“Final Products” means 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–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 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.
“Public Sector” means (a) the following organizations to the extent that they are not for profit organizations: (i) Governments including without limitation government ministries and agencies, together with government–funded institutions and programs, such as state–run hospitals and prison services in those countries; (ii) NGOs including without limitation those recognized by the applicable local government ministry; (iii) UN–related organizations working for or in those countries, including but not limited to UNDP and UNICEF; (iv) Not–for–profit organizations including without limitation, Médecins Sans Frontières, Save–the–Children, OXFAM and the International Committee of the Red Cross (ICRC); (v) Funding mechanisms and programs funded by such mechanisms, including without limitation, Unitaid, PEPFAR, USAID, Global Fund, etc.; and (vi) agencies based outside of an applicable country to the extent that they are supplying Licensed Products in the Territory, and (b) nominally for profit procurement organisations but only to the extent that such procurements are supporting not–for–profit treatment programmes as described in (a) above.
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.
2.3. Notwithstanding anything contained in this Agreement, it shall not be a breach of this Agreement for MPP, or MPP Licensees, to:
2.3.1. supply to a country where a compulsory licence has been issued by the government of such country or;
2.4. UW reserves all rights not expressly granted to MPP under this Agreement, including (without limitation) the right to enter into separate licensing agreements with Commercialisation Partners for HICs with measures to protect volumes destined for purchase for and in the Territory.
2.6. Upon reaching stage gate 3D–SG2 for a particular Final Product as described within the Stage Gate Framework, the Parties will confer and come to mutual agreement on the question of whether a Development Partner is necessary for the further development of that Licensed Product, or alternatively whether the Development Partner can be bypassed in favor of proceeding directly from contract manufacturer to Commercialisation Partner(s).
3. Right to Sublicense to MPP Sublicensees
3.1. MPP may grant sub-licenses and may disclose to MPP Licensees only such of the Confidential Information as is necessary for the exercise of the rights sub–licensed, subject in each case to the following conditions:
3.1.1. MPP and UW will mutually agree on suitable MPP Licensees within 30 days of MPP proposing a potential MPP Licensee, where a potential MPP Licensee is deemed to be mutually agreed unless otherwise noted in writing by UW stating the grounds and the mitigation approach; and
3.1.2. MPP will ensure that Commercialisation Partners selected possess or will possess prior to any applicable activities relating to the Licensed Products sufficient known sources of supply and production capacity to ensure continuity of supply of the Licensed Product to the Public Sector in accordance with Minimum Supply Targets provided that UW shares with MPP the Minimum Supply Targets in timely manner; and
3.1.3. MPP will not enter into Development Agreements or Commercialisation Agreements for Licensed Products prior to agreement between UW and Unitaid on the Specific Access Commitments for such Licensed Products; and
3.1.4. MPP provides UW with a copy of each Sub–Licence Agreement together with a summary of the same, within 10 days after its grant; and
3.1.5. the MPP Licensee accepts obligations and conditions consistent with those in this Agreement including Schedule 3 and Schedule 4 (as applicable); and
3.1.6. MPP will ensure that the Sub–Licence Agreement(s) will grant to UW a non–exclusive, perpetual, worldwide, royalty–free license to use any Improvement[.]
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.
2. Term: The Sub–licence Agreement will be in force from the date of its signature until the date on which the last Licensed Patent associated with the Licensed Technology has expired, lapsed or has been invalidated
4. Grant–back rights: Development Partner will grant to MPP and UW a perpetual, irrevocable, worldwide, royalty–free, non–exclusive, sub-licensable licence over any Improvement (and shall promptly execute such document as UW may reasonably request accordingly). Such licence will not affect the Licensee’s ownership of the Improvements. MPP will have the right to sub-license such rights to its Commercialisation Partner(s).
5. Waiver of data exclusivity rights: Development Partner agrees, where applicable and to the extent that it is able: (a) to not seek; and (b) to waive, regulatory exclusivity in the Territory in relation to any data relating to the Licensed Products.
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.
4. Term: The Commercialisation Agreement will be in force from the date of its signature until the date on which the last Licensed Patent associated with the Licensed Technology has expired, lapsed or has been invalidated.
6. Grant–back rights: Commercialisation Partner will grant to MPP and UW a perpetual, irrevocable, worldwide, royalty–free, non–exclusive, sub-licensable licence over any Improvement (and shall promptly execute such document as UW may reasonably request accordingly). Such licence will not affect the Commercialisation Partner’s ownership of the Improvements. Commercialisation Partner will agree to engage in good–faith negotiations should MPP desire to further sublicense such Improvements. UW shall be entitled to grant sub–licences (without further right to sublicense) to other third parties, provided that it will be prohibited from sublicensing to a Direct Competitor (to be defined in the Commercialisation Agreement) of the Commercialisation Partner in the Territory without its written consent.
7. Waiver of data exclusivity rights: Commercialisation Partner agrees, where applicable and to the extent that it is able: (a) to not seek; and (b) to waive, regulatory exclusivity in the Territory in relation to any data relating to the Licensed Products.
14. Trademarks and names: Commercialisation Partner will not use UW’s or MPP’s name or logo nor the name of any of the inventors or other principal researchers in any kind of packaging and promotional material other than for the purposes of complying with the Commercialisation Agreement, without the prior written permission of both MPP’s and UW’s authorised representative. Licensed Product manufactured under the Commercialisation Agreement will be marked (to the extent not prohibited by law): (i) with a notice that such Licensed Product is sold under a license from UW and MPP; and (ii) with all markings and notices as may be required by applicable law, including in relation to patent and other intellectual property.