definiens: shall mean any adverse event associated wi th the use of any Agreement Product in humans, whether or not consider ed drug - related . The definition includes an adverse event occur ring in the course of the use of an Agreement Product in professional pr actice, in studies, in investigations or in tests . The definition also includes an adverse event occurring from Agreement Product ove rdose ( whether accidental or intentional ), from Agreement Product abuse, or from Agreement Product withdrawal, as well as any toxicity, sensi tivity, failure of expected pharmacological action, or laboratory abno rmality which is or is thought by the reporter to be serious or a ssociated with relevant clinical signs or symptoms . For the purpos es of this Agreement, shall mean an Adve rse Event that is fatal, life - threatening, 30 < PAGE > CO NFIDENTIAL TREATMENT REQUEST permanently disabling or incapacitating, r esults in new or prolonged in - patient hospitalization, is a congenita l anomaly, cancer or overdose . With respect to any Agreement Pr oduct, [COMPANY] shall notify [COMPANY], or any successor departme nt specified by [COMPANY], as soon as possible, but ( i ) no later than twenty - four ( 24 ) hours following its receipt of information conce rning a possible Serious Adverse Event and ( ii ) no later than forty -eight ( 48 ) hours following its receipt of information of a possible Adverse Event that is not a Serious Adverse Event . Notif ication shall be given by telephone, with a facsimile confirmation i mmediately following