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 in sufficient quantities to meet country needs.
“Minimum Supply Targets” means any targets agreed between Unitaid and MedinCell 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. For the avoidance of doubt, the Minimum Supply Targets may be expressed as a specific volume of the Final Product or a means of calculation of the volume, for example, “20% of the estimated target market for the Final Product in the Territory.”
“Polymer Supplier” means CM Biomaterials B.V.
3. RIGHT TO SUB-LICENSE TO MPP LICENSEES
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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”):
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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:
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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;
5. POLYMER SUPPLY
5.1. Concurrently with the execution and delivery of a Sub-License Agreement, MPP and MedinCell shall procure that the Development and/or the Commercialisation Partner and the Polymer Supplier have entered into the Polymer Supply Agreement under which the Development Partner and/or the Commercialisation Partner will exclusively purchase to Polymer Supplier all Polymers for the Development and Commercialisation of the Products.
5.2. MedinCell shall ensure that the Polymer Supplier will commit to the achievement of the Access Objective and will comply with the same commitments as the MPP Licensee Commitments.
5.3. MPP acknowledges that the exclusive purchase of all Polymers for the Development and/or Commercialisation of the Final Product, as per the terms and conditions of the Polymer Supply Agreement, is and will remain an essential condition of this Agreement and each Sub-License Agreement.
5.4. The exclusive supply of Polymers pursuant to clause 5.1 will terminate once this Agreement terminates and for each Development/Commercialisation Partner once such Development/Commercialisation Agreement terminates.
Schedule 4 Commercialisation Agreement Term Sheet
2. Access Commitments: Commercialisation Partner will ensure that Final Products are made available in accordance with the following specific commitments (the “MPP Licensee Commitments“) and therefore shall:
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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.
For the purposes of the Commercialisation Agreement, the “Specific Access Commitments” are:
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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;