definiens: means ( a ) any finding fro m tests in laboratory animals or in vitro that sugg ests a significant risk for human subjects including repor ts of mutagenicity, teratogenicity or carcinogenici ty and ( b ) any undesirable, untoward or noxious event or exper ience associated with the clinical, commercial or o ther use, or occurring following administration, of any Licen sed Compound or Licensed Product in humans, occurri ng at any dose, whether expected or unexpected and whethe r considered related or unrelated to any Licensed Compound or Licensed Product, including such an eve nt or experience as occurs in the course of the use of any Licensed Compound or Licensed Product in profession al practice, in a clinical trial, from overdose, wh ether accidental or intentional, from abuse, from withdra wal or from a failure of expected pharmacological o r biological therapeutic action of any Licensed Compo und or Licensed Product, and including those events or experiences that are required to be reported to the FDA under 21 C.F.R. Sections 312.32 or 314.80, or to foreign Regulatory Authorities under corresponding applicab le Law outside the United States