Common use of Adverse Event Reporting Requirements Clause in Contracts

Adverse Event Reporting Requirements. Connetics shall be solely responsible for submitting Adverse Event Reports to the FDA, except to the extent (if at all) that MGI may be required by law to make such reports itself. During the Term of this Agreement, MGI shall promptly forward to Connetics at the address set forth in Section 11.3 any reports MGI receives of adverse events (distinguished as serious and non-serious by FDA regulations), concerning side effects, injury, toxicity or sensitivity reaction including unexpected increased incidence and severity associated with commercial or clinical uses, studies, investigations or test with the Product (animal or human), throughout the world, whether or not determined to be attributable to the Product. For purposes of this Section 7.3, "promptly" means as soon as practicable, but in no event later than (a) five business days for serious adverse events after receipt of complete information regarding such events, or (b) thirty calendar days for non-serious adverse events after receipt of complete information regarding such events. Connetics shall transmit adverse event reports to MGI on a periodic basis, but no less often than once every six (6) months; provided, however, that Connetics shall promptly notify MGI of any adverse event report requiring the cessation or substantial alteration of detailing activities by the MGI Sales Force. MGI shall hold all such communications in the strictest confidence and subject to the terms of Section 11.1 of this Agreement.

Adverse Event Reporting Requirements. Connetics shall be solely responsible for submitting Adverse Event Reports to the FDA, except to the extent (if at all) that MGI may be required by law to make such reports itself. During the Term of this Agreement, MGI shall promptly forward to Connetics at the address set forth in Section SECTION 11.3 any reports MGI receives of adverse events (distinguished as serious and non-serious by FDA regulations), concerning side effects, injury, toxicity or sensitivity reaction including unexpected increased incidence and severity associated with commercial or clinical uses, studies, investigations or test with the Product (animal or human), throughout the world, whether or not determined to be attributable to the Product. For purposes of this Section SECTION 7.3, "promptly" means as soon as practicable, but in no event later than (a) five business days for serious adverse events after 11 receipt of complete information regarding such events, or (b) thirty calendar days for non-serious adverse events after receipt of complete information regarding such events. Connetics shall transmit adverse event reports to MGI on a periodic basis, but no less often than once every six (6) months; provided, however, that Connetics shall promptly notify MGI of any adverse event report requiring the cessation or substantial alteration of detailing activities by the MGI Sales Force. MGI shall hold all such communications in the strictest confidence and subject to the terms of Section SECTION 11.1 of this Agreement.