Provision Language
5. Intellectual Property
[…]
5.5 Technology Transfer. Following the execution of this Agreement, Gilead will, upon Licensee’s written request provided no later than ninety (90) days following execution of the Agreement, transfer know-how or information owned or controlled by Gilead that is specified in Appendix 3 hereto (“Technology Transfer Package”) on an ongoing, rolling basis. Gilead will use commercially reasonable efforts to commence making such Technology Transfer Package available as expediently as practicable following request and in any event within 30 days of the request. If Licensee does not notify Gilead of its desire to receive such technology transfer such ninety (90) day period, then Gilead will be under no obligation to make such technology transfer or subsequently provide further information or know-how. If requested, the information and know-how transferred to Licensee pursuant to the terms of this Section 5.5 shall be sufficient to enable Licensee to manufacture Lenacapavir and Product, at commercial-scale quantities. Gilead shall have no further obligation to transfer any other know-how under this Agreement
Appendix 3: Terms for Technology Transfer
Gilead will make the following information available to Licensee in accordance with Section 5.5 to fully enable Licensee to manufacture Lenacapavir and Product, as applicable, 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.
5. Representative samples of materials on request.