University of Washington – MPP, Long-acting Injectable HIV Treatment License Agreement

Intellectual Property | Protection of IP

Summary of Approaches

Who has the decision-making authority and responsibility for patent prosecution, maintenance and enforcement? How should IP protection expenses be allocated between the parties?
- UW is solely responsible for patent prosecution, maintenance and enforcement.
- UW has the right, but not the duty, to bring infringement actions. UW bears its own expenses.
Is there a mechanism for information sharing and cooperation between the parties in relation to patent prosecution, maintenance and enforcement activities? How should IP protection expenses be allocated between the parties?
- UW must disclose a “freedom to operate” analysis conducted for funder Unitaid that MPP may provide to sublicensees.
- MPP is required to reasonably assist UW in infringement actions at MPP’s own expense, provided that the assistance is needed for UW to fully exercise its rights in the proceeding.

Annotations

This agreement is a Patent and Know-How License relating to an investigational, long-acting, injectable combination HIV drug from the University of Washington (“UW”) to the Medicines Patent Pool (“MPP”). It is effective as of December 6, 2021.The purpose of the agreement is the further development and accessible commercialization of UW’s new therapy for the prevention and/or treatment of HIV (“Field”) for use in low- and middle-income countries (“LMIC”, the “Territory”). An agreement with Unitaid, which funded UW pre-clinical research, requires UW to license the new therapy to MPP, which must make it widely available to LMIC public purchasers as quickly and affordably as possible. The Agreement contemplates that MPP will sublicense UW technology to third party Development Partners and Commercialization Partners globally. UW is entitled to veto proposed sublicensees. The term sheets for the anticipated Development Agreements and Commercialization Agreements are included as schedules to this agreement; we have included analysis of these term sheets under the relevant issues.

Unitaid plays a significant continuing role, including setting specific access commitments for MPP sublicensees, such as an affordable price, minimum supply targets, and a registration strategy.

UW is required to transfer preclinical data, technical information and know-how in addition to certain future improvements on the present technology. Sublicensees must license back any of their improvements to MPP and UW. UW must consider in good faith additional agreements that would permit MPP sublicensing to treat diseases in LMICs other than HIV.

Provision Language

8. Intellectual Property Management

The MPP shall have no rights in relation to the conduct of any matter relating to the Licensed Patents, including the filing, prosecution and maintenance thereof.

9. Intellectual Property Infringement

9.1 UW, or any third party UW elects, will be responsible (at its own expense and discretion) for, and be in control of, the prosecution, maintenance and enforcement of all Licensed Patents.

9.2 UW will have the transferable right but not any obligation to bring an infringement action and any such action shall be at its own expense and entirely under its own direction and control.

9.3 MPP will (at its own expense) reasonably assist UW in any action or proceeding being prosecuted if so requested by UW and such reasonable assistance is necessary for UW to fully exercise its rights under such proceeding.

9.4 Upon request, UW shall provide promptly to MPP the freedom to operate analysis, performed in accordance with the Unitaid Agreement, to be shared with Development Partner or Commercialisation Partner.

9.5 MPP will promptly inform UW if it becomes aware of any infringement or potential infringement of any of the Licensed Patents in the Field.

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University of Washington – MPP, Long-acting Injectable HIV Treatment License Agreement

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University of Washington – MPP, Long-acting Injectable HIV Treatment License Agreement

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