definiens: ( as defined in 21 CFR 314.3(b ) andcomparable regulations outside the United States ) with respect to Idera ’s clinical trial data and results related to anyIdera Product, as necessary for [COMPANY] and its permitted assigns and sublicensees to prepare and submitsubmissions to Regulatory Authorities and maintain Regulatory Approvals related to the Diagnostic Test and relatedmatters, in each case for the Diagnostic Test Intended Use . [COMPANY] hereby grants to Idera a non - exclusive, non - transferable ( except in connection with a permitted assignment, sublicense or subcontract ) ( asdefined in 21 CFR 314.3(b ) and comparable regulations outside the United States ) with respect to [COMPANY] ’s clinicalsample analytical trial data and results related to the Diagnostic Test, as necessary for Idera and its permittedassigns and sublicensees to prepare and submit submissions to Regulatory Authorities, and to maintain RegulatoryApprovals, related to any Idera Product and related matters, in each case for the Diagnostic Test Intended Use