling supplement for TYMLOS in connection with the results from our ACTIVExtend trial to reflect that after 24 months of open-label alendronate therapy, the vertebral fracture risk reduction achieved with TYMLOS therapy was maintained. In January 2019, the European Commission adopted a decision refusing approval of our European Marketing Authorization Application (“MAA”) for abaloparatide-SC. In May 2020, we announced that our bone histomorphometry study, which evaluated the early effects of TYMLOS on tissue-based indices of bone formation and resorption in postmenopausal women, met its primary endpoint of change from baseline to three months in mineralizing surface in the cancellous bone envelope (one of the dynamic indicators of bone formation). Data from this study was presented in September 2020. On July 30, 2020 the United States Patent Office extended the term of US patent 7,803,770 (Method of Treating Osteoporosis Comprising Administration of PTHRP Analog) 1,303 days to April 28, 2031. US Patent 7,803,770 is listed in the FDA Orange book and covers TYMLOS.
We are developing an abaloparatide transdermal patch (“abaloparatide-patch”), for potential use in the treatment of postmenopausal women with osteoporosis. In May 2019, we received a special protocol assessment agreement from the FDA for our Phase 3 study of abaloparatide-patch. We initiated our Phase 3 wearABLe study of abaloparatide-patch in August 2019 and completed enrollment in September 2020. The wearABLe study is a single, pivotal, randomized, open label, active-controlled, bone mineral density (“BMD”) non-inferiority bridging study with an enrollment of approximately 500 patients with postmenopausal osteoporosis at high risk of fracture, which if successful, will support an NDA submission. The primary endpoint of the study is percentage change in lumbar spine BMD at 12 months. Non-inferiority of abaloparatide-patch to abaloparatide-SC will be concluded if the lower bound of the 2-sided 95% confidence interval for the estimated treatment
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difference (abaloparatide-patch minus abaloparatide-SC) in the percentage change from baseline in lumbar spine BMD at 12 months is above -2.0%. In February 2018, we entered into a Scale-Up and Commercial Supply Agreement with 3M Company (“3M”) pursuant to which 3M agreed to exclusively manufacture Phase 3 and global commercial supplies of abaloparatide-patch. In May 2020, 3M announced that it completed its sale of its drug delivery business, which manufactures clinical trial supplies of abaloparatide-patch, to Kindeva Drug Delivery (“Kindeva”), an affiliate of Altaris Capital Partners, LLC (“Altaris”). In partnership with 3M, we selected Patheon N.V., now known as Thermo Fisher Scientific (“Thermo Fisher”), to conduct the abaloparatide-patch coating process and packaging operations. We have successfully completed development activities associated with the scale up of manufacturing to supply our ongoing abaloparatide-patch Phase 3 wearABLe study. In October 2018, we committed to fund 3M’s purchase of capital equipment totaling approximately $9.6 million in preparation for manufacturing Phase 3 and potential commercial supplies of abaloparatide-patch. Milestone payments for the equipment commenced in the fourth quarter of 2018 and are expected to be paid in full in the second quarter of 2021. In addition, there are cancellable purchase commitments in place to fund the facility build out and future purchases of capital equipment. In December 2019, we aligned with the FDA on requirements for NDA filing. In preparation for potential FDA approval of the abaloparatide-patch, our commercial manufacturing facility build out is complete, and equipment is on site to manufacture sterile drug product at our partner’s commercial manufacturing site.
In connection with our strategic plan to focus on bone health and targeted endocrine diseases, we entered into a license agreement with Berlin-Chemie AG, a company of the Menarini Group (“Berlin-Chemie”), on July 23, 2020 under which we granted Berlin-Chemie an exclusive license to develop and commercialize products containing elacestrant (RAD1901), a selective estrogen receptor degrader (“SERD”), worldwide. Elacestrant is being developed for potential use in the treatment of hormone receptor-positive breast cancer. We simultaneously entered into a transition services agreement (the “TSA”) with Berlin-Chemie, pursuant to which we will perform certain services for Berlin-Chemie related to the EMERALD Phase 3 monotherapy study of elacestrant, which we initiated in late November 2018, until the earlier of the completion of the contemplated services or the filing with the FDA of an NDA for elacestrant. Pursuant to the terms of the Berlin-Chemie Agreement, Berlin-Chemie is required to make an initial license fee payment to us of $30.0 million.
Pursuant to the TSA, we remain responsible for conducting the EMERALD Phase 3 monotherapy study of elacestrant. Target enrollment was reached in September 2020. The Phase 3 study is a single, randomized, open label, active-controlled Phase 3 trial of elacestrant as a second or third-line monotherapy in 478 patients with estrogen receptor-positive (“ER+”) and human epidermal growth factor receptor 2-negative (“HER2-”) advanced or metastatic breast cancer who have received prior treatment with one or two endocrine therapies, including a cyclin-dependent kinase (“CDK”) 4/6 inhibitor. Patients in the study will be randomized to receive either elacestrant or the investigator’s choice of an approved hormonal agent. The primary endpoint of the study will be progression-free survival (“PFS”), which we will analyze in the overall patient population and in patients with estrogen receptor 1 gene (“ESR1”) mutations. Secondary endpoints will include evaluation of overall survival (“OS”), objective response rate (“ORR”), and duration of response (“DOR”). We believe that, depending on results, this single trial could support applications for marketing approvals for elacestrant as a second- and third-line monotherapy in the U.S., European Union (“EU”), and other markets. In November 2018, the FDA granted Fast Track Designation for elacestrant for the population included in the Phase 3 study.
Completing the divestment of our oncology program, in September 2020 we sold RAD140, our internally discovered non-steroidal selective androgen receptor modulator (“SARM”) to Ellipses Pharma. Pursuant to the Asset Purchase Agreement (“APA”), Ellipses Pharma will be responsible for the clinical development and commercialization of the asset. We will be entitled to receive royalties under the APA.
Abaloparatide
In April 2017, the FDA approved TYMLOS (abaloparatide-SC) for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. We are developing two formulations of abaloparatide: abaloparatide-SC and abaloparatide-patch.
Abaloparatide-SC
TYMLOS was approved in the United States in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The first commercial sales of TYMLOS in the United States occurred in May 2017 and as of October 1, 2020, TYMLOS was available and covered for approximately 279 million U.S. insured lives, representing approximately 99% of U.S. commercial and 83% of Medicare Part D insured lives.
We are commercializing TYMLOS in the United States through our commercial organization. In the first quarter of 2020, we executed a transition of our external distribution model from full-line wholesalers to specialty distributors and specialty
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pharmacies. Under this distribution model, both the specialty distributors and specialty pharmacies take physical delivery of TYMLOS and pharmacies dispense TYMLOS directly to patients.
We hold worldwide commercialization rights to abaloparatide-SC, except for Japan, where we are entitled to receive milestones and royalties based on the development and commercialization of abaloparatide-SC in Japan under our license and development agreement with Teijin. In January 2019, the European Commission adopted a decision refusing approval of our MAA for abaloparatide-SC.
In July 2017, we entered into a license and development agreement with Teijin for abaloparatide-SC in Japan. Pursuant to the agreement, we received an upfront payment and may receive additional milestone payments upon the achievement of certain regulatory and sales milestones, and a fixed low double-digit royalty based on net sales of abaloparatide-SC in Japan during the royalty term. In February 2020, we elected not to exercise our option to negotiate for a co-promotion agreement with Teijin for abaloparatide-SC in Japan. In May 2020, we announced that Teijin submitted an NDA for abaloparatide-SC in Japan for the treatment of osteoporosis in patients who are at high risk for fracture. The application is based on the positive results of the Phase 3 clinical trial of abaloparatide-SC in Japan in women and men with osteoporosis, which achieved its primary efficacy endpoint.
In March 2018, we initiated a clinical trial in men with osteoporosis which, if successful, will form the basis of a supplemental NDA seeking to expand the use of TYMLOS to increase bone mass in men with osteoporosis at high risk for fracture. We completed patient enrollment in September 2020 and expect to report top-line data from the study in the second half of 2021. The study is a randomized, double-blind, placebo-controlled trial that has enrolled 228 men with osteoporosis. The primary endpoint is change in lumbar spine BMD at 12 months compared with placebo. In previous clinical trials, TYMLOS has demonstrated increases in BMD in postmenopausal women. The study includes specialized high-resolution imaging to examine the effect of abaloparatide on bone structure, such as the hip, in a subset of the study participants.
In June 2018, the FDA approved a labeling supplement for TYMLOS to revise the needle length in the Instructions for Use from 8 mm to 5 mm. We believe health care providers, specialty pharmacies, and patients may prefer a shorter needle size for injectable products like TYMLOS.
In October 2018, the FDA approved a labeling supplement for TYMLOS to reflect that after 24 months of open-label alendronate therapy, the vertebral fracture risk reduction achieved with TYMLOS therapy was maintained.
In May 2020, we announced that our bone histomorphometry study, which evaluated the early effects of TYMLOS on tissue-based indices of formation in postmenopausal women, met its primary endpoint of change from baseline to 3 months in mineralizing surface in the cancellous bone envelope (one of the dynamic indicators of bone formation). We presented data from this study in September 2020.
On July 30, 2020 the United States Patent Office extended the term of US patent 7,803,770 (Method of Treating Osteoporosis Comprising Administration of PTHRP Analog) 1,303 days to April 28, 2031. US Patent 7,803,770 is listed in the FDA Orange book and covers TYMLOS.
Abaloparatide-patch
We are also developing abaloparatide-patch, based on 3M’s patented Microstructured Transdermal System technology, for potential use as a short wear-time transdermal patch. We hold worldwide commercialization rights to the abaloparatide-patch technology and are developing abaloparatide-patch toward future global regulatory submissions to build upon the potential success of TYMLOS. Our development strategy for abaloparatide-patch is to bridge to the established efficacy and safety of our approved abaloparatide-SC formulation.
We commenced a human replicative clinical evaluation of the optimized abaloparatide-patch in December 2015, with the goal of achieving comparability to abaloparatide-SC. In September 2016, we presented results from this evaluation of the first and second abaloparatide-patch prototypes, demonstrating that formulation technology can modify the pharmacokinetic profile of abaloparatide, including Tmax, half-life (“T1/2”), and area under the curve (“AUC”). In March 2018, we announced that through further optimization we had achieved comparability to the abaloparatide-SC profile with a third prototype (the “current abaloparatide-patch”). The current abaloparatide-patch optimized the drug-device combination through process improvements, a finalized formulation, selection of a dose (300 µg), and the introduction of a new clinical applicator, which were designed to improve the ease of use and patient experience. In the second half of 2018, we completed further evaluation confirming that a five minute application of the current abaloparatide-patch to the thigh resulted in a pharmacokinetic exposure highly similar (AUC >90%) to abaloparatide-SC.
In May 2019, we received a special protocol assessment (“SPA”) agreement from the FDA for our Phase 3 study of abaloparatide-patch, which means the FDA considers the study design to be adequate and well-controlled to support marketing approval provided the study endpoints are achieved. We initiated our Phase 3 wearABLe study of abaloparatide-patch in
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August 2019 and completed enrollment in September 2020. We expect to report top-line data from the study in the second half of 2021. The wearABLe study is a single, pivotal, randomized, open label, active-controlled, BMD non-inferiority bridging study with an enrollment of approximately 500 patients with postmenopausal osteoporosis at high risk of fracture, which if successful, will support an NDA submission. The primary endpoint of the study is percentage change in lumbar spine BMD at 12 months. Non-inferiority of abaloparatide-patch to abaloparatide-SC will be concluded if the lower bound of the 2-sided 95% confidence interval for the estimated treatment difference (abaloparatide-patch minus abaloparatide-SC) in the percentage change from baseline in lumbar spine BMD at 12 months is above -2.0%.
In July 2019, we obtained preliminary results from a patient assessment study which evaluated self-administration of abaloparatide-patch over 29 days in 22 post-menopausal women with low bone density. Study patients were observed at a study site on the first, 15th and 29th day of the study. Top-line results showed that study patients were able to follow the instructions for use (“IFU”) and applied the patches accurately on 99.7% of all applications. The safety data from this study showed that most of the study patients had mild, transient redness at the application site. The mean subject acceptability score on a 5-point scale was 4.5, 4.6 and 4.5 on day 1, 15 and 29, respectively. The laboratory data from this study included an exploratory assessment of PINP, a biomarker that indicates bone formation. At baseline the median PINP level in this study was 50.5 ng/ml, increasing to a median value of 100.1 ng/ml at day 29, while, by comparison, the median PINP values observed with abaloparatide-SC in the ACTIVE study were 50.6 ng/ml at baseline and 100.5 ng/ml at one month.
In February 2018, we entered into the Scale-Up and Commercial Supply Agreement pursuant to which 3M agreed to exclusively manufacture Phase 3 and global commercial supplies of abaloparatide-patch. In partnership with 3M, we selected Thermo Fisher to conduct the abaloparatide-patch coating process and packaging operations. In May 2020, 3M announced that it completed its sale of its drug delivery business, which manufactures clinical trial supplies of abaloparatide-patch, to Kindeva, an affiliate of Altaris. As part of the transaction, 3M retained a minority interest in Kindeva and our Scale-Up and Commercial Supply Agreement with 3M was transferred to Kindeva.
In October 2018, we committed to fund 3M’s purchase of capital equipment totaling approximately $9.6 million in preparation for manufacturing Phase 3 and potential commercial supplies of abaloparatide-patch. Milestone payments for the equipment commenced in the fourth quarter of 2018 and are expected to be paid in full in the second quarter of 2021. In addition, there are cancellable purchase commitments in place to fund the facility build out and future purchases of capital equipment.
In December 2019, we aligned with the FDA on requirements for NDA filing. In preparation for potential FDA approval of the abaloparatide-patch, our commercial manufacturing facility build out is complete, and equipment is on site to manufacture sterile drug product at our partner’s commercial manufacturing site.
Elacestrant (RAD1901)

In July 2020, we entered into a license agreement with Berlin-Chemie under which we granted Berlin-Chemie an exclusive license to develop and commercialize products containing elacestrant (RAD1901), a selective estrogen receptor degrader (“SERD”), worldwide. We simultaneously entered into the TSA with Berlin-Chemie, pursuant to which we will perform certain services for Berlin-Chemie related to the EMERALD Phase 3 monotherapy study of elacestrant, which we initiated in late November 2018, until the earlier of the completion of the contemplated services or the filing with the FDA of an NDA for elacestrant. Elacestrant is being evaluated for potential use as a once daily oral treatment for advanced ER-positive and HER2-negative breast cancer, the most common subtype of the disease. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer.
Phase 3 - EMERALD Study
Pursuant to the TSA, we remain responsible for conducting the EMERALD Phase 3 monotherapy study of elacestrant, which we initiated in late November 2018. Target enrollment was reached in September 2020. The Phase 3 study is a single, randomized, open label, active-controlled Phase 3 trial of elacestrant as a second- or third-line monotherapy in 478 patients with ER+ and HER2- advanced or metastatic breast cancer who have received prior treatment with one or two endocrine therapies, including a CDK 4/6 inhibitor. Patients in the study are randomized to receive either elacestrant or the investigator’s choice of an approved hormonal agent. The primary endpoint of the study is PFS, which we will analyze in the overall patient population and in patients with ESR1 mutations. Secondary endpoints include evaluation of OS, ORR, and DOR. We believe that, depending on results, this single trial could support applications for marketing approvals for elacestrant as a second- and third-line monotherapy in the U.S., EU and other markets. In November 2018, the FDA granted Fast Track designation for elacestrant consistent with the population to be included in the Phase 3 study.
Phase 1 - Dose-Escalation and Expansion Study
In December 2014, we commenced a Phase 1, multiple-part study of elacestrant in postmenopausal women with ER-positive and HER2-negative advanced breast cancer to determine the recommended Phase 2 dose (RP2D) and to make a preliminary
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evaluation of the potential anti-tumor effect of elacestrant. The patients enrolled in this study were heavily pretreated ER-positive, HER2-negative advanced breast cancer patients, and about 50% had ESR1 mutations. Following dose escalation, the RP2D was determined to be 400mg once daily.
In December 2019, we reported final data from this Phase 1 study, which included mature data from 50 patients treated at the 400 mg dose in Parts A through D of this study. In cohorts A through C, patients had to have received prior endocrine therapy but there were no other specifications on the number of lines or type of endocrine therapy. In these cohorts, the elacestrant single agent ORR was 27.3% with six confirmed partial responses in 22 patients with response evaluation criteria in solid tumors (“RECIST”) measurable disease. The median PFS was 5.4 months and clinical benefit rate at 24 weeks was 47.4%. These results showed that elacestrant was well-tolerated with the most commonly reported adverse events being low grade nausea, dyspepsia and vomiting.
We initiated Part D of the Phase 1 dose-escalation and expansion study to evaluate the safety and preliminary efficacy of elacestrant at a 400 mg tablet dose in a population with different eligibility requirements from Parts A, B, and C of this study. In Part D, patients were required to have at least two prior lines of endocrine therapy for advanced/metastatic breast cancer, including fulvestrant, and prior treatment with a CDK 4/6 inhibitor. Ten patients of an originally planned thirty-six were enrolled in Part D. Overall the patients in Part D were more heavily pretreated and more likely to have visceral metastases than patients in Parts A through C of this study. In the nine patients with measurable disease, four had a best response of stable disease, two of them for greater than 24 weeks. Combined data, as of October 24, 2019, from all four study Parts (A through D) at 400 mg showed that the overall elacestrant single agent ORR was 19.4% and the median PFS was 4.5 months.
Phase 1 - FES-PET Study
In December 2015, we commenced a Phase 1 18-F fluoroestradiol positron emission tomography (“FES-PET”) study in patients with metastatic breast cancer in the European Union, which included the use of FES-PET imaging to assess estrogen receptor occupancy in tumor lesions following elacestrant treatment.
In December 2017, we reported data from the Phase 1 FES-PET study showing that elacestrant demonstrated robust reduction in tumor ER availability in patients with advanced ER+ breast cancer who progressed on prior endocrine therapy. Seven out of eight patients dosed in the 400-mg cohort, and four out of seven patients dosed in the 200-mg cohort, had a tumor FES-PET signal intensity reduction equal to, or greater than, 75% at day 14 compared to baseline. The reduction in FES uptake supports flexibility for both 200-mg and 400-mg elacestrant dose selection for further clinical development in combination studies with various targeted agents and was similar in patients harboring mutant or wild-type ESR-1. The most commonly reported adverse events were grade 1 and 2 nausea and dyspepsia.
RAD140
RAD140 is an internally discovered SARM. The androgen receptor, or AR, is highly expressed in many ER-positive, ER-negative, and triple-negative receptor breast cancers. Due to its receptor and tissue selectivity, potent activity, oral bioavailability, and long half-life, we believe RAD140 could have clinical potential in the treatment of breast cancer.
Completing the divestment of our oncology program, in September 2020 we sold RAD140, our internally discovered SARM to Ellipses Pharma. Pursuant to the APA Ellipses Pharma will be responsible for the clinical development and commercialization of the asset. Radius will be entitled to receive royalties under the APA.
Financial Overview
Product Revenue
Product revenue is derived from our sales of our commercial product, TYMLOS, in the United States.
Cost of Product Revenue
Cost of product revenue consist primarily of costs associated with the manufacturing of TYMLOS, royalties owed to our licensor for such sales, and certain period costs.
Research and Development Expenses
Research and development expenses consist primarily of clinical trial costs made to contract research organizations (“CROs”), salaries and related personnel costs, fees paid to consultants and outside service providers for regulatory and quality assurance support, licensing of drug compounds and other expenses relating to the manufacture, development, testing and enhancement of our product candidates. We expense our research and development costs as they are incurred.
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None of the research and development expenses, in relation to our investigational product candidates, are currently borne by third parties, with the exception of elacestrant (RAD1901). Abaloparatide represents the largest portion of our research and development expenses for our investigational product candidates since our inception. We began tracking program expenses for TYMLOS (abaloparatide-SC) in 2005, and program expenses from inception to September 30, 2020 were approximately $237.0 million. We began tracking program expenses for abaloparatide-patch in 2007, and program expenses from inception to September 30, 2020 were approximately $131.5 million. We began tracking program expenses for elacestrant (RAD1901) in 2006, and program expenses from inception to September 30, 2020 were approximately $152.8 million. We began tracking program expenses for RAD140 in 2008, and program expenses from inception to September 30, 2020 were approximately $18.2 million. These expenses relate primarily to external costs associated with manufacturing, preclinical studies and clinical trial costs.
Costs related to facilities, depreciation, stock-based compensation, and research and development support services are not directly charged to programs as they benefit multiple research programs that share resources.
The following table sets forth our research and development expenses that are directly attributable to the programs listed below for the three and nine months ended September 30, 2020 and 2019 (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
 
2020201920202019
Program-specific costs - external:
Abaloparatide-SC
$1,885 $1,948 $6,530 $6,027 
Abaloparatide-patch
18,709 7,170 53,071 16,533 
Elacestrant (RAD1901)
21,858 8,670 40,117 18,218 
RAD140
477 564 985 2,005 
Total program-specific costs - external
$42,929 $18,352 $100,703 $42,783 
Shared-services costs - external:
R&D support costs
3,038 3,527 9,947 9,658 
Other operating costs
152 506 543 1,686 
Total shared-services costs - external
$3,190 $4,033 $10,490 $11,344 
Shared-services costs - internal
Personnel-related costs
6,544 6,834 21,022 20,266 
Stock-based compensation
1,753 1,613 5,228 5,678 
Occupancy costs
197 754 745 1,501 
Depreciation expense
220 205 534 658 
Total shared-services costs - internal
$8,714 $9,406 $27,529 $28,103 
Total research and development costs
$54,833 $31,791 $138,722 $82,230 
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist primarily of salaries and related expenses for commercial operations, executive, finance and other administrative personnel, professional fees, business insurance, rent, general legal activities, including the cost of maintaining our intellectual property portfolio, and other corporate expenses.
Our results also include stock-based compensation expense as a result of the issuance of stock option, restricted stock unit, and performance unit grants to our employees, directors and consultants. The stock-based compensation expense is included in the respective categories of expense in our condensed consolidated statements of operations and comprehensive loss (i.e., research and development or general and administrative expenses). We expect to record additional non-cash compensation expense in the future, which may be significant.
Interest Income
Interest income reflects interest earned on our cash, cash equivalents and marketable securities.
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Interest Expense
Interest expense consists of interest expense related to the aggregate $305.0 million principal amount of Convertible Notes the Company issued in a registered underwritten public offering on August 14, 2017 and interest expense related to the aggregate $55.0 million term loan entered into on January 10, 2020 pursuant to the Credit and Security Agreement, as amended, with MidCap Financial Trust, in its capacity as administrative agent and as a lender, and the financial institutions or other entities from time to time parties thereto (the “Term Loan”). A portion of the interest expense on the Convertible Notes is non-cash expense relating to accretion of the debt discount and amortization of issuance costs.
Critical Accounting Policies and Estimates
Our management’s discussion and analysis of financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”), and generally accepted accounting principles in the United States (“U.S. GAAP”). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses, as well as related disclosures. We evaluate our policies and estimates on an ongoing basis, including those related to revenue recognition, accrued clinical expenses, research and development expenses, stock-based compensation and fair value measures, among others, which we discussed in our Annual Report on Form 10-K for the year ended December 31, 2019. We base our estimates on historical experience and various other assumptions that we believe are reasonable under the circumstances. Our actual results may differ from these estimates under different assumptions or conditions.
We have reviewed our policies and estimates to determine our critical accounting policies for the three and nine months ended September 30, 2020. There were no changes to significant accounting policies during the nine months ended September 30, 2020, except for the adoption of certain ASUs issued by the FASB, as disclosed above within Note 2, “Basis of Presentation and Significant Accounting Policies,” in the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.
Results of Operations
Three Months Ended September 30, 2020 and 2019 (in thousands, except percentages)
 Three Months Ended  
 September 30,Change
 20202019$%
Revenues:
Product revenue, net$50,412 $46,766 $3,646 %
License revenue27,414 — 27,414 100 %
Total revenue77,826 46,766 31,060 66 %
Operating expenses:
Cost of sales - product3,839 3,971 (132)(3)%
Cost of sales - intangible amortization200 200 — — 
Research and development, net of amounts reimbursable39,450 31,791 7,659 24 %
Selling, general and administrative33,692 35,617 (1,925)(5)%
Income (Loss) from operations645 (24,813)25,458 103 %
Other (expense) income:    
Other expense, net(87)59 (146)(247)%
Interest expense(7,069)(6,298)(771)(12)%
Interest income222 1,008 (786)(78)%
Net loss$(6,289)$(30,044)$23,755 79 %

Product revenue— We began U.S. commercial sales of TYMLOS in May 2017, following receipt of FDA marketing approval on April 28, 2017. For the three months ended September 30, 2020 we recorded approximately $50.4 million of net product revenue compared to $46.8 million for the three months ended September 30, 2019. The increase in product revenue was primarily driven by an increase in sales volume as a result of greater market penetration, increased pricing, and a decrease in revenue reserves. Although the potential impact of the COVID-19 pandemic on our product revenue is unclear, we expect net sales of TYMLOS to be negatively impacted by the COVID-19 pandemic into the remainder of 2020, depending on its duration.
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License revenue— We entered into the License Agreement with Berlin-Chemie on July 23, 2020. For the three months ended September 30, 2020, we recorded $27.4 million of license revenue in connection with this agreement.
Cost of sales Cost of sales was $4.0 million for the three months ended September 30, 2020 compared to $4.2 million for the three months ended September 30, 2019. The decrease in cost of sales was driven by the decrease in downstream service fees. Although the potential impact of the COVID-19 pandemic on our cost of sales is unclear, we expect cost of sales to fluctuate in a manner consistent with net sales of TYMLOS during the duration of the COVID-19 pandemic.
Research and development expenses— For the three months ended September 30, 2020, research and development expense was $39.5 million compared to $31.8 million for the three months ended September 30, 2019, an increase of $7.7 million, or 24%. This increase was primarily driven by a $11.5 million increase in abaloparatide-patch program costs. This increase was offset by a decrease of $0.1 million in RAD140 program cost, a decrease of $0.1 million in Abaloparatide-SC program cost, a $0.5 million decrease in occupancy and depreciation, a $0.3 million decrease in travel and entertainment expense, a $0.5 million decrease in professional fees, a $0.2 million decrease in compensation expense, and a $2.2 million decrease in elacestrant program costs, which is comprised of a $13.2 million increase in gross program expenses offset by $15.4 million of billed reimbursable expenses. We will be reimbursed for the costs incurred in connection with the elacestrant project pursuant to the terms of the TSA with Berlin-Chemie, under which the Company will perform certain services for Berlin-Chemie related to the EMERALD Phase 3 monotherapy study until the earlier of the completion of the contemplated services or the filing with the FDA of a NDA for elacestrant.
Selling, general and administrative expenses— For the three months ended September 30, 2020, selling, general and administrative expenses were $33.7 million compared to $35.6 million for the three months ended September 30, 2019, a decrease of $1.9 million, or 5%. This decrease was primarily the result of a $0.8 million decrease in travel and entertainment expenses, a $2.3 million decrease in professional support costs, a $0.5 million decrease in compensation cost, and a $0.1 million decrease in other operating costs. These decreases were partially offset by a $1.8 million increase in occupancy and depreciation costs.
Other expense, net— For the three months ended September 30, 2020, other expense, net of other income, was $87.0 thousand, as compared to other expense, net of other income of $59.0 thousand during the three months ended September 30, 2019. Other expense, net of other income, of $87.0 thousand for the three months ended September 30, 2020 consisted primarily of other taxes and foreign currency revaluation exchange losses. The $59.0 thousand of other expense, net of other income, for the three months ended September 30, 2019 was primarily due to other taxes.
Interest income—For the three months ended September 30, 2020, interest income was approximately $0.2 million compared to $1.0 million for the three months ended September 30, 2019, a decrease of $0.8 million, or 78%. This decrease was primarily due to the decrease in the balance of our investments as a result of investment maturities used to fund operations.
Interest expense—For the three months ended September 30, 2020, interest expense was approximately $7.1 million compared to $6.3 million for the three months ended September 30, 2019, an increase of $0.8 million, or 12%. This increase was the result of continued amortization on the Convertible Notes, as well as addition of the Term Loan and interest expense thereon during the three months ended September 30, 2020.
Results of Operations
Nine Months Ended September 30, 2020 and 2019 (in thousands, except percentages)
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 Nine Months Ended  
 September 30,Change
 20202019$%
Revenues:
Product revenue, net$148,448 $117,652 $30,796 26 %
License revenue27,414 — 27,414 100 %
Total revenue175,862 117,652 58,210 49 %
Operating expenses:    
Cost of sales - product11,771 10,809 962 %
Cost of sales - intangible amortization599 599 — — 
Research and development, net of amounts reimbursable123,340 82,230 41,110 50 %
Selling, general and administrative108,356 116,918 (8,562)(7)%
Loss from operations(68,204)(92,904)24,700 27 %
Other (expense) income:   
Other expense, net(144)21 (165)(786)%
Interest expense(20,747)(18,500)(2,247)(12)%
Interest income1,272 3,105 (1,833)(59)%
Net loss$(87,823)$(108,278)$20,455 19 %

Product revenue— We began U.S. commercial sales of TYMLOS in May 2017, following receipt of FDA marketing approval on April 28, 2017. For the nine months ended September 30, 2020 we recorded approximately $148.4 million of net product revenue compared to $117.7 million for the nine months ended September 30, 2019. The increase in product revenue was driven by an increase in sales volume and increased pricing. Although the potential impact of the COVID-19 pandemic on our product revenue is unclear, we expect net sales of TYMLOS to be negatively impacted by the COVID-19 pandemic into the remainder of 2020, depending on its duration.
License revenue— We have entered into the License Agreement with Berlin-Chemie on July 23, 2020. For the nine months ended September 30, 2020 we recorded approximately $27.4 million in connection with this agreement.
Cost of sales— For the nine months ended September 30, 2020, cost of sales was $12.4 million compared to $11.4 million for the nine months ended September 30, 2019. The increase in cost of sales was driven by the increase in product revenue. Although the potential impact of the COVID-19 pandemic on our cost of sales is unclear, we expect cost of sales to fluctuate in a manner consistent with net sales of TYMLOS during the duration of the COVID-19 pandemic.
Research and development expenses— For the nine months ended September 30, 2020, research and development expense was $123.3 million compared to $82.2 million for the nine months ended September 30, 2019, an increase of $41.1 million, or 50%. This increase was primarily driven by a $36.5 million increase in abaloparatide-patch project costs, a $6.4 million increase in project costs for elacestrant, a $0.5 million increase in abaloparatide-SC project costs, a $0.3 million increase in professional fees services, and a $0.3 million increase in compensation expenses. These increases were partially offset by a $1.0 million decrease in RAD140 project costs, a $0.9 million decrease in occupancy and depreciation costs, and a $1.0 million decrease in travel and entertainment expenses. We will be reimbursed for the costs incurred in connection with the elacestrant project pursuant to the terms of the TSA with Berlin-Chemie, under which the Company will perform certain services for Berlin-Chemie related to the EMERALD Phase 3 monotherapy study until the earlier of the completion of the contemplated services or the filing with the FDA of a NDA for elacestrant.
Selling, general and administrative expenses— For the nine months ended September 30, 2020, selling, general and administrative expenses were $108.4 million compared to $116.9 million for the nine months ended September 30, 2019, a decrease of $8.6 million, or 7%. This decrease was primarily the result of a $6.3 million decrease in professional fees, a $3.3 million decrease in travel and entertainment expenses and a $0.3 million decrease in other operating expenses. These decreases were offset by a $0.3 million increase in compensation related expenses and an $1.0 million increase in occupancy and depreciation.
Other expense, net— For the nine months ended September 30, 2020, other expense, net of other income, was $144.0 thousand as compared to other expense, net of income, of $21.0 thousand during the nine months ended September 30, 2019. Other expense, net of other income, of $144.0 thousand for the nine months ended September 30, 2020 consisted primarily of
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other tax expenses. The other expense, net of other income, of $21.0 thousand for the nine months ended September 30, 2019 was primarily due to other taxes and foreign currency revaluation losses.
Interest income—For the nine months ended September 30, 2020, interest income was approximately $1.3 million compared to $3.1 million for the nine months ended September 30, 2019, a decrease of $1.8 million, or 59%. This decrease was primarily due to the decrease in the balance of our investments as a result of investment maturities in the nine months ended September 30, 2020.
Interest expense—For the nine months ended September 30, 2020, interest expense was approximately $20.7 million compared to $18.5 million for the nine months ended September 30, 2019, an increase of $2.2 million or 12%. This increase was the result of continued amortization on our Convertible Notes as well as the addition of the Term Loan and interest expense during the nine months ended September 30, 2020 as compared to the nine months ended September 30, 2019.
Liquidity and Capital Resources
From inception to September 30, 2020, we have incurred an accumulated deficit of $1,324.4 million, primarily as a result of expenses incurred through a combination of research and development activities related to our various product candidates and expenses supporting those activities. Our total cash, cash equivalents, marketable securities, and investments balance as of September 30, 2020 was $125.7 million, which included an initial license fee payment of $30.0 million from Berlin-Chemie. We have financed our operations since inception primarily through the public offerings of our common stock, issuance of convertible debt, private sales of preferred stock, and borrowings under credit facilities. Following our U.S. commercial launch of TYMLOS in May 2017, we have begun financing a portion of our operations through product revenue.

Based upon our cash, cash equivalents, marketable securities, and investments balance as of September 30, 2020, we believe that, prior to the consideration of potential proceeds from partnering and/or collaboration activities, including the license agreement with Berlin-Chemie, we have sufficient capital as well as access to other capital discussed in Note 7, “Term Loan and Credit Facility” to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, to fund our development plans, U.S. commercial and other operational activities for at least one year from the date of this filing. We expect to finance the future U.S. commercial activities and development costs of our clinical product portfolio with our existing cash, cash equivalents, marketable securities, and investments, as well as through future product sales, or through strategic financing opportunities, that could include, but are not limited to partnering or other collaboration agreements, future offerings of equity, royalty-based financing arrangements, the incurrence of additional debt, or other alternative financing arrangements, which may involve a combination of the foregoing. 
There is no guarantee that any of these strategic or financing opportunities will be executed or executed on favorable terms, and some could be dilutive to existing stockholders. Market volatility resulting from the COVID-19 pandemic or other factors could also adversely impact our ability to access capital as and when needed. Our future capital requirements will depend on many factors, including the impacts of the COVID-19 pandemic and the scope of and progress in our research and development and commercialization activities, the results of our clinical trials, and the review and potential approval of our products by the FDA or other foreign regulatory authorities. The successful development of our product candidates is subject to numerous risks and uncertainties associated with developing drugs, which could have a significant impact on the cost and timing associated with the development of our product candidates. If we fail to obtain additional future capital, we may be unable to complete our planned commercialization activities or complete preclinical and clinical trials and obtain approval of any of our product candidates from the FDA and foreign regulatory authorities.
TYMLOS is our only approved product and our business currently depends heavily on its successful commercialization. Successful commercialization of an approved product is an expensive and uncertain process. See “Risk Factors - Risks Related to the Commercialization and Development of Our Product Candidates” set forth in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019, as amended by the Risk Factors set forth in Part II, “Item IA. Risk Factors” in our Form 10-Q for the quarter ended June, 30, 2020, as amended by the Risk Factors set forth in Part II, “Item 1A. Risk Factors” in this Form 10-Q for the quarter ended September, 30, 2020.
The following table sets forth the major sources and uses of cash for each of the periods set forth below (in thousands):
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 Nine Months Ended  
 September 30,Change
 20202019$%
Net cash (used in) provided by:    
Operating activities$(46,600)$(75,011)$28,411 38 %
Investing activities46,984 98,911 (51,927)(52)%
Financing activities11,560 5,709 5,851 102 %
Net increase in cash, cash equivalents, and restricted cash$11,944 $29,609 $(17,665)(60)%
Cash Flows from Operating Activities
Net cash used in operating activities during the nine months ended September 30, 2020 was $46.6 million, which was primarily the result of a net loss of $87.8 million, partially offset by $36.5 million of net non-cash adjustments to reconcile net loss to net cash used in operations and net changes in working capital of $4.7 million. The $87.8 million net loss was primarily due to abaloparatide-SC program costs, abaloparatide-TD program costs, elacestrant and RAD140 program development expenses along with employee compensation incurred to support the commercialization of TYMLOS in the United States. The $36.5 million net non-cash adjustments to reconcile net loss to net cash used in operations primarily included stock-based compensation expense of $19.8 million, amortization of debt discount of $13.3 million, depreciation of $1.6 million, amortization for premium of market securities of $0.2 million and impairment loss on right of use assets of $1.5 million.
Net cash used in operating activities during the nine months ended September 30, 2019 was $75.0 million, which was primarily the result of a net loss of $108.3 million, partially offset by $30.6 million of net non-cash adjustments to reconcile net loss to net cash used in operations and net changes in working capital of $2.6 million. The $108.3 million net loss was primarily due to abaloparatide-SC program costs, elacestrant and RAD140 program development expenses along with employee compensation incurred to support the commercialization of TYMLOS in the United States. The $30.6 million non-cash adjustments to reconcile net loss to net cash used in operations included stock-based compensation expense of $16.9 million, amortization of debt discount of $11.6 million, impairment charge for the right of use operating lease of $0.3 million, depreciation of $1.8 million and loss on fixed asset disposal of $0.2 million.
Cash Flows from Investing Activities
Net cash provided by investing activities during the nine months ended September 30, 2020 was $47.0 million, which was the result of $86.9 million in sales and maturities of marketable securities, partially offset by $39.9 million in purchases of marketable securities.
Net cash provided by investing activities during the nine months ended September 30, 2019 was $98.9 million, which was primarily the result of $135.5 million in sales and maturities of marketable securities, partially offset by $36.6 million in purchases of marketable securities.
Our investing cash flows will be impacted by the timing of our purchases and sales of our marketable securities. Because our marketable securities are primarily short-term in duration, we would not expect our operational results or cash flows to be significantly affected by a change in market interest rates.
Cash Flows from Financing Activities
Net cash provided by financing activities during the nine months ended September 30, 2020 was $11.6 million, which consisted of $9.9 million of net proceeds from issuance of term loan and $1.6 million received upon issuance of common stock under the Radius Health, Inc. 2016 Employee Stock Purchase Plan (“ESPP”).
Net cash provided by financing activities during the nine months ended September 30, 2019 was $5.7 million, which consisted of $3.9 million of proceeds received from exercises of stock options and $1.8 million received upon issuance of common stock under the ESPP.
Borrowings and Other Liabilities
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In August 2017, we issued $300.0 million aggregate principal amount of the Convertible Notes, as discussed in more detail in Note 6, “Convertible Notes Payable,” to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q. We received net proceeds of approximately $290.8 million from the sale of the Convertible Notes, after deducting fees and expenses of $9.2 million. In addition, in September 2017, we issued an additional $5.0 million aggregate principal amount of the Convertible Notes pursuant to the exercise of an over-allotment option granted to the underwriters in the offering. We received net proceeds of approximately $4.8 million from the sale of the over-allotment option, after deducting fees and expenses of $0.2 million.
Future minimum payments on our Convertible Notes as of September 30, 2020 are as follows (in thousands):
Years ending December 31,
Future Minimum Payments
2020$— 
20219,150 
20229,150 
20239,150 
2024314,150 
Total minimum payments
$341,600 
Less: interest
(36,600)
Less: unamortized discount
(96,098)
Less: current portion
— 
Long Term Debt
$208,902 
Term Loan and Credit Facility
In January 2020, we entered into the Term Loan, as discussed in more detail in Note 7, “Term Loan and Credit Facility,” to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.
Future minimum payments on our Term Loan as of September 30, 2020 are as follows (in thousands):
Years ended December 31,
Future Minimum Payments
2020$196 
2021786 
2022786 
20237,044 
20243,611 
Total minimum payments
$12,423 
Less: interest
(2,423)
Less: unamortized discount
(59)
Less: current portion
— 
Long Term Debt
$9,941 
Contractual Obligations
Contractual obligations represent future cash commitments and liabilities under agreements with third parties and exclude contingent liabilities for which we cannot reasonably predict future payment. We enter into contracts in the normal course of business for marketing and promotion, commercial activities, preclinical and clinical research studies, research supplies, and other services and products for operating purposes. These contracts generally provide for termination on notice, and therefore are cancellable contracts and not included in the table of contractual obligations and commitments. In addition, we have certain obligations to make future payments to third parties that become due and payable on the achievement of certain development, regulatory and commercial milestones, such as the start of a clinical trial, filing of an NDA, approval by the FDA, or product launch. The disclosed balances exclude the potential payments we may be required to make under our agreements because the timing of payments and actual amounts paid under those agreements may be different depending on the timing of receipt of goods or services or changes to agreed-upon terms or amounts for some obligations, and those agreements are cancellable upon
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written notice by us and therefore, not long-term liabilities. Additionally, the expected timing of payment of the obligations presented below is estimated based on current information.
Supply and Manufacturing Agreements
In June 2016, we entered into a Supply Agreement with Ypsomed AG (“Ypsomed”), as amended, pursuant to which Ypsomed agreed to supply commercial and clinical supplies of a disposable pen injection device customized for subcutaneous injection of abaloparatide. We agreed to purchase a minimum number of devices at prices per device that decrease with an increase in quantity supplied. In addition, we made milestone payments for Ypsomed’s capital developments in connection with the initiation of the commercial supply of the device and paid a one-time capacity fee. All costs and payments under the agreement are delineated in Swiss Francs. The agreement had an initial term of three years which began on June 1, 2017, after which, it automatically renewed for a two-year term. Following its current term, the agreement automatically renews for additional two-year terms unless either party terminates the agreement upon 18 months’ notice prior to the end of the then-current term. For the two-year term beginning May 2020, we are required to purchase a minimum number of batches for CHF 1.9 million (approximately $2.1 million).
In June 2016, we entered into a Commercial Supply Agreement with Vetter Pharma International GmbH (“Vetter”), as amended, pursuant to which Vetter agreed to formulate the finished abaloparatide-SC drug product containing abaloparatide active pharmaceutical ingredient fill cartridges with the drug product, assemble the pen delivery device, and to package the pen for commercial distribution. We agreed to purchase the cartridges and pens in specified batch sizes at a price per unit. For labeling and packaging services, we have agreed to pay a per unit price dependent upon the number of pens loaded with cartridges that are labeled and packaged. These prices are subject to an annual price adjustment. The agreement has an initial term of five years, which began on January 1, 2016, after which, it automatically renews for two-year terms unless either party notifies the other party two years before the end of the then-current term that it does not intend to renew.
In July 2016, we entered into a Manufacturing Services Agreement with Polypeptide Laboratories Holding AB (“PPL”), as amended, as successor-in-interest to Lonza Group Ltd., pursuant to which PPL has agreed to manufacture the commercial and clinical supplies of abaloparatide API. We have agreed to purchase the API in batches at a price per gram in euros, subject to an annual increase by PPL. We were required to purchase a minimum number of batches annually, equal to €2.9 million ($3.4 million) per year, subject to any annual price adjustments, during the initial term, except in calendar years 2019 and 2020. We were not subject to the minimum purchase requirement in 2019 and are not in 2020.
License Agreement Obligations
TYMLOS (abaloparatide)
In September 2005, we entered into a license agreement with an affiliate of Ipsen Pharma SAS (“Ipsen”), as amended, or the License Agreement, under which we exclusively licensed certain Ipsen compound technology and related patents covering abaloparatide to research, develop, manufacture and commercialize certain compounds and related products in all countries, except Japan and France (where our commercialization rights were subject to certain co-marketing and co-promotion rights exercisable by Ipsen, provided that certain conditions included in the License Agreement were met). We believe that Ipsen’s co-marketing and co-promotion rights in France have permanently expired. Ipsen also granted us an exclusive right and license under the Ipsen compound technology and related patents to make and have made compounds or product in Japan. Ipsen further granted us an exclusive right and license under certain Ipsen formulation technology and related patents solely for purposes of enabling us to develop, manufacture and commercialize compounds and products covered by the compound technology license in all countries, except Japan and France (as discussed above).
In consideration for these rights, we made nonrefundable, non-creditable payments in the aggregate of $13.0 million to Ipsen, including payment in recognition of certain milestones having been achieved through September 30, 2020. The License Agreement provides for further payments upon the achievement of certain future regulatory and commercial milestones. Total additional milestone payments that could be payable under the agreement are €24.0 million (approximately $28.1 million). In connection with the FDA’s approval of TYMLOS in April 2017, we paid Ipsen a milestone of €8.0 million (approximately $9.4 million) under the License Agreement, which we have recorded as an intangible asset within the consolidated balance sheet and will amortize over the remaining patent life or the estimated useful life of the underlying product. The License Agreement provides that we are obligated to pay to Ipsen a fixed five percent royalty based on net sales of products containing abaloparatide by us or our sublicensees on a country-by-country basis until the later of the last to expire of the licensed patents or for a period of 10 years after the first commercial sale in such country. The royalty expense was approximately $2.5 million and $7.4 million for the three and nine months ended September 30, 2020. The date of the last to expire of the abaloparatide patents licensed from or co-owned with Ipsen, barring any extension thereof, is expected to be March 26, 2028.
If we sublicense abaloparatide to a third party, the agreement provides that we would pay a percentage of certain payments received from such sublicensee (in lieu of milestone payments not achieved at the time of such sublicense). The applicable
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percentage is in the low double-digit range. In addition, if we or our sublicensees commercialize a product that includes a compound discovered by us based on or derived from confidential Ipsen know-how, the agreement provides that we would pay to Ipsen a fixed low single-digit royalty on net sales of such product on a country-by-country basis until the later of the last to expire of our patents that cover such product or for a period of 10 years after the first commercial sale of such product in such country.
The License Agreement expires on a country-by-country basis on the later of (1) the date the last remaining valid claim in the licensed patents expires in that country, or (2) a period of 10 years after the first commercial sale of the licensed products in such country, unless it is sooner terminated in accordance with its terms.
Prior to executing the License Agreement for abaloparatide with Radius, Ipsen licensed the Japanese rights for abaloparatide to Teijin. Teijin submitted an NDA for abaloparatide-SC in Japan for the treatment of osteoporosis in patients who are at high risk for fracture. We maintain full global rights to our development program for abaloparatide-patch.
Pursuant to a final decision in arbitration proceedings with Ipsen in connection with the License Agreement, we are obligated to pay Ipsen $5.0 million if abaloparatide receives marketing approval in Japan and a fixed mid single-digit royalty based on net sales of abaloparatide in Japan.
Abaloparatide-patch
In February 2018, we entered into a Scale-Up And Commercial Supply Agreement (the “Supply Agreement”) with 3M Company and 3M Innovative Properties Company (collectively with 3M Company, “3M”), pursuant to which 3M agreed to exclusively manufacture Phase 3 and global commercial supplies of an abaloparatide-coated transdermal patch product (“Product”) and associated applicator devices (“Applicator”). Under the Supply Agreement, 3M agreed to manufacture Product and Applicator for us according to agreed-upon specifications in sufficient quantities to meet our projected supply requirements. 3M agreed to manufacture commercial supplies of Product at unit prices that decrease with an increase in the quantity we order. We are obligated to pay 3M a mid-to-low single-digit royalty on worldwide net sales of Product and reimburse 3M for certain capital expenditures incurred to establish commercial supply of Product. We are responsible for providing, at our expense, supplies of abaloparatide drug substance to be used in manufacturing Product. During the term of the Supply Agreement, 3M and Radius have agreed to work exclusively with each other with respect to the delivery of abaloparatide, parathyroid hormone (“PTH”), and/or PTH related proteins via active transdermal, intradermal, or microneedle technology. In October 2018, the Company committed to fund 3M’s purchase of capital equipment totaling approximately $9.6 million in preparation for manufacturing Phase 3 and potential commercial supplies of Product. Milestone payments for the equipment commenced in the fourth quarter of 2018 and are expected to be paid in full in the second quarter of 2021.
The initial term of the Supply Agreement began on its effective date and will continue for five years after the first commercial sale of Product. The Supply Agreement then automatically renews for successive three-year terms, unless earlier terminated pursuant to its terms or upon either party’s notice of termination to the other 24 months prior to the end of the then-current term. The Supply Agreement may be terminated by either party upon an uncured material breach of its terms by the other party, or due to the other party’s bankruptcy, insolvency, or dissolution. We may terminate the Supply Agreement upon the occurrence of certain events, including for certain clinical, technical, or commercial reasons impacting Product, if we are unable to obtain U.S. regulatory approval for Product within a certain time period, or if we cease development or commercialization of Product. 3M may terminate the Supply Agreement upon the occurrence of certain events, including if there are certain safety issues related to Product, if we are unable to obtain U.S. regulatory approval for Product within a certain time period, or if we fail to order Product for a certain period of time after commercial launch of the Product in the U.S. Upon certain events of termination, 3M is required to transfer the manufacturing processes for Product and Applicator to us or a mutually agreeable third party and continue supplying Product and Applicator for a period of time pursuant to our projected supply requirements.
In May 2020, 3M announced that it completed its sale of its drug delivery business, which manufactures clinical trial supplies of abaloparatide-patch, to Kindeva Drug Delivery (“Kindeva”), an affiliate of Altaris Capital Partners, LLC. As part of the transaction, 3M retained a minority interest in Kindeva and the Supply Agreement with 3M was transferred to Kindeva.
In June 2009, we entered into a Development and Clinical Supplies Agreement with 3M, as amended (the “Development Agreement”), under which Product and Applicator development activities occur and 3M has manufactured phase 1 and 2 clinical trial supplies for us on an exclusive basis. The initial term of the Development Agreement remained in effect until June 2019 and then automatically renews for successive one-year terms, unless earlier terminated, until the earliest of (i) the expiration or termination of the Supply Agreement, (ii) the mutual written agreement of the parties, or (iii) prior written notice by either party to the other party at least ninety days prior to the end of the then-current term of the Development Agreement that such party declines to extend the term. Either party may terminate the agreement in the event of an uncured material breach by the other party. We pay 3M for services delivered pursuant to the agreement on a fee-for-service or a fee-for-deliverable
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basis as specified in the agreement. We have paid 3M approximately $30.2 million, in the aggregate, through September 30, 2020 with respect to performance under the Development Agreement.
Elacestrant (Eisai)
In June 2006, we entered into a license agreement (“Eisai Agreement”), with Eisai Co. Ltd. (“Eisai”). Under the Eisai Agreement, Eisai granted to us an exclusive right and license to research, develop, manufacture and commercialize elacestrant (RAD1901) and related products from Eisai in all countries, except Japan. In consideration for the rights to elacestrant, we paid Eisai an initial license fee of $0.5 million, which was expensed during 2006. In March 2015, we entered into an amendment to the Eisai Agreement, or the “Eisai Amendment,” in which Eisai granted to us the exclusive right and license to research, develop, manufacture and commercialize elacestrant in Japan. In consideration for the rights to elacestrant in Japan, we paid Eisai an initial license fee of $0.4 million upon execution of the Eisai Amendment, which was recognized as research and development expense in 2015. The Eisai Agreement, as amended, also provides for additional payments of up to $22.3 million, payable upon the achievement of certain future clinical and regulatory milestones. To date, we have paid Eisai approximately $1.0 million in connection with the achievement of certain milestones.
Under the Eisai Agreement, as amended, should a product covered by the licensed technology be commercialized, we will be obligated to pay to Eisai royalties in a variable mid-single-digit range based on net sales of the product on a country-by-country basis. The royalty rate will be reduced, on a country-by-country basis, at such time as the last remaining valid claim in the licensed patents expires, lapses or is invalidated and the product is not covered by data protection clauses. In addition, the royalty rate will be reduced, on a country-by-country basis, if, in addition to the conditions specified in the previous sentence, sales of lawful generic versions of such product account for more than a specified minimum percentage of the total sales of all products that contain the licensed compound during a calendar quarter. The latest licensed patent is expected to expire, barring any extension thereof, on August 18, 2026.
The Eisai Agreement, as amended, also grants us the right to grant sublicenses with prior written approval from Eisai. If we sublicense the licensed technology to a third party, we will be obligated to pay Eisai, in addition to the milestones referenced above, a fixed low double-digit percentage of certain fees received from such sublicensee and royalties in the low single-digit range based on net sales of the sublicensee. In connection with the Berlin-Chemie exclusive license, we granted to Berlin-Chemie to develop and commercialize products containing elacestrant (RAD1901) worldwide and we are obligated to pay Eisai a fee of $3.0 million in accordance with the Eisai Agreement. The Eisai Agreement expires on a country-by-country basis on the later of (1) the date the last remaining valid claim in the licensed patents expires, lapses or is invalidated in that country, the product is not covered by data protection clauses, and the sales of lawful generic versions of the product account for more than a specified percentage of the total sales of all pharmaceutical products containing the licensed compound in that country; or (2) a period of 10 years after the first commercial sale of the licensed products in such country, unless it is sooner terminated.
Elacestrant (Duke)
In December 2017, we and Duke University (“Duke”) entered into a patent license agreement, as amended, (the “Duke Agreement”) pursuant to which we acquired the exclusive worldwide license to certain Duke patents associated with elacestrant (RAD1901) related to the use of elacestrant in the treatment of breast cancer as a monotherapy and in a combination therapy (collectively “Duke Patents”).
In consideration for these rights, we incurred non-refundable, non-creditable obligations to pay Duke, totaling $1.3 million, which were expensed as research and development during 2017. The Duke Agreement provides for further payments upon the achievement of certain future regulatory and commercial milestones totaling up to $3.8 million. The agreement provides that we would pay Duke a fixed low single-digit royalty based on net sales, on a country-by-country basis, beginning in August 2029 and ending upon expiration of the last patent rights to expire.
If we sublicense the Duke Patents to a third party, the agreement provides that we will pay Duke a percentage of certain payments we received from such sublicensee(s). The applicable percentage is in the high single-digit range on certain payments received in excess of a pre-specified amount. The Duke Agreement may be terminated by either party upon an uncured material breach of the agreement by the other party. We may terminate the agreement upon 60 days written notice to Duke, if we suspend our manufacture, use and sale of the licensed products.
Abaloparatide-SC (Teijin)
In July 2017, we entered into a license and development agreement with Teijin for abaloparatide-SC in Japan (the “Teijin Agreement”). Teijin is developing abaloparatide-SC in Japan under an agreement with Ipsen and has initiated a Phase 3 trial in Japanese patients with osteoporosis. Pursuant to the Teijin Agreement, we granted Teijin (i) an exclusive payment bearing license under certain of our intellectual property to develop and commercialize abaloparatide-SC in Japan, (ii) a non-exclusive payment bearing license under certain of our intellectual property to manufacture abaloparatide-SC for commercial supply in
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Japan, (iii) a right of reference to certain of our regulatory data related to abaloparatide-SC for purposes of developing, manufacturing and commercializing abaloparatide-SC in Japan, (iv) a manufacture transfer package, upon Teijin’s request, consisting of information and our know-how that is necessary for the manufacture of active pharmaceutical ingredient and abaloparatide-SC, and (v) a right to request that we use commercially reasonable efforts to manufacture (or arrange for a third party to manufacture) and supply (or arrange for a third party to supply), at Teijin’s expense, the active pharmaceutical ingredient (“API”) for the clinical supply of abaloparatide-SC in sufficient quantities to enable Teijin to conduct its clinical trials in Japan. In addition, we agreed to use commercially reasonable efforts to arrange for Teijin to directly enter into commercial supply agreements with our then existing contract manufacturers of abaloparatide-SC API and drug product.
In consideration for these rights, we received an upfront payment of $10.0 million. The Teijin Agreement also provides for additional payments to us of up to an aggregate of $40.0 million upon the achievement of certain regulatory and sales milestones, and requires Teijin to pay us a fixed low double-digit royalty based on net sales of abaloparatide-SC in Japan during the royalty term, as defined below.
Teijin granted us (i) an exclusive license under certain of Teijin’s intellectual property to develop, manufacture and commercialize abaloparatide-SC outside Japan and (ii) a right of reference to certain of Teijin’s regulatory data related to abaloparatide-SC for purposes of developing, manufacturing and commercializing abaloparatide-SC outside Japan. We maintain full global rights to our development program for abaloparatide-patch, which is not part of the Teijin Agreement. Pursuant to the Teijin Agreement, the parties may further collaborate on new indications for abaloparatide-SC.
Unless earlier terminated, the Teijin Agreement expires on the later of the (i) date on which the use, sale or importation of abaloparatide-SC is no longer covered by a valid claim under our patent rights licensed to Teijin in Japan, (ii) expiration of marketing or data exclusivity for abaloparatide-SC in Japan, or (iii) 10th anniversary of the first commercial sale of abaloparatide-SC in Japan.
Elacestrant (Berlin-Chemie)
In July 2020, we entered into a license agreement (“Berlin-Chemie Agreement”) with Berlin-Chemie AG, a company of the Menarini Group (“Berlin-Chemie”) under which we granted Berlin-Chemie an exclusive license to develop and commercialize products containing elacestrant (RAD1901) worldwide.
We simultaneously entered into a Transition Services Agreement (the “TSA”) with Berlin-Chemie, pursuant to which we will perform certain services for Berlin-Chemie related to the EMERALD Phase 3 monotherapy study until the earlier of the completion of the contemplated services or the filing with the FDA of an NDA for elacestrant. Pursuant to the TSA, Berlin-Chemie will reimburse us for all out-of-pocket and full-time employee costs in performing the services. We will continue to incur research and development expenses in support of scale up costs under the TSA.
Pursuant to the terms of the Berlin-Chemie Agreement, Berlin-Chemie is required to make an initial license fee payment to the Company of $30.0 million. We are also eligible to receive up to $20.0 million in development and regulatory milestone payments and up to $300.0 million in sales milestone payments, with such payments contingent on the achievement of specified milestones with respect to the licensed products. We are also eligible to receive tiered royalties on sales of licensed products at percentages ranging from low to mid-teens, subject to certain reductions. Royalties on net sales will be payable on a product-by-product and country-by-country basis until the latest of the expiration date of the last to expire of the relevant patent rights, the expiration of regulatory exclusivity, or ten years from such first commercial sale.
The Berlin-Chemie Agreement will continue on a licensed product-by-licensed product and country-by-country basis until the last to expire royalty term. Either party may terminate the Berlin-Chemie Agreement for an uncured material breach by the other party or upon the bankruptcy or insolvency of the other party. We may terminate the Berlin-Chemie Agreement for certain patent challenges or if no development, manufacture or commercialization activity occurs in any given 24-month period. Berlin-Chemie may terminate the Berlin-Chemie Agreement at its discretion for any reason by delivering written notice to us with 180 days written notice; provided that such termination will not be effective for a period of time after the effective date.
Net Operating Loss Carryforwards
As of December 31, 2019, we had federal and state net operating loss carryforwards of approximately $974.3 million and $681.8 million, respectively, subject to limitation, as described below. If not utilized, the net operating loss carryforwards will expire at various dates through 2039.
Under Section 382 of the Internal Revenue Code of 1986, or Section 382, substantial changes in our ownership may limit the amount of net operating loss carryforwards that could be used annually in the future to offset taxable income. We have completed studies through December 31, 2015, to determine whether any ownership change has occurred since our formation and have determined that transactions have resulted in two ownership changes, as defined under Section 382. There could be additional ownership changes subsequent to December 31, 2015 and/or in the future that could further limit the amount of net
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operating loss and tax credit carryforwards that we can utilize. A full valuation allowance has been recorded against our net operating loss carryforwards and other deferred tax assets, as the realization of the deferred tax asset is uncertain.
As a result, we have not recorded any federal or state income tax benefit in our condensed consolidated statements of operations.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements or any relationships with unconsolidated entities of financial partnerships, such as entities often referred to as structured finance or special purpose entities.
New Accounting Standards
See Note 2 - Basis of Presentation and Significant Accounting Policies - Accounting Standards Updates in the accompanying unaudited condensed consolidated financial statements in this Quarterly Report for a discussion of new accounting standards.
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Item 3.   Quantitative and Qualitative Disclosures about Market Risk.
We are exposed to market risk related to changes in the dollar/euro exchange rate because a portion of our development costs are denominated in euros. We do not hedge our foreign currency exchange rate risk. However, an immediate 10 percent adverse change in the dollar/euro exchange rate would not have a material effect on financial results.
We are exposed to market risk related to changes in interest rates. As of September 30, 2020, we had cash, cash equivalents, restricted cash, marketable securities and investments of $126.3 million, consisting of cash, money market funds, domestic corporate debt securities, domestic corporate commercial paper and agency bonds. This exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates, particularly because our investments are in marketable securities. Because our marketable securities are short-term in duration, and have a low risk profile, an immediate 10% change in interest rates would not have a material effect on the fair market value of our portfolio. We generally have the ability to hold our investments until maturity, and therefore we would not expect our operating results or cash flows to be affected to any significant degree by a change in market interest rates on our investments. We carry our investments based on publicly available information. As of September 30, 2020, we did not have any hard-to-value investment securities or securities for which a market is not readily available or active.
We are not subject to significant credit risk as this risk does not have the potential to materially impact the value of our assets and liabilities.
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Item 4.   Controls and Procedures.
Disclosure Controls and Procedures
Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of as of September 30, 2020.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting during the three months ended September 30, 2020 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.


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PART II— OTHER INFORMATION
Item 1.      Legal Proceedings.
From time to time, we are party to litigation arising in the ordinary course of our business. As of September 30, 2020, we were not party to any significant litigation.
Item 1A.  Risk Factors.
Our business faces significant risks and uncertainties. Certain important factors may have a material adverse effect on our business prospects, financial condition and results of operations, and you should carefully consider them. Accordingly, in evaluating our business, we encourage you to carefully consider the discussion of risk factors in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019, which could materially affect our business, financial condition or future results, in addition to other information contained in or incorporated by reference into this Quarterly Report on Form 10-Q and our other public filings with the Securities and Exchange Commission, or the SEC.

The Company reviewed its risk factors as of September 30, 2020 and determined that there were no material changes from the ones set forth in its Annual Report on Form 10-K for the year ended December 31, 2019, other than those included below.

The ongoing COVID-19 pandemic is having and is expected to continue to have an adverse impact on our business, financial condition and results of operations, including our commercial operations and sales, clinical trials, preclinical studies, and employees.

Since December 2019, a novel strain of coronavirus, SARSCoV-2, which causes coronavirus disease 2019 (COVID-19), has spread to multiple countries, including the United States. The COVID-19 pandemic is evolving, and to date has led to the implementation of various responses, including government-imposed quarantines, travel restrictions and other public health safety measures.

In response to the spread of SARS-CoV-2 and COVID-19, in March 2020, we closed our administrative offices and as of September 30, 2020, they remain closed, with our employees continuing their work outside of our offices. We have selectively resumed in-person interactions by our customer-facing personnel in compliance with local and state restrictions. We also continue to engage with customers virtually as we seek to continue to support healthcare professionals and patient care. However, our ability to engage in personal interactions with physicians and customers remains limited, and it is unknown when our offices will reopen and these interactions will be fully resumed.

We continue to monitor our operations and applicable government recommendations, and we have made modifications to our normal operations because of the COVID-19 pandemic, including requiring most office-based employees to work remotely. Notwithstanding these measures, the COVID-19 pandemic could affect the health and availability of our workforce as well as those of the third parties we rely on taking similar measures. If members of our management and other key personnel in critical functions across our organization are unable to perform their duties or have limited availability due to COVID-19, we may not be able to execute on our business strategy and/or our operations may be negatively impacted. We may also experience limitations in employee resources, including because of sickness of employees or their families or the desire of employees to avoid contact with individuals or large groups of people. In addition, we have experienced and will continue to experience disruptions to our business operations resulting from quarantines, self-isolations and other restrictions on the ability of our employees to perform their jobs.

The current COVID-19 pandemic is adversely impacting our business, and future public health crises such as pandemics or similar outbreaks may have similar adverse impacts on our business in the future. We have experienced disruptions that are impacting the commercialization of our only product, TYMLOS. The rate of new patients starting on TYMLOS therapy has slowed as patients are unable or unwilling to see their doctor for diagnosis and treatment due to illness, quarantine, travel restrictions or financial hardship. As a result, we may not be able to meet our expectations with respect to TYMLOS sales. Business interruptions from the current COVID-19, or a future, pandemic may also adversely impact the third parties we solely rely on to sufficiently manufacture TYMLOS and to produce our product candidates in quantities we require, which may adversely impact the commercialization of TYMLOS and our research and development activities and potential commercialization of our product candidates.
While we have completed enrollment in our Phase 3 trials, we may experience slowdown or disruption to our trials if infection levels surge.

Successful clinical trials are dependent upon global clinical trial sites, many of which are being adversely affected by the current pandemic. We are currently conducting clinical trials for our product candidates in many countries, including the United States, European Union, Canada, United Kingdom, Australia, South Korea, Argentina, and Israel, and may expand to other geographies. Many of the regions in which we operate are currently being, or may in the future be, affected by the COVID-19 pandemic. We are following health authority guidance regarding missed study visits and procedures. Some factors from the
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COVID-19 outbreak that may delay or otherwise further adversely affect enrollment in the clinical trials of our product candidates, as well as adversely impact our business generally, include:

increased rates of patients withdrawing from our clinical trials following enrollment as a result of contracting COVID-19, being forced to quarantine, or not accepting home health visits, particularly for older patients with a higher risk of contracting COVID-19;
delays or difficulties in patient and site adherence to all protocol-specified procedures, potentially jeopardizing data quality and trial integrity;
diversion of healthcare resources away from the conduct of clinical trials to focus on pandemic concerns, including the attention of physicians serving as our clinical trial investigators, diversion of hospitals and medical centers or sites serving as our clinical trial sites and hospital or other staff supporting the conduct of our clinical trials;
limitations on travel that could interrupt key trial activities, such as clinical trial site initiations and monitoring, domestic and international travel by employees, contractors or patients to clinical trial sites, including any government-imposed travel restrictions or quarantines that may impact the ability or willingness of patients, employees or contractors to travel to our clinical trial sites or secure visas or entry permissions, any of which could delay or adversely impact the conduct or progress of our clinical trials;
potential interruption or delays in the operations of the U.S. Food and Drug Administration and foreign regulatory authorities, or independent review boards or ethics committees, which may impact review and approval timelines;
potential interruption of, or delays in receiving, supplies of our product candidates from our contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems; or in the clinical trial sites’ ability to maintain continuous supply of product candidates to patients;
longer payment and reimbursement cycles and uncertainties regarding the collectability of accounts receivable; and
business disruptions caused by potential workplace, laboratory and office closures and an increased reliance on employees working from home, disruptions to or delays in ongoing laboratory experiments and operations, staffing shortages, travel imitations or mass transit disruptions, any of which could adversely impact our business operations or delay necessary interactions with local regulators, ethics committees and other important agencies and contractors.
These and other factors arising from the COVID-19 pandemic could worsen in countries that are already afflicted with COVID-19, could continue to spread to additional countries, or could return to countries where the pandemic has been partially contained, each of which could further adversely impact our ability to conduct clinical trials and our business generally, and could have a material adverse impact on our operations and financial condition and results. In addition, the trading prices for our common stock and other biopharmaceutical companies have been, and will likely continue to be, highly volatile as a result of the COVID-19 pandemic, and may limit our ability to raise additional capital.
Health regulatory agencies globally may experience disruptions in their operations as a result of the COVID-19 pandemic. The FDA and comparable foreign regulatory agencies may have slower response times or be under-resourced to continue to monitor our clinical trials and, as a result, review, inspection, and other timelines may be materially delayed. It is unknown how long these disruptions could continue, were they to occur. Any elongation or de-prioritization of our clinical trials or delay in regulatory review resulting from such disruptions could materially affect the development and study of our product candidates. For example, regulatory authorities may require that we not distribute a product candidate lot until the relevant agency authorizes its release. Such release authorization may be delayed as a result of the coronavirus pandemic and could also result in delays to our clinical trials.
In response to the COVID-19 pandemic, the Coronavirus Aid, Relief and Economic Security Act (CARES Act) was signed into law in March 2020. The CARES Act is aimed at providing emergency assistance and health care for individuals, families and businesses affected by the COVID-19 pandemic and generally supporting the United States economy. Due to the recent enactment of the CARES Act, there is a high degree of uncertainty around its implementation. We expect that additional state and federal healthcare reform measures may be adopted in the future, any of which could limit the amounts that federal and state governments will pay for our commercial product, TYMLOS®, which could result in reduced demand. The current COVID-19 pandemic may introduce temporary or permanent healthcare reform measures for which we cannot predict the financial impact on our business.
The COVID-19 outbreak continues to rapidly evolve. While the impacts of the COVID-19 outbreak are having and will continue to have an adverse effect on our business, financial condition and results of operations, the ultimate extent to which the outbreak impacts our business, including our commercial results, financial condition, liquidity, future results of operations, clinical trials, preclinical studies, and our workforce, will depend on the duration and extent of future developments, which are highly uncertain and cannot be predicted with confidence. These future developments include the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions and actions to contain the outbreak or treat its impact, such as social
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distancing and quarantines or lock-downs in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.
We have experienced adverse impacts on our business for the quarter ended September 30, 2020 due to the global outbreak of COVID-19. The current COVID-19 pandemic has presented a substantial public health and economic challenge around the world and is affecting our employees, patients, and business operations, as well as the broader U.S. economy and financial markets. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning COVID-19, the actions taken to contain it or treat its impact and the economic impact on local, regional, and national markets.
We have entered into, and in the future may enter into, license and/or collaborations with third parties for the development and commercialization of our product candidates. If those license and/or collaborations, including, without limitation, our license arrangement with Berlin-Chemie for the development and commercialization of elacestrant worldwide, are not successful, we may not be able to capitalize on the market potential of these product candidates.
We have in the past, currently have, and may in the future, seek third-party licensees and/or collaborators for the development and commercialization of some of our product candidates on a selective basis. Our likely licensees and/or collaborators for any arrangements include large and mid-size pharmaceutical companies, regional and national pharmaceutical companies and biotechnology companies. For example, we recently licensed elacestrant for development and commercialization worldwide to Berlin-Chemie AG, a company of the Menarini Group (“Berlin-Chemie”). We will not derive revenue from Berlin-Chemie’s sales of elacestrant, if any, and, in return for the license rights granted, will receive specified payments in the form of an upfront payment, certain milestone payments, if achieved, and royalties on the licensee’s sales of elacestrant, if approved, during a specified period. In addition, we will continue to incur research and development expenses in support of scale up costs, pursuant to a transition services agreement we entered into with Berlin-Chemie in connection with the license agreement.
To the extent we have, and if we do enter into any further such arrangements with any third parties, we will likely have limited control over the amount and timing of resources that our licensees and/or collaborators dedicate to the development or commercialization of our product candidates. Our ability to generate revenues from our arrangement with Berlin-Chemie or any other arrangements will depend on our licensees’ and/or collaborators’ abilities and efforts to successfully perform the functions assigned to them in these arrangements. Licenses and collaborations involving our product candidates would pose numerous risks to us, including the following:
licensees and/or collaborators have significant discretion in determining the efforts and resources that they will apply to these arrangements and may not perform their obligations as expected;
licensees and/or collaborators may de-emphasize or not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in their strategic focus, including as a result of a sale or disposition of a business unit or development function, or available funding or external factors such as an acquisition that diverts resources or creates competing priorities;
licensees and/or collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;
licensees and/or collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates if they believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; license or collaboration arrangements may subject us to exclusivity provisions which could restrict our ability to compete in certain territories, including those licensed to the licensee and/or collaborator;
a licensee or collaborator with marketing and distribution rights to multiple products may not commit sufficient resources to the marketing and distribution of our product relative to other products;
licensees or collaborators may not properly obtain, maintain, defend or enforce our intellectual property rights or may use our proprietary information and intellectual property in such a way as to invite litigation or other intellectual property related proceedings that could jeopardize or invalidate our proprietary information and intellectual property or expose us to potential litigation or other intellectual property related proceedings;
disputes may arise between the licensees and/or collaborators and us that result in the delay or termination of the research, development or commercialization of our products or product candidates or that result in costly litigation or arbitration that diverts management attention and resources;
licenses and/or collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates;
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license and/or collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all; and
if a licensee or collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program could be delayed, diminished or terminated.
If our license arrangement with Berlin-Chemie, or any future license or collaboration we may enter into, if any, is not successful, our business, financial condition, results of operations, prospects and development and commercialization efforts may be adversely affected. Any termination or expiration of our license agreement with Berlin-Chemie, or any future license or collaboration we may enter into, if any, could adversely affect us financially or harm our business reputation, development and commercialization efforts.
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Item 2.                            Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3.                            Defaults Upon Senior Securities.
None.
Item 4.                            Mine Safety Disclosures. 
None.
Item 5.                            Other Information.
None.
Item 6.                            Exhibits.
A list of exhibits is set forth in the Exhibit Index below, which is incorporated herein by reference.
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EXHIBIT INDEX
Unless otherwise indicated, all references to previously filed Exhibits refer to the Company’s filings with the Securities and Exchange Commission, under File No. 001-35726.
  Incorporated by ReferenceFiled/
Exhibit    FilingFurnished
NumberExhibit DescriptionFormFile No.ExhibitDateHerewith
Restated Certificate of Incorporation8-K001-357263.16/13/2014
Amended and Restated By-Laws8-K001-357263.13/2/2018
License Agreement, dated as of July 23, 2020, by and between the Company and Berlin-Chemie AG
*
Partial Release and Acknowledgement Agreement, dated as of July 23, 2020, by and between the Company and MidCap Financial Trust
*
General Release of Claims, dated as of September 22, 2020, by and between the Company and Jose (Pepe) Carmona
*
Certification of Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a)/15d-14(a)*
Certification of Principal Financial Officer pursuant to Exchange Act Rule 13a-14(a)/15d-14(a)*
Certification of Chief Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002**
101.SCHInline XBRL Taxonomy Extension Schema Document*
101.CALInline XBRL Taxonomy Extension Calculation Linkbase Document*
101.LABInline XBRL Taxonomy Extension Label Linkbase Document*
101.PREInline XBRL Taxonomy Extension Presentation Linkbase Document*
101.DEFInline XBRL Taxonomy Extension Definition Linkbase Document*
104 Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.*)         *
^ Pursuant to 17 C.F.R §§230.406 and 230.83, the confidential portions of this exhibit have been omitted and are marked accordingly.

*     Filed herewith.
**     Furnished herewith.



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SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 
 
 RADIUS HEALTH, INC.
   
 By:/s/ G. Kelly Martin
  G. Kelly Martin
  President and Chief Executive Officer
  (Principal Executive Officer)
   
Date: November 5, 2020  
   
   
 By:/s/ Dan Dolan
  Dan Dolan
  Head of Financial Planning and Analysis, Treasurer
  (Principal Accounting and Financial Officer)
   
Date: November 5, 2020  

47
exhibit101-original
Exhibit 10.1 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO RADIUS HEALTH, INC. IF PUBLICLY DISCLOSED CONFIDENTIAL LICENSE AGREEMENT This License Agreement (this “Agreement”), dated as of July 23, 2020 (the “Effective Date”), is made by and between Radius Pharmaceuticals, Inc., organized under the laws of Delaware having business offices at 950 Winter Street, Waltham, MA 02451 (“Radius”), and Berlin-Chemie AG – Menarini Group, organized under the laws of Germany having business offices at Glienicker Weg 125, 12849 Berlin, Germany (“Licensee”). Radius and Licensee are sometimes hereinafter referred to each as a “Party” and collectively as the “Parties.” WHEREAS, Radius is engaged in the development of elacestrant (RAD1901), a selective estrogen receptor degrader, and controls certain patent rights and know-how with respect thereto; WHEREAS, Licensee desires to obtain exclusive rights under the Radius Patent Rights and Radius Know-How in order to commercialize pharmaceutical products containing elacestrant (RAD1901) including the Licensed Product (all capitalized terms as hereinafter defined); WHEREAS, on the Effective Date, the Parties will enter into the Transition Services Agreement (as hereinafter defined) pursuant to which Radius will conduct certain Development (as hereinafter defined) activities relating to the Licensed Product, including submission of a Regulatory Filing in the United States, until Licensee elects to take over such Development or until completion of the services contemplated in the Transition Services Agreement; and WHEREAS, the Parties desire to enter into an agreement pursuant to which Radius will grant an exclusive license to Licensee under the Radius Patent Rights and Radius Know-How for Licensee to Develop, Manufacture and Commercialize Licensed Compound and Licensed Products in the Territory (all capitalized terms as hereinafter defined), all on the terms set forth below. NOW, THEREFORE, the Parties hereby agree as follows: Section 1. Definitions. For the purpose of this Agreement, the following terms and phrases (and cognates) will have the meanings set forth below: 1.1 “Accounting Standards” means, with respect to Radius, U.S. Generally Accepted Accounting Principles, and, with respect to Licensee, IFRS (International Financial Reporting Standards), in each case, consistently applied. 1.2 “Affiliate” of a Person means any other Person which (directly or indirectly) is controlled by, controls or is under common control with such Person. For the purposes of this definition, the term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to any Person means (a) in the case of a corporate entity, direct or indirect ownership of voting securities entitled to cast at least fifty percent (50%) of the votes in the election of directors, (b) in the case of a non-corporate entity, direct or indirect ownership of at least fifty percent (50%), including ownership by trusts with substantially the same beneficial interest, of the equity interests with the power to direct the management and policies of such Person, provided that if local law


 
LICENSE AGREEMENT restricts foreign ownership, control will be established by direct or indirect ownership of the maximum ownership percentage that may, under such local law, be owned by foreign interests, or (c) the power to direct the management or policies of a Person, whether through ownership of voting securities, by contract or otherwise. 1.3 “Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31. 1.4 “Calendar Year” means each successive period of twelve (12) months commencing on January 1 and ending on December 31. 1.5 “Change of Control” means with respect to a Party, (a) completion of a merger, reorganization, amalgamation, arrangement, share exchange, consolidation, tender or exchange offer, private purchase, business combination, recapitalization or other transaction involving a Party as a result of which the stockholders of such Party immediately preceding such transaction hold less than fifty percent (50%) of the outstanding shares, or less than fifty percent (50%) of the outstanding voting power, respectively, of the ultimate company or entity resulting from such transaction immediately after consummation thereof (including a company or entity which as a result of such transaction owns the then- outstanding securities of a Party or all or substantially all of a Party’s assets, either directly or through one or more subsidiaries), (b) the adoption of a plan relating to the liquidation or dissolution of a Party, other than in connection with a corporate reorganization (without limitation of clause (a), above); (c) any sale, lease, exchange, contribution or other transfer (in one transaction or a series of related transactions) to a Third Party of all or substantially all the assets of a Party (determined on a consolidated basis); or (d) the sale or disposition to a Third Party of assets or businesses that constitute fifty percent (50%) or more of the total revenue or assets of a Party (determined on a consolidated basis). 1.6 “China” means People’s Republic of China, including Hong Kong SAR, Macau SAR and Taiwan. 1.7 “Clinical Studies” means any study in which human subjects are dosed with a drug, whether approved or investigational, including any Phase 1, 2, 3 or 4 clinical study. 1.8 “Combination” means a Combination Product or Combination Therapy. 1.9 “Combination Product” means a Licensed Product that includes at least one additional active ingredient other than Licensed Compound. Drug delivery vehicles, adjuvants, and excipients will not be deemed to be “active ingredients”, except in the case where such delivery vehicle, adjuvant, or excipient is recognized as an active ingredient in accordance with 21 C.F.R. § 210.3(b)(7) (as amended), or any foreign counterpart. 1.10 “Combination Therapy” means a therapy comprised of a Licensed Product and one or more other therapeutically or prophylactically active ingredients, whether priced and sold in a single package containing such multiple products, packaged separately but sold together for a single price, or sold under separate price points but labeled for use together, including all dosage forms, formulations, presentations, and package configurations. Drug delivery vehicles, adjuvants, and excipients will not be deemed to be “active ingredients”, except in the case where such delivery vehicle, adjuvant, or excipient is recognized as an active ingredient in accordance with 21 C.F.R. § 210.3(b)(7) (as amended), or any foreign counterpart. 1.11 “Commercially Reasonable Efforts” means [*]. 2


 
LICENSE AGREEMENT 1.12 “Commercialize”, “Commercializing” or “Commercialization” means activities directed to obtaining pricing and reimbursement approvals, carrying out Phase 4 clinical studies for, marketing, promoting, distributing, importing, exporting, offering for sale or selling any pharmaceutical product, including any Licensed Product. 1.13 “Commercialization Budget” means the budget for conducting Commercialization of any Licensed Product in the Territory pursuant to the Commercialization Plan during a given Calendar Year and the two (2) succeeding Calendar Quarters, which budget will be updated and amended concurrently with the Commercialization Plan in accordance with Section 5.1(b). 1.14 “Commercialization Plan” means the plan setting forth the activities and timelines relating to the Commercialization of any Licensed Product in the Territory during a given Calendar Year and the [*] ([*]) succeeding Calendar Quarters, including the Commercialization Budget and annual Net Sales forecasts for the Territory, as updated and amended from time to time in accordance with the procedures set forth in this Agreement. Licensee will provide an initial Commercialization Plan to Radius within [*] ([*]) months after the Effective Date of this Agreement. 1.15 “Companion Diagnostic” means any product or service, in each case approved, cleared or authorized by the competent Regulatory Authority in the Territory, that: (a) identifies a person having a disease or condition or a molecular genotype or phenotype that predisposes a person to such disease or condition, in each case, for which a Licensed Compound or Licensed Product could be used to treat or prevent such disease or condition; or (b) is used to select a therapeutic or prophylactic regimen, wherein at least one (1) potential such therapeutic or prophylactic regimen involves a Licensed Compound or Licensed Product, and where the selected regimen is determined to likely be effective or to be safe for a person, based on the use of such product or service. 1.16 “Confidential Information” means all Know-How, marketing plans, strategies and customer lists, and other information or material that are disclosed or provided by a Party or its Affiliates to the other Party or its Affiliates, regardless of whether any of the foregoing are marked “confidential” or “proprietary” or communicated to the other by the disclosing Party or its Affiliates in oral, written, graphic, or electronic form. 1.17 “Confidentiality Agreement” means the Confidential Disclosure Agreement, dated as of January 23, 2019, by and between Radius and an Affiliate of Licensee. 1.18 “Controlled” means, with respect to any Know-How, patent rights or other intellectual property right, the possession (whether by ownership or license, other than by a license or sublicense granted pursuant to this Agreement) by a Party or its Affiliates of the ability to grant to the other Party a license or access as provided herein to such item, without violating the terms of any agreement or other arrangement with any Third Party or, other than under the Duke License Agreement or the Eisai License Agreement, being obligated to pay any royalties or other consideration therefor, in existence as of the time such Party or its Affiliates would first be required hereunder to grant the other Party such license or access. For clarity, the Duke Patent Rights and Eisai IP are “Controlled” by Radius unless and until assigned by Radius to Licensee. 1.19 “Develop”, “Developing” or “Development” means non-clinical and clinical drug development activities reasonably related to the development and submission of information to a Regulatory Authority, including toxicology, pharmacology and other discovery and pre-clinical efforts, test method development and stability testing, manufacturing process development and improvement, process validation, process scale-up, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, Clinical Studies, regulatory affairs, and Regulatory 3


 
LICENSE AGREEMENT Approvals (and specifically excluding activities directed to obtaining pricing and reimbursement approvals). 1.20 “Development Budget” means the budget for conducting Development of the Licensed Compounds and Licensed Products pursuant to the Development Plan, which budget will be updated and amended concurrently with the Development Plan in accordance with Section 4.1(c). 1.21 “Development Plan” means the plan setting forth the activities and timelines relating to the Development of the Licensed Compounds and Licensed Products in the Field in the Territory, including all of the activities and timelines through the achievement of Regulatory Approval in the Major Market Countries for at least one (1) Licensed Product as a monotherapy for each Indication reflected in such Development Plan, including as applicable with respect to any Combination Products. An initial draft of the Development Plan for the Territory excluding the United States will be provided to Radius within [*] ([*]) months after the Effective Date and shall be attached hereto as Exhibit A-1. 1.22 “Diligent Efforts” has the meaning set forth in the Transition Services Agreement. 1.23 “Duke License Agreement” means the Patent License Agreement dated as of December 8, 2017, between Radius and Duke University (“Duke”), as such agreement may be amended or restated from time to time. 1.24 “Duke Patent Rights” has the meaning set forth in the preamble to Exhibit F. 1.25 “Duke Patent Prosecution and Maintenance Costs” has the meaning set forth in Clause 1.3 of Exhibit F. 1.26 “Eisai Know-How” means [*]. 1.27 “Eisai IP” means the Eisai Know-How, Eisai Patents, and Eisai’s undivided interest in the Joint Patents. 1.28 “Eisai License Agreement” means the License Agreement dated as of June 29, 2006, between Radius and Eisai Co., Ltd. (“Eisai”), as such agreement may be amended or restated from time to time. 1.29 “Eisai Patents” means all patents and patent applications which are or become owned by Eisai and/or its Affiliates, or to which Eisai and/or its Affiliates, otherwise have, now or in the future, the right to grant licenses, and which generically or specifically claim Compound and/or Product, a use for Compound and/or Product, a process for manufacturing Compound and/or Product, or an intermediate use in such process. Included within the definition of Eisai Patents are all continuations, continuations-in-part, divisions, patents of addition, reissues, re-examinations, renewals or extensions thereof and all Supplementary Protection Certificates. Also included within the definition are any improvements on Compound and/or Product or intermediates or manufacturing process required or useful for production of Compound and/or Product which are developed by or for Eisai and/or its Affiliates, or to which Eisai and/or its Affiliates otherwise has the right to grant licenses, now or in the future, during the term of this Agreement. Eisai Patents also includes any patent application covering an invention solely owned by Eisai in accordance with Article 6.4 of the Eisai License Agreement. The Eisai Patents existing as of the Effective Date as set forth in Exhibit C-2. 1.30 “EMA” means the European Medicines Agency and any successor agency thereto. 4


 
LICENSE AGREEMENT 1.31 “European Union” or “E.U.” means the European Union and all its then-current member countries but including in any case France, Germany, Italy, Spain and the United Kingdom regardless of whether they are then-current member countries. 1.32 “Euro” or “EUR” means Euros, the currency of the European Union. 1.33 “Executive Officers” means (a) for Radius, [*]; and (b) for Licensee, [*]. In the event that the position of any of the Executive Officers identified in this Section 1.33 no longer exists due to a corporate reorganization, corporate restructuring or the like that results in the elimination of the identified position, the applicable Executive Officer will be replaced with another executive officer with responsibilities and seniority comparable to the eliminated Executive Officer. 1.34 “FDA” means the United States Food and Drug Administration or any successor agency thereto. 1.35 “Field” means [*]. 1.36 “First Commercial Sale” means, with respect to any Licensed Product in a given country or region in the Territory, the first sale of such Licensed Product in such country or region. Notwithstanding the foregoing, sales for Clinical Studies purposes or compassionate or similar use will not be considered to constitute a First Commercial Sale. For clarity, First Commercial Sale will be determined on a Licensed Product-by-Licensed Product and country-by-country (or region-by-region) basis, as applicable. 1.37 “Generic Product” means, with respect to a particular Licensed Product in a country, a generic pharmaceutical product that: (a) (i) contains the same active ingredient as the Licensed Compound in such Licensed Product; and (ii) is approved for use in such country by a Regulatory Authority through an Abbreviated New Drug Application (as permitted in the United States of America pursuant to the Federal Food, Drug, and Cosmetic Act, as amended, and the regulations promulgated thereunder, pursuant to Article 10.1 of Directive 2001/83/EC of the European Parliament and Council of 6 November 2001, as amended, or any enabling legislation thereof, or pursuant to any similar abbreviated route of approval in any other countries in the Territory); or (b) (i) contains the same active ingredient as the Licensed Compound in such Licensed Product; and (ii) is approved for use in such country by a Regulatory Authority through a regulatory pathway referencing clinical data first submitted by a Party or its Affiliates or Sublicensees for obtaining Regulatory Approval for such Licensed Product. 1.38 “Good Clinical Practice” means the current standards for clinical trials for pharmaceuticals, as set forth in the ICH guidelines and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good clinical practice as are required by any organizations and Governmental Authorities in countries in which a Licensed Product is intended to be sold to the extent such standards are not less stringent than United States Good Clinical Practice. 1.39 “Good Laboratory Practice” means the current standards for laboratory activities for pharmaceuticals, as set forth in the FDA’s Good Laboratory Practice regulations or the Good Laboratory Practice principles of the Organization for Economic Co-Operation and Development, as amended from time to time, and such standards of good laboratory practice as are required by any organizations and Governmental Authorities in countries in which a Licensed Product is intended to be sold, to the extent such standards are not less stringent than United States Good Laboratory Practice. 1.40 “Good Manufacturing Practice” means the part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use as defined in 21 C.F.R. § 210 and 211, European Directive 2003/94/EC, Eudralex 4, 5


 
LICENSE AGREEMENT Annex 16 (in each case as amended), and applicable United States, EU, Canadian and ICH Guidance or regulatory requirements for a Licensed Product. 1.41 “Governmental Authority” means any United States federal, state or local or any foreign government, or political subdivision thereof, or any multinational organization or authority or any authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof), or any governmental arbitrator or arbitral body. 1.42 “ICH” means the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. 1.43 “In-License Agreements” means the Duke License Agreement and Eisai License Agreement. 1.44 “IND” means an Investigational New Drug application, Clinical Study Application, Clinical Trial Exemption, or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority (which in countries of the E.U. and in other markets may include an “Investigational Medicinal Product Dossier” or “IMPD” filed or to be filed as part of the application to the relevant Regulatory Authority). 1.45 “Indication” means a disease (a) for which a Licensed Product is indicated for treatment and (ii) that is described in the Licensed Product label as required by the Regulatory Approval granted by the applicable Regulatory Authority. An Indication is only distinct from another Indication (a) if the diseases associated with such Indications are listed in two (2) different blocks of the ICD-10 and (b) Regulatory Approvals are based, in whole or in part, on separate clinical studies. 1.46 “Japan” means Japan, including its territories and possessions. 1.47 “Joint Inventions” has the meaning set forth in Clause 1.10 of Exhibit G. 1.48 “Joint Patent Agreement” has the meaning set forth in Clause 1.10 of Exhibit G. 1.49 “Joint Patents” has the meaning set forth in Clause 1.10 of Exhibit G. 1.50 “Know-How” means know-how, trade secrets, chemical and biological materials, formulations, information, documents, studies, results, data and regulatory approvals, data (including from Clinical Studies), filings and correspondence (including DMFs), including biological, chemical, pharmacological, toxicological, pre-clinical, clinical and assay data, manufacturing processes and data, specifications, sourcing information, assays, and quality control and testing procedures, whether or not patented or patentable. 1.51 “Knowledge” means the actual knowledge of a Party or any of its Affiliates without any duty of inquiry. 1.52 “Law” means any federal, state, provincial, local, international or multinational law, statute, standard, ordinance, code, rule, regulation, resolution or promulgation, or any order, writ, judgment, injunction, decree, stipulation, ruling, determination or award entered by or with any Governmental Authority, or any license, franchise, permit or similar right granted under any of the foregoing, or any similar provision having the force or effect of law. 6


 
LICENSE AGREEMENT 1.53 “Licensed Compound” means the compound known as elacestrant (RAD1901), as further described on Exhibit B, the backup compounds listed on Schedule 1.53, and in each case, any modification, improvement, derivative or Structural Analog thereof, including any metabolite, salt, ester, free acid form, free base form, crystalline form, amorphous form, pro-drug form, racemate, chelate, polymorph, tautomer, solvate, or optical isomer thereof. 1.54 “Licensed Product” means any pharmaceutical product containing any Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms. For clarification, Licensed Product will include any Combination. 1.55 “Licensee-Eisai Joint Invention” has the meaning set forth in Clause 1.4 of Exhibit G. 1.56 “Licensee-Eisai Joint Patent” has the meaning set forth in Clause 1.10 of Exhibit G. 1.57 “Licensee-Invented Patents” has the meaning set forth in the preamble to Exhibit G. 1.58 “Loss of Market Exclusivity” means an event where, with respect to any Licensed Product in any country one or more Generic Products are being marketed in such country. 1.59 “Loss of Market Exclusivity Initial Threshold” means, on a Licensed Product-by-Licensed Product and country-by-country basis, (a) Loss of Market Exclusivity has occurred for such Licensed Product in such country, and (b) average quarterly total aggregate sales in value of such Licensed Product sold in that country during any Calendar Quarter following introduction of such Generic Product in such country have fallen by at least [*] ([*]) in that country as compared to the average quarterly total aggregate sales in value of such Licensed Product sold in such country during the last [*] ([*]) full Calendar Quarters prior to the Calendar Quarter in which such Generic Product was first introduced. 1.60 “MAA” means (a) a marketing authorization application filed with (i) the EMA under the centralized EMA filing procedure or (ii) a Regulatory Authority in any country of the European Union if the centralized EMA filing procedure is not used or (b) any other equivalent or related regulatory submission, in either case to gain approval to market a Licensed Product in any country in or outside the European Union, in each case including, for clarity, amendments thereto and supplemental applications. 1.61 “Major Market Countries” means each of China, France, Germany, Italy, Spain, the United States and the United Kingdom. 1.62 “Manufacture” or “Manufacturing” means activities related to the manufacture, formulation and packaging of any compound or product, including any Licensed Compounds and Licensed Products, including related quality control and quality assurance and product release activities. 1.63 “NDA” means a New Drug Application filed with the FDA (including amendments and supplements thereto) to obtain Regulatory Approval in the U.S., or any corresponding applications or submissions filed with the relevant Regulatory Authorities to obtain Regulatory Approvals in any other country or region in the Territory (including any MAA). 1.64 “Net Sales” means the aggregate amount billed, invoiced or otherwise charged by Licensee, its Affiliates or Sublicensees for the sale of the Licensed Products to a Third Party in the Territory, less the following deductions related to Licensed Products, to the extent such deductions are actually paid or incurred, and are reasonable and customary: [*]. Net Sales will be determined from the books and records of Licensee, its Affiliates and Sublicensees maintained in accordance with the Accounting Standards. Net Sales for any Combination will be calculated on a country-by-country basis by multiplying actual Net Sales 7


 
LICENSE AGREEMENT of such Combination by the fraction A/B, where A is the gross invoice price for the Licensed Product contained in such Combination if such Licensed Product is sold separately in finished form in such country, and B is the gross invoice price for such Combination in such country. If such Licensed Product is not sold separately in finished form in such country, the Parties will determine Net Sales for such Licensed Product by mutual agreement based on the relative contribution of such Licensed Product and each such other active ingredients in such Combination in accordance with the above formula, and will take into account in good faith any applicable allocations and calculations that may have been made for the same period in other countries. 1.65 “Patent Challenge” means any challenge in a legal or administrative proceeding to the patentability, validity or enforceability of any of the Radius Patent Rights (or any claim thereof), including by: (a) filing or pursuing a declaratory judgment action in which any of the Radius Patent Rights is alleged to be invalid or unenforceable; (b) citing prior art against any of the Radius Patent Rights (other than art required to be cited under a duty of candor to a patent office), filing a request for or pursuing a re- examination of any of the Radius Patent Rights (other than with Radius’s written agreement), or becoming a party to or pursuing an interference; or (c) filing or pursuing any re-examination, opposition, cancellation, nullity or other like proceedings against any of the Radius Patent Rights; but excluding any challenge raised as a defense against a claim, action or proceeding asserted by Radius or its Affiliates against Licensee or its Affiliates or Sublicensees. 1.66 “Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, beneficiary or trustee of any trust, incorporated association, joint venture, or similar entity or organization, including a government or political subdivision or department or agency of a government. 1.67 “Phase 3 Clinical Study” means a clinical study of a product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar clinical study prescribed by the Regulatory Authorities in a foreign country. 1.68 “Pivotal Study” means, with respect to any Licensed Product, a clinical study that at the time of initiation (or any later point, if applicable), is expected or otherwise designed to provide the basis for submitting an application for Regulatory Approval for such Licensed Product thereof, including but not limited to a Phase II/III clinical study or Phase IIb clinical study. 1.69 “Prosecute” or “Prosecution” means in relation to any patent rights, (a) to prepare and file patent applications, including re-examinations or re-issues thereof, and represent applicants or assignees before relevant patent offices or other relevant Governmental Authorities during examination, re- examination and re-issue thereof, in appeal processes and interferences, or any equivalent proceedings, (b) to defend all such applications against Third Party oppositions or other challenges, (c) to secure the grant of any patents arising from such patent application, (d) to maintain in force any issued patent (including through payment of any relevant maintenance fees), (e) obtain and maintain patent term extension or supplemental protection certificates or their equivalents, and (f) to make all decisions with regard to any of the foregoing activities. 1.70 “Prosecuting Party” has, with respect to a Joint Patent, the meaning set forth in Clause 1.10 of Exhibit G. 1.71 “Radius-Eisai Joint Invention” has the meaning set forth in the preamble to Exhibit G. 8


 
LICENSE AGREEMENT 1.72 “Radius-Eisai Joint Patent” has the meaning set forth in the preamble to Exhibit G. The Radius-Eisai Joint Patents existing as of the Effective Date are set forth in Exhibit C-3. 1.73 “Radius-Invented Patent Prosecution and Maintenance Costs” has the meaning set forth in Clause 1.9 of Exhibit G. 1.74 “Radius-Invented Patents” has the meaning set forth in the preamble to Exhibit G. The Radius-Invented Patents existing as of the Effective Date are set forth in Exhibit C-3. 1.75 “Radius Know-How” means (a) all Know-How Controlled by Radius or any of its Affiliates as of the Effective Date and that is solely related to the Licensed Compounds or Licensed Products, and (b) all Know-How within the TSA Inventions. 1.76 “Radius Patent Rights” means (a) the patents and patent applications listed in Exhibit C-1, C-2 and C-3 attached hereto, plus any conversion, continuation, division or substitution thereon, any reissues, reexaminations or extensions thereof, any continuation-in-part application or patent that is entitled to the priority date of, and is directed specifically to subject matter specifically described in, at least one of the patents or patent applications described above, and any foreign counterparts of any of the foregoing, and (b) all patents and patent applications that specifically claim or cover the TSA Inventions, plus any conversion, continuation, division or substitution thereon, any reissues, reexaminations or extensions thereof, any continuation-in-part application or patent that is entitled to the priority date of, and is directed specifically to subject matter specifically described in, at least one of the patents or patent applications described above, and any foreign counterparts of any of the foregoing. For the sake of clarity, the Radius Patent Rights include the Duke Patent Rights, the Eisai Patents, the Joint Patents and the Radius-Invented Patents. 1.77 “Regulatory Approval” means, with respect to a country or region in the Territory, approvals, licenses, registrations or authorizations from the relevant Regulatory Authority necessary in order to import, distribute, market or sell a pharmaceutical product (including any Licensed Product) in such country or region, but not including any pricing or reimbursement approvals. Regulatory Approvals include approvals by the relevant Regulatory Authority of an NDA. 1.78 “Regulatory Authority” means the FDA, the EMA, and any other analogous government regulatory authority or agency involved in granting approvals (including any required pricing or reimbursement approvals) for the Development, Manufacture or Commercialization of any pharmaceutical product (including any Licensed Product) in the Territory. 1.79 “Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a Licensed Product other than patent rights, including, without limitation, rights conferred in the U.S. under the Hatch-Waxman Act or the FDA Modernization Act of 1997 (including pediatric exclusivity), orphan drug exclusivity, or rights similar thereto outside the U.S. 1.80 “Regulatory Filing” means any documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to any compound or product (including any Licensed Compound or Licensed Product), or its use or potential use in humans, including any documents submitted to any Regulatory Authority and all supporting data, including INDs and NDAs, and all correspondence with any Regulatory Authority with respect to such compound or product (including minutes of any meetings, telephone conferences or discussions with any Regulatory Authority). 1.81 [*]. 9


 
LICENSE AGREEMENT 1.82 “Structural Analog” means a compound covered by the chemical structure set forth on Schedule 1.82. 1.83 “Sublicensee” means any Affiliate of Licensee or any Third Party that is granted a license or sublicense by Licensee in accordance with Section 2.2 with respect to the Licensed Compound or Licensed Product. 1.84 “Territory” means worldwide. 1.85 “Third Party” means any Person other than Licensee or Radius or any of their respective Affiliates. 1.86 “Transfer Inventory” means the Licensed Compounds and Licensed Products and other materials and data listed on a schedule to be mutually agreed by the Parties in the Transition Services Agreement in the quantities as set forth therein, in the form in which it exists as of the Effective Date and to the extent such can be transferred in compliance with applicable Laws and in accordance with the relevant informed consents. 1.87 “TSA Inventions” has the meaning set forth in the Transition Services Agreement. 1.88 “United States” or “U.S.” means the United States of America, including its territories and possessions, and the District of Columbia. 1.89 “US$” means US dollars, the currency of the U.S. The following additional defined terms have the meanings set forth in the section indicated: Defined Term Section Additional Payment Section 7.5(e)(iii) Affected Party Section 11.3 Agreement Introductory Paragraph Alternative Product Section 2.3(b) Bankruptcy Event Section 11.3 Claim Section 10.6(c) 10.6(c) CREATE Act Section 8.1(g) CRE Considerations Section 1.11 Disclosing Party Section 9.1(a) Effective Date Introductory Paragraph Existing Licensed Product Contracts Section 3.3 Generic Step-Down Rate Section 7.3(c)(ii) Hatch-Waxman Time Period Section 8.2(b) Indemnitee Section 10.6(c) Indemnitor Section 10.6(c) Issuing Party Section 9.2(c) Licensee Introductory Paragraph Licensee Indemnitees Section 10.6(b) Losses Section 10.6(a) Milestone Events Section 7.2(a) Milestone Payments Section 7.2(a) Non-Publishing Party Section 9.2(e) 10


 
LICENSE AGREEMENT Party Introductory Paragraph Publishing Party Section 9.2(e) Radius Introductory Paragraph Radius Indemnitees Section 10.6(a) Receiving Party Section 9.1(a) Release Section 9.2(c) Reversion IP Section 11.7(f) Reviewing Party Section 9.2(c) Sublicense Section 2.2(b) Term Section 11.1 Transition Services Agreement Section 3.4 U.S. Know-How Step-Down Rate Section 7.3(c)(i) Withholding Action Section 7.5(e)(ii) Section 2. License Grants. 2.1 License Grants. (a) Subject to the terms and conditions of this Agreement, Radius, on behalf of itself and its Affiliates, hereby grants to Licensee a non-transferable (except in accordance with Section 12.1), exclusive (even as to Radius), royalty-bearing license, with the right to sublicense in accordance with Section 2.2 only, under the Radius Patent Rights and Radius Know-How, to Develop, have Developed, make, have made, use, sell, offer for sale, Commercialize, import and export one or more Licensed Compound(s) and Licensed Product(s) in the Field in the Territory. (b) Notwithstanding the exclusive license granted to Licensee in Section 2.1(a), Radius and its Affiliates will retain the non-exclusive rights under the Radius Patent Rights and Radius Know-How to (i) make, have made, use and have used Licensed Compounds, and Licensed Products for non-clinical and clinical research purposes, and (ii) to exercise its rights and perform its obligations under the Transition Services Agreement. The licenses granted in this Section 2.1 will not grant or create (by implication, estoppel or otherwise) any license or right under any Radius Patent Rights or Radius Know- How to Develop, Manufacture or Commercialize any molecule that is not a Licensed Compound or Licensed Product. The foregoing retained rights are sublicensable by Radius to Third Parties only with the prior written consent of Licensee, which consent will not be unreasonably withheld, conditioned or delayed. 2.2 Sublicenses. (a) Licensee may grant sublicenses (or any options to a sublicense) of the rights granted by Radius to Licensee hereunder (i) to its Affiliates without prior written consent, and (ii) to Third Parties only with the prior written consent of Radius. (b) Each sublicense (or any option to a sublicense) granted by a Licensee to a Third Party pursuant to this Section 2.2 (each a “Sublicense”) will (i) be in writing; (ii) be subject and subordinate to, and consistent with, the terms and conditions of this Agreement; (iii) require the applicable Sublicensee to comply with all applicable terms of this Agreement (except for the payment obligations, for which Licensee will remain responsible) and contain such obligations as to permit Licensee to comply with its obligations under this Agreement and to permit Radius to comply with Radius’ obligations under the In-License Agreements. Licensee will provide Radius with a copy of each agreement containing any Sublicense or any amendment or modification to any Sublicense within [*] ([*]) days of execution. No 11


 
LICENSE AGREEMENT Sublicense will diminish, reduce or eliminate any obligation of Licensee under this Agreement, and Licensee will remain responsible for its obligations under this Agreement and will be responsible for the performance of the relevant Sublicensee as if such Sublicensee were “Licensee” hereunder. Each Sublicense granted by Licensee to any rights licensed to it hereunder will terminate immediately upon the termination of the license from Radius to Licensee with respect to such rights. 2.3 Exclusivity and Alternative Products. (a) Exclusivity. Beginning on the Effective Date until the date that is [*], except pursuant to the terms of this Agreement, neither Licensee nor any of its Affiliates shall (alone or with or for any Third Party) [*]. To Licensee’s Knowledge, as of the Effective Date, neither Licensee nor any of its Affiliates owns or otherwise in-licenses any compound or product that qualifies as an Alternative Product hereunder. (b) For purposes hereof, “Alternative Product” means [*]. 2.4 License Limitations and In-License Agreements. (a) Except as expressly set forth in this Agreement, no licenses or other rights are granted or created hereunder to use any patent right, Know-How or other intellectual property rights owned or in-licensed by Radius or any of its Affiliates. All licenses and other rights are or will be granted only as expressly provided in this Agreement, and no other licenses or other rights are or will be created or granted hereunder by implication, estoppel or otherwise. (b) Radius represents to Licensee, and Licensee acknowledges, that sublicenses granted to Licensee under Section 2.1(a) are subject to the rights and obligations of Radius under the In- License Agreements. Radius will comply with all applicable provisions of the In-License Agreements, and will perform and take such actions as may be required to allow Radius to comply with its obligations thereunder. In addition, Radius shall not amend or modify the In-License Agreements in a way that would have a material adverse effect on Licensee’s rights and obligations hereunder without Licensee’s consent. Licensee shall perform under this Agreement and shall take all reasonable actions required by Radius to permit Radius to comply with Radius’ obligations under the In-License Agreements. Section 3. Transfer of Radius Know-How; Transfer Inventory; Existing Licensed Product Agreements; Transition Services. 3.1 Radius Know-How. During the [*] ([*]) day period following the Effective Date, Radius will provide to Licensee one (1) electronic copy of all documents, data or other information in Radius’s or its Affiliates possession or Control as of the Effective Date to the extent that such documents, data or other information describe or contain Radius Know-How and the relevant know-how of Radius’ licensors and Third Party providers concerning the Licensed Compound and the Licensed Product. During the term of the Transition Services Agreement, Radius will continue to deliver to Licensee all Radius Know-How with respect to Licensed Compound and Licensed Product in Radius’s or its Affiliates possession or Control. 3.2 Transfer Inventory. As set forth in the Transition Services Agreement, Radius will transfer to Licensee, at Licensee’s sole cost (including both for the transfer and Radius’ and its Affiliates’ fully burdened manufacturing costs therefor), all Transfer Inventory in accordance with a schedule to be mutually agreed by the Parties; provided, however, that such transfer timeline may be reasonably extended for items that, despite Diligent Efforts by Radius, are not practicable to transfer within such time period, in which case Radius will continue to use Diligent Efforts to transfer such items as promptly as practicable after such period. 12


 
LICENSE AGREEMENT 3.3 Existing Licensed Product Agreements. Radius has entered into certain contracts, listed on an exhibit to the Transition Services Agreement, with Third Parties, which contracts relate solely to the Development, Manufacture or Commercialization of any Licensed Compound or Licensed Product (the “Existing Licensed Product Contracts”). Upon Licensee’s request, Radius will use Diligent Efforts (subject, as applicable, to the applicable terms thereof, including any consent of the counterparty thereto) to obtain, as applicable, the consent of the counterparty to assign and to assign the Existing Licensed Product Contracts to Licensee. After such assignment, Licensee will be solely responsible for the performance of the obligations (including payment obligations), which arise on or after the relevant assignment date, under the Existing Licensed Product Contracts. 3.4 Transition Services Agreement. On the Effective Date, the Parties will execute the transition services agreement in a form substantially identical to the one attached hereto as Exhibit D (the “Transition Services Agreement”), pursuant to which Radius will perform certain clinical, regulatory and other activities in the interest of Licensee relating to the Licensed Compounds, Licensed Products and, to the extent applicable, Companion Diagnostic. Section 4. Development. 4.1 Development Plan; Amendments; Development Responsibilities. (a) Development Plan. Except as set forth in the Transition Services Agreement, the global Development of the Licensed Compounds and Licensed Products, including pre-clinical Development activities, if any, will be governed by the Development Plan. Licensee agrees to exercise Commercially Reasonable Efforts to conduct all Development activities relating to the Licensed Products as a monotherapy in the Major Market Countries in accordance with the Development Plan (except for those activities for which Radius is responsible under the Transition Services Agreement) at Licensee’s sole cost and expense. Additionally, during the Term Licensee will continue evaluating the opportunity to Develop Combinations, provided that Licensee shall not be under any obligation to Develop Combinations. The outcome of such evaluations will be shared with Radius. Licensee may not Develop, Commercialize, or otherwise exploit any Combination Product without Radius’ prior written consent, not to be unreasonably withheld. (b) Transition Services. The Parties acknowledge that pursuant to the Transition Services Agreement, Radius is responsible for performing the Services (as defined in the Transition Services Agreement) in accordance with the Development Plan and with the Services Schedules (as defined in the Transition Services Agreement), and the Transition Services Agreement provides for the reimbursement by Licensee of the costs incurred by Radius in performing such Services in accordance with the Development Budget set forth therein. Within [*] ([*]) months after the Effective Date of this Agreement, Licensee will provide Radius with a Development Plan relating to the Licensed Product as a monotherapy for the registration of the Licensed Product outside the U.S.. Licensee may amend the Development Plan during the Term; provided that any such amendment is consistent with the Parties’ respective Development obligations set forth in Section 4.2 and in the Transition Services Agreement with the aim at allowing the Licensed Product to enter into the market as soon as practicable in such Major Market Countries. The Development Plan will include overall total estimated budget figures for the initial Development Budget as described in Section 4.1(b). The Development Plan will include general study design parameters, specific staffing requirements and the funding budget for each stage of clinical Development for each Indication in the Development Plan, and will be consistent with the terms of this Agreement. The terms of and activities set forth in the Development Plan will at all times be designed to be in compliance with all applicable Laws and to be conducted in accordance with professional and ethical standards customary in the pharmaceutical industry. 13


 
LICENSE AGREEMENT (c) Development Budget. The Development Budget included in the Development Plan will set forth the estimated budgeted amounts for Development costs and expenses under the Development Plan. Within [*] ([*]) months after the Effective Date of this Agreement, Licensee will share with Radius a Development Budget relating to the Development Plan of Licensed Product monotherapy for the seeking of Regulatory Approval of the Licensed Product in the Major Market Countries outside of the United States. Licensee may amend the Development Budget for the Major Market Countries during the Term, always with the aim at allowing the Licensed Product to enter into the market as soon as practicable in such Major Market Countries. Concurrently with the annual update of the Development Plan in accordance with Section 4.2(c), Licensee also will prepare an updated Development Budget covering the next Calendar Year and the two (2) succeeding Calendar Quarters thereafter and a forecast of the annual development budgets through receipt of Regulatory Approval for each Indication reflected in such Development Budget. (d) Updates to Development Plan. Should the Development Services be transferred to Licensee pursuant to the provisions of the Transition Services Agreement and Radius receives notices from Eisai which indicates that Eisai does not believe performance of the Development Plan is consistent with the obligations to use Commercially Reasonable Efforts in Developing Licensed Compound and/or Licensed Product in the Territory, Radius shall inform Licensee and the Parties shall immediately meet to discuss in good faith on possible actions or conducts that the Parties would consider to be an acceptable remediation of such inconsistency versus Eisai’s indications and in order to prevent any possible complaint by Eisai. 4.2 Development Efforts; Manner of Performance; Reports. (a) Licensee Development Efforts. Without limiting the foregoing sentence and except as set forth in the Transition Services Agreement, Licensee will use Commercially Reasonable Efforts to seek and attempt to obtain Regulatory Approval for Licensed Products as monotherapy in each of the Major Market Countries. Without limiting the generality of the foregoing, and except as set forth in the Transition Services Agreement, Licensee will use Commercially Reasonable Efforts to execute and perform, or cause to be performed, the Development Plan, in accordance with the timelines set forth therein. Licensee will conduct its Development activities in good scientific manner and in compliance with applicable Law, including Laws regarding environmental, safety and industrial hygiene, any applicable anti-corruption or anti-bribery laws or regulations, and Good Laboratory Practice, Good Clinical Practice, current standards for pharmacovigilance practice, and all applicable requirements relating to the protection of human subjects. (b) Cost and Expense. Licensee will be responsible for the costs and expenses for all Development activities under this Agreement in compliance with the Development Plan and Development Budget and will keep Radius reasonably informed as to the progress of such activities. (c) Development Reports and Updates. Licensee will, through receipt of Regulatory Approval for each Indication reflected in the Development Plan and with respect to its own Development activities, (i) provide to Radius each Calendar Quarter, a written progress report that includes, as applicable, information regarding accrual, site initiation, progress on protocol writing, meeting requests and briefing documents, in the case of clinical or regulatory activities, and in other cases such information as is reasonably necessary to convey a reasonably comprehensive understanding of the status of the applicable Development activity, (ii) annually, together with the progress report delivered during the Calendar Quarter that includes the anniversary of the Effective Date, Licensee shall provide Radius with a copy of the then-current Development Plan and Development Budget and (iii) upon the request of Radius, no more than once per Calendar Year, representatives of Licensee shall participate in a telephone conference with Radius’ representatives to provide an oral update on and answer Radius’ questions 14


 
LICENSE AGREEMENT regarding Licensee’s progress in the Development of the Licensed Compounds and Licensed Products (including to discuss the information in (i) and (ii) above). In addition to the foregoing, Licensee will provide notice to Radius if Licensee elects to suspend or no longer proceed with Developing or Commercializing any Licensed Compounds or Licensed Products for any Indication. (d) Compliance Audits. With respect to any facility or site at which Licensee conducts Development activities pursuant to this Agreement or the Development Plan, Radius will have the right, at its expense, upon reasonable written notice to Licensee (and if applicable, such Affiliate), and during normal business hours, to inspect such site and facility and any records relating thereto once per year, or more often with reasonable cause, to verify Licensee’s compliance with the terms of this Agreement pertaining to Development of the Licensed Compounds and Licensed Products pursuant to all applicable Laws, including Good Laboratory Practices, Good Clinical Practices and current standards for pharmacovigilance practice. Such inspection will be subject to the confidentiality provisions set forth in Section 9. 4.3 Regulatory Submissions and Regulatory Approvals. (a) Regulatory Responsibilities. As of the Effective Date, except as set forth in the Transition Services Agreement, Licensee will be responsible, at its sole cost and expense, to use its Commercially Reasonable Efforts to seek and attempt to (i) obtain all Regulatory Approvals for the Licensed Product in monotherapy in the Field in the Major Market Countries, (ii) following Regulatory Approval to continue active, diligent marketing efforts throughout the life of this Agreement, and (iii) following Regulatory Approval, to obtain and retain any governmental approvals to manufacture and/or sell Licensed Products for all relevant activities of Licensee and Sublicensees. Further, for the sake of clarity, Licensee shall use Commercially Reasonable Efforts to make commercially reasonable amounts of Licensed Products available. (b) Transfer of Regulatory Filings. As soon as reasonably practicable after the Effective Date, but with an effort to avoid any adverse impact on or disruption to the activities under the Transition Services Agreement, at Licensee’s cost, Radius will use Commercially Reasonable Efforts to transfer and assign to Licensee Radius’s entire right, title, and interest in and to all INDs, other Regulatory Filings, and other regulatory documentation in the Territory with respect to all Licensed Compounds and Licensed Products, in each case, that is in the possession and control of Radius, excluding any drug master files maintained by Radius or a Third Party solely with respect thereto. (c) Ownership of Regulatory Approvals. Licensee will own all regulatory submissions, including all applications, for Regulatory Approvals for the Licensed Products in the Field in the Territory filed after the Effective Date. (d) Pricing and Reimbursement Approvals. Licensee will be responsible for and have the exclusive right to seek and attempt to obtain pricing and reimbursement approvals for the Licensed Products in the Field in the Territory, provided that Licensee will keep Radius reasonably informed with regard to any pricing or reimbursement approval proceedings for the Licensed Products in the Field in the Territory. Section 5. Commercialization. 5.1 Commercialization Plan and Budget. (a) Commercialization Plan. The Commercialization of the Licensed Products in the Field in the Territory will be governed by the Commercialization Plan. The Commercialization Plan will 15


 
LICENSE AGREEMENT be updated annually as provided in Section 5.2(c). Any updated Commercialization Plan will include at a minimum, a situation analysis and an overall strategy for the Commercialization of the Licensed Products in the Field throughout the Territory (including branding, positioning, promotional materials, market preparation, field force size, etc.), strategies for detailing and promotion of the Licensed Products in the Territory, the Commercialization Budget, Net Sales and market forecasts for the Territory, and an anticipated timeline for Commercialization of the Licensed Products throughout the Territory. The terms of and activities set forth in the Commercialization Plan will at all times be designed to be in compliance with all applicable Laws and to be conducted in accordance with professional and ethical standards customary in the pharmaceutical industry. Notwithstanding the foregoing, Licensee shall be free to reasonably update, change and modify the Commercialization Plan; such updates, changes and modifications shall be shared with Radius. (b) Commercialization Budget. The Commercialization Budget included in any updated Commercialization Plan will be a written budget setting forth the budgeted amounts for costs with respect to activities set forth in the Commercialization Plan during the then-current Calendar Year and the two (2) succeeding Calendar Quarters thereafter, broken down by Calendar Quarter. Such Commercialization Budget also will include a breakout of costs by functional area or category (and may set forth budgets for Commercialization activities in the Territory on a regional basis, rather than a country-by-country basis, defining the regions in a manner consistent with Licensee’s internal procedures). Notwithstanding the foregoing, Licensee shall be free to reasonably update, change and modify the Commercialization Budget and will keep Radius reasonably informed as to such updates, changes and modifications. 5.2 Commercialization Efforts; Manner of Performance; Reports. (a) Commercialization Efforts. Licensee will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Territory in each of the Major Market Countries. Without limiting the generality of the foregoing, Licensee will use Commercially Reasonable Efforts to execute and to perform, or cause to be performed, the Commercialization Plan. (b) Cost and Expense. Licensee will be responsible, at its sole cost and expense, for all Commercialization activities under this Agreement or the Commercialization Plan and will keep Radius reasonably informed as to the progress of such activities. (c) Commercialization Reports. During the Term and following the First Commercial Sale of a Licensed Product, Licensee will provide to Radius (i) annually, a copy of the then- current Commercialization Plan and Commercialization Budget and (ii) upon the request of Radius no more than once per Calendar Year, representatives of Licensee will provide an oral update on Licensee’s progress in the Commercialization of the Licensed Compounds and Licensed Products. Further, Licensee will provide notice to Radius if Licensee elects to suspend or no longer proceed with Commercializing any Licensed Compounds or Licensed Products. Section 6. Manufacturing. 6.1 Except to the extent otherwise provided in the Transition Services Agreement, Licensee will be solely responsible, at its cost and expense, for Manufacturing and supplying the requirements for the Development and Commercialization of the Licensed Compounds and Licensed Products in the Territory. Section 7. Licensee Payments. 16


 
LICENSE AGREEMENT 7.1 Initial License Fee. Licensee will pay to Radius within [*] ([*]) days after the Effective Date a one-time payment of thirty million US dollars (US$30,000,000). Such payment will be non- refundable and non-creditable and not subject to set-off. 7.2 Milestone Payments. (a) As set forth in the following table, Licensee will make the following payments (the “Milestone Payments”) to Radius upon achievement of each of the milestone events set forth in the tables below (the “Milestone Events”) by Licensee or its Affiliates or Sublicensees. Each Milestone Payment will be payable by Licensee to Radius within [*] ([*]) days after the achievement of the corresponding Milestone Event. Such payments will be non-refundable and non-creditable and not subject to set-off (except as provided in Section 11.9). Development and Commercialization Milestones No. Development Milestone Event Milestone Payment 1 [*] [*] 2 [*] [*] 3 [*] [*] If, [*], then (i) Milestone Payment 2 set forth above will become payable [*], and (ii) Milestone Payment 3 set forth above will become payable upon [*]. If, [*], then (i) Milestone Payment No. 2 set forth above will be [*] and will become payable upon [*], and (ii) Milestone Payment No. 3 set forth above will be [*] and will become payable upon [*]. Sales Milestones Sales Milestone Event Milestone Payment Total Net Sales of Licensed Products in the Territory in a Calendar [*] Year equal to or greater than [*] Total Net Sales of Licensed Products in the Territory in a Calendar [*] Year equal to or greater than [*] Total Net Sales of Licensed Products in the Territory in a Calendar [*] Year equal to or greater than [*] Total Net Sales of Licensed Products in the Territory in a Calendar [*] Year equal to or greater than [*] Total Net Sales of Licensed Products in the Territory in a Calendar [*] Year equal to or greater than [*] 17


 
LICENSE AGREEMENT (b) Each of the Milestone Payments will be payable only once upon the first achievement of the corresponding Milestone Event, regardless of the number of Licensed Products that achieve such Milestone Event or the number of times the Milestone Event is achieved. (c) Multiple Total Net Sales Milestone Payments as set forth above shall be payable by Licensee in a given Calendar Year in the event two (2) or more Net Sales Milestones Events are achieved in the same Calendar Year. By way of example, [*] 7.3 Royalties. (a) Royalties. Licensee will pay to Radius royalties at the graduated royalty rates specified in the following table with respect to the aggregate annual Net Sales of all Licensed Products in the Territory in a Calendar Year: Aggregate Annual Worldwide Net Sales of All Licensed Products in a Calendar Year Royalty Rate Portion of aggregate Annual Net Sales up to and including [*] [*] Portion of aggregate Annual Net Sales greater than [*] up to and including [*] [*] Portion of aggregate Annual Net Sales greater than [*] up to and including [*] [*] Portion of aggregate Annual Net Sales by Licensee, its Affiliates and Sublicensees greater than [*] [*] The applicable royalty rate will be calculated as provided in this Section 7.3(a) by reference to the aggregate annual worldwide Net Sales of all Licensed Products. [*]. (b) Royalty Term. The royalties due under Section 7.3(a) will be payable on Net Sales from the First Commercial Sale of a particular Licensed Product until the latest of, on a country-by-country basis, [*]. (c) Royalty Reductions. (i) U.S. Sales. If royalties are payable under this Section 7.3 on Net Sales of a particular Licensed Product for use in the United States after the expiration of all U.S. Radius Patent Rights (including any applicable patent term extension) claiming the use, sale, offer for sale or importation of such Licensed Product, then the royalties payable on Net Sales of such Licensed Product for use in the United States will be calculated as set forth in Section 7.3(a), provided that the portion of the royalties payable on Net Sales of such Licensed Product for use in the United States will be reduced, subject to Section 7.3(c)(iv), by [*] ([*]) (the “U.S. Know-How Step-Down Rate”) after the date of expiration of all such U.S. Radius Patent Rights. For clarity, there will be no reduction on royalties payable on Net Sales of Licensed Products for use in any country or region in the Territory other than in the United States. (ii) Reduction for Generic Competition. Subject to Section 7.3(c)(iv), on a Licensed Product-by-Licensed Product and country-by-country basis, upon the First Commercial Sale of any Generic Product, as from the first Calendar Quarter this Section 7.3(c)(ii) applies, the applicable royalty 18


 
LICENSE AGREEMENT rates for annual Net Sales of such Licensed Product otherwise due in such country pursuant to Section 7.3(a): (1) for all countries of the Territory excluding US - will be reduced by [*] ([*]) (the “Generic Step-Down Rate”); (2) for US, will be reduced to [*] ([*]) of the amount for US under Section 7.3(a); provided, however, that the royalties payable on Net Sales for a Licensed Product in the United States shall not be reduced by more than [*] ([*]) in the aggregate pursuant to Sections 7.3(c)(i) and 7.3(c)(ii) with respect to the amount originally due under Section 7.3(a), unless in case of Loss of Market Exclusivity occurs in United States. (For the sake of clarity, further to the event set forth under Section 7.3(c)(i) above, the royalty due for the US to Radius under Section 7.3(a) will be reduced by [*]; upon the First Commercial Sale of any Generic Product in the US the royalty due for the US will be further reduced so that the total royalty due for the US will be [*] of the amount due for the US under Section 7.3(a)). Additionally, in the event of Loss of Market Exclusivity with respect to a Licensed Product in a country, as from the first Calendar Quarter this Section 7.3(c)(ii) applies the applicable royalty rates for annual Net Sales of such Licensed Product otherwise due in such country pursuant to Section 7.3(a) will be reduced by [*]. (iii) Third Party Payments. Without prejudice to Section 7.3(c)(iv), on a Licensed Product-by-Licensed Product and country-by-country basis, in the event that Licensee determines in good faith that patents controlled by a Third Party would be infringed by the manufacturing, use or sale of such Licensed Product in such country under this Agreement, Licensee may credit any amounts due to such Third Party in such country against the royalties due and payable by Licensee to Radius on the Net Sales for such Licensed Product in such Calendar Quarter in such country. (iv) Cumulative Reductions Floor. On a Licensed Product-by-Licensed Product and country-by-country basis, in no event will the royalties otherwise due to Radius for any Licensed Product in a Calendar Quarter in a given country during the royalty term for such Licensed Product be reduced by more than [*] ([*]) of the amount that would otherwise be due in such Calendar Quarter for such Licensed Product in such country but for the reductions set forth in Section 7.3(c)(i), Section 7.3(c)(ii), or Section 7.3(c)(iii). [*]. (d) Only One Royalty. Only one royalty will be due with respect to the sale of the same unit of Licensed Product. Only one royalty will be due hereunder on the sale of a Licensed Product even if the manufacture, use, sale, offer for sale or importation of such Licensed Product infringes more than one claim of the Radius Patent Rights. (e) No Other Deductions. Without prejudice to Section 7.5(e), there will be no other deductions or reductions to any royalties payable to Radius hereunder, except to the extent provided by Section 7.3(c). All royalty payments will be non-refundable and non-creditable and not subject to set-off (except as provided in Section 11.9). (f) Products Containing the Licensed Compound. Should, during the Term, any product containing the Licensed Compound which does not fall within the definition of Generic Product but which has received Regulatory Approval for the same indication(s) as the Licensed Product, lawfully enter the market in a given country(ies) of the Territory (and without infringing any of the Radius Patent Rights), the Parties shall promptly meet in order to discuss in good faith how to cope with this new scenario with the aim at preserving the commercial viability of the Licensed Product in the concerned country(ies). 7.4 Duke License Agreement and Eisai License Agreement Payments. For clarity, except for what is expressly provided for hereunder, Radius will be solely responsible for any and all payments, including all royalty and milestone payments provided for in the Duke License Agreement and Eisai License Agreement. 7.5 Payment Terms. 19


 
LICENSE AGREEMENT (a) Manner of Payment. All payments to be made by Licensee to Radius hereunder will be made in United States dollars by wire transfer to such bank account as Radius may designate. Licensee shall promptly establish and consistently employ a system of specific nomenclature and type designations for Licensed Products to permit identification and segregation of various types where necessary, and shall require Sublicensees to use the same nomenclature and type designations. (b) Reports and Royalty Payments. For as long as royalties are due under Section 7.3(a), Licensee will furnish to Radius (i) within [*] days after the end of each Calendar Quarter, a written report, showing the amount of Net Sales of Licensed Products and royalty due for such Calendar Quarter. Royalty payments for each Calendar Quarter will be due within [*] ([*]) days following the end of the relevant Calendar Quarter. The report will include, at a minimum, the following information for the applicable Calendar Quarter, each listed by product and by country of sale: (i) the number of units of Licensed Products sold by Licensee and its Affiliates and Sublicensees on which royalties are owed to Radius hereunder; (ii) the gross amount received for such sales; (iii) deductions (a) taken from Net Sales as specified in the definition thereof and (b) made pursuant to Section 7.5(e); (iv) Net Sales; (v) the royalties and Milestone Payments owed to Radius, listed by category; and (vi) the computations for any applicable currency conversions pursuant to Section 7.5(d). All such reports will be treated as Confidential Information of Licensee. (c) Records and Audits. Licensee will keep, and will cause each of its Affiliates and Sublicensees, as applicable, to keep adequate books and records of accounting for the purpose of calculating all amounts due to Radius hereunder. For the [*] ([*]) years following the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of Licensee’s Affiliates and Sublicensees, as applicable) will be kept at each of their principal place of business and will be open for inspection at reasonable times and upon reasonable notice by an independent certified accountant selected by Radius, and which is reasonably acceptable to Licensee, for the sole purpose of inspecting the amounts due to Radius under this Agreement. In no event will such inspections be conducted hereunder more frequently than once every [*] ([*]) months. Such accountant must have executed and delivered to Licensee and its Affiliates and Sublicensees, as applicable, a confidentiality agreement as reasonably requested by Licensee, which will include provisions limiting such accountant’s disclosure to Radius to only the consolidated results and basis for such results of such inspection. The results of such inspection, if any, will be binding on both Parties. Any underpayments will be paid by Licensee within [*] ([*]) days of notification of the results of such inspection. Any overpayments will be fully creditable against amounts payable in subsequent payment periods. Radius will pay for such inspections, except that in the event there is any upward adjustment in amounts payable for any Calendar Year shown by such inspection of more than [*] ([*]) of the amount paid, Licensee will reimburse Radius for any reasonable out-of-pocket costs of such accountant. Any underpayments or overpayments under this Section 7.5(c) will be subject to the currency exchange provisions set forth in Section 7.5(d) as applied to the Calendar Quarter during which the payment obligations giving rise to such underpayment or overpayment were incurred by Licensee. (d) Currency Exchange. With respect to Net Sales invoiced in United States dollars, the Net Sales and the amounts due to Radius hereunder will be expressed in United States dollars. With respect to Net Sales invoiced in a currency other than United States dollars, the Net Sales will be expressed in the domestic currency of the entity making the sale, together with the United States dollars equivalent, calculated based on standard methodologies employed by Licensee for consolidation purposes for the Calendar Quarter for which remittance is made for royalties. For purposes of calculating Net Sales as set forth in Section 7.3(a), the aggregate Net Sales with respect to each Calendar Quarter within a Calendar Year will be calculated based on the currency exchange rates for the Calendar Quarter in which such Net Sales occurred, in a manner consistent with the exchange rate procedures set forth in the immediately preceding sentence. 20


 
LICENSE AGREEMENT (e) Taxes. (i) If Licensee is required by the Law of any jurisdiction to deduct, or withhold any tax from any sum payable to Radius according to Sections 7.1.-7.3 above, such deduction or withholding of any tax will be deducted by Licensee as required by Law from such sum payable and shall be paid by Licensee to the proper tax authority. Official receipts indicating proof of payment of any withholding taxes shall be secured by Licensee and made available to Radius upon request. (ii) If, as a result of a Withholding Action by Licensee (including any assignee or successor), withholding is required by applicable Law and the amount of such withholding exceeds the amount of withholding that would have been required if Licensee had not committed the Withholding Action, then Licensee shall pay an additional amount to Radius such that, after withholding from the payment contemplated by this Agreement and such additional amount, Radius receives the same amount as it would have received from Licensee absent such Withholding Action by Licensee. If as a result of a Withholding Action by Radius (including any assignee or successor) the amount of withholding under the Law of the applicable jurisdiction exceeds the amount of such withholding that would have been required in the absence of such Withholding Action by Radius, Licensee shall not be required to pay any additional amount to Radius and any additional amount shall be paid to the proper tax authority according to Section 7.5(e)(i). A “Withholding Action” is defined as (a) a permitted assignment or sublicense of this Agreement (in whole or in part) by a Party to an Affiliate or a Third Party or the exercise by a Party of its rights under this Agreement (in whole or in part) through an Affiliate, or (b) a redomiciliation or change of tax residency of a Party. (iii) If, as a result of a change in Law after the Effective Date, any withholding or deduction of tax is imposed on any payment made by Licensee to Radius (other than as contemplated by Section 7.5(e)(ii)), Licensee shall pay additional amounts to Radius, such that, after giving effect to the tax withholding, Radius receives the payment net of the tax withholding plus [*] (“Additional Payment”). In order to receive the Additional Payment, Radius shall provide reasonable evidence to Licensee that Radius is unable to use the relevant amount to obtain double taxation relief by crediting it from its own corporation tax liability. Should Radius be able to partially or fully recover any amounts withheld or deducted that caused the Additional Payment, then the Additional Payment shall be reduced accordingly. (iv) The Parties will cooperate with each other in seeking exemption or reduction in the deduction or withholding of any tax under any double taxation or other similar treaty or agreement in force and in seeking to receive a refund of any withholding tax or to claim a foreign tax credit. If permitted and based on Licensee’s reasonable interpretation of German (and any other applicable) Law in consultation with Radius, and taking into account that Radius agrees to provide any documents relating to a claim for the benefits of the bilateral income tax treaty between the United States and Germany, including with respect to the 0% tax rate for “royalties”, Licensee shall not withhold on any payments made to Radius pursuant to this Agreement. (v) In addition, the Parties will cooperate in accordance with applicable Laws to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) in connection with this Agreement. (f) Blocked Payments. In the event that, by reason of applicable Law in any country, it becomes impossible or illegal for Licensee to transfer, or have transferred on its behalf, payments owed to Radius hereunder, Licensee will promptly notify Radius of the conditions preventing such transfer and such payments will be deposited in local currency in the relevant country to the credit of Radius in a recognized banking institution designated by Radius or, if none is designated by Radius within a period 21


 
LICENSE AGREEMENT of [*] ([*]) days, in a recognized banking institution selected by Licensee, as the case may be, and identified in a written notice given to Radius. (g) Interest Due. Licensee will pay Radius interest on any payments that are not paid on or before the date such payments are due under this Agreement at a rate of [*] calculated on the total number of days payment is delinquent. 7.6 Mutual Convenience. The royalty and other payment obligations set forth hereunder have been agreed to by the Parties for the purpose of reflecting and advancing their mutual convenience, including the ease of calculating and paying royalties and other amounts to Radius. Licensee hereby stipulates to the fairness and reasonableness of such royalty and other payments obligations and covenants not to allege or assert, nor to allow any of its Sublicensees or Affiliates to allege or assert, nor further to cause or support any other Third Parties to allege or assert, that any such royalty or other payments obligations are unenforceable or illegal in any way. Section 8. Patent Prosecution, Infringement and Extensions, Trademarks. 8.1 Prosecution and Maintenance. (a) The Prosecution and maintenance of all Duke Patent Rights shall be governed by Exhibit F and the Prosecution and maintenance of all Eisai Patents, Joint Patents, Radius-Invented Patents and Licensee-Invented Patents shall be governed by Exhibit G. The provisions in this Section 8.1 shall supplement Exhibit F and Exhibit G. (b) For so long as Licensee Prosecutes the patents and patent applications within the Radius Patent Rights pursuant to Exhibit F and Exhibit G, Radius shall promptly cooperate with Licensee’s reasonable requests for data, affidavits, and other information and assistance. Any reasonable and documented out-of-pocket costs and expenses incurred by Radius in connection with such requests shall be shared equally between the Parties; provided, however, that any expenses incurred in connection with such requests shall be shared equally between the Parties until [*]; provided that upon and following [*], Licensee shall bear [*]. (c) For so long as Licensee Prosecutes the patents and patent applications within the Radius Patent Rights and Licensee-Invented Patents pursuant to Exhibit F and Exhibit G, any reasonable and documented out-of-pocket costs incurred by Radius only in connection with the review of, and comments on, papers relating to the Prosecution of such patents and patent applications within the Radius Patent Rights and Licensee-Invented Patents that are provided by Licensee to Radius in accordance with Clause 1.2 of Exhibit F and Clauses 1.8 and 1.10 of Exhibit G shall be shared equally between the Parties; provided, however, that any expenses incurred in connection with such review and comments shall be shared equally between the Parties until [*] and that upon and following [*], Licensee shall bear [*]; and provided, further, that Licensee’s obligation to bear such costs shall be limited to [*]. (d) For so long as Licensee Prosecutes the patents and patent applications within the Radius Patent Rights and Licensee-Invented Patents, Licensee will have final decision-making authority with respect to the Prosecution of the patents and patent applications within the Radius Patent Rights and Licensee-Invented Patents that it Prosecutes in accordance with Exhibit F and Exhibit G; provided, however, that Licensee may not use such final decision-making authority in a manner inconsistent with the Duke License Agreement or the Eisai License Agreement. (e) In no event will any of the patents and patent applications within the Radius Patent Rights and Licensee-Invented Patents be permitted to lapse or be abandoned in any country without Radius 22


 
LICENSE AGREEMENT first being given an opportunity to assume full responsibility for the continued Prosecution of such patents or patent applications. Licensee will provide Radius with written notice of any decision not to continue the Prosecution of any patent application or patent within the Radius Patent Rights or the Licensee-Invented Patents in any country at least [*] ([*]) days prior to any filing deadline or pending lapse or abandonment thereof. Any such patent application(s) and patent(s) will remain a “Radius Patent Right” hereunder. (f) Patent Extensions; Orange Book Listings; Patent Certifications. (i) Patent Term Extension. If elections with respect to obtaining patent term extension or supplemental protection certificates or their equivalents in any country with respect to any Licensed Product becomes available, upon Regulatory Approval or otherwise, as between the Parties and subject to Exhibits F and G, Licensee will have the first right in accordance to file and maintain any such patent term extension or supplemental protection certificates or their equivalent for the Radius Patent Rights. (ii) Data Exclusivity and Orange Book Listings. With respect to data exclusivity periods (such as those periods listed in the Orange Book (including any available pediatric extensions) or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83, and all equivalents in any country), [*], in consultation with [*], will seek and maintain all such data exclusivity periods that may be available for any of the Licensed Products. [*] will determine which Radius Patent Rights and Licensee-Invented Patents, if any, will be listed in the Orange Book or any similar patent listing in any country with respect to the Licensed Products. (iii) Notification of Patent Certification. Each Party will notify and provide the other with copies of any allegations of alleged patent invalidity, unenforceability or non-infringement of a Radius Patent Right and Licensee-Invented Patents pursuant to a Paragraph IV Patent Certification by a Third Party filing an Abbreviated New Drug Application, an application under §505(b)(2) of the United States Federal Food, Drug, and Cosmetic Act (as amended or any replacement thereof), or any other similar patent certification by a Third Party, and any foreign equivalent thereof. (g) CREATE Act. Notwithstanding anything to the contrary in this Agreement, each Party will have the right to invoke the Cooperative Research and Technology Enhancement Act of 2004, 35 U.S.C. § 103(c)(2)-(c)(3) (the “CREATE Act”) when exercising its rights under this Agreement, but only with the prior written consent of the other Party in its sole discretion. In the event that a Party intends to invoke the CREATE Act, once agreed to by the other Party as required by the preceding sentence, it will notify the other Party and the other Party will cooperate and coordinate its activities with such Party with respect to any filings or other activities in support thereof. The Parties acknowledge and agree that this Agreement is a “joint research agreement” as defined in the CREATE Act. (h) Cooperation. Each Party will reasonably cooperate with the other Party in the Prosecution of the Radius Patent Rights. Such cooperation includes promptly executing all documents, or requiring inventors, subcontractors, employees and consultants and agents of such Party and its Affiliates, and for Licensee, Sublicensees, to execute all documents, as reasonable and appropriate so as to enable the Prosecution of any such Radius Patent Rights in any country. Furthermore, promptly at Licensee’s request, Radius shall (i) fully cooperate, and, to the extent needed, cause its Affiliates and use Diligent Efforts to have Eisai and Duke fully cooperate, with Licensee’s reasonable requests that Radius (or Eisai or Duke) execute and deliver documents, and do filings and take other actions in the future in order for Licensee to carry out the purposes of the Agreement, such cooperation not to be unreasonably denied or delayed, and (ii) fully cooperate, and, to the extent needed, cause its Affiliates and use Diligent Efforts to have Eisai and Duke fully cooperate, with all reasonable requests of Licensee in order for Licensee to record the license hereby granted by Radius to Licensee under the Radius Patent Rights promptly 23


 
LICENSE AGREEMENT following execution, and Radius shall do so by executing (including, where needed, notarization and legalization) and delivering such instruments, and/or taking such other actions, or by using Diligent Efforts to have Eisai and Duke execute (including, where needed, notarization and legalization) and deliver such instruments, and/or take such other actions, at Licensee’s sole expense, as reasonably requested by Licensee for purposes of such recordal. 8.2 Enforcement and Defense. (a) The enforcement and defense of all Duke Patent Rights shall be governed by Exhibit F and the enforcement and defense of all Eisai Patents, Joint Patents, Radius-Invented Patents and Licensee-Invented Patents shall be governed by Exhibit G. The provisions in this Section 8.2 supplement Exhibit F and Exhibit G. (b) Subject to the provisions of Exhibit F and Exhibit G, in case of an actual or suspected infringement of any Radius Patent Right and/or any Licensee-Invented Patent, or in case the validity or enforceability of any Radius Patent Right and/or any Licensee-Invented Patent is challenged in any action or proceeding (other than any interferences, oppositions, reissue proceedings or reexaminations) or Radius or Licensee receives a notice of Paragraph IV Patent Certification as described in Section 8.1(f)(iii), if Licensee elects not to settle, defend or bring any action for infringement within [*] ([*]) months after becoming aware of such suspected infringement or action or proceeding (and in all events at least [*] ([*]) days before the end of the applicable Hatch-Waxman Time Period, as defined below), then, subject to the provisions in Exhibit F and Exhibit G, Radius may defend or bring such action at its own expense, in its own name and entirely under its own direction and control, subject to the following: Licensee will reasonably assist Radius in any action or proceeding being defended or prosecuted if so requested, and will join such action or proceeding if requested by Radius. Licensee will have the right to participate in any such action or proceeding with its own counsel at its own expense. For purposes of this Agreement, “Hatch- Waxman Time Period” means the applicable period of time during which a patent holder or licensee has the right to file an infringement suit to maintain certain rights and privileges upon receipt of Paragraph IV Patent Certification by a Third Party filing an Abbreviated New Drug Application or an application under § 505(b)(2) of the United States Food, Drug, and Cosmetic Act (as amended), or any other similar patent certification by a Third Party, or any foreign equivalent thereof. (c) Withdrawal. If either Party brings an action or proceeding under this Section 8.2 and subsequently ceases to pursue or withdraws from such action or proceeding, it will promptly notify the other Party and the other Party may substitute itself for the withdrawing Party under the terms of this Section 8.2. 8.3 Patent Marking. Licensee will mark, and will cause all of its Affiliates and Sublicensees to mark, Licensed Products with all Radius Patent Rights in accordance with applicable Law, which marking obligation will continue for as long as required under applicable Law. 8.4 Trademarks. Licensee shall have the right to select the trademark(s) and/or logo(s) under which to Commercialize Licensed Products in the Field in the Territory. Licensee shall be responsible for the registration, maintenance and defense of such trademarks used in connection with the Commercialization of any Licensed Product in the Field in the Territory, as well as all expenses associated therewith. Section 9. Confidential Information and Publicity. 9.1 Confidentiality. 24


 
LICENSE AGREEMENT (a) Confidential Information. Except as expressly provided herein, each of the Parties agrees that, for itself and its Affiliates, and during the Term and for a period of [*] ([*]) years thereafter, a Party and its Affiliates (the “Receiving Party”) receiving Confidential Information of the other Party or its Affiliates (the “Disclosing Party”) will (i) not disclose such Confidential Information to any Third Party without the prior written consent of the Disclosing Party, except for disclosures expressly permitted below, and (ii) not use such Confidential Information for any purpose except those licensed or otherwise authorized or permitted by this Agreement. (b) Exceptions. The obligations in Section 9.1(a) will not apply with respect to any portion of the Confidential Information that the Receiving Party can show by competent proof: (i) is publicly disclosed by the Disclosing Party, either before or after it is disclosed to the Receiving Party hereunder; (ii) was lawfully known to the Receiving Party or any of its Affiliates, without any obligation to keep it confidential or any restriction on its use, prior to disclosure by the Disclosing Party; (iii) is subsequently disclosed to the Receiving Party or any of its Affiliates by a Third Party lawfully in possession thereof and without any obligation to keep it confidential or any restriction on its use; (iv) is published by a Third Party or otherwise becomes publicly available or enters the public domain, either before or after it is disclosed to the Receiving Party; or (v) has been independently developed by employees or contractors of the Receiving Party or any of its Affiliates without the aid, application or use of Confidential Information of the Disclosing Party. (c) Authorized Disclosures. The Receiving Party may disclose Confidential Information belonging to the Disclosing Party to the extent (and only to the extent) such disclosure is reasonably necessary in the following instances: (i) subject to Section 9.2, by either Party in order to comply with applicable Laws (including any securities Laws or regulation or rules of a securities exchange) or with a legal or administrative proceeding; (ii) by either Party, in connection with prosecuting or defending litigation, making regulatory filings, and Prosecuting Radius Patent Rights in accordance with Section 8; (iii) by Licensee, to its Affiliates, potential and future Sublicensees, permitted acquirers or assignees under Section 12.1, subcontractors, investment bankers, investors, lenders, and their and each of Licensee and its Affiliates’ respective directors, employees, contractors, agents, attorneys and other professional advisors; and (iv) by Radius, to its Affiliates, permitted acquirers or assignees under Section 12.1, subcontractors, investment bankers, investors (including royalty purchasers), lenders, and their and each of Radius and its Affiliates’ respective directors, employees, contractors, agents, attorneys and other professional advisors; provided that (A) with respect to Section 9.1(c)(i) or 9.1(c)(ii), where reasonably possible and to the extent permitted by any applicable Law, the Receiving Party will notify the Disclosing Party of the Receiving Party’s intent to make any disclosure pursuant thereto sufficiently prior 25


 
LICENSE AGREEMENT to making such disclosure so as to allow the Disclosing Party adequate time to take whatever action it may deem appropriate to protect the confidentiality of the information to be disclosed, and (B) with respect to Sections 9.1(c)(iii) and 9.1(c)(iv), each of those named people and entities must be bound prior to disclosure by confidentiality and non-use restrictions or obligations at least as restrictive as those contained in this Section 9 (other than investment bankers, investors and lenders, who must be bound prior to disclosure by commercially reasonable obligations of confidentiality). Further, with respect to Section 9.1(c)(i), in the event either Party intends to make a disclosure pursuant thereto, to the extent permitted by applicable Law, the other Party will have a reasonable time period to review and comment on the proposed disclosure or filing that relates to this Agreement (including the right to request redaction of material terms to the extent permitted by any applicable Laws), and the Party intending to make such disclosure will consider in good faith any reasonable comments thereon provided by the other Party. 9.2 Terms of this Agreement; Publicity. (a) Terms of this Agreement. The Parties agree that the terms of this Agreement will be treated as Confidential Information of both Parties, and thus may be disclosed only as permitted by this Section 9. (b) Restrictions. No Party to this Agreement will originate any publicity, news release or other public announcement, written or oral, relating to this Agreement, the transactions contemplated hereby or the terms hereof, or the existence of any arrangement between the Parties, without the prior written consent of the other Party, such consent not to be unreasonably withheld, delayed, or conditioned, whether named in such publicity, news release or other public announcement or not, except as required by applicable Laws. (c) Review. In the event either Party (the “Issuing Party”) desires to issue any publicity, new release or other public announcement relating to this Agreement or the transactions contemplated hereby or the terms hereof, the Issuing Party will provide the other Party (the “Reviewing Party”) with a copy of the proposed release, announcement or statement (the “Release”). The Issuing Party will specify with each such Release, taking into account the urgency of the matter being disclosed, a reasonable period of time within which the Reviewing Party may provide any comments on such Release and if the Reviewing Party fails to provide any comments during the response period called for by the Issuing Party, the Reviewing Party will be deemed to have consented to the issuance of such Release; provided, however, that as it relates to the disclosure of the results of any clinical trial conducted by Licensee or any health or safety matter related to a Licensed Product, Radius acknowledges that announcements may need to be made on extremely short notice, and although Licensee will endeavor to provide Radius adequate time for such a review, Licensee will be free to make necessary public disclosures as promptly as it deems necessary and appropriate. If the Reviewing Party provides any comments, the Parties will consult on such Release and work in good faith to prepare a mutually acceptable Release. If the Reviewing Party does not provide its consent, not to be unreasonably withheld, conditioned or delayed, to the issuance of the Release, the Issuing Party will not issue the Release except as required by Law or as otherwise expressly set forth herein. Each Party may subsequently publicly disclose any information previously contained in any Release so consented to. If either Party concludes that a copy of this Agreement must be filed with the United States Securities and Exchange Commission or similar regulatory agency in a country other than the United States, at least [*] ([*]) days in advance of any such filing such Party will provide the other Party with a copy of this Agreement showing any provisions hereof as to which the Party proposes to request confidential treatment, will provide the other Party with an opportunity to comment on any such proposed redactions and to suggest additional redactions, and will take such Party’s reasonable and timely comments into consideration before filing the Agreement. 26


 
LICENSE AGREEMENT (d) Press Release Regarding Execution of the Agreement. The Parties agree to issue the joint press release in Exhibit E promptly following the Effective Date. (e) Publication of Clinical Data. Unless otherwise required by any applicable Law, each Party agrees that it shall not publish or present to the public the results of non-clinical scientific studies or clinical trials related to the Licensed Product without the opportunity for prior review by the other Party. If a Party (the “Publishing Party”) wishes to publish or to present to the public such results, then it shall provide the other Party (the “Non-Publishing Party”) the opportunity to review any of the Publishing Party’s proposed abstracts, manuscripts or presentations (including verbal presentations) which relate to the Licensed Product at least [*] ([*]) days prior to its intended submission for publication and agrees, upon request, not to submit any such abstract or manuscript for publication until the other Party is given a reasonable period of time to secure patent protection for any material in such publication which it believes to be patentable. Both Parties understand that a reasonable commercial strategy may require delay of publication of information or filing of patent applications. The Parties agree to review and consider delay of publication and filing of patent applications under certain circumstances. Neither Party shall have the right to publish or present to the public Confidential Information of the other Party, except as permitted under Section 9. Nothing contained in this Section 9.2(e) shall prohibit the inclusion of the results of non-clinical scientific studies or clinical trials related to the Licensed Product necessary for a patent application. 9.3 Relationship to the Confidentiality Agreement. This Agreement supersedes the Confidentiality Agreement, provided that all “Confidential Information” disclosed or received by the parties thereunder will be deemed “Confidential Information” hereunder and will be subject to the terms and conditions of this Agreement. 9.4 Use of Name. Licensee shall, and shall require its Affiliates to, refrain from using and to require Sublicensees to refrain from using the name, mark, logo, image or any adaption thereof of Duke or its employees in publicity or advertising without the prior written approval of Duke. Reports in scientific literature and presentations of joint research and development work are not publicity. Notwithstanding this provision, without prior written approval of Duke, Licensee and Sublicensees may state publicly that Licensed Products were developed by Licensee based upon an invention(s) developed at Duke University and/or that the Duke Patent Rights were licensed from Duke University. However, in no event, shall Licensee or Sublicensee represent, either directly or indirectly, that any Licensed Product is a product of Duke. For purposes of this Section 9.4 only, “Licensed Product” means any product that contains the Licensed Compound and, but for this Agreement, comprises an infringement (including contributory or inducement), of an issued or unexpired claim contained in the Duke Patent Rights in the country in which any such product or product is made, used, imported, offered for sale or sold. Section 10. Warranties; Limitations of Liability; Indemnification and Disclaimers. 10.1 Radius Representations and Warranties. Radius covenants, represents and warrants to Licensee that as of the Effective Date: (a) Radius is duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is organized, and it has full right and authority to enter into this Agreement and to grant the licenses and other rights to Licensee as herein described. (b) Radius Controls the Radius Patent Rights and the Radius Know-How and has full right and authority to grant the licenses and rights under the Radius Patent Rights and the Radius Know- How to Licensee as provided for hereunder. 27


 
LICENSE AGREEMENT (c) This Agreement has been duly authorized by all requisite corporate action, and when executed and delivered will become a valid and binding contract of Radius enforceable against Radius in accordance with its terms. (d) The execution, delivery and performance of this Agreement does not conflict with any other agreement, contract, instrument or understanding, oral or written, to which Radius is a party, or by which it is bound, nor will it violate any applicable Laws. (e) All necessary consents, approvals and authorizations of all Governmental Authorities and other Persons required to be obtained by Radius in connection with the execution and delivery of this Agreement and the performance of its obligations hereunder have been obtained. (f) Attached hereto as Exhibit C is a complete and accurate list of all patent rights owned or in-licensed by Radius or any of its Affiliates that the manufacture, use, sale, offer for sale or importation of the Licensed Compounds or any Licensed Product would infringe. All patent rights listed on Exhibit C are Radius Patent Rights hereunder. To Radius’s Knowledge, no Third Party action or proceeding has been commenced or threatened in writing, alleging that any of the issued claims included in the Radius Patent Rights are invalid or unenforceable. (g) No lien on or security interest exists in, upon, and to the Radius Patent Rights and Radius Know How and it will not, nor will it permit any of its Affiliates to, directly or indirectly, create, assume or suffer to exist any lien on or security interest in all or any portion of the Radius Patent Rights and/or Radius Know How for so long and during the period that this Agreement remains in full force and effect or that the Radius Patent Rights and the Radius Know How remain subject to the license to Licensee. (h) To Radius’s Knowledge, all information and data that exists as of the Effective Date that is material to the Development, Manufacture or Commercialization of Licensed Compounds or Licensed Products and is in the possession or control of Radius or its Affiliates as of the Effective Date has been included in the electronic data room made available to Licensee by Radius prior to the Effective Date, and such information or data contained in such data room is true and correct (subject to any redactions to such information or data) in all material respects as well as the information delivered to Licensee upon Licensee’s request is true and correct in all material respects as of the date such requests for information were made by Licensee. 10.2 Licensee Representations and Warranties. Licensee covenants, represents and warrants to Radius that as of the Effective Date: (a) Licensee is duly organized, validly existing and in good standing under the laws of the state or jurisdiction in which it is organized, and it has full right and authority to enter into this Agreement and to accept the rights and licenses granted as herein described. (b) This Agreement has been duly authorized by all requisite corporate action, and when executed and delivered will become a valid and binding contract of Licensee enforceable against Licensee in accordance with its terms. (c) The execution, delivery and performance of this Agreement does not conflict with any other agreement, contract, instrument or understanding, oral or written, to which Licensee is a party, or by which it is bound, nor will it violate any applicable Laws. 28


 
LICENSE AGREEMENT (d) All necessary consents, approvals and authorizations of all Governmental Authorities and other Persons required to be obtained by Licensee in connection with the execution and delivery of this Agreement and the performance of its obligations hereunder have been obtained. 10.3 Ethical Business Practices. (a) Either Party agrees to conduct its own activities contemplated herein in a manner which is consistent with both applicable Laws and good business ethics. In the performance of this Agreement either Party and its Affiliates and its and their employees and agents (i) will not offer to make, make, promise, authorize or accept any payment or giving anything of value, including, without limitation, bribes, either directly or indirectly to any public official, Regulatory Authority or anyone else for the purpose of influencing, inducing or rewarding any act, omission or decision in order to secure an improper advantage, or obtain or retain business and (ii) will comply with all applicable anti-corruption and anti- bribery Laws. Either Party will notify the other Party immediately upon becoming aware of any breach of its obligations under this Section. Either Party warrants to the other Party that none of its or its Affiliates’ officer, director, partner, owner, principal, employee or agent is an official or employee of a governmental agency or instrumentality or a government owned company in a position to influence action or a decision regarding its activities contemplated in this Agreement. (b) In the event that either Party has reason to believe that a breach of this Section 10.3 by the other Party or its Affiliates has occurred or may occur, either Party is entitled to audit the other Party and its Affiliates, which will fully cooperate in connection with any such audit. (c) Either Party will promptly notify the other Party in the event of any government investigation or inquiry related to compliance with applicable anti-corruption and anti-bribery Laws in connection with this Agreement and will allow the other Party to participate to the extent permitted by any applicable Law. (d) Either Party expressly understands and agrees that any breach of this Section 10.3 is considered a material breach of this Agreement entitling the other Party to terminate this Agreement in accordance with Section 11.2. 10.4 Disclaimer. (a) EXCEPT AS EXPRESSLY SET FORTH HEREIN, NEITHER RADIUS NOR LICENSEE MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO ANY RADIUS PATENT RIGHTS OR RADIUS KNOW-HOW, ANY LICENSED COMPOUNDS, OR ANY LICENSED PRODUCTS, INCLUDING ANY WARRANTIES OF VALIDITY OR ENFORCEABILITY OF ANY PATENTS, TITLE, QUALITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, PERFORMANCE OR NONINFRINGEMENT OF ANY THIRD PARTY PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS. (b) Licensee acknowledges that Duke makes no representations or warranties that any claim within the Duke Patent Rights is or will be held valid, patentable or enforceable, or that the manufacture, importation, use, offer for sale, sale or other distribution of any Licensed Products will not infringe upon any patent or other rights. Additionally, Licensee acknowledges that DUKE MAKES NO REPRESENTATIONS, EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND ASSUMES NO RESPONSIBILITIES WHATEVER WITH RESPECT TO DESIGN, DEVELOPMENT, 29


 
LICENSE AGREEMENT MANUFACTURE, USE, SALE OR OTHER DISPOSITION BY LICENSEE OR SUBLICENSEES OF LICENSED PRODUCTS. LICENSEE AND SUBLICENSEES ASSUME THE ENTIRE RISK AS TO PERFORMANCE OF LICENSED PRODUCTS. (c) Without prejudice to Section 10.8 which applies as between Radius and Licensee, Licensee acknowledges that EISAI SHALL NOT BE LIABLE TO LICENSEE FOR ANY SPECIAL, CONSEQUENTIAL, EXEMPLARY, OR INCIDENTAL DAMAGES ARISING FROM ANY CLAIM RELATING TO EISAI IP, WHETHER SUCH CLAIM IS BASED ON CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, EVEN IF AN AUTHORIZED REPRESENTATIVE OF LICENSEE IS ADVISED OF THE POSSIBILITY OR LIKELIHOOD OF SAME. 10.5 Performance by Affiliates and Subcontractors. Each Party will have the right to utilize the services of its Affiliates or Third Party subcontractors in connection with the performance of the activities for which it is responsible under this Agreement, including with respect to Licensee, the Development Plan or the Commercialization Plan; provided, however, that such Party will remain responsible under this Agreement for the performance and compliance of such Affiliates and Third Party subcontractors. The Party utilizing such subcontractors also will ensure that such Affiliate or Third Party is subject to obligations protecting and limiting use and disclosure of Confidential Information, the Licensed Compounds, Licensed Products, patent rights and Know-How at least to the same extent as set forth under this Agreement. 10.6 Indemnification. (a) Licensee Indemnity. Licensee hereby agrees to indemnify, defend and hold Radius and its Affiliates, and their respective employees, directors, agents and consultants, and their respective successors, heirs and assigns and representatives (“Radius Indemnitees”) harmless from and against all claims, liability, threatened claims, damages, expenses (including reasonable attorneys’ fees), suits, proceedings, losses or judgments, whether for money or equitable relief, of any kind, including but not limited to death, personal injury, illness, product liability or property damage or the failure to comply with applicable Law (collectively, “Losses”), arising from any Third Party claim due to (i) the Development, Commercialization (including promotion, advertising, offering for sale, sale or other disposition), transfer, importation or exportation, Manufacture, labeling, handling or storage, or use of, or exposure to, any Licensed Compound or Licensed Products by or for Licensee or any of its Affiliates, Sublicensees, subcontractors, agents and consultants or any other person; or (ii) any material breach of any obligation, representation or warranty of Licensee hereunder; or (iii) Licensee’s (or its Affiliates’ and Sublicensees’) negligence, recklessness or willful misconduct; or (iv) the use or practice by Licensee of any invention related to the Duke Patent Rights (but without prejudice to Licensee right under Section 7.3(c)(iii), to the extent applicable), except, in each case, to the extent that such Losses arise from (A) infringement or misappropriation of patent or other intellectual property rights or know-how by any Radius Indemnitees, (B) the negligence, recklessness or willful misconduct of any Radius Indemnitees, or (C) any material breach of any obligation, representation or warranty of Radius hereunder; or (D) to the extent the Losses are indemnifiable by Radius under Section 10.6(b). (b) Radius Indemnity. Radius hereby agrees to indemnify, defend and hold Licensee, its Affiliates and Sublicensees, and their respective employees, directors, agents and consultants, and their respective successors, heirs and assigns and representatives (“Licensee Indemnitees”) harmless from and against all Losses arising from any Third Party claim due to (i) the Development, transfer, importation or exportation, Manufacture, labeling, handling or storage, or use of, or exposure to, any Licensed Compounds or Licensed Products by or for Radius or any of its Affiliates, sublicensees (excluding Licensee), subcontractors, agents and consultants; or (ii) any material breach of any obligation, representation or warranty of Radius hereunder; or (iii) Radius’s (or its Affiliates’ and sublicensees’) negligence, recklessness or willful misconduct, except , in each case, to the extent that such Losses arise 30


 
LICENSE AGREEMENT from (A) infringement or misappropriation of patent or other intellectual property rights or know-how by any Licensee Indemnitees, (B) the negligence, recklessness or willful misconduct of any Licensee Indemnitees, or (C) any material breach of any obligation, representation or warranty of Licensee hereunder; or (D) to the extent the Losses are indemnifiable by Licensee under Section 10.6(a). (c) Indemnification Procedure. A claim to which indemnification applies under Section 10.6(a) or Section 10.6(b) will be referred to herein as a “Claim”. If any Person (each, an “Indemnitee”) intends to claim indemnification under this Section 10.6, the Indemnitee will notify the other Party (the “Indemnitor”) in writing promptly upon becoming aware of any claim that may be a Claim (it being understood and agreed, however, that the failure by an Indemnitee to give such notice will not relieve the Indemnitor of its indemnification obligation under this Agreement except and only to the extent that the Indemnitor is actually prejudiced as a result of such failure to give notice). Subject to Section 11.9, the Indemnitor will have the right to assume and control the defense of such Claim at its own expense with counsel selected by the Indemnitor and reasonably acceptable to the Indemnitee. The Indemnitee or its licensor (in the case of Radius) will have the right to participate and to retain its own counsel, with the fees and expenses to be paid by the Indemnitee, if representation of such Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential differing interests between such Indemnitee and any other party represented by such counsel in such proceedings. If the Indemnitor does not assume the defense of such Claim as aforesaid, the Indemnitee, at Indemnitor’s expense, may defend such Claim but will have no obligation to do so. The Indemnitee will not settle or compromise any Claim without the prior written consent of the Indemnitor, and the Indemnitor will not settle or compromise any Claim in any manner which would have an adverse effect on the Indemnitee’s interests, or otherwise create an obligation or admission of liability for Indemnitee without the prior written consent of the Indemnitee, which consent, in each case, will not be unreasonably withheld. The Indemnitee will reasonably cooperate with the Indemnitor at the Indemnitor’s expense and will make available to the Indemnitor all pertinent information under the control of the Indemnitee, which information will be subject to Section 9. 10.7 Insurance. During the Term and for at least [*] ([*]) years thereafter, Licensee will maintain at its sole cost and expense, an adequate liability insurance or self-insurance program (including product liability insurance) to protect against potential liabilities and risk arising out of activities to be performed under this Agreement and upon such terms (including coverages, deductible limits and self-insured retentions) as are customary in the pharmaceutical industry for the activities to be conducted by Licensee under this Agreement. The coverage limits set forth herein will not create any limitation on Licensee’s liability to Radius under this Agreement. Additionally, Licensee shall specify Duke as an additional insured in its above coverage for all product liability claims with respect to any Licensed Products manufactured, used, sold, licensed or otherwise distributed by or on behalf of Licensee. 10.8 Limitation of Liability. EXCEPT IN CASE OF FRAUD, GROSS NEGLIGENCE, WILLFUL MISCONDUCT AND INDEMNIFICATION UNDER SECTIONS 10.6(a) and 10.6(b) ABOVE AND INDEMNIFICATION UNDER SECTION 2.2 OF EXHIBIT F, NO PARTY WILL BE LIABLE TO THE OTHER PARTY FOR ANY INCIDENTAL, SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES. Section 11. Term, Termination and Survival. 11.1 Term. This Agreement will commence as of the Effective Date and, unless sooner terminated in accordance with the terms hereof or by mutual written agreement of the Parties, will continue on a country-by-country and Licensed Product-by-Licensed Product basis until the end of the period during which royalties are due hereunder on Net Sales of such Licensed Product in such country (the “Term”). Upon the end of such period for such Licensed Product in such country, the license grant contained in 31


 
LICENSE AGREEMENT Section 2.1 will become perpetual, irrevocable, non-terminable, royalty free and fully paid up with respect to such Licensed Product in such country. 11.2 Termination for Material Breach. Either Party will have the right to terminate this Agreement upon delivery of written notice to the other Party in the event of any material breach in the performance by such other Party of any term or condition under this Agreement, provided that such termination will not be effective if such breach has been cured within [*] ([*]) days after written notice thereof is given by the terminating Party to such other Party specifying the nature of the alleged breach.. 11.3 Bankruptcy. To the extent permitted by Law, upon the filing or institution of bankruptcy, reorganization, liquidation or receivership proceedings, or upon an assignment of a substantial portion of the assets for the benefit of creditors (a “Bankruptcy Event”) by either Party, Radius, in the case of a Bankruptcy Event by Licensee, or Licensee, in the case of a Bankruptcy Event by Radius, may terminate this Agreement; provided, however, that, in the case of any involuntary bankruptcy proceeding, such right to terminate will only become effective if the subject Party consents to the involuntary bankruptcy or such proceeding is not dismissed within [*] ([*]) days after the filing thereof. Each Party will retain and may fully exercise all of its rights and elections under the U.S. Bankruptcy Code and foreign equivalents, including that upon commencement of a bankruptcy proceeding by or against such Party undergoing a bankruptcy proceeding (the “Affected Party”) under the U.S. Bankruptcy Code or foreign equivalents, the non-Affected Party will be entitled to complete duplicates of or complete access to, as such non-Affected Party deems appropriate, any Know-How and patent and other intellectual property rights and all embodiments hereof licensed or to be transferred to such non-Affected Party hereunder by the Affected Party. Such Know-How, rights and embodiments will be promptly delivered to the non-Affected Party (a) upon any such commencement of a bankruptcy proceeding and upon written request thereof by the non- Affected Party, unless the Affected Party elects to continue to perform all of its obligations under this Agreement, or (b) if not delivered under the foregoing clause (a), upon the rejection of this Agreement by or on behalf of the Affected Party upon written request therefore by the non-Affected Party. This Section 11.3 is without prejudice to any rights the non-Affected Party may have arising under the U.S. Bankruptcy Code, foreign equivalents or other Law. Without prejudice to the foregoing, notwithstanding anything to the contrary in this Agreement or otherwise, the Parties agree that in the event that this Agreement is terminated or rejected by a Party or its receiver or trustee under applicable bankruptcy laws due to such Party’s Bankruptcy Event, then all rights and licenses granted under or pursuant to this Agreement by such Party to the other Party are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code and any similar law or regulation in any other country, licenses of rights to “intellectual property” as defined under Section 101(35A) of the United States Bankruptcy Code. The Parties agree that all intellectual property rights licensed hereunder, including without limitation, any patents or patent applications of or Controlled by a Party in any country covered by the license grants under this Agreement, are part of the “intellectual property” as defined under Section 101(35A) of the United States Bankruptcy Code subject to the protections afforded the non- terminating Party under the Section 365(n) of the United States Bankruptcy Code, and any similar law or regulation in any other country. 11.4 Termination by Radius for Cessation. Radius shall have the right to terminate this Agreement if, no Development, Manufacture or Commercialization activity, in each case to the extent to be performed by Licensee hereunder, is conducted by Licensee, its Affiliates or Sublicensees [*], and such cessation is not due to any action by any Regulatory Authority that prevents, limits or otherwise adversely affects any such Development, Manufacture or Commercialization activity, including for safety or CMC issues. 11.5 Termination by Radius for Patent Challenge. 32


 
LICENSE AGREEMENT (a) Radius will have the right to terminate this Agreement in full upon written notice to Licensee in the event that Licensee or any of its Affiliates or Sublicensees directly or indirectly asserts a Patent Challenge; provided that with respect to any such Patent Challenge by any non-Affiliate Sublicensee, Radius will not have the right to terminate this Agreement under this Section 11.5 if Licensee (i) causes such Patent Challenge to be terminated or dismissed or (ii) terminates such Sublicensee’s sublicense to the Radius Patent Rights being challenged by the Sublicensee, in each case within [*] ([*]) days of Radius’s notice to Licensee under this Section 11.5. In the event Licensee or any of its Affiliates intends to assert a Patent Challenge in any forum, not less than [*] ([*]) days prior to making any such assertion, Licensee will provide to Radius a complete written disclosure of each basis known to Licensee and its Affiliates for such assertion. (b) Licensee acknowledges and agrees that this Section 11.5 is reasonable, valid and necessary for the adequate protection of Radius’s interest in and to the Radius Patent Rights, and that Radius would not have granted to Licensee the licenses under those Radius Patent Rights, without this Section 11.5. Radius will have the right, at any time in its sole discretion, to strike this Section 11.5 (or any portion thereof) from this Agreement, and Radius will have no liability whatsoever as a result of the presence or absence of this Section 11.5 (or any struck portion thereof). 11.6 Discretionary Termination by Licensee. Licensee will have the right to terminate this Agreement in full or on a country-by-country basis at its discretion for any reason by delivering written notice to Radius, such termination to be effective [*] days ([*]) days following the date of such notice, provided that (a) any such termination will not be effective before [*]; and (b) Licensee has paid to Radius all Milestone Payments and royalties due and payable up to the effective date of termination. 11.7 Effect of Termination. Upon termination of this Agreement pursuant to Section 11.2, 11.3, 11.4, 11.5 or 11.6: (a) Except as may otherwise be agreed in writing by the Parties, Licensee will be responsible at its own expense for an orderly wind-down, in accordance with accepted pharmaceutical industry norms and ethical practices, of any then on-going Clinical Studies hereunder for which it has responsibility. (b) Should Licensee or any of its Affiliates or Sublicensees have any inventory of any Licensed Product, each of them will have [*] [*]) months thereafter in which to, at Radius’s sole discretion, either (i) dispose of such inventory (subject to the payment to Radius of any royalties or other amounts due hereunder thereon) or (ii) transfer such inventory to Radius at Licensee’s cost. (c) All licenses and other rights granted by Radius to Licensee hereunder will terminate and such licenses and other rights will revert to Radius, and Licensee and its Affiliates and Sublicensees will have no further rights to use any Radius Patent Rights or Radius Know-How (except as expressly set forth in Sections 11.7(a) and 11.7(b)). Each Party will promptly return to the other Party (or as directed by such other Party destroy and certify to such other Party in writing as to such destruction) all of such other Party’s Confidential Information and any materials, Licensed Compound and Licensed Products provided by or on behalf of such other Party hereunder that are in such Party’s (or its Affiliates’ or in the case of Licensee’s Sublicensees’) possession or control, save that such Party will have the right to retain (A) one (1) copy of intangible Confidential Information of such other Party for legal purposes, and (B) any of the foregoing under which such Party retains any license or other right hereunder. Subject to Sections 11.7(a) and 11.7(b), Licensee and its Affiliates and Sublicensees will not continue to Develop, Manufacture or Commercialize any Licensed Compounds or Licensed Products. 33


 
LICENSE AGREEMENT (d) All Regulatory Approvals, Regulatory Filings, regulatory documents and regulatory communications owned (in whole or in part) or otherwise controlled by Licensee and its Affiliates and Sublicensees concerning any Licensed Compounds and Licensed Products will be assigned to Radius, and Licensee will provide to Radius one (1) copy of the foregoing and all documents contained in or referenced in any such items, together with the raw and summarized data for any Clinical Studies (and where reasonably available, electronic copies thereof). In the event of failure to obtain assignment, Licensee hereby consents and grants to Radius the right to access and reference (without any further action required on the part of Licensee, whose authorization to file this consent with any Regulatory Authority is hereby granted) any such item. (e) At Radius’s election, Licensee will use reasonable efforts to assign to Radius or its designee all then-existing Manufacturing contracts with Third Party contract manufacturers in connection with the Manufacture of any Licensed Compounds and Licensed Products. After such assignment, Radius will be solely responsible for the performance of the obligations under such Manufacturing contracts. (f) Licensee will grant (without any further action required on the part of Licensee) to Radius and its Affiliates a worldwide, perpetual and irrevocable, nontransferable (except in connection with a permitted assignment of this Agreement in accordance with Section 12.1), royalty-free and fully paid-up, license, with the right to grant sublicenses through multiple tiers, in the Territory on an exclusive (even as to Licensee) basis, under all Reversion IP that (x) is owned or in-licensed by Licensee (or any of its Affiliates or Sublicensees), to the extent permissible under the relevant in-license agreement, as of the date of notice of termination, (y) is actually being used to Develop, Manufacture or Commercialize the Licensed Compound or any Licensed Products as of the date of notice of termination, and (z) only to the extent necessary to Develop, Manufacture and Commercialize, and for the sole purpose of Developing, Manufacturing, and Commercializing, in each case, the Licensed Compound or any Licensed Products (along with other active ingredients in any Licensed Products); in all cases in the Territory and in the Field. At Radius’s written request, the Parties will enter into commercially reasonable Prosecution and enforcement and defense terms for the Reversion IP in a form substantially similar to the terms contained herein for the benefit of Licensee. For purposes hereof, “Reversion IP” means any patent rights or Know- How owned or in-licensed by Licensee or any of its Affiliates or Sublicensees that specifically claim or cover the Licensed Compound or any Licensed Products, or their method of manufacture or use. (g) Upon Radius’s request, Licensee agrees to discuss in good faith and reasonably cooperate with Radius with respect to the assignment and transfer to Radius of Licensee’s and its Affiliates’ right, title and interest in and to any agreements between Licensee or any of its Affiliates and Third Parties that relate solely to the Development, Manufacture or Commercialization of any Licensed Compound or Licensed Product (including any Third Party licenses or sublicenses) and for any such agreement that does not relate solely to the Development, Manufacture or Commercialization of Licensed Compounds or Licensed Products, the assignment (or license, if applicable) to Radius of only such portions of such agreements relating thereto. (h) Only in case this Agreement is terminated by Radius for (i) Licensee’s breach of this Agreement pursuant to Section 11.2 or (ii) Licensee’s Patent Challenge pursuant to Section 11.5, Licensee will assign (or, if applicable, will cause its Affiliates or Sublicensees to assign) to Radius all of Licensee’s (and such Affiliates’ or Sublicensees’) worldwide right, title and interest in and to any registered or unregistered trademarks or internet domain names that are specific to and solely used for any Licensed Products (it being understood that the foregoing will not include any trademarks or internet domain names that contain the corporate or business name(s) of Licensee or any of its Affiliates or Sublicensees). 34


 
LICENSE AGREEMENT 11.8 Survival. In addition to the termination consequences set forth in Section 11.7, the following provisions will survive expiration or termination of this Agreement for any reason: Sections 2.2 (mutatis mutandis with respect to licenses granted to Radius under Section 11.7(f)), 7.6, 10.3, 10.6, 11.1 (last sentence, in the case of expiration of this Agreement) and 11.3 (excluding the first sentence thereof), this Section 11.8, the last sentence of Section 2.2(b), and all of Section 1, Section 9 and Section 12. Expiration or termination of this Agreement for any reason will not relieve the Parties of any liability or obligation which accrued hereunder prior to the effective date of such termination or expiration, nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity, with respect to any breach of this Agreement nor prejudice either Party’s right to obtain performance of any obligation. All other rights and obligations will terminate upon termination or expiration of this Agreement. 11.9 Right to Set-off. Notwithstanding anything to the contrary in this Agreement (other than the last sentence of Section 7.1), each Party has the right at all times to retain and set off against all amounts due and owing to the other Party, as determined in a final judgment or award, any damages or awards recovered by such Party for any Losses incurred by such Party. Section 12. General Provisions. 12.1 Assignment. (a) This Agreement may not be assigned by either Party, nor may either Party delegate its obligations or otherwise transfer licenses or other rights created by this Agreement, except as expressly permitted hereunder or otherwise without the prior written consent of the other Party, which consent will not be unreasonably withheld, delayed or conditioned; provided that without consent either Party may assign this Agreement in its entirety to an Affiliate, or in connection with a Change of Control of the assigning Party. Each Party will provide prompt written notice to the other Party of any such permitted assignment. (b) Notwithstanding anything to the contrary in Section 12.1(a) or elsewhere in this Agreement, Radius may sell, transfer or assign its rights to any Third Party to receive payments under Section 7, and Radius may disclose Confidential Information of Licensee to one or more Third Party(ies) in connection with any such assignment to enable the Third Party(ies) to evaluate and monitor any such purchase, transfer or assignment, provided that such Third Party(ies) are subject to confidentiality obligations consistent with those set forth in Section 9. Radius will provide prompt written notice to Licensee of any such sale, transfer or assignment of its rights to any Third Party to receive payments under Section 7, provided however that in no event Licensee shall be obligated to make a payment to any Third Party if such payment may be in violation of any applicable Law. (c) Any attempted assignment, delegation or transfer in violation of this Section 12.1 will be void ab initio. Any permitted assignee will assume all assigned obligations of its assignor under this Agreement. The terms and conditions of this Agreement will inure to the benefit of, and be binding upon, the legal representatives, successors and permitted assigns of the Parties. 12.2 Severability. If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein will not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties will in such an instance use their reasonable commercial efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement. 35


 
LICENSE AGREEMENT 12.3 Cumulative Remedies. All rights and remedies of the Parties hereunder will be cumulative and in addition to all other rights and remedies provided hereunder or available by agreement, at Law or otherwise. 12.4 Amendment; Waiver. This Agreement may not be modified, amended or rescinded, in whole or part, except by a written instrument signed by the Parties; provided that any unilateral undertaking or waiver made by one Party in favor of the other will be enforceable if undertaken in a writing signed by the Party to be charged with the undertaking or waiver. No delay or omission by either Party hereto in exercising any right or power occurring upon any noncompliance or default by the other Party with respect to any of the terms of this Agreement will impair any such right or power or be construed to be a waiver thereof. A waiver by either of the Parties of any of the covenants, conditions or agreements to be performed by the other will not be construed to be a waiver of any succeeding breach thereof or of any other covenant, condition or agreement herein contained. 12.5 Notices. Except as otherwise provided herein, all notices under this Agreement will be sent by certified mail or by overnight courier service, postage prepaid, to the following addresses of the respective Parties: If to Licensee, to: Berlin-Chemie AG Glienicker Weg 125, 12849 Berlin Attention: President of the Board of Director With a required copy to: Berlin-Chemie AG Glienicker Weg 125, 12849 Berlin Attention: Head of Legal Department If to Radius, to: Radius Pharmaceuticals, Inc. 950 Winter Street Waltham, MA 02451 Attention: Secretary With a required copy to: Goodwin Procter LLP 100 Northern Avenue Boston, MA 02210 Attention: Sarah A. Solomon or to such address as each Party may hereafter designate by notice to the other Party. A notice will be deemed to have been given on the date it is received by all required recipients for the noticed Party. 12.6 Applicable Law. This Agreement will be governed by and construed in accordance with the laws of the State of New York, without regard to its conflicts of law provisions; provided that any dispute relating to the scope, validity, enforceability or infringement of any patent rights will be governed by, and construed and enforced in accordance with, the substantive laws of the jurisdiction in which such patent rights apply. Each Party agrees to submit to the exclusive jurisdiction of the United States District Court and state courts located in New York, New York with respect to any claim, suit or action in law or equity arising in any way out of this Agreement or the subject matter hereof. 12.7 Relationship of the Parties. Each Party is an independent contractor under this Agreement. Nothing contained herein is intended or is to be construed so as to constitute Radius and Licensee as partners, agents or joint venturers. Except as set forth herein with respect to Duke or Eisai or their Affiliates, neither Party will have any express or implied right or authority to assume or create any obligations on 36


 
LICENSE AGREEMENT behalf of or in the name of the other Party or to bind the other Party to any contract, agreement or undertaking with any Third Party. There are no express or implied third party beneficiaries hereunder (except for Licensee Indemnitees other than Licensee and Radius Indemnitees other than Radius for purposes of Sections 10.6(a) or 10.6(b), as applicable). 12.8 Entire Agreement. This Agreement (along with the Exhibits), and the Transition Services Agreement, contains the entire understanding of the Parties with respect to the subject matter hereof and supersedes and replaces any and all previous arrangements and understandings, including the Confidentiality Agreement, whether oral or written, between the Parties with respect to the subject matter hereof. 12.9 Headings. The captions to the several Sections hereof are not a part of this Agreement, but are merely guides or labels to assist in locating and reading the several Sections hereof. 12.10 Waiver of Rule of Construction. Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement will be construed against the drafting Party will not apply. 12.11 Interpretation. Whenever any provision of this Agreement uses the term “including” (or “includes”), such term will be deemed to mean “including without limitation” (or “includes without limitations”). “Herein,” “hereby,” “hereunder,” “hereof” and other equivalent words refer to this Agreement as an entirety and not solely to the particular portion of this Agreement in which any such word is used. The term “or” means “and/or” hereunder. All definitions set forth herein will be deemed applicable whether the words defined are used herein in the singular or the plural. Unless otherwise provided, all references to Sections and Exhibits in this Agreement are to Sections and Exhibits of this Agreement. References to any Sections include Sections and subsections that are part of the related Section (e.g., a section numbered “Section 2.2” would be part of “Section 2”, and references to “Section 2.2” would also refer to material contained in the subsection described as “Section 2.2(a)”). 12.12 Counterparts; Facsimiles. This Agreement may be executed in one (1) or more counterparts, each of which will be deemed an original and all of which together will constitute one and the same instrument. Facsimile or PDF execution (including electronic signature) and delivery of this Agreement by either Party will constitute a legal, valid and binding execution and delivery of this Agreement by such Party. [Remainder of this Page Intentionally Left Blank] 37


 
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their respective duly authorized representatives as of the Effective Date. RADIUS PHARMACEUTICALS, INC. By: /s/ Kelly Martin (Signature) Name: Kelly Martin Title: Chief Executive Officer BERLIN-CHEMIE AG By: /s/ Pio Mei (Signature) Name: Pio Mei Title: Member of Executive Board By: /s/ Attilio Sebastio (Signature) Name: Attilio Sebastio Title: Member of Executive Board


 
LICENSE AGREEMENT SCHEDULE 1.53 Backup Compounds 1902 genus: 1902 Selection Case genus:


 
LICENSE AGREEMENT 1902 lead compounds:


 
LICENSE AGREEMENT


 
LICENSE AGREEMENT


 
LICENSE AGREEMENT


 
LICENSE AGREEMENT SCHEDULE 1.82 Structural Analog 1. A compound represented by the following formula (I); wherein f g’ f’ g’ Z represents a bond, a C1-C4 alkylene group or –CR ’R -CH2-O- wherein R and R independently represent a C1-C6 alkyl group; -T-NRaRb represents -NRaRb, , or ; A represents a 5- to 14-membered heteroarylene group which may have one or more substituents or a C6-C14 arylene group which may have one or more substituents; c c Y represents a C1-C4 alkylene group or –CH2-NR - wherein R represents a C1-C6 alkyl group which may have a substituent; ring G is a ring or a fused ring system selected from the group consisting of;


 
LICENSE AGREEMENT , , , , , , , , , , , , , , , , , , , , , , , , , , , , , and ; wherein each Rh is independently selected from hydrogen or CH3; Rg is hydrogen, C1-C3 alkyl, C1-C3 fluoroalkyl, CN, fluorine, chlorine or bromine; and each Re is independently selected from hydrogen, halogen, OH, O(CO)R, O(CO)NR1R2, OPO3, OSO3,O(SO2)NR1R2, or wherein two adjacent Re together form: , , , or ; wherein each R3 is hydrogen, C1-C12 acyl, or C1-C12 acyloxy; and each R4 is independently hydrogen, C1- C3 alkyl, fluorine or chlorine;


 
LICENSE AGREEMENT R’ represents 1 to 4 substituents independently selected from a hydrogen and a C1-C6 alkoxy group; a partial structure in formula (I) represented by the following formula: or R’’ represents a hydroxyl group that may be further protected by a protecting group or a C1-C6 alkoxy group which may have a substituent; U and V are each independently selected from CRa’ or N; each Ra’ is independently selected from: H, C1-C3 alkyl, C1-C3 fluoroalkyl, phenyl (optionally substituted with


 
LICENSE AGREEMENT 1-3 groups selected from fluorine, chlorine, C1-C3 alkyl, CN, OC1-C3 alkyl, OH), OH, OC1-3alkyl, CN, fluorine, or chlorine; and Ra and Rb are the same as or different from each other and each represents a hydrogen atom, a C1- C6 alkyl group which may have one or more substituents, or a C3-C8 cycloalkyl group which may have one or more substituents, or when Ra and Rb are bonded together, they may form, together with the nitrogen atom that is adjacent to a Ra and Rb, a 4- to 10-membered single ring which may have one or more substituents; and L represents a single bond, or a salt thereof.


 
EXHIBIT A-1 INITIAL DEVELOPMENT PLAN [*]


 
EXHIBIT B LICENSED COMPOUND Elacestrant (RAD1901)


 
EXHIBIT C-1 DUKE PATENT RIGHTS Application Filing Patent Issue Type Country Title Appl. Type Status Ownership No. Date No. Date 1901 DUKE Patent United Method of 61/971,627 3-28- Provisional Expired -- -- Duke States Treating 2017 University Cancer Using Selective Estrogen Receptor Modulators Patent United Method of 14/512,061 10-10- Non- Issued 9421264 8- Duke States Treating 2014 Provisional 23- University Cancer 2016 Using Selective Estrogen Receptor Modulators Patent United Method of 62/129,379 3-6-2015 Provisional Expired -- -- Duke States Treating University Cancer Using Selective Estrogen Receptor Modulators Patent PCT Method of PCT/US2015/ 3-28- PCT Expired -- -- Duke Treating 023216 2015 University Cancer Using Selective Estrogen Receptor Modulators Patent United Method of 15/214,187 7-19- Non- Issued 10071066 9- Duke States Treating 2016 Provisional 11- University Cancer 2018 Using Selective Estrogen Receptor Modulators Patent United Method of 15/129,197 26-Sep- Non- Issued 10420734 24- Duke States Treating 16 Provisional Sep- University NP Cancer 19 Using Selective Estrogen Receptor Modulators


 
LICENSE AGREEMENT Application Filing Patent Issue Type Country Title Appl. Type Status Ownership No. Date No. Date 1901 DUKE Patent Canada Method of 2943611 3-28- CA NP Pending -- -- Duke Treating 2015 University Cancer National Using Entry Selective 9-22- Estrogen 2016 Receptor Modulators Patent Europe Method of 15769394.6 3-28- EP NP Published -- -- Duke Treating 2015 University Cancer National Using Entry Selective 10- Estrogen 27/2016 Receptor Modulators Patent Europe Method of Proposed Proposed EP Div Proposed -- -- Duke DIV Treating University Cancer Using Selective Estrogen Receptor Modulators Patent United Method of 16/041,416 20-Jul- Non- Abandoned -- -- Duke States Treating 18 Provisional University CON 2 Cancer Using Selective Estrogen Receptor Modulators Patent United Method of 16/549,828 23-Aug- Non- Published -- -- Duke States Treating 19 Provisional University CON 3 Cancer Using Selective Estrogen Receptor Modulators Patent United Method of 16/721,329 19-Dec- Non- Published -- -- Duke States Treating 19 Provisional University CON 4 Cancer Using Selective Estrogen Receptor Modulators


 
LICENSE AGREEMENT EXHIBIT C-2 EISAI PATENT RIGHTS Filing Appl. Issue Type Country Title Application No. Status Patent No. Ownership Date Type Date 1901 EISAI COM Patent Australia Selective 2003292625 25- Nat'l Issued 2003292625 20- Eisai R&D Estrogen Dec- Phase Nov- Management Receptor 03 of 08 Co., Ltd. Modulator PCT Patent Canada Selective 2512000 25- Nat'l Issued 2512000 9- Eisai R&D Estrogen Dec- Phase Aug- Management Receptor 03 of 11 Co., Ltd. Modulator PCT Patent Europe Selective 03782904.1 25- Nat'l Issued 1577288 23- Eisai R&D Estrogen Dec- Phase in CH, Jul- Management Receptor 03 of DE, GB, 14 Co., Ltd. Modulator PCT FR, LI, NL 11/30/18 Patent Poland Selective -- -- -- Issued 186710 -- Eisai R&D Estrogen Management Receptor Co., Ltd. Modulator Patent India Selective 2829/DELNP/2005 25- Nat'l Issued 323625 24- Eisai R&D Estrogen Dec- Phase Oct- Management Receptor 03 of 19 Co., Ltd. Modulator PCT Patent Japan Selective 2004562947 25- Nat'l Issued 4500689 23- Eisai R&D Estrogen Dec- Phase Apr- Management Receptor 03 of 10 Co., Ltd. Modulator PCT


 
LICENSE AGREEMENT Filing Appl. Issue Type Country Title Application No. Status Patent No. Ownership Date Type Date 1901 EISAI COM Patent United Selective 11/158,245 22- CIP Issued 7,612,114 3- Eisai R&D States Estrogen Jun- of Nov- Management Receptor 05 PCT 09 Co., Ltd. Modulator Patent United Selective 12/544,965 20- DIV Issued 7,960,412 14- Eisai R&D States Estrogen Aug- of Jun- Management Receptor 09 '245 11 Co., Ltd. Modulator Patent United Selective 13/048,391 15- DIV Issued 8,399,520 19- Eisai R&D States Estrogen Mar- of Mar- Management Receptor 11 '965 13 Co., Ltd. Modulator Patent PCT Selective PCT/JP03/16808 25- PCT Expired -- -- Eisai Co., Estrogen Dec- Ltd. Receptor 03 Modulator


 
EXHIBIT C-3 RADIUS-INVENTED PATENT RIGHTS Issu Filin Typ Countr Appl. Patent e Title Application No. g Status Ownership e y Type No. Dat Date e 1901 THERAPEUTIC REGIMENS United Therapeuti 12- Paten Provision Radius Health, States c 61/334,095 May- Expired -- -- t al Inc. PRV Regimens 10 Therapeuti 12- Non- Paten PCT/US2011/0363 Radius Health, PCT c May- Provision Expired -- -- t 11 Inc. Regimens 10 al Therapeuti 9- Nat’l Paten United Abandone Radius Health, c 13/697,230 Nov- Phase of -- -- t States d Inc. Regimens 12 PCT CON of United Therapeuti 19- 31- Radius Paten US 9,555,01 States c 14/281,475 May- Issued Jan- Pharmaceutical t 13/697,23 4 CON Regimens 14 17 s, Inc. 0 Therapeuti 12- Nat’l Paten Abandone Radius Health, Canada c 2799183 May- Phase of -- -- t d Inc. Regimens 11 PCT Abandone d Therapeuti 12- Nat’l 20- Paten all Radius Health, Europe c 11781299.0 May- Phase of 2568806 Mar t Validatio Inc. Regimens 11 PCT -13 n countries Therapeuti 12- 18- Radius Paten Europe DIV of Abandone c 16163037.1 May- 3106159 Nov Pharmaceutical t DIV EP ‘299 d Regimens 11 -16 s, Inc. Therapeuti 12- Nat’l 8- Paten Mexic Radius Health, c MX/a/2012/013014 May- Phase of Issued 342898 Nov t o Inc. Regimens 11 PCT -12


 
LICENSE AGREEMENT Filin Issu Appl. Patent Type Country Title Application No. g Status e Ownership Type No. Date Date 1901 HF: MOT HOT FLASHES Treatment of vasomoto r United symptoms 22- Radius Paten Provision Expire States with 60/816,191 Jun- -- -- Pharmaceutical t al d PRV Selective 06 s, Inc. estrogen receptor modulator s Treatment of vasomoto r symptoms 22- Non- Radius Paten PCT/US2007/0145 Expire PCT with Jun- Provision -- -- Pharmaceutical t 98 d Selective 07 al s, Inc. estrogen receptor modulator s Treatment of vasomoto r symptoms 22- Nat'l 2- Radius Paten 2,656,06 Canada with 2,656,067 Jun- Phase of Issued Jan- Pharmaceutical t 7 Selective 07 '598 PCT 14 s, Inc. estrogen receptor modulator s Treatment of vasomoto r Validation symptoms 22- 1- Radius Paten Switzerlan of with 07796378.3 Jun- Issued 2037905 May Pharmaceutical t d 2037905 Selective 07 -13 s, Inc. Patent estrogen receptor modulator s Treatment of vasomoto r Validation symptoms 22- 1- Radius Paten of Germany with 07796378.3 Jun- Issued 2037905 May Pharmaceutical t 2037905 Selective 07 -13 s, Inc. Patent estrogen receptor modulator s


 
LICENSE AGREEMENT Filin Issu Appl. Patent Type Country Title Application No. g Status e Ownership Type No. Date Date 1901 HF: MOT HOT FLASHES Treatment of vasomoto r symptoms 22- Nat'l 1- Radius Paten Europe with 07796378.3 Jun- Phase of Issued 2037905 May Pharmaceutical t Selective 07 '598 PCT -13 s, Inc. estrogen receptor modulator s Treatment of vasomoto r Validation symptoms 22- 1- Radius Paten of Spain with 07796378.3 Jun- Issued 2037905 May Pharmaceutical t 2037905 Selective 07 -13 s, Inc. Patent estrogen receptor modulator s Treatment of vasomoto r Validation symptoms 22- 1- Radius Paten of France with 07796378.3 Jun- Issued 2037905 May Pharmaceutical t 2037905 Selective 07 -13 s, Inc. Patent estrogen receptor modulator s Treatment of vasomoto r Validation symptoms 22- 1- Radius Paten Great of with 07796378.3 Jun- Issued 2037905 May Pharmaceutical t Britain 2037905 Selective 07 -13 s, Inc. Patent estrogen receptor modulator s Treatment of vasomoto r Validation symptoms 22- 1- Radius Paten of Ireland with 07796378.3 Jun- Issued 2037905 May Pharmaceutical t 2037905 Selective 07 -13 s, Inc. Patent estrogen receptor modulator s


 
LICENSE AGREEMENT Filin Issu Appl. Patent Type Country Title Application No. g Status e Ownership Type No. Date Date 1901 HF: MOT HOT FLASHES Treatment of vasomoto r Validation symptoms 22- 1- Radius Paten of Italy with 07796378.3 Jun- Issued 2037905 May Pharmaceutical t 2037905 Selective 07 -13 s, Inc. Patent estrogen receptor modulator s Treatment of vasomoto r United symptoms 27- Nat'l 13- Radius Paten 8,933,13 States with 12/308,640 Oct- Phase of Issued Jan- Pharmaceutical t 0 NP Selective 09 '598 PCT 15 s, Inc. estrogen receptor modulator s Typ Filing Paten Issue Ownershi Country Title Application No. Appl. Type Status e Date t No. Date p 1901 ER MUTANTS Method United s of 29- Radius Paten States Treatin 62/154,699 Apr- Provisional Expired -- -- Pharmaceuti t PRV g 15 cals, Inc. Cancer Method United s of 30- Radius Paten States Treatin 62/155,451 Apr- Provisional Expired -- -- Pharmaceuti t PRV g 15 cals, Inc. Cancer Method United s of 6- Radius Paten States Treatin 62/252,085 Nov- Provisional Expired -- -- Pharmaceutical t PRV g 15 s, Inc. Cancer


 
LICENSE AGREEMENT Typ Filing Paten Issue Ownershi Country Title Application No. Appl. Type Status e Date t No. Date p 1901 ER MUTANTS Method United s of 10- Radius Paten States Treatin 62/265,696 Dec- Provisional Expired -- -- Pharmaceuti t PRV g 15 cals, Inc. Cancer Method s of 29- Radius Paten Non- PCT Treatin PCT/US2016/30317 Apr- Expired -- -- Pharmaceuti t Provisional g 16 cals, Inc. Cancer Method Nat'l phase s of 29- Radius Paten of Australia Treatin 2016256470 Apr- Pending -- -- Pharmaceuti t PCT/US16/ g 16 cals, Inc. 30317 Cancer Method Nat'l phase s of 29- Radius Paten of Brazil Treatin BR 112017023233-2 Apr- Published -- -- Pharmaceuti t PCT/US16/ g 16 cals, Inc. 30317 Cancer Method Nat'l phase s of 29- Radius Paten of Canada Treatin 2,984,195 Apr- Pending -- -- Pharmaceuti t PCT/US16/ g 16 cals, Inc. 30317 Cancer Method Nat'l phase s of 29- Radius Paten of China Treatin 201680038908.9 Apr- Published -- -- Pharmaceuti t PCT/US16/ g 16 cals, Inc. 30317 Cancer Method Nat'l phase s of 29- Radius Paten of Europe Treatin 16787290.2 Apr- Published -- -- Pharmaceuti t PCT/US16/ g 16 cals, Inc. 30317 Cancer


 
LICENSE AGREEMENT Typ Filing Paten Issue Ownershi Country Title Application No. Appl. Type Status e Date t No. Date p 1901 ER MUTANTS Method s of 29- Radius Paten Hong OFF EP Treatin 18110956.1 Apr- Published -- -- Pharmaceuti t Kong 16787290.2 g 16 cals, Inc. Cancer Method Nat'l phase s of 29- Radius Paten of Israel Treatin 255148 Apr- Published -- -- Pharmaceuti t PCT/US16/ g 16 cals, Inc. 30317 Cancer Method Nat'l phase s of 29- Radius Paten of Japan Treatin 2018-509731 Apr- Published -- -- Pharmaceuti t PCT/US16/3 g 16 cals, Inc. 0317 Cancer Method Nat'l phase s of 29- Radius Paten South of Treatin 10-2017-7034603 Apr- Published -- -- Pharmaceuti t Korea PCT/US16/ g 16 cals, Inc. 30317 Cancer Method Nat'l phase s of 29- Radius Paten of Mexico Treatin MX/a/2017/013801 Apr- Pending -- -- Pharmaceuti t PCT/US16/ g 16 cals, Inc. 30317 Cancer Method Nat'l phase s of 29- Radius Paten New of Treatin 737825 Apr- Pending -- -- Pharmaceuti t Zealand PCT/US16/ g 16 cals, Inc. 30317 Cancer Method Nat'l phase Russian s of 29- Radius Paten of Federatio Treatin 2017140674 Apr- Pending -- -- Pharmaceuti t PCT/US16/ n g 16 cals, Inc. 30317 Cancer


 
LICENSE AGREEMENT Typ Filing Paten Issue Ownershi Country Title Application No. Appl. Type Status e Date t No. Date p 1901 ER MUTANTS Method Nat'l phase s of 29- Radius Paten Singapor of Abandon Treatin 11201708858W Apr- -- -- Pharmaceuti t e PCT/US16/ ed g 16 cals, Inc. 30317 Cancer Method Singapor s of 29- Radius Paten e Treatin 10201903993U Apr- Divisional Published Pharmaceuti t Division g 16 cals, Inc. al Cancer United Method States s of 26- CON of Radius Paten CON Treatin 15/794,774 Oct- PCT/US16/ Published -- -- Pharmaceuti t CON of g 17 30317 cals, Inc. PCT Cancer Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 COMBINATION W/ CDK 4/6 INHIBITOR Methods United 15- Radius for Patent States 62/192,940 Jul- Provisional Expired -- -- Pharmaceuticals, Treating PRV 15 Inc. Cancer Methods United 10- Radius for Patent States 62/265,658 Dec- Provisional Expired -- -- Pharmaceuticals, Treating PRV 15 Inc. Cancer Methods United 15- Radius for Patent States 62/323,572 Apr- Provisional Expired -- -- Pharmaceuticals, Treating PRV 16 Inc. Cancer


 
LICENSE AGREEMENT Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 COMBINATION W/ CDK 4/6 INHIBITOR Methods 29- Radius for Non- Patent PCT PCT/US2016/30321 Apr- Expired -- -- Pharmaceuticals, Treating Provisional 16 Inc. Cancer Methods Nat'l Phase 29- Radius for of Patent Australia 2016256471 Apr- Pending -- -- Pharmaceuticals, Treating PCT/US16/ 16 Inc. Cancer 30321 Methods Nat'l Phase 29- Radius for BR of Patent Brazil Apr- Published -- -- Pharmaceuticals, Treating 112017023269-3 PCT/US16/ 16 Inc. Cancer 30321 Methods Nat'l Phase 29- Radius for of Patent Canada 2,984,200 Apr- Pending -- -- Pharmaceuticals, Treating PCT/US16/ 16 Inc. Cancer 30321 Methods Nat'l Phase 29- Radius for of Patent China 201680039059.9 Apr- Published -- -- Pharmaceuticals, Treating PCT/US16/ 16 Inc. Cancer 30321 Methods Nat'l Phase 29- Radius for of Patent Europe 16787291.0 Apr- Published -- -- Pharmaceuticals, Treating PCT/US16/ 16 Inc. Cancer 30321 Methods 29- Radius Hong for OFF EP Patent 18110957.0 Apr- Published -- -- Pharmaceuticals, Kong Treating 16787291.0 16 Inc. Cancer


 
LICENSE AGREEMENT Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 COMBINATION W/ CDK 4/6 INHIBITOR Methods Nat'l Phase 29- Radius for of Patent Israel 255189 Apr- Pending -- -- Pharmaceuticals, Treating PCT/US16/ 16 Inc. Cancer 30321 Methods Nat'l Phase 29- Radius for of Patent Japan 2018-509732 Apr- Published -- -- Pharmaceuticals, Treating PCT/US16/ 16 Inc. Cancer 30321 Methods Nat'l Phase 29- Radius South for of Patent 10-2017-7034606 Apr- Published -- -- Pharmaceuticals, Korea Treating PCT/US16/ 16 Inc. Cancer 30321 Methods Nat'l Phase 29- Radius for of Patent Mexico MX/a/2017/013802 Apr- Pending -- -- Pharmaceuticals, Treating PCT/US16/ 16 Inc. Cancer 30321 Methods Nat'l Phase 29- Radius New for of Patent 737822 Apr- Pending -- -- Pharmaceuticals, Zealand Treating PCT/US16/ 16 Inc. Cancer 30321 Methods Nat'l Phase 29- Radius Russian for of Patent 2017140675 Apr- Pending -- -- Pharmaceuticals, Federation Treating PCT/US16/ 16 Inc. Cancer 30321 Methods Nat'l Phase 29- Radius for of Patent Singapore 11201708860S Apr- Pending -- -- Pharmaceuticals, Treating PCT/US16/ 16 Inc. Cancer 30321


 
LICENSE AGREEMENT Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 COMBINATION W/ CDK 4/6 INHIBITOR Methods United 24- Radius for CON of US Patent States 16/580,914 Sep- Published -- -- Pharmaceuticals, Treating 15/794,861 CON 2 19 Inc. Cancer United Methods 26- CON of Radius States for Patent 15/794,861 Oct- PCT/US16/ Abandoned -- .. Pharmaceuticals, CON Treating 17 30321 Inc. of PCT Cancer Filin Issu Paten Type Country Title Application No. g Appl. Type Status e Ownership t No. Date Date 1901 COMBINATION W/ M-TOR INHIBITORS Method United s for 15- Radius Paten States Treatin 62/192,944 Jul- Provisional Expired -- -- Pharmaceutical t PRV g 15 s, Inc. Cancer Method United s for 10- Radius Paten States Treatin 62/265,663 Dec- Provisional Expired -- -- Pharmaceutical t PRV g 15 s, Inc. Cancer Method United s for 15- Radius Paten States Treatin 62/323,576 Apr- Provisional Expired -- -- Pharmaceutical t PRV g 16 s, Inc. Cancer Method s for 29- Radius Paten PCT/US2016/3031 Non- PCT Treatin Apr- Expired -- -- Pharmaceutical t 6 Provisional g 16 s, Inc. Cancer


 
LICENSE AGREEMENT Filin Issu Paten Type Country Title Application No. g Appl. Type Status e Ownership t No. Date Date 1901 COMBINATION W/ M-TOR INHIBITORS Method Nat'l phase s for 29- of Radius Paten Australia Treatin 2016256469 Apr- PCT/US16 Pending -- -- Pharmaceutical t g 16 / s, Inc. Cancer 30316 Method Nat'l phase s for 29- of Radius Paten BR Brazil Treatin Apr- PCT/US16 Published -- -- Pharmaceutical t 112017023228-6 g 16 / s, Inc. Cancer 30316 Method Nat'l phase s for 29- of Radius Paten Canada Treatin 2,984,357 Apr- PCT/US16 Pending -- -- Pharmaceutical t g 16 / s, Inc. Cancer 30316 Method Nat'l phase s for 29- of Radius Paten China Treatin 201680038907.4 Apr- PCT/US16 Published -- -- Pharmaceutical t g 16 / s, Inc. Cancer 30316 Method Nat'l phase s for 29- of Radius Paten Europe Treatin 16787289.4 Apr- PCT/US16 Published -- -- Pharmaceutical t g 16 / s, Inc. Cancer 30316 Method s for 29- OFF EP Radius Paten Hong Treatin 18110955.2 Apr- 16787289. Published -- -- Pharmaceutical t Kong g 16 4 s, Inc. Cancer Method Nat'l phase s for 29- of Radius Paten Israel Treatin 255261 Apr- PCT/US16 Pending -- -- Pharmaceutical t g 16 / s, Inc. Cancer 30316


 
LICENSE AGREEMENT Filin Issu Paten Type Country Title Application No. g Appl. Type Status e Ownership t No. Date Date 1901 COMBINATION W/ M-TOR INHIBITORS Method Nat'l phase s for 29- of Radius Paten Japan Treatin 2017-556627 Apr- PCT/US16 Published -- -- Pharmaceutical t g 16 / s, Inc. Cancer 30316 Method Nat'l phase s for 29- of Radius Paten South Treatin 10-2017-7034608 Apr- PCT/US16 Published -- -- Pharmaceutical t Korea g 16 / s, Inc. Cancer 30316 Method Nat'l phase s for 29- of Radius Paten MX/a/2017/01379 Mexico Treatin Apr- PCT/US16 Pending -- -- Pharmaceutical t 4 g 16 / s, Inc. Cancer 30316 Method Nat'l phase s for 29- of Radius Paten New Treatin 737819 Apr- PCT/US16 Pending -- -- Pharmaceutical t Zealand g 16 / s, Inc. Cancer 30316 Method Nat'l phase Russian s for 29- of Radius Paten Federatio Treatin 2017140676 Apr- PCT/US16 Pending -- -- Pharmaceutical t n g 16 / s, Inc. Cancer 30316 Method Nat'l phase s for 29- of Radius Paten Singapore Treatin 11201708861V Apr- PCT/US16 Pending -- -- Pharmaceutical t g 16 / s, Inc. Cancer 30316 Method Nat'l phase United s for 26- of Radius Paten States Abandone Treatin 15/794,910 Oct- PCT/US16 Pharmaceutical t CON d g 2017 / s, Inc. of PCT Cancer 30316


 
LICENSE AGREEMENT Filin Issu Paten Type Country Title Application No. g Appl. Type Status e Ownership t No. Date Date 1901 COMBINATION W/ M-TOR INHIBITORS Method United s For 20- Radius Paten States CON of Treatin 16/545,859 Aug- Published -- -- Pharmaceutical t CON 15/794,910 g 19 s, Inc. of 439320 Cancer Filin Typ Countr Appl. Patent Issue Title Application No. g Status Ownership e y Type No. Date Date 1901 POLYMORPHS Polymorph United ic Forms 5- Radius Pate Provision States of 62/442,921 Jan- Expired -- -- Pharmaceutica nt al PRV RAD1901- 17 ls, Inc. 2HCL Polymorph ic Forms 5- Non Radius Pate United 103850 8/20/20 of 15/863,850 Jan- Provision Issued Pharmaceutica nt States 08 19 RAD1901- 18 al ls, Inc. 2HCL Polymorph ic Forms 28- Radius Pate United Divisiona Allowe of 16/456,314 Jun- -- -- Pharmaceutica nt States l d RAD1901- 19 ls, Inc. 2HCL Polymorph Radius ic Forms 6- Pate United Divisiona Pharmaceutica of 16/921,684 July- Pending -- -- nt States l ls, RAD1901- 20 Inc. 2HCL Polymorph ic Forms 5- Non- Radius Pate PCT/US2018/012 PCT of Jan- Provision Expired -- -- Pharmaceutica nt 714 RAD1901- 18 al ls, Inc. 2HCL


 
LICENSE AGREEMENT Filin Typ Countr Appl. Patent Issue Title Application No. g Status Ownership e y Type No. Date Date 1901 POLYMORPHS Polymorph ic Forms 5- Radius Pate Austral NP of of AU 2018205285 Jan- Pending -- -- Pharmaceutica nt ia PCT RAD1901- 18 ls, Inc. 2HCL Polymorph ic Forms 5- Radius Pate NP of Canada of 3047411 Jan- Pending -- -- Pharmaceutica nt PCT RAD1901- 18 ls, Inc. 2HCL Polymorph ic Forms 5- Radius Pate NP of Publish China of 201880006119.6 Jan- -- -- Pharmaceutica nt PCT ed RAD1901- 18 ls, Inc. 2HCL Polymorph ic Forms 5- Radius Pate EP 18736577.0 NP of Publish Europe of Jan- -- -- Pharmaceutica nt 3565542 PCT ed RAD1901- 18 ls, Inc. 2HCL Polymorph OFF EP ic Forms 5- Radius Pate Hong EP of 62020005942.1 Jan- Pending -- -- Pharmaceutica nt Kong 18736577 RAD1901- 18 ls, Inc. .0 2HCL Polymorph ic Forms 5- Radius Pate NP of Publish Israel of IL 267772 Jan- -- -- Pharmaceutica nt PCT ed RAD1901- 18 ls, Inc. 2HCL Polymorph ic Forms 5- Radius Pate NP of Publish Japan of JP 2019-536266 Jan- -- -- Pharmaceutica nt PCT ed RAD1901- 18 ls, Inc. 2HCL


 
LICENSE AGREEMENT Filin Typ Countr Appl. Patent Issue Title Application No. g Status Ownership e y Type No. Date Date 1901 POLYMORPHS Polymorph ic Forms 5- Radius Pate South KR 10-2019- NP of Publish of Jan- -- -- Pharmaceutica nt Korea 7022624 PCT ed RAD1901- 18 ls, Inc. 2HCL Polymorph ic Forms 5- Radius Pate MX/a/2019/00774 NP of Mexico of Jan- Pending -- -- Pharmaceutica nt 8 PCT RAD1901- 18 ls, Inc. 2HCL


 
LICENSE AGREEMENT Application Filing Patent Issue Type Country Title Appl. Type Status Ownership No. Date No. Date 1901 POLYMORPHS (PATTERN B) Polymorphic United Radius Forms of 4-Jul- Patent States 62/694,003 Provisional Expired -- -- Pharmaceuticals, RAD1901- 18 PRV Inc. 2HCL Polymorphic PCT Radius Forms of PCT/US2019/ 3-Jul- Patent PCT 30 mo. Published -- -- Pharmaceuticals, RAD1901- 040527 19 4-Jan-21 Inc. 2HCL


 
LICENSE AGREEMENT Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 MOT OVARIAN CANCER Methods United for 27- Radius Patent States Treating 62/400,495 Sep- Provisional Expired -- -- Pharmaceuticals, PRV Ovarian 16 Inc. Cancer Methods for 27- PCT/US2017/ Non- Radius Health, Patent PCT Treating Sep- Expired -- -- 053834 Provisional Inc. Ovarian 17 Cancer Methods for 27- Radius Health, Patent Australia Treating AU 2017336564 Sep- NP of PCT Pending -- -- Inc. Ovarian 17 Cancer Methods for BR 27- Radius Health, Patent Brazil Treating 11 2019 Sep- NP of PCT Published -- -- Inc. Ovarian 004276-8 17 Cancer Methods for 27- Radius Health, Patent Canada Treating CA 3036568 Sep- NP of PCT Pending -- -- Inc. Ovarian 17 Cancer Methods for 27- CN Radius Health, Patent China Treating Sep- NP of PCT Published -- -- 201780058319.1 Inc. Ovarian 17 Cancer Methods for 27- Radius Health, Patent Europe Treating EP 17857371.3 Sep- NP of PCT Published -- -- Inc. Ovarian 17 Cancer


 
LICENSE AGREEMENT Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 MOT OVARIAN CANCER Methods for 27- Hong OFF EP Radius Health, Patent Treating 19129832.2 Sep- Pending -- -- Kong 17857371.3 Inc. Ovarian 17 Cancer Methods for 27- Radius Health, Patent Israel Treating IL 265537 Sep- NP of PCT Pending -- -- Inc. Ovarian 17 Cancer Methods for 27- Radius Health, Patent Japan Treating JP 2019-515854 Sep- NP of PCT Published -- -- Inc. Ovarian 17 Cancer Methods for 27- South KR 10-2019- Radius Health, Patent Treating Sep- NP of PCT Published -- -- Korea 7011747 Inc. Ovarian 17 Cancer Methods for 27- MX/a/2019/ Radius Health, Patent Mexico Treating Sep- NP of PCT Pending -- -- 003311 Inc. Ovarian 17 Cancer Methods for 27- New Radius Health, Patent Treating NZ 751032 Sep- NP of PCT Pending -- -- Zealand Inc. Ovarian 17 Cancer Methods for 27- Russian Radius Health, Patent Treating RU 2019108382 Sep- NP of PCT Pending -- -- Federation Inc. Ovarian 17 Cancer


 
LICENSE AGREEMENT Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 MOT OVARIAN CANCER Methods for 27- SG Radius Health, Patent Singapore Treating Sep- NP of PCT Pending -- -- 1120190759X Inc. Ovarian 17 Cancer Methods for 25- Radius United Patent Treating 16/336,358 Mar- NP of PCT Published -- -- Pharmaceuticals, States NP Ovarian 19 Inc. Cancer Application Filing Patent Issue Type Country Title Appl. Type Status Ownership No. Date No. Date 1901 + ABEMACICLIB Elacestrant In Combination United 30- Radius With Patent States 62/773,960 Nov- Provisional Expired -- -- Pharmaceuticals, Abemaciclib PRV 18 Inc. In Women With Breast Cancer Elacestrant In Combination 26- PCT Radius With PCT/US2019/ Patent PCT Nov- 30-mo. Published -- -- Pharmaceuticals, Abemaciclib 063239 19 30-May-21 Inc. In Women With Breast Cancer


 
LICENSE AGREEMENT Application Filing Patent Issue Type Country Title Appl. Type Status Ownership No. Date No. Date 1901 RESISTANT TO CDK 4/6 INHIBITORS Anti-Tumor Activity of United Elacestrant 6- Radius Patent States in Models 62/776,323 Dec- Provisional Expired -- -- Pharmaceuticals, PRV Resistant to 18 Inc. CDK 4/6 Inhibitors Anti-Tumor Activity of Elacestrant 6- PCT Radius PCT/US2019/ Patent PCT in Models Dec- 30 mo. 6- Published -- -- Pharmaceuticals, 065005 Resistant to 19 June-21 Inc. CDK 4/6 Inhibitors


 
LICENSE AGREEMENT Application Filing Patent Issue Type Country Title Appl. Type Status Ownership No. Date No. Date 1901 ESR1 MUTATIONS Anti-Tumor Activity of Elacestrant in Models United Harboring 6- Radius Patent States ESR1 62/776,338 Dec- Provisional Expired -- -- Pharmaceuticals, PRV Mutations 18 Inc. Resistant to Standard of Care Therapies Anti-Tumor Activity of Elacestrant in Models Harboring 6- PCT Radius PCT/US2019/ Patent PCT ESR1 Dec- 30-mo. 6- Published -- -- Pharmaceuticals, 064980 Mutations 19 June-21 Inc. Resistant to Standard of Care Therapies


 
LICENSE AGREEMENT Application Filing Patent Issue Type Country Title Appl. Type Status Ownership No. Date No. Date 1901 PROCESS CHEMISTRY United Processes 12- Radius Patent States and 62/804,391 Feb- Provisional Expired -- -- Pharmaceuticals, PRV Compounds 19 Inc. Processes 11- PCT Radius PCT/US2020/ Patent PCT and Feb- 30 mo. 12- Pending -- -- Pharmaceuticals, 017777 Compounds 20 Aug-21 Inc. Application Filing Patent Issue Type Country Title Appl. Type Status Ownership No. Date No. Date 1902 COMPOSITION OF MATTER Compounds United 22- Radius and methods Patent States 62/620,441 Jan- Provisional Expired -- -- Pharmaceuticals, of Using and PRV 18 Inc. Making Estrogen 22- Radius Receptor- PCT/US2019/ Non- Patent PCT Jan- Pending -- -- Pharmaceuticals, Modulating 014581 Provisional 19 Inc. Compounds Estrogen 22- Radius Receptor- Patent Australia TBD Jul- NP of PCT Pending -- -- Pharmaceuticals, Modulating 20 Inc. Compounds Estrogen 22- Radius Receptor- Patent Brazil TBD Jul- NP of PCT Pending -- -- Pharmaceuticals, Modulating 20 Inc. Compounds


 
LICENSE AGREEMENT Application Filing Patent Issue Type Country Title Appl. Type Status Ownership No. Date No. Date 1902 COMPOSITION OF MATTER Estrogen 22- Radius Receptor- Patent Canada TBD Jul- NP of PCT Pending -- -- Pharmaceuticals, Modulating 20 Inc. Compounds Estrogen 22- Radius Receptor- Patent China TBD Jul- NP of PCT Pending -- -- Pharmaceuticals, Modulating 20 Inc. Compounds Estrogen 22- Radius Receptor- Patent Europe TBD Jul- NP of PCT Pending -- -- Pharmaceuticals, Modulating 20 Inc. Compounds Estrogen 22- Radius Hong Receptor- Patent TBD Jul- NP of PCT Pending -- -- Pharmaceuticals, Kong Modulating 20 Inc. Compounds Estrogen 22- Radius Receptor- Patent Israel TBD Jul- NP of PCT Pending -- -- Pharmaceuticals, Modulating 20 Inc. Compounds Estrogen 22- Radius Receptor- Patent Japan TBD Jul- NP of PCT Pending -- -- Pharmaceuticals, Modulating 20 Inc. Compounds Estrogen 22- Radius South Receptor- Patent TBD Jul- NP of PCT Pending -- -- Pharmaceuticals, Korea Modulating 20 Inc. Compounds


 
LICENSE AGREEMENT Application Filing Patent Issue Type Country Title Appl. Type Status Ownership No. Date No. Date 1902 COMPOSITION OF MATTER Estrogen 22- Radius Receptor- Patent Mexico TBD Jul- NP of PCT Pending -- -- Pharmaceuticals, Modulating 20 Inc. Compounds Estrogen 22- Radius New Receptor- Patent TBD Jul- NP of PCT Pending -- -- Pharmaceuticals, Zealand Modulating 20 Inc. Compounds Estrogen 22- Radius Russian Receptor- Patent TBD Jul- NP of PCT Pending -- -- Pharmaceuticals, Federation Modulating 20 Inc. Compounds Estrogen 22- Radius Receptor- Patent Singapore TBD Jul- NP of PCT Pending -- -- Pharmaceuticals, Modulating 20 Inc. Compounds Estrogen 22- Radius United Receptor- Patent TBD Jul- NP of PCT Pending -- -- Pharmaceuticals, States NP Modulating 20 Inc. Compounds Application Filing Patent Issue Type Country Title Appl. Type Status Ownership No. Date No. Date 1902 SELECTION Estrogen United Radius Receptor- 22- Patent States 62/876,963 Provisional Pending -- -- Pharmaceuticals, Modulating Jul-19 PRV Inc. Compounds


 
LICENSE AGREEMENT Application Filing Patent Issue Type Country Title Appl. Type Status Ownership No. Date No. Date 1902 SELECTION Estrogen Radius Receptor- 22- Non- Patent PCT TBD Pending -- -- Pharmaceuticals, Modulating Jul-20 Provisional Inc. Compounds


 
LICENSE AGREEMENT EXHIBIT D TRANSITION SERVICES AGREEMENT [*]


 
LICENSE AGREEMENT EXHIBIT E PRESS RELEASE Menarini Group and Radius Health Announce Global License Agreement for the Development and Commercialization of elacestrant • Menarini licenses global development and commercialization rights of elacestrant, an oral SERD currently in late stage Phase 3 development • Elacestrant further strengthens Menarini’s global oncology portfolio, recently bolstered by the acquisition of Stemline Therapeutics in the U.S. • Radius will receive $30M as an upfront payment and up to $320M in additional milestones along with tiered low to mid-teen percentage royalties WALTHAM, Mass. – Florence, Italy, July 23, 2020 – The Menarini Group and Radius Health, Inc. (Nasdaq: RDUS) announced today that the companies have entered into an exclusive global license agreement for development and commercialization of elacestrant. Elacestrant is an oral SERD, a selective estrogen receptor degrader, currently being evaluated in the EMERALD Phase 3 study as hormonal treatment for postmenopausal women and men with advanced ER+/HER2- breast cancer. Under the agreement, Menarini Group will be responsible for worldwide commercialization of elacestrant, after the completion of EMERALD Phase 3 study and, assuming positive results, successful registration of elacestrant. Elcin Barker Ergun, Chief Executive Officer of Menarini Group, commented: “Elacestrant is a perfect addition to our global oncology portfolio following our recent acquisition of Stemline Therapeutics and entering the US biopharmaceuticals market. Oral SERDs can potentially lead to new treatment paradigms in breast cancer and we look forward to advancing elacestrant’s development to provide novel options that can help patients.” Kelly Martin, Chief Executive Officer of Radius commented, “Menarini will be a terrific global partner on this program and, given their recent investment and expansion in the oncology space, we are extremely pleased to have completed this transaction with them.” Martin further commented that “this transaction is a significant step for Radius and provides us with flexibility in moving forward.” As part of the agreement, Radius will receive an upfront payment of $30 million and up to $320 million in additional payments based on the successful achievement of future development and sales milestones. Menarini Group will make tiered, low to mid-teen percentage royalty payments to Radius Health on global net sales. Radius will continue to be responsible for the conduct and completion of the Phase 3 EMERALD study through NDA filing. Costs associated with this activity will be reimbursed by Menarini Group.


 
LICENSE AGREEMENT About Menarini Group Menarini Group is a leading international pharmaceutical company with a presence in 140 countries, including a direct presence in over 70 countries. Its global platform extends throughout Europe, U.S., Central America, Africa, the Middle East and Asia Pacific, and generates over $4.2 billion in annual sales. Menarini is committed to oncology, with an already commercialized product in the US and several new investigational drugs in development for the treatment of a variety of tumors. For over 130 years, Menarini has also been investing in the development, production and distribution of pharmaceuticals to serve patients and physicians around the world with a full portfolio of products covering a number of different therapeutic areas. About Radius Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics. Radius’ lead product, TYMLOS (abaloparatide) injection, was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The Radius clinical pipeline includes the investigational use of abaloparatide injection for the treatment of men with osteoporosis, an investigational abaloparatide-patch for potential use in osteoporosis; the investigational drug elacestrant (RAD1901) for potential use in hormone-receptor positive breast cancer out-licensed to Menarini Group; and the investigational drug RAD140, a non-steroidal, selective androgen receptor modulator (SARM) under investigation for potential use in hormone-receptor positive breast cancer. For more information, please visit www.radiuspharm.com. About Elacestrant (RAD1901) Elacestrant is a selective estrogen receptor degrader (SERD), which is being evaluated for potential use as a once daily oral treatment in patients with advanced estrogen receptor positive, HER2 negative (HER2-), breast cancer, the most common form of the disease. Fulvestrant is the only SERD that has been approved and marketed in this indication and has generated over $1 billion worldwide revenues. Unlike fulvestrant, which is administered as an intramuscular injection, elacestrant, if approved, has the potential to improve the patient experience with oral dosing. In addition, preclinical data have shown elacestrant to have greater antitumor activity than fulvestrant in in vivo models suggesting the potential for improved efficacy in patients. In a Phase 1 study with a heavily pre-treated population (n=50), elacestrant had an acceptable safety profile with the most commonly reported adverse events being low grade nausea and dyspepsia, and demonstrated single-agent activity with a 19.4% objective response rate (ORR) and 4.5 months progression-free survival (PFS). Encouraging activity was seen in patients whose tumors harbored ESR1 mutations as well as in patients whose disease had progressed after prior treatment with fulvestrant or CDK4/6 inhibitors. Studies completed to date indicate that elacestrant has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer. About EMERALD Phase 3 Study The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in advanced/metastatic ER-positive (ER+)/HER2- breast cancer patients. The study will enroll approximately 460 patients who have received prior treatment with one or two lines of endocrine therapy, including a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients in the study will be randomized to receive either elacestrant or the investigator’s choice of an approved hormonal agent. The primary endpoint of the study will be progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations. Secondary endpoints will include evaluation of overall survival (OS), objective response rate (ORR), and duration of response (DOR). Top-line data from the EMERALD study is expected to be reported in the second half of 2021.


 
LICENSE AGREEMENT Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential market opportunity for elacestrant, including the potential achievement of development and sales milestones related to elacestrant; our expectations regarding the completion of, and timing of results from, the EMERALD study; our expectations regarding an NDA filing in the U.S. and other regulatory filings globally for elacestrant; our expectations regarding our license agreement with Menarini for elacestrant; and the potential clinical uses and therapeutic and other benefits of elacestrant, abaloparatide-SC, abaloparatide-patch, and RAD140. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: Our inability to ensure the timing of results from the EMERALD trial or that its primary endpoint will be met; Menarini’s inability to ensure that elacestrant will obtain regulatory approval or be successfully commercialized, if approved, including as a result of risks related to coverage, pricing and reimbursement, manufacturing, supply and distribution, and potential adverse impacts on the EMERALD trial or Menarini’s business from the ongoing COVID-19 pandemic; risks related to competitive products; risks of litigation or other challenges regarding intellectual property rights; risks that adverse side effects of elacestrant will be identified during commercialization, if approved, or during development activities. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ending December 31, 2019 and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Menarini Group Press & Media Relations Valeria Speroni Cardi Email: pressoffice@menarini.com Radius Investor Relations & Media Contact: Elhan Webb, CFA Email: ewebb@radiuspharm.com Phone: 617-551-4011


 
LICENSE AGREEMENT EXHIBIT F DUKE ADDITIONAL TERMS “Duke Patent Rights” means Duke’s legal rights under the patent laws of the United States or relevant foreign countries for all of the following: (a) the following United States and foreign patent(s) and/or patent application(s), including all divisionals, continuations, continuations-in-part arising from or claiming priority to any of the Duke Patent Rights and containing claims covering the chemical compound known as RAD1901 or elacestrant in any and all fields of use, and foreign counterparts of the same: US Patent 9,421,264 (US Application No.: 14/512,061), USSN 62/129,379, USSN 61/971,627, PCT/US2015/023216, USSN 15/214,187, USSN 15/129,197, EPO 15769394.6 (EP 3122426), CA 2,943,611. (b) United States and foreign patents issued from the applications listed in subparagraph (a) above, including any reviewed, reissued or re-examined patents, and supplementary protection certificates, and foreign counterparts of the same, based upon the same. (c) Any applications claiming priority from any of the listed applications. The Duke Patent Rights existing as of the Effective Date are set forth in Exhibit C-1 to the Agreement. Clause 1 - Patent Prosecution and Maintenance 1.1 Radius and Licensee shall cooperate, and Radius shall use Diligent Efforts to cause Duke to cooperate, where needed or appropriate, in all aspects of filing, prosecuting, and maintaining all of the patents and patent applications that form the basis for the Duke Patent Rights, including, without limitation, (a) administrative reexaminations and reviews; and (b) disputes (including litigation) regarding inventorship and derivation, oppositions and interferences. Upon [*] election to apply for and prosecute a patent term extension for patents included in the Duke Patent Rights, Radius and Licensee shall cooperate, and Radius shall use Diligent Efforts to cause Duke to cooperate, where needed or appropriate, in such application and prosecution. 1.2 Promptly, and in any case no later than [*] days, after the Effective Date, [*] shall (i) provide [*] with all documentation and information in [*] possession relating to the filing, prosecution and maintenance of the Duke Patent Rights by uploading such documentation and information in an orderly fashion to a shared virtual data room or a shared virtual ‘folder’ (such as a Google Drive ‘folder’), (ii) clearly identify any and all prosecution matters that require immediate attention as of the Effective Date, (iii) formally notify all patent attorneys in charge of the filing, prosecution and maintenance of the Duke Patent Rights of [*] assumption of responsibility and full authority for such matters (or cause all such patent attorneys to be so notified), and (iv) liaise [*] with all such patent attorneys; provided, however, that, [*]. In consultation with [*], [*] shall develop the prosecution strategy and [*] shall draft substantive responses to the patent offices and shall make reasonable efforts to allow [*] sufficient time to review, comment, and advise upon


 
LICENSE AGREEMENT such strategy and response. It is understood and agreed that in the event of any disagreement on the prosecution strategy and/or the contents of a substantive response, as between the Parties and for so long as [*] prosecutes the patents and patent applications that form the basis for the Duke Patent Rights, [*] shall have the final decision-making authority with regard to the filing, prosecution and maintenance of the Duke Patent Rights in any country in the Territory; provided that [*] may not use such final decision-making authority in a manner inconsistent with the Duke License Agreement. 1.3 For so long as [*] prosecutes the patents and patent applications that form the basis for the Duke Patent Rights, the out-of-pocket costs and expenses (including, but not limited to, patent attorney fees and maintenance fees) for the filing, prosecution, maintenance and extension of all the patents and patent applications that form the basis for the Duke Patent Rights (the “Duke Patent Prosecution and Maintenance Costs”) incurred by [*] after the Effective Date of the Agreement and until the Second NDA Anniversary shall be equally shared between Licensee and Radius and, upon and following Second NDA Anniversary, [*] shall bear one hundred percent (100%) of the Duke Patent Prosecution and Maintenance Costs incurred by [*]. [*] shall reimburse [*] for fifty (50) percent of the Duke Patent Prosecution and Maintenance Costs incurred by Licensee prior to the Second NDA Anniversary within [*] ([*]) calendar days following receipt of Licensee’s invoice, and [*] shall invoice [*] for such Duke Patent Prosecution and Maintenance Costs no more frequently than once in each calendar quarter. [*] shall reimburse [*] for all reasonable and actual documented fees and costs incurred by [*] after the Effective Date relating to the activities described in this Clause 1. Such reimbursement shall be made within [*] ([*]) days of receipt of [*] receipt of [*] invoice [*]. 1.4 [*] 1.5 If [*] provides [*] with written notification that it will no longer support the filing, prosecution, or maintenance of a specified patent(s) and/or patent application(s) within the Duke Patent Rights, then [*] responsibility for fees and costs related to the filing, prosecution, and maintenance of such subject Duke Patent Rights will terminate [*] ([*]) days after [*] receipt of such written notification. [*]. Clause 2 – Enforcement and Defense 2.1 Each Party shall promptly advise the other Party in writing of any known acts of actual or potential infringement of the Duke Patent Rights by a Third Party. [*] has the first option (but not the obligation) to police the Duke Patent Rights against infringement by Third Parties within the Territory. [*] shall not file any suit without (a) first performing a thorough, diligent investigation of the merits of such suit, including with respect to the validity and enforceability of the Duke Patent Rights, to which [*] shall promptly and fully cooperate with all reasonable requests of [*], at [*] cost and expenses, with all reasonable requests of [*]; (b) there being reasonable legal and economic bases for doing so; (c) notifying [*] [*] before any such filing. This right to police includes filing, prosecuting, and settling all infringement actions at its expense, except that [*] shall make any such settlement only with the consent of [*], not to be unreasonably withheld or delayed. [*] has the right to file suit using counsel of its choosing, subject to [*] approval, which shall not be unreasonably withheld or delayed. [*] may grant to third parties the right to enforce hereunder, but only with the express written permission of [*], not to be unreasonably withheld or delayed. 2.2 Subject to Clause 2.1 above, [*] shall reasonably assist, [*], [*] in any suit brought by [*] to enforce the Duke Patent Rights, if so requested (the assistance so provided by [*], the “Enforcement Assistance”). [*] shall reimburse [*] for all reasonable and actual documented fees, costs and expenses incurred by [*] in providing Enforcement Assistance to [*] that are reimbursable by [*] pursuant to Section 8.2 of the Duke License Agreement. Such reimbursement shall be made within twenty-five (25) days of receipt of [*]


 
LICENSE AGREEMENT invoice. [*] shall be named in or join, [*], any action or proceeding brought by [*] to enforce the Duke Patent Rights, if required to be named in or joined in such action or proceeding, or if requested by [*], and [*] shall bear all of [*] related and reasonable costs and expenses; provided, however, that if [*] elect to be represented by independent legal counsel, [*] shall bear the related fees and costs. [*] retains the right to participate, with counsel of its own choosing and at its own expense, in any action under this Clause 2. Provided that if [*] is controlling enforcement activities, [*] shall defend, indemnify and hold harmless [*] with respect to any claims asserted by an alleged infringer reasonably related to the enforcement of the Duke Patent Rights under this Clause, including but not limited to antitrust counterclaims and claims for recovery of attorney fees. 2.3 [*] acknowledges that Duke and its employees have a vital interest in lawsuits relating to the validity and enforceability of the Duke Patent Rights. If a Third Party files a suit, including as a counterclaim, alleging that any of the Duke Patent Rights is invalid or unenforceable, [*] shall have the right (but not the obligation) to participate in such suit (if not brought against [*]) and in any case to assume control of the defense of such claim, provided, however, that if [*] assumes control of the defense, [*] shall consult with [*] with respect to such defense, and shall reasonably consider [*] input. In furtherance of such defense, at the onset of such claim and as reasonable during the pendency of any such claim, the Parties shall meet and confer in good faith to set a plan for handling the defense thereof. Notwithstanding, in the event that the Parties cannot agree on how to proceed with respect to such claim, [*] shall have the right to control the defense thereof. Licensee and Radius shall equally share the out-of-pocket costs and fees associated with the activities under this Clause 2.3. The Parties shall consider reasonable controls on costs and fees as part of an aforementioned meet and confer with respect to the handling of the defense. Notwithstanding, if a third party asserts jurisdiction for any such action solely as the result of acts of [*], then [*] shall be responsible for such reasonable costs and fees. 2.4 If [*] recovers damages associated with the Duke Patent Rights in patent litigation or settlement thereof, the award shall first be divided [*].


 
EXHIBIT G EISAI ADDITIONAL TERMS For purposes of this Exhibit G: “Compound” means elacestrant or any derivative or analogue thereof. “Product” means any pharmaceutical drug in final packaged form containing the Compound or any derivative or analogue thereof, the development, manufacture, use or sale of which, absent the licenses granted to Licensee hereunder, would infringe the Eisai Patents or which make use of any Joint Patents. “Affiliates” means any corporation, firm, partnership or other entity which directly or indirectly owns, is owned by or is under common ownership with a Party to the extent of more than fifty (50) percent of the equity having the power to vote on or direct the affairs of any such corporation, firm, partnership, or other entity. “Radius-Eisai Joint Invention” means any invention developed by or on behalf of Radius and disclosed by Radius to Eisai pursuant to Section 6.3 of the Eisai License Agreement. Any patent application claiming a Radius-Eisai Joint Invention, and any patent stemming therefrom, shall be referred to as a “Radius-Eisai Joint Patent”. The Radius-Eisai Joint Patents existing as of the Effective Date are set forth in Exhibit C-3. “Radius-Invented Patents” means all patents and patent applications which are or become owned by Radius and/or its Affiliates, or to which Radius and/or its Affiliates otherwise have, now or in the future, the right to grant licenses, and which generically or specifically claim Compound and/or Product, a use for Compound and/or Product, a process for manufacturing Compound and/or Product, or an intermediate used in such process. Included within the definition of Radius-Invented Patents are all continuations, continuations-in-part, divisions, patents of addition, reissues, re-examinations, renewals or extensions thereof and all Supplementary Protection Certificates. Also included within the definition are all patents and patent applications claiming any improvements on Compound and/or Product or intermediates or manufacturing process required or useful for production of Compound and/or Product which are developed by or for Radius and/or its Affiliates, or to which Radius and/or its Affiliates otherwise have the right to grant licenses, now or in the future, during the term of the Agreement. Radius-Invented Patents also includes any patent application covering an invention solely owned by Radius in accordance with Article 6.4 of the Eisai License Agreement. The Radius-Invented Patents existing as of the Effective Date are set forth in Exhibit C-3. “Licensee-Invented Patents” means [*]. Clause 1 – Patent Prosecution and Maintenance 1.1 The Agreement, including, without limitation, this Exhibit G, does not convey to Licensee any rights in any Eisai Know-How or Eisai Patents by implication, estoppel or otherwise except for the rights expressly granted in Section 2.1 of the Agreement. Sole and exclusive title to all Eisai Know-How and Eisai Patents shall at all times remain vested in Eisai. Except as expressly provided in this Exhibit G or in the Agreement, the Agreement, including, without limitation, this Exhibit G, does not convey to Eisai and/or Radius any rights in any Know-How developed or otherwise obtained by Licensee and/or its Affiliates, including, but not limited to, any invention, whether patentable or not, or any information regarding the utility or safety of Compound or Product, or any Licensee-Invented Patents by implication, estoppel or otherwise.


 
LICENSE AGREEMENT 1.2 Notwithstanding Clause 1.1 above, during the term of the Eisai License Agreement, Licensee shall share with Radius all preclinical and clinical data, including safety data post-approval, provided that all such data generated by Licensee shall be at all times solely owned by Licensee. During the term of the Eisai License Agreement, Licensee shall promptly inform Radius of any Eisai Know-How that becomes known to Licensee, if and to the extent Licensee is positively aware that it is Eisai Know-How, and, subject to Clause 1.1 above and the confidentiality provision set forth in Section 9 of the Agreement, of information that it obtains or develops regarding the utility or safety of Compound or Product. 1.3 During the term of the Eisai License Agreement, Licensee shall promptly notify Radius of any invention made by its employees, agents or independent contractors regarding (i) Compound (including, without limitation, intermediates and prodrugs), (ii) new form, use, manufacture, composition of Compound (including intermediates and prodrugs), or (iii) any improvements on Compound and/or Product. Licensee shall not take any steps with respect to filing a patent application for such invention before the ownership of such invention is determined by the Parties through good faith consultation in accordance with Clause 1.4 below. 1.4 Upon Licensee notifying Radius as provided in Clause 1.3 above, the Parties (with Radius relaying any comments of Eisai) shall promptly consult in good faith to determine the ownership of such invention. Any invention disclosed by Licensee to Radius pursuant to Clause 1.3 above shall be [*]. 1.5 Upon the request of Licensee, Radius shall request that Eisai [*]. 1.6 Upon the request of Radius, Licensee shall disclose the complete texts of any Licensee-Invented Patent. Radius shall have the right to review, with Licensee’s prior written consent, which shall not be unreasonably withheld, all information received by Licensee concerning the institution or possible institution of any interference, opposition, re-examination, reissue, revocation, nullification or any official proceeding involving a Radius-Invented Patent anywhere in the world. Radius shall hold all information disclosed to it under this Clause 1.6 as strictly confidential in accordance with the confidentiality provision set forth in Section 9 of the Agreement. 1.7 The Parties acknowledge that [*] shall have the sole right and authority to prepare, file, prosecute, maintain and obtain extensions of all patent applications and patents included within Eisai Patents in Japan and the Territory. [*] shall use Diligent Efforts to cause [*] to use all commercially reasonable efforts to prosecute and maintain all patent applications and patents included within the Eisai Patents. [*] shall reimburse [*] for twenty-five (25) percent of [*] actual external costs and expenses incurred by [*] after the Effective Date with respect to prosecuting and maintaining such Eisai Patents in the Territory. [*] shall promptly furnish or have furnished to [*] copies of all patents, patent applications, substantive patent office actions, and substantive responses received or filed in connection with any applications for the Eisai Patents and use reasonable efforts to solicit [*] advice and review of Eisai Patents and material prosecution matters related thereto in reasonable time prior to filing thereof, and [*] shall deliver any such comments to [*] and shall use Diligent Efforts to cause [*] to consider in good faith [*] reasonable comments and suggestions related thereto, which comments and suggestions shall be provided to [*] without any delay. [*] is not required to have English translations of the records provided to [*] for that purpose but shall provide copies of all correspondence and documents that are provided to it in English from patent officials or outside counsel. [*] agrees to grant to [*] the right to assume responsibility for any of Eisai Patents or any part of Eisai Patents which [*] determines in its sole discretion to abandon or otherwise cause or allow to be forfeited, provided [*] grants [*] such right in writing. 1.8 [*] shall have the sole right and authority to file, prosecute, maintain and obtain extensions of all patent applications and patents included within Radius-Invented Patents and Licensee-Invented Patents in Japan and the Territory. [*] shall use all commercially reasonable efforts to prosecute and maintain all


 
LICENSE AGREEMENT patent applications and patents included within Radius-Invented Patents and Licensee-Invented Patents. [*] shall promptly furnish or have furnished to [*] copies of all patents, patent applications, substantive patent office actions, and substantive responses received or filed in connection with such applications for Radius- Invented Patents and Licensee-Invented Patents and use reasonable efforts to solicit [*] advice and review of Radius-Invented Patents and Licensee-Invented Patents and material prosecution matters related thereto in reasonable time prior to filing thereof; [*] shall consider in good faith [*] reasonable comments and suggestions related thereto, which comments and suggestions shall promptly be provided to [*]. [*] is not required to have English translations of the records provided to [*] under this Clause 1.8, but shall provide copies of all correspondence and documents that are provided to it in English from patent officials or outside counsel. [*] agrees to grant to [*] the right to assume responsibility for the filing, prosecution and maintenance of any Radius-Invented Patent, Radius-Eisai Joint Patent and Licensee-Invented Patent or any part of a Radius-Invented Patent, Radius-Eisai Joint Patent or Licensee-Invented Patent which [*] intends to abandon or otherwise cause or allow to be forfeited. Such grant shall be made in writing and shall not be inferred from the circumstances. [*] shall hold, and shall cause any of Affiliates to hold, all information disclosed to it under this Clause 1.8 as confidential in accordance with the confidentiality provisions set forth in Section 9 of the Agreement. 1.9 For so long as [*] prosecutes the Radius-Invented Patents, the out-of-pocket costs and expenses (including, but not limited to, patent attorney fees and maintenance fees) for the filing, prosecution, maintenance and extension of the Radius-Invented Patents (the “Radius-Invented Patent Prosecution and Maintenance Costs”) incurred by [*] after the Effective Date and until the Second NDA Anniversary shall be [*] prior to the [*] within [*] ([*]) calendar days following receipt of [*] invoice and [*] shall invoice [*] for such Radius-Invented Patent Prosecution and Maintenance Costs no more frequently than [*]. [*] shall bear all Radius-Invented Patent Prosecution and Maintenance Costs incurred by [*] after [*]. Promptly, and in any case no later than [*] days, after the Effective Date, [*] shall (i) provide [*] with all documentation and information in Radius’ possession relating to the filing, prosecution and maintenance of the Radius-Invented Patents and Radius-Eisai Joint Patents by uploading such documentation and information in an orderly fashion to a shared virtual data room or a shared virtual ‘folder’ (such as a Google Drive ‘folder’), (ii) clearly identify any and all prosecution matters that require immediate attention as of the Effective Date, (iii) formally notify all patent attorneys in charge of the filing, prosecution and maintenance of the Radius-Invented Patents and Radius-Eisai Joint Patents of [*] assumption of responsibility and full authority for such matters (or cause all such patent attorneys to be so notified), and (iv) liaise [*] with all such patent attorneys. 1.10 With respect to any potentially patentable Radius-Eisai Joint Invention or Licensee-Eisai Joint Invention (collectively, the “Joint Inventions”), the Parties shall meet and agree in writing upon whether and when patent applications shall be filed for such Joint Invention (any such agreement, a “Joint Patent Agreement”; any patent application directed to a Licensee-Eisai Joint Invention, and any patent issuing therefrom, a “Licensee-Eisai Joint Patent”; and the Radius-Eisai Joint Patents and the Licensee-Eisai Joint Patents, collectively, the “Joint Patents”), using outside legal counsel selected by either Radius or Licensee, as the case may be, and Eisai. The selected outside counsel shall be responsible to either Radius or Licensee, as the case may be, and Eisai, and shall use reasonable efforts to solicit either Radius or Licensee, as the case may be, and Eisai’s advice on material prosecution matters related thereto. Unless the applicable Joint Patent Agreement provides otherwise, Licensee shall bear the costs and expenses incurred with respect to the prosecution of the Licensee-Eisai Joint Patents in the Territory. If Licensee is the Prosecuting Party (as this term is defined in this Clause 1.10) of a Radius-Eisai Joint Patent, (i) the costs and expenses for the filing, prosecution, maintenance and extension of such Radius-Eisai Joint Patent incurred by Licensee after the Effective Date and until [*], it being understood that [*] shall invoice [*] for such costs and expenses no more frequently than once in each calendar quarter; and (ii) [*] shall bear all costs and expenses for the filing, prosecution, maintenance and extension of such Radius-Eisai Joint Patent incurred after [*]. As between Radius and Licensee, the Party that bears the costs and expenses for the prosecution of a Joint


 
LICENSE AGREEMENT Patent (the “Prosecuting Party”) shall have final decision-making authority in respect of the prosecution of such Joint Patent and its maintenance in the Territory; provided, however, that such final decision making authority may not be used in a manner inconsistent with the Eisai License Agreement. The Prosecuting Party shall provide the other Party, and Radius shall provide Eisai, reasonable opportunity to review and comment on such prosecution efforts regarding the applicable Joint Patent in the particular jurisdictions, and such other Party shall provide the Prosecuting Party reasonable assistance in such efforts. The Prosecuting Party shall provide the other Party, and Radius shall provide Eisai, with a copy of all material communications from any patent authority in the applicable jurisdictions regarding the Joint Patent being prosecuted by such Prosecuting Party, and shall provide drafts of any material filings or responses to be made to such patent authorities a reasonable amount of time in advance of submitting such filings or responses. In particular, the Prosecuting Party shall provide the other Party, and Radius shall provide Eisai, with all information necessary or desirable to enable the other Party to comply with the duty of candor/duty of disclosure requirements of any patent authority. Neither Party shall grant any Third Party(ies) the right to practice the Joint Patents or any Joint Inventions without prior consent of the other Party or Eisai anywhere in the world. Any royalty from such Third Parties shall be governed by the applicable Joint Patent Agreement; provided that [*]. [*] may determine that it is no longer interested in supporting the continued prosecution or maintenance of a particular Joint Patent in a country or jurisdiction, in which case, [*]. 1.11 The Parties will discuss and recommend for which, if any, of the patents within the Eisai Patents, Radius-Invented Patents, Licensee-Invented Patents and Joint Patents in the world patent term extensions should be sought. As between the Parties, [*] shall have the final decision-making authority with respect to applying for any such patent term extensions in the world, and will act with reasonable promptness in light of the development stage of Products to apply for any such patent term extensions; provided that in respect of the Eisai Patents Licensee may not use such final decision-making authority in a manner inconsistent with the Eisai License Agreement. If in a particular country or jurisdiction in the world only one such patent can obtain a patent term extension, then the Parties will consult in good faith to determine which such patent should be the subject of efforts to obtain a patent term extension. As between the Parties, the Prosecuting Party will have final decision-making authority in case of disagreement provided that in respect of the Eisai Patents Licensee may not use such final decision-making authority in a manner inconsistent with the Eisai License Agreement. The Party that does not apply for an extension hereunder will cooperate fully with the other Party in making such filings or actions, for example and without limitation, making available all required regulatory data and information and executing any required authorizations to apply for such patent term extension. 1.12 Subject always to Section 7.3(c)(iii) of the Agreement, .in the event that a Third Party sues either Party, its Affiliates, licensees or sublicensees for patent infringement involving the manufacture, use, sale, distribution or marketing of Product anywhere in the world, the Party sued shall promptly notify the other Party with regard to such action. With respect to the defense of any such action in the Territory, the Party sued shall be wholly responsible for the defense of such action and shall bear all costs and expenses associated therewith. In any event, the Party sued shall have the right to request, solely at its own expense, the other Party to assist and cooperate in connection with the defense of such suit. Upon such request, the other Party shall use [*] all reasonable efforts to assist and cooperate in connection with the defense of such suit. 1.13 In the event that either Party becomes aware of actual or threatened infringement of Eisai Patents, Radius-Invented Patents, Licensee-Invented Patents, or Joint Patents anywhere in the world, it shall promptly notify the other Party thereof in writing, which notice shall include all information available to the notifying Party regarding such alleged infringement. With respect to infringement of Eisai Patents anywhere in the world, the Parties acknowledge that pursuant to the Eisai License Agreement, [*] has the first right (but not the obligation) to pursue any and all injunctive, compensatory and other remedies (collectively, “Remedies”) against the infringing third party. In the event [*] does not elect to enforce the


 
LICENSE AGREEMENT Eisai Patents, [*] shall notify [*] in writing promptly after [*] receives such notice from [*], and [*] shall have the right (but not the obligation) to commence a suit or take action to enforce the applicable Eisai Patents against such infringing third party in the Territory. In the event [*] notifies [*] that [*] has a reasonable business basis not to enforce such Eisai Patents in the Territory, with the determination of reasonableness taking into account the costs of such litigation, its likelihood for success, the potential damages or settlement recovery, and the potential for exposure to counterclaims and defenses against [*] with respect to the validity of the Eisai Patents, [*] shall provide such notice to [*] promptly following receipt of such notice from [*], in which case [*] shall not have such enforcement right in the Territory; provided that, the Parties will discuss in good faith whether Section 7.3(c)(ii) of the Agreement shall apply, mutatis mutandis, with respect to the applicable country(ies) where such infringement exists as if no patent protection or data protection clauses are in effect for such country(ies). The Party pursuing Remedies pursuant to this Clause 1.12 in respect of Eisai Patents, Radius-Invented Patents, Licensee-Invented Patents or Joint Patents shall bear its own costs and expenses relating to such pursuit. [*]. With respect to infringement of Radius-Invented Patents and Licensee-Invented Patents anywhere in the world, [*] shall have the first right (but not the obligation) to pursue any and all Remedies against the infringing third party. [*] shall have a period of [*] to elect to so enforce such Radius-Invented Patents or Licensee-Invented Patents. In the event [*] does not so elect, it shall so notify [*] in writing [*]. In the event that a third party infringes any Joint Patents, [*] shall have the first right (but not the obligation) to pursue Remedies against the infringing third party if such infringement is conducted in the Territory. In any event as set forth in this Clause 1.13, upon request from the other Party, [*] and [*] shall assist one another and cooperate in the pursuit of Remedies, including without limitation joining such action as a party plaintiff if required by applicable law to pursue such action, without charge to the other Party for costs and expenses incurred thereby. 1.14 The Parties shall keep one another informed of the status of their respective activities regarding any litigation or settlement thereof concerning the Product. Neither Party shall enter into any settlement or consent judgment or other voluntary final disposition of any suit defended or action brought pursuant to Clause 1.13 without the other Party's prior written consent, which consent shall not be unreasonably withheld.


 
exhibit102-originalv2
Exhibit 10.2 PARTIAL RELEASE AND ACKNOWLEDGEMENT AGREEMENT This PARTIAL RELEASE AND ACKNOWLEDGEMENT AGREEMENT (this “Agreement”), dated as of July 22, 2020, is made by and among MIDCAP FINANCIAL TRUST, a Delaware statutory trust, as agent under Term Loan Credit Agreement referred to below (in such capacity and together its successors and assigns, the “Term Loan Agent”), MIDCAP FUNDING IV TRUST, a Delaware statutory trust, as agent under Revolving Credit Agreement referred to below (in such capacity and together its successors and assigns, the “Revolving Loan Agent” and, together with the Term Loan Agent, the “Agents”) RADIUS HEALTH, INC., a Delaware corporation (“Radius Health”), and RADIUS PHARMACEUTICALS, INC., a Delaware corporation (“Radius Pharma”, together with Radius Health, the “Grantors” and each, a “Grantor”). WHEREAS, pursuant to (i) that certain Credit and Security Agreement (Term Loan), dated as of January 10, 2020, among the Grantors, the Term Loan Agent and the Lenders and other parties thereto (as the same may have been amended, modified, restated, replaced or supplemented from time to time, the “Term Loan Credit Agreement”) and that certain Intellectual Property Security Agreement, dated as of January 10, 2020, among the Grantors and the Term Loan Agent (as the same may have been amended, modified, restated, replaced or supplemented from time to time, the “Term Loan IP Security Agreement”) and (ii) that certain Credit and Security Agreement (Revolving Loan), dated as of January 10, 2020, among the Grantors, the Revolving Loan Agent and the Lenders and other parties thereto (as the same may have been amended, modified, restated, replaced or supplemented from time to time, the “Revolving Credit Agreement”, together with the Term Loan Credit Agreement, the “Credit Agreements”) and that certain Intellectual Property Security Agreement, dated as of January 10, 2020, among the Grantors and the Revolving Loan Agent (as the same may have been amended, modified, restated, replaced or supplemented from time to time, the “Revolving IP Security Agreement”), the Grantors assigned and granted to each of (i) Revolving Loan Agent, for the benefit of itself and the Lenders under (and as defined in) the Revolving Credit Agreement and (ii) Term Loan Agent, for the benefit of itself and the Lenders under (and as defined in) the Term Loan Credit Agreement, a security interest in and to the personal property of the Grantors as specified therein, including the property set forth on Exhibit A hereto; WHEREAS, the Term Loan IP Security Agreement was duly filed and recorded with the United States Patent and Trademark Office on January 15, 2020 at reel/frame 51618/200 and on January 23, 2020 at reel/frame 6838/0823, and the Revolving IP Security Agreement was duly filed and recorded with the United States Patent and Trademark Office on January 15, 2020 at reel/frame 51618/758 and on January 23, 2020 at reel/frame 6838/0837; WHEREAS, pursuant to that certain License Agreement (such agreement, as may be amended or restated from time to time in accordance with the terms thereof and of the Credit Agreements, the “License Agreement”), dated as of the date hereof, between Radius Pharma and Berlin-Chemie AG - Menarini Group, organized under the laws of Germany having business offices at Glienicker Weg 125, 12849 Berlin, Germany (including its permitted successors and assigns, “Licensee”), Radius Pharma has (a) granted to Licensee an exclusive, worldwide, royalty-bearing license under the Radius Elacestrant Patent Rights and the Radius Elacestrant Know-How to research, develop, have developed, make, have made, use, sell, offer for sale, commercialize, import and export one or more Licensed Compound(s) and Licensed Product(s) (each as defined in Exhibit A hereto) (such license grant, as contemplated under the License Agreement, the “License”); and (b) agreed to grant the right to use certain regulatory filings and other assets of the Grantors that are related solely to the Licensed Compounds and Licensed Products; WHEREAS, in connection with the License Agreement, the Grantors have requested that each Agent release, discharge, relinquish, terminate and dissolve its security interest in and continuing lien on, and security interest in and to, the Elacestrant Collateral (as defined in Exhibit A hereto); and


 
WHEREAS, pursuant to that certain Transition Services Agreement (such agreement, as may be amended or restated in accordance with the terms thereof and of the Credit Agreements, the “Transition Services Agreement”), dated as of the date hereof, between Radius Health and Licensee, Grantor has agree to perform certain clinical, regulatory and other activities relating to the Licensed Compound(s) and Licensed Products. NOW, THEREFORE, in consideration of the foregoing, the terms and conditions set forth in this Agreement, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, each Agent and the Grantors hereby agree as follows: 1. Recitals. This Agreement shall constitute a Financing Document under each Credit Agreement and the Recitals and each reference to the Credit Agreements, unless otherwise expressly noted, will be deemed to reference the Credit Agreements as supplemented hereby. Capitalized terms used but not otherwise defined herein shall have the meanings ascribed to them in the applicable Credit Agreement (including those capitalized terms used in the Recitals hereto). 2. Release. In reliance on the certifications set forth in Section 3(a) below, each Agent, without recourse, representation or warranty, automatically upon the execution and delivery of the License Agreement, and without any action required by any other Person, hereby (a) releases all of its right, title and interest in and to the Elacestrant Collateral, and reassigns and transfers all of its right, title and interest that such Agent may have in the Elacestrant Collateral, to the Grantors, and confirms that any Lien, security interest or other encumbrance of any kind in favor of such Agent on or in respect of the Elacestrant Collateral is hereby automatically discharged and released pursuant to Section 11.9 of each of the Credit Agreements, (b) authorizes Grantors or Grantors’ authorized representative (including the Licensee) to record this Agreement with the United States Patent and Trademark Office, and (c) agrees to file Uniform Commercial Code (UCC3) financing statement amendments in a form previously agreed by the Licensee with the Delaware Secretary of State promptly following the date hereof. Each Agent further agrees to execute and deliver to Grantors such further documents and instruments which any Grantor may reasonably request (at Grantors’ sole cost and expense) in order to release or terminate any security interest in favor of such Agent in the Elacestrant Collateral. Except as otherwise expressly set forth herein, this Agreement does not release any Lien granted by the Grantors in favor of either Agent, for the benefit of the applicable Lenders, pursuant to the Credit Agreements or any other Financing Documents. In the event the License Agreement is terminated or all or any portion of the Elacestrant Collateral is no longer subject to the License and the Grantors retain ownership of the Elacestrant Collateral (or such portion thereof), (i) a security interest in the Elacestrant Collateral (or such portion thereof) shall simultaneously and automatically be granted in favor of each Agent under Section 9 of the applicable Credit Agreement and the Elacestrant Collateral (or such portion thereof) shall be included in the Collateral and the Agents’ Liens shall reattach thereto and (ii) the Grantors shall promptly and duly take, execute, acknowledge and deliver all such further acts, documents and assurances as may be necessary or as either Agent may reasonably request in order to grant and evidence and perfect such security interests. 3. Acknowledgement by Grantors. a. The Grantors hereby certify that (i) the granting of the License pursuant to the License Agreement is an Asset Disposition permitted pursuant to clause (i) of the definition of Permitted Asset Dispositions in each of the Credit Agreements and (ii) no Event of Default has occurred and is continuing at the time such License is granted or would immediately result therefrom. Without limiting the foregoing, Grantors represent, warrant and covenant to each Agent that, at all times, the Elacestrant Collateral, including all assets set forth on Exhibit A, are Oncology Assets and that no other assets of any Credit Party (other than the Oncology Assets) are included in the definition of Elascestrant Collateral.


 
b. The Grantors hereby acknowledge that the License Agreement and any and all proceeds and products (other than any products that themselves constitute Elascestrant Collateral) thereof (including all Payment Rights (as defined below) thereunder) shall constitute Collateral and that all references to “Collateral” contained in the Credit Agreement or the other Financing Documents are hereby deemed for all purposes to include the License Agreement and the proceeds thereof (including all Payment Rights thereunder) as part of the Collateral. For the avoidance of doubt, in no event shall the License Agreement or the proceeds and products (other than any products that themselves constitute Elascestrant Collateral) thereof (including all Payment Rights thereunder) constitute Excluded Property. The term “Payment Rights” as used herein means, collectively: (i) all proceeds received by or on behalf of Radius Pharma under the License Agreement, (ii) all rights to payment of Radius Pharma under the License Agreement and (iii) all rights of Radius Pharma related, ancillary or incidental to the foregoing clauses (i) and (ii). For purposes of this clause (b), the term “proceeds” shall have the meaning set forth in the UCC. c. The Grantors agree, on behalf of themselves and the other Credit Parties, that they will not, without Agents’ prior consent, amend, supplement or otherwise modify the License Agreement, or any other material agreement related thereto, or enter into any agreement or other document related to the License Agreement or the Elascestrant Collateral, in each case, to the extent such amendment, supplement or modification or new agreement or document would be materially adverse to either Agent or the Lenders or their Collateral. 4. Acknowledgement by Each Agent. Each Agent (a) acknowledges and agrees on behalf of itself and (b) confirms that the Required Lenders under each of the Credit Agreements has acknowledged and agreed that, in each case, pursuant to Section 10.1(g) of the License Agreement, Radius Pharma has covenanted that it will not, nor will it permit any of its Affiliates to, directly or indirectly, create, assume or suffer to exist any Lien on or security interest in all or any portion of the Elacestrant Collateral for so long and during the period that the License Agreement remains in full force and effect or that the Elacestrant Collateral remains subject to the License (in accordance with its terms). 5. Miscellaneous. a. The agreements of each Agent hereunder are made without recourse to or warranty by such Agent. It is expressly agreed and understood that this is a partial release and that it shall in no manner release, affect or otherwise impair the liens and security interest in favor of either Agent, under the Credit Agreements or otherwise, against any Collateral other than the Elacestrant Collateral. Other than the Liens expressly released pursuant to Section 2 above, each Grantor confirms and agrees that all security interests and Liens granted to each Agent continue in full force and effect, and that all Collateral remains free and clear of any Liens, other than Permitted Liens. b. GOVERNING LAW. THIS AGREEMENT AND ALL DISPUTES AND OTHER MATTERS RELATING HERETO OR THERETO OR ARISING THEREFROM (WHETHER SOUNDING IN CONTRACT LAW, TORT LAW OR OTHERWISE), SHALL BE GOVERNED BY, AND SHALL BE CONSTRUED AND ENFORCED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF NEW YORK, WITHOUT REGARD TO CONFLICTS OF LAWS PRINCIPLES (OTHER THAN SECTION 5-1401 OF THE GENERAL OBLIGATIONS LAW). c. WAIVER OF JURY TRIAL. EACH PARTY HERETO HEREBY IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL ACTION OR PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY AND AGREES THAT ANY SUCH


 
ACTION OR PROCEEDING SHALL BE TRIED BEFORE A COURT AND NOT BEFORE A JURY. EACH PARTY HERETO ACKNOWLEDGES THAT THIS WAIVER IS A MATERIAL INDUCEMENT TO ENTER INTO A BUSINESS RELATIONSHIP, THAT EACH HAS RELIED ON THE WAIVER IN ENTERING INTO THIS AGREEMENT, AND THAT EACH WILL CONTINUE TO RELY ON THIS WAIVER IN THEIR RELATED FUTURE DEALINGS. EACH PARTY WARRANTS AND REPRESENTS THAT IT HAS HAD THE OPPORTUNITY OF REVIEWING THIS JURY WAIVER WITH LEGAL COUNSEL, AND THAT IT KNOWINGLY AND VOLUNTARILY WAIVES ITS JURY TRIAL RIGHTS. d. Counterparts. This Agreement may be signed in any number of counterparts, each of which shall be deemed an original and all of which when taken together shall constitute one and the same instrument. Delivery of an executed counterpart of this Agreement by facsimile or by electronic mail delivery of an electronic version (e.g., .pdf or .tif file) of an executed signature page shall be effective as delivery of an original executed counterpart hereof and shall bind the parties hereto. e. Successors and Assigns. This Agreement shall be binding upon the successors and assigns of each Agent, and shall be binding upon each Grantor and its successors and assigns. No Person other than the parties hereto shall have any rights hereunder or be entitled to rely on this Agreement and all third-party beneficiary rights are hereby expressly disclaimed; provided that, notwithstanding the foregoing, the Licensee shall be an express third-party beneficiary solely of clause (b) of Section 2 hereof, and such clause shall expressly inure to the benefit of the Licensee and the Licensee shall be entitled to rely on and enforce the provisions of such clause but not in respect of any other provision of this Agreement. [remainder of this page intentionally left blank]


 
IN WITNESS WHEREOF, intending to be legally bound, each of the parties have caused this Agreement to be executed as of the day and year first above mentioned. GRANTORS: RADIUS HEALTH, INC. By:/s/ Jose Carmona Name: Jose Carmona Title: Chief Financial Officer RADIUS PHARMACEUTICALS, INC. By: /s/ Jose Carmona Name: Jose Carmona Title: Chief Financial Officer 1


 
MIDCAP FINANCIAL TRUST, as Term Loan Agent By: Apollo Capital Management, L.P., its investment manager By: Apollo Capital Management GP, LLC, its general partner By: /s/ Maurice Amsellem Name: Maurice Amsellem Title: Authorized Signatory MIDCAP FUNDING IV TRUST, as Revolving Loan Agent By: Apollo Capital Management, L.P., its investment manager By: Apollo Capital Management GP, LLC, its general partner By: /s/ Maurice Amsellem Name: Maurice Amsellem Title: Authorized Signatory 2


 
Exhibit A “Elacestrant Collateral” means all term loan credit Collateral (as such term is defined in the Term Loan Credit Agreement) and all revolving credit Collateral (as such term is defined in the Revolving Credit Agreement), as applicable, that, in each case, is related solely to the Licensed Compounds or Licensed Products, specifically including (without limitation) the Radius Elacestrant Patent Rights, Radius Elacestrant Know-How, Elacestrant Contracts, Elacestrant Upstream Licenses and TSA Inventions; provided that Elacestrant Collateral shall not include any of the following assets or property: (i) cash or cash equivalents, (ii) deposit accounts or securities accounts, (iii) accounts or accounts receivable, (iv) the License Agreement (or any payments or rights to payment thereunder), (v) any other contract or agreement (or any payments or rights to payment thereunder) that provides for any payments to, or received by or on behalf of, any Grantor (or any of its Affiliates) by Licensee or any Affiliate thereof or any of their respective successors or assigns, (vi) any payments or rights to payment of any Grantor, or any Affiliate thereof, under any other contract or agreement related to the License Agreement or the Licensed Product or Licensed Compounds or (vii) any proceeds in respect of any of the foregoing. For purposes of the foregoing, the following terms shall have the following meanings: 1.1 “Affiliate” of a Person means any other Person which (directly or indirectly) is controlled by, controls or is under common control with such Person. For the purposes of this definition, the term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to any Person means (a) in the case of a corporate entity, direct or indirect ownership of voting securities entitled to cast at least fifty percent (50%) of the votes in the election of directors, (b) in the case of a non-corporate entity, direct or indirect ownership of at least fifty percent (50%), including ownership by trusts with substantially the same beneficial interest, of the equity interests with the power to direct the management and policies of such Person, provided that if local law restricts foreign ownership, control will be established by direct or indirect ownership of the maximum ownership percentage that may, under such local law, be owned by foreign interests, or (c) the power to direct the management or policies of a Person, whether through ownership of voting securities, by contract or otherwise. 1.2 “Combination” means a Combination Product or Combination Therapy. 1.3 “Combination Product” means a Licensed Product that includes at least one additional active ingredient other than Licensed Compound. Drug delivery vehicles, adjuvants, and excipients will not be deemed to be “active ingredients”, except in the case where such delivery vehicle, adjuvant, or excipient is recognized as an active ingredient in accordance with 21 C.F.R. § 210.3(b)(7) (as amended), or any foreign counterpart. 1.4 “Combination Therapy” means a therapy comprised of a Licensed Product and one or more other therapeutically or prophylactically active ingredients, whether priced and sold in a single package containing such multiple products, packaged separately but sold together for a single price, or sold under separate price points but labeled for use together, including all dosage forms, formulations, presentations, and package configurations. Drug delivery vehicles, adjuvants, and excipients will not be deemed to be “active ingredients”, except in the case where such delivery vehicle, adjuvant, or excipient is recognized as an active ingredient in accordance with 21 C.F.R. § 210.3(b)(7) (as amended), or any foreign counterpart. 1.5 “Confidential Information” means all Radius Elacestrant Know-How, marketing plans, strategies and customer lists, and other information or material that are disclosed or provided by Radius Health or its Affiliates to Licensee or its Affiliates pursuant to the terms of the Transition Services


 
Agreement, regardless of whether any of the foregoing are marked “confidential” or “proprietary” or communicated to the other by Radius Health or its Affiliates in oral, written, graphic, or electronic form. 1.6 “Duke License Agreement” means that certain Patent License Agreement dated as of December 8, 2017, by and between Radius Pharma and Duke University (“Duke”) as such agreement may be amended or restated from time to time in a manner that is not prohibited under the Financing Documents. 1.7 “Duke Patent Rights” means Duke’s legal rights under the patent laws of the United States or relevant foreign countries for all of the following: (a) the following United States and foreign patent(s) and/or patent application(s), including all divisionals, continuations, continuations-in-part arising from or claiming priority to any of the Duke Patent Rights and containing claims covering the chemical compound known as RAD1901 or elacestrant in any and all fields of use, and foreign counterparts of the same: US Patent 9,421,264 (US Application No.: 14/512,061), USSN 62/129,379, USSN 61/971,627, PCT/US2015/023216, USSN 15/214,187, USSN 15/129,197, EPO 15769394.6 (EP 3122426), CA 2,943,611. (b) United States and foreign patents issued from the applications listed in subparagraph (a) above, including any reviewed, reissued or re-examined patents, and supplementary protection certificates, and foreign counterparts of the same, based upon the same. (c) Any applications claiming priority from any of the listed applications. The Duke Patent Rights existing as of the Effective Date are set forth on Appendix 6 to this Exhibit A. 1.8 “Effective Date” means July 22, 2020. 1.9 “Eisai License Agreement” means that certain License Agreement, dated as of June 29, 2006, by and between Radius Pharma and Eisai Co., Ltd. (“Eisai”), as such agreement may be amended or restated from time to time in a manner that is not prohibited under the Financing Documents. 1.10 “Eisai Patents” means all patents and patent applications which are or become owned by Eisai and/or its Affiliates, or to which Eisai and/or its Affiliates, otherwise have, now or in the future, the right to grant licenses, and which generically or specifically claim Compound and/or Product, a use for Compound and/or Product, a process for manufacturing Compound and/or Product, or an intermediate use in such process. Included within the definition of Eisai Patents are all continuations, continuations-in-part, divisions, patents of addition, reissues, re-examinations, renewals or extensions thereof and all Supplementary Protection Certificates. Also included within the definition are any improvements on Compound and/or Product or intermediates or manufacturing process required or useful for production of Compound and/or Product which are developed by or for Eisai and/or its Affiliates, or to which Eisai and/or its Affiliates otherwise has the right to grant licenses, now or in the future, during the term of the License Agreement. Eisai


 
Patents also includes any patent application covering an invention solely owned by Eisai in accordance with Article 6.4 of the Eisai License Agreement. For purposes of this clause 1.10 (“Eisai Patents”), clause 1.17 (“Radius-Eisai Joint Invention”), clause 1.18 (“Radius-Eisai Joint Patents”), and clause 1.20 (“Radius Elacestrant Invented Patent”), (i) “Compound” means elacestrant or any derivative or analogue thereof, (ii) “Product” means any pharmaceutical drug in final packaged form containing the Compound or any derivative or analogue thereof, the development, manufacture, use or sale of which, absent the licenses granted to Licensee under the License Agreement, would infringe the Eisai Patents or which make use of any Radius-Eisai Joint Patents, and (iii) “Affiliates” means any corporation, firm, partnership or other entity which directly or indirectly owns, is owned by or is under common ownership with Eisai to the extent of more than fifty (50) percent of the equity having the power to vote on or direct the affairs of any such corporation, firm, partnership, or other entity The Eisai Patents existing as of the Effective Date as set forth on Appendix 6 to this Exhibit A. 1.11 “Elacestrant Contracts” means (a) the contracts listed on Appendix 4 to this Exhibit A, solely to the extent that such contracts are solely related to the Licensed Compounds or Licensed Products, and (b) any contracts that Radius Health or its Affiliates enter into after the Effective Date, solely for the purpose of carrying out the Services on behalf of Radius Health. 1.12 “Elacestrant Upstream Licenses” means the Duke License Agreement and Eisai License Agreement. 1.13 “Know-How” means all know-how, trade secrets, chemical and biological materials, formulations, information, documents, studies, results, data and regulatory approvals, data (including from clinical studies), filings and correspondence (including drug master files), including biological, chemical, pharmacological, toxicological, pre-clinical, clinical and assay data, manufacturing processes and data, specifications, sourcing information, assays, and quality control and testing procedures, whether or not patented or patentable. 1.14 “Licensed Compound” means the compound known as elacestrant (RAD1901), as further described on Appendix 1 to this Exhibit A, the backup compounds listed on Appendix 2 to this Exhibit A, and in each case, any modification, improvement, derivative or Structural Analog thereof, including any metabolite, salt, ester, free acid form, free base form, crystalline form, amorphous form, pro-drug form, racemate, chelate, polymorph, tautomer, solvate, or optical isomer thereof. 1.15 “Licensed Product” means any pharmaceutical product containing any Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms. For clarification, Licensed Product will include any Combination. 1.16 “Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, beneficiary or trustee of any trust, incorporated association, joint venture, or similar entity or organization, including a government or political subdivision or department or agency of a government. 1.17 “Radius-Eisai Joint Invention” means any invention developed by or on behalf of Radius Pharma and disclosed by Radius Pharma to Eisai pursuant to Section 6.3 of the Eisai License Agreement.


 
1.18 “Radius-Eisai Joint Patents” means any patent application claiming a Radius-Eisai Joint Invention, and any patent stemming therefrom. The Radius-Eisai Joint Patents existing as of the Effective Date are set forth in Appendix 6 to this Exhibit A. 1.19 “Radius Elacestrant Know-How” means (a) all Know-How that is related solely to the Licensed Compounds or Licensed Products and is controlled by Radius Pharma or any of its Affiliates as of the Effective Date, and (b) all Know-How within the TSA Inventions. 1.20 “Radius Elacestrant Invented Patents” means all patents and patent applications which are or become owned by Radius Pharma and/or its Affiliates, to which Radius Pharma and/or its Affiliates otherwise have, now or in the future, the right to grant licenses, and which generically or specifically claim Compound and/or Product, a use for Compound and/or Product, a process for manufacturing Compound and/or Product, or an intermediate used in such process. Included within the definition of Radius Elacestrant Invented Patents are all continuations, continuations-in-part, divisions, patents of addition, reissues, re-examinations, renewals or extensions thereof and all Supplementary Protection Certificates. Also included within the definition are all patents and patent applications any improvements on Compound and/or Product or intermediates or manufacturing process required or useful for production of Compound and/or Product which are developed by or for Radius Pharma and/or its Affiliates, or to which Radius Pharma and/or its Affiliates otherwise have the right to grant licenses, now or in the future, during the term of the License Agreement. Radius Elacestrant Invented Patents also includes any patent application covering an invention solely owned by Radius in accordance with Article 6.4 of the Eisai License Agreement. The Radius Elacestrant Invented Patents existing as of the Effective Date are set forth in in Appendix 5 to this Exhibit A. 1.21 “Radius Elacestrant Patent Rights” means (a) the patents and patent applications listed in Appendix 5 and Appendix 6 to this Exhibit A, plus any conversion, continuation, division or substitution thereon, any reissues, reexaminations or extensions thereof, any continuation-in-part application or patent that is entitled to the priority date of, and is directed specifically to subject matter specifically described in, at least one of the patents or patent applications described above, and any foreign counterparts of any of the foregoing, and (b) all patents and patent applications that specifically claim or cover the TSA Inventions, plus any conversion, continuation, division or substitution thereon, any reissues, reexaminations or extensions thereof, any continuation-in-part application or patent that is entitled to the priority date of, and is directed specifically to subject matter specifically described in, at least one of the patents or patent applications described above, and any foreign counterparts of any of the foregoing. For the sake of clarity, the Radius Elacestrant Patent Rights include the Duke Patent Rights, the Eisai Patents, the Radius-Eisai Joint Patents, and the Radius Elacestrant Invented Patents. 1.22 “Services” means the services to be performed by or on behalf of Radius Health in the interest of Licensee pursuant to the Transition Services Agreement. 1.23 “Structural Analog” means a compound covered by the chemical structure set forth on Appendix 3 to this Exhibit A. 1.24 “TSA Inventions” means any materials, data, processes, documents, deliverables, information (including Confidential Information), discoveries, inventions, know-how and the like developed or generated by or on behalf of Radius Health after the Effective Date during the course of performing the Services, whether or not patentable, and all related patent, copyright and other intellectual property rights in any of the foregoing.


 
Appendix 1 to Exhibit A Licensed Compound Elacestrant (RAD1901)


 
Appendix 2 to Exhibit A Backup Compounds 1902 genus: 1902 Selection Case genus:


 
1902 lead compounds:


 


 


 


 
Appendix 3 to Exhibit A Structural Analog 1. A compound represented by the following formula (I); wherein f g’ f’ g’ Z represents a bond, a C1-C4 alkylene group or –CR ’R -CH2-O- wherein R and R independently represent a C1-C6 alkyl group; -T-NRaRb represents -NRaRb, , or ; A represents a 5- to 14-membered heteroarylene group which may have one or more substituents or a C6-C14 arylene group which may have one or more substituents; c c Y represents a C1-C4 alkylene group or –CH2-NR - wherein R represents a C1-C6 alkyl group which may have a substituent; ring G is a ring or a fused ring system selected from the group consisting of;


 
, , , , , , , , , , , , , , , , , , , , , , , , , , , , , and ; wherein each Rh is independently selected from hydrogen or CH3; Rg is hydrogen, C1-C3 alkyl, C1- C3 fluoroalkyl, CN, fluorine, chlorine or bromine; and each Re is independently selected from hydrogen, halogen, OH, O(CO)R, O(CO)NR1R2, OPO3, OSO3,O(SO2)NR1R2, or wherein two adjacent Re together form: , , , or ;


 
wherein each R3 is hydrogen, C1-C12 acyl, or C1-C12 acyloxy; and each R4 is independently hydrogen, C1-C3 alkyl, fluorine or chlorine; R’ represents 1 to 4 substituents independently selected from a hydrogen and a C1-C6 alkoxy group; a partial structure in formula (I) represented by the following formula: or R’’ represents a hydroxyl group that may be further protected by a protecting group or a C1-C6 alkoxy group which may have a substituent; U and V are each independently selected from CRa’


 
or N; each Ra’ is independently selected from: H, C1-C3 alkyl, C1-C3 fluoroalkyl, phenyl (optionally substituted with 1-3 groups selected from fluorine, chlorine, C1-C3 alkyl, CN, OC1-C3 alkyl, OH), OH, OC1-3alkyl, CN, fluorine, or chlorine; and Ra and Rb are the same as or different from each other and each represents a hydrogen atom, a C1-C6 alkyl group which may have one or more substituents, or a C3-C8 cycloalkyl group which may have one or more substituents, or when Ra and Rb are bonded together, they may form, together with the nitrogen atom that is adjacent to a Ra and Rb, a 4- to 10-membered single ring which may have one or more substituents; and L represents a single bond, or a salt thereof.


 
Appendix 4 to Exhibit A Elacestrant Contracts as of the Effective Date 1. Companion Diagnostics Master Collaboration Agreement, by and between Guardant Health, Inc. and Radius Pharmaceuticals, Inc., dated as of July 8, 2020 2. Master Services Agreement, by and between Radius Health, Inc. and Guardant Health, Inc., dated as of September 14, 2016 and amended October 22, 2018 3. Patient Referral Agreement, by and between Radius Health, Inc. and Guardant Health, Inc., dated as of February 7, 2020 4. Master Services Agreement, by and between Radius Health, Inc. and Mayne Pharma Inc., d/b/a Metrics Contract Services, dated as of October 30, 2015 and amended August 12, 2019 5. Master Services Agreement, by and between Radius Health, Inc. and Sambi Pharma PVT Ltd, dated as of January 7, 2020 6. Professional Services Agreement, by and between Radius Health, Inc. and Link2Trials B.V., dated as of May 1, 2019 7. Development and Manufacturing Services Agreement, by and between Radius Pharmaceuticals, Inc. and Asymchem, Inc., dated as of October 17, 2018 8. Master Services Agreement, by and between Radius Health, Inc. and Sai Life Sciences Limited, dated as of May 13, 2016 9. Master Services Agreement, by and between Radius Health, Inc. and ARC Trinova Limited trading as “Arcinova”, dated as of October 16, 2018 10. Master Services Agreement, by and between Radius Health, Inc. and CRF Health Management Limited, dated as of May 8, 2018 11. Master Agreement for Pharmaceutical Development and Technology Transfer Services, by and between Patheon, Inc. and Radius Pharmaceuticals, Inc., dated as of March 27, 2017 12. Master Clinical Contract Services Agreement, by and between Radius Health, Inc. and Parexel International (IRL) Limited, dated as of April 24, 2015 and amended April 24, 2018, but only with respect to Statement of Work RAD1901-308 dated as of December 14, 2017


 
Appendix 5 to Exhibit A Patents Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 THERAPEUTIC REGIMENS United 12- Therapeutic Radius Health, Patent States 61/334,095 May- Provisional Expired -- -- Regimens Inc. PRV 10 12- Therapeutic Non- Radius Health, Patent PCT PCT/US2011/036311 May- Expired -- -- Regimens Provisional Inc. 10 9- Nat’l United Therapeutic Radius Health, Patent 13/697,230 Nov- Phase of Abandoned -- -- States Regimens Inc. 12 PCT United 19- 31- Radius Therapeutic CON of US Patent States 14/281,475 May- Issued 9,555,014 Jan- Pharmaceuticals, Regimens 13/697,230 CON 14 17 Inc. 12- Nat’l Therapeutic Radius Health, Patent Canada 2799183 May- Phase of Abandoned -- -- Regimens Inc. 11 PCT


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 THERAPEUTIC REGIMENS Abandoned 12- Nat’l 20- Therapeutic all Radius Health, Patent Europe 11781299.0 May- Phase of 2568806 Mar- Regimens Validation Inc. 11 PCT 13 countries 12- 18- Radius Europe Therapeutic DIV of EP Patent 16163037.1 May- Abandoned 3106159 Nov- Pharmaceuticals, DIV Regimens ‘299 11 16 Inc. 12- Nat’l 8- Therapeutic Radius Health, Patent Mexico MX/a/2012/013014 May- Phase of Issued 342898 Nov- Regimens Inc. 11 PCT 12 Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 HF: MOT HOT FLASHES Treatment of vasomotor United symptoms with 22- Radius Patent States Selective 60/816,191 Jun- Provisional Expired -- -- Pharmaceuticals, PRV estrogen 06 Inc. receptor modulators


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 HF: MOT HOT FLASHES Treatment of vasomotor symptoms with 22- Radius Non- Patent PCT Selective PCT/US2007/014598 Jun- Expired -- -- Pharmaceuticals, Provisional estrogen 07 Inc. receptor modulators Treatment of vasomotor symptoms with 22- Nat'l 2- Radius Patent Canada Selective 2,656,067 Jun- Phase of Issued 2,656,067 Jan- Pharmaceuticals, estrogen 07 '598 PCT 14 Inc. receptor modulators Treatment of vasomotor Validation symptoms with 22- 1- Radius of Patent Switzerland Selective 07796378.3 Jun- Issued 2037905 May- Pharmaceuticals, 2037905 estrogen 07 13 Inc. Patent receptor modulators Treatment of vasomotor Validation symptoms with 22- 1- Radius of Patent Germany Selective 07796378.3 Jun- Issued 2037905 May- Pharmaceuticals, 2037905 estrogen 07 13 Inc. Patent receptor modulators


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 HF: MOT HOT FLASHES Treatment of vasomotor symptoms with 22- Nat'l 1- Radius Patent Europe Selective 07796378.3 Jun- Phase of Issued 2037905 May- Pharmaceuticals, estrogen 07 '598 PCT 13 Inc. receptor modulators Treatment of vasomotor Validation symptoms with 22- 1- Radius of Patent Spain Selective 07796378.3 Jun- Issued 2037905 May- Pharmaceuticals, 2037905 estrogen 07 13 Inc. Patent receptor modulators Treatment of vasomotor Validation symptoms with 22- 1- Radius of Patent France Selective 07796378.3 Jun- Issued 2037905 May- Pharmaceuticals, 2037905 estrogen 07 13 Inc. Patent receptor modulators Treatment of vasomotor Validation symptoms with 22- 1- Radius Great of Patent Selective 07796378.3 Jun- Issued 2037905 May- Pharmaceuticals, Britain 2037905 estrogen 07 13 Inc. Patent receptor modulators


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 HF: MOT HOT FLASHES Treatment of vasomotor Validation symptoms with 22- 1- Radius of Patent Ireland Selective 07796378.3 Jun- Issued 2037905 May- Pharmaceuticals, 2037905 estrogen 07 13 Inc. Patent receptor modulators Treatment of vasomotor Validation symptoms with 22- 1- Radius of Patent Italy Selective 07796378.3 Jun- Issued 2037905 May- Pharmaceuticals, 2037905 estrogen 07 13 Inc. Patent receptor modulators Treatment of vasomotor United symptoms with 27- Nat'l 13- Radius Patent States Selective 12/308,640 Oct- Phase of Issued 8,933,130 Jan- Pharmaceuticals, NP estrogen 09 '598 PCT 15 Inc. receptor modulators


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 ER MUTANTS Methods United 29- Radius of Patent States 62/154,699 Apr- Provisional Expired -- -- Pharmaceuticals, Treating PRV 15 Inc. Cancer Methods United 30- Radius of Patent States 62/155,451 Apr- Provisional Expired -- -- Pharmaceuticals, Treating PRV 15 Inc. Cancer Methods United 6- Radius of Patent States 62/252,085 Nov- Provisional Expired -- -- Pharmaceuticals, Treating PRV 15 Inc. Cancer Methods United 10- Radius of Patent States 62/265,696 Dec- Provisional Expired -- -- Pharmaceuticals, Treating PRV 15 Inc. Cancer Methods 29- Radius of Patent PCT PCT/US2016/30317 Apr- Non-Provisional Expired -- -- Pharmaceuticals, Treating 16 Inc. Cancer


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 ER MUTANTS Methods 29- Nat'l phase of Radius of Patent Australia 2016256470 Apr- PCT/US16/ Pending -- -- Pharmaceuticals, Treating 16 30317 Inc. Cancer Methods 29- Nat'l phase of Radius of BR 112017023233- Patent Brazil Apr- PCT/US16/ Published -- -- Pharmaceuticals, Treating 2 16 30317 Inc. Cancer Methods 29- Nat'l phase of Radius of Patent Canada 2,984,195 Apr- PCT/US16/ Pending -- -- Pharmaceuticals, Treating 16 30317 Inc. Cancer Methods 29- Nat'l phase of Radius of Patent China 201680038908.9 Apr- PCT/US16/ Published -- -- Pharmaceuticals, Treating 16 30317 Inc. Cancer Methods 29- Nat'l phase of Radius of Patent Europe 16787290.2 Apr- PCT/US16/ Published -- -- Pharmaceuticals, Treating 16 30317 Inc. Cancer


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 ER MUTANTS Methods 29- Radius Hong of OFF EP Patent 18110956.1 Apr- Published -- -- Pharmaceuticals, Kong Treating 16787290.2 16 Inc. Cancer Methods 29- Nat'l phase of Radius of Patent Israel 255148 Apr- PCT/US16/ Published -- -- Pharmaceuticals, Treating 16 30317 Inc. Cancer Methods 29- Radius of Nat'l phase of Patent Japan 2018-509731 Apr- Published -- -- Pharmaceuticals, Treating PCT/US16/30317 16 Inc. Cancer Methods 29- Nat'l phase of Radius South of Patent 10-2017-7034603 Apr- PCT/US16/ Published -- -- Pharmaceuticals, Korea Treating 16 30317 Inc. Cancer Methods 29- Nat'l phase of Radius of Patent Mexico MX/a/2017/013801 Apr- PCT/US16/ Pending -- -- Pharmaceuticals, Treating 16 30317 Inc. Cancer


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 ER MUTANTS Methods 29- Nat'l phase of Radius New of Patent 737825 Apr- PCT/US16/ Pending -- -- Pharmaceuticals, Zealand Treating 16 30317 Inc. Cancer Methods 29- Nat'l phase of Radius Russian of Patent 2017140674 Apr- PCT/US16/ Pending -- -- Pharmaceuticals, Federation Treating 16 30317 Inc. Cancer Methods 29- Nat'l phase of Radius of Patent Singapore 11201708858W Apr- PCT/US16/ Abandoned -- -- Pharmaceuticals, Treating 16 30317 Inc. Cancer Methods 29- Radius Singapore of Patent 10201903993U Apr- Divisional Published Pharmaceuticals, Divisional Treating 16 Inc. Cancer United Methods States 26- CON of Radius of Patent CON 15/794,774 Oct- PCT/US16/ Published -- -- Pharmaceuticals, Treating CON of 17 30317 Inc. Cancer PCT


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 COMBINATION W/ CDK 4/6 INHIBITOR United Methods for 15- Radius Patent States Treating 62/192,940 Jul- Provisional Expired -- -- Pharmaceuticals, PRV Cancer 15 Inc. United Methods for 10- Radius Patent States Treating 62/265,658 Dec- Provisional Expired -- -- Pharmaceuticals, PRV Cancer 15 Inc. United Methods for 15- Radius Patent States Treating 62/323,572 Apr- Provisional Expired -- -- Pharmaceuticals, PRV Cancer 16 Inc. Methods for 29- Radius Non- Patent PCT Treating PCT/US2016/30321 Apr- Expired -- -- Pharmaceuticals, Provisional Cancer 16 Inc. Nat'l Phase Methods for 29- Radius of Patent Australia Treating 2016256471 Apr- Pending -- -- Pharmaceuticals, PCT/US16/ Cancer 16 Inc. 30321


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 COMBINATION W/ CDK 4/6 INHIBITOR Nat'l Phase Methods for 29- Radius BR of Patent Brazil Treating Apr- Published -- -- Pharmaceuticals, 112017023269-3 PCT/US16/ Cancer 16 Inc. 30321 Nat'l Phase Methods for 29- Radius of Patent Canada Treating 2,984,200 Apr- Pending -- -- Pharmaceuticals, PCT/US16/ Cancer 16 Inc. 30321 Nat'l Phase Methods for 29- Radius of Patent China Treating 201680039059.9 Apr- Published -- -- Pharmaceuticals, PCT/US16/ Cancer 16 Inc. 30321 Nat'l Phase Methods for 29- Radius of Patent Europe Treating 16787291.0 Apr- Published -- -- Pharmaceuticals, PCT/US16/ Cancer 16 Inc. 30321 Methods for 29- Radius Hong OFF EP Patent Treating 18110957.0 Apr- Published -- -- Pharmaceuticals, Kong 16787291.0 Cancer 16 Inc.


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 COMBINATION W/ CDK 4/6 INHIBITOR Nat'l Phase Methods for 29- Radius of Patent Israel Treating 255189 Apr- Pending -- -- Pharmaceuticals, PCT/US16/ Cancer 16 Inc. 30321 Nat'l Phase Methods for 29- Radius of Patent Japan Treating 2018-509732 Apr- Published -- -- Pharmaceuticals, PCT/US16/ Cancer 16 Inc. 30321 Nat'l Phase Methods for 29- Radius South of Patent Treating 10-2017-7034606 Apr- Published -- -- Pharmaceuticals, Korea PCT/US16/ Cancer 16 Inc. 30321 Nat'l Phase Methods for 29- Radius of Patent Mexico Treating MX/a/2017/013802 Apr- Pending -- -- Pharmaceuticals, PCT/US16/ Cancer 16 Inc. 30321 Nat'l Phase Methods for 29- Radius New of Patent Treating 737822 Apr- Pending -- -- Pharmaceuticals, Zealand PCT/US16/ Cancer 16 Inc. 30321


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 COMBINATION W/ CDK 4/6 INHIBITOR Nat'l Phase Methods for 29- Radius Russian of Patent Treating 2017140675 Apr- Pending -- -- Pharmaceuticals, Federation PCT/US16/ Cancer 16 Inc. 30321 Nat'l Phase Methods for 29- Radius of Patent Singapore Treating 11201708860S Apr- Pending -- -- Pharmaceuticals, PCT/US16/ Cancer 16 Inc. 30321 United Methods for 24- Radius CON of US Patent States Treating 16/580,914 Sep- Published -- -- Pharmaceuticals, 15/794,861 CON 2 Cancer 19 Inc. United Methods for 26- CON of Radius States Patent Treating 15/794,861 Oct- PCT/US16/ Abandoned -- .. Pharmaceuticals, CON Cancer 17 30321 Inc. of PCT


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 COMBINATION W/ M-TOR INHIBITORS United Methods for 15- Radius Patent States Treating 62/192,944 Jul- Provisional Expired -- -- Pharmaceuticals, PRV Cancer 15 Inc. United Methods for 10- Radius Patent States Treating 62/265,663 Dec- Provisional Expired -- -- Pharmaceuticals, PRV Cancer 15 Inc. United Methods for 15- Radius Patent States Treating 62/323,576 Apr- Provisional Expired -- -- Pharmaceuticals, PRV Cancer 16 Inc. Methods for 29- Radius Non- Patent PCT Treating PCT/US2016/30316 Apr- Expired -- -- Pharmaceuticals, Provisional Cancer 16 Inc. Nat'l phase Methods for 29- Radius of Patent Australia Treating 2016256469 Apr- Pending -- -- Pharmaceuticals, PCT/US16/ Cancer 16 Inc. 30316


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 COMBINATION W/ M-TOR INHIBITORS Nat'l phase Methods for 29- Radius BR of Patent Brazil Treating Apr- Published -- -- Pharmaceuticals, 112017023228-6 PCT/US16/ Cancer 16 Inc. 30316 Nat'l phase Methods for 29- Radius of Patent Canada Treating 2,984,357 Apr- Pending -- -- Pharmaceuticals, PCT/US16/ Cancer 16 Inc. 30316 Nat'l phase Methods for 29- Radius of Patent China Treating 201680038907.4 Apr- Published -- -- Pharmaceuticals, PCT/US16/ Cancer 16 Inc. 30316 Nat'l phase Methods for 29- Radius of Patent Europe Treating 16787289.4 Apr- Published -- -- Pharmaceuticals, PCT/US16/ Cancer 16 Inc. 30316 Methods for 29- Radius Hong OFF EP Patent Treating 18110955.2 Apr- Published -- -- Pharmaceuticals, Kong 16787289.4 Cancer 16 Inc.


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 COMBINATION W/ M-TOR INHIBITORS Nat'l phase Methods for 29- Radius of Patent Israel Treating 255261 Apr- Pending -- -- Pharmaceuticals, PCT/US16/ Cancer 16 Inc. 30316 Nat'l phase Methods for 29- Radius of Patent Japan Treating 2017-556627 Apr- Published -- -- Pharmaceuticals, PCT/US16/ Cancer 16 Inc. 30316 Nat'l phase Methods for 29- Radius South of Patent Treating 10-2017-7034608 Apr- Published -- -- Pharmaceuticals, Korea PCT/US16/ Cancer 16 Inc. 30316 Nat'l phase Methods for 29- Radius of Patent Mexico Treating MX/a/2017/013794 Apr- Pending -- -- Pharmaceuticals, PCT/US16/ Cancer 16 Inc. 30316 Nat'l phase Methods for 29- Radius New of Patent Treating 737819 Apr- Pending -- -- Pharmaceuticals, Zealand PCT/US16/ Cancer 16 Inc. 30316


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 COMBINATION W/ M-TOR INHIBITORS Nat'l phase Methods for 29- Radius Russian of Patent Treating 2017140676 Apr- Pending -- -- Pharmaceuticals, Federation PCT/US16/ Cancer 16 Inc. 30316 Nat'l phase Methods for 29- Radius of Patent Singapore Treating 11201708861V Apr- Pending -- -- Pharmaceuticals, PCT/US16/ Cancer 16 Inc. 30316 United Nat'l phase Methods for 26- Radius States of Patent Treating 15/794,910 Oct- Abandoned Pharmaceuticals, CON PCT/US16/ Cancer 2017 Inc. of PCT 30316 United Methods For 20- Radius States CON of Patent Treating 16/545,859 Aug- Published -- -- Pharmaceuticals, CON 15/794,910 Cancer 19 Inc. of 439320


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 POLYMORPHS Polymorphic United 5- Radius Forms of Patent States 62/442,921 Jan- Provisional Expired -- -- Pharmaceuticals, RAD1901- PRV 17 Inc. 2HCL Polymorphic 5- Radius United Forms of Non Patent 15/863,850 Jan- Issued 10385008 8/20/2019 Pharmaceuticals, States RAD1901- Provisional 18 Inc. 2HCL Polymorphic 28- Radius United Forms of Patent 16/456,314 Jun- Divisional Allowed -- -- Pharmaceuticals, States RAD1901- 19 Inc. 2HCL Polymorphic 6- Radius United Forms of Patent 16/921,684 July- Divisional Pending -- -- Pharmaceuticals, States RAD1901- 20 Inc. 2HCL Polymorphic 5- Radius Forms of Non- Patent PCT PCT/US2018/012714 Jan- Expired -- -- Pharmaceuticals, RAD1901- Provisional 18 Inc. 2HCL


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 POLYMORPHS Polymorphic 5- Radius Forms of Patent Australia AU 2018205285 Jan- NP of PCT Pending -- -- Pharmaceuticals, RAD1901- 18 Inc. 2HCL Polymorphic 5- Radius Forms of Patent Canada 3047411 Jan- NP of PCT Pending -- -- Pharmaceuticals, RAD1901- 18 Inc. 2HCL Polymorphic 5- Radius Forms of Patent China 201880006119.6 Jan- NP of PCT Published -- -- Pharmaceuticals, RAD1901- 18 Inc. 2HCL Polymorphic 5- Radius Forms of EP 18736577.0 Patent Europe Jan- NP of PCT Published -- -- Pharmaceuticals, RAD1901- 3565542 18 Inc. 2HCL Polymorphic 5- OFF EP Radius Hong Forms of Patent 62020005942.1 Jan- EP Pending -- -- Pharmaceuticals, Kong RAD1901- 18 18736577.0 Inc. 2HCL


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 POLYMORPHS Polymorphic 5- Radius Forms of Patent Israel IL 267772 Jan- NP of PCT Published -- -- Pharmaceuticals, RAD1901- 18 Inc. 2HCL Polymorphic 5- Radius Forms of Patent Japan JP 2019-536266 Jan- NP of PCT Published -- -- Pharmaceuticals, RAD1901- 18 Inc. 2HCL Polymorphic 5- Radius South Forms of KR 10-2019- Patent Jan- NP of PCT Published -- -- Pharmaceuticals, Korea RAD1901- 7022624 18 Inc. 2HCL Polymorphic 5- Radius Forms of Patent Mexico MX/a/2019/007748 Jan- NP of PCT Pending -- -- Pharmaceuticals, RAD1901- 18 Inc. 2HCL


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 POLYMORPHS (PATTERN B) Polymorphic United Radius Forms of 4-Jul- Patent States 62/694,003 Provisional Expired -- -- Pharmaceuticals, RAD1901- 18 PRV Inc. 2HCL Polymorphic PCT Radius Forms of PCT/US2019/ 3-Jul- Patent PCT 30 mo. Published -- -- Pharmaceuticals, RAD1901- 040527 19 4-Jan-21 Inc. 2HCL


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 MOT OVARIAN CANCER Methods for United 27- Radius Treating Patent States 62/400,495 Sep- Provisional Expired -- -- Pharmaceuticals, Ovarian PRV 16 Inc. Cancer Methods for 27- Treating PCT/US2017/ Non- Radius Health, Patent PCT Sep- Expired -- -- Ovarian 053834 Provisional Inc. 17 Cancer Methods for 27- Treating Radius Health, Patent Australia AU 2017336564 Sep- NP of PCT Pending -- -- Ovarian Inc. 17 Cancer Methods for BR 27- Treating Radius Health, Patent Brazil 11 2019 Sep- NP of PCT Published -- -- Ovarian Inc. 004276-8 17 Cancer Methods for 27- Treating Radius Health, Patent Canada CA 3036568 Sep- NP of PCT Pending -- -- Ovarian Inc. 17 Cancer


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 MOT OVARIAN CANCER Methods for 27- Treating CN Radius Health, Patent China Sep- NP of PCT Published -- -- Ovarian 201780058319.1 Inc. 17 Cancer Methods for 27- Treating Radius Health, Patent Europe EP 17857371.3 Sep- NP of PCT Published -- -- Ovarian Inc. 17 Cancer Methods for 27- Hong Treating OFF EP Radius Health, Patent 19129832.2 Sep- Pending -- -- Kong Ovarian 17857371.3 Inc. 17 Cancer Methods for 27- Treating Radius Health, Patent Israel IL 265537 Sep- NP of PCT Pending -- -- Ovarian Inc. 17 Cancer Methods for 27- Treating Radius Health, Patent Japan JP 2019-515854 Sep- NP of PCT Published -- -- Ovarian Inc. 17 Cancer


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 MOT OVARIAN CANCER Methods for 27- South Treating KR 10-2019- Radius Health, Patent Sep- NP of PCT Published -- -- Korea Ovarian 7011747 Inc. 17 Cancer Methods for 27- Treating MX/a/2019/ Radius Health, Patent Mexico Sep- NP of PCT Pending -- -- Ovarian 003311 Inc. 17 Cancer Methods for 27- New Treating Radius Health, Patent NZ 751032 Sep- NP of PCT Pending -- -- Zealand Ovarian Inc. 17 Cancer Methods for 27- Russian Treating Radius Health, Patent RU 2019108382 Sep- NP of PCT Pending -- -- Federation Ovarian Inc. 17 Cancer Methods for 27- Treating SG Radius Health, Patent Singapore Sep- NP of PCT Pending -- -- Ovarian 1120190759X Inc. 17 Cancer


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 MOT OVARIAN CANCER Methods for 25- Radius United Treating Patent 16/336,358 Mar- NP of PCT Published -- -- Pharmaceuticals, States NP Ovarian 19 Inc. Cancer Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 + ABEMACICLIB Elacestrant In Combination United Radius With 30- Patent States 62/773,960 Provisional Expired -- -- Pharmaceuticals, Abemaciclib In Nov-18 PRV Inc. Women With Breast Cancer Elacestrant In Combination PCT Radius With PCT/US2019/ 26- Patent PCT 30-mo. Published -- -- Pharmaceuticals, Abemaciclib In 063239 Nov-19 30-May-21 Inc. Women With Breast Cancer


 
Filing Patent Issue Type Country Title Application No. Appl. Type Status Ownership Date No. Date 1901 RESISTANT TO CDK 4/6 INHIBITORS Anti-Tumor Activity of United Elacestrant in Radius 6-Dec- Patent States Models 62/776,323 Provisional Expired -- -- Pharmaceuticals, 18 PRV Resistant to Inc. CDK 4/6 Inhibitors Anti-Tumor Activity of Elacestrant in PCT Radius PCT/US2019/ 6-Dec- Patent PCT Models 30 mo. 6- Published -- -- Pharmaceuticals, 065005 19 Resistant to June-21 Inc. CDK 4/6 Inhibitors


 
Application Filing Patent Issue Type Country Title Appl. Type Status Ownership No. Date No. Date 1901 ESR1 MUTATIONS Anti-Tumor Activity of Elacestrant in Models United Radius Harboring 6-Dec- Patent States 62/776,338 Provisional Expired -- -- Pharmaceuticals, ESR1 18 PRV Inc. Mutations Resistant to Standard of Care Therapies Anti-Tumor Activity of Elacestrant in Models PCT Radius Harboring PCT/US2019/ 6-Dec- Patent PCT 30-mo. 6- Published -- -- Pharmaceuticals, ESR1 064980 19 June-21 Inc. Mutations Resistant to Standard of Care Therapies


 
Filing Issue Type Country Title Application No. Appl. Type Status Patent No. Ownership Date Date 1901 PROCESS CHEMISTRY United Radius Processes and 12-Feb- Patent States 62/804,391 Provisional Expired -- -- Pharmaceuticals, Compounds 19 PRV Inc. PCT Radius Processes and PCT/US2020/ 11-Feb- Patent PCT 30 mo. 12- Pending -- -- Pharmaceuticals, Compounds 017777 20 Aug-21 Inc. Application Filing Issue Type Country Title Appl. Type Status Patent No. Ownership No. Date Date 1902 COMPOSITION OF MATTER Compounds United Radius and methods of 22-Jan- Patent States 62/620,441 Provisional Expired -- -- Pharmaceuticals, Using and 18 PRV Inc. Making Estrogen Radius Receptor- PCT/US2019/ 22-Jan- Non- Patent PCT Pending -- -- Pharmaceuticals, Modulating 014581 19 Provisional Inc. Compounds


 
Application Filing Issue Type Country Title Appl. Type Status Patent No. Ownership No. Date Date 1902 COMPOSITION OF MATTER Estrogen Radius Receptor- 22-Jul- Patent Australia TBD NP of PCT Pending -- -- Pharmaceuticals, Modulating 20 Inc. Compounds Estrogen Radius Receptor- 22-Jul- Patent Brazil TBD NP of PCT Pending -- -- Pharmaceuticals, Modulating 20 Inc. Compounds Estrogen Radius Receptor- 22-Jul- Patent Canada TBD NP of PCT Pending -- -- Pharmaceuticals, Modulating 20 Inc. Compounds Estrogen Radius Receptor- 22-Jul- Patent China TBD NP of PCT Pending -- -- Pharmaceuticals, Modulating 20 Inc. Compounds Estrogen Radius Receptor- 22-Jul- Patent Europe TBD NP of PCT Pending -- -- Pharmaceuticals, Modulating 20 Inc. Compounds


 
Application Filing Issue Type Country Title Appl. Type Status Patent No. Ownership No. Date Date 1902 COMPOSITION OF MATTER Estrogen Radius Hong Receptor- 22-Jul- Patent TBD NP of PCT Pending -- -- Pharmaceuticals, Kong Modulating 20 Inc. Compounds Estrogen Radius Receptor- 22-Jul- Patent Israel TBD NP of PCT Pending -- -- Pharmaceuticals, Modulating 20 Inc. Compounds Estrogen Radius Receptor- 22-Jul- Patent Japan TBD NP of PCT Pending -- -- Pharmaceuticals, Modulating 20 Inc. Compounds Estrogen Radius South Receptor- 22-Jul- Patent TBD NP of PCT Pending -- -- Pharmaceuticals, Korea Modulating 20 Inc. Compounds Estrogen Radius Receptor- 22-Jul- Patent Mexico TBD NP of PCT Pending -- -- Pharmaceuticals, Modulating 20 Inc. Compounds


 
Application Filing Issue Type Country Title Appl. Type Status Patent No. Ownership No. Date Date 1902 COMPOSITION OF MATTER Estrogen Radius New Receptor- 22-Jul- Patent TBD NP of PCT Pending -- -- Pharmaceuticals, Zealand Modulating 20 Inc. Compounds Estrogen Radius Russian Receptor- 22-Jul- Patent TBD NP of PCT Pending -- -- Pharmaceuticals, Federation Modulating 20 Inc. Compounds Estrogen Radius Receptor- 22-Jul- Patent Singapore TBD NP of PCT Pending -- -- Pharmaceuticals, Modulating 20 Inc. Compounds Estrogen Radius United Receptor- 22-Jul- Patent TBD NP of PCT Pending -- -- Pharmaceuticals, States NP Modulating 20 Inc. Compounds


 
Application Filing Issue Type Country Title Appl. Type Status Patent No. Ownership No. Date Date 1902 SELECTION Estrogen United Radius Receptor- 22-Jul- Patent States 62/876,963 Provisional Pending -- -- Pharmaceuticals, Modulating 19 PRV Inc. Compounds Estrogen Radius Receptor- 22-Jul- Non- Patent PCT TBD Pending -- -- Pharmaceuticals, Modulating 20 Provisional Inc. Compounds


 
Appendix 6 to Exhibit A Patent Rights Application Patent Type Country Title Filing Date Appl. Type Status Issue Date Ownership No. No. 1901 EISAI COM Patent Australia Selective 2003292625 25-Dec-03 Nat'l Phase Issued 20032926 20-Nov-08 Eisai R&D Estrogen of PCT 25 Manageme Receptor nt Co., Ltd. Modulator Patent Canada Selective 2512000 25-Dec-03 Nat'l Phase Issued 2512000 9-Aug-11 Eisai R&D Estrogen of PCT Manageme Receptor nt Co., Ltd. Modulator Patent Europe Selective 03782904.1 25-Dec-03 Nat'l Phase Issued 1577288 23-Jul-14 Eisai R&D Estrogen of PCT in CH, Manageme Receptor DE, GB, nt Co., Ltd. Modulator FR, LI, NL 11/30/18 Patent Poland Selective -- -- -- Issued 186710 -- Eisai R&D Estrogen Manageme Receptor nt Co., Ltd. Modulator


 
Application Patent Type Country Title Filing Date Appl. Type Status Issue Date Ownership No. No. 1901 EISAI COM Patent India Selective 2829/DELNP 25-Dec-03 Nat'l Phase Issued 323625 24-Oct-19 Eisai R&D Estrogen /2005 of PCT Manageme Receptor nt Co., Ltd. Modulator Patent Japan Selective 2004562947 25-Dec-03 Nat'l Phase Issued 4500689 23-Apr-10 Eisai R&D Estrogen of PCT Manageme Receptor nt Co., Ltd. Modulator Patent United Selective 11/158,245 22-Jun-05 CIP of PCT Issued 7,612,114 3-Nov-09 Eisai R&D States Estrogen Manageme Receptor nt Co., Ltd. Modulator Patent United Selective 12/544,965 20-Aug-09 DIV of '245 Issued 7,960,412 14-Jun-11 Eisai R&D States Estrogen Manageme Receptor nt Co., Ltd. Modulator Patent United Selective 13/048,391 15-Mar-11 DIV of '965 Issued 8,399,520 19-Mar-13 Eisai R&D States Estrogen Manageme Receptor nt Co., Ltd. Modulator


 
Application Patent Type Country Title Filing Date Appl. Type Status Issue Date Ownership No. No. 1901 EISAI COM Patent PCT Selective PCT/JP03/16 25-Dec-03 PCT Expired -- -- Eisai Co., Estrogen 808 Ltd. Receptor Modulator Application Filing Patent Issue Type Country Title Appl. Type Status Ownership No. Date No. Date 1901 DUKE Patent United Method of 61/971,627 3-28- Provisional Expired -- -- Duke States Treating Cancer 2017 University Using Selective Estrogen Receptor Modulators Patent United Method of 14/512,061 10-10- Non- Issued 9421264 8-23- Duke States Treating Cancer 2014 Provisional 2016 University Using Selective Estrogen Receptor Modulators


 
Application Filing Patent Issue Type Country Title Appl. Type Status Ownership No. Date No. Date 1901 DUKE Patent United Method of 62/129,379 3-6-2015 Provisional Expired -- -- Duke States Treating Cancer University Using Selective Estrogen Receptor Modulators Patent PCT Method of PCT/US2015/ 3-28- PCT Expired -- -- Duke Treating Cancer 023216 2015 University Using Selective Estrogen Receptor Modulators Patent United Method of 15/214,187 7-19- Non- Issued 10071066 9-11- Duke States Treating Cancer 2016 Provisional 2018 University Using Selective Estrogen Receptor Modulators Patent United Method of 15/129,197 26-Sep- Non- Issued 10420734 24-Sep- Duke States Treating Cancer 16 Provisional 19 University NP Using Selective Estrogen Receptor Modulators Patent Canada Method of 2943611 3-28- CA NP Pending -- -- Duke Treating Cancer 2015 University Using Selective National Estrogen Entry Receptor 9-22- Modulators 2016


 
Application Filing Patent Issue Type Country Title Appl. Type Status Ownership No. Date No. Date 1901 DUKE Patent Europe Method of 15769394.6 3-28- EP NP Published -- -- Duke Treating Cancer 2015 University Using Selective National Estrogen Entry Receptor 10- Modulators 27/2016 Patent Europe Method of Proposed Proposed EP Div Proposed -- -- Duke DIV Treating Cancer University Using Selective Estrogen Receptor Modulators Patent United Method of 16/041,416 20-Jul-18 Non- Abandoned -- -- Duke States Treating Cancer Provisional University CON 2 Using Selective Estrogen Receptor Modulators Patent United Method of 16/549,828 23-Aug- Non- Published -- -- Duke States Treating Cancer 19 Provisional University CON 3 Using Selective Estrogen Receptor Modulators Patent United Method of 16/721,329 19-Dec- Non- Published -- -- Duke States Treating Cancer 19 Provisional University CON 4 Using Selective Estrogen Receptor Modulators


 
exhibit103-originalv2
Exhibit 10.3 GENERAL RELEASE OF CLAIMS This General Release of Claims (“Release”) is entered into between Jose I. Carmona (“Executive”), and Radius Health, Inc. (the “Company”) (collectively referred to herein as the “Parties”). WHEREAS, Executive and the Company are parties to that certain Executive Severance Agreement dated as of June 18, 2020 (the “Severance Agreement”); WHEREAS, the Parties agree that Executive is entitled to certain severance benefits under the Severance Agreement, subject to Executive's execution and non-revocation of this Release; WHEREAS, the Company and Executive now wish to fully and finally to resolve all matters between them. NOW, THEREFORE, in consideration of, and subject to, (i) the severance benefits payable to Executive pursuant to the Severance Agreement and (ii) the Accelerated Vesting (as defined below), each of which shall only be provided to Executive if this Release becomes effective in the time period set forth herein, the adequacy of which is hereby acknowledged by Executive, and which Executive acknowledges that he or she would not otherwise be entitled to receive, Executive and the Company hereby agree as follows: 1. Severance Benefits and Accelerated Vesting. If Executive executes and does not revoke this Release, then (a) subject to the terms of this Release and the Severance Agreement, the Executive will receive the severance benefits under Section 2(a) of the Severance Agreement, and (b) the Company will accelerate the vesting of 15,000 restricted stock units (“RSUs”) previously awarded to Executive, with such vesting to occur as of the later of the Separation Date or the Effective Date, as such terms are defined herein (the “Accelerated Vesting”), provided that any forfeiture of the 15,000 RSUs to be vested pursuant to this Release that would otherwise occur on the Separation Date in the absence of this Release will be delayed to the extent necessary to effectuate the terms of this Release and will only occur if the Accelerated Vesting does not occur due to the absence of this Release becoming fully effective within the time period set forth herein. Notwithstanding the foregoing, no additional vesting of the RSUs shall occur during the period between the Separation Date and the date that the Accelerated Vesting occurs. 2. General Release of Claims by Executive. (a) Executive, on behalf of himself or herself and his or her executors, heirs, administrators, representatives and assigns, hereby agrees to release and forever discharge the Company and all predecessors, successors and their respective parent corporations, affiliates, related, and/or subsidiary entities, and all of their past and present investors, directors, shareholders, officers, general or limited partners, employees, attorneys, creditors, agents and representatives, and the employee benefit plans in which Executive is or has been a participant by virtue of his or her employment with or service to the Company (collectively, the “Company Releasees”), from any and all claims, debts, demands, accounts, judgments, rights, causes of action, equitable relief, damages, costs, charges, complaints, obligations, promises, agreements, controversies, suits, expenses, compensation, responsibility and liability of every kind and character whatsoever (including attorneys’ fees and costs), whether in law or equity, known or unknown, asserted or unasserted,


 
suspected or unsuspected (collectively, “Claims”), which Executive has, had or may have had against such entities based on any events or circumstances arising or occurring on or prior to the date hereof, including without limitation arising directly or indirectly out of, relating to, or in any other way involving in any manner whatsoever Executive's employment by or service to the Company or the termination thereof, including without limitation any and all claims arising under federal, state, or local laws relating to employment, including without limitation claims of wrongful discharge, breach of express or implied contract, fraud, misrepresentation, defamation, or liability in tort, of retaliation or discrimination under federal, state or local law, claims under the Worker Adjustment and Retraining Notification Act, 29 U.S.C. § 2101 et seq., or the Fair Labor Standards Act, 29 U.S.C. § 201 et seq., claims for wages, bonuses, incentive compensation, commissions, vacation pay or any other compensation or benefits, either under the Massachusetts Wage Act, M.G.L. c. 149, §§148- lS0C, or otherwise, claims for damages or other remedies of any sort, including, without limitation, compensatory damages, punitive damages, injunctive relief and attorney's fees, and claims of any kind that may be brought in any court or administrative agency including, without limitation, claims under Title VII of the Civil Rights Act of 1964, as amended, 42 U.S.C. Section 2000, gg.; the Americans with Disabilities Act, as amended, 42 U.S.C. § 12101 et seq.; the Rehabilitation Act of 1973, as amended, 29 U.S.C. § 701 et seq.: the Civil Rights Act of 1866, and the Civil Rights Act of 1991; 42 U.S.C. Section 1981, et seq.; the Age Discrimination in Employment Act, as amended, 29 U.S.C. Section 621, et seq. (the “ADEA”); the Equal Pay Act, as amended, 29 U.S.C. Section 206(d); regulations of the Office of Federal Contract Compliance, 41 C.F.R. Section 60, et seq.; the Family and Medical Leave Act, as amended, 29 U.S.C. § 2601 et seq.; the Fair Labor Standards Act of 1938, as amended, 29 U.S.C. § 201 et seq.; the Employee Retirement Income Security Act, as amended, 29 U.S.C. § 1001 et seq.; and any similar state or local law. Executive agrees not to accept damages of any nature, other equitable or legal remedies for Executive’s own benefit or attorney’s fees or costs from any of the Company Releasees with respect to any Claim released by this Release. Notwithstanding the generality of the foregoing, Executive does not release the following: (i) Claims that may arise after Executive signs this Release; (ii) Claims for unemployment compensation or any state disability insurance benefits pursuant to the terms of applicable state law; (iii) Claims for workers’ compensation insurance benefits under the terms of any worker’s compensation insurance policy or fund of the Company; (iv) Claims pursuant to the terms and conditions of the federal law known as COBRA; (v) Claims for indemnity under the bylaws of the Company or its affiliates, as provided for by law or under any applicable insurance policy with respect to Executive’s liability as an employee, director or officer of the Company pursuant to which Executive is covered as of the effective date of Executive’s termination of employment with the Company and its subsidiaries; (vi) Claims for payment under Section 2(a) of the Severance Agreement; and (vii) Any rights that cannot be released as a matter of applicable law, but


 
only to the extent such rights may not be released under such applicable law. (b) Executive acknowledges that this Release was presented to him or her on September 23, 2020 in connection with his or her termination of employment on September 23, 2020 (“Separation Date”) and that Executive is entitled to have twenty-one (21) days’ time from the Separation Date in which to consider it. Executive further acknowledges that the Company has advised him or her that he or she is waiving his or her rights under the ADEA, and that Executive should consult with an attorney of his or her choice before signing this Release, and Executive has had sufficient time to consider the terms of this Release. Executive represents and acknowledges that if Executive executes this Release before twenty-one (21) days have elapsed, Executive does so knowingly, voluntarily, and upon the advice and with the approval of Executive’s legal counsel (if any), and that Executive voluntarily waives any remaining consideration period. (c) Executive understands that after executing this Release, Executive has the right to revoke it within seven (7) business days after his or her execution of it. Executive understands that this Release will not become effective and enforceable unless the seven (7) business day revocation period passes and Executive does not revoke the Release in writing. Executive understands that this Release may not be revoked after the seven (7) business day revocation period has passed. Executive also understands that any revocation of this Release must be made in writing and delivered to the Company at its principal place of business within the seven (7) business day period. (d) Executive understands that this Release shall become effective, irrevocable, and binding upon Executive on the eighth (8th) business day after his or her execution of it, so long as Executive has not revoked it within the time period and in the manner specified in clause (c) above (the “Effective Date”). Executive further understands that Executive will not be given any severance benefits under the Severance Agreement unless this Release is effective on or before the date that is 60 days following the date of Executive's termination of employment. 3. Continuing Obligations. Executive acknowledges that Executive's obligations under the Confidentiality and Non-Competition Agreement between Executive and the Company dated May 11, 2017 (the “Confidentiality and Non-Compete Agreement”) shall continue in effect. The terms of the Confidentiality and Non-Compete Agreement are hereby incorporated by reference as material terms of this Release. For the avoidance of doubt, however, pursuant to the federal Defend Trade Secrets Act of 2016, Executive shall not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of a trade secret that (a) is made (i) in confidence to a federal, state, or local government official, either directly or indirectly, or to an attorney; and (ii) solely for the purpose of reporting or investigating a suspected violation of law; or (b) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal. 4. Protected Disclosures and Other Protected Actions. Nothing contained in this Release, the Severance Agreement, or the Confidentiality and Non-Compete Agreement limits Executive's ability to file a charge or complaint with any federal, state or local governmental agency or commission (a “Government Agency”). In addition, nothing contained in this Release, the Severance Agreement, or the Confidentiality and Non-Compete Agreement limits Executive's ability to communicate with any Government Agency or otherwise participate in any investigation or proceeding that may be conducted by any Government Agency, including Executive's ability to provide documents or other information, without notice to the Company, nor does anything contained in this Release, the Severance Agreement, or the Confidentiality and Non-Compete Agreement apply


 
to truthful testimony in litigation. If Executive files any charge or complaint with any Government Agency and if the Government Agency pursues any claim on Executive's behalf, or if any other third party pursues any claim on Executive's behalf, Executive waives any right to monetary or other individualized relief (either individually, or as part of any collective or class action); provided that nothing in this Release limits any right Executive may have to receive a whistleblower award or bounty for information provided to the Securities and Exchange Commission. 5. No Assignment. Executive represents and warrants to the Company Releasees that there has been no assignment or other transfer of any interest in any Claim that Executive may have against the Company Releasees. Executive agrees to indemnify and hold harmless the Company Releasees from any liability, claims, demands, damages, costs, expenses and attorneys’ fees incurred as a result of any such assignment or transfer from Executive. 6. Severability. In the event any provision of this Release is found to be unenforceable by an arbitrator or court of competent jurisdiction, such provision shall be deemed modified to the extent necessary to allow enforceability of the provision as so limited, it being intended that the Parties shall receive the benefit contemplated herein to the fullest extent permitted by law. If a deemed modification is not satisfactory in the judgment of such arbitrator or court, the unenforceable provision shall be deemed deleted, and the validity and enforceability of the remaining provisions shall not be affected thereby. 7. Interpretation; Construction. The headings set forth in this Release are for convenience only and shall not be used in interpreting this Release. This Release has been drafted by legal counsel representing the Company, but Executive has participated in the negotiation of its terms. Furthermore, Executive acknowledges that Executive has had an opportunity to review and revise the Release and have it reviewed by legal counsel, if desired, and, therefore, the normal rule of construction to the effect that any ambiguities are to be resolved against the drafting Party shall not be employed in the interpretation of this Release. Either Party's failure to enforce any provision of this Release shall not in any way be construed as a waiver of any such provision, or prevent that party thereafter from enforcing each and every other provision of this Release. 8. Governing Law and Venue. This Release will be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts applicable to contracts made and to be performed wholly within such Commonwealth, and without regard to the conflicts of laws principles that would result in the applicable of the laws of another jurisdiction. Any suit brought hereon shall be brought in the state or federal courts sitting in Boston, Massachusetts, the parties hereby waiving any claim or defense that such forum is not convenient or proper. Each Party hereby agrees that any such court shall have in personam jurisdiction over it and consents to service of process in any manner authorized by Massachusetts law. 9. Entire Agreement. This Release, the Severance Agreement, the Confidentiality and Non-Compete Agreement, the Radius Health, Inc. 2018 Stock Option and Incentive Plan, any predecessor plan, the applicable stock option, restricted stock unit agreement or other equity award agreements between Executive and the Company (subject to the Accelerated Vesting set forth above) constitute the entire agreement of the Parties in respect of the subject matter contained herein and therein and supersede all prior or simultaneous representations, discussions, negotiations and agreements, whether written or oral. This Release may be amended or modified only with the written consent of Executive and an authorized representative of the Company. No oral waiver, amendment


 
or modification will be effective under any circumstances whatsoever. 10. Counterparts. This Release may be executed in multiple counterparts, each of which shall be deemed to be an original but all of which together shall constitute one and the same instrument. (Signature Page Follows)


 
IN WITNESS WHEREOF, and intending to be legally bound, the Parties have executed the foregoing Release effective as of the Effective Date. RADIUS HEALTH, INC. Dated: 9/22/2020 By: /s/ Chhaya Shah Name: Chhaya Shah Title: Chief Business Officer EXECUTIVE Dated: 9/22/2020 By: /s/ Jose I. Carmona


 
Document

Exhibit 31.1
 
CERTIFICATIONS
 
I, G. Kelly Martin, certify that:
 
1.              I have reviewed this Quarterly Report on Form 10-Q of Radius Health, Inc.;
 
2.              Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3.              Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4.              The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
a.              Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
b.              Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
c.               Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
d.              Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.
 
5.              The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s Board of Directors (or persons performing the equivalent functions):
 
a.              All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
b.              Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
 
Date: November 5, 2020
 
 /s/ G. Kelly Martin
 G. Kelly Martin
 President and Chief Executive Officer


Document

Exhibit 31.2
 
CERTIFICATIONS
 
I, Dan Dolan, certify that:
 
1.              I have reviewed this Quarterly Report on Form 10-Q of Radius Health, Inc.;
 
2.              Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3.              Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4.              The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
a.              Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
b.              Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
c.               Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
d.              Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.
 
5.              The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s Board of Directors (or persons performing the equivalent functions):
 
a.              All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
b.              Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
 
Date: November 5, 2020
 
 /s/ Dan Dolan
 Dan Dolan
 Head of Financial Planning and Analysis, Treasurer
(Principal Accounting and Financial Officer)


Document

Exhibit 32.1
 
CERTIFICATION OF CHIEF EXECUTIVE OFFICER AND
CHIEF FINANCIAL OFFICER PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
 
Each of G. Kelly Martin and Dan Dolan hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, in his capacity as President and Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer), respectively, of Radius Health, Inc. (the “Company”), that, to his knowledge, the Quarterly Report of the Company on Form 10-Q for the period ended September 30, 2020 as filed with the Securities and Exchange Commission (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
Date:November 5, 2020 
  
 By:/s/ G. Kelly Martin
 G. Kelly Martin
 President and Chief Executive Officer
  
Date:November 5, 2020 
  
 By:/s/ Dan Dolan
 Dan Dolan
 Head of Financial Planning and Analysis, Treasurer
(Principal Accounting and Financial Officer)
 
This written statement is being furnished to the Securities and Exchange Commission as an exhibit to the Report, and “accompanies” such Report to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Report to which it relates), notwithstanding any general incorporation language contained in such filing. A signed original of this statement has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.


v3.20.2
Cover Page - shares
9 Months Ended
Sep. 30, 2020
Nov. 02, 2020
Cover [Abstract]    
Document Type 10-Q  
Document Quarterly Report true  
Document Period End Date Sep. 30, 2020  
Document Transition Report false  
Entity File Number 001-35726  
Entity Registrant Name Radius Health, Inc.  
Entity Incorporation, State or Country Code DE  
Entity Tax Identification Number 80-0145732  
Entity Address, Address Line One 950 Winter Street  
Entity Address, City or Town Waltham  
Entity Address, State or Province MA  
Entity Address, Postal Zip Code 02451  
City Area Code 617  
Local Phone Number 551-4000  
Title of 12(b) Security Common Stock, $0.0001 par value per share  
Trading Symbol RDUS  
Security Exchange Name NASDAQ  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Large Accelerated Filer  
Entity Small Business false  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding (in shares)   46,547,387
Entity Central Index Key 0001428522  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Document Fiscal Year Focus 2020  
Document Fiscal Period Focus Q3  
v3.20.2
Condensed Consolidated Balance Sheets - USD ($)
$ in Thousands
Sep. 30, 2020
Dec. 31, 2019
Current assets:    
Cash and cash equivalents $ 81,830 $ 69,886
Restricted cash 567 567
Marketable securities 43,873 91,015
Accounts receivable, net 21,175 23,289
Inventory 7,506 5,323
Prepaid expenses 11,346 12,131
Other current assets 17,078 846
Total current assets 183,375 203,057
Property and equipment, net 1,276 2,293
Intangible assets 5,984 6,583
Right of use assets - operating leases 4,832 6,704
Other assets 484 514
Total assets 195,951 219,151
Current liabilities:    
Accounts payable 15,767 6,030
Accrued expenses and other current liabilities 63,662 53,030
Operating lease liability, current 2,229 2,198
Total current liabilities 81,658 61,258
Convertible notes payable 208,902 195,591
Term loan 9,941 0
Operating lease liability, long term 4,031 4,581
Total liabilities 304,532 261,430
Commitments and contingencies
Stockholders’ equity (deficit):    
Common stock, 0.0001 par value; 200,000,000 shares authorized, 46,548,201 shares and 46,189,870 shares issued and outstanding at September 30, 2020 and December 31, 2019 5 5
Additional paid-in-capital 1,215,769 1,194,327
Accumulated other comprehensive income 82 3
Accumulated deficit (1,324,437) (1,236,614)
Total stockholders’ equity (deficit) (108,581) (42,279)
Total liabilities and stockholders’ equity (deficit) $ 195,951 $ 219,151
v3.20.2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
Sep. 30, 2020
Dec. 31, 2019
Statement of Financial Position [Abstract]    
Common stock, par value (in dollars per share) $ 0.0001 $ 0.0001
Common stock, shares authorized (in shares) 200,000,000 200,000,000
Common stock, shares issued (in shares) 46,548,201 46,189,870
Common stock, shares outstanding (in shares) 46,548,201 46,189,870
v3.20.2
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2020
Sep. 30, 2019
Sep. 30, 2020
Sep. 30, 2019
REVENUES:        
Total revenue $ 77,826 $ 46,766 $ 175,862 $ 117,652
OPERATING EXPENSES:        
Cost of sales - product 3,839 3,971 11,771 10,809
Cost of sales - intangible amortization 200 200 599 599
Research and development, net of amounts reimbursable [1] 39,450 31,791 123,340 82,230
Selling, general and administrative 33,692 35,617 108,356 116,918
Income (Loss) from operations 645 (24,813) (68,204) (92,904)
OTHER INCOME (EXPENSE):        
Other (expense) income (87) 59 (144) 21
Interest expense (7,069) (6,298) (20,747) (18,500)
Interest income 222 1,008 1,272 3,105
NET LOSS (6,289) (30,044) (87,823) (108,278)
OTHER COMPREHENSIVE LOSS:        
Unrealized (loss) gain from available-for-sale debt securities (26) 66 79 776
COMPREHENSIVE LOSS (6,315) (29,978) (87,744) (107,502)
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS - BASIC AND DILUTED (Note 8) $ (6,289) $ (30,044) $ (87,823) $ (108,278)
LOSS PER SHARE:        
Basic and diluted (in dollars per share) $ (0.14) $ (0.65) $ (1.89) $ (2.36)
WEIGHTED AVERAGE SHARES:        
Basic and diluted (in shares) 46,493,126 46,141,217 46,395,124 45,975,691
Product revenue, net        
REVENUES:        
Total revenue $ 50,412 $ 46,766 $ 148,448 $ 117,652
License revenue        
REVENUES:        
Total revenue $ 27,414 $ 0 $ 27,414 $ 0
[1] Amounts reimbursable for the three and nine months ended September 30, 2020 were $15.4 million and $0 for the three and nine months ended September 30, 2019.
v3.20.2
Condensed Consolidated Statements of Operations and Comprehensive Loss (Parenthetical) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2020
Sep. 30, 2019
Sep. 30, 2020
Sep. 30, 2019
Income Statement [Abstract]        
Reimbursable expenses $ 15,400,000 $ 0 $ 15,400,000 $ 0
v3.20.2
Condensed Consolidated Statements of Cash Flows - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2020
Sep. 30, 2019
CASH FLOWS USED IN OPERATING ACTIVITIES:    
Net loss $ (87,823) $ (108,278)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization 1,616 1,785
Amortization of premium/discount on marketable securities, net 237 (246)
Amortization of debt discount and debt issuance costs 13,313 11,638
Impairment loss on operating lease right of use assets 1,510 339
Stock-based compensation 19,821 16,911
Loss on property and equipment disposals 0 201
Changes in operating assets and liabilities:    
Inventory (2,183) 1,299
Accounts receivable, net 2,114 (4,770)
Prepaid expenses 785 (1,359)
Other current assets (16,232) 344
Operating lease right of use assets 1,472 1,507
Other long-term assets 30 132
Accounts payable 9,737 382
Accrued expenses and other current liabilities 10,632 6,879
Lease liability, operating leases (1,629) (1,704)
Other non-current liabilities 0 (71)
Net cash used in operating activities (46,600) (75,011)
CASH FLOWS PROVIDED BY INVESTING ACTIVITIES:    
Purchases of marketable securities (39,916) (36,589)
Sales and maturities of marketable securities 86,900 135,500
Net cash provided by investing activities 46,984 98,911
CASH FLOWS PROVIDED BY FINANCING ACTIVITIES:    
Proceeds from exercise of stock options and warrant exercises 0 3,869
Proceeds from issuance of term loan 10,000 0
Payment of debt issuance costs (61) 0
Proceeds from issuance of shares under employee stock purchase plan 1,621 1,840
Net cash provided by financing activities 11,560 5,709
NET INCREASE IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH 11,944 29,609
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT BEGINNING OF PERIOD 70,453 59,881
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT END OF PERIOD 82,397 89,490
SUPPLEMENTAL DISCLOSURES:    
Cash paid for interest 9,658 9,150
Cash paid for amounts included in the measurement of operating lease liabilities 1,932 2,068
Right of use assets obtained in exchange for operating lease liability $ 1,110 $ 8,289
v3.20.2
Condensed Consolidated Statements of Stockholders' Equity (Deficit) - USD ($)
$ in Thousands
Total
Common Stock
Additional Paid-In Capital
Accumulated Other Comprehensive Income (Loss)
Accumulated
Deficit
Beginning balance (in shares) at Dec. 31, 2018   45,563,693      
Beginning balance at Dec. 31, 2018 $ 60,632 $ 5 $ 1,165,003 $ (755) $ (1,103,621)
Increase (Decrease) in Stockholders' Equity [Roll Forward]          
Net loss (108,278)       (108,278)
Unrealized gain (loss) from available-for-sale securities 776     776  
Vesting of restricted shares (in shares)   75,331      
Vesting of restricted shares 0        
Exercise of options (in shares)   341,337      
Exercise of options 2,869   2,869    
Exercise of warrants (in shares)   81,104      
Exercise of warrants 1,000   1,000    
Share-based compensation expense related to share-based awards for employee stock purchase plan 456   456    
Issuance of common stock upon purchase by employee stock purchase plan (in shares)   111,705      
Issuance of common stock upon purchase by employee stock purchase plan 1,840   1,840    
Share-based compensation expense 16,455   16,455    
Ending balance (in shares) at Sep. 30, 2019   46,173,170      
Ending balance at Sep. 30, 2019 (24,250) $ 5 1,187,623 21 (1,211,899)
Beginning balance (in shares) at Jun. 30, 2019   46,125,197      
Beginning balance at Jun. 30, 2019 (134) $ 5 1,181,761 (45) (1,181,855)
Increase (Decrease) in Stockholders' Equity [Roll Forward]          
Net loss (30,044)       (30,044)
Unrealized gain (loss) from available-for-sale securities 66     66  
Share-based compensation expense related to share-based awards for employee stock purchase plan 20   20    
Issuance of common stock upon purchase by employee stock purchase plan (in shares)   47,973      
Issuance of common stock upon purchase by employee stock purchase plan 813   813    
Share-based compensation expense 5,029   5,029    
Ending balance (in shares) at Sep. 30, 2019   46,173,170      
Ending balance at Sep. 30, 2019 (24,250) $ 5 1,187,623 21 (1,211,899)
Beginning balance (in shares) at Dec. 31, 2019   46,189,870      
Beginning balance at Dec. 31, 2019 (42,279) $ 5 1,194,327 3 (1,236,614)
Increase (Decrease) in Stockholders' Equity [Roll Forward]          
Net loss (87,823)       (87,823)
Unrealized gain (loss) from available-for-sale securities 79     79  
Vesting of restricted shares (in shares)   242,974      
Vesting of restricted shares 0        
Issuance of common stock upon purchase by employee stock purchase plan (in shares)   115,357      
Issuance of common stock upon purchase by employee stock purchase plan 1,621   1,621    
Share-based compensation expense 19,821   19,821    
Ending balance (in shares) at Sep. 30, 2020   46,548,201      
Ending balance at Sep. 30, 2020 (108,581) $ 5 1,215,769 82 (1,324,437)
Beginning balance (in shares) at Jun. 30, 2020   46,448,491      
Beginning balance at Jun. 30, 2020 (109,419) $ 5 1,208,616 108 (1,318,148)
Increase (Decrease) in Stockholders' Equity [Roll Forward]          
Net loss (6,289)       (6,289)
Unrealized gain (loss) from available-for-sale securities (26)     (26)  
Vesting of restricted shares (in shares)   39,650      
Vesting of restricted shares 0        
Issuance of common stock upon purchase by employee stock purchase plan (in shares)   60,060      
Issuance of common stock upon purchase by employee stock purchase plan 631   631    
Share-based compensation expense 6,522   6,522    
Ending balance (in shares) at Sep. 30, 2020   46,548,201      
Ending balance at Sep. 30, 2020 $ (108,581) $ 5 $ 1,215,769 $ 82 $ (1,324,437)
v3.20.2
Organization
9 Months Ended
Sep. 30, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Organization Organization
Radius Health, Inc. (“Radius” or the “Company”) is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics. In April 2017, the Company’s first commercial product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapies. In July 2017, the Company entered into a license and development agreement with Teijin Limited (“Teijin”) for abaloparatide for subcutaneous injection (“abaloparatide-SC”) in Japan, under which the Company received an upfront payment and is entitled to receive milestone payments upon the achievement of certain regulatory and sales milestones, and a fixed low double-digit royalty based on net sales of abaloparatide-SC in Japan during the royalty term. In January 2019, the European Commission adopted a decision refusing approval of the Company’s European Marketing Authorisation Application (“MAA”) for abaloparatide-SC. The Company is developing an abaloparatide transdermal patch, or abaloparatide-patch, for potential use in the treatment of postmenopausal women with osteoporosis. In connection with its strategic plans to focus on bone health and targeted endocrine diseases, in July 2020 the Company entered into a license agreement with Berlin-Chemie AG, a company of the Menarini Group (“Berlin-Chemie”), under which the Company granted Berlin-Chemie an exclusive license to develop and commercialize products containing elacestrant (RAD1901), a selective estrogen receptor degrader (“SERD”), worldwide. Elacestrant is being developed for potential use in the treatment of hormone receptor-positive breast cancer. Further, the Company completed its divestment of its oncology program with the sale of RAD140, an internally discovered non-steroidal selective androgen receptor modulator (“SARM”) the Company was developing for potential use in the treatment of hormone receptor-positive breast cancer, to Ellipses Pharma in September 2020.
The Company is subject to the risks associated with biopharmaceutical companies with a limited operating history, including dependence on key individuals, a developing business model, the necessity of securing regulatory approvals to market its investigational product candidates, market acceptance of the Company’s investigational product candidates following receipt of regulatory approval, competition for its investigational product candidates following receipt of regulatory approval, and the continued ability to obtain adequate financing to fund the Company’s future operations, inclusive of the impacts from the coronavirus disease 2019 (“COVID-19”) pandemic. The Company has incurred losses and expects to continue to incur additional losses for the foreseeable future. As of September 30, 2020, the Company had an accumulated deficit of $1,324.4 million, and total cash, cash equivalents, and marketable securities of $125.7 million.
The ongoing global COVID-19 pandemic has resulted in significant governmental measures being implemented to control the spread of the virus and while the Company cannot predict their scope and severity, these developments and measures have had an effect on the Company’s business, results of operations and financial condition and may adversely affect its business, results of operations and financial condition in the future. The Company is closely monitoring the impact of the COVID-19 pandemic on all aspects of its business and is taking steps to minimize its impact on its business. However, the full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, including sales, expenses, reserves and allowances, manufacturing, clinical trials, research and development costs and employee-related amounts, will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the outbreak, new information that may emerge concerning the severity of COVID-19 pandemic or the effectiveness of actions taken to contain the pandemic or minimize its impact, among others. Furthermore, if the Company or any of the third parties with whom it engages were to experience additional or prolonged shutdowns or other business disruptions, the Company’s ability to conduct its business in the manner and on the timelines presently planned could be materially or negatively affected, which could have a material adverse impact on its business, results of operations and financial condition.
Based upon its cash, cash equivalents, and marketable securities balance as of September 30, 2020, the Company believes that, prior to the consideration of revenue from the potential future sales of any of its investigational product candidates that may receive regulatory approval or proceeds from partnering and/or collaboration activities, it has sufficient capital as well as access to other capital discussed in Note 7, “Term Loan and Credit Facility” to fund its development plans, U.S. commercial scale-up and other operational activities, for at least one year from the date of this filing. The Company expects to finance the future development costs of its clinical product portfolio with its existing cash and cash equivalents, and marketable securities, or through strategic financing opportunities that could include, but are not limited to collaboration or partnership agreements, future offerings of its equity, or the incurrence of debt. However, there is no guarantee that any of these strategic or financing opportunities will be executed or executed on favorable terms, and some could be dilutive to existing stockholders. If the Company fails to obtain additional future capital, it may be unable to complete its clinical trials and obtain approval of certain investigational product candidates from the FDA or foreign regulatory authorities.
v3.20.2
Basis of Presentation and Significant Accounting Policies
9 Months Ended
Sep. 30, 2020
Accounting Policies [Abstract]  
Basis of Presentation and Significant Accounting Policies Basis of Presentation and Significant Accounting Policies
Basis of Presentation—The accompanying unaudited condensed consolidated financial statements and the related disclosures of the Company have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01. Accordingly, they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included.
When preparing financial statements in conformity with U.S. GAAP, the Company must make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expenses and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the nine months ended September 30, 2020 are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2020. Subsequent events have been evaluated up to the date of issuance of these financial statements. These interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes, which are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 (“2019 Form 10-K”), filed with the Securities and Exchange Commission (“SEC”) on February 27, 2020.
Significant Accounting Policies—The significant accounting policies identified in the Company’s 2019 Form 10-K that require the Company to make estimates and assumptions include: revenue recognition, inventory obsolescence, long-lived assets and intangible assets, accounting for stock-based compensation, contingencies, tax valuation reserves, fair value measures, and accrued expenses. There were no changes to significant accounting policies during the nine months ended September 30, 2020, except for the adoption of the Accounting Standards Updates (“ASU”) issued by the Financial Accounting Standards Board (“FASB”) detailed below.
Accounting Standards Updates—Recently Adopted—In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). Certain amendments thereto were also issued by the FASB. ASU 2016-13 and the related amendments require that credit losses be reported using an expected losses model, representing the entity’s current estimate of credit losses expected to be incurred. The previous accounting guidance, as applied by the Company through December 31, 2019, was based on an incurred losses model. The standard replaces the incurred loss impairment methodology under current U.S. GAAP with a methodology that reflects expected credit losses and requires the use of a forward-looking expected credit loss model for accounts receivables, loans, and other financial instruments. For available-for-sale debt securities with unrealized losses, ASU 2016-13 and the related amendments now requires allowances to be recorded instead of reducing the amortized cost of the investment. These amendments under ASU 2016-13 are effective for interim and annual fiscal periods beginning after December 15, 2019. The Company adopted ASU 2016-13 as of January 1, 2020 and it did not have a material impact on the Company’s condensed consolidated financial statements.
In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement - Disclosure Framework - Changes to the Disclosure Requirement for Fair Value Measurement, or (“ASU 2018-13”). The amendments in ASU 2018-13 modify the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement, based on the concepts in the Concepts Statement, including the consideration of costs and benefits. The amendments under ASU 2018-13 are effective for interim and annual fiscal periods beginning after December 15, 2019, with early adoption permitted. The Company adopted ASU 2018-13 on January 1, 2020 and it did not have a material impact on the Company’s condensed consolidated financial statements.
In August 2018, the FASB issued ASU 2018-15, Intangible-Goodwill and Other Internal-Use Software (Subtopic 350-40) (“ASU 2018-15”). ASU 2018-15 updates guidance regarding accounting for a cloud computing arrangement that is a service contract. The amendments under ASU 2018-15 are effective for interim and annual fiscal periods beginning after December 15, 2019, with early adoption permitted. The Company adopted ASU 2018-15 on January 1, 2020 and it did not have a material impact on the Company’s condensed consolidated financial statements.
Other - In March 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was signed into law and provides an estimated $2.2 trillion to fight the COVID-19 pandemic and stimulate the economy. The business tax provisions of the CARES Act include temporary changes to income and non-income-based tax laws. Some of the key income tax provisions include eliminating the 80% of taxable income limitations by allowing corporate entities to fully utilize net operating loss (“NOL”) carryforwards to offset taxable income in 2018, 2019, or 2020 and reinstating it for tax years after 2020; allowing NOLs generated in 2018, 2019, or 2020 to be carried back five years; increasing the net interest expense deduction limit to 50% of adjusted taxable income from 30% for the 2019 and 2020 tax years; allowing taxpayers with alternative minimum tax credits to claim a refund for the entire amount of the credit instead of recovering the credit through refunds over a period of years, as required by the 2017 Tax Cut and Jobs Act; and allowing entities to deduct more of their charitable cash contributions made
during calendar year 2020 by increasing the taxable income limitation to 25% from 10%. Companies are required to account for these provisions in the period that includes the March 2020 enactment date (i.e., the first quarter for calendar year-end entities). The Company has assessed the impact of these provisions and they are not material to the Company’s condensed consolidated financial statements or related disclosures. Measures of the CARES Act not related to income-based taxes include allowing an employer to pay its share of Social Security payroll taxes that would otherwise be due from the date of enactment through December 31, 2020 over the following two years and allowing eligible employers subject to closure due to the COVID-19 pandemic to receive a 50% credit on qualified wages against their employment taxes each quarter, with any excess credits eligible for refunds. These measures of the CARES Act are also not material to the Company’s condensed consolidated financial statements as the Company did not apply for any credit during the period.
Accounting Standards Updates, Recently Issued—In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes (“ASU 2019-12”). ASU 2019-12 eliminates certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interest period and the recognition of deferred tax liabilities for outside basis differences, and also clarifies and simplifies other aspects of the accounting for income taxes. The amendments under ASU 2010-12 are effective for interim and annual fiscal periods beginning after December 15, 2020, with early adoption permitted. The Company is currently evaluating the effects the adoption of ASU 2019-12 will have on its consolidated financial statements and related disclosures.
In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”). The guidance simplifies the complexity associated with applying U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. More specifically, the amendments focus on the guidance for convertible instruments and derivative scope exception for contracts in an entity’s own equity. ASU 2020-06 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company is currently in the process of determining the effect that the adoption will have on its condensed consolidated financial statements and related disclosures.
v3.20.2
Marketable Securities
9 Months Ended
Sep. 30, 2020
Investments, Debt and Equity Securities [Abstract]  
Marketable Securities Marketable Securities
Available-for-sale marketable securities and cash and cash equivalents as of September 30, 2020 and December 31, 2019 consisted of the following (in thousands):
 September 30, 2020
 Amortized Cost ValueGross 
Unrealized 
Gains
Gross 
Unrealized 
Losses
Fair Value
Cash and cash equivalents:    
Cash$55,796 $— $— $55,796 
Money market funds26,034 — — 26,034 
Total$81,830 $— $— $81,830 
Marketable securities:    
Domestic corporate debt securities$38,822 $91 $(3)$38,910 
Domestic corporate commercial paper4,968 — (5)4,963 
Total$43,790 $91 $(8)$43,873 
 
 December 31, 2019
 Amortized Cost ValueGross 
Unrealized 
Gains
Gross 
Unrealized 
Losses
Fair Value
Cash and cash equivalents:    
Cash$34,726 $— $— $34,726 
Money market funds35,160 — — 35,160 
Total$69,886 $— $— $69,886 
Marketable securities:    
Domestic corporate debt securities$41,229 $$(3)$41,229 
Domestic corporate commercial paper24,900 — 24,905 
Agency bonds12,391 (3)12,389 
US treasury bonds12,492 — — 12,492 
Total$91,012 $$(6)$91,015 
The Company reviews marketable securities whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time. We evaluate whether the decline in fair value has resulted from credit losses or other factors. In making this assessment, we consider the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and adverse conditions specifically related to the security, among other factors. If this assessment indicates that a credit loss exists, the present value of cash flows expected to be collected from the security are compared to the amortized cost basis of the security. If the present value of cash flows expected to be collected is less than the amortized cost basis, a credit loss exists and an allowance for credit losses is recorded for the credit loss on the condensed consolidated balance sheet, limited by the amount that the fair value is less than the amortized cost basis. Any impairment that is not related to credit is recognized in other comprehensive income.
Changes in the allowance for credit losses are recorded as a provision for (or reversal of) credit loss expense on the condensed consolidated statement of operations. Losses are charged against the allowance when the Company believes the uncollectability of an available-for-sale debt security is confirmed or when either of the criteria regarding intent or requirement to sell is met. The unrealized losses at September 30, 2020 and December 31, 2019 are attributable to changes in interest rates and the Company does not believe any unrealized losses represent credit losses.
As of September 30, 2020 and December 31, 2019, the Company had 2 and 8 available-for-sale debt securities in an unrealized loss position, respectively, for which an allowance for credit losses has not been recorded. The following table summarizes such investments by major security type and length of time in a continuous unrealized loss position as of September 30, 2020 (in thousands).
Less than 12 Months12 months or longerTotal
Fair valueUnrealized lossesFair valueUnrealized lossesFair valueUnrealized losses
Available-for-sale debt securities
Domestic corporate debt securities$4,621 $(3)— — $4,621 $(3)
Domestic corporate commercial paper4,964 (5)— — 4,964 (5)
Total available-for-sale debt securities$9,585 $(8)— — $9,585 $(8)
v3.20.2
Fair Value Measurements
9 Months Ended
Sep. 30, 2020
Fair Value Disclosures [Abstract]  
Fair Value Measurements Fair Value Measurements
The Company determines the fair value of its financial instruments based upon the fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Below are the three levels of inputs that may be used to measure fair value:
Level 1—Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
Level 2—Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
Transfers into or out of any hierarchy level are recognized at the end of the reporting period in which the transfers occurred. There were no material transfers between any levels during the nine months ended September 30, 2020. There were no material transfers between any levels during 2019.
The following table summarizes the financial instruments measured at fair value on a recurring basis in the Company’s accompanying condensed consolidated balance sheets as of September 30, 2020 and December 31, 2019 (in thousands):
 As of September 30, 2020
 Level 1Level 2Level 3Total
Assets    
Cash and cash equivalents:    
Cash$55,796 $— $— $55,796 
Money market funds (1)26,034 — — 26,034 
Total$81,830 $— $— $81,830 
Marketable Securities    
Domestic corporate debt securities (2)$— $38,910 $— $38,910 
Domestic corporate commercial paper (2)— 4,963 — 4,963 
Total$— $43,873 $— $43,873 
 
 As of December 31, 2019
 Level 1Level 2Level 3Total
Assets    
Cash and cash equivalents:    
Cash$34,726 $— $— $34,726 
Money market funds (1)35,160 — — 35,160 
Total$69,886 $— $— $69,886 
Marketable Securities    
Domestic corporate debt securities (2)$— $41,229 $— $41,229 
Domestic corporate commercial paper (2)— 24,905 — 24,905 
Agency bonds (2)— 12,389 — 12,389 
US treasury bonds (2)$— $12,492 $— $12,492 
Total$— $91,015 $— $91,015 
(1)                           Fair value is based upon quoted market prices.
(2)                           Fair value is based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant assumptions are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. Inputs are obtained from various sources, including market participants, dealers and brokers.
As of September 30, 2020, the carrying amounts of the cash and cash equivalents, restricted cash, accounts receivable, prepaid expenses, other current assets, accounts payable, accrued expenses, long-term debt and operating lease liabilities approximated their estimated fair values.
v3.20.2
Inventory
9 Months Ended
Sep. 30, 2020
Inventory Disclosure [Abstract]  
Inventory InventoryInventory consisted of the following as of September 30, 2020 and December 31, 2019 (in thousands):
September 30,
2020
December 31,
2019
Raw materials$4,475 $4,093 
Work in process1,299 — 
Finished goods1,732 1,230 
Total inventories$7,506 $5,323 
Finished goods manufactured by the Company have a 36-month shelf life from date of manufacture.
v3.20.2
Convertible Notes Payable
9 Months Ended
Sep. 30, 2020
Debt Disclosure [Abstract]  
Convertible Notes Payable Convertible Notes Payable
On August 14, 2017, in a registered underwritten public offering, the Company issued $300.0 million aggregate principal amount of 3% Convertible Senior Notes due September 1, 2024 (the “Convertible Notes”). In addition, on September 12, 2017, the Company issued an additional $5.0 million principal amount of Convertible Notes pursuant to the exercise of an over-allotment option granted to the underwriters in the offering. In accordance with accounting guidance for debt with conversion and other options, the Company separately accounted for the liability component (the “Liability Component”) and embedded conversion option (the “Equity Component”) of the Convertible Notes by allocating the proceeds between the Liability Component and the Equity Component, due to the Company’s ability to settle the Convertible Notes in cash, common stock or a combination of cash and common stock, at its option. In connection with the issuance of the Convertible Notes, the Company incurred approximately $9.4 million of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees, and allocated these costs to the Liability and Equity Components based on the allocation of the proceeds. Of the total $9.4 million of debt issuance costs, $4.3 million was allocated to the Equity Component and recorded as a reduction to additional paid-in capital and $5.1 million was allocated to the Liability Component and is now recorded as a reduction of the Convertible Notes in the Company’s condensed consolidated balance sheet. The portion allocated to the Liability Component is amortized to interest expense using the effective interest method over seven years.
The Convertible Notes are senior unsecured obligations of the Company and bear interest at a rate of 3.00% per annum, payable semi-annually in arrears on March 1 and September 1. Upon conversion, the Convertible Notes will be convertible into cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s election. The Convertible Notes will be subject to redemption at the Company’s option, under certain restrictions as noted below, on or after September 1, 2021, in whole or in part, if the conditions described below are satisfied. The redemption of the Convertible Notes may also be subject to certain restrictions included in Note 7, “Term Loan and Credit Facility”. The Convertible Notes will mature on September 1, 2024, unless earlier converted, redeemed or repurchased in accordance with their terms. Subject to satisfaction of certain conditions and during the periods described below, the Convertible Notes may be converted at an initial conversion rate of 20.4891 shares of common stock per $1,000 principal amount of the Convertible Notes (equivalent to an initial conversion price of approximately $48.81 per share of common stock).
Holders of the Convertible Notes may convert all or any portion of their notes, in multiples of $1,000 principal amount, at their option at any time prior to the close of business on the business day immediately preceding June 1, 2024 only under the following circumstances:
(1)if the last reported sale price of the Company’s common stock for at least 20 trading days (whether consecutive or not) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day;
(2)during the five-business day period after any five-consecutive trading day period (the “measurement period”) in which the “trading price” per $1,000 principal amount of the Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day;
(3)if the Company calls the Convertible Notes for redemption, until the close of business on the business day immediately preceding the redemption date; or
(4)upon the occurrence of specified corporate events.
As of September 30, 2020, none of the above circumstances had occurred and, as such, the Convertible Notes were not convertible.
Prior to September 1, 2021, the Company may not redeem the Convertible Notes. On or after September 1, 2021, the Company may redeem for cash all or part of the Convertible Notes if the last reported sale price of the Company’s common stock equals or exceeds 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30-
consecutive trading day period ending within five trading days prior to the date on which the Company provides notice of the redemption. The redemption price will be the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. In addition, calling any Convertible Note for redemption will constitute a make-whole fundamental change with respect to that Convertible Note, in which case the conversion rate applicable to the conversion of that Convertible Note, if it is converted in connection with the redemption, will be increased in certain circumstances.
The initial carrying amount of the Liability Component of $166.3 million was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The allocation was performed in a manner that reflected the Company’s non-convertible debt borrowing rate for similar debt. The Equity Component of the Convertible Notes of $138.7 million was recognized as a debt discount and represents the difference between the proceeds from the issuance of the Convertible Notes of $305.0 million and the fair value of the Liability of the Convertible Notes of approximately $166.3 million on their respective dates of issuance. The excess of the principal amount of the Liability Component over its carrying amount (the “Debt Discount”) is amortized to interest expense using the effective interest method over seven years. The Equity Component is not remeasured as long as it continues to meet the conditions for equity classification. In connection with issuance of the Convertible Notes, the Company also incurred certain offering costs directly attributable to the offering. Such costs are deferred and amortized over the term of the debt to interest expense using the effective interest method.
The outstanding balances of the Convertible Notes as of September 30, 2020 consisted of the following (in thousands):
2024 Convertible Notes
Liability component:
Principal$305,000 
Less: debt discount and issuance costs, net(96,098)
Net carrying amount$208,902 
Equity component:$134,450 
The Company determined the expected life of the Convertible Notes was equal to their seven-year term. The effective interest rate on the Liability Components of the Convertible Notes for the period from the date of issuance through September 30, 2020 was 13.04%. As of September 30, 2020, the “if-converted value” did not exceed the remaining principal amount of the Convertible Notes. The fair value of the Convertible Notes are based on data from readily available pricing sources which utilize market observable inputs and other characteristics for similar types of instruments, and, therefore, the Convertible Notes are classified within Level 2 in the fair value hierarchy. The fair value of the Convertible Notes, which differs from their carrying value, is influenced by interest rates, the Company’s stock price and stock price volatility. The estimated fair value of the Convertible Notes as of September 30, 2020 was approximately $250.8 million.
The following table sets forth total interest expense recognized related to the Convertible Notes during the three and nine months ended September 30, 2020 and 2019 (in thousands):
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020201920202019
Contractual interest expense$2,288 $2,288 $6,863 $6,863 
Amortization of debt discount4,421 3,865 12,830 11,216 
Amortization of debt issuance costs165 145 480 421 
Total interest expense$6,874 $6,298 $20,173 $18,500 
Future minimum payments on the Company’s long-term debt as of September 30, 2020 are as follows (in thousands):
Years ended December 31,
Future Minimum Payments
2020$— 
20219,150 
20229,150 
20239,150 
2024314,150 
Total minimum payments
$341,600 
Less: interest
(36,600)
Less: unamortized discount
(96,098)
Less: current portion
— 
Long Term Debt
$208,902 
Term Loan and Credit Facility
On January 10, 2020, the Company and Radius Pharmaceuticals, Inc., a wholly-owned subsidiary of the Company (collectively, the “Borrowers”), entered into a (i) Credit and Security Agreement, as amended (Term Loan) (the “Term Credit Agreement”) with MidCap Financial Trust, in its capacity as administrative agent (the “Agent”) and as a lender, and the financial institutions or other entities from time to time parties thereto and (ii) Credit and Security Agreement (Revolving Loan) (the “Revolving Credit Agreement,” together with the Term Credit Agreement, the “Credit Agreements”), with the Agent, and the financial institutions or other entities from time to time parties thereto.
The Credit Agreements consist of a secured term loan facility (the “Term Facility”) in an aggregate amount of $55.0 million, which will be made available to the Borrowers under the following four tranches: (i) Tranche 1 - $10.0 million, available at closing; (ii) Tranche 2 - $15.0 million, available no earlier than June 25, 2020, but no later than December 31, 2020; (iii) Tranche 3 - $15.0 million, available no later than December 31, 2021, subject to the Company’s satisfaction of certain conditions described in the Term Credit Agreement; and (iv) Tranche 4 - $15.0 million, available no later than December 31, 2021, subject to the Company’s satisfaction of certain conditions described in the Term Credit Agreement.
The Credit Agreements also consist of a secured revolving credit facility (the “Revolving Facility”, together with the Term Facility, the “Facilities”) under which the Borrowers may borrow up to $20.0 million, the availability of which is determined based on a borrowing base as follows: (i) up to 85% of the net collectible value of the Borrowers’ domestic accounts receivable due from eligible direct and third-party payors, plus (ii) up to 40% of the Borrowers’ domestic eligible inventory, provided that the availability from eligible inventory may not exceed 20% of the total availability at any time. The Borrowers also have the right, subject to certain customary conditions, to increase the Revolving Facility by $20.0 million.
The Facilities have a maturity date of June 1, 2024. The Borrowers guarantee their obligations under the Credit Agreements. The obligations are secured by first priority liens on substantially all of the assets of the Borrowers, including, with certain exceptions, all of the capital stock of the Borrowers’ subsidiaries. On July 23, 2020, the Company entered into a Partial Release and Acknowledgement Agreement (the “Release Agreement”) with the Agent pursuant to which the Agent agreed to release the security interest on certain assets of the Company that are licensed to Berlin-Chemie AG pursuant to the license agreement between the Company and Berlin-Chemie AG.
The proceeds of the Term Facility may be used for (i) transaction fees in connection with the transactions contemplated by the Credit Agreements, (ii) the payment in full on the closing date of certain existing debt, and (iii) working capital needs and general corporate purposes of the Borrowers and their subsidiaries. The proceeds of the Revolving Facility may be used for (i) transaction fees in connection with the transactions contemplated by the Credit Agreements and (ii) working capital needs and general corporate purposes of the Borrowers and their subsidiaries.
Borrowings under the Term Facility will bear interest through maturity at a variable rate based upon the LIBOR rate plus 5.75%, subject to a LIBOR floor of 2.00%. Borrowings under the Revolving Facility will bear interest through maturity at a variable rate based upon the LIBOR rate plus 3.50%, subject to a LIBOR floor of 2.00%.
Subject to the terms and conditions set forth in the Credit Agreements, the Borrowers may be required to make certain mandatory prepayments prior to maturity.
The Credit Agreements contain affirmative and negative covenants customarily applicable to senior secured credit facilities, including covenants that, among other things, will limit or restrict the ability of the Borrowers, subject to negotiated exceptions, to incur additional indebtedness and additional liens on their assets, engage in mergers or acquisitions or dispose of assets, pay dividends or make other distributions, voluntarily prepay other indebtedness as noted above in Note 6, “Convertible Notes Payable,” enter into transactions with affiliated persons, make investments, and change the nature of their businesses. The
Credit Agreements also contain customary events of default, including subject to thresholds and grace periods, among others, payment default, covenant default, cross default to other material indebtedness, and judgment default. In addition, the Credit Agreements require the Borrowers to maintain a minimum level of net revenue, or in the case where the Borrowers fail to maintain a minimum level of net revenue, certain levels of market capitalization and unrestricted cash. As of September 30, 2020, the Company was not in violation of any covenants contained in the Credit Agreements.
As of September 30, 2020, the Company had received net proceeds of approximately $9.8 million from the Term Loan, net of fees and expenses of $0.2 million. The estimated fair value of the Term Facility as of September 30, 2020 was approximately $8.2 million. The outstanding balance of the Term Loan as of September 30, 2020 was (in thousands):
Term loan
Principal$10,000 
Less: debt issuance costs, net(59)
Net carrying amount$9,941 
The following table sets forth total interest expense recognized related to the Term Facility during the three and nine months ended September 30, 2020 (in thousands):
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020201920202019
Contractual interest expense$198 $— $573 $— 
Amortization of debt discount— — 
Total interest expense$199 $— $575 $— 
Future minimum payments on the Term Facility as of September 30, 2020 are as follows (in thousands):
Years ended December 31,
Future Minimum Payments
2020$196 
2021786 
2022786 
20237,044 
20243,611 
Total minimum payments
$12,423 
Less: interest
(2,423)
Less: unamortized issuance costs
(59)
Less: current portion
— 
Long Term Debt
$9,941 
v3.20.2
Term Loan and Credit Facility
9 Months Ended
Sep. 30, 2020
Debt Disclosure [Abstract]  
Term Loan and Credit Facility Convertible Notes Payable
On August 14, 2017, in a registered underwritten public offering, the Company issued $300.0 million aggregate principal amount of 3% Convertible Senior Notes due September 1, 2024 (the “Convertible Notes”). In addition, on September 12, 2017, the Company issued an additional $5.0 million principal amount of Convertible Notes pursuant to the exercise of an over-allotment option granted to the underwriters in the offering. In accordance with accounting guidance for debt with conversion and other options, the Company separately accounted for the liability component (the “Liability Component”) and embedded conversion option (the “Equity Component”) of the Convertible Notes by allocating the proceeds between the Liability Component and the Equity Component, due to the Company’s ability to settle the Convertible Notes in cash, common stock or a combination of cash and common stock, at its option. In connection with the issuance of the Convertible Notes, the Company incurred approximately $9.4 million of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees, and allocated these costs to the Liability and Equity Components based on the allocation of the proceeds. Of the total $9.4 million of debt issuance costs, $4.3 million was allocated to the Equity Component and recorded as a reduction to additional paid-in capital and $5.1 million was allocated to the Liability Component and is now recorded as a reduction of the Convertible Notes in the Company’s condensed consolidated balance sheet. The portion allocated to the Liability Component is amortized to interest expense using the effective interest method over seven years.
The Convertible Notes are senior unsecured obligations of the Company and bear interest at a rate of 3.00% per annum, payable semi-annually in arrears on March 1 and September 1. Upon conversion, the Convertible Notes will be convertible into cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s election. The Convertible Notes will be subject to redemption at the Company’s option, under certain restrictions as noted below, on or after September 1, 2021, in whole or in part, if the conditions described below are satisfied. The redemption of the Convertible Notes may also be subject to certain restrictions included in Note 7, “Term Loan and Credit Facility”. The Convertible Notes will mature on September 1, 2024, unless earlier converted, redeemed or repurchased in accordance with their terms. Subject to satisfaction of certain conditions and during the periods described below, the Convertible Notes may be converted at an initial conversion rate of 20.4891 shares of common stock per $1,000 principal amount of the Convertible Notes (equivalent to an initial conversion price of approximately $48.81 per share of common stock).
Holders of the Convertible Notes may convert all or any portion of their notes, in multiples of $1,000 principal amount, at their option at any time prior to the close of business on the business day immediately preceding June 1, 2024 only under the following circumstances:
(1)if the last reported sale price of the Company’s common stock for at least 20 trading days (whether consecutive or not) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day;
(2)during the five-business day period after any five-consecutive trading day period (the “measurement period”) in which the “trading price” per $1,000 principal amount of the Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day;
(3)if the Company calls the Convertible Notes for redemption, until the close of business on the business day immediately preceding the redemption date; or
(4)upon the occurrence of specified corporate events.
As of September 30, 2020, none of the above circumstances had occurred and, as such, the Convertible Notes were not convertible.
Prior to September 1, 2021, the Company may not redeem the Convertible Notes. On or after September 1, 2021, the Company may redeem for cash all or part of the Convertible Notes if the last reported sale price of the Company’s common stock equals or exceeds 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30-
consecutive trading day period ending within five trading days prior to the date on which the Company provides notice of the redemption. The redemption price will be the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. In addition, calling any Convertible Note for redemption will constitute a make-whole fundamental change with respect to that Convertible Note, in which case the conversion rate applicable to the conversion of that Convertible Note, if it is converted in connection with the redemption, will be increased in certain circumstances.
The initial carrying amount of the Liability Component of $166.3 million was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The allocation was performed in a manner that reflected the Company’s non-convertible debt borrowing rate for similar debt. The Equity Component of the Convertible Notes of $138.7 million was recognized as a debt discount and represents the difference between the proceeds from the issuance of the Convertible Notes of $305.0 million and the fair value of the Liability of the Convertible Notes of approximately $166.3 million on their respective dates of issuance. The excess of the principal amount of the Liability Component over its carrying amount (the “Debt Discount”) is amortized to interest expense using the effective interest method over seven years. The Equity Component is not remeasured as long as it continues to meet the conditions for equity classification. In connection with issuance of the Convertible Notes, the Company also incurred certain offering costs directly attributable to the offering. Such costs are deferred and amortized over the term of the debt to interest expense using the effective interest method.
The outstanding balances of the Convertible Notes as of September 30, 2020 consisted of the following (in thousands):
2024 Convertible Notes
Liability component:
Principal$305,000 
Less: debt discount and issuance costs, net(96,098)
Net carrying amount$208,902 
Equity component:$134,450 
The Company determined the expected life of the Convertible Notes was equal to their seven-year term. The effective interest rate on the Liability Components of the Convertible Notes for the period from the date of issuance through September 30, 2020 was 13.04%. As of September 30, 2020, the “if-converted value” did not exceed the remaining principal amount of the Convertible Notes. The fair value of the Convertible Notes are based on data from readily available pricing sources which utilize market observable inputs and other characteristics for similar types of instruments, and, therefore, the Convertible Notes are classified within Level 2 in the fair value hierarchy. The fair value of the Convertible Notes, which differs from their carrying value, is influenced by interest rates, the Company’s stock price and stock price volatility. The estimated fair value of the Convertible Notes as of September 30, 2020 was approximately $250.8 million.
The following table sets forth total interest expense recognized related to the Convertible Notes during the three and nine months ended September 30, 2020 and 2019 (in thousands):
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020201920202019
Contractual interest expense$2,288 $2,288 $6,863 $6,863 
Amortization of debt discount4,421 3,865 12,830 11,216 
Amortization of debt issuance costs165 145 480 421 
Total interest expense$6,874 $6,298 $20,173 $18,500 
Future minimum payments on the Company’s long-term debt as of September 30, 2020 are as follows (in thousands):
Years ended December 31,
Future Minimum Payments
2020$— 
20219,150 
20229,150 
20239,150 
2024314,150 
Total minimum payments
$341,600 
Less: interest
(36,600)
Less: unamortized discount
(96,098)
Less: current portion
— 
Long Term Debt
$208,902 
Term Loan and Credit Facility
On January 10, 2020, the Company and Radius Pharmaceuticals, Inc., a wholly-owned subsidiary of the Company (collectively, the “Borrowers”), entered into a (i) Credit and Security Agreement, as amended (Term Loan) (the “Term Credit Agreement”) with MidCap Financial Trust, in its capacity as administrative agent (the “Agent”) and as a lender, and the financial institutions or other entities from time to time parties thereto and (ii) Credit and Security Agreement (Revolving Loan) (the “Revolving Credit Agreement,” together with the Term Credit Agreement, the “Credit Agreements”), with the Agent, and the financial institutions or other entities from time to time parties thereto.
The Credit Agreements consist of a secured term loan facility (the “Term Facility”) in an aggregate amount of $55.0 million, which will be made available to the Borrowers under the following four tranches: (i) Tranche 1 - $10.0 million, available at closing; (ii) Tranche 2 - $15.0 million, available no earlier than June 25, 2020, but no later than December 31, 2020; (iii) Tranche 3 - $15.0 million, available no later than December 31, 2021, subject to the Company’s satisfaction of certain conditions described in the Term Credit Agreement; and (iv) Tranche 4 - $15.0 million, available no later than December 31, 2021, subject to the Company’s satisfaction of certain conditions described in the Term Credit Agreement.
The Credit Agreements also consist of a secured revolving credit facility (the “Revolving Facility”, together with the Term Facility, the “Facilities”) under which the Borrowers may borrow up to $20.0 million, the availability of which is determined based on a borrowing base as follows: (i) up to 85% of the net collectible value of the Borrowers’ domestic accounts receivable due from eligible direct and third-party payors, plus (ii) up to 40% of the Borrowers’ domestic eligible inventory, provided that the availability from eligible inventory may not exceed 20% of the total availability at any time. The Borrowers also have the right, subject to certain customary conditions, to increase the Revolving Facility by $20.0 million.
The Facilities have a maturity date of June 1, 2024. The Borrowers guarantee their obligations under the Credit Agreements. The obligations are secured by first priority liens on substantially all of the assets of the Borrowers, including, with certain exceptions, all of the capital stock of the Borrowers’ subsidiaries. On July 23, 2020, the Company entered into a Partial Release and Acknowledgement Agreement (the “Release Agreement”) with the Agent pursuant to which the Agent agreed to release the security interest on certain assets of the Company that are licensed to Berlin-Chemie AG pursuant to the license agreement between the Company and Berlin-Chemie AG.
The proceeds of the Term Facility may be used for (i) transaction fees in connection with the transactions contemplated by the Credit Agreements, (ii) the payment in full on the closing date of certain existing debt, and (iii) working capital needs and general corporate purposes of the Borrowers and their subsidiaries. The proceeds of the Revolving Facility may be used for (i) transaction fees in connection with the transactions contemplated by the Credit Agreements and (ii) working capital needs and general corporate purposes of the Borrowers and their subsidiaries.
Borrowings under the Term Facility will bear interest through maturity at a variable rate based upon the LIBOR rate plus 5.75%, subject to a LIBOR floor of 2.00%. Borrowings under the Revolving Facility will bear interest through maturity at a variable rate based upon the LIBOR rate plus 3.50%, subject to a LIBOR floor of 2.00%.
Subject to the terms and conditions set forth in the Credit Agreements, the Borrowers may be required to make certain mandatory prepayments prior to maturity.
The Credit Agreements contain affirmative and negative covenants customarily applicable to senior secured credit facilities, including covenants that, among other things, will limit or restrict the ability of the Borrowers, subject to negotiated exceptions, to incur additional indebtedness and additional liens on their assets, engage in mergers or acquisitions or dispose of assets, pay dividends or make other distributions, voluntarily prepay other indebtedness as noted above in Note 6, “Convertible Notes Payable,” enter into transactions with affiliated persons, make investments, and change the nature of their businesses. The
Credit Agreements also contain customary events of default, including subject to thresholds and grace periods, among others, payment default, covenant default, cross default to other material indebtedness, and judgment default. In addition, the Credit Agreements require the Borrowers to maintain a minimum level of net revenue, or in the case where the Borrowers fail to maintain a minimum level of net revenue, certain levels of market capitalization and unrestricted cash. As of September 30, 2020, the Company was not in violation of any covenants contained in the Credit Agreements.
As of September 30, 2020, the Company had received net proceeds of approximately $9.8 million from the Term Loan, net of fees and expenses of $0.2 million. The estimated fair value of the Term Facility as of September 30, 2020 was approximately $8.2 million. The outstanding balance of the Term Loan as of September 30, 2020 was (in thousands):
Term loan
Principal$10,000 
Less: debt issuance costs, net(59)
Net carrying amount$9,941 
The following table sets forth total interest expense recognized related to the Term Facility during the three and nine months ended September 30, 2020 (in thousands):
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020201920202019
Contractual interest expense$198 $— $573 $— 
Amortization of debt discount— — 
Total interest expense$199 $— $575 $— 
Future minimum payments on the Term Facility as of September 30, 2020 are as follows (in thousands):
Years ended December 31,
Future Minimum Payments
2020$196 
2021786 
2022786 
20237,044 
20243,611 
Total minimum payments
$12,423 
Less: interest
(2,423)
Less: unamortized issuance costs
(59)
Less: current portion
— 
Long Term Debt
$9,941 
v3.20.2
Net Loss Per Share
9 Months Ended
Sep. 30, 2020
Earnings Per Share [Abstract]  
Net Loss Per Share Net Loss Per Share
Basic and diluted net loss per share for the periods set forth below is calculated as follows (in thousands, except share and per share amounts):
Three Months Ended
September 30,
Nine Months Ended
September 30,
 2020201920202019
Numerator:    
Net loss$(6,289)$(30,044)$(87,823)$(108,278)
Denominator:    
Weighted-average number of common shares used in loss per share - basic and diluted46,493,126 46,141,217 46,395,124 45,975,691 
Loss per share - basic and diluted$(0.14)$(0.65)$(1.89)$(2.36)
The following potentially dilutive securities, prior to the use of the treasury stock method, have been excluded from the computation of diluted weighted-average shares outstanding, as they would be anti-dilutive. For the three and nine months ended September 30, 2020 and 2019, respectively, all of the Company’s options to purchase common stock and restricted stock units outstanding were assumed to be anti-dilutive as earnings attributable to common stockholders was in a loss position.
Three and Nine Months Ended September 30,
 20202019
Options to purchase common stock5,868,348 4,860,997 
Restricted stock units686,069 655,723 
Performance units70,000 79,000 
The Company has the option to settle the conversion obligation for the Convertible Notes in cash, shares or any combination of the two. As the Convertible Notes are not convertible as of September 30, 2020, they are not participating securities and they will not have an impact on the calculation of basic earnings or loss per share. Based on the Company’s net loss position, there is no impact on the calculation of dilutive loss per share during the three and nine-month periods ended September 30, 2020 and 2019, respectively.
v3.20.2
Product Revenue Reserves and Allowances
9 Months Ended
Sep. 30, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Product Revenue Reserves and Allowances Product Revenue Reserves and Allowances
To date, the Company’s only source of product revenue has been from the U.S. sales of TYMLOS, which it began shipping to customers in May 2017. The following table summarizes activity in each of the product revenue allowance and reserve categories for the nine months ended September 30, 2020 and 2019 (in thousands):
Chargebacks, Discounts, and FeesGovernment and other rebatesReturnsTotal
Ending balance at December 31, 2018$3,198 $7,620 $411 $11,229 
Provision related to sales in the current year21,203 44,426 698 66,327 
Adjustments related to prior period sales(27)697 — 670 
Credits and payments made(19,759)(34,190)(575)(54,524)
Ending balance at September 30, 20194,615 18,553 534 23,702 
Ending balance at December 31, 2019$5,739 $17,280 $1,583 $24,602 
Provision related to sales in the current year16,123 57,120 2,030 75,273 
Adjustments related to prior period sales(107)(1,570)— (1,677)
Credits and payments made(20,011)(50,717)(893)(71,621)
Ending balance at September 30, 2020$1,744 $22,113 $2,720 $26,577 
Chargebacks, discounts, fees, and returns are recorded as reductions of trade receivables, net on the condensed consolidated balance sheets. Government and other rebates are recorded as a component of accrued expenses and other current liabilities on the condensed consolidated balance sheets.
To date, the Company has no bad debt write-offs and the Company does not currently have credit issues with any customers. There were no credit losses associated with the Company’s trade receivables as of September 30, 2020 and 2019.
v3.20.2
License Revenue and Reimbursable Expenses
9 Months Ended
Sep. 30, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
License Revenue and Reimbursable Expenses License Revenue and Reimbursable Expenses
General
The Company has generated revenue from contracts with customers, which include upfront payments for licenses.
Berlin-Chemie
On July 23, 2020, the Company entered into a license agreement (“License Agreement”) with Berlin-Chemie under which the Company granted Berlin-Chemie an exclusive license to develop and commercialize products containing elacestrant (RAD1901) worldwide.
The Company and Berlin-Chemie simultaneously entered into a Transition Services Agreement (the “TSA”), pursuant to which the Company agreed to perform certain services for Berlin-Chemie related to the EMERALD Phase 3 monotherapy study until the earlier of the completion of the contemplated services or the filing with the FDA of a New Drug Application for elacestrant. Pursuant to the TSA, Berlin-Chemie agreed to reimburse the Company for all out-of-pocket and full-time employee costs in performing the services, for total estimated reimbursements of $111.5 million. The Company will continue to incur research and development expenses in support of scale up costs under the TSA.
Pursuant to the terms of the License Agreement, Berlin-Chemie made a nonrefundable initial license fee payment to the Company of $30.0 million in July 2020. The Company is also eligible to receive up to $20.0 million in development and regulatory milestone payments and up to $300.0 million in sales milestone payments, with such payments contingent on the achievement of specified milestones with respect to the licensed products. The Company is also eligible to receive tiered royalties on sales of licensed products at percentages ranging from low to mid-teens, subject to certain reductions. Royalties on net sales will be payable on a product-by-product and country-by-country basis until the latest of the expiration date of the last to expire of the relevant patent rights, the expiration of regulatory exclusivity, or ten years from such first commercial sale.
The License Agreement will continue on a licensed product-by-licensed product and country-by-country basis until the last to expire royalty term. Either party may terminate the License Agreement for an uncured material breach by the other party or upon the bankruptcy or insolvency of the other party. The Company may terminate the License Agreement for certain patent challenges or if no development, manufacture or commercialization activity occurs in any given 24-month period. Berlin-Chemie may terminate the License Agreement at its discretion for any reason by delivering 180 days’ prior written notice to the Company; provided that such termination will not be effective prior to the third anniversary of the effective date.
The Company determined that the License Agreement and TSA should be combined and evaluated as a single arrangement as they were executed on the same date and negotiated as a package. The arrangement with Berlin-Chemie provides for the transfer of the following goods or services: (i) license, (ii) know-how, (iii) regulatory filings, (iv) inventory, (v) transition services, including certain clinical, manufacturing, regulatory and other services associated with the Phase 3 EMERALD monotherapy study, and (vi) participation in various joint committees.
Management applied the guidance in ASC 606 to identify all distinct goods and services within the arrangement to assess whether there is a unit of account that should be accounted for under ASC 606. Management evaluated all of the promised goods or services within the contract and determined which of those were separate performance obligations. The Company determined that the license granted, at arrangement inception, should be combined with the know-how and regulatory filings as they are not capable of being distinct (the “License”). The Company also concluded that the license rights, know-how, and regulatory filings are capable of being distinct from the supply of inventory, as Berlin-Chemie would be able to benefit from the inventory on its own or with other resources that are readily available, and capable of being distinct from the transition services and participation in joint committees as these are research and development services that can typically be performed by other third parties.
The License is an element of the arrangement that is subject to the revenue recognition accounting guidance, as the performance obligation is an output of the Company’s ordinary activities in exchange for consideration. Conversely, the transition services, the participation on joint committees, and transfer of inventory are elements of the arrangements that are outside the scope of the revenue recognition guidance, as the Company is providing goods and services that are not an output of the Company’s ordinary activities.
The transaction price at inception is comprised of fixed consideration of $30.0 million. The $30.0 million upfront fee, which represents the fixed consideration in the transaction price, was allocated to the License and the supply of inventory, on a relative standalone selling price basis. The Company estimated the standalone selling price for the license by applying a risk adjusted, net present value, estimate of future potential cash flows approach and determined the standalone selling price for the inventory
using a cost approach. Accordingly, the Company has allocated $27.4 million to the license and $2.6 million to the inventory. The Company concluded that the reimbursements for the research and development transition services and participation in the joint steering committees was commensurate with the standalone selling prices of the services, and as such, will be attributed to those services. The reimbursements for these services will be recorded as a reduction of the related research and development expenses as the expenses are incurred.
Under the Berlin-Chemie agreements, the Company is eligible to receive various development and regulatory, and sales milestones. There is uncertainty that the events to obtain the development and regulatory milestones will be achieved. The Company has thus determined that all such milestones will be constrained until it is deemed probable that a significant revenue reversal will not occur. Additional transaction price recognized in future periods related to milestone payments and royalties will be allocated solely to the License.
Sales milestones and sales-based royalties were also excluded from the transaction price as the license is deemed to be the predominant item to which the sales milestones and sales-based royalties relate. The Company will recognize such revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
During the three and nine months ended September 30, 2020, the Company recognized $27.4 million of license revenue, as it had satisfied its promises under the performance obligation for the license, including the transfer of know-how and regulatory filings, by transferring them at a point in time during the quarter. During the three and nine months ended September 30, 2020, the Company recorded $15.4 million as a reduction of research and development expenses for reimbursement of transition services performed under the TSA.
v3.20.2
Commitments and Contingencies
9 Months Ended
Sep. 30, 2020
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies Commitments and Contingencies
Litigation
From time to time, the Company may become subject to legal proceedings and claims which arise in the ordinary course of its business. The Company records a liability in its condensed consolidated financial statements for these matters when a loss is known or considered probable and the amount can be reasonably estimated. The Company reviews these estimates each accounting period as additional information is known and adjusts the loss provision when appropriate. If a matter is both probable to result in a liability and the amounts of loss can be reasonably estimated, the Company estimates and discloses the possible loss or range of loss to the extent necessary to make the condensed consolidated financial statements not misleading. If the loss is not probable or cannot be reasonably estimated, a liability is not recorded in its consolidated financial statements.
As of September 30, 2020, the Company was not party to any significant litigation.
Manufacturing Agreements
In June 2016, the Company entered into a Supply Agreement with Ypsomed AG (“Ypsomed”), as amended, pursuant to which Ypsomed agreed to supply commercial and clinical supplies of a disposable pen injection device customized for subcutaneous injection of abaloparatide. The Company has agreed to purchase a minimum number of devices at prices per device that decrease with an increase in quantity supplied. In addition, the Company has agreed to make milestone payments for Ypsomed’s capital developments in connection with the initiation of the commercial supply of the device and to pay a one-time capacity fee. All costs and payments under the agreement are delineated in Swiss Francs. The agreement had an initial term of three years, which began on June 1, 2017, after which it automatically renewed for a two-year term. Following its current term, the agreement automatically renews for additional two-year terms unless either party terminates the agreement upon 18 months’ notice prior to the end of the then-current term. For the two-year term beginning May 2020, the Company is required to purchase a minimum number of batches for CHF 1.9 million (approximately $2.1 million).
In June 2016, the Company entered into a Commercial Supply Agreement with Vetter Pharma International GmbH (“Vetter”), as amended, pursuant to which Vetter agreed to formulate the finished abaloparatide-SC drug product containing abaloparatide active pharmaceutical ingredient fill cartridges with the drug product, assemble the pen delivery device, and package the pen for commercial distribution. The Company agreed to purchase the cartridges and pens in specified batch sizes at a price per unit. For labeling and packaging services, the Company agreed to pay a per unit price dependent upon the number of pens loaded with cartridges that are labeled and packaged. These prices are subject to an annual price adjustment. The agreement has an initial term of five years, which began on January 1, 2016, after which, it automatically renews for two-year terms unless either party notifies the other party two years before the end of the then-current term that it does not intend to renew.
In July 2016, the Company entered into a Manufacturing Services Agreement with Polypeptide Laboratories Holding AB (“PPL”), as amended, as successor-in-interest to Lonza Group Ltd., pursuant to which PPL agreed to manufacture the commercial and clinical supplies of abaloparatide API. The Company agreed to purchase the API in batches at a price per gram
in euros, subject to an annual increase by PPL. The agreement has an initial term of six years, which began on June 28, 2016, after which, it automatically renews for three-year terms unless either party provides notice of non-renewal 24 months before the end of the then-current term. The Company was required to purchase a minimum number of batches annually, equal to approximately €2.9 million (approximately $3.4 million) per year, subject to any annual price adjustments, during the initial term, except in calendar years 2019 and 2020. The Company was not subject to the minimum purchase requirement in 2019 and is not in 2020.
Related Party Transactions
Since December 2019, an immediate family member of Jessica Hopfield (a member of the Company’s Board of Directors) has been an executive officer of one of the Company’s customers, AmerisourceBergen Corporation (“ABC”). The activities with ABC and its affiliates are in the ordinary course of business and were primarily for commercial distribution of TYMLOS and service fees. As of September 30, 2020, the Company recognized net revenues of approximately $23.7 million in connection with product sales of TYMLOS and paid ABC and its affiliates approximately $2.0 million for services under various commercial and services agreements. In addition, no accounts receivable were recorded within the Company’s consolidated balance sheets as of September 30, 2020.
v3.20.2
Income Taxes
9 Months Ended
Sep. 30, 2020
Income Tax Disclosure [Abstract]  
Income Taxes Income TaxesThe Company did not record a federal or state income tax provision or benefit for each of the nine months ended September 30, 2020 and 2019 due to the expected loss before income taxes to be incurred for the years ended December 31, 2020 and 2019, as well as the Company’s continued maintenance of a full valuation allowance against its net deferred tax assets.
v3.20.2
Basis of Presentation and Significant Accounting Policies (Policies)
9 Months Ended
Sep. 30, 2020
Accounting Policies [Abstract]  
Basis of presentation and significant accounting policies
Basis of Presentation—The accompanying unaudited condensed consolidated financial statements and the related disclosures of the Company have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01. Accordingly, they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included.
When preparing financial statements in conformity with U.S. GAAP, the Company must make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expenses and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the nine months ended September 30, 2020 are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2020. Subsequent events have been evaluated up to the date of issuance of these financial statements. These interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes, which are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 (“2019 Form 10-K”), filed with the Securities and Exchange Commission (“SEC”) on February 27, 2020.
Significant Accounting Policies—The significant accounting policies identified in the Company’s 2019 Form 10-K that require the Company to make estimates and assumptions include: revenue recognition, inventory obsolescence, long-lived assets and intangible assets, accounting for stock-based compensation, contingencies, tax valuation reserves, fair value measures, and accrued expenses. There were no changes to significant accounting policies during the nine months ended September 30, 2020, except for the adoption of the Accounting Standards Updates (“ASU”) issued by the Financial Accounting Standards Board (“FASB”) detailed below.
Accounting standards updates, recently adopted
Accounting Standards Updates—Recently Adopted—In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). Certain amendments thereto were also issued by the FASB. ASU 2016-13 and the related amendments require that credit losses be reported using an expected losses model, representing the entity’s current estimate of credit losses expected to be incurred. The previous accounting guidance, as applied by the Company through December 31, 2019, was based on an incurred losses model. The standard replaces the incurred loss impairment methodology under current U.S. GAAP with a methodology that reflects expected credit losses and requires the use of a forward-looking expected credit loss model for accounts receivables, loans, and other financial instruments. For available-for-sale debt securities with unrealized losses, ASU 2016-13 and the related amendments now requires allowances to be recorded instead of reducing the amortized cost of the investment. These amendments under ASU 2016-13 are effective for interim and annual fiscal periods beginning after December 15, 2019. The Company adopted ASU 2016-13 as of January 1, 2020 and it did not have a material impact on the Company’s condensed consolidated financial statements.
In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement - Disclosure Framework - Changes to the Disclosure Requirement for Fair Value Measurement, or (“ASU 2018-13”). The amendments in ASU 2018-13 modify the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement, based on the concepts in the Concepts Statement, including the consideration of costs and benefits. The amendments under ASU 2018-13 are effective for interim and annual fiscal periods beginning after December 15, 2019, with early adoption permitted. The Company adopted ASU 2018-13 on January 1, 2020 and it did not have a material impact on the Company’s condensed consolidated financial statements.
In August 2018, the FASB issued ASU 2018-15, Intangible-Goodwill and Other Internal-Use Software (Subtopic 350-40) (“ASU 2018-15”). ASU 2018-15 updates guidance regarding accounting for a cloud computing arrangement that is a service contract. The amendments under ASU 2018-15 are effective for interim and annual fiscal periods beginning after December 15, 2019, with early adoption permitted. The Company adopted ASU 2018-15 on January 1, 2020 and it did not have a material impact on the Company’s condensed consolidated financial statements.
Other - In March 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was signed into law and provides an estimated $2.2 trillion to fight the COVID-19 pandemic and stimulate the economy. The business tax provisions of the CARES Act include temporary changes to income and non-income-based tax laws. Some of the key income tax provisions include eliminating the 80% of taxable income limitations by allowing corporate entities to fully utilize net operating loss (“NOL”) carryforwards to offset taxable income in 2018, 2019, or 2020 and reinstating it for tax years after 2020; allowing NOLs generated in 2018, 2019, or 2020 to be carried back five years; increasing the net interest expense deduction limit to 50% of adjusted taxable income from 30% for the 2019 and 2020 tax years; allowing taxpayers with alternative minimum tax credits to claim a refund for the entire amount of the credit instead of recovering the credit through refunds over a period of years, as required by the 2017 Tax Cut and Jobs Act; and allowing entities to deduct more of their charitable cash contributions made
during calendar year 2020 by increasing the taxable income limitation to 25% from 10%. Companies are required to account for these provisions in the period that includes the March 2020 enactment date (i.e., the first quarter for calendar year-end entities). The Company has assessed the impact of these provisions and they are not material to the Company’s condensed consolidated financial statements or related disclosures. Measures of the CARES Act not related to income-based taxes include allowing an employer to pay its share of Social Security payroll taxes that would otherwise be due from the date of enactment through December 31, 2020 over the following two years and allowing eligible employers subject to closure due to the COVID-19 pandemic to receive a 50% credit on qualified wages against their employment taxes each quarter, with any excess credits eligible for refunds. These measures of the CARES Act are also not material to the Company’s condensed consolidated financial statements as the Company did not apply for any credit during the period.
Accounting Standards Updates, Recently Issued—In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes (“ASU 2019-12”). ASU 2019-12 eliminates certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interest period and the recognition of deferred tax liabilities for outside basis differences, and also clarifies and simplifies other aspects of the accounting for income taxes. The amendments under ASU 2010-12 are effective for interim and annual fiscal periods beginning after December 15, 2020, with early adoption permitted. The Company is currently evaluating the effects the adoption of ASU 2019-12 will have on its consolidated financial statements and related disclosures.
In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”). The guidance simplifies the complexity associated with applying U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. More specifically, the amendments focus on the guidance for convertible instruments and derivative scope exception for contracts in an entity’s own equity. ASU 2020-06 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company is currently in the process of determining the effect that the adoption will have on its condensed consolidated financial statements and related disclosures.
v3.20.2
Marketable Securities (Tables)
9 Months Ended
Sep. 30, 2020
Investments, Debt and Equity Securities [Abstract]  
Schedule of available-for-sale marketable securities and cash and cash equivalents
Available-for-sale marketable securities and cash and cash equivalents as of September 30, 2020 and December 31, 2019 consisted of the following (in thousands):
 September 30, 2020
 Amortized Cost ValueGross 
Unrealized 
Gains
Gross 
Unrealized 
Losses
Fair Value
Cash and cash equivalents:    
Cash$55,796 $— $— $55,796 
Money market funds26,034 — — 26,034 
Total$81,830 $— $— $81,830 
Marketable securities:    
Domestic corporate debt securities$38,822 $91 $(3)$38,910 
Domestic corporate commercial paper4,968 — (5)4,963 
Total$43,790 $91 $(8)$43,873 
 
 December 31, 2019
 Amortized Cost ValueGross 
Unrealized 
Gains
Gross 
Unrealized 
Losses
Fair Value
Cash and cash equivalents:    
Cash$34,726 $— $— $34,726 
Money market funds35,160 — — 35,160 
Total$69,886 $— $— $69,886 
Marketable securities:    
Domestic corporate debt securities$41,229 $$(3)$41,229 
Domestic corporate commercial paper24,900 — 24,905 
Agency bonds12,391 (3)12,389 
US treasury bonds12,492 — — 12,492 
Total$91,012 $$(6)$91,015 
Schedule of debt securities, available for sale, unrealized loss position The following table summarizes such investments by major security type and length of time in a continuous unrealized loss position as of September 30, 2020 (in thousands).
Less than 12 Months12 months or longerTotal
Fair valueUnrealized lossesFair valueUnrealized lossesFair valueUnrealized losses
Available-for-sale debt securities
Domestic corporate debt securities$4,621 $(3)— — $4,621 $(3)
Domestic corporate commercial paper4,964 (5)— — 4,964 (5)
Total available-for-sale debt securities$9,585 $(8)— — $9,585 $(8)
v3.20.2
Fair Value Measurements (Tables)
9 Months Ended
Sep. 30, 2020
Fair Value Disclosures [Abstract]  
Summary of financial instruments measured at fair value on a recurring basis
The following table summarizes the financial instruments measured at fair value on a recurring basis in the Company’s accompanying condensed consolidated balance sheets as of September 30, 2020 and December 31, 2019 (in thousands):
 As of September 30, 2020
 Level 1Level 2Level 3Total
Assets    
Cash and cash equivalents:    
Cash$55,796 $— $— $55,796 
Money market funds (1)26,034 — — 26,034 
Total$81,830 $— $— $81,830 
Marketable Securities    
Domestic corporate debt securities (2)$— $38,910 $— $38,910 
Domestic corporate commercial paper (2)— 4,963 — 4,963 
Total$— $43,873 $— $43,873 
 
 As of December 31, 2019
 Level 1Level 2Level 3Total
Assets    
Cash and cash equivalents:    
Cash$34,726 $— $— $34,726 
Money market funds (1)35,160 — — 35,160 
Total$69,886 $— $— $69,886 
Marketable Securities    
Domestic corporate debt securities (2)$— $41,229 $— $41,229 
Domestic corporate commercial paper (2)— 24,905 — 24,905 
Agency bonds (2)— 12,389 — 12,389 
US treasury bonds (2)$— $12,492 $— $12,492 
Total$— $91,015 $— $91,015 
(1)                           Fair value is based upon quoted market prices.
(2)                           Fair value is based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant assumptions are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. Inputs are obtained from various sources, including market participants, dealers and brokers.
v3.20.2
Inventory (Tables)
9 Months Ended
Sep. 30, 2020
Inventory Disclosure [Abstract]  
Schedule of inventory Inventory consisted of the following as of September 30, 2020 and December 31, 2019 (in thousands):
September 30,
2020
December 31,
2019
Raw materials$4,475 $4,093 
Work in process1,299 — 
Finished goods1,732 1,230 
Total inventories$7,506 $5,323 
v3.20.2
Convertible Notes Payable (Tables)
9 Months Ended
Sep. 30, 2020
Debt Disclosure [Abstract]  
Schedule of outstanding balances of convertible notes
The outstanding balances of the Convertible Notes as of September 30, 2020 consisted of the following (in thousands):
2024 Convertible Notes
Liability component:
Principal$305,000 
Less: debt discount and issuance costs, net(96,098)
Net carrying amount$208,902 
Equity component:$134,450 
Schedule of interest expense recognized related to debt
The following table sets forth total interest expense recognized related to the Convertible Notes during the three and nine months ended September 30, 2020 and 2019 (in thousands):
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020201920202019
Contractual interest expense$2,288 $2,288 $6,863 $6,863 
Amortization of debt discount4,421 3,865 12,830 11,216 
Amortization of debt issuance costs165 145 480 421 
Total interest expense$6,874 $6,298 $20,173 $18,500 
The following table sets forth total interest expense recognized related to the Term Facility during the three and nine months ended September 30, 2020 (in thousands):
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020201920202019
Contractual interest expense$198 $— $573 $— 
Amortization of debt discount— — 
Total interest expense$199 $— $575 $— 
Schedule of future minimum payments on long-term debt Future minimum payments on the Company’s long-term debt as of September 30, 2020 are as follows (in thousands):
Years ended December 31,
Future Minimum Payments
2020$— 
20219,150 
20229,150 
20239,150 
2024314,150 
Total minimum payments
$341,600 
Less: interest
(36,600)
Less: unamortized discount
(96,098)
Less: current portion
— 
Long Term Debt
$208,902 
Future minimum payments on the Term Facility as of September 30, 2020 are as follows (in thousands):
Years ended December 31,
Future Minimum Payments
2020$196 
2021786 
2022786 
20237,044 
20243,611 
Total minimum payments
$12,423 
Less: interest
(2,423)
Less: unamortized issuance costs
(59)
Less: current portion
— 
Long Term Debt
$9,941 
v3.20.2
Term Loan and Credit Facility (Tables)
9 Months Ended
Sep. 30, 2020
Debt Disclosure [Abstract]  
Schedule of carrying values of debt instruments The outstanding balance of the Term Loan as of September 30, 2020 was (in thousands):
Term loan
Principal$10,000 
Less: debt issuance costs, net(59)
Net carrying amount$9,941 
Schedule of interest expense recognized related to debt
The following table sets forth total interest expense recognized related to the Convertible Notes during the three and nine months ended September 30, 2020 and 2019 (in thousands):
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020201920202019
Contractual interest expense$2,288 $2,288 $6,863 $6,863 
Amortization of debt discount4,421 3,865 12,830 11,216 
Amortization of debt issuance costs165 145 480 421 
Total interest expense$6,874 $6,298 $20,173 $18,500 
The following table sets forth total interest expense recognized related to the Term Facility during the three and nine months ended September 30, 2020 (in thousands):
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020201920202019
Contractual interest expense$198 $— $573 $— 
Amortization of debt discount— — 
Total interest expense$199 $— $575 $— 
Schedule of future minimum payments on long-term debt Future minimum payments on the Company’s long-term debt as of September 30, 2020 are as follows (in thousands):
Years ended December 31,
Future Minimum Payments
2020$— 
20219,150 
20229,150 
20239,150 
2024314,150 
Total minimum payments
$341,600 
Less: interest
(36,600)
Less: unamortized discount
(96,098)
Less: current portion
— 
Long Term Debt
$208,902 
Future minimum payments on the Term Facility as of September 30, 2020 are as follows (in thousands):
Years ended December 31,
Future Minimum Payments
2020$196 
2021786 
2022786 
20237,044 
20243,611 
Total minimum payments
$12,423 
Less: interest
(2,423)
Less: unamortized issuance costs
(59)
Less: current portion
— 
Long Term Debt
$9,941 
v3.20.2
Net Loss Per Share (Tables)
9 Months Ended
Sep. 30, 2020
Earnings Per Share [Abstract]  
Schedule of basic and diluted net loss per share
Basic and diluted net loss per share for the periods set forth below is calculated as follows (in thousands, except share and per share amounts):
Three Months Ended
September 30,
Nine Months Ended
September 30,
 2020201920202019
Numerator:    
Net loss$(6,289)$(30,044)$(87,823)$(108,278)
Denominator:    
Weighted-average number of common shares used in loss per share - basic and diluted46,493,126 46,141,217 46,395,124 45,975,691 
Loss per share - basic and diluted$(0.14)$(0.65)$(1.89)$(2.36)
Schedule of potentially dilutive securities excluded from the computation of diluted weighted-average shares outstanding
The following potentially dilutive securities, prior to the use of the treasury stock method, have been excluded from the computation of diluted weighted-average shares outstanding, as they would be anti-dilutive. For the three and nine months ended September 30, 2020 and 2019, respectively, all of the Company’s options to purchase common stock and restricted stock units outstanding were assumed to be anti-dilutive as earnings attributable to common stockholders was in a loss position.
Three and Nine Months Ended September 30,
 20202019
Options to purchase common stock5,868,348 4,860,997 
Restricted stock units686,069 655,723 
Performance units70,000 79,000 
v3.20.2
Product Revenue Reserves and Allowances (Tables)
9 Months Ended
Sep. 30, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Schedule of product revenue allowance and reserve categories The following table summarizes activity in each of the product revenue allowance and reserve categories for the nine months ended September 30, 2020 and 2019 (in thousands):
Chargebacks, Discounts, and FeesGovernment and other rebatesReturnsTotal
Ending balance at December 31, 2018$3,198 $7,620 $411 $11,229 
Provision related to sales in the current year21,203 44,426 698 66,327 
Adjustments related to prior period sales(27)697 — 670 
Credits and payments made(19,759)(34,190)(575)(54,524)
Ending balance at September 30, 20194,615 18,553 534 23,702 
Ending balance at December 31, 2019$5,739 $17,280 $1,583 $24,602 
Provision related to sales in the current year16,123 57,120 2,030 75,273 
Adjustments related to prior period sales(107)(1,570)— (1,677)
Credits and payments made(20,011)(50,717)(893)(71,621)
Ending balance at September 30, 2020$1,744 $22,113 $2,720 $26,577 
v3.20.2
Organization (Details) - USD ($)
$ in Thousands
Sep. 30, 2020
Dec. 31, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Accumulated deficit $ (1,324,437) $ (1,236,614)
Cash, cash equivalents, marketable securities, and investments $ 125,700  
v3.20.2
Marketable Securities - Schedule of Available-for-sale Marketable Securities and Cash and Cash Equivalents (Details) - USD ($)
$ in Thousands
Sep. 30, 2020
Dec. 31, 2019
Cash and cash equivalents:    
Amortized Cost Value $ 81,830 $ 69,886
Fair Value 81,830 69,886
Marketable securities:    
Amortized Cost Value 43,790 91,012
Gross  Unrealized  Gains 91 9
Gross  Unrealized  Losses (8) (6)
Fair Value 43,873 91,015
Cash    
Cash and cash equivalents:    
Amortized Cost Value 55,796 34,726
Fair Value 55,796 34,726
Money market funds    
Cash and cash equivalents:    
Amortized Cost Value 26,034 35,160
Fair Value 26,034 35,160
Domestic corporate debt securities    
Marketable securities:    
Amortized Cost Value 38,822 41,229
Gross  Unrealized  Gains 91 3
Gross  Unrealized  Losses (3) (3)
Fair Value 38,910 41,229
Domestic corporate commercial paper    
Marketable securities:    
Amortized Cost Value 4,968 24,900
Gross  Unrealized  Gains 0 5
Gross  Unrealized  Losses (5) 0
Fair Value $ 4,963 24,905
Agency bonds    
Marketable securities:    
Amortized Cost Value   12,391
Gross  Unrealized  Gains   1
Gross  Unrealized  Losses   (3)
Fair Value   12,389
US treasury bonds    
Marketable securities:    
Amortized Cost Value   12,492
Gross  Unrealized  Gains   0
Gross  Unrealized  Losses   0
Fair Value   $ 12,492
v3.20.2
Marketable Securities - Narrative (Details) - security
Sep. 30, 2020
Dec. 31, 2019
Investments, Debt and Equity Securities [Abstract]    
Debt securities held in an unrealized loss position for less than 12 months 2 8
v3.20.2
Marketable Securities - Schedule of Debt Securities in an Unrealized Loss Position (Details)
$ in Thousands
Sep. 30, 2020
USD ($)
Debt Securities, Available-for-sale, Unrealized Loss Position [Line Items]  
Debt securities, available for sale, in an unrealized loss positon for less than 12 months, fair value $ 9,585
Debt securities, available for sale, held in an unrealized loss position for less than 12 months, unrealized losses (8)
Debt securities, available for sale, held in an unrealized loss position for more than 12 months, fair value 0
Debt securities, available for sale, held in an unrealized loss position for more than 12 months, unrealized losses 0
Debt securities, available for sale, unrealized loss position, fair value 9,585
Debt securities, available for sale, unrealized loss position, unrealized losses (8)
Domestic corporate debt securities  
Debt Securities, Available-for-sale, Unrealized Loss Position [Line Items]  
Debt securities, available for sale, in an unrealized loss positon for less than 12 months, fair value 4,621
Debt securities, available for sale, held in an unrealized loss position for less than 12 months, unrealized losses (3)
Debt securities, available for sale, held in an unrealized loss position for more than 12 months, fair value 0
Debt securities, available for sale, held in an unrealized loss position for more than 12 months, unrealized losses 0
Debt securities, available for sale, unrealized loss position, fair value 4,621
Debt securities, available for sale, unrealized loss position, unrealized losses (3)
Domestic corporate commercial paper  
Debt Securities, Available-for-sale, Unrealized Loss Position [Line Items]  
Debt securities, available for sale, in an unrealized loss positon for less than 12 months, fair value 4,964
Debt securities, available for sale, held in an unrealized loss position for less than 12 months, unrealized losses (5)
Debt securities, available for sale, held in an unrealized loss position for more than 12 months, fair value 0
Debt securities, available for sale, held in an unrealized loss position for more than 12 months, unrealized losses 0
Debt securities, available for sale, unrealized loss position, fair value 4,964
Debt securities, available for sale, unrealized loss position, unrealized losses $ (5)
v3.20.2
Fair Value Measurements (Details) - USD ($)
$ in Thousands
Sep. 30, 2020
Dec. 31, 2019
Assets    
Cash and cash equivalents $ 81,830 $ 69,886
Marketable Securities 43,873 91,015
Cash    
Assets    
Cash and cash equivalents 55,796 34,726
Money market funds    
Assets    
Cash and cash equivalents 26,034 35,160
Domestic corporate debt securities    
Assets    
Marketable Securities 38,910 41,229
Domestic corporate commercial paper    
Assets    
Marketable Securities 4,963 24,905
Agency bonds    
Assets    
Marketable Securities   12,389
US treasury bonds    
Assets    
Marketable Securities   12,492
Recurring basis    
Assets    
Cash and cash equivalents 81,830 69,886
Marketable Securities 43,873 91,015
Recurring basis | Cash    
Assets    
Cash and cash equivalents 55,796 34,726
Recurring basis | Money market funds    
Assets    
Cash and cash equivalents 26,034 35,160
Recurring basis | Domestic corporate debt securities    
Assets    
Marketable Securities 38,910 41,229
Recurring basis | Domestic corporate commercial paper    
Assets    
Marketable Securities 4,963 24,905
Recurring basis | Agency bonds    
Assets    
Marketable Securities   12,389
Recurring basis | US treasury bonds    
Assets    
Marketable Securities   12,492
Recurring basis | Level 1    
Assets    
Cash and cash equivalents 81,830 69,886
Marketable Securities 0 0
Recurring basis | Level 1 | Cash    
Assets    
Cash and cash equivalents 55,796 34,726
Recurring basis | Level 1 | Money market funds    
Assets    
Cash and cash equivalents 26,034 35,160
Recurring basis | Level 1 | Domestic corporate debt securities    
Assets    
Marketable Securities 0 0
Recurring basis | Level 1 | Domestic corporate commercial paper    
Assets    
Marketable Securities 0 0
Recurring basis | Level 1 | Agency bonds    
Assets    
Marketable Securities   0
Recurring basis | Level 1 | US treasury bonds    
Assets    
Marketable Securities   0
Recurring basis | Level 2    
Assets    
Cash and cash equivalents 0 0
Marketable Securities 43,873 91,015
Recurring basis | Level 2 | Cash    
Assets    
Cash and cash equivalents 0 0
Recurring basis | Level 2 | Money market funds    
Assets    
Cash and cash equivalents 0 0
Recurring basis | Level 2 | Domestic corporate debt securities    
Assets    
Marketable Securities 38,910 41,229
Recurring basis | Level 2 | Domestic corporate commercial paper    
Assets    
Marketable Securities 4,963 24,905
Recurring basis | Level 2 | Agency bonds    
Assets    
Marketable Securities   12,389
Recurring basis | Level 2 | US treasury bonds    
Assets    
Marketable Securities   12,492
Recurring basis | Level 3    
Assets    
Cash and cash equivalents 0 0
Marketable Securities 0 0
Recurring basis | Level 3 | Cash    
Assets    
Cash and cash equivalents 0 0
Recurring basis | Level 3 | Money market funds    
Assets    
Cash and cash equivalents 0 0
Recurring basis | Level 3 | Domestic corporate debt securities    
Assets    
Marketable Securities 0 0
Recurring basis | Level 3 | Domestic corporate commercial paper    
Assets    
Marketable Securities $ 0 0
Recurring basis | Level 3 | Agency bonds    
Assets    
Marketable Securities   0
Recurring basis | Level 3 | US treasury bonds    
Assets    
Marketable Securities   $ 0
v3.20.2
Inventory (Details) - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2020
Dec. 31, 2019
Inventory Disclosure [Abstract]    
Raw materials $ 4,475 $ 4,093
Work in process 1,299 0
Finished goods 1,732 1,230
Total inventories $ 7,506 $ 5,323
Finished goods shelf life 36 months  
v3.20.2
Convertible Notes Payable - Narrative (Details) - Convertible debt - 3.00% Convertible notes
1 Months Ended
Sep. 12, 2017
USD ($)
day
business_day
$ / shares
Sep. 30, 2020
USD ($)
Sep. 17, 2019
USD ($)
Aug. 14, 2017
USD ($)
Debt Instrument [Line Items]        
Aggregate principal amount $ 5,000,000.0     $ 300,000,000.0
Debt instrument stated rate 3.00%     3.00%
Debt issuance costs $ 9,400,000      
Debt instrument term 7 years      
Conversion ratio 0.0204891      
Initial conversion price (in dollars per share) | $ / shares $ 48.81      
Initial carrying amount   $ 208,902,000 $ 166,300,000  
Equity component   134,450,000 138,700,000  
Proceeds from the issuance of debt   $ 305,000,000 $ 305,000,000.0  
Debt discount, remaining discount amortization period 7 years      
Effective interest rate   13.04%    
Estimated fair value   $ 250,800,000    
Stock price trigger at greater than or equal to 130%        
Debt Instrument [Line Items]        
Consecutive or non-consecutive trading days 20 days      
Consecutive trading days | day 30      
Percentage of stock price trigger 130.00%      
Stock price trigger less than 98%        
Debt Instrument [Line Items]        
Consecutive trading days | day 5      
Percentage of stock price trigger 98.00%      
Trading days | business_day 5      
Stock price trigger at greater than or equal to 130%, on or after September 1, 2021        
Debt Instrument [Line Items]        
Consecutive or non-consecutive trading days 20 days      
Consecutive trading days | day 30      
Percentage of stock price trigger 130.00%      
Consecutive trading days, redemption notice period | day 5      
Additional Paid-In Capital        
Debt Instrument [Line Items]        
Debt issuance costs $ 4,300,000      
Convertible notes        
Debt Instrument [Line Items]        
Debt issuance costs $ 5,100,000      
v3.20.2
Convertible Notes Payable - Summary of Outstanding Balances of Convertible Notes (Details) - Convertible debt - 3.00% Convertible notes - USD ($)
$ in Thousands
Sep. 30, 2020
Sep. 17, 2019
Debt Instrument [Line Items]    
Principal $ 305,000 $ 305,000
Less: debt discount and issuance costs, net (96,098)  
Net carrying amount 208,902 166,300
Equity component $ 134,450 $ 138,700
v3.20.2
Convertible Notes Payable - Summary of Total Interest Expense Recognized Related to the Convertible Notes (Details) - Convertible debt - 3.00% Convertible notes - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2020
Sep. 30, 2019
Sep. 30, 2020
Sep. 30, 2019
Debt Instrument [Line Items]        
Contractual interest expense $ 2,288 $ 2,288 $ 6,863 $ 6,863
Amortization of debt discount 4,421 3,865 12,830 11,216
Amortization of debt issuance costs 165 145 480 421
Total interest expense $ 6,874 $ 6,298 $ 20,173 $ 18,500
v3.20.2
Convertible Notes Payable - Schedule of Future Minimum Payments on Long-Term Debt (Details) - Convertible debt - 3.00% Convertible notes - USD ($)
$ in Thousands
Sep. 30, 2020
Sep. 17, 2019
Future Minimum Payments    
2020 $ 0  
2021 9,150  
2022 9,150  
2023 9,150  
2024 314,150  
Total minimum payments 341,600  
Less: interest (36,600)  
Less: unamortized discount (96,098)  
Less: current portion 0  
Net carrying amount $ 208,902 $ 166,300
v3.20.2
Term Loan and Credit Facility - Narrative (Details) - USD ($)
9 Months Ended
Jan. 10, 2020
Sep. 30, 2020
Medium-term Notes | Term Facility    
Debt Instrument [Line Items]    
Aggregate principal amount $ 55,000,000.0  
Debt instrument, LIBOR floor 2.00%  
Medium-term Notes | Term Facility | London Interbank Offered Rate (LIBOR)    
Debt Instrument [Line Items]    
Basis spread (as a percent) 5.75%  
Medium-term Notes | Term Facility | Debt Instrument, Tranche One    
Debt Instrument [Line Items]    
Aggregate principal amount $ 10,000,000.0 $ 10,000,000
Proceeds from issuance of long-term debt   9,800,000
Debt issuance costs   200,000
Estimated fair value   $ 8,200,000
Medium-term Notes | Term Facility | Debt Instrument, Tranche Two    
Debt Instrument [Line Items]    
Aggregate principal amount 15,000,000.0  
Medium-term Notes | Term Facility | Debt Instrument, Tranche Three    
Debt Instrument [Line Items]    
Aggregate principal amount 15,000,000.0  
Medium-term Notes | Term Facility | Debt Instrument, Tranche Four    
Debt Instrument [Line Items]    
Aggregate principal amount 15,000,000.0  
Line of Credit | Revolving Credit Facility    
Debt Instrument [Line Items]    
Maximum borrowing capacity $ 20,000,000.0  
Debt instrument, covenant, percent net collectible value of accounts receivable 85.00%  
Debt instrument, covenant, percent of eligible inventory 40.00%  
Debt instrument, covenant, inventory percentage of availability 20.00%  
Potential increase in maximum borrowing capacity $ 20,000,000.0  
Debt instrument, LIBOR floor 2.00%  
Line of Credit | Revolving Credit Facility | London Interbank Offered Rate (LIBOR)    
Debt Instrument [Line Items]    
Basis spread (as a percent) 3.50%  
v3.20.2
Term Loan and Credit Facility - Carrying Value (Details) - Medium-term Notes - Term Facility - USD ($)
Sep. 30, 2020
Jan. 10, 2020
Debt Instrument [Line Items]    
Principal   $ 55,000,000.0
Debt Instrument, Tranche One    
Debt Instrument [Line Items]    
Principal $ 10,000,000 $ 10,000,000.0
Less: debt issuance costs, net (59,000)  
Net carrying amount $ 9,941,000  
v3.20.2
Term Loan and Credit Facility - Interest Expense (Details) - Debt Instrument, Tranche One - Medium-term Notes - Term Facility - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2020
Sep. 30, 2019
Sep. 30, 2020
Sep. 30, 2019
Debt Instrument [Line Items]        
Contractual interest expense $ 198 $ 0 $ 573 $ 0
Amortization of debt discount 1 0 2 0
Total interest expense $ 199 $ 0 $ 575 $ 0
v3.20.2
Term Loan and Credit Facility - Future Minimum Payments (Details) - Debt Instrument, Tranche One - Medium-term Notes - Term Facility
$ in Thousands
Sep. 30, 2020
USD ($)
Debt Instrument [Line Items]  
2020 $ 196
2021 786
2022 786
2023 7,044
2024 3,611
Total minimum payments 12,423
Less: interest (2,423)
Less: unamortized issuance costs (59)
Less: current portion 0
Net carrying amount $ 9,941
v3.20.2
Net Loss Per Share - Basic and Diluted (Details) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2020
Sep. 30, 2019
Sep. 30, 2020
Sep. 30, 2019
Numerator:        
Net loss $ (6,289) $ (30,044) $ (87,823) $ (108,278)
Denominator:        
Weighted-average number of common shares used in loss per share - basic and diluted (in shares) 46,493,126 46,141,217 46,395,124 45,975,691
Loss per share - basic and diluted (in dollars per share) $ (0.14) $ (0.65) $ (1.89) $ (2.36)
v3.20.2
Net Loss Per Share - Antidilutive Securities (Details) - shares
3 Months Ended 9 Months Ended
Sep. 30, 2020
Sep. 30, 2019
Sep. 30, 2020
Sep. 30, 2019
Options to purchase common stock        
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Potentially dilutive securities, prior to the use of the treasury stock method, excluded from the computation of diluted weighted-average shares outstanding, as they would be anti-dilutive (in shares) 5,868,348 4,860,997 5,868,348 4,860,997
Restricted stock units        
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Potentially dilutive securities, prior to the use of the treasury stock method, excluded from the computation of diluted weighted-average shares outstanding, as they would be anti-dilutive (in shares) 686,069 655,723 686,069 655,723
Performance units        
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Potentially dilutive securities, prior to the use of the treasury stock method, excluded from the computation of diluted weighted-average shares outstanding, as they would be anti-dilutive (in shares) 70,000 79,000 70,000 79,000
v3.20.2
Product Revenue Reserves and Allowances (Details) - USD ($)
9 Months Ended
Sep. 30, 2020
Sep. 30, 2019
Summary of Activity of Product Revenue Allowance and Reserves    
Bad debt write-offs $ 0 $ 0
Trade receivables, credit losses 0 0
Product Revenue Allowance and Reserves    
Summary of Activity of Product Revenue Allowance and Reserves    
Beginning balance 24,602,000 11,229,000
Provision related to sales in the current year 75,273,000 66,327,000
Adjustments related to prior period sales (1,677,000) 670,000
Credits and payments made (71,621,000) (54,524,000)
Ending balance 26,577,000 23,702,000
Chargebacks, Discounts, and Fees    
Summary of Activity of Product Revenue Allowance and Reserves    
Beginning balance 5,739,000 3,198,000
Provision related to sales in the current year 16,123,000 21,203,000
Adjustments related to prior period sales (107,000) (27,000)
Credits and payments made (20,011,000) (19,759,000)
Ending balance 1,744,000 4,615,000
Government and other rebates    
Summary of Activity of Product Revenue Allowance and Reserves    
Beginning balance 17,280,000 7,620,000
Provision related to sales in the current year 57,120,000 44,426,000
Adjustments related to prior period sales (1,570,000) 697,000
Credits and payments made (50,717,000) (34,190,000)
Ending balance 22,113,000 18,553,000
Returns    
Summary of Activity of Product Revenue Allowance and Reserves    
Beginning balance 1,583,000 411,000
Provision related to sales in the current year 2,030,000 698,000
Adjustments related to prior period sales 0 0
Credits and payments made (893,000) (575,000)
Ending balance $ 2,720,000 $ 534,000
v3.20.2
License Revenue and Reimbursable Expenses (Details) - USD ($)
3 Months Ended 9 Months Ended
Jul. 23, 2020
Sep. 30, 2020
Sep. 30, 2019
Sep. 30, 2020
Sep. 30, 2019
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]          
License revenue   $ 77,826,000 $ 46,766,000 $ 175,862,000 $ 117,652,000
Reimbursable expenses   15,400,000 0 15,400,000 0
License revenue          
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]          
License revenue   $ 27,414,000 $ 0 $ 27,414,000 $ 0
Menarini Group          
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]          
Reimbursement of cost $ 111,500,000        
License fee 30,000,000.0        
Upfront payment received 30,000,000.0        
License 27,400,000        
Inventory 2,600,000        
Menarini Group | Maximum          
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]          
Development and regulatory milestone payments receivable 20,000,000.0        
Sales milestone payments receivable $ 300,000,000.0        
v3.20.2
Commitments and Contingencies - Manufacturing Agreements (Details)
€ in Millions, SFr in Millions, $ in Millions
1 Months Ended 9 Months Ended
May 31, 2020
CHF (SFr)
May 31, 2020
USD ($)
Jul. 31, 2016
USD ($)
Jul. 31, 2016
EUR (€)
Jun. 30, 2016
Sep. 30, 2020
USD ($)
Affiliated Entity            
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Revenue from related parties           $ 23.7
Due to related parties           $ 2.0
Ypsomed Supply Agreement            
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Services agreement, term         3 years  
Services agreement, renewal term         2 years  
Services agreement, additional renewal term         2 years  
Service agreement, period required for notice of non-renewal         18 months  
Total minimum payments inclusive of milestone payments and one-time capacity fee SFr 1.9 $ 2.1        
Vetter Supply Agreement            
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Services agreement, term         5 years  
Services agreement, renewal term         2 years  
Service agreement, period required for notice of non-renewal         2 years  
Lonza Agreement            
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]            
Services agreement, term     6 years 6 years    
Services agreement, renewal term     3 years 3 years    
Service agreement, period required for notice of non-renewal     24 months 24 months    
Annual minimum batches     $ 3.4 € 2.9