Gilead – MPP – Arene Lifesciences, HIV Therapeutic License Agreement

Liability | Insurance

Summary of Approaches

Will the parties be required to obtain insurance to protect against certain liabilities in relation to the project?
- Arene Lifesciences must obtain general liability insurance, including product liability, with a limit of not less than $1 million. Certificates of the insurance must be provided to MPP and Gilead 30 days prior to first commercial launch, and the insurance must be maintained for 2 years after the agreement.

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

9. Insurance

Within thirty (30) days prior to the first commercial launch by Licensee of a Product, and each year thereafter for so long as this Agreement is in effect, Licensee shall provide to Gilead and MPP certificates of insurance by insurers acceptable to Gilead and MPP evidencing comprehensive general liability coverage, including products liability, with a combined limit of no less than one million dollars ($1,000,000.00) for bodily injury, including personal injury, and property damage. Gilead shall have the right to provide any such certificate to Japan Tobacco. Licensee shall not cancel any such policy without at least sixty (60) days prior written notice to Gilead and MPP, and agrees that such policy shall be maintained (or have an extended reporting period) of at least two (2) years after the termination of this Agreement.

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Gilead – MPP – Arene Lifesciences, HIV Therapeutic License Agreement

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