SDEA. Within ninety (90) days after the Effective Date, the Parties shall enter into an agreement to initiate the process for the exchange of pharmacovigilance data in a mutually agreed format to ultimately be reflected in a definitive safety data exchange agreement (“SDEA”), including post-marketing spontaneous reports received by a Party or its Affiliates in order to monitor the safety of the Product and to meet reporting requirements with any applicable Governmental Authority. The Parties agree that there shall only be one SDEA with respect to this Agreement and the Asset Purchase Agreement.
Appears in 3 contracts
Sources: License Agreement, License Agreement (Kadmon Holdings, LLC), License Agreement (Kadmon Holdings, LLC)