Provision Language
Schedule 2 – Form of Sublicense
4. DEVELOPMENT, REGISTRATION AND COMMERCIALISATION
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4.2 Compliance. The Licensee shall:
4.2.1 undertake all activities in connection with Licensed Compound and Licensed Product in accordance with all Applicable Law and good industry practice. The Licensee shall manufacture Licensed Compound and Licensed Product in a manner consistent with (i) Good Manufacturing Practice and (ii) WHO pre-qualification standards or the standards of any Stringent Regulatory Authority. Where such standards are not yet available, the Licensee will obtain temporary approval through a WHO Expert Review Panel, as appropriate and if applicable;
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4.6 Quality Audits. The Licensee shall immediately notify the Licensor of any quality audits conducted by WHO or a Stringent Regulatory Authority that results in any major observations or actions in relation to Licensed Compound and/or Licensed Product or the manufacturing sites where Licensed Compound and/or Licensed Product is being manufactured or proposed to be manufactured.