Provision Language
BMS – MPP Agreement
6. PHARMACOVIGILANCE AND QUALITY MATTERS
[…]
6.2 Quality. The MPPs will require its Sublicensees to manufacture the Licensed Compound and Licensed Products in a manner consistent with:
(a) World Health Organization (WHO) pre-qualification standards, as appropriate and if applicable; or
(b) the standards of any Stringent Regulatory Authority. For the purposes of this Section 6.2(b) a Stringent Regulatory Authority is 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 MPP or its Sublicensees will obtain temporary approval through a WHO Expert Review Panel, as appropriate and if applicable.
Form of Sublicense
6. PHARMACOVIGILANCE AND QUALITY MATTERS
[…]
6.2 Quality. The Sublicensee 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. For the purposes of this Section 6.2(b) a Stringent Regulatory Authority is 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.