definiens: means the development of an undesirable medical condition or the deterioration of a pre - existing medical condition in a patient or clinical investigation subject following or during exposure to a pharmaceuticalproduct or investigational drug, whether or not considered causally related to such product or drug, the exacerbation ofany pre - existing condition(s ) occurring during the use of such product or drug, or any other adverse experience oradverse drug experience described in the FDA ’s Investigational New Drug safety reporting and NDA post - marketingreporting regulations, 21 C.F.R. 312.32 and 314.80, respectively, and any applicable corresponding regulations outsideof the United States, in each case as may be amended from time to time . For purposes of this Agreement, shall include symptoms ( e.g., nausea, chest pain ), signs ( e.g., tachycardia, enlargedliver ) or the 7abnormal results of an investigation ( e.g., laboratory findings, electrocardiogram ), including unfavorable side effects, toxicity, injury, overdose or sensitivity reactions . Failure of a product to exhibit its expected pharmacologic / biologiceffect in a clinical study is not considered an Adverse Event