definiens: means, with respect to a Seller Product, any unde sirable, untoward or noxious event or experience associated with the use, or occurring during or following the administration, of such product in humans, occurrin g at any dose, whether expected and whether considered related to or caused by such Seller Prod uct, including such an event or experience as occur s in the course of the use of such Seller Product in pro fessional practice, in a clinical trial, from overd ose, whether accidental or intentional, from abuse, from withdrawal or from a failure of expected pharmacological or biological therapeutic action of such Seller Product, and including those events or experiences that are required to be reported to the FDA under 21 C.F.R. sections 312.32, 314.80 or 600.80, as applicable, or to foreign Governmental A uthorities under corresponding applicable Law outside the United States