Provision Language
7. Representations, Warranties and Covenants
7.1 Ability to Perform. Gilead and Licensee each represent and warrant that:
(a) they are duly organized, validly existing and in good standing under the laws of the jurisdiction of their incorporation and have full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
(b) this Agreement has been duly executed and delivered, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof; and
(c) the execution, delivery and performance of this Agreement does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party.
7.2 Diversion of Product and Technology
(a) Licensee covenants and agrees that Licensee and its Affiliates shall not, and shall require its permitted subcontractors and Third Party Resellers or direct Customers not to directly or indirectly: (i) sell, re-sell, consign, seek to sell, promote or advertise for sale, export, ship, transport, or seek, solicit or distribute to any third party or divert or allow the diversion of Lenacapavir to third parties in a manner inconsistent with this Agreement, (ii) remove, or allow the removal of Products outside of the Territory, (iii) divert or allow the diversion of Licensed Technology to any third party, (iv) take any action that Gilead determines in good faith to be in furtherance of the activities described in Sections 7.2(a)(i) – (iii), or (v) assist or support, directly or indirectly, any third party in the conduct of the activities described in Sections 7.2(a)(i) – (iv). The Parties agree that it shall not be a breach of Section 3.1 or this Section 7.2 for Licensee or its Affiliate to file marketing approval applications for Product in a country outside of the Territory, or for Licensee or its Affiliate to provide developmental quantities of Lenacapavir or Product in support of such marketing approval applications or a third party’s application for marketing approval, in each case, as required by applicable regulatory authorities in such country, it being understood that this provision shall not be construed as expressly or implicitly granting Licensee any right or license under any Gilead intellectual property right beyond the licenses granted in Article 2 of this Agreement or otherwise providing any authorization by Gilead to do so, and does not constitute a waiver of any rights of Gilead under law that it may have to contest the filing or granting of such marketing approval applications.
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7.3 Compliance
(a) General. Licensee covenants and agrees that it shall perform all activities under this Agreement in accordance with all applicable laws, rules, and regulations, including, without limitation, with respect to privacy, data protection, recalls, safety and reporting requirements and shall obtain, have and maintain all necessary regulatory approvals, Marketing Authorizations, permits and licenses, at Licensee’s expense for the manufacture and sale of the Lenacapavir and/or Product and any other Licensee activities contemplated under this Agreement. In particular, Licensee shall use its best efforts to obtain all applicable Marketing Authorizations for the sale of Products for PrEP in each country in the Territory. If Licensee obtains, and verifies to Gilead that it has obtained, all applicable Marketing Authorizations for each of the eighteen (18) Target Countries within three (3) years of the earlier of the date upon which Gilead receives (a) FDA approval; or (b) WHO PQ for the Product, then Gilead will consider appointing Licensee as a preferred partner (subject to Licensee fulfilling other relevant selection criteria) with respect to any future product formulation of Lenacapavir which Gilead is intending to license.
(b) FCPA and UK Bribery Act. Licensee covenants and agrees that neither the Licensee, nor any of its Affiliates, nor any of their respective directors, officers, employees or agents (all of the foregoing, including Affiliates collectively, “Licensee Representatives”) has taken any action, directly or indirectly, that would result in a violation by such persons of the Foreign Corrupt Practices Act of 1977, as amended (such act, including the rules and regulations thereunder, the “FCPA”), the U.K. Bribery Act of 2010 (“Bribery Act”), or any other applicable anti-bribery or anticorruption laws, rules or regulations (collectively with the FCPA and the Bribery Act, the “Anticorruption Laws”). Licensee covenants and agrees that Licensee and Licensee Representatives have conducted and will conduct their businesses in compliance with the Anticorruption Laws. Licensee covenants and agrees that it shall provide to Gilead on the Effective Date and within thirty (30) days after the beginning of each calendar year thereafter, certification in writing by Licensee of Licensee’s compliance with the Anticorruption Laws.
(c) Anti-Trust laws. Licensee shall, and shall ensure its Affiliates, shall, conduct all activities in connection with this Agreement in compliance with: (i) all antitrust and competition laws applicable in the countries in which Licensee sells or supplies the Products, and (ii) any other applicable antitrust or competition law rules or regulations (collectively, all the foregoing the “Competition Law Standards”).
(d) Conflicts. Neither Party shall be required to take any action or perform any obligation under this Agreement to the extent that such action or obligation is in direct conflict with any applicable law, rule or regulation, provided, however, that both Licensee and Gilead are in agreement regarding (i) the requirements of such law, rule or regulation, and (ii) the affect that such law, rule or regulation has on such action or obligation required under this Agreement.
7.4 Patent Infringement. Licensee covenants and agrees that it shall not infringe the Patents outside the scope of the licenses granted to it pursuant to Article 2.
7.5 EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, GILEAD DOES NOT GIVE ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF NON-INFRINGEMENT IN THE TERRITORY. Gilead also does not give any warranty, express or implied, with regard to the safety or efficacy of Lenacapavir or the Product and it shall be the sole responsibility of the Licensee to ensure such safety or efficacy.