definiens: means, with respect to Shared Clinical Trial Data, ( a ) the inclusion of such Shared Clinical Data in a core report of an NDA filedby a Party ( as evidenced by ( i ) the use of a bridging study to utilize such Shared Clinical Data, ( ii ) the elimination for the need to [ * * * ] such Shared ClinicalData through a clinical trial within such Party 's respective geographic territory, or ( iii ) such other reference use of such Shared Clinical Data consistent withclauses ( i)-(ii ) above ), or ( b ) the use of such Shared Clinical Data by a Party in a manner substantially similar to that contained in a full Clinical Study Report(CSR ), as described in ICH Harmonized Guideline E3 ( Structure and Content of Clinical Study Reports ), and including the appendices specified in Section16 of such guideline that are applicable to such Party ’s NDA . For purposes of clarity, it shall not be deemed to be a Material Use of clinical data if suchclinical data is used only to support an NDA filing