definiens: shall mean any [ o sa e b~ ( ! ver · a Y ntext so ! il . Quires rodU for IS a y. u a n 0 er e tid . n ClClne Rrepgralio in Inal osage form fa ulalia ( ! rese osage fO ali · ve ( ! e were IlY e ( ! e t ere t tam!lQ cen e extensio r a li : a · config s i e uding suc Pro uct In eveloll ent w ere the conte so reg, re, thRegulatory Approval " 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 governmental entity, necessary for the manufacture, marketing or sale of the Product or conduct of clinicat triats in a regUlatory jurisdiction, excluding Price and Reimbursement Approval