Common use of Adverse Event Reports Clause in Contracts

Adverse Event Reports. Each of Ista and Allergan shall report to the other potentially serious or unexpected adverse events (including adverse drug experiences, as defined in 21 C.F.R. Section 314.80 or other applicable regulations ) with respect to the Product of which it becomes aware promptly and in no event later than five (5) days after initial receipt of the information by such party. Each such report shall identify lot numbers and customers affected, if known. Each of Ista and Allergan shall report to the other party summaries of other adverse events with respect to the Product every twelve (12) months.