Licensee acknowledges that following execution of the TDF License Agreement Gilead provided to Licensee, and Licensee received, a onetime technology transfer of know-how relating to TDF and TDF Product. Promptly following the Effective Date, Gilead agrees to make a one-time technology transfer of know-how owned or controlled by Gilead that specifically relates to the manufacture of FTC (as defined in Section 7.5 below) to the extent and in the manner specified in
Appendix 3 hereto. In addition, promptly following Gilead’s receipt of marketing approval from the FDA (and on a Product-by-Product basis), Gilead shall make a onetime technology transfer of know-how (a) owned or controlled by Gilead as of the Effective Date, or (b) exclusively licensed by Gilead from Japan Tobacco pursuant to the Japan Tobacco Agreement, relating to the manufacture of EVG, COBI and the Quad to the extent and in the manner specified in Appendix 3 hereto (such TDF, FTC, EVG, COBI and Quad know-how, the “Licensed Know-How”). Such Licensed Know-How shall be sufficient to enable Licensee to manufacture TDF and TDF Product, EVG and COBI, EVG Product, COBI Product and Quad, at commercial-scale quantities. Gilead shall have no further obligation to transfer any other know-how to Licensee.
(According to the Appendix 3, Gilead shall provide Licensee with the following information to fully enable Licensee to manufacture the Products: (1) manufacturing process descriptions, specifications and methods; (2) stability data; (3) analytical method validation; and (4) discussion of impurities.)