FOURTH AMENDMENT TO THE LICENSE AGREEMENT OF SEPTEMBER 20, 2013
EXHIBIT 10.3.5
FOURTH AMENDMENT
TO THE LICENSE AGREEMENT OF SEPTEMBER 20, 2013
This Fourth Amendment to the License Agreement of September 20, 2013 (hereinafter referred to as the “Amendment”) is made and executed as of this 2nd day of October, 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 ###-###-####, 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”.
WHEREAS, this Amendment pertains to that certain agreement titled “License Agreement” between the Parties, dated September 20, 2013, as amended October 9, 2020 (the “First Amendment”),
January 25, 2022 (the “Second Amendment”) and February 19, 2024 (the “Third Amendment”); (the License Agreement, as amended by the First Amendment, Second Amendment, Third Amendment and the present Fourth Amendment, hereinafter referred to as the “Agreement”); and
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:
For the purposes of this section, the definitions shall have following meanings: “Personal Data” are any information which are related to an identified or identifiable natural person disclosed by Orion to Licensee pursuant to this Section 7.7. “Data Controller” means an entity that directs the purposes and means of processing of personal data. “Data Protection Legislation” means the following legislation, only to the extent applicable to the relevant Party independent of the other Party,(a) national laws implementing Directive on Privacy
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and Electronic Communications (2002/58/EC); (b) the General Data Protection Regulation (2016/679); and (c) any other similar national privacy law within the European Economic Area.
The Parties acknowledge and agree that each of them shall process Personal Data and act as an independent Data Controller in each of their own rights with respect to the processing of Personal Data. Each Party, as Data Controller, processes Personal Data it receives from the other Party for its own purposes as a Data Controller. Each Party shall process personal data in accordance with Data Protection Legislation.
Each Party is responsible (i) for providing all notices that Data Protection Legislation requires that Party to provide to individuals, including its employees, officers and representatives where relevant, who are the subject of Personal Data; and (ii) for ensuring that in respect of such personal data, it has a valid legal basis for Personal Data processing to the extent required to do so by Data Protection Legislation.
The Parties are not joint controllers pursuant to Article 26 GDPR.
To the extent that Orion transfers any Personal Data to Licensee outside of the EU/EEA, excluding, however, such countries, which are deemed by the European Commission to provide adequate protection to data subjects (pursuant to Article 45 of the EU GDPR), the Parties agree that the current approved EU standard contractual clauses for transfers to controllers shall be signed between the parties (“Standard Contractual Clauses (Controller)”) and shall apply in respect of such personal data transfer. The EU Standard Contractual Clauses (Controller) are attached to this Fourth Amendment as Appendix 1.
Each Party shall notify the other Party promptly after discovery of any accidental, unauthorized, or unlawful destruction, loss, alteration, or disclosure of, or access to, the personal data (“Personal Data Breach”), and shall take immediate steps to rectify any Personal Data Breach.
Furthermore both Parties agree to comply with all laws, regulations and official policies which are in effect and which apply to the subject matter of this Agreement. Without limiting the generality of the foregoing, Licensee hereby agrees to materially comply with the premise of the obligations provided in Orion’s general information security requirements, which are attached to this Fourth amendment as Appendix 2.
***Balance of page left blank. Signature page follows.***
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IN WITNESS WHEREOF, the Parties, through their authorized representatives, have executed two (2) identical counterparts of this Amendment.
Orion Corporation |
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By: /s/ Olavi Kilkku |
| By: /s/ Heikki Mansikka |
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Name: Olavi Kilkku |
| Name: Heikki Mansikka |
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Title: Director, R&D |
| Title: VP, R&D |
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Tenax Therapeutics, Inc. |
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By: /s/ Chris Giordano |
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Name: Chris Giordano |
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Title: President & CEO |
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Appendix 1 STANDARD CONTRACTUAL CLAUSES
Appendix 2 Orion’s general information security requirements
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