definiens: means ( i ) any finding from tests in laboratory animals or in vitro that suggests a significant risk for human subjectsincluding reports of mutagenicity, teratogenicity or carcinogenicity and ( ii ) any undesirable, untoward or noxious eventor experience associated with the clinical, commercial or other use or occurring following administration, of a productin humans, occurring at any dose, whether expected or unexpected and whether or not considered related to orcaused by a product, including such an event or experience as occurs in the course of the use of a product inprofessional practice, in a clinical trial, from overdose, whether accidental or intentional, from abuse, from withdrawalor from a failure of expected pharmacological or biological therapeutic action of a product, and including those eventsor experiences that are required to be reported to the FDA under 21 C.F.R. Sections 312.32 or 314.80 or to RegulatoryAuthorities under corresponding applicable Law outside the United States