Provision Language
Schedule 4 – Development Agreement Term Sheet
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2. Regulatory/Quality: Development Partner will agree to manufacture all Licensed Product in a manner consistent with (i) World Health Organization (“WHO“) pre-qualification standards; and/or (ii) the standards of any Stringent Regulatory Authority, where available. Stringent Regulatory Authority (“SRA“) is defined as regulatory authorities which are members, observers or associates of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, as may be updated from time to time. Where such approvals are not yet available, the Development Partner will obtain temporary approval through a WHO Expert Review Panel, as appropriate and if applicable.
Schedule 5 – Commercialisation Agreement Term Sheet
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2. Regulatory/Quality: Commercialisation Partner will agree to manufacture all Licensed Product in a manner consistent with (i) World Health Organization (“WHO“) pre-qualification standards; and/or (ii) the standards of any Stringent Regulatory Authority, where available. Stringent Regulatory Authority (“SRA“) is defined as regulatory authorities which are members, observers or associates of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, as may be updated from time to time. Where such approvals are not yet available, the Commercialization Partner will obtain temporary approval through a WHO Expert Review Panel, as appropriate and if applicable.