Master Alliance Provisions Guide (MAPGuide)

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

  • Intellectual Property | Ownership of background IP
  • Intellectual Property | Use of background IP

Defintions

Final Productsmeans long-acting formulations of the following drug combination products in the Field developed using UW’s proprietary drug combination nanoparticle platform technology developed with Unitaid funding, by or under the direction of the Principal Investigator: – 3-drug combination product including tenofovir, lamivudine and dolutegravir (TLD) (“3-Drug Combination”); and/or – 2-drug combination product including either: (i) tenofovir and dolutegravir (TD); or (ii) lamivudine and dolutegravir (LD) (“2-Drug Combination”); provided that the composition and commencement of development of the 2-Drug Combination and continued development of both products is subject to Unitaid’s formal written approval in accordance with terms of the Unitaid Agreement. For the avoidance of doubt, “Final Products” means all of the products under development or developed by UW using Unitaid funding at the relevant time and “Final Product” means any one of them, as the context requires. 

Licensed Know-howmeans any and all technical information or know-how (including, without limitation, all manufacturing data, the percentages and specifications of ingredients, the manufacturing process, specifications, assays, quality control and testing procedures) that is reasonably necessary for the making of the Final Products and: (i) was developed by UW by or under the direction of the Principal Investigator on or before the Effective Date; or (ii) is generated by UW by or under the direction of the Principal Investigator or acquired by UW after the Effective Date. 

Licensed Patentsmeans any and all patents and patent applications filed by UW either before, on, or after the Effective Date describing: (i) the drug combination nanoparticle platform technology; (ii) the long-acting formulations used in the Final Products; or (iii) any other intellectual property reasonably necessary for the making of the Final Products; where each of (i), (ii) and (ii) were developed by or under the direction of the Principal Investigator. For information purposes only, a list of patents and patent applications relevant to the Final Products which have been granted or filed as at the Effective Date, and which UW expects to file after the Effective Date, is attached to this Agreement in Schedule 1. The Licences Patents include the the patents and patent applications referred to above as may be amended from time to time, including any continuations, continuations in part, extensions, reissues, divisions, and any supplementary protection certificates and similar rights deriving priority from any of these 

Licensed Technologymeans the Licensed Patents and the Licensed Know-how. 

2. Grant of Licence and Reservation of Rights

2.1 Subject to the terms of this Agreement and with effect from the Effective Date, UW grants to MPP: 

2.1.1. a non-exclusive, non-transferable worldwide licence under the Licensed Technology to grant sub-licences, in accordance with the terms set forth in Schedule 3, to Development Partner(s) to develop, or have developed, Licensed Technology into Licensed Products in the Field; and 

2.1.2. a non-exclusive, non-transferable, worldwide licence under the Licensed Technology to grant sub-licences, in accordance with the terms set forth in Schedule 4, to Commercialisation Partner(s) to make, have made, use, offer for sale, sell, have sold, export or import the Licensed Products in the Field exclusively for administration to patients in the Territory. The sub-licences will be royalty-free for sales into both the Public Sector and Private Sector and solely for use in the Territory. 

2.2. For the avoidance of doubt no rights are afforded to MPP under this Agreement for MPP or MPP Licensees to: 

2.2.1. use the Licensed Technology outside the Field; or

2.2.2. offer for sale, sell, have sold or otherwise commercialise Licensed Products for use outside the Territory; or 

2.2.3. have any right, title or interest to any intellectual property unless otherwise explicitly stated; or 

2.2.4. in the case of MPP, to directly practice such licences or otherwise exploit the Licensed Technology for any other purpose other than to grant sub-licences under Clause 3.1.1 and 3.1.2 of this Agreement.

Schedule 3: Development Agreement Term Sheet

1. Scope of the grant: MPP will grant a non-exclusive, non-transferable worldwide licence under the Licensed Technology to allow Development Partners to develop, or have developed, Licensed Technology into Licensed Products in the Field. For the avoidance of doubt, Development Partner will be expressly prohibited from:

i) further sub-licensing, and

ii) except if the Development Partner is a Commercialisation Partner selling, or distributing in any manner, the Licensed Technology to any other third party.

Schedule 4: Commercialization Agreement Term Sheet

1. Scope of the grant: MPP will grant a Commercialisation Partner a non-exclusive, non-transferable worldwide licence under the Licensed Technology to allow Commercialisation Partners to make, have made, use, offer for sale, sell, have sold, export and import the Licensed Products for the purposes of commercialising Licensed Products in the Field and in the Territory. The Licence will be royalty-free for sales to both Public Sector and Private Sector for use solely in the Territory.

For the avoidance of doubt Commercialisation Partner will be expressly prohibited from further sub-licensing the Licensed Technology to any other third parties.