definiens: shall mean ( a ) any finding from tests in laboratory animals or in vitro that suggests a signiFicant risk for human subjects including reports of mutagenicit y, teratogenicity or carcinogenicity and ( b ) any undesirabl e, untoward or noxious event or experience associated with the clinical, commercial or other use, or occurring following administration, of the Compound or the Product in humans, occurring at any dose, whether expected or unexpected and whether considered related or unrelated to the Compound or the Product, including such an event or experience as occurs in the course of the use of the Compound or the Product in professional practice, in a clinical trial, from overdose, whether accidental or intentional, from abuse, from withdrawal or from a Failure of expected pharmacological or biological therapeutic action of the Compound or the Product, and including those events or experiences that are required to be reported to the FDA under 21 C.F.R. Articles 312.32 or 314.80, as such regulations may be amended from time to time, or to foreign Regulatory Authorities under corresponding Applicable Law outside the United States