Master Alliance Provisions Guide (MAPGuide)

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

  • Information & materials sharing | Information sharing
  • Information & materials sharing | Technology transfer

Definitions

Encumbrance” means any legal obligations to any third party (including but not limited to research funders or collaborators) or rights, interest or objections of an inventor, their department or faculty, that would in UW’s sole opinion restrict or adversely affect its ability to grant rights over the intellectual property; and any reference to “unencumbered” shall be construed accordingly.

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 Patents” means 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 Technology” means the Licensed Patents and the Licensed Know-how.

Minimum Supply Targets” means any targets agreed between Unitaid and UW in accordance with the terms of the Unitaid Agreement in relation to minimum production capacity, minimum annual production volumes, maximum order lead time for delivery and/or minimum order quantity for a Final Product, each for the benefit of the Public Sector in the Territory.

3. Right to Sublicense to MPP Sublicensees

3.4 UW shall provide to MPP in relation to the sublicensing:

a) the target formulation profile in relation to the Final Product in a timely manner and in any case as soon as such profile is agreed;
b) the Minimum Supply Targets agreed with Unitaid at the earliest opportunity.

3.5. UW shall further provide, upon MPP request, the MPP Licensee with pre-clinical data and related documentation generated by the UW in relation to the Licensed Product to the extent that such documents are reasonably necessary for the Development or registration or commercialisation of the Final Product.

4. Licensed Know-how

For each Development Agreement and/or Commercialisation Agreement executed with an MPP Licensee, UW will make reasonable efforts within reasonable amount of time to perform an initial transfer to MPP for use by an MPP Licensee, of the Licensed Know-how. Further transfer to MPP of Licensed Know-how may occur during the sub-license in accordance with Clause 7 of this Agreement.

7. UW Treatment Advances Using Long-Acting Injectables For HIV

7.1 UW will make reasonable efforts to communicate, through the laboratory of the Principal Investigator, in writing to MPP within a reasonable time, but in any case not to exceed 120 days, any technical development that may improve the LAI’s used in the treatment of HIV, which is developed in the laboratory of the Principal Investigator and UW comes to hold exclusive rights to and is free from any Encumbrances. UW’s obligation to communicate technical developments according to Clause 7.1 shall expire on the fifth anniversary of the Effective Date unless renewed or extended in writing. 

7.2 Upon receiving from UW a disclosure of a technical development as described in Clause 7.1 that may improve the treatment of HIV, in accordance with Clause 7.1, MPP shall inform UW within 120 days whether the said technical development is of interest. 

7.3 In the event MPP wishes the technical development as described in Clause 7.1 to be licensed to MPP and the technical development is free from any Encumbrance and is an advancement of an LAI, then UW and MPP shall amend Schedule 1 to incorporate any relevant patents and patent applications and/or effect a suitable transfer of know-how in accordance with Clause 4. 

7.4 In the event a technical development in accordance with Clause 7.1 comes to have its exclusive rights vested in UW, is free from any Encumbrance, is not an advancement of an LAI and is of interest to MPP in accordance with Clause 7.2, then UW and MPP shall discuss in good faith if both Parties agree to a new license agreement for said technical development.

Schedule 3: Development Agreement Term Sheet

3. Improvements: If at any time during the term of the Sub-licence Agreement the Development Partner (or any of its employees, agents, or other persons acting under its authority) makes, develops, conceives, acquires, reduces to practice, becomes entitled to or secures control over any Improvement it will communicate such Improvement to MPP and UW in full together with all available information concerning the mode of working and using the same. MPP and UW will treat this information as confidential. To the extent that the Development Partner is under a contractual obligation to provide access to any Improvement to a third party, in no event is the Development Partner authorised to provide access to any Licensed Technology without UW’s written consent. 

10. Reporting: [… ] 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

5. Improvements: If at any time during the term of the Commercialisation Agreement the Commercialisation Partner (or any of its employees, agents, or other persons acting under its authority) makes, develops, conceives, acquires, reduces to practice, becomes entitled to or secures control over any Improvement it shall communicate such Improvement to MPP and UW in full together with all available information concerning the mode of working and using the same. MPP and UW shall treat this information as confidential. To the extent that the Commercialisation Partner is under a contractual obligation to provide access to any Improvement to a third party, in no event is the Development Partner authorised to provide access to any Licensed Technology without UW’s written consent.