Communications with Government Agencies. Connetics shall have the sole right and responsibility and shall bear all costs related to communications with any government agencies to satisfy their requirements regarding the authorization and/or continued authorization to market the Product in commercial quantities in the Territory. MGI shall promptly notify Connetics of any inquiry or other communication that it receives from the FDA concerning the Product. Connetics shall be primarily responsible for all communications with the FDA (and state equivalent agencies) concerning the Product, including but not limited to reporting adverse events and responding to any inquiries concerning advertising, detailing or promotional materials. MGI, however, shall be able to communicate with the any such governmental agency regarding the Product if:
Appears in 4 contracts
Samples: Promotion Agreement (Connetics Corp), Promotion Agreement (Mgi Pharma Inc), Promotion Agreement (Mgi Pharma Inc)
