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.”
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;
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.
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;
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 and MedinCell.