definiens: means ( a ) for purposes of Section 5.4, the significant possibility, in the reasonablebelief of [COMPANY], that the conduct of the applicable Clinical Trial or other clinical study poses ( i ) a significantly higherrisk of either an adverse effect on * * * of the applicable * * * Program DART or * * * Licensed Product, as compared to * * *, forsuch * * * Program DART or * * * Licensed Product, or ( ii ) a significant risk of an adverse effect on the ability of MacroGenicsor its Affiliates or Sublicensees to recruit patients for active Clinical Trials conducted, or planned Clinical Trials ( for which aprotocol has been submitted to and not disapproved by [COMPANY] pursuant to Section 5.5, as of the time of submission toMacroGenics pursuant to Section 5.4 of a protocol for the applicable Clinical Trial or study proposed to be conducted byGilead or its Affiliates or Sublicensees ) to be conducted, by [COMPANY] or its Affiliates or Sublicensees in the MacroGenicsTerritory with respect to such * * * Program DART or Licensed Product ; and ( b ) for purposes of Section 5.5, the significantpossibility, in the 17 * * * = Portions of this exhibit have been omitted pursuant to a request for confidential treatment . An unredactedversion of this exhibit has been filed separately with the Commission.reasonable belief of [COMPANY], that the conduct of the applicable Clinical Trial or other clinical study poses ( i ) a significantlyhigher risk of either an adverse effect * * * Licensed Product, as compared to * * *, for such * * * Program DART or * * * Licensed Product, or ( ii ) a significant risk of an adverse effect on the ability of [COMPANY] or its Affiliates or Sublicensees to * * * ( ( A ) with respect to planned Clinical Trials to be conducted in the [COMPANY] Territory, that are subject to a protocol that hasreceived internal approval by [COMPANY], and ( B ) with respect to planned Clinical Trials to be conducted in the MacroGenicsTerritory, for which a protocol has been submitted to and not disapproved by [COMPANY] pursuant to Section 5.4, as of thetime of submission to [COMPANY] pursuant to Section 5.5 of a protocol for the applicable Clinical Trial or study proposed to beconducted by [COMPANY] or its Affiliates or Sublicensees ) to be conducted, by [COMPANY] or its Affiliates or Sublicensees in theGilead Territory with respect to such * * * Program DART or Licensed Product