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. The investigator is responsible for the detection and documentation of events meeting the criteria and definition of an adverse event (AE) or a serious adverse event (SAE), as provided in this protocol. Routine, adverse events of special interest (AESI), and expedited adverse event report forms and their supporting documentation must be submitted to DSSM according to the instructions in Sections 10.3, 10.4 and 10.6.
Adverse Event Reporting Requirements. In the event that Supplier and its Employees, during the course of performing the Services, become aware of an Adverse Event or other reportable AE safety information (including but not limited to medication error, pregnancies, overdoses and laboratory parameters) reported by investigators or study site employees, Supplier is required to collect and submit within one business day from becoming aware, the appropriate information to AstraZeneca as described in the instructions provided in the applicable clinical study protocol. AstraZeneca is solely responsible for reporting AEs and other safety information to regulatory and government authorities.
Adverse Event Reporting Requirements. Because the Pfizer Product used in this interventional study is approved for marketing in the U.S. for the indication under study, potential drug-induced liver injury as assessed by laboratory test values (“Hy’s Law Cases”, as discussed in the Reporting of Serious Adverse Events section of the Agreement) are not reportable to Pfizer unless the Principal Investigator classifies such an occurrence as a serious adverse event.
Adverse Event Reporting Requirements. Because this [is a prospective non- interventional study] [is a retrospective non-interventional study] [Study involves the use of a Pfizer product that includes a device component] [Study involves the use of a Pfizer product that is a mature marketed oncology product with a well- established safety profile], the requirements for reporting serious adverse events (“SAEs”) to Pfizer differ somewhat from the standard interventional-study requirements included in the Agreement. Requirements applicable to this Study are as follows: [Insert the Adverse Event text appropriate to the circumstances]
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
