definiens: means the development of an undesirable medical condition or the deterioration of a pre - existingmedical condition in a patient or clinical investigation subject following or during exposure to or use of a Compound orLicensed Product, whether or not considered causally related to such Compound or Licensed Product, the exacerbation of anypre - existing condition(s ) occurring following or during exposure to or use of such Compound or Licensed Product, or anyother adverse experience or adverse drug experience ( as described in the FDA ’s Investigational New Drug safety reporting andNDA post - marketing reporting regulations, 21 C.F.R. § § 312.32 and 314.80, respectively, and any applicable correspondingregulations outside the U.S. Territory, in each case as may be amended from time to time ), occurring following or duringexposure to or use of a Compound or Licensed Product . For purposes of this Agreement, shall include symptoms ( e.g., nausea, chest pain ), signs ( e.g., tachycardia, enlarged liver ) or the abnormal results of aninvestigation ( e.g., laboratory findings, electrocardiogram ), including unfavorable side effects, toxicity, injury, overdose orsensitivity reactions