BMS – MPP, Hepatitis C Antiviral (daclatasvir – DAC) License & Tech Transfer Agreement

Business model | Regulatory strategy

Structural Questions

Which party is responsible for obtaining and maintaining regulatory approvals?
In which jurisdiction(s) should the responsible party seek regulatory approvals
Will the parties seek regulatory exclusivity in any jurisdictions?
How will the parties cooperate and share information related to regulatory approvals? Do the parties grant each other rights of reference to their regulatory materials?
What are the parties’ obligations in relation to pharmacovigilance activities?

Summary of Approaches

BMS – MPP Agreement & Form of Sublicense

Which party is responsible for obtaining and maintaining regulatory approvals?
- Sublicensees are responsible for regulatory approvals for the Territory.
How will the parties cooperate and share information related to regulatory approvals? Do the parties grant each other rights of reference to their regulatory materials?
- The technology transfer information will include the data, including clinical data, reasonably necessary for product registration. BMS will also waive regulatory exclusivity to the extent required.
- Sublicensees must send to MPP, and MPP must send to BMS, quarterly reports of regulatory filing plans, approvals, rejections or expiration, and activities related obtaining and maintaining approvals.
What are the parties’ obligations in relation to pharmacovigilance activities?
- The sublicensee is required to maintain a system for receiving, recording and reporting adverse events and fulfilling any other reporting requirements.

Annotations

This License and Technology Transfer Agreement, dated November 2015, is between Bristol-Myers Squibb Company (“BMS“) and the Medicines Patent Pool Foundation (“MPP“). Under the agreement, MPP receives a royalty-free license under certain BMS patents and manufacturing know-how to make, use and sell daclatasvir (“Licensed Compound“, “DAC“), a Hepatitis C Virus (HCV) medicine, and products containing the License Compound (“Licensed Product“).

The license is granted to MPP solely for the purpose of enabling MPP to grant sublicenses, which must be in a form substantially similar to the Form of Sublicense. Sublicensees are permitted to manufacture and sell Licensed Products solely for the treatment of HCV or other use consistent with a label approved by a regulatory authority (“Field“) for use in a list of low- and middle-income countries provided in Schedule D to the sublicense (“Territory“). A list of sublicensees and copies of the related sublicense agreements are published on MPP’s website.

Sublicensees must use reasonable efforts to promote affordable access and to manufacture and commercialize the Licensed Product in sufficient quantities to meet the needs in the Territory. The supply commitments also include acting upon reasonable requests by MPP to manufacture sufficient quantities of certain product presentations and strengths, and to respond to relevant tenders for the Licensed Product.

Provision Language

BMS – MPP Agreement

6. PHARMACOVIGILANCE AND QUALITY MATTERS

6.1 Pharmacovigilance

(a) The MPP will require that its Sublicensees, in accordance with its standard protocols, maintain effective and reliable systems for receiving and tabulating any reports of adverse reactions to the Licensed Products and to report such information on a timely basis to the relevant regulatory authorities. The MPP will require that its Sublicensees be responsible for fulfilling all required reporting responsibilities under applicable laws and regulations within the Territory.

9 AUDIT AND REPORTS

9.1 Reports. The MPP will send to BMS within forty-five (45) calendar days following the end of each calendar quarter the number of units of Licensed Products sold by strength / formulation by country and the number of kilograms of Licensed Compound sold. The MPP shall also provide BMS with a quarterly written report setting forth each Sublicensee’s (a) Licensed Products in its development pipeline, (b) status of development of each Licensed Product in development, (c) regulatory filing plan for each Licensed Product, (d) a list of countries within the Territory for which such regulatory approvals or authorizations have been obtained for any Licensed Product, (e) any rejection, withdrawal, expiration or other significant regulatory development for any Licensed Product, and (f) a description of activities performed by MPP relating to filing, obtaining, or maintaining regulatory approvals or authorizations in the Territory for the Licensed Product and/or Licensed Compound. The MPP and BMS agree to confer on a quarterly basis regarding such reports and also review development and filing status of Licensed Products.

Form of sublicense

6.1 Pharmacovigilance (a) The Sublicensee will, in accordance with its standard protocols, maintain effective and reliable systems for receiving and tabulating any reports of adverse reactions to the Licensed Products and to report such information on a timely basis to the relevant regulatory authorities. The Sublicensee shall be responsible for fulfilling all required reporting responsibilities under applicable laws and regulations within the Territory.

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BMS – MPP, Hepatitis C Antiviral (daclatasvir – DAC) License & Tech Transfer Agreement

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