Common use of Adverse Event Reports Clause in Contracts

Adverse Event Reports. The Parties shall cooperate in the coordination of common reporting to Regulatory Authorities, on a timely basis, of all safety-related and adverse events occurring during clinical development and subsequent to the grant of Regulatory Approvals. Prior to commencing clinical trials on any Licensed Product, the Parties or their authorized agents shall enter into a written agreement concerning policies and procedures for pharmacovigilance and adverse event reporting, which shall be binding on both Parties.

Adverse Event Reports. The Parties either directly or through the STEERING COMMITTEE, as deemed appropriate, shall cooperate in the coordination of common reporting to Regulatory Authoritiesregulatory authorities, on a timely basis, of all safety-related and adverse events occurring during clinical development and subsequent to the grant of Regulatory Approvalsmarketing approvals. Prior to commencing clinical trials on any Licensed ProductFLU VACCINE PRODUCT, the Parties or their authorized agents shall enter into a written agreement concerning policies and procedures for pharmacovigilance and adverse event reporting, which shall be binding on both Parties.