Master Alliance Provisions Guide (MAPGuide)

Gilead, HIV Therapeutic (Lenacapavir) Template License Agreement

  • Business model | Regulatory strategy

6. Manufacturing and Commercialization of Product

6.3 Regulatory Filings and Inspections. Except as provided otherwise herein, Licensee shall be responsible for obtaining and maintaining all applicable regulatory or other approvals or authorizations to carry out its activities in the Territory as set forth in this Agreement and subject to the restrictions on scope in Section 2.1(c). Gilead may, in its discretion, elect to file for regulatory or other approval or authorization to make and sell Lenacapavir and Product anywhere in the Territory. Upon either Party’s request, the other Party shall provide non-proprietary data that the other Party believes is reasonably necessary to obtain any such approvals, authorizations, permits or licenses. Licensee shall obtain, have and maintain all required registrations for its manufacturing facilities for Lenacapavir and Product. Licensee shall allow appropriate regulatory authorities to inspect such facilities to the extent required by applicable law, rule or regulation. Gilead agrees to selectively waive NCE Exclusivity for the limited purpose of enabling Licensee to obtain tentative approval of the Product in order for the Licensee to manufacture or sell product in compliance with the terms and conditions of this Agreement. This selective waiver, as it applies to the US market, is conditioned on the submission of a Paragraph III certification (21 U.S.C. 355(j)(2)(A)(vii)(III)) for each and every patent or exclusivity listed in the US FDA Orange Book with respect to Lenacapavir, including patents that claim each of the active pharmaceutical ingredients in the Product. Licensee agrees not to amend its generic application with the US FDA to include any Paragraph IV certification (21 USC 355(j)(2)(A)(vii)(IV)) for the Product licensed herein if the generic application relies on the Licensed Know How or any other Confidential Information of the Gilead. For the avoidance of doubt, subject to Licensee’s compliance with limitations on use of Licensed Know-How and other Confidential Information of Gilead hereunder, this paragraph does not restrict Licensee from submitting a separate generic application with a Paragraph IV certification (an “Independent ANDA Application”) to the extent the Licensee would otherwise be legally permitted and able to do but-for this Agreement, namely without the benefit of any of NCE exclusivity, and without reliance upon Licensed Know-How or other Confidential Information of Gilead, provided that any such Independent ANDA Application (and any communications with the FDA related to the application) do not reference, incorporate, or otherwise rely upon any prior regulatory filing or approvals obtained by Licensee through the use of Licensed Know-How and Other Confidential Information of Gilead. Licensee agrees not to pursue or obtain regulatory exclusivity for Product in any country worldwide.

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6.6 Safety Reporting.

(a) Licensee is responsible for all single and periodic reporting to all applicable regulatory authorities for the Product manufactured by or on behalf of Licensee under the Agreement.

(b) Licensee is responsible for all pharmacovigilance activities with respect to such Product regardless of the Territory, including but not limited to all associated signal detection, risk management and product labelling requirements.

(c) In the event Licensee receives an individual case safety report associated with any Gilead proprietary product, Licensee agrees to forward such reports to Gilead within fifteen (15) calendar days of awareness and in English to E-Mail: Safety_FC@gilead.com Fax: +1-650-522-5477. When sending any such reports by email, to the above address, Licensee will ensure an acknowledgement is received from Gilead (to confirm receipt) and document the acknowledgement. If not received within one (1) business day, the safety report should be resent. (d) Licensee will forward details of any confirmed safety signals or emerging safety issues relating to Product manufactured by or on behalf of Licensee under this Agreement and any supporting documentation to the risk management contact at Gilead: PSAlliances@gilead.com.

7. Representations, Warranties and Covenants

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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.