definiens: shall mean, with respect to the Finished Product, any adverse event associated with the use of the Finished Product in a patient or clinical investigation, whether or not considered drug related, including the following : an adverse ev ent occurring in the course of the use of the Finished Product in professional practice ; an adverse event occurring from drug overdose, whether accidental or intentional ; an adverse event occurring from drug abuse ; an adverse event occurring from drug with drawal ; and any significant and consistent failure of expected pharmacological action . Adverse Events shall include, without limitation, any unfavorable and unintended sign ( including, without limitation, an abnormal laboratory finding ), exacerbation of a pre - existing condition, intercurrent illness, drug interaction, significant worsening of a disease under investigation or treatment, significant failure of expected pharmacological or biological action, and/or symptom or disease temporally associated with the use of the Finished Product, whether or not considered related to the Finished Product . Notwithstanding anything foregoing to the contrary, with respect to the Territory in which the Finished Product is marketed, Adverse Events shall include any experi ence required to be reported to a relevant authority in any such country