definiens: means any Serious Adverse Event ( an ) that ( i ) is determined by anindependent safety review committee overseeing the safety of the relevant clinical study to be directly related to the CoveredProduct ( not predominantly related to any compound with which the Covered Product is co - administered ) and to have(a ) resulted in death, ( b ) been life - threatening, ( c ) required inpatient hospitalization or a significant prolongation of existinghospitalization, ( d ) resulted in persistent or significant disability or incapacity, ( e ) resulted in a congenital anomaly or birthdefect, or ( f ) required significant intervention to prevent permanent impairment or damage ; and ( ii ) ( x ) results in the FDA’splacing a clinical hold on the development program of the Covered Product or ( y ) is likely to result in a significant delay inthe scheduled dosing of patients with the Covered Product in the INH-189 - 003 clinical study ( Study of Safety & Efficacy ofINX-08189 in Adjunctive Treatment With Pegasys ® Copegus ® in Chronically - infected HCV Genotype 2 and 3 )