Gilead – MPP – Arene Lifesciences, HIV Therapeutic License Agreement

Intellectual Property | Protection of IP

Annotations

This license agreement between Gilead Sciences, Inc, the Medicines Patent Pool (“MPP”) and Arene Lifesciences Ltd (“Licensee”) and the first amendment to it were signed in April 2018 and subsequently amended in November 2019. It follows a separate agreement between Gilead and MPP which allows MPP to grant sublicenses to manufacturers of generic pharmaceutical products in relation to several HIV therapeutics developed by Gilead.

The licensed Active Pharmaceutical Ingredients under this agreement are tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”); elvitegravir (“EVG”), cobicistat (“COBI”) and bictegravir (“BIC”, added in Amendment 1). The scope of the license also covers a product referred to as the “Quad” which is a single-tablet, fixed-dose product containing a combination of either TDF or TAF and emtricitabine, EVG and COBI. The agreement defines a number of Products using either a single licensed API on its own, or a licensed API in combination with other APIs.

The Field for the license grants any use that is consistent with the label approved by the FDA or applicable foreign regulatory authority in the country of sale for the use for the specific product, this includes both the treatment and pre-exposure prophylaxis (PrEP) of HIV infection.

The Territory for the agreement is separated into the TDF-TAF Territory (117 countries – see Amendment 2, Appendix 1), the COBI Territory (117 countries – see Amendment 2, Appendix 5) and the EVG-Quad Territory (109 countries – see Amendment 1, Appendix 6), and the BIC Territory (117 countries – see Amendment 2, Appendix 7).

Gilead and MPP have similar sublicense agreements in place with Adcock Ingram (South Africa) and Anhui Biochem (China).

Provision Language

5. Intellectual Property

5.1 Maintenance of Patents. Neither Gilead nor MPP (or, where applicable, Japan Tobacco) shall be obliged to maintain or enforce the Patents.

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Gilead – MPP – Arene Lifesciences, HIV Therapeutic License Agreement

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Gilead – MPP – Arene Lifesciences, HIV Therapeutic License Agreement

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