Common use of Adverse Event Reporting Clause in Contracts

Adverse Event Reporting. PRONOVA and RELIANT shall report to the other any information obtained or received from any source concerning any adverse drug experience in connection with the use of the Product, any Additional Product, the API, any active pharmaceutical ingredient substantially similar to the API, or any Other Product, including the incidence or severity thereof, including, but not limited to events associated with non-clinical studies, clinical uses, post-Registration studies, investigations or tests, reports in scientific literature or unpublished papers, or notices from regulatory authorities, whether or not determined to be attributable to the Product, any Additional Product, the API, any active pharmaceutical ingredient substantially similar to the API, or any Other Product. Reports of routine adverse drug experiences of the type defined in Section 314.80 (or Section 600.80, as applicable) of Title 21 of the U.S. Code of Federal Regulations shall be exchanged by each Party on a calendar quarter basis. Reports of Serious Adverse Drug Experiences and unexpected adverse drug experiences or information that would require an IND safety report as described in 21 CFR 312.32 shall be made available to the other Party as soon as practicable but in no event more four (4) days after a Party becomes aware of same. Upon receipt of any such information concerning any Serious Adverse Drug Experience or unexpected adverse drug experience or information that would require an IND safety report as described in 21 CFR 312.32 by either PRONOVA or RELIANT, the Parties shall promptly consult each other and use commercially reasonable efforts to arrive at a mutually acceptable procedure for taking such possible actions as appropriate or required under the circumstances. If either Party has information that would require the filing of a 3-day Field Alert report under 21 CFR Section 314.81, that Party shall immediately notify the other Party. RELIANT shall make the required report or submission to the FDA or take any other action that the Parties deem to be appropriate or required by applicable law and provide a copy to PRONOVA.