DEVELOPMENT AND REGISTRATION. 4.1. The Sublicensee agrees that it will manufacture the Product in a manner consistent with (i) WHO pre-qualification standards; or (ii) the standards of any Stringent Regulatory Authority, defined as a regulatory authority which was a member or observer of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”), or associated with an ICH member through a legally-binding, mutual recognition agreement, in each case as before 23 October 2015. Where such standards are not yet available, the Sublicensee will obtain temporary approval through a WHO Expert Review Panel, as appropriate and if applicable.
Appears in 2 contracts
Samples: Patent and Know How Licence Agreement, Patent and Know How Licence Agreement
DEVELOPMENT AND REGISTRATION. 4.1. The Sublicensee agrees that it will manufacture the Materials and Product in a manner consistent with (i) WHO pre-qualification standards; or (ii) the standards of any Stringent Regulatory Authority, defined as a regulatory authority which was a member or observer of the International Council on Harmonisation Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”), or associated with an ICH member through a legally-binding, mutual recognition agreement, in each case as before 23 October 2015. Where such standards are not yet available, the Sublicensee will obtain temporary approval through a WHO Expert Review Panel, as appropriate and if applicable.
Appears in 2 contracts
Samples: Patent and Material License Agreement, Patent and Material License Agreement
