Master Alliance Provisions Guide (MAPGuide)

University of Washington – Medicines Patent Pool, Long-acting Injectable HIV Treatment License Agreement

  • Consortium structure & management | Reporting Requirements
  • Consortium structure & management | Roles & Responsibilities

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.

6. Reporting

MPP will send to UW within 30 business days following the end of each calendar year, a written report setting forth each Licensee’s (a) Licensed Products development pipeline, (b) status of development of each Licensed Product in development, (c) regulatory filing plan for each Licensed Product, and (d) a list of countries within the Territory for which such regulatory approvals or authorizations have been obtained for any Licensed Product.

Schedule 3: Development Agreement Term Sheet

10. Reporting: Within ten (10) business days following the end of each calendar quarter, Development Partner will be required to provide MPP and UW with a quarterly written report setting forth in relation to that quarter the following: (a) summary of project implementation and current schedule of anticipated events or milestones including status of readiness of labs, plants, machinery as required, (b) details of project related specific recruitments and a summary of resources (dollar value) spent in the reporting period if any, (c) Licensed Products in its development pipeline, (e) status of development of each Licensed Product in development, (f) any scientific discoveries or Know-how developed; (g) any other information that MPP and UW may require to monitor progress and implementation of the projects. MPP and Licensee will agree to meet on a quarterly basis regarding such reports. MPP agrees that information contained in quarterly and other such reports shall be treated as confidential; provided, however, that such information may be shared with UW, MPP’s funders, UW’s funder, and funders, if any, of the project under consideration; and that status update may be publicly disclosed by the MPP or UW. Within thirty (30) days of the end of the Development Partner’s programme they will deliver to MPP and UW a complete dossier of information allow MPP to effect an efficient technology transfer to the Commercialisation Partner and UW to effect an efficient technology transfer to its licensees including its licensees outside the Territory.

Schedule 4: Commercialisation Agreement Term Sheet

11. Reporting: Within 10 business days following the end of each calendar quarter, Commercialisation Partner will be required to provide MPP and UW 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 UW and Unitaid; and that aggregated data may be publicly disclosed by MPP.