University of Liverpool – MPP, HIV Therapeutic Collaboration Agreement and Patent & Know-How License

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

Which party is responsible for obtaining and maintaining regulatory approvals? In which jurisdiction(s) should the responsible party seek regulatory approvals?
- The Commercialization Partner is responsible for filing for the regulatory approvals needed to ensure access to Licensed Products in the Territory.
Will the parties seek regulatory exclusivity in any jurisdictions?
- Commercialisation Partners must agree: (i) not to seek regulatory exclusivity in the Territory; and (ii) to waive regulatory exclusivity rights for data relating to Licensed Products.
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?
- Commercialisation Partners are required to provide quarterly reports including regulatory filing plans for each Licensed Product and a list of countries within the Territory where regulatory approvals have been obtained.

Annotations

This Collaboration Agreement and Patent and Know-How License (“Agreement“), dated November 24, 2015, is between the University of Liverpool (the “University”) and the Medicines Patent Pool Foundation (“MPP”). The Agreement governs certain collaborative activities between the parties to identify and engage with third parties including funders, PDPs, and manufacturers and distributors, to create solid drug nanoparticles of antiretroviral drugs (“ARV-SDN“) and develop them into pharmaceutical product formulations at commercial scale.

MPP obtains non-exclusive licenses to grant sublicenses under the University’s patents and know-how related to ARV-SDNs (“Licensed Technology“). MPP may grant sublicenses to Development Partners to develop products incorporating the Licensed Technology (“Licensed Products“), and to Commercialisation Partners to make and sell Licensed Products for the prevention and treatment of HIV (“Field“).

The Territory for the sublicense grants is a list of 137 low- and middle- income countries, divided into three groups by income level. Different royalty rates apply to each country group, with Group 1 (Low-income countries, Least Developed Countries, and all countries in sub-Saharan Africa) being royalty-free. Sales to public sector entities in the lower-middle income group, and all pediatric HIV formulations are also royalty free.

MPP must ensure that the terms of any sublicense agreements are in accordance with the terms set out in Schedules 4 & 5 to the Agreement which include grant-back rights for improvements, regulatory and quality requirements, and reporting obligations.

Provision Language

Schedule 2 – Responsibilities of the Parties

Schedule 5 – Commercialization Agreement Term Sheet

[…]

7. Waiver of data exclusivity rights: Commercialization Partner agrees, where applicable and to the extent that it is able: (a) to not seek; and (b) to waive, regulatory exclusivity in the Territory in relation to any data relating to the Licensed Products.

[…]

10. Reporting: Within 10 business days following the end of each calendar quarter, Commercialisation Partner will be required to provide MPP and the University with a quarterly written report setting forth in relation to that quarter (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 filed or obtained for any Licensed Product and (e) the Licensed Products (in terms of smallest units and patient packs for each formulation) sold or supplied by the Licensee under the Commercialisation Agreement during such agreement quarter, on a country-by-country basis; f) any scientific discoveries or Know how developed related to the Licensed Technology. MPP and Licensee will agree to meet on a quarterly basis regarding such reports and also review development and filing status of Licensed Products. MPP will agree that information contained in quarterly and other such reports shall be treated as confidential; provided, however, that such information may be shared with the University; and that aggregated data may be publicly disclosed by MPP.

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University of Liverpool – MPP, HIV Therapeutic Collaboration Agreement and Patent & Know-How License

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University of Liverpool – MPP, HIV Therapeutic Collaboration Agreement and Patent & Know-How License

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