definiens: means ( a ) all licenses, permits, certiﬁcates, clearances, exemptions, approvals, consents and other authorizations, including those prepared for submission to or issued by any Regulatory Authority or research ethics committee ( including pre - market notiﬁcationclearances, 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, registrationnotiﬁcations or their foreign equivalent ), that are required for the Product or Purchased Assets or the Exploitation thereof ; 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 anyother Regulatory Authority or research ethics committee, relating to any license, permit, certiﬁcate, clearance, exemption, approval, consent or otherauthorization described in clause ( a )