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.”
RECITALS
I. WHEREAS, MPP is a non- profit organisation with a mission to improve the health of people living in the developing world by increasing access to quality, safe, efficacious and affordable medicines by facilitating access to intellectual property on those medicines.
II. WHEREAS, MedinCell owns or controls certain valuable rights, title and interest in and/or has the right to sublicense the Licensed Technology (as defined below) which would be incorporated in the Final Product.
III. WHEREAS, MedinCell entered into a grant agreement n°2020-40-IMPACT with Unitaid on March 23, 2020 (the “Unitaid Agreement“) with the key objective to Develop and Commercialise the Final Product as a complementary vector control method to reduce malaria transmission.
IV. WHEREAS, under the Unitaid Agreement, MedinCell agreed to grant to MPP a licence under the Licensed Technology solely to allow MPP to enter into sub-licence agreements for the Development and Commercialisation of the Final Product in the Field for the benefit of the Public Sector in the Territory in order to achieve the Access Objective required by Unitaid under the Unitaid Agreement.
V. The rights granted under this Agreement will allow MPP to enter into sub-licensing agreements with Development Partners and/or Commercialisation Partners to Develop and/or Commercialise the Final Product for the purpose to achieve the Access Objective as mentioned above.
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”):
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.
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:
i. legally commit to, in the Commercialisation Agreement 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 the 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.
For the purposes of the 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 and MedinCell.