definiens: means ( a ) all licenses, permits, certiﬁcates, clearances, exemptions, approvals, consents andother authorizations that the Company owns, holds or possesses, including those prepared for submission to or issued by anyRegulatory 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 approvalsand authorizations, CE Mark certifications, pricing and reimbursement approvals, Labeling approvals, registration notifications or theirforeign equivalent ), that are required for or relate to the Purchased Assets or the Exploitation of theA-17Purchased Assets, including those set forth on Schedule B-1 ; and ( b ) all applications, supporting ﬁles, writings, data, studies andreports, and all correspondence to, with, or from the FDA or any other Regulatory Authority or research ethics committee, relating toany license, permit, certificate, clearance, exemption, approval, consent or other authorization described in clause ( a )