definiens: means, with respect to use . of any Product or Injection Catheter, any adverse event ( within the meaning of applicable FDA regulations, and including, without limitation, any unfavorable and unintended sign ( including, without limitation, an abnormal laboratory fmding ), 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, or symptom or disease temporally associated with the use of such Product or Injection Catheter, whether or not considered to be related to such Product or Injection Catheter ), which event is associated with the use of such Product or Injection Catheter ( i ) in clinical investigation, or ( ii ) by a patient once such Product or Injection Catheter has been approved, whether or not such event is considered to be drug - related . AE(s ) shall include such events ( i ) occurring in the course of the use of such Product or Injection Catheter in professional practice ; ( ii ) occurring from drug overdose whether accidental or intentional ; MPDOCSOI/27570 1 ( iii ) occurring from drug abuse ; ( iv ) occurring from drug withdrawal ; and ( v ) any significant and consistent failure of expected pharmacological action . Notwithstanding the foregoing, AEs shall include any experience required to be reported to a relevant authority in any such country