definiens: means the development of an undesirable medical c ondition or the deterioration of a pre - existing medical condition in a patient or clinical investigation subject following or during exposure to a pharmaceutical product or investigational drug, whe ther or not considered causally related to such pro duct or drug, the exacerbation of any pre - existing conditio n(s ) occurring during the use of such product or dr ug, or any other adverse experience or adverse drug experience described in the FDA ’s Investigational New Drug sa fety reporting and regulatory approval post - marketing re porting regulations, 21 C.F.R. § § 312.32 and 314.80, respectively, and any applicable corresponding regu lations outside the U.S. For purposes of this Agree ment, ( a ) will include [ * * * ], and ( b ) the failure of a product to exhibit its ex pected pharmacologic / biologic effect in a Clinical Trial [ * * * ]