definiens: means, with respect to the Products anywhere in the world, ( a ) any approvals, clearances, registrations, licenses, biologics license applications, listings, permits, investigational new drug exemptions, INDs, new drug applications, ODDs, breakthrough therapy designations, fast track designations, clinical trial authorizations or marketing authorizations, including FDA druglistings, marketing authorization approvals and other national or regional marketing authorizations or permits and CE marks, together with anysupplements or amendments thereto ( collectively, ), whether pending or issued, to Seller or any of its Subsidiaries bythe relevant Governmental Entity solely related to the research, development, manufacture, importation, distribution, marketing or sale of theProducts over which such Governmental Entity has authority, ( b ) any rights that Seller or an Affiliate of Seller has in any Registration Approvalunder any agreement pursuant to which any such Registration Approval is held in the name of a third party and ( c ) pricing and reimbursementapproval ( if applicable or available ) and all national drug code numbers ( if any ) assigned to the Products