definiens: means, with respect to a Licensed Product : ( a ) a Regulatory Authority or safety data review board for the clini cal trials of such Licensed Product has required ( i ) termination or suspension of all clinical trials of such Licens ed Product in a country due to safety issues or ( ii ) following approval of a Drug Approval Application for a Licen sed Product in a country, a Regulatory Authority wi thdraws such approval in such country due to safety issues, in each case ( ( i ) and ( ii ) ) for reasons related to a Licensed Compound and not, for example, due to Other Actives contained in such Licensed Product or to Manufactu ring - related deficiencies or defects ( in either case ( ( i ) or ( ii ) ), a with respect to the applicable country ) ; or ( b ) it is re asonably determined that ( i ) the medical risk / benef it of such Licensed Product is so unfavorable that it would be incompatible with the welfare of patients to Devel op or Commercialize ( or to continue to Develop or Commerc ialize ) such Licensed Product or ( ii ) the efficacy of such Licensed Product, as evidenced by the ability of a Licensed Compound to bind to or inactivate antiplat elet efficacy of the Ticagrelor Compound or its active m etabolite, is so minimal that it would not be comme rcially reasonable to continue to Develop such Licensed Pro duct, in each case ( ( i ) and ( ii ) ) for reasons relat ed to a Licensed Compound and not, for example, due to Othe r Actives contained in such Licensed Product or to Manufacturing - related deficiencies or defects ( in e ither case ( ( i ) or ( ii ) ), a )