Common use of Adverse Event Reports Clause in Contracts

Adverse Event Reports. In order to comply with adverse event reporting regulations of the FDA (as provided in Title 21 of the Code of Federal Regulations) and other international regulatory agencies, each Party acknowledges that once the parties hereunder are selling and/or clinically testing in humans any Product they must report promptly to each other the occurrence of adverse events regarding Products for timely reporting to the FDA and other reporting agencies.