Master Alliance Provisions Guide (MAPGuide)

MPP – BMS Sublicense & Tech Transfer Agreement

  • Other | Regulatory strategy

7. Pharmacovigilance and Quality Matters

7.1 Pharmacovigilance

(a) If the Sublicensee becomes aware of any adverse reaction relating to the Licensed Compound or Licensed Products in connection with this Sublicense Agreement, the Sublicensee must inform BMS within 24 hours of its becoming aware and cooperate with BMS in fulfilling BMS’s reporting responsibilities under applicable laws and regulations.

(b) The Sublicensee will maintain effective and reliable systems for receiving and tabulating any reports of adverse reactions to the Licensed Products and to report such information on a timely basis to the relevant authorities and to BMS pursuant to the terms of this Sublicense Agreement.

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.