Gilead, HIV Therapeutic (Lenacapavir) Template License Agreement

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Gilead Sciences Ireland UC (“Gilead“) entered into this Lenacapavir License Agreement (“Agreement“) with six pharmaceutical manufacturers (“Licensee“) on September 24, 2024. Per Gilead’s related press release, the Agreement is part of Gilead’s strategy to facilitate access to its proprietary compound Lenacapavir in 120 primarily low- and lower-middle income countries.

Under the Agreement, the Licensee is granted a royalty-free, non-exclusive license to manufacture and sell Lenacapavir and finished pharmaceutical product containing Lenacapavir that is bioequivalent to Gilead’s branded product (“Product“) in 120 primarily low- and lower-middle income countries (“Territory“) for use in pre-exposure prophylaxis (PrEP) and treatment of heavily treatment-experienced HIV patients (“Field“). Sales of Lenacapavir are restricted to certain product suppliers, and sales of the Product are restricted to hospitals, governments or other care sites, and third party distributors.

Gilead agrees to provide a Technology Transfer Package to the Licensee if requested within 90 days of agreement execution. The information and know-how transferred will be sufficient to enable the Licensee to manufacture Lenacapavir and Product at commercial scale. Gilead also agrees to selectively waive certain regulatory exclusivity to the extent required for the Licensee to obtain tentative approval of the Product.

The Licensee’s obligations under the Agreement include taking measures to prevent diversion of the Product outside of the intended country of sale and distribution, conducting manufacturing activities in accordance with appropriate quality standards, and providing monthly reports on product sales and regulatory activities.

Provision Language

4. Consideration/Payment Terms/Audit

4.1 No Royalties. No royalties will be owed by Licensee to Gilead on Licensee’s sale of Product hereunder.

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Gilead, HIV Therapeutic (Lenacapavir) Template License Agreement

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Gilead, HIV Therapeutic (Lenacapavir) Template License Agreement

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