definiens: means the technical, med ical and scientific licenses, registrations, author izations and approvals required for marketing or use of a pr oduct ( including, without limitation, approvals of, biologic license applications, investigational new drug appl ications, pre- and post- approvals, pricing and Thi rd Party reimbursement approvals, and labeling approvals and any supplements and amendments to any of such approvals ) of any national, supra - national, regiona l, state or local regulatory agency, department, bu reau, commission, council or other governmental entity, n ecessary for the development, manufacture, distribu tion, marketing, promotion, offer for sale, use, import, export or sale of Collaboration Products or Unilate ral Products in a regulatory jurisdiction . In the United States, its territories and possessions, Regulatory Approv al means approval of a biologics license application, new dr ug application or equivalent by the FDA