(e) Neither GCC nor any GCC Subsidiary has received any written notice from any person, or have Knowledge of, any actual or threatened claim or assertion that the use or practice of the Product Technology infringes or misappropriates the intellectual property rights of a Third Party.
(f) There are no actual, pending, or alleged or threatened in writing, adverse actions, suits, claims, interferences or formal governmental investigations by or against GCC or any GCC Subsidiary in or before any court or Governmental Authority involving Product Technology.
(g) GCC and GCC Subsidiaries have complied in all material respects with all applicable Laws, including all good clinical practices, good laboratory practices and good manufacturing practices, permits, governmental licenses, registrations, approvals, authorizations, orders, injunctions and decrees, in the research, development, manufacture and use of any Product, and neither GCC nor any GCC Subsidiary has received any written notice from any Governmental Authority claiming that any such activities as conducted by it are not in such compliance.
(h) All of GCC’s and GCC Subsidiaries’ employees acting on its behalf who have performed research, development, manufacturing or regulatory activities with respect to any Product are and will be obligated under a binding written agreement to comply with obligations of confidentiality and non-use no less restrictive than those set forth in Article 9 of the Option Agreement.
7.3 Covenants. Each Party covenants to the other Party as follows:
(a) No Debarment. Neither such Party, nor, in the case of GCC, its GCC Subsidiaries, is debarred or disqualified under the United States Federal Food, Drug and Cosmetic Act or comparable applicable Laws in the Territory and, in the course of development, manufacturing or other activities relating to any Product, neither Party, nor, in the case of GCC, its GCC Subsidiaries, has used or shall use any employee, consultant or subcontractor who has been debarred or disqualified or, to such Party’s Knowledge, is the subject of debarment or disqualification proceedings by a Regulatory Authority. Each Party shall notify the other Party promptly upon becoming aware that any of its or its subsidiaries’ employees, consultants or subcontractors involved in any development, manufacturing or other activities relating to any Product has been debarred or disqualified or is the subject of debarment or disqualification proceedings by any Regulatory Authority.
(b) Compliance. Both Parties and their respective Affiliates shall comply in all material respects with all applicable Laws in the development, manufacture and commercialization of any Product, in each case, to the extent applicable, including the statutes, regulations and written directives of the FDA, the EMA and any other Regulatory Authorities, the Federal Food, Drug & Cosmetic Act, as amended, the Prescription Drug Marketing Act, the Federal Health Care Programs Anti-Kickback Law, 42 U.S.C. 1320a-7b(b), the statutes, regulations and written directives of Medicare, Medicaid and all other health care programs, as defined in 42 U.S.C. § 1320a-7b(f), and the Foreign Corrupt Practices Act of 1977, each as may be amended from time to time.
(c) Employees and Subcontractors. During the Term, all employees and subcontractors of a Party or its Affiliates performing research, development, commercialization or other activities contemplated hereunder on behalf of such Party or its Affiliates shall be obligated to undertake in writing obligations of ownership of Information, discoveries and inventions which are the same as those undertaken by the Parties pursuant to Section 5.1.
7.4 Additional GCC Covenant. GCC hereby covenants to Artiva that during the Term, GCC shall not amend, modify or terminate any of the Existing Third Party Agreements in a manner that could affect Artiva, except with Artiva’s prior written consent.
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