Adverse Event Reports. Within ninety (90) days after the date of this Agreement, the Parties shall enter into an agreement to initiate a process for the exchange of adverse event safety data in a mutually agreed format, including, but not limited to, post-marketing spontaneous reports received by the Party or its Affiliates in order to monitor the safety of the Product and to meet reporting requirements with any applicable Regulatory Authority.
Appears in 6 contracts
Samples: Development and License Agreement (Enanta Pharmaceuticals Inc), License Agreement, Collaborative Development and License Agreement (Enanta Pharmaceuticals Inc)