Provision Language
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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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
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3.4.2. For the purposes of this Agreement and any Development and Commercialisation Agreement, the “Specific Access Commitments” are:
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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 3. Development Agreement Term Sheet
7. 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 Final Product.
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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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
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For the purposes of the Commercialisation Agreement, the “Specific Access Commitments” are:
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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. 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 Final Product