Provision Language
Definitions
“Access Objective” means the objective required by Unitaid under the Unitaid Agreement to ensure that the Final Product is made widely available, as quickly as possible, and on a continuing basis, at an Affordable Price, to the Public Sector in the Territory and in sufficient quantities to meet the needs of those countries. In the event that the Final Product is made available in the Private Sector in the Territory, it shall be at affordable pricing (which, in the private sector, shall be considered to be no more than reasonable pricing, in line with industry standards). MPP shall ensure that each Development Partner and/or each Commercialisation Partner agrees in the Development Agreement or Commercialisation Agreement to comply with the Access Objective.
“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 Product and: (i) was developed by MedinCell on or before the Effective Date; or (ii) is generated by MedinCell or acquired by MedinCell after the Effective Date. Licenced Know-How does not include any know-how related to the Polymer Manufacturing Technology.
“Licensed Patents” means any and all patents and patent applications filed by MedinCell either before on (as listed in Schedule 1), and/or after the Effective Date, as may be revised or amended from time to time describing: (i) the BEPO® drug delivery technology; (ii) the long-acting ivermectin formulation; or (iii) any other Intellectual Property, which is reasonably necessary for the making, using, selling, stock-piling, importing or marketing of the Final Product, but excluding the Polymer Manufacturing Technology. For information purposes only, a list of patents and patent applications relevant to the Final Product which have been granted or filed at the Effective Date is attached to this Agreement in Schedule 1.
“Licensed Technology” means the Licensed Patents and the Licensed Know-how but excluding the Polymer Synthesis Technology including any improvements made by Medincell or on its behalf thereto.
“Non-Severable Improvement” means any Improvement which cannot be exploited without infringing the Licensed Technology.
“Polymer Synthesis Technology” means all Intellectual Property related to polymer manufacture, synthesis and purification, Controlled by MedinCell or any of its Affiliates before, on or after the Effective Date.
“Severable Improvement(s)” means an Improvement which if used or practiced without a license from MedinCell would not infringe any Intellectual Property Rights in the Licensed Technology.
“Territory” means all low and middle-income countries according to the World Bank country classification as of the Effective Date, set out in Schedule 2.
2. GRANT OF LICENCE AND RESERVATION OF RIGHTS
2.1. Subject to the terms of this Agreement and with effect from the Effective Date, MedinCell hereby grants to MPP, and MPP hereby accepts:
2.1.1. a non-exclusive, royalty-free, 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, the Final Product in the Field for the benefit of the Public Sector and the Private Sector in the Territory; 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 Final Product in the Field exclusively for the benefit of the Public Sector and the Private Sector in the Territory. The sub-licences will be:
a) royalty-free for sales into the Public Sector for use in the Territory; and
b) royalty bearing, for sales into the Private Sector for use in the Territory, which royalty rate shall be reasonable, in line with industry practices and negotiated between MPP, the Commercialisation Partner and MedinCell before the signature of a Commercialisation Agreement. In the event that the Final Product is made available in the Private Sector in the Territory, it shall be at affordable pricing.
2.1.3. If determined necessary or appropriate by MedinCell or MPP in the interest of achieving the Access Objective, MedinCell shall grant to MPP so that MPP could grant to the Commercialisation Partner a separate licence of the Licensed Technology for the purpose of enabling such Commercialisation Partner to make, have made, use, offer for sale, sell, have sold, export, import or distribute the Final Product in High Income Countries, provided that such separate licence may be royalty-bearing and the amount of royalties remains reasonable in line with industry practices.
2.2. For the avoidance of doubt no rights are granted 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 the Final Product 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 to MPP Licensees under clauses 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;
2.3.2. conduct any activities where such activities would not infringe a Licensed Patent granted and in force, and does not rely on or use the Licensed Know-How.
2.4. MedinCell 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 by the Public Sector in the Territory.
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2.8. MPP will use its best efforts to identify Commercialisation Partner(s) capable of commercially Exploiting the Licensed Technology and any Final Product in accordance with the terms of this Agreement.
3. RIGHT TO SUB-LICENSE TO MPP LICENSEES
3.1 It is understood and agreed that MPP will not itself Develop and/or Commercialise the Final Product or Exploit the Licensed Technology, but it will do so through its MPP Licensees (without receiving compensation in exchange for such rights.
3.2. Identification of MPP Licensees. MPP may grant sublicenses to any Development Partner or Commercialisation Partner with demonstrated commitments (as defined below in clause 3.4.1) to achieve the Access Objective, ability and readiness to Develop and/or Commercialise the Final Product under the terms and conditions set forth in the form of Schedule 3 and/or Schedule 4.
3.3. Medincell’s consent. MedinCell shall have the right of approval over any proposed MPP Sublicensee within sixty (60) days following the written proposition of MPP, such approval not to be unreasonably withheld based on the criteria listed under clause 3.2. MedinCell’s consent shall be understood as provided unless otherwise notified by MedinCell in writing stating the grounds for MedinCell’s withholding of consent to MPP’s initial written notice of the proposed MPP Sublicensee, such notice to include reasonably adequate information regarding the proposed MPP Sublicensee to permit MedinCell to assess the proposed MPP Sublicensee’s compliance with the criteria defined in clause 3.2.
3.4. MPP may grant sub-licences 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:
3.4.1. MPP shall procure that any and all Development and/or Commercialisation Partner commits to achieve the Access Objective including the following specific commitments (the “MPP Licensee Commitments”):
i. legally commit to, in the Development and/or Commercialisation Agreement (as appropriate) and comply with the Specific Access Commitments (as defined below) for the Final Product;
ii. endeavour to ensure equitable access to the Final Product by the Public Sector in the Territory;
iii. undertake commercially reasonable efforts to Manufacture the Final Product at the lowest possible cost and pass on any significant reduction in the production and distribution costs of the Final Product to the benefit of the sale price offered to the Public Sector in the Territory;
iv. agree that compliance with the Price Commitment will be subject to audit by an independent firm of accountants at any time. The result of the audit will be binding, and such Commercialisation Partner should agree to implement any adjustment to the Affordable Price which is deemed required as a result of the audit;
v. prioritise delivery of firm orders from the Public Sector over firm orders from the Private Sector;
vi. implement measures to protect volumes destined for purchase by the Public Sector in the Territory;
vii. possesses or will possess prior to any applicable activities related to the Final Product, sufficient known sources of supply and production capacity to ensure a continuity of supply of the Final Product to the Public Sector in the Territory in accordance with any Minimum Supply Targets, provided that MedinCell shares with MPP the Minimum Supply Targets in a timely manner;
viii. hold, or will hold prior to any applicable activities related to the Final Product, all necessary foreign, federal, state, local, and other governmental licenses, approvals and permits necessary to use, design, Develop, produce, Manufacture, offer for sale, sell, distribute, import and export the Final Product in the relevant country in the Territory; and
ix. make best efforts to ensure that the Final Product can be purchased by the Public Sector in the Territory through relevant governmental or international procurement mechanisms including, without limitation, Global Fund and the President’s Malaria Initiative.
3.4.2. For the purposes of this Agreement and any Development and Commercialisation Agreement, the “Specific Access Commitments” are:
a. “Price Commitment” – the Final Product will be made available to the Public Sector in the Territory at a price which is no more than the Affordable Price;
b. “Supply Commitment” – the Final Product will be made available in a timely manner and in sufficient quantities to meet the needs of the Public Sector in the Territory, including in accordance with any Minimum Supply Targets;
c. “Registration Commitment” – the Final Product will be registered in the Key Registration Countries when available and in accordance with the timeline agreed between Unitaid and MedinCell; Medincell shall communicate the Key Registration Countries to MPP as soon as available and in any case in a timely manner.
d. “QA Commitment” – the Final Product will be developed in accordance with appropriate quality standards and Commercialisation Partners will seek, when appropriate, approval or a positive recommendation for the Final Product from the WHO Prequalification Programme (PQ), Global Fund/Unitaid Expert Review Panel (ERP), US FDA and/or another WHO Listed Regulatory Authority as agreed between Unitaid, MedinCell and MPP.
3.4.3. MPP will not enter into Development Agreements or Commercialisation Agreements for the Final Product prior to agreement between MedinCell and Unitaid on the Specific Access Commitments for such Final Product.
3.4.4. MPP will provide MedinCell with a copy of each Sub-Licence Agreement together with a summary of the same, within 10 days of execution of each Sub-license.
3.4.5. Any Sub-License Agreement will be entered into subject to the following: (i) shall refer to this Agreement and will be subject to this Agreement; and (ii) each MPP Licensee will accept obligations and conditions consistent with those in this Agreement including Schedule 3 and Schedule 4 (as applicable); and (iii) each MPP Licensee will confirm in writing that it has received the terms and conditions of this Agreement and agree not to perform any acts or omissions that would place MPP in breach of this Agreement.
3.4.6. MPP will ensure that Sub-licence Agreements contain all the commitments stated in clause 3.4.2 herein, release language, indemnifying obligations against any loss, damages, costs, claims or expenses which are awarded against or suffered by MedinCell, its officers, employees, sub-contractors and agents as a result of any act or omission of the MPP Licensee, insurance requirements as included in Schedule 3 and Schedule 4; and MedinCell shall be considered a third-party beneficiary to the Sub-licence Agreement(s) and will have the right to enforce and rely on the terms of the Sub-licence Agreement(s), as if it were a party thereto.
3.5. MPP agrees to monitor compliance of each MPP Licensee. Such monitoring shall include:
3.5.1 reviewing with all reasonable skill and care any reports provided to MPP by the MPP Licensee under the relevant sections of the Sub-Licence Agreement;
3.5.2 fully exercising the audit right set out in the Sub-Licence Agreement(s) as soon as MPP has reasonable cause to believe (or as soon as MedinCell and MPP have agreed that they have reasonable cause to believe) an audit is necessary.
Schedule 3. Development Agreement Term Sheet
1. Scope of the grant: MPP will grant a non-exclusive, royalty free, non-transferable worldwide licence under the Licensed Technology to allow Development Partners to develop, or have developed, Licensed Technology into Final 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.
3. Improvements:
3.1 Severable Improvements: The Development Partner shall promptly disclose to MedinCell and MPP in such detail as MedinCell and/or MPP may reasonably require a written description of all Severable Improvements that it may develop, conceive or reduce to practice during the Term. The Parties shall discuss in good faith an arrangement suitable to both Medincell and the Development Partner which should take into account a fair and reasonable compensation for the Development Partner as well as commercial strategy of Medincell.
3.2 Non-Severable Improvements:
a. The Development Partner shall grant to MedinCell a first option to discuss an assignment of Non-Severable Improvements against a fair and equitable compensation on an arm length basis; and in case such assignment is agreed upon, Medincell grants to:
i. the Development Partner a non-exclusive, royalty-free, non-transferable, worldwide license to use the Non-Severable Improvements in the Field, in the Territory during the Term; and
ii. MPP a right to grant licences on the Non-Severable Improvements as follows: non- exclusive, royalty-free, non-transferable, worldwide license to use the Non-Severable Improvements in the Field, in the Territory during the Term.
b. If the Parties fail to reach an agreement in accordance with section 3.2 a) above within 6 months following the option grant to discuss an assignment, then the Development Partner grants to Medincell a non- exclusive, worldwide, royalty-free, sub-licensable license over any Non-Severable Improvement for any use in the Field, irrespective of expiration or termination of this Agreement.
Schedule 4. Commercialisation 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 Final Product for the purposes of commercialising the Final Product in the Field for the benefit of the Public Sector and in the Territory. The Licence will be royalty-free for sales to Public Sector for use in the Territory and royalty-bearing for sales into the Private Sector for use in the Territory, which royalty rate shall be reasonable, in line with industry practice and shall be negotiated between MedinCell, MPP and the Commercialisation Partner before the execution of a Commercialisation Agreement. In the event that the Final Product is made available in the Private Sector in the Territory, it shall be at affordable pricing (which, in the private sector, shall be considered to be no more than reasonable pricing, in line with industry standards). For the avoidance of doubt, the Commercialisation Partner will be expressly prohibited from further sub-licensing the Licensed Technology to any other Third Parties.
5. Improvements:
5.1 Severable Improvements: The Commercialisation Partner shall promptly disclose to MedinCell and MPP in such detail as MedinCell and/or MPP may reasonably require a written description of all Severable Improvements that it may develop, conceive or reduce to practice during the Term. The Parties shall discuss in good faith an arrangement suitable to both Medincell and the Commercialisation Partner which should take into account a fair and reasonable compensation for the Commercialisation Partner as well as commercial strategy of Medincell.
5.2 Non-Severable Improvements:
a. The Commercialisation Partner shall grant to MedinCell a first option to discuss an assignment of Non-Severable Improvements against a fair and equitable compensation on an arm length basis; and in case such assignment is agreed upon, Medincell grants to:
i. the Commercialisation Partner a non-exclusive, royalty-free, non- transferable, worldwide license to use the Non-Severable Improvements in the Field, in the Territory during the Term; and
ii. MPP a right to grant licences on the Non-Severable Improvements as follows: non-exclusive, royalty-free, non-transferable, worldwide license to use the Non-Severable Improvements in the Field, in the Territory during the Term.
b. If the Parties fail to reach an agreement in accordance with 5.2 a) above within 6 months following the option grant to discuss an assignment, then the Commercialisation Partner grants to Medincell a non- exclusive, worldwide, royalty-free, sub-licensable license over any Non-Severable Improvement for any use in the Field, irrespective of expiration or termination of this Agreement.
12. Trademarks and names: […] The Final Product manufactured under the Commercialisation Agreement will be marked (to the extent not prohibited by law): (i) with a notice that such Final Product is sold under a license from MedinCell 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.