Common use of Adverse Drug Experiences Clause in Contracts

Adverse Drug Experiences. For the reporting of adverse drug experiences, the responsibilities of the Parties are as follows: 6.4.1 Wyeth shall be responsible for follow-up of all reports of adverse events or experiences (“AEs”) or Other Information Reportable to Wyeth (as hereinafter defined) and for the preparation and submission to the FDA of all safety reports required per US Code of Federal Regulations (CFR), title 21 § 314.80. 6.4.2 An AE is any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a person administered any Detailed Product or in a clinical study. The event or experience does not need to be causally related to such Detailed Product or clinical study. An AE includes, but is not limited to: (a) Any clinically significant worsening of a pre-existing condition; (b) An AE occurring from Detailed Product overdose (i.e., a dose higher than that prescribed by a healthcare professional for clinical reasons, or a dose higher than that described on the Detailed Product label) whether accidental or intentional; (c) An AE occurring from abuse (e.g., use for non-clinical reasons) of the Detailed Product; (d) An AE occurring from discontinuation of the Detailed Product (Detailed Product withdrawal); and (e) Any failure of expected pharmacological action.