Provision Language
BMS – MPP License
7. PHARMACOVIGILANCE AND QUALITY MATTERS
[…]
7.2 Quality
MPP will require the Sublicensees to manufacture Licensed Compound and Licensed Products in a manner consistent with:
(a) World Health Organization (WHO) pre-qualification standards; or
(b) the standards of any Stringent Regulatory Authority, defined as regulatory authorities which are members, observers or associates of the International Conference of Harmonization 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 Sublicensees will obtain temporary approval through a WHO Expert Review Panel, as appropriate and if applicable.
7. PHARMACOVIGILANCE AND QUALITY MATTERS
[…]
Form of Sublicense
7.2 Quality
The Sublicensees will manufacture the Licensed Compound and Licensed Products in a manner consistent with:
(a) World Health Organization (WHO) pre-qualification standards; or
(b) the standards of any Stringent Regulatory Authority, defined as regulatory authorities which are members, observers or associates of the International Conference of Harmonization 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 Sublicensee will obtain temporary approval through a WHO Expert Review Panel, as appropriate and if applicable.