Pharmacovigilance Activities Clause Samples
Pharmacovigilance Activities. Without prejudice to INMM ’s obligations according to this PV Agreement, Pharmacovigilance activities for the Product(s) are the responsibility of Bayer. This includes but is not limited to:
1. global safety database maintenance
2. answers/statements concerning safety issues 3. labeling changes 4. expedited regulatory reporting 5. periodic regulatory reporting 6. submission and maintenance of RMPs, if required 7. signal detection and risk management 8. literature screening
Pharmacovigilance Activities. AbbVie shall have no ongoing pharmacovigilance obligations with respect to the Licensed Compounds or Licensed Products. Sionna shall assume all pharmacovigilance activities and obligations for the Licensed Compounds and Licensed Products as of the Effective Date. The Parties do not intend to enter into a safety data exchange agreement, but shall coordinate regarding transfer of the global safety database for the Licensed Products from AbbVie to Sionna within a timeframe mutually agreed by the Parties following the Effective Date.