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): February 19, 2024

101 Glen Lennox Drive, Suite 300

Chapel Hill, NC 27517

(Address of principal executive offices) (Zip Code)

919-855-2100

(Registrant’s telephone number, including area code)

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:

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

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2).

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. ☐

Item 1.01 Entry into a Material Definitive Agreement.

On February 19, 2024, Tenax Therapeutics, Inc. (the “Company”) and Orion Corporation (“Orion”) entered into an amendment (the “Amendment”) to that certain License Agreement between the Company and Orion dated as of September 20, 2013, as previously amended on October 9, 2020 and January 25, 2022 (the “Agreement”). The Amendment broadened the geographic scope of the original license, granting the Company the exclusive right to develop and commercialize certain levosimendan-based products worldwide, formerly rights limited to Canada and the United States, but excluded the treatment of neurological conditions from the Company’s right of first refusal under the Agreement to obtain rights to develop and commercialize new formulations, routes of administration, dosages, or indications of levosimendan-based products. The Amendment also reduced the tiered royalties based on worldwide net sales of the product by the Company and its sublicensees, increased the Agreement’s existing milestone payment due to Orion upon the grant of United States Food and Drug Administration approval of a levosimendan-based product to $10.0 million and added a milestone payment to Orion of $5.0 million due upon the grant of regulatory approval for a levosimendan-based product in Japan. The Amendment also (i) increased the Company’s obligations to make certain non-refundable commercialization milestone payments to Orion, aggregating to up to $45.0 million, contingent upon achievement of certain cumulative worldwide sales of the product by the Company, and (ii) reduced the maximum price per capsule payable by the Company to Orion, under a yet-to-be-negotiated supply agreement, for the commercial supply of oral levosimendan-based product.

The foregoing summary of the material terms of the Amendment is subject to the full and complete terms of the Amendment, a copy of which is attached to this Current Report on Form 8-K as Exhibit 10.1 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

*Portions of this Exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K. The Company agrees to furnish supplementally an unredacted copy of this Exhibit to the Securities and Exchange Commission upon request.

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.

EXHIBIT 10.1

CERTAIN INFORMATION IDENTIFIED WITH THE MARK “[***]” HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE SUCH INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED

THIRD AMENDMENT

TO THE LICENSE AGREEMENT OF SEPTEMBER 20, 2013

This Third Amendment to the License Agreement of September 20, 2013 (hereinafter referred to as the “Amendment”) is made and executed as of this 19^th day of February, 2024 (“Effective Date of Amendment”) by and between:

Orion Corporation, Business Identity Code 1999212-6, a company registered under the laws of Finland and having its principal office at Orionintie 1, 02200 Espoo, Finland (hereinafter referred to as “Orion”); and

Tenax Therapeutics, Inc., EIN number 26-2593535, a company registered under the laws of the State of Delaware, and having its principal office at 101 Glen Lennox Drive, Suite 300, Chapel Hill, NC 27517, USA (hereinafter referred to as “Licensee”).

Orion and Licensee are collectively referred to herein as the “Parties” and each individually as a “Party”.

NOW, THEREFORE, the Parties, in consideration of the premises and of the mutual agreement, covenants and conditions hereinafter set forth, hereby agree and convene as follows:

1 TERMS USED IN THIS AMENDMENT

1.1 Unless otherwise explicitly agreed herein, all capitalized terms used herein shall have the same meaning as given to them under the Agreement.

2 AMENDMENTS TO THE AGREEMENT

2.1 Section 1.26. (“Line Extension Products”) of the Agreement shall be replaced with the following:

1.26. “Line Extension Products” means new developments of the Product, for instance, as to the formulation, presentation, means of delivery, route of administration, dosage or indication (whether or not patented or patentable). Notwithstanding the foregoing, any new development(s) of the Product intended to be used in the field of neurological disorders or diseases shall not be considered Line Extension Product(s).

2.2 Section 1.50. (“Territory”) of the Agreement shall be replaced with the following:

1.50. “Territory” means the United States of America and Canada, and their respective territories, commonwealths and possessions. Notwithstanding the foregoing, solely with respect to the Oral Product, the Modified Oral Product and the Subcutaneously Administered Product, the “Territory” means the entire world.

2.3 Section 3.2. (Development Milestone Payments) of the Agreement shall be replaced with the following:

3.2. Development Milestone Payments. Licensee shall pay to Orion the following non-refundable development milestone payments no later than twenty-eight (28) days after the achievement of the applicable milestone event by or on behalf of Licensee, an Affiliate thereof, or a Sublicensee (or jointly or in the aggregate by or on behalf of the same):

If Licensee, and/or any of its Affiliates and/or Sublicensees Develop the Product for several indications subsequent to which two (or more) Regulatory Approvals in the United States, Canada, or Japan, respectively, are applied for, each of the above development milestone payments is payable also for each such additional indication in the United States, Canada, or Japan, respectively; provided, however, that no additional development milestone payments will be due in case Licensee, an Affiliate thereof, or a Sublicensee submits a sNDA for an extension of the indication for the Product in the United States, Canada, or Japan, as applicable.

2.4 Section 3.3. (Commercialization Milestone Payments) of the Agreement shall be replaced with the following:

3.3. Commercialization Milestone Payments. Licensee shall pay to Orion the following non-refundable commercialization milestone payments, contingent upon occurrence of the specified event and payable the first time such milestone event is achieved:

2.5 Subsection 4.1.1. of the Agreement, pertaining to the royalty payments on Net Sales in Territory, shall be replaced with the following:

4.1.1. During the Term:

2.6 The Agreement is hereby amended by adding the following Section 6.5:

The Parties agree that Licensee’s obligations under this Section 6 shall only apply with respect to the Development or Commercialization of the Product in the Territory by or on behalf of Licensee, its Affiliates, and/or Sublicensees. Orion shall ensure that any Affiliate thereof or licensee, sublicensee, or other development or commercial partner of Orion or any Affiliate thereof with respect to any Levosimendan-containing product (“Levo Product”) provides Orion with sufficient information (and rights thereunder) to enable (i) Orion to satisfy its obligations under this Section 6 and (ii) Licensee, its Affiliates, and Sublicensees to satisfy their obligations with respect to the Product to any Regulatory Authority or under any applicable law, rule, or regulation.

2.7 Section 15.1 of the Agreement is hereby amended by replacing clauses (c) and (d) thereof with the following:

2.9 Section 15.2 of the Agreement is hereby amended by replacing clause (c) thereof with the following:

2.10 The following amendment is hereby agreed and made in respect of the second sentence of Section 2.9.ii. of the First Amendment as amended by Section 2.2 of the Second Amendment:

In the event Orion uses the Supply Option in respect of the Oral Product, the Parties shall separately negotiate on such supply of the Oral Product, it being agreed that Orion may not require a higher transfer price for the Oral Product than [***] per capsule.

3 EFFECTIVE DATE

3.1 The amendments to the Agreement agreed upon herein shall become effective as of the Effective Date of Amendment.

4 OTHER PROVISIONS

4.1 For the avoidance of doubt it is stated that except for what has been stipulated herein above, all other terms and conditions of the Agreement will remain unchanged.

4.2 The terms and conditions of the Agreement with regard to the choice of law and dispute resolution will apply to this Amendment.

***Balance of page left blank. Signature page follows.***

IN WITNESS WHEREOF, the Parties, through their authorized representatives, have executed two (2) identical counterparts of this Amendment.