Master Alliance Provisions Guide (MAPGuide)

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

  • Business model | Quality management
  • Business model | Regulatory strategy

Definitions

Licensed Product” means any Final Product which (i) entirely or partially uses the Licensed Technology in either its development, manufacture, regulatory approval or (ii) whose manufacture, use or sale would constitute an infringement of any patent claim within the Licensed Technology.

Schedule 4: Commercialisation Agreement Term Sheet

2. Access Commitments: Commercialisation Partner will ensure that Licensed Products are made available in accordance with the following specific access commitments (the “Specific Access Commitments”): […]

d. Registration Commitment: the Licensed Products will be registered in certain priority countries as designated by MPP, upon agreement with Unitaid to determine the registration plan and timeline.

e. QA Commitment: the Licensed Products will be developed in accordance with appropriate quality standards and Commercialisation Partners will seek approval or a positive recommendation for Licensed Products from the WHO Prequalification Progrmme (PQ), Global Fund/Unitaid Expert Review Panel (ERP), US FDA and/or another WHO Listed Regulatory Authority as agreed between MPP and the Commercialisation Partner.

10. Timelines: The Commercialisation Agreement will include timelines for the development, regulatory approvals and placing of the Licensed Products in the market.