definiens: shall mean, with respect to the Product, any adverse event associated with the use of the Product in apatient or clinical investigation, whether or not considered drug related, including the following : an adverse eventoccurring in the course of the use of the Product in professional practice ; an adverse event occurring from drugoverdose whether accidental or intentional ; an adverse event occurring from drug abuse ; an adverse event occurringfrom drug withdrawal ; and any significant and consistent failure of expected pharmacological action . AE shall include, without limitation, any unfavorable and unintended sign ( including, without limitation, an abnormal laboratory finding),an exacerbation of a pre - existing condition, intercurrent illness, drug interaction, significant worsening of a diseaseunder investigation or treatment, significant failure of expected pharmacological or biological action, symptom ordisease temporally associated with the use of the Product, whether or not considered related to - 1 -the Product . Notwithstanding anything foregoing to the contrary, with respect to the Territory in which the Product ismarketed, AEs shall include any experience required to be reported to a relevant authority in any such country