definiens: shall mean ( a ) any finding from tests in laboratory animals or in vitro thatsuggests a significant risk for human subjects including reports of mutagenicity, teratogenicity or carcinogenicity and ( b ) anyundesirable, untoward or noxious event or experience associated with the clinical, commercial or other use or occurringfollowing administration, of a Licensed Product in humans, occurring at any dose, whether expected or unexpected andwhether or not considered related to or caused by a Licensed Product, including such an event or experience as occurs in thecourse of the use of a Licensed Product in professional practice, in a clinical trial, from overdose, whether accidental orintentional, from abuse, from withdrawal or from a failure of expected pharmacological or biological therapeutic action of aLicensed Product, and including those events or experiences- 49 - that are required to be reported to the FDA under 21 C.F.R. sections 312.32 or 314.80 or to Regulatory Authorities undercorresponding Applicable Law outside the United States