definiens: ( as defined in 21 CFR 314.3(b ) ) with respect to [COMPANY] ’s clinical trialdata and results related to any Product, solely as necessary for [COMPANY] or its Affiliate, licensee orsublicensee or distributor to prepare and submit submissions to Regulatory Authorities and maintainRegulatory Approvals related to the Companion Diagnostic . [COMPANY] hereby grants to [COMPANY] a non - exclusive, non - transferable ( except in connection with a permitted assignment of this Agreement, sublicense of the rights granted to it hereunder, or subcontract ) ( as defined in 21CFR 314.3(b ) ) with respect to [COMPANY] ’s clinical sample analytical trial data and results related to theCompanion Diagnostic, solely as necessary for [COMPANY] to prepare and submit submissions to RegulatoryAuthorities, and to maintain Regulatory Approvals, related to any Product