definiens: means ( a ) all licenses, permits, certificates, clearances, exemptions, approvals, consents and other authorizationsthat any Seller owns, holds or possesses, including those prepared for submission to or issued by any Regulatory Authority or research ethics committee(including pre - market notification clearances, pre - market approvals, investigational device exemptions, non - clinical and clinical study authorizations, product re- certifications, manufacturing approvals and authorizations, CE Mark certifications, pricing and reimbursement approvals, Labeling approvals, registration notifications or their foreign equivalent ), that are required for or relate to the Purchased Assets or the Exploitation of the Purchased Assets, including those set forth on Schedule 3.10(a ) ; and ( b ) all applications, supporting files, writings, data, studies and reports, and all correspondence to, with, orfrom the FDA or any other Regulatory Authority or research ethics committee, relating to any license, permit, certificate, clearance, exemption, approval, consent or other authorization described in clause ( a )