Master Alliance Provisions Guide (MAPGuide)

Gilead HCV License Agreement with Indian Generic Manufacturers

  • IP ownership & licensing | Use of background IP

§2.1 Licenses:

(a) API License. Subject to the terms and conditions of this Agreement, Gilead hereby grants to Licensee a royalty-free, non-exclusive, non-sublicensable (other than a sublicense to an Affiliate), non-transferable license under the Licensed Technology to (i) make API only in India; and (ii) sell API only in India and solely to Licensed Product Suppliers for the Field.

(b) Product License. Subject to the terms and conditions of this Agreement, Gilead hereby grants to Licensee a royalty-bearing, non-exclusive, non-sublicensable (other than a sublicense to an Affiliate), non-transferable license under the Licensed Technology solely to (i) make Product from Licensed API in India and (ii) sell, have sold, offer for sale, export from India and import such Product made from Licensed API in the Territory for the Field.

§4.1 Royalty:

As consideration for the licenses granted in Section 2, Licensee shall pay Gilead the following royalties on Net Sales of Product in the Territory for the duration of the Royalty Term:

(a) 7% of Net Sales of Sof Product in the Territory.

(i) If any country within the Territory issues a valid, bona fide compulsory license pursuant to (1) the requirements promulgated under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) or (2) valid laws within such country (“Compulsory License”) for any Product, then for the duration of such Compulsory License the royalty payable by Licensee on Net Sales for such Product in such country shall be reduced to the royalty rate paid to Gilead by such country for such Product under such Compulsory License.

§5.1 Maintenance of Patents:

Gilead shall not be obligated to maintain or enforce the Patents.

§5.2 Cooperation:

If either party becomes aware of a suspected infringement of any Patent, such party will notify the other party promptly, and following such notification, the parties agree to discuss the scope of such infringement. Gilead will have the sole right, but not the obligation, to bring an infringement action at its own expense, in its own name, and entirely under its own direction and control. Licensee will have no obligation to assist Gilead with the enforcement or defense of the Patents.

§5.5 Technology Transfer:

During the term of this Agreement, Gilead will make the following technology transfers available to Licensee:

(a) Within ninety (90) days following the Effective Date, Gilead will make a one-time technology transfer available to Licensee of know-how owned or controlled by Gilead as of the Effective Date relating to the manufacture of Sof and Sof Product to the extent and in the manner specified in Appendix 3 hereto.

(b) Within ninety (90) days following Gilead’s receipt of marketing approval from the FDA for a Sof/LDV Product, Gilead will make a one-time technology transfer available to Licensee of know-how owned or controlled by Gilead relating to the manufacture of LDV and Sof/LDV Product to the extent and in the manner specified in Appendix 3 hereto.

(c) Within ninety (90) days following Gilead’s receipt of marketing approval from the FDA for an LDV Product, Gilead will make a one-time technology transfer available to Licensee of know-how owned or controlled by Gilead relating to the manufacture of LDV Product to the extent and in the manner specified in Appendix 3 hereto.

With respect to each of the foregoing technology transfers, Licensee shall notify Gilead of its desire to receive such technology transfer within the time period therefor, and following receipt of such notice Gilead will promptly make the applicable technology transfer. If Licensee does not notify Gilead of its desire to receive a particular technology transfer within the time period therefor, then Gilead will be under no obligation to make such technology transfer. The know-how transferred to Licensee pursuant to the terms of this Section 5.5 shall be sufficient to enable Licensee to manufacture API, Sof Product, Sof/LDV Product and LDV Product, as applicable, at commercial-scale quantities. Gilead shall have no further obligation to transfer any other know-how under this Agreement.

§3.1 Sourcing of API from API Suppliers:

Licensee agrees that it shall not make or use any API other than API that is Licensed API for the manufacture of any Product for sale in the Territory. If Licensee wishes to manufacture Product using API made by either a Gilead Supplier or a Licensed API Supplier, then Licensee shall notify Gilead in writing, and shall certify that its arrangement with such Gilead Supplier or Licensed API Supplier, as applicable, is consistent with the terms and conditions of this Agreement. Licensee shall provide Gilead with written copies of all agreements between Licensee and such Gilead Supplier or Licensed API Supplier upon execution. In the event that any inconsistency is found which had not been specifically discussed and agreed with Gilead, Gilead shall have the right to require Licensee to terminate such agreement with such Gilead Supplier or Licensed API Supplier.­