definiens: shall mean ( a ) any finding from tests in laboratory animals or in vitro studies 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 Licensed Compound or Licensed Product in humans, occurring at any dose, whether expected orunexpected and whether considered related or unrelated to Licensed Compound or Licensed Product, including such an eventor experience as occurs in the course of the use of Licensed Compound or Licensed Product in professional practice, in aclinical trial, from overdose, whether accidental or intentional, from abuse, from withdrawal or from a failure of expectedpharmacological or biological therapeutic action of Licensed Compound or Licensed Product, and including those events orexperiences that are required to be reported to the FDA under 21 C.F.R. Sections 312.32 or 314.80, or to foreign RegulatoryAuthorities under corresponding Applicable Law outside the United States