Provision Language
5. Intellectual Property
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5.4 Technology Transfer. Promptly following the Effective Date, Gilead shall make a one–time technology transfer of know–how owned or controlled by Gilead as of the Effective Date relating to the manufacture of TDF, TDF Product and TDF Quad, COBI, COBI Product, EVG and EVG Product to the extent and in the manner specified in Appendix 3 hereto. Promptly following the later of the Effective Date and Gilead’s receipt of marketing approval from the FDA for a TAF Product, Gilead shall make available a one–time technology transfer of know–how owned or controlled by Gilead relating to the manufacture of TAF and TAF Product, to the extent, and in the manner specified in Appendix 3 hereto. Promptly following the later of the Effective Date and Gilead’s receipt of marketing approval from the FDA for the TAF Quad, Gilead shall make available a one–time technology transfer of know–how owned or controlled by Gilead relating to the manufacture of TAF Quad, to the extent, and in the manner specified in Appendix 3 hereto Except as expressly provided in this Section 5.4, Gilead shall have no further obligation to transfer any other know–how under this Agreement.
[Added by Amendment 1] Promptly following the later of the Amendment Effective Date and Gilead’s receipt of marketing approval from the FDA for a Product containing BIC, Gilead shall make available a one–time technology transfer of know–how owned or controlled by Gilead relating to the manufacture of BIC and such FDA–approved Product containing BIC, as applicable, to the extent, and in the manner specified in Appendix 3 attached hereto. Except as expressly provided in this Section 7, Gilead shall have no further obligation to transfer any other know–how under this Amendment.
Appendix 3 – Terms for Technology Transfer
Gilead will make available to Licensee the following information in accordance with Section 5.4 to fully enable Licensee to manufacture FTC, TAF, TDF, EVG, COBI, TDF Product, TAF Product, EVG Product, COBI Product and Quad Product at commercial–scale quantities and in compliance with Gilead’s required quality specifications:
1. Manufacturing process descriptions, specifications and methods;
2. Stability data;
3. Analytical method validation; and
4. Discussion of impurities.