Section 6.5 BioAge Covenants. BioAge covenants to Amgen that:
(a) it will conduct, and will cause its contractors to conduct, all preclinical and clinical studies for the Product and manufacturing of the Product, in accordance with (i) all U.S. Laws and the Laws of the country in which such clinical studies are conducted, and (ii) the known or published standards of the FDA and the Regulatory Authority in such country, including but not limited to good laboratory practice, good clinical practice, and current good manufacturing practices. Neither BioAge, nor any officer, employee or agent of BioAge, will knowingly make an untrue statement of a material fact to any Regulatory Authority with respect to the Product (whether in any submission to such Regulatory Authority or otherwise), and neither will knowingly fail to disclose a material fact required to be disclosed to any Regulatory Authority with respect to the Product;
(b) it (and its Affiliates) will not employ or otherwise use in any capacity the services of any Person debarred or excluded under United States Law, including under 21 U.S.C. § 335a and 42 U.S.C. § 1320a-7(a), or any foreign equivalent thereof, including any Person that has been: (i) debarred by the FDA (or subject to a similar sanction of a Regulatory Authority), or that is subject of an FDA debarment investigation or proceeding (or similar proceeding of a Regulatory Authority), or is otherwise ineligible to participate in federal healthcare programs or federal procurement or non-procurement programs; or (ii) has been convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), but has not yet been excluded, debarred, suspended or otherwise declared ineligible;
(c) if, during the term of this Agreement, BioAge becomes aware that any Person employed or retained by it to perform any of its obligations under, or services related to, this Agreement: (i) comes under investigation by the FDA, or a similar Regulatory Authority, (ii) is debarred, excluded, suspended, disqualified or subject to a similar sanction of a Regulatory Authority, or (iii) engages in any conduct or activity that could lead to any of the aforementioned actions or similar sanctions of a Regulatory Authority, BioAge shall immediately notify Amgen;
(d) it shall comply with all applicable Law, International Trade Law, Proper Conduct Practices, and Anti-Corruption Laws in connection with the performance of its rights, duties and obligations under this Agreement;
(e) it shall provide Amgen with any information required by Amgen to comply with International Trade Laws with respect to this Agreement;
(f) it shall promptly provide Amgen with written notice upon receiving a formal notification that it is the target of a formal or informal request for information, subpoena, investigation, litigation, penalty, or claim from any Governmental Authority, or any Third Party, for violation or potential violation of any applicable Anti-Corruption Law, International Trade Laws or Proper Conduct Practices;
(g) prior to beginning any development or commercialization of any Product under this Agreement, each of its employees, agents, independent contractors or Affiliates involved in the development or commercialization of any Product shall be required to undergo compliance training with respect to Proper Conduct Practices and Anti-Corruption Laws;
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