definiens: means ( a ) all licenses, permits, certificates, clearances, exemptions, approvals, consents a nd other authorizations, 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 require d for any Product or Purchased Assets or the Exploitation thereof, including those set forth on Schedule 3.10(a ) ; and ( b ) all applications, supporting files, drug master files, adverse event data, writings, data, studies and reports, and all correspondence to, with, or from 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 )