definiens: ( as defined in 21 CFR 314.3(b ) and comparableregulations outside the United States ) with respect to clinical trial Data and results related to any [COMPANY] Product andControlled by [COMPANY], as necessary for [COMPANY] and its permitted assigns and sublicensees to prepare and submit submissionsto Regulatory Authorities and maintain Regulatory Approvals related to the Diagnostic Test and related matters . Abbotthereby grants to [COMPANY] a non - exclusive, non - transferable ( except in connection with a permitted assignment, sublicense orsubcontract ) ( as defined in 21 CFR 314.3(b ) and comparable regulations outside the United States ) withrespect to [COMPANY] ’s clinical sample analytical trial data and results related to the Diagnostic Test, as necessary for [COMPANY] andits permitted assigns and sublicensees to prepare and submit submissions to Regulatory Authorities, and to maintainRegulatory Approvals, related to any [COMPANY] Product and related matters