definiens: as defined in Section 1.2, and consistent with FDA law, regulation and guidanc e. As defined in Section 1.2, 21 CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CER TAIN PORTIONS OF THIS DOCUMENT . EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK * * *, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION an Adverse Drug Experience includes the FDA definit ion of at 21 C.F.R. § 314.80(a ): “ Any adverse event associated w ith the use of a drug in humans, whether or not considered drug related, including the follo wing : An adverse event occurring in the course of the use of a drug product in professional practice ; an adverse event occurring from drug overdose whether accidental or intentional ; an adverse event occurring from drug abuse ; an adverse event occurring from drug withdra wal ; and any failure of expected pharmacological action ” . Distributor shall inform i ts employees and agents that all events within the definition of an Adverse Drug Experience shall be immediately reported to a designated responsible employee of the Distributor, and that under no circumstances shall an employee or agent ( a ) fail to internally report suc h an event based on his or her opinion that the event is not related to Product use, or ( b ) del ay a report based on his or her opinion that the event is not,, or as these terms are understood under 21 C.F.R. § 314.80(a )