UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

  

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported) March 23, 2020

 

Hoth Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

  

Nevada   001-38803   82-1553794
(State or other jurisdiction
of incorporation)
  (Commission File Number)   (I. R. S. Employer
Identification No.)

 

1 Rockefeller Plaza, Suite 1039  
New York, New York 10020  
(Address of principal executive offices, including ZIP code)  
   
(646) 756-2997  
(Registrant’s telephone number, including area code)  
   
Not Applicable  
(Former name or former address, if changed since last report)  

  

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

  

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common stock, $0.0001 par value   HOTH   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company   ☒

 

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.   ☐

 

 

 

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Item 1.01 Entry into a Material Definitive Agreement.

 

On March 23, 2020, Hoth Therapeutics, Inc. (the “Company”) entered into a Royalty and Development Agreement (the “Voltron Agreement”) with Voltron Therapeutics, Inc. (“Voltron”), to form a joint venture entity, named HaloVax, LLC (“HaloVax”), to jointly develop potential product candidates for the prevention of the Coronavirus (COVID-19) based upon certain technology that had been exclusively licensed by Voltron from The General Hospital Corporation (d/b/a Massachusetts General Hospital). Pursuant to the Voltron Agreement, the Company shall be granted the right to receive sales-based royalties at low single digit percentages. The Voltron Agreement shall continue until the earlier of (i) the approval of a New Drug Application (or its equivalent) for the Licensed Products (as defined in the Voltron Agreement) by the United States Federal Drug Administration, (ii) cessation of development of Licensed Products (iii) the sale of license of Licensed Products to a third party, and (iii) mutual consent of the parties, at which time the joint development committee to be formed pursuant to the terms of the Voltron Agreement shall be disbanded. The Voltron Agreement may be terminated by either the Company or Voltron in the event of (i) a breach of any material term of the Voltron Agreement that is not cured within 90 days, subject to certain exceptions or (ii) the commencement by or against either party of any bankruptcy, insolvency or reorganization proceeding which has not been dismissed within 90 days after commencement.

 

In addition, pursuant to the terms of the Voltron Agreement, on March 23, 2020, the Company and HaloVax entered into a Membership Interest Purchase Agreement (the “Purchase Agreement”) pursuant to which the Company shall purchase 5% of HaloVax’s outstanding membership interests for $250,000 on or prior to May 23, 2020 (the “Initial Closing Date”) and shall have the option to purchase up to an additional 25% of HaloVax’s membership interests (for $3,000,000 (inclusive of the $250,000), which option shall expire 30 days after the Initial Closing Date.

 

The foregoing summaries of the Voltron Agreement and Purchase Agreement do not purport to be complete and are qualified in their entirety by reference to the Voltron Agreement and Purchase Agreement which are filed as Exhibits 10.1 and 10.2, respectively, to this Current Report on Form 8-K and are hereby incorporated by reference.

 

Voltron is owned by Majella Partners, LLC (“Majella”) which is owned 50% by STAQ Partners LLC (“STAQ”). Matthew Eitner, the Chief Executive Officer of Laidlaw & Company (UK) Ltd. (“Laidlaw”), and James Ahern, the Head of Capital Markets of Laidlaw, are members of STAQ, owning 76% of the membership interests in STAQ.  In addition, Matthew Eitner is the Managing Member of Majella. The board of directors of Voltron is composed of Matthew Eitner and Patrick Gallagher, Senior Managing Director Head of Institutional Sales of Laidlaw and Chief Executive Officer of Voltron. Laidlaw has been compensated in the past by Voltron for services provided as a financial advisor to Voltron. Laidlaw did not receive any remuneration in connection with the Voltron Agreement. 

 

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Item 8.01 Other Events.

 

On March 23, 2020, the Company issued a press release announcing the execution of the Voltron Agreement and Purchase Agreement. The Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

Risk Factors

 

The Company is supplementing or amending the risk factors previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2019, as applicable, with the following risk factors:

 

Risks Related to Our Business 

 

Our business may be adversely affected by the ongoing coronavirus pandemic.

 

The outbreak of the novel Coronavirus (COVID-19) has evolved into a global pandemic. The coronavirus has spread to many regions of the world. The extent to which the coronavirus impacts our business and operating results will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning the coronavirus and the actions to contain the coronavirus or treat its impact, among others.

Should the coronavirus continue to spread, our business operations could be delayed or interrupted. For instance, our clinical trials may be affected by the pandemic. Site initiation, participant recruitment and enrollment, participant dosing, distribution of clinical trial materials, study monitoring and data analysis may be paused or delayed due to changes in hospital or university policies, federal, state or local regulations, prioritization of hospital resources toward pandemic efforts, or other reasons related to the pandemic. If the coronavirus continues to spread, some participants and clinical investigators may not be able to comply with clinical trial protocols. For example, quarantines or other travel limitations (whether voluntary or required) may impede participant movement, affect sponsor access to study sites, or interrupt healthcare services, and we may be unable to conduct our clinical trials. Further, if the spread of the coronavirus pandemic continues and our operations are adversely impacted, we risk a delay, default and/or nonperformance under existing agreements which may increase our costs. These cost increases may not be fully recoverable or adequately covered by insurance. 

 

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Infections and deaths related to the pandemic may disrupt the United States’ healthcare and healthcare regulatory systems. Such disruptions could divert healthcare resources away from, or materially delay FDA review and/or approval with respect to, our clinical trials. 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.

We currently utilize third parties to, among other things, manufacture raw materials. If either any third-party parties in the supply chain for materials used in the production of our product candidates are adversely impacted by restrictions resulting from the coronavirus outbreak, our supply chain may be disrupted, limiting our ability to manufacture our product candidates for our clinical trials and research and development operations.

In the event of a shelter-in-place order or other mandated local travel restrictions, our employees conducting research and development or manufacturing activities may not be able to access their laboratory or manufacturing space, and our core activities may be significantly limited or curtailed, possibly for an extended period of time.

The spread of the coronavirus, which has caused a broad impact globally, including restrictions on travel and quarantine policies put into place by businesses and governments, may have a material economic effect on our business. While the potential economic impact brought by and the duration of the pandemic may be difficult to assess or predict, it has already caused, and is likely to result in further, significant disruption of global financial markets, which may reduce our ability to access capital either at all or on favorable terms. In addition, a recession, depression or other sustained adverse market event resulting from the spread of the coronavirus could materially and adversely affect our business and the value of our common stock.

The ultimate impact of the current pandemic, or any other health epidemic, is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole. However, these effects could have a material impact on our operations, and we will continue to monitor the situation closely.

 

Risks Relating to Our Joint Venture Agreement

If our joint venture with HaloVax is not successful or if we fail to realize the benefits we anticipate from such joint venture, we may not be able to capitalize on the full market potential of our potential products .

On March 23, 2020, we entered into the Voltron Agreement to form a joint venture entity named HaloVax to jointly develop potential product candidates for the prevention of the Coronavirus (COVID-19) based upon certain technology that had been exclusively licensed by Voltron from The General Hospital Corporation (d/b/a Massachusetts General Hospital). Pursuant to the terms of the Voltron Agreement we are entitled to receive sales-based royalties at low single digit percentages. In addition, pursuant to the Membership Interest Purchase Agreement with HaloVax we are required to acquire 5% of HaloVax for an aggregate purchase price of $250,000 and have the option to purchase up to an additional 25% of HaloVax’s membership interests. Furthermore, we shall contribute proceeds of the development of products to prevent the Coronavirus (COVID-19). If and to the extent we and HaloVax are unable to develop potential product candidates for the prevention of the Coronavirus (COVID-19), we will not be entitled to any sale-based royalties the value of our ownership interest in HaloVax could decline in which case we may lose all or part of our investment in HaloVax.

 

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While Voltron has agreed to cooperate and use commercially reasonable efforts to exchange information and resources that will lead to the development activities, and has agreed to establish a Joint Development Committee consisting of seven members, two of which are to be selected by us, to plan, review, coordinate and oversee the performance of the development activities and timelines with respect to development activities, we have limited contractual rights to direct its activities. Moreover, we will not have any other control with respect to the operations of HaloVax. Therefore, HaloVax will have a greater influence with respect to its commercialization efforts and other operations. In general, our joint venture with HaloVax subjects us to a number of related risks including that:

Risks Related to Product Development, Regulatory Approval, Manufacturing and Commercialization

 

Although we have entered into the Voltron Agreement pursuant to which we and HaloVax intend to jointly develop products to prevent, Coronavirus (COVID-19), no assurance can be given as to when, if ever, we will be able to develop any products for such purpose and if developed that such products will be successfully commercialized.

 

On March 23, 2020, we entered into the Voltron Agreement pursuant to which we and HaloVax will work to jointly develop potential product candidates to prevent Coronavirus (COVID-19); however, no assurance can be given as to when, if ever, we will be able to develop any products for such purpose. Furthermore, we are subject to risks including, but not limited to, the following with respect to the development of a treatment for Coronavirus (COVID-19):

 

  the marketing approval process of the FDA is lengthy, time consuming and inherently unpredictable, and we cannot guarantee that we will ever have a marketable product;

 

  we may encounter substantial delays in completing our clinical studies which in turn will require additional costs, or we may fail to demonstrate adequate safety and efficacy to the satisfaction of applicable regulatory authorities;

  

  conducting successful clinical studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit;

 

  to the extent that there are additional treatments available for Coronavirus (COVID-19), to be commercially successful, physicians must be persuaded that using our products are effective alternatives to other existing therapies and treatments;

 

  we may depend on third parties for manufacturing our proposed product candidates and any conflicts with such partners could delay or prevent the development or commercialization of such product candidates;

 

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  if third-party contract manufacturers upon whom we rely to formulate and manufacture our product candidates do not perform, fail to manufacture according to our specifications or fail to comply with strict regulations, our clinical studies could be adversely affected and the development of our product candidates could be delayed or terminated or we could incur significant additional expenses;

 

  adverse events involving our products may lead the FDA to delay or deny clearance for our products or result in product recalls that could harm our reputation, business and financial results; and

 

  if we fail to comply with healthcare regulations, we could face substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be adversely affected.

 

We depend upon the success of the BioLexa Platform, which has not yet demonstrated efficacy in Phase 2 clinical trials, as well as our other licensed products and technologies. If we are unable to generate revenues from the BioLexa Platform or our other licensed products and technologies, our ability to create stockholder value will be limited.

 

We intend to conduct our first Phase 1 study in healthy adults with an immediate transition to a randomized, vehicle controlled Phase 1b trial in adolescent eczema patients comparing BioLexa to the base vehicle. Following our Phase 1b trial, we intend to conduct up to two Phase 2 trials in atopic dermatitis patients comparing BioLexa to the base vehicle. We expect the clinical program to be completed, subject to receipt of funding by us, by the end of 2020 or early 2021 with an NDA submission targeted for mid to late 2021.

 

In addition, we have licensed a genetic marker for food allergies, products and technology for therapeutic uses related to lupus in human beings, patents related to an exon skipping approach for treating allergic diseases and patents related to aprepitant which is used to treat side effects from drugs used for the treatment of cancer.  Furthermore, we formed a joint venture entity, HaloVax, with Voltron to commence preclinical studies for the development of vaccine prospects for Coronavirus (COVID-19) based upon VaxCelerate, a self-assembling vaccine platform exclusively licensed by Voltron from the Vaccine and Immunotherapy Center (VIC) at Mass Gen. We do not generate revenues from any drug products. We may not be successful in obtaining acceptance from the regulatory authorities to start our clinical trials. If we do not obtain such acceptance, the time in which we expect to commence clinical programs for any product candidate will be extended and such extension will increase our expenses and increase our need for additional capital. Moreover, there is no guarantee that our clinical trials will be successful or that we will continue clinical development in support of an approval from the regulatory authorities for any indication. We note that most drug candidates never reach the clinical stage and even those that do commence clinical development have only a small chance of successfully completing clinical development and gaining regulatory approval. Therefore, our business currently depends entirely on the successful development, regulatory approval and commercialization of our product candidates, which may never occur.

 

Risks Relating to Our Intellectual Property Rights

 

We rely on licenses granted to us by Chelexa, the University of Cincinnati, Zylö, North Carolina State University George Washington University and Voltron (collectively, the “Licensors”), and if such licensors do not adequately defend such licenses, our business may be harmed.

 

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Our primary asset is a sublicense agreement with Chelexa pursuant to which Chelexa has granted us an exclusive sublicense to use its BioLexa Platform, a proprietary, patented, drug compound platform developed at the University of Cincinnati. The license enables us to develop the platform for any indications in humans. In addition, we entered into (i) an exclusive license agreement with the University of Cincinnati with respect to a patented, novel genetic marker for food allergies; (ii) the Sublicense Agreement with Zylö in connection with the development of a treatment for patients suffering from CLE including patents with respect thereto developed by Albert Einstein College of Medicine; (iii) a license agreement with NCSU with respect to NCSU’s exon skipping approach for treating allergic diseases; (iv) a license agreement with GW with respect to aprepitant as used in treating side effects from drugs used for the treatment of cancer; and (v) the Voltron Agreement with Voltron with respect to the formation of HaloVax, a joint venture entity formed to commence preclinical studies for the development of vaccine prospects for Coronavirus (COVID-19). We rely on the Licensors to protect the intellectual property, including the patents, covered by our licenses. We have limited control over the activities of the Licensors or over any other intellectual property that may be related to the BioLexa Platform, the genetic marker, CLE, exon skipping approach for treating allergic diseases, aprepitant or Coronavirus (COVID-19). For example, we cannot be certain that activities by the Licensors have been or will be conducted in compliance with applicable laws and regulations. We may have no control or input over whether, and in what manner, the Licensors may enforce or defend the patents against a third-party. The Licensors may enforce or defend the patent less vigorously than if we had enforced or defended the patents ourselves. Further, the Licensors may not necessarily seek enforcement in scenarios in which we would feel that enforcement was in our best interests. For example, the Licensors may not enforce the patents against a competitor of ours who is not a direct competitor of the Licensors, applicable. If our in-licensed intellectual property is found to be invalid or unenforceable, then the Licensors may not be able to enforce the patents against a competitor of ours. If we fail to meet our obligations under the sublicense agreement with Chelexa or Chelexa fails to meet its obligations under its license agreement with the University of Cincinnati, then the University of Cincinnati may terminate the license agreement with Chelexa thereby terminating our sublicense agreement with Chelexa, and we will be unable to conduct our business. Similarly, if we fail to meet our obligations under the sublicense agreement with Zylö or Zylö fails to meet its obligations under its license agreement with Albert Einstein College of Medicine, then Albert Einstein College of Medicine may terminate the license agreement with Zylö thereby terminating our sublicense agreement with Zylö, and we will be unable to conduct our business with respect to the development of treatment for patients suffering from CLE. Moreover, if we fail to meet our obligations under the Voltron Agreement with Voltron or Voltron ails to meet its obligations under its license agreement with The General Hospital Corporation (d/b/a Massachusetts General Hospital) (“Mass Gen”) thereby terminating the Voltron Agreement, we will be unable to conduct our business with respect to the development of a treatment relating to Coronavirus (COVID-19). In addition, if we fail to meet our obligations under the license agreement with the University of Cincinnati, NCSU or GW then the University of Cincinnati, NCSU or GW, as applicable, may terminate our license agreement, and we will be unable to continue to use their products in our business. Although we may choose to terminate our license agreements, doing so would allow a third party to seek and obtain an exclusive license to the BioLexa Platform, the genetic marker and the patents relating to CLE NCSU’s exon skipping approach for treating allergic diseases, aprepitant and Coronavirus (COVID-19). If a third party obtains an exclusive license to intellectual property with respect to the foregoing products and technologies formerly licensed to us, then the third party may seek to enforce the intellectual property against us which may have a material adverse effect on our business.

 

We are dependent upon our sublicense agreement with Chelexa with respect to the BioLexa Platform, Zylö with respect the development of a treatment for patients suffering from CLE and Voltron with respect to the development of a treatment for Coronavirus (COVID-19); however, we have no control over the license agreement between Chelexa and the University of Cincinnati, the license agreement between Zylö and Albert Einstein College of Medicine and the license agreement between Voltron and Mass Gen.

 

Our agreements with Chelexa, Zylö and Voltron are subject to many risks and uncertainties. Although we are dependent upon our sublicense agreement with Chelexa with respect to the BioLexa Platform, Zylö with respect the development of a treatment for patients suffering from CLE, and Voltron with respect the development of a treatment for Coronavirus (COVID-19), we have no control over the license agreement between Chelexa and the University of Cincinnati pursuant to which the University of Cincinnati licensed the BioLexa Platform to Chelexa, the license agreement between Zylö and Albert Einstein College of Medicine pursuant to which Albert Einstein College of Medicine licensed certain patent rights relating to CLE to Zylö or Voltron and Mass Gen pursuant to which Mass Gen licensed certain patent rights relating to VaxCelerate, a self-assembling vaccine platform, to Voltron. In the event that Chelexa is unable to fulfill its obligations to the University of Cincinnati pursuant to the terms of its license agreement, the University of Cincinnati may terminate the license thereby voiding our sublicense. Similarly, in the event that Zylö is unable to fulfill its obligations to Albert Einstein College of Medicine pursuant to the terms of its license agreement, Albert Einstein College of Medicine may terminate the license thereby voiding our sublicense. Furthermore, in the event that Voltron is unable to fulfill its obligations to Mass Gen pursuant to the terms of its license agreement, Mass Gen may terminate the license thereby voiding the Voltron Agreement. In the event that either the license agreement between Chelexa and the University of Cincinnati, the license agreement between Zylö and Albert Einstein College of Medicine or the license between Voltron and Mess Gen is terminated, there may be a material adverse effect upon our business.

 

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Our business depends upon securing and protecting critical intellectual property.

 

Although we do not own and only license intellectual property, to the extent we develop intellectual property, our commercial success will depend in part on obtaining and maintaining patent, trade secret, copyright and trademark protection of our technologies in the United States and other jurisdictions as well as successfully enforcing and defending such intellectual property rights against third-party challenges. We will only be able to protect our intellectual property from unauthorized use by third parties to the extent that valid and enforceable intellectual property protection, such as patents or trade secrets, cover them. In particular, we place considerable emphasis on obtaining patent and trade secret protection for significant new technologies, products and processes. Furthermore, the degree of future protection of our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage. Moreover, the degree of future protection of our proprietary rights is uncertain for products that are currently in the early stages of development because we cannot predict which of these products will ultimately reach the commercial market or whether the commercial versions of these products will incorporate proprietary technologies.

 

Risks Related to Our Common Stock

 

The price of our common stock may fluctuate substantially.

 

You should consider an investment in our common stock to be risky, and you should invest in our common stock only if you can withstand a significant loss and wide fluctuations in the market value of your investment. Some factors that may cause the market price of our common stock to fluctuate, in addition to the other risks mentioned in this “Risk Factors” section, are:

 

  sale of our common stock by our shareholders, executives, and directors;
     
  volatility and limitations in trading volumes of our shares of common stock;
     
  our ability to obtain financings to conduct and complete research and development activities including, but not limited to, our clinical trials, and other business activities;
     
  the timing and success of introductions of new products by us or our competitors or any other change in the competitive dynamics of our industry, including consolidation among competitors;
     
  our ability to attract new customers;
     
  our ability to secure resources and the necessary personnel to conduct clinical trials on our desired schedule;
     
  commencement, enrollment or results of our clinical trials for our product candidates or any future clinical trials we may conduct;
     
  changes in the development status of our product candidates;
     
  any delays or adverse developments or perceived adverse developments with respect to the FDA’s review of our planned pre-clinical and clinical trials;
     
  any delay in our submission for studies or product approvals or adverse regulatory decisions, including failure to receive regulatory approval for our product candidates;
     
  unanticipated safety concerns related to the use of our product candidates;
     
  changes in our capital structure or dividend policy, future issuances of securities, sales of large blocks of common stock by our shareholders;
  our cash position;
 

announcements and events surrounding financing efforts, including debt and equity securities;

 

 

our inability to enter into new markets or develop new products;

 

  reputational issues;

 

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  announcements of acquisitions, partnerships, collaborations, joint ventures, new products, capital commitments, or other events by us or our competitors;

 

  changes in general economic, political and market conditions in or any of the regions in which we conduct our business including as a result of the recent pandemic related to Coronavirus (COVID-19);

 

  changes in industry conditions or perceptions;

 

  analyst research reports, recommendation and changes in recommendations, price targets, and withdrawals of coverage;

 

  departures and additions of key personnel;

 

  disputes and litigations related to intellectual properties, proprietary rights, and contractual obligations;

 

  changes in applicable laws, rules, regulations, or accounting practices and other dynamics; and

 

  other events or factors, many of which may be out of our control.

 

In addition, if the market for stocks in our industry or industries related to our industry, or the stock market in general, experiences a loss of investor confidence, the trading price of our common stock could decline for reasons unrelated to our business, financial condition and results of operations. If any of the foregoing occurs, it could cause our stock price to fall and may expose us to lawsuits that, even if unsuccessful, could be costly to defend and a distraction to management.

 

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Cautionary Note Regarding Forward Looking Statements

 

This Current Report on Form 8-K includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this Current Report on Form 8-K include, but are not limited to, statements that relate to the joint venture and the preclinical development of the self-assembling vaccine technology for Coronavirus (COVID-19) and the potential development of products related to Coronavirus (COVID-19)and other information that is not historical information. When used herein, words such as "anticipate", "being", "will", "plan", "may", "continue", and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption "Risk Factors" in the Company’s Form 10K for the period ending December 31, 2019, and the Company’s other filings made with the Securities and Exchange Commission. Consequently, forward-looking statements should be regarded solely as the Company’s current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. The Company cannot guarantee future results, events, levels of activity, performance or achievements. The Company does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

 

Item 9.01 Financial Statements and Exhibits.

 

(d)          Exhibits.

 

Exhibit No.   Description
     
10.1   Development and Royalty Agreement by and between the Company and Voltron Therapeutics, Inc. dated March 23, 2020
10.2   Membership Interest Purchase Agreement by and between the Company and HaloVax, LLC dated March 23, 2020
99.1   Press Release Dated May 23, 2020

 

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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 hereunto duly authorized.

 

Date: March 23, 2020 Hoth Therapeutics, Inc.
   
  /s/ Robb Knie
  Robb Knie
  Chief Executive Officer

 

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Exhibit 10.1

 

DEVELOPMENT AND ROYALTY AGREEMENT

 

This DEVELOPMENT AND ROYALTY AGREEMENT (this “Agreement”) is made and entered into as of March [●], 2020 (the “Effective Date”), by and between Voltron Therapeutics, Inc., a Delaware corporation (the “Voltron”), and Hoth Therapeutics, Inc., a Nevada corporation (“Hoth”).

 

WHEREAS, The General Hospital Corporation, d/b/a Massachusetts General Hospital, a not-for-profit Massachusetts corporation that is a center for patient care, research and education, having a principal place of business at 55 Fruit Street, Boston, MA 02114 (“Mass General”), owns certain Patent Rights (as defined herein);

 

WHEREAS, Mass General granted to Voltron an exclusive license (the “Mass General License”) to make, have made, use, have used, sell and have sold Products and Processes (as each of those terms are defined herein) covered by one or more of the claims of the Patent Rights (as defined herein) in the Licensed Field as defined in the Mass General License;

 

WHEREAS, Hoth is a clinical-stage biopharmaceutical company with expertise in the pre-clinical and clinical development of pharmaceutical products;

 

WHEREAS, Voltron will, subsequent to execution of this Agreement, form HaloVax, LLC (the “Company”) for the purpose of developing a vaccine for the treatment of COVID-19 and other related corona viruses;

 

WHEREAS, the parties, wish to enter into this Development and Royalty Agreement pursuant to which Hoth will assist the Company in the development of Licensed Products (as defined below) in the Field (as defined below);

 

WHEREAS, in connection with this Agreement and upon the formation of the Company, Hoth has agreed to purchase from the Company, and the Company has agreed to issue to Hoth membership interests of the Company (the “Membership Interests”), with an option to purchase additional Membership Interests, upon the terms and conditions set forth in a Membership Interest Purchase Agreement (the “MIPA”) annexed hereto as Exhibit A;

 

WHEREAS, in connection with entry into this Agreement and Hoth’s purchase of the Membership Interests, Hoth will be granted certain Royalty Rights (as defined herein) upon the Closing Date (as defined herein) as more fully set forth in this Agreement;

 

WHEREAS, it is the intent of the parties that any developments and associated intellectual property resulting from this Agreement will be owned, deployed and/or exploited by the Company, except as otherwise provided by the terms of this Agreement.

 

NOW, THEREFORE, in consideration of the mutual terms, conditions and other agreements set forth herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound hereby, the parties hereto hereby agree to the following as set forth herein.

 

 

 

 

1. Definitions.

 

For purposes of this Agreement, the terms set forth below shall have the corresponding meanings provided below.

 

1.1 “Affiliate” shall mean any corporation, firm, limited liability company, partnership or other entity that directly controls or is controlled by or is under common control with a party to this Agreement. For purposes of this Section 1.1, “control” means ownership, directly or indirectly through one or more Affiliates, of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%) or more of the equity interests in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby a party controls or has the right to control the Board of Directors or equivalent governing body of a corporation or other entity.

 

1.2 “Closing” shall mean the Initial Closing set forth in Section 3(a) of the MIPA.

 

1.3 “Closing Date” shall mean the date of the Initial Closing as set forth in Section (3)(a) of the MIPA.

 

1.4 “Company” shall have the meaning set forth in the preamble.

 

1.5 “Confidential Information” shall mean with respect to a party (the “Receiving Party”), all information which is disclosed by the other Party (the “Disclosing Party”) to the Receiving Party hereunder or to any of its employees, consultants, Affiliates, licensees or sublicensees, except to the extent that the Receiving Party can demonstrate by written record or other suitable physical evidence that such information, (a) as of the date of disclosure is demonstrably known to the Receiving Party or its Affiliates other than by virtue of a prior confidential disclosure to such party or its Affiliates; (b) as of the date of disclosure is in, or subsequently enters, the public domain, through no fault or omission of the Receiving Party; (c) is obtained from a third party having a lawful right to make such disclosure free from any obligation of confidentiality to the Disclosing Party; or (d) is independently developed by or for the Receiving Party without reference to or reliance upon any Confidential Information of the Disclosing Party. If a Receiving Party is required to disclose Confidential Information of the Disclosing Party by reason of legal, accounting or regulatory requirements, the Receiving Party shall give the Disclosing Party reasonable advance notice of such disclosure and shall use reasonable efforts to secure confidential treatment of such Confidential Information required to be disclosed.

 

1.6 “Development Plan” shall have the meaning set forth in Section 3.2.

 

1.7 “Effective Date” shall have the meaning set forth in the preamble.

 

1.8 “Field” shall mean all products and processes or uses developed hereunder, whether or not related to the Patent Rights, for the prevention, interception or treatment of COVID-19 and other related corona viruses, or otherwise.

 

1.9 “First Commercial Sale” means, on a country by country basis, with respect to a Licensed Product, the first bona fide sale of such Licensed Product to a third party by or on behalf of the Company, its Affiliates or licensees in a country in the Territory after regulatory approval has been achieved for such Licensed Product in such country. For greater certainty, sales for test marketing, sampling and promotional uses, clinical trial purposes or compassionate or similar use shall not be considered to constitute a First Commercial Sale, so long as the Licensed Product is provided free of charge, or at or below cost.

 

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1.10 “Hoth” shall have the meaning set forth in the preamble.

 

1.11 “Intellectual Property” means U.S. and foreign patents and patent applications, utility models and utility model applications, design patents or registered industrial designs and design applications or applications for registration of industrial designs, copyrights, know-how, trade secrets, other intellectual property rights, inventions, discoveries and technical information, including, but not limited to, information embodied in drawings, designs, mask works, mask work applications, material specifications, processing instructions, formulas, equipment specifications, product specifications, confidential data computer software, electronic files, research notebooks, invention disclosures, research and development reports and the like related thereto.

 

1.12 “Joint Development Committee” shall have the meaning set forth in Section 3.2.

 

1.13 “Licensed Product” means products and services that are made, made for, used, imported, offered for sale or sold by Company or its Affiliates or sublicensees and that would (i) in the absence of the License, infringe (or, in the case of pending patent applications, upon issuance, would infringe) at least one claim of the Patent Rights in the Field or (ii) use a process or machine covered by a claim of Patent Rights in the Field, whether the claim is issued or pending. Licensed Product shall also include any other product that is jointly developed by Company and Hoth during the Term of this Agreement whether inside or outside the Field.

 

1.14 “Membership Interests” shall have the meaning set forth in the preamble.

 

1.15 “MIPA” shall have the meaning set forth in the preamble of this Agreement.

 

1.16 “Net Sales” shall mean the total consideration, in any form, received by the Company or its Affiliates as consideration for the sale of the Licensed Products throughout the Territory during each calendar quarter, less the following amounts incurred, allowed, accrued, paid or otherwise specifically allocated to the Licensed Products by the Company or its Affiliates during such calendar quarter with respect to sales of the Licensed Products regardless of the calendar quarter in which such sales were made:

 

(a) customary and reasonable trade discounts actually allowed after the initial sale, refunds, returns and recalls, rebates and chargebacks for government and managed care contracts;

 

(b) when included in gross sales, customary and reasonable freight, shipping, duties, and sales, V.A.T. and/or use taxes based on sales prices, but not including taxes when assessed on income derived from such sales;

 

(c) freight, distribution, insurance and other transportation charges, whether or not specifically identified as such in the invoice to the third party;

 

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(d) amounts repaid or credited by reason of rejections, defects or returns or because of chargebacks, retroactive price reductions, refunds or billing errors; and

 

(e) any royalty amounts or license fees payable by the Company to a third party for access to, or licensing in of, such third party’s intellectual property rights for use or exploitation of the Licensed Products.

 

(f) Specifically excluded from the definition of “Net Sales” are amounts attributable to any Sale of any Product or Process between or among Company and any Company Affiliate and/or sublicensee, unless the transferee is the end purchaser, user or consumer of such Product or Process and a “Sale” shall not include transfers or dispositions of such Product or Process for pre-clinical or non-commercial clinical purposes, as samples or under named patient use, compassionate use, or patient assistance, to the extent such Sale(s) of Product or Processes are at or below Actual Manufacturing Cost.

 

1.17 “Patent Rights” shall have the meaning set forth in the Mass General License as limited to the Field

 

1.18 “Processes” means any processes, method or service the use or performance of which, in whole or in part absent the license granted hereunder would infringe, or is covered by, one or more of the Valid Claims of the Patent Rights.

 

1.19 “Royalty” shall have the meaning set forth in Section 2.2 of this Agreement.

 

1.20 “Royalty Payments” shall have the meaning set forth in Section 2.2 of this Agreement.

 

1.21 “Royalty Percentage” shall have the meaning set forth in Section 2.2 of this Agreement.

 

1.22 “Royalty Rights” shall have the meaning set forth in Section 2.1 of this Agreement.

 

1.23 “Royalty Term” means, with respect to each Licensed Product, on a country by country basis in each country, commencing on the First Commercial Sale of the Licensed Product until the last of:

 

(a) the expiration of the last to expire of the Valid Claims covering such Licensed Product in such country; and

 

(b) the expiration of any regulatory exclusivity period covering such Licensed Product in such country.

 

For clarity, by way of example, the Royalty Term in the United States extends to 2040 at the time of this Agreement, which period may be altered by the prosecution of the Company’s patent claims and new patent filings from time-to-time. Furthermore, the Company will use commercially reasonable efforts to maximize market exclusivity.

 

1.24 “Subsequent Subscription Amount” shall have the meaning set forth in Section 3(b) of the MIPA.

 

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1.25 “Territory” means worldwide.

 

1.26 “Valid Claim” means a claim (i) of an issued and unexpired United States patent that has not been revoked or held permanently unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through re-issue or disclaimer or otherwise, or (ii) of any patent application included that has not been cancelled, withdrawn or abandoned or been pending for more than six (6) years.

 

2. Royalty Rights.

 

2.1 Grant of Royalty to Hoth. As of the Closing Date, Hoth is hereby granted royalty rights which include a right to receive a royalty based on Net Sales of any Licensed Products in accordance with Section 2.2 (the “Royalty Rights”).

 

2.2 Royalties.

 

(a) The Company shall pay Hoth a royalty (the “Royalty”) of one percent (1%) of Net Sales (the “Royalty Percentage”) in the Territory (the “Royalty Payments”). Royalties will be payable during the Royalty Term on a calendar quarter basis, within sixty (60) days after the end of each calendar quarter, based upon the Net Sales during such calendar quarter.

 

(b) The Company shall increase the Royalty Percentage in one-third percent (1/3%) increments for the duration of the Royalty Term for each Subsequent Subscription Amount paid by Hoth in accordance with the terms and conditions of the MIPA.

 

2.3 Royalty Statements. The Company will deliver to Hoth within sixty (60) days after the end of each calendar quarter in which Licensed Products for which the Company owes a royalty hereunder are sold, a detailed statement showing (i) Net Sales made by the Company and its Affiliates of each such Licensed Product; and (ii) the amount and calculation of royalties due on such Net Sales. The Company shall keep full, true and accurate books of accounts based on good accounting principles and other records containing relevant information and data which may be necessary to ascertain and verify the remuneration payable to Hoth hereunder for a period of three (3) years following the year to which such records relate. During the Term and for a period of three (3) years following its termination, Hoth shall have the right to audit, or have an agent, accountant or other representative, audit such books, records and supporting data upon thirty (30) days notice. Any audit shall be at Hoth’s expense, except that the Company shall reimburse Hoth for the cost of the audit in the event that Hoth discovers an underpayment of ten percent (10%) or more of the amount due.

 

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3. Development of Licensed Products.

 

3.1 Cooperation. Hoth and the Company generally intend to cooperate and use commercially reasonable efforts to exchange information and resources that will lead to the development of Licensed Products. All of the information exchanged between the parties shall be Confidential Information entitled to the protections in Section 4 below.

 

3.2 Joint Development Committee; Committee Responsibilities. Hoth and the Company will establish a Joint Development Committee (the “JDC”) to plan, review, coordinate and oversee the Company’s performance of the development activities and timelines with respect to Licensed Products. The Joint Development Committee shall review and approve a written development plan describing the major tasks to be achieved regarding Licensed Products (“Development Plan”), submitted by the Company within one hundred and eighty (180) days after the Effective Date. The responsibilities of the Joint Development Committee shall consist of:

 

(a) Facilitating the exchange of materials and information between the parties;

 

(b) Approving a Development Plan, as well as any modifications of the foregoing;

 

(c) Monitoring the progress of the Development Plan;

 

(d) Reviewing and discussing the results of the Development Plan; and

 

(e) Such other responsibilities as the parties may mutually agree in writing to delegate to the Joint Development Committee.

 

3.3 Membership. The JDC shall include two (2) representatives of Hoth and five (5) representatives of the Company, with each party’s members selected by that party. Each party may replace its Joint Development Committee representatives at any time, upon written notice to the other party.

 

3.4 Meetings. The JDC shall meet at least quarterly, or more frequently as agreed by the parties, at such locations as the parties agree, and will otherwise communicate regularly. Meetings may also be held by telephone or videoconference in lieu of in-person meetings, at such times as the parties agree. With the consent of the parties, other representatives of each party may attend JDC meetings as nonvoting observers. Each party shall be responsible for all of its own expenses associated with attendance of such meetings.

 

3.5 Decision Making. With respect to decisions taken on matters placed by either party before the JDC, each party shall have one vote. Decisions of the JDC shall be made by unanimous approval of the parties. If the members of the JDC cannot reach an agreement after commercially reasonable efforts to do so, then either party’s representative to the Joint Development Committee may refer such dispute to the respective Chief Executive Officers or their designees of each party, who shall meet in person or by telephone within thirty (30) days after such referral to attempt in good faith to resolve such dispute. Notwithstanding the foregoing, with respect to matters under the responsibility of the Joint Development Committee, the Company will have the tie- breaking vote on any disputes.

 

3.6 Ownership of Intellectual Property. All Intellectual Property of the Company shall be and remain the property of the Company, and Hoth shall not acquire any rights therein. All Intellectual Property of Hoth shall be and remain the property of Hoth, and the Company shall not acquire any rights therein. All fees and royalties related to Licensed Products shall be the property of the Company except as set forth in Section 2. The parties agree to execute all appropriate license agreements and any other documents necessary to effectuate the intent of this Section 3.6.

 

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4. Confidentiality.

 

4.1 Confidentiality Obligation. Each party acknowledges and agrees that all of the other party’s Confidential Information, and the Confidential Information jointly developed by the parties subsequent to the date of this Agreement, is confidential and proprietary. Each party agrees to hold the other party’s Confidential Information in strict confidence and agrees not to use or disclose such Confidential Information or any jointly developed Confidential Information to any third party for any purpose other than as permitted or required hereunder. Each party shall take the same reasonable measures necessary to prevent any disclosure by its employees, agents, contractors or consultants of the other party’s Confidential Information as it applies to the protection of its own Confidential Information, including, without limitation, the use of appropriate non-disclosure agreements with employees, agents, contractors, or consultants. All Confidential Information provided by one party to the other party hereunder, shall remain the property of the disclosing party. The receiving party shall, within ten (10) days of a written request to do so or within thirty (30) days of termination of this Agreement, return to the disclosing party, or at the receiving party’s option, destroy all Confidential Information that has been provided in tangible form and shall, unless prohibited by law, destroy or otherwise render unintelligible all other Confidential Information. All Confidential Information jointly developed by Hoth and the Company shall be owned jointly by Hoth and the Company. Each of Hoth and the Company shall be entitled to retain a copy or copies of any jointly developed Confidential Information upon the termination of this Agreement, subject to each party’s obligations with respect to such jointly developed Confidential Information as set forth in this Agreement.

 

4.2 Injunctive Relief. The parties acknowledge that monetary damages may not be sufficient remedy for a breach of obligation of confidentiality in this Agreement and agree that each Party shall be entitled to seek appropriate equitable remedies, including injunctive relief, to prevent the unauthorized use or disclosure of any of its Confidential Information.

 

4.3 Term. The obligations under this Section 4 expire ten (10) years after disclosure of Confidential Information from one party to the other party, or five (5) years after termination of this Agreement, whichever occurs earlier.

 

5. Representations and Warranties; Indemnification.

 

5.1 Representations of Hoth. Hoth represents, warrants and covenants to the Company that:

 

(a) This Agreement constitutes a valid and legally binding agreement of Hoth, enforceable against Hoth in accordance with its terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and similar laws of general applicability relating to or affecting creditors’ rights and to general equity principles.

 

(b) Neither the execution and delivery of this Agreement, nor the consummation of the transactions contemplated herein, will violate any provision of the articles of incorporation, bylaws or other governing instruments of Hoth or any law, rule, regulation, writ, judgment, injunction, decree, determination, award or other order of any court or governmental agency or instrumentality, domestic or foreign, or conflict with or result in any breach of any of the terms of or constitute a default under or result in termination of or the creation or imposition of any mortgage, deed of trust, pledge, lien, security interest or other charge or encumbrance of any nature pursuant to the terms of any contract or agreement to which Hoth is a party or by which Hoth or any of its assets is bound.

 

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(c) Hoth has all rights and licenses required in order to provide the Confidential Information, which is, or may be, provided to the Company hereunder; provided, however, that nothing herein shall be construed as a representation or warranty of non-infringement of third party patent rights.

 

5.2 Representations of Voltron. Voltron represents, warrants and covenants to Hoth that:

 

(a) This Agreement constitutes a valid and legally binding agreement of Voltron, enforceable against Voltron in in accordance with its terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and similar laws of general applicability relating to or affecting creditors’ rights and to general equity principles.

 

(b) Neither the execution and delivery of this Agreement nor the consummation of the transactions contemplated herein will violate any provision of the charter and bylaws of Voltron or any law, rule, regulation, writ, judgment, injunction, decree, determination, award or other order of any court or governmental agency or instrumentality, domestic or foreign, or conflict with or result in any breach of any of the terms of or constitute a default under or result in termination of or the creation or imposition of any mortgage, deed of trust, pledge, lien, security interest or other charge or encumbrance of any nature pursuant to the terms of any contract or agreement to which Voltron is a party or by which the Company or any of its assets is bound.

 

(c) Voltron will execute such agreements as reasonably necessary which may include a sublicense of the Patent Rights granted Voltron in the Mass General License for use in the Field so as to enable the Company to perform its obligations hereunder.

 

(d) Voltron has all rights and licenses required in order to provide the Confidential Information, which is, or may be, provided to Hoth hereunder; provided, however, that nothing herein shall be construed as a representation or warranty of non-infringement of third party patent rights.

 

Disclaimer of Warranties. EXCEPT FOR THE EXPRESS WARRANTIES STATED IN THIS SECTION 5, NEITHER PARTY MAKES ANY WARRANTIES OR REPRESENTATIONS OF ANY KIND, EXPRESS OR IMPLIED. THE PARTIES, INCLUDING COMPANY ACKNOWLEDGE AND UNDERSTAND THAT THERE IS NO GUARANTEE THAT THE PARTIES WILL BE ABLE TO SUCCESSFULLY DEVELOP OR COMMERCIALIZE ANY LICENSED PRODUCTS OR SERVICES OR THAT SUCH LICENSED PRODUCTS OR SERVICES, IF COMMERCIALIZED, WILL BE ACCEPTED BY OR SUCCESSFUL IN THE MARKET.

 

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5.3 Indemnification by Hoth. Hoth shall indemnify, defend and hold harmless Voltron and the Company and each of its subsidiaries, officers, directors, shareholder, employees, agents and Affiliates (collectively, all such indemnified persons are referred to in this Section as the “Indemnified Parties”) against and in respect of any and all third party claims, demands, losses, obligations, liabilities, damages, deficiencies, actions, settlements, judgments, costs and expenses which the Indemnified Parties may incur or suffer or with which it may be faced (including reasonable costs and legal fees incident thereto or in seeking indemnification therefor), arising out of or based upon (i) the breach by Hoth of any of its representations, warranties, covenants or agreements contained or incorporated in this Agreement, or (ii) any act or omission of Hoth, its agents, employees or its suppliers, or products, except to the extent of injury or damage due to Indemnified Parties’ negligence or willful misconduct.

 

5.4 Indemnification by the Voltron. Voltron shall indemnify, defend and hold harmless Hoth and each of its subsidiaries, officers, directors, shareholder, employees, agents and Affiliates (collectively, all such indemnified persons are referred to in this Section as the “Voltron Indemnified Parties”) against and in respect of any and all third party claims, demands, losses, obligations, liabilities, damages, deficiencies, actions, settlements, judgments, costs and expenses which Indemnified Parties may incur or suffer or with which it may be faced (including reasonable costs and legal fees incident thereto or in seeking indemnification therefor), arising out of or based upon (i) the breach by Voltron of any of its representations, warranties, covenants or agreements contained or incorporated in this Agreement, or (ii) any act or omission of Voltron, its agents, employees or its suppliers, or products, except to the extent of injury or damage due to Voltron Indemnified Parties’ negligence or willful misconduct.

 

5.5 Limitation of Liability. EXCEPT IN THE CASE OF MISAPPROPRIATION OF THE CONFIDENTIAL INFORMATION OR INTELLECTUAL PROPERTY OF ONE PARTY BY ANOTHER PARTY HEREUNDER, IN NO EVENT SHALL EITHER HOTH OR THE COMPANY BE LIABLE TO ANY PARTY FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL OR OTHER SIMILAR DAMAGES UNDER OR AS A RESULT OF THIS AGREEMENT.

 

6. Term and Termination.

 

6.1 This Agreement shall take effect as of the Effective Date and shall continue in force until the earlier of (i) the approval of a New Drug Application (or its equivalent) for the Licensed Products by the United States Federal Drug Administration, (ii) cessation of development of Licensed Products (iii) the sale of license of Licensed Products to a third party, or (iii) mutual consent of the parties, at which time the JDC shall be disbanded.

 

6.2 Termination For Cause. This Agreement may be terminated at any time in accordance with the following provisions:

 

(a) by written notice from Hoth to Voltron in the event of (i) a breach of any material term of this Agreement by Voltron that is not cured within ninety (90) calendar days after receipt by Voltron of written notice from Hoth specifying the nature of and basis for the asserted breach; provided, that if such breach cannot reasonably be cured within ninety (90) days, such breach shall be deemed cured if Voltron commences to cure such breach within such 90-day period and diligently thereafter pursues such cure, or (ii) the commencement by or against Voltron of any bankruptcy, insolvency or reorganization proceeding which has not been dismissed within ninety (90) days after commencement; or

 

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(b) by written notice from Voltron to Hoth the event of (i) a breach of any material term of this Agreement by Hoth that is not cured within ninety (90) calendar days after receipt by Hoth of written notice from the Company specifying the nature of and basis for the asserted breach; provided, that if such breach cannot reasonably be cured within ninety (90) days, such breach shall be deemed cured if Hoth commences to cure such breach within such 90-day period and diligently thereafter pursues such cure, or (ii) the commencement by or against Hoth of any bankruptcy, insolvency or reorganization proceeding which has not been dismissed within ninety (90) days after commencement. In the event that Hoth fails to purchase the Membership Interests as provided in the MIPA, Voltron may immediately terminate this Agreement on written notice to Hoth and this Agreement shall be terminated and of no further force and effect.

 

6.3 Rights and Obligations on Termination. In the event of termination or expiration of this Agreement for any reason, the Parties shall have the following rights and obligations (in addition to such rights, obligations and remedies they may have at law and in equity with respect to any breach of this Agreement):

 

(a) Except in the case of termination by Company under Section 6.2(b), Hoth’s right to receive the Royalty shall survive termination or expiration of this Agreement;

 

(b) The rights and obligations of the parties under Section 4, Section 5, Section 6 and Section 7 shall survive any termination or expiration of this Agreement; and

 

(c) Upon termination or expiration of this Agreement, each party will return to the other all tangible Confidential Information to the other party. 

 

7. Miscellaneous.

 

7.1 Notices. All notices, requests, demands and other communications provided in connection with this Agreement shall be in writing and shall be deemed to have been duly given at the time when hand delivered, delivered by express courier, or sent by facsimile (with receipt confirmed by the sender’s transmitting device) in accordance with the contact information provided below or such other contact information as the parties may have duly provided by notice.

 

To Voltron:

 

Voltron Therapeutics, Inc.

575 Fifth Avenue, 14th Floor

New York, NY 10019

With a copy to:

Lowenstein Sandler LLP

One Lowenstein Drive

Roseland, New Jersey 07068

Telephone: (973) 597-6394

Email: MLerner@lowenstein.com

Attention: Michael Lerner

 

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To Hoth:

 

Hoth Therapeutics, Inc.

1 Rockefeller Plaza, Suite 1039

New York, NY 10020

Telephone: (646) 756-2997

E-mail: robb@hoththerapeutics.com

Attention: Robb Knie

With a copy to:

Sheppard, Mullin, Richter & Hampton LLP

30 Rockefeller Plaza

New York, New York 10112

Telephone: (212) 653-8700

Email: rafriedman@sheppardmullin.com

Attention: Richard Friedman, Esq.

 

7.2 Survival of Covenants. Each party hereto agrees that the covenants of such party contained in this Agreement shall survive the Closing.

 

7.3 Entire Agreement. This Agreement contains the entire agreement between the parties hereto in respect of the subject matter contained herein and supersedes all prior agreements and understandings of the parties, oral and written, with respect to the subject matter contained herein.

 

7.4 Third Party Beneficiaries. This Agreement is intended for the benefit of the parties hereto and their respective permitted successors and assigns and is not for the benefit of, nor may any provision hereof be enforced by, any other person.

 

7.5 Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of the parties and their successors and assigns. For the sake of clarity, this Agreement shall be binding upon an acquirer of the Company or on the purchaser of all or substantially all of the assets of the Company.

 

7.6 Amendment; Waivers. All modifications, amendments or waivers to this Agreement shall require the written consent of both the Company and Hoth.

 

7.7 Applicable Law; Disputes. This Agreement shall be governed by and construed in accordance with the laws of the State of New York without giving effect to the conflict of law provisions thereof, and the parties hereto irrevocably submit to the exclusive jurisdiction of the United States District Court for the Southern District of New York, or, if jurisdiction in such court is lacking, the Supreme Court of the State of New York, New York County, in respect of any dispute or matter arising out of or connected with this Agreement.

 

7.8 Waiver of Jury Trial. In any action, suit, or proceeding in any jurisdiction brought by one party against the other party, the parties each knowingly and intentionally, to the greatest extent permitted by applicable law, hereby absolutely, unconditionally, irrevocably and expressly waive forever trial by jury.

 

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7.9 Further Assurances. Each party hereto shall do and perform or cause to be done and performed all such further acts and shall execute and deliver all such other agreements, certificates, instruments and documents as any other party hereto reasonably may request in order to carry out the intent and accomplish the purposes of this Agreement and the consummation of the transactions contemplated hereby.

 

7.10 Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed to be an original and all of which taken together shall constitute one and the same instrument. This Agreement may also be executed via facsimile, which shall be deemed an original.

 

[SIGNATURE PAGES IMMEDIATELY FOLLOW]

 

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IN WITNESS WHEREOF, Hoth and the Company have caused this Agreement to be duly executed as of the date first above written.

 

  VOLTRON THERAPEUTICS, INC.
   
  By:  
  Name:
  Title:

 

  HOTH THERAPEUTICS, INC.
   
  By:  
  Name:
  Title:

 

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Exhibit 10.2

 

Membership Interest Purchase Agreement

 

This Membership Interest Purchase Agreement (this “Agreement”), dated as of March [●], 2020 (the “Effective Date”), is entered into between HaloVax, LLC, a Delaware limited liability company (the “Company”), and Hoth Therapeutics, Inc., a Nevada corporation (“Purchaser”).

 

Recitals

 

WHEREAS, on March 23, 2020, Voltron Therapeutics, Inc. (“Voltron”) and the Purchaser entered into a Development and Royalty Agreement (the “Development and Royalty Agreement”) pursuant to which Voltron agreed to form the Company to develop certain products for the prevention, interception or treatment of COVID-19 and related corona viruses (the “Licensed Products”); and

 

WHEREAS, pursuant to the Development and Royalty Agreement, the Purchaser agreed to assist Voltron and the Company in the development of the Licensed Products and to purchase from the Company a percentage of the Company’s outstanding membership interests (the “Membership Interests”); and

 

WHEREAS, the Company wishes to sell to the Purchaser, and Purchaser wishes to purchase from the Company, a percentage of the Company’s outstanding Membership Interests, subject to the terms and conditions set forth herein.

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements hereinafter set forth and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

 

1. Subscription.

 

(a) The Purchaser, intending to be legally bound, hereby irrevocably agrees to purchase five percent (5%) of the Company’s outstanding Membership Interests (the “Initial Membership Interests”) as of the Initial Closing Date (as defined below) for a purchase price of $250,000.

 

(b) The Purchaser shall have the option (the “Option”), during the Term, to purchase from the Company up to an additional twenty-five percent (25%) of the Company’s outstanding Membership Interests (the “Additional Membership Interests” and, together with the Initial Membership Interests, the “Purchased Membership Interests”) as of each Subsequent Closing (as defined below) date for up to an aggregate purchase price of $2,750,000 (the “Additional Option”). The Option will expire thirty (30) days after the Initial Closing Date.

 

2. The Offering. The offering of the Purchased Membership Interests contemplated hereby (the “Offering”) is being made in reliance on the exemption from registration provided in Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”).

 

 

 

 

3. Deliveries and Payment.

 

(a) Simultaneously with the execution hereof, the Purchaser shall deliver to the Company a completed and executed signature page to this Agreement.

 

(b) The Initial Membership Interests will be issued and sold by the Company to the Purchaser at a closing (the “Initial Closing”) to occur on or before May 23, 2020 (the “Initial Closing Date”). At the Initial Closing, the Company shall issue and sell to the Purchaser and the Purchaser shall purchase from the Company the Initial Membership Interests.

 

(c) Any Additional Membership Interests will be issued and sold by the Company to the Purchaser at subsequent closings (each, a “Subsequent Closing”). At each Subsequent Closing, the Company shall issue and sell to the Purchaser and the Purchaser shall purchase from the Company such number of Additional Membership Interests as determined by the Purchaser, in its sole and absolute discretion; provided, that the Option must be exercised for (i) at least $1,000,000 (inclusive of the $250,000 paid pursuant to the Section 1(a)) (the “Minimum Subscription Amount”) and (ii) no more than $3,000,000 (inclusive of the $250,000 paid for the Initial Membership Interests pursuant to Section 1(a)) (the “Maximum Subscription Amount”); provided further, that, if more than $2,000,000 of Membership Interests (in the aggregate) are purchased, at Hoth’s option, Hoth may elect to receive the value of the last $1,000,000, representing ten percent (10%) of the Membership Interests of the Company, either in (i) Membership Interests or (ii) a pre-paid option to purchase such Additional Membership Interests. Each Subsequent Closing shall be deemed a “Subsequent Subscription Amount” for purposes of this Agreement.

 

(d) On or before the Initial Closing and each Subsequent Closing, the Purchaser shall make a wire transfer payment in the full amount of the purchase price for the Purchased Membership Interests to an account specified in writing by the Company.

 

4. Acceptance of Subscription. The Purchaser understands and agrees that the Company, in its sole discretion, reserves the right to accept or reject this subscription or any other subscription for the Purchased Membership Interests, in whole or in part, notwithstanding prior receipt by the Purchaser of notice of acceptance of a subscription. The Company shall have no obligation hereunder until the Company executes and delivers to the Purchaser an executed copy of this Agreement. If any subscription is rejected in whole or in part or the Offering is terminated, all funds received from the Purchaser will be returned without interest or offset, and this Agreement shall thereafter be of no further force or effect.

 

Within five (5) calendar days of the Initial Closing and each Subsequent Closing, the Company shall deliver the Purchased Membership Interests to the Purchaser at the address set forth on the signature page hereto.

 

5. Representations and Warranties.

 

The Company hereby represents and warrants to Purchaser as of the date of this Agreement as set forth below.

 

(a) The Company is a limited liability company duly organized, validly existing and in good standing under the laws of the State of Delaware. The Company has all requisite power and authority to (1) own and operate its properties and assets, (2) execute and deliver this Agreement, (3) issue and sell the Purchased Membership Interests, (4) carry out the provisions of this Agreement, and (5) carry on its business as presently conducted and as presently proposed to be conducted. The Company is duly authorized to do business and is in good standing in all jurisdictions in which the nature of its activities and of its properties makes such qualification necessary, except for those jurisdictions in which failure to do so would not have a material adverse effect on the Company or its business.

 

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(b) All action on the part of the Company, its officers, board of managers and members necessary for the authorization of this Agreement, the performance of all obligations of the Company hereunder at the Initial Closing or each Subsequent Closing and the authorization, sale, issuance and delivery of the Purchased Membership Interests pursuant hereto has been taken or will be taken prior to the Initial Closing or each Subsequent Closing, as applicable. This Agreement, when executed and delivered, will be a valid and binding obligation of the Company enforceable in accordance with its terms except (1) as limited by the applicable bankruptcy, insolvency, reorganization, moratorium or other laws of general application affecting enforcement of creditors’ rights, and (2) general principles of equity that restrict the availability of equitable remedies.

 

(c) The execution, delivery and performance by the Company of this Agreement and the consummation by the Company of the transactions contemplated hereby do not, and will not, (i) conflict with or violate any provision of the Company’s certificate or articles of organization, bylaws or other organizational or charter documents, (ii) in any material respect, conflict with, or constitute a default (or an event that with notice or lapse of time or both would become a default) under, or give to others any rights of termination, amendment, acceleration or cancellation (with or without notice, lapse of time or both) of, any agreement, credit facility, debt or other instrument (evidencing a Company debt or otherwise) or other understanding to which the Company is a party or by which any property or asset of the Company is bound, or affected, or (iii) in any material respect, result in a violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction of any court or governmental authority to which the Company is subject (including, assuming the accuracy of the representations and warranties of the Purchaser set forth in this Section 5, federal and state securities laws and regulations and the rules and regulations of any self-regulatory organization to which the Company or their respective securities are subject, including all applicable trading markets), or by which any property or asset of the Company is bound or affected, except in the case of clauses (ii) and (iii) such as would not, have a material adverse effect on the Company or its business.

 

The Purchaser hereby acknowledges, represents, warrants, and agrees as follows:

 

(a) The Purchaser is a corporation duly organized, validly existing and in good standing under the laws of the State of Nevada with the requisite corporate power and authority to enter into and to consummate the transactions contemplated by this Agreement and otherwise to carry out its obligations hereunder. The purchase by the Purchaser of the Purchased Membership Interests hereunder has been duly authorized by all necessary corporate action on the part of the Purchaser. This Agreement has been duly executed and delivered by the Purchaser and constitutes the valid and binding obligation of the Purchaser, enforceable against it in accordance with its terms, except (i) as limited by general equitable principles and applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally, and (ii) as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies.

 

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(b) None of the Purchased Membership Interests are registered under the Act, or any state securities laws. The Purchaser understands that the offering and sale of the Purchased Membership Interests is intended to be exempt from registration under the Act by virtue of Section 4(a)(2) thereof based, in part, upon the representations, warranties and agreements of the Purchaser contained in this Agreement.

 

(c) The execution, delivery and performance by the Purchaser of this Agreement and the consummation by the Purchaser of the transactions contemplated hereby do not and will not (i) result in a violation of the organizational documents of the Purchaser or (ii) conflict with, or constitute a default (or an event which with notice or lapse of time or both would become a default) under, or give to others any rights of termination, amendment, acceleration or cancellation of, any agreement, indenture or instrument to which the Purchaser is a party, or (iii) result in a violation of any law, rule, regulation, order, judgment or decree (including federal and state securities laws) applicable to the Purchaser, except in the case of clauses (ii) and (iii) above, for such that are not material and do not otherwise affect the ability of the Purchaser to consummate the transactions contemplated hereby.

 

(d) The Purchased Membership Interests to be received by the Purchaser hereunder will be acquired for such Purchaser’s own account, not as nominee or agent, and not with a view to the resale or distribution of any part thereof in violation of the Act, and the Purchaser has no present intention of selling, granting any participation in, or otherwise distributing the same in violation of the Act without prejudice, however, to the Purchaser’s right at all times to sell or otherwise dispose of all or any part of such Purchased Membership Interests in compliance with applicable federal and state securities laws. The Purchaser is not a broker-dealer registered with the Securities and Exchange Commission (“SEC”) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or an entity engaged in a business that would require it to be so registered.

 

(e) The Purchaser, either alone or together with its representatives, has such knowledge, sophistication and experience in business and financial matters so as to be capable of evaluating the merits and risks of the prospective investment in the Purchased Membership Interests, and has so evaluated the merits and risks of such investment. The Purchaser understands that it must bear the economic risk of this investment in the Purchased Membership Interests indefinitely, and is able to bear such risk and is able to afford a complete loss of such investment.

 

(f) Neither the SEC nor any state securities commission or other regulatory authority has approved the Purchased Membership Interests, or passed upon or endorsed the merits of the Offering or confirmed the accuracy or determined the adequacy of any information provided by the Company to the Purchaser in connection with the Offering.

 

(g) The Purchaser has had an opportunity to receive all information related to the Company requested by it and to ask questions of and receive answers from the Company regarding the Company, its business and the terms and conditions of the offering of the Purchased Membership Interests.

 

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(h) The Purchaser is unaware of, is in no way relying on, and did not become aware of the Offering through or as a result of, any form of general solicitation or general advertising.

 

(i) The Purchaser has taken no action that would give rise to any claim by any person for brokerage commissions, finders’ fees or the like relating to this Agreement or the transactions contemplated hereby (other than commissions payable by the Company pursuant to the terms of any contract to which the Company is a party).

 

(j) The Purchaser is aware that an investment in the Company is subject to substantial risks.

 

(k) At the time the Purchaser was offered the Purchased Membership Interests, it was, and at the date hereof it is an “accredited investor” as defined in Rule 501(a) under the Act or a “qualified institutional buyer” as defined in Rule 144A(a) under the Act.

 

(l) It is understood that the certificates representing the Purchased Membership Interests will bear the following legends:

 

THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED, AND, ACCORDINGLY, MAY NOT BE TRANSFERRED UNLESS (I) SUCH MEMBERSHIP INTERESTS HAVE BEEN REGISTERED FOR SALE PURSUANT TO THE SECURITIES ACT OF 1933, AS AMENDED, (II) SUCH MEMBERSHIP INTERESTS MAY BE SOLD PURSUANT TO RULE 144, OR (III) THE COMPANY HAS RECEIVED AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO IT THAT SUCH TRANSFER MAY LAWFULLY BE MADE WITHOUT REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

 

TRANSFER OF THE MEMBERSHIP INTERESTS REPRESENTED HEREBY IS RESTRICTED PURSUANT TO THE TERMS OF AN AGREEMENT BETWEEN THE COMPANY AND THE INITIAL PURCHASER OF THIS SECURITY AND THE COMPANY’S OPERATING AGREEMENT, AS APPLICABLE. ANY PURPORTED TRANSFER IN VIOLATION OF SUCH AGREEMENT IS NULL AND VOID, AB INITIO.

 

6. Tag-Along Rights.

 

(a) Tag-Along Rights.

 

(i) If the Company wishes to sell, give, assign, hypothetic, pledge, encumber, grant a security interest in or otherwise dispose of (whether by operation of law or otherwise) (each a “Transfer”) fifty percent (50%) of its Membership Interests to a third-party purchaser, then the Purchaser shall have the right to sell to such third-party purchaser, upon the same terms and conditions as the Company, up to that number of Membership Interests held by the Purchaser equal to that percentage of the number of Membership Interests proposed to be Transferred by the Company determined by dividing the total number of Membership Interests then owned by the Purchaser by the total number of Membership Interests then owned by the Company.

 

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(ii) The Company shall give written notice to the Purchaser of each proposed sale by it of Membership Interests which gives rise to the rights of the Purchaser set forth in this Section 6(a) at least fifteen (15) days prior to the proposed consummation of such sale, setting forth the number of Membership Interests proposed to be sold, the name and address of the proposed third-party purchaser, the proposed amount and form of consideration and terms and conditions of payment offered by such third-party purchaser, the percentage of Membership Interests that the Purchaser may sell to such third-party purchaser (determined in accordance with Section 6(a)), and a representation that such third-party purchaser has been informed of the “tag-along” rights provided for in this Section 6(a) and has agreed to purchase Membership Interests in accordance with the terms hereof. The tag-along rights provided by this Section 6(a) must be exercised by the Purchaser pursuant to this Section 6(a) within ten (10) days following receipt of the notice required by the preceding sentence, by delivery of a written notice to the Company indicating the Purchaser wishes to exercise its rights and specifying the number of Membership Interests (up to the maximum number of Membership Interests owned by the Purchaser required to be purchased by such third-party purchaser) it wishes to sell. The failure of the Purchaser to respond within such 10-day period shall be deemed to be a waiver of the Purchaser rights under this Section 6(a), provided that the Purchaser may waive its rights under this Section 6(a) prior to the expiration of such 10-day period by giving written notice to the Company. If a third-party purchaser fails to purchase Membership Interests from the Purchaser pursuant to this Section 6(a), then the Company shall not be permitted to consummate the proposed sale of its Membership Interests unless and until, simultaneous with such sale, the Company purchases from the Purchaser the number of Membership Interests the Purchaser is entitled to sell under this Section 6(a) on the same terms and conditions as the Company is Transferring its Membership Interests to the third-party purchaser.

 

(b) General. Any attempt to Transfer any Membership Interests or any rights thereunder in violation of this Agreement shall be null and void ab initio.

 

7. Modification. This Agreement shall not be modified or waived except by an instrument in writing signed by the party against whom any such modification or waiver is sought.

 

8. Notices. Any notice or other communication required or permitted to be given hereunder shall be in writing and shall be deemed effectively given: (a) upon personal delivery to the party notified, (b) when sent by confirmed email or facsimile if sent during normal business hours of the recipient, if not, then on the next business day, (c) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one day after deposit with a nationally recognized overnight courier, specifying next day delivery, with written verification of receipt. All communications shall be sent to the parties at their respective address, email or facsimile number set forth on the signature page hereto, or to such other address as such party shall have furnished in writing in accordance with the provisions of this Section 8.

 

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9. Assignability. This Agreement and the rights, interests and obligations hereunder are not transferable or assignable by the Purchaser and the transfer or assignment of any Purchased Membership Interests acquired by the Purchaser shall be made only in accordance with all applicable laws and the terms of the Company’s Operating Agreement, as applicable. Any purported transfer in violation of this Agreement or the Operating Agreement, as applicable, shall be null and void ab initio.

 

10. Applicable Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New York applicable to contracts to be wholly- performed within said State.

 

11. Dispute Resolution. The parties (a) hereby irrevocably and unconditionally submit to the jurisdiction of the state courts of New York located in New York county and to the jurisdiction of the United States District Court for the Southern District of New York for the purpose of any suit, action or other proceeding arising out of or based upon this Agreement, (b) agree not to commence any suit, action or other proceeding arising out of or based upon this Agreement except in such courts, and (c) hereby waive, and agree not to assert, by way of motion, as a defense, or otherwise, in any such suit, action or proceeding, any claim that it is not subject personally to the jurisdiction of the above-named courts, that its property is exempt or immune from attachment or execution, that the suit, action or proceeding is brought in an inconvenient forum, that the venue of the suit, action or proceeding is improper or that this Agreement or the subject matter hereof may not be enforced in or by such court.

 

WAIVER OF JURY TRIAL: EACH PARTY HEREBY WAIVES ITS RIGHTS TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION BASED UPON OR ARISING OUT OF THIS AGREEMENT, THE PURCHASED MEMBERSHIP INTERESTS OR THE SUBJECT MATTER HEREOF OR THEREOF. THE SCOPE OF THIS WAIVER IS INTENDED TO BE ALL-ENCOMPASSING OF ANY AND ALL DISPUTES THAT MAY BE FILED IN ANY COURT AND THAT RELATE TO THE SUBJECT MATTER OF THIS TRANSACTION, INCLUDING, WITHOUT LIMITATION, CONTRACT CLAIMS, TORT CLAIMS (INCLUDING NEGLIGENCE), BREACH OF DUTY CLAIMS, AND ALL OTHER COMMON LAW AND STATUTORY CLAIMS.

 

12. Blue Sky Qualification. The purchase of Purchased Membership Interests under this Agreement is expressly conditioned upon the exemption from qualification of the offer and sale thereof, as applicable, from applicable federal and state securities laws. The Company shall not be required to qualify the Offering or any issuance of Purchased Membership Interests under the securities laws of any jurisdiction.

 

13. Use of Pronouns. All pronouns and any variations thereof used herein shall be deemed to refer to the masculine, feminine, neuter, singular or plural as the identity of the person or persons referred to may require.

 

14. Miscellaneous.

 

(a) This Agreement, including all attachments, schedules and exhibits thereto, constitutes the entire agreement between the Purchaser and the Company with respect to the subject matter hereof and supersede all prior oral or written agreements and understandings, if any, relating to the subject matter hereof.

 

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(b) The representations and warranties of the Purchaser made in this Agreement shall survive the execution and delivery hereof and delivery of the Purchased Membership Interests.

 

(c) Each of the parties hereto shall pay its own fees and expenses (including the fees of any attorneys, accountants, appraisers or others engaged by such party) in connection with this Agreement and the transactions contemplated hereby whether or not the transactions contemplated hereby are consummated.

 

(d) This Agreement may be executed in one or more counterparts (including electronic counterparts), each of which shall be deemed an original, but all of which shall together constitute one and the same instrument. This Agreement will be binding on the parties hereto and their successors, permitted assigns and legal representatives.

 

(e) Each provision of this Agreement shall be considered separable and, if for any reason any provision or provisions hereof are determined to be invalid or contrary to applicable law, such invalidity or illegality shall not impair the operation of or affect the remaining portions of this Agreement.

 

(f) Paragraph and Section titles are for convenience and descriptive purposes only and are not to be considered in construing or interpreting this Agreement.

 

[SIGNATURE PAGE FOLLOWS]

 

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In Witness Whereof, the parties hereto have executed this Agreement as of the last date set forth in the spaces provided below on which a party executed this Agreement.

 

PURCHASER:  
   
HOTH THERAPEUTICS, INC.  
     
By:    
Name: Robb Knie  
Title: Chief Executive Officer  
     
Date:    

 

Address: 1 Rockefeller Plaza, Suite 1039, New York, NY 10020

 

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In Witness Whereof, the parties hereto have executed this Agreement as of the last date set forth in the spaces provided below on which a party executed this Agreement.

 

COMPANY:  
   
HALOVAX, LLC  
     
By:    
Name:              
Title:    
     
Date:    

 

 

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Exhibit 99.1

 

 

Hoth Therapeutics Announces Agreement to Joint Development For a Self-Assembling
Vaccine (SAV) for the Potential Prevention of the Coronavirus (COVID-19)

 

 

The SAV technology has been exclusively licensed from Massachusetts General Hospital

 

Preclinical development to be undertaken in conjunction with Voltron Therapeutics and the Vaccine & Immunotherapy
Center (VIC) at Massachusetts General Hospital

 

NEW YORK, NY March 23, 2020/ PRNewswire/ Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced it has reached an agreement with Voltron Therapeutics, Inc. (Voltron) to form a joint venture entity, to be named HaloVax, to commence preclinical studies for the development of vaccine prospects to prevent the Coronavirus (COVID-19) based upon VaxCelerate, a self-assembling vaccine (SAV) platform exclusively licensed by Voltron from the Vaccine and Immunotherapy Center (VIC) at Massachusetts General Hospital (MGH).

 

Hoth and Voltron, with the support of MGH, will work jointly on exploring and developing this SAV technology as a means to aid patients at risk of being infected with COVID-19. The VaxCelerate vaccine platform was developed as a means of rapidly generating and pre-clinically testing a new vaccine against specific pathogen targets. The technology which received Department of Defense (DoD) funding has demonstrated proof of concept in Lassa Fever, an emerging infectious disease. HaloVax intends to use these same SAV principles to assist in the development of a potential vaccine against the COVID-19 pandemic.

 

Hoth believes VaxCelerate offers two unique elements to combat the Coronavirus - one fixed immune adjuvant and one variable immune targeting and offers several potential advantages over other compounds in combination therapy. In infectious applications, it allows rapid development against viruses and other pathogens. The vaccine focuses on both DNA and internal / external mutated proteins providing the immune system with more potential targets to attack.

 

VaxCelerate was created by Dr. Mark Poznansky, MD, PhD, and Dr. Jeffrey Gelfand, MD, who will both continue to support its research and development. Dr. Poznansky is the Director of the Vaccine and Immunotherapy Center (VIC) and a Physician at Massachusetts General Hospital, as well as an Associate Professor of Medicine at Harvard Medical School. Dr. Poznansky will serve as both scientific founder and scientific advisory board member of Halovax to help advise on the early clinical research and implementation of testing in the hospital setting.

 

Dr. Gelfand is an infectious disease specialist in Boston, Massachusetts. He received his medical degree from Tufts University School of Medicine and has been in practice for more than 20 years. Dr. Gelfand’s specializes in infectious disease. He is also a Clinical Professor of Medicine at Harvard University, where he has developed a novel approach for targeting (tumor) antigens whose sequence may not be known or structure even identified.

 

Dr. Mark Poznansky, Director, Vaccine and Immunotherapy Center, of MGH stated, “The team at the Vaccine and Immunology Center at Massachusetts General Hospital is focused on developing a self-assembling vaccine (SAV) for COVID-19 through its existing VaxCelerate platform. The mobilization of T-cells in the eradication of viruses is well documented.   Our experience in proof of concept studies supports the ability of the SAV to evoke immune responses to viruses.   Through our partnership with Voltron, we look forward to collaborating to bring this technology to the clinic and exploring how it can potentially be used to prevent the virus in the population at large and especially individuals who are at risk for the most serious consequences of COVID-19 infection.” 

 

 

 

 

  

Dr. Michael Callahan, Chief of Translational Medicine, Vaccine and Immunotherapy Center, of MGH said, “We believe this SAV technology developed at the VIC, which has proof of concept data in infectious diseases and oncology in four animal models, has the potential to assist in the rapid development and testing of products to prevent, intercept or treat COVID-19. The customizable cellular immunity generated by the SAV may safely and effectively protect patients worldwide.”

 

Dr. Andrew Herr, PhD, Hoth’s Scientific Advisor, will work closely with Dr. Pozansky and Dr. Gelfand. Dr. Herr is an associate professor in the Division of Immunobiology and Center for Systems Immunology, with an affiliate appointment in the Division of Infectious Diseases at Cincinnati Children’s Hospital within the UC Department of Pediatrics. Dr. Herr completed his thesis work in molecular biophysics from Washington University in St. Louis, and completed his postdoctoral work in structural immunology at the California Institute of Technology as a Damon Runyon Research Fellow. He was recruited to the University of Cincinnati College of Medicine as an Ohio Eminent Scholar in Structural Biology before moving to Cincinnati Children’s Hospital.

 

“COVID-19 is global a pandemic. With the support of Andy Herr, Hoth’s Scientific Advisor and professor of infectious diseases at the University of Cincinnati, we intend to leverage our resources to develop products designed to prevent this deadly virus. We believe that the VaxCelerate technology has the potential to provide a differentiated approach to finding a COVID-19 vaccine.” said Mr. Robb Knie, Chief Executive Officer of Hoth.

 

Pursuant to the agreement, Hoth shall be granted the right to receive single digit royalties from the sale of any products developed, and shall have the right to acquire up to a 30% equity interest in HaloVax.

 

About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for dermatological disorders. Hoth's pipeline has the potential to improve the quality of life for patients suffering from indications including atopic dermatitis, chronic wounds, psoriasis, asthma and acne. To learn more, please visit www.hoththerapeutics.com.

 

 

 

 

Forward Looking Statements


This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements that relate to the joint venture and the preclinical development of the SAV technology for COVID-19 and the potential development of products related to COVID-19 and other information that is not historical information. When used herein, words such as "anticipate", "being", "will", "plan", "may", "continue", and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Hoth's current expectations and various assumptions. Hoth believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption "Risk Factors" in Hoth's Form 10K for the period ending December 31, 2019, and Hoth's other filings made with the Securities and Exchange Commission. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

 


Investor Contact:
Phone: (646) 756-2997
Email: investorrelations@hoththerapeutics.com 
www.hoththerapeutics.com

 

KCSA Strategic Communications
Valter Pinto, Managing Director 
(212) 896-1254
Hoth@kcsa.com