Provision Language
Annexure A: License Agreement
3. SUBLICENSE
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3.2. MPP shall only enter into Sublicenses with entities that have produced reasonable evidence demonstrating their intent and capability to: (i) comply with applicable laws relating to corruption (including but not limited to: anti-bribery laws and the U.S. Foreign Corrupt Practices Act and the UK Bribery Act), where certification to this effect, absent other contrary evidence, shall constitute reasonable evidence under this Section 3.2; (ii) manufacture and distribute Licensed Product in a manner consistent with GDP and GMP, and either WHO pre-qualification standards or the standards of any Stringent Regulatory Authority; and (iii) make the Licensed Product available in the Territory at terms that will facilitate access to the Licensed Product solely for use in the Field within the Territory.
Annexure A, Schedule 3: Form of Sublicense
2. GRANT OF LICENSE
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2.10 Notwithstanding the Effective Date of this Agreement, the Licensee undertakes not to sell or offer for sale a Licensed Product in a Target Country in the Territory prior to (i) the relevant Approval Date for that Licensed Product for that Target Country and (ii) WHO prequalification or approval by a Stringent Regulatory Authority (or, as a provisional measure, the review of the Licensed Product by a WHO Expert Review Panel and a notification of no-objection from that WHO Expert Review Panel for time-limited use of the Licensed Product).
3. COMMERCIALISATION AND REGISTRATION
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3.3 Licensee agrees that it will manufacture and distribute the Licensed Product in a manner consistent with the following standards as applicable: (i) WHO pre-qualification standards or the standards of any Stringent Regulatory Authority (unless, as a provisional measure, the Licensed Product has been reviewed by a WHO Expert Review Panel and a notification of no-objection has been issued from that WHO Expert Review Panel for time-limited use of the Licensed Product); and (ii) GMP and GDP.
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3.9 The Licensee will manufacture and sell the Licensed Product in accordance with all laws and regulations relevant to the manufacture and sale of the Licensed Product for use in the Field in the Territory and in accordance with good industry practice.