definiens: means any Biological Samples that remain aftercompletion of all protocol - required testingconducted as part of the Phase I / II ClinicalTrial by or on behalf of Spark prior to the timethat Spark transfers to [COMPANY] and Pfizerbecomes the sponsor of the IND(s ) for thePhase I / II Clinical Trial.(c ) means : ( i ) the terms of the Agreement, including, but not limited to, standard operatingprocedures ( ) and other documentsreferred to in the Agreement or otherwise usedby Spark in the conduct of the Phase I / IIClinical Trial ; ( ii ) the13CONFIDENTIALEXECUTION VERSIONNovember 6, 2017protocol(s ) for the Phase I / II Clinical Trial ( the ) ; ( iii ) theInvestigator Brochure(s ) for the Phase I / II Clinical Trial ; ( iv ) the termsof the IRB / IEC approval(s ) for the Phase I / II Clinical Trial ; ( v ) allApplicable Laws ; and ( vi ) all applicable GxP