Common use of Pharmacovigilance Clause in Contracts

Pharmacovigilance. Promptly following the Effective Date, the Parties shall enter into an agreement, on agreed terms, governing the process for the exchange of adverse event safety data, including, but not limited to, post-marketing spontaneous reports received by a Party or its Affiliates in order to monitor the safety of a Licensed Product and to meet reporting requirements with any applicable Regulatory Authority in the Territory and outside of the Territory (“Pharmacovigilance Agreement”).

Pharmacovigilance. Promptly following Within [***] days after the Effective Date, the Parties shall enter into an agreement, on agreed terms, governing the agreement to initiate a process for the exchange of adverse event safety data, including, but not limited to, post-marketing data (including postmarketing spontaneous reports received by each Party and its Affiliates) in a Party or its Affiliates mutually agreed format in order to monitor the safety of a the Licensed Product Products and to meet reporting requirements with any applicable Regulatory Authority in the Territory and outside of the Territory (“Pharmacovigilance Agreement”)Authority.