definiens: shall mean any approvals, licences, registrations or authorisations of any supranational, national, regional, state or local Regulatory Authority or other regulatory agency, department, bureau or governmenta l entity, necessary to determine or set the pricing of a Product, andlor its reimbursement level by the relevant health authorities, providers or other funding institutions, at supranatio nal, national, regional, state or local leveL 1.40 . shall mean any [ . i ud 9 s co uct.containlng any te so ~u lresJi1 Utis ooreemenL or ( ill ) acci e p - reQ§ a 1.41 . shall mean any approvals, licences, registrations or authorisations of any supranational, national, regional, state or local Regulatory Authority or other regulatory agency, departme nt, bureau or governmenta l entity, necessary for the manufactu re, marketing or sale of the Product or conduct of clinical tfials in a regulatory jurisdiction, excluding Price and Reimbursement Approval