Provision Language
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–how” means 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 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.
“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.
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.
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.
14. General
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14.13 Resolution by senior executives. All disputes, controversies or claims between the Parties in connection with this Agreement, its construction, or the rights, duties or liabilities of either Party under this Agreement (a “Dispute”) must be resolved pursuant to the following resolution process in this Clause 14.13 and the jurisdiction Clause 14.14. The Parties to any dispute may alter or amend these procedures by agreement in writing.
14.13.1 To commence the resolution process, any Party may serve notice to the other Party identifying: (i) the nature of the Dispute; and (ii) the amount in Dispute.
14.13.2 Once notice is received, the Parties must first attempt in good faith to resolve such Dispute by negotiation and consultation between themselves.
14.13.3 In the event that such Dispute is not resolved on an informal basis within 30 days after such notice is received, either Party may, by written notice to the other Party, refer the Dispute to the Executive Director in the case of the MPP and to Associate Vice Provost Innovation Development and Commercialization in the case of UW (together the “Designated Officers”) for attempted resolution by good faith negotiation.
14.13.4 If any Dispute is not resolved by the Designated Officers, then either Party may seek resolution in accordance to Clause 14.14.
14.14 Governing law. This Agreement is governed by, and is to be construed in accordance with, laws of the State of New York. Except as provided in Clause 14.13 if any dispute is not resolved by the Designated Officers, then any Dispute which has arisen or may arise out of, or in connection with, this Agreement shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by one or more arbitrators appointed in accordance with the said Rules The seat of arbitration shall be New York, New York, USA and the arbitration shall be conducted in English.
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 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.
15. Governing Law/ADR: The governing law for the Development Agreement will be the laws of England in a court of law in England. All disputes will be resolved via an alternative dispute mechanism to be set forth in the agreement.
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.
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.
16. Governing Law/ADR: The governing law for the Commercialisation Agreement will be the laws of England in a court of law in England. All disputes will be resolved via an alternative dispute mechanism to be set forth in the Commercialisation Agreement.