definiens: shall mean any : ( i ) permit, license, certificate, concession, Consent, clearance, confirmation, exemption, franchise, cert ification, designation, rating, registration, varia nce, qualification or accreditation issued, granted, giv en or otherwise made available by or under the auth ority of any Governmental Authority or pursuant to any Legal Req uirement, including all applications for any of the foregoing, together with any renewals, extensions or modificat ions thereof and additions thereto ( ) ; ( ii ) with respect to a pharmaceutical or biological product in a coun try or regulatory jurisdiction, the approval or oth er action of a Governmental Authority necessary for the testing, m anufacturing, marketing, labeling, distribution, ad vertising, commercial sale or use of such product in such coun try or regulatory jurisdiction, including the autho rization of an Investigational New Drug Application or NDA by t he FDA or any analogous approval in jurisdictions o ther than the United States, and including any or similar designation, but, in all cases, exc luding any separate pricing or reimbursement approval, where r equired ( ) ; or ( iii ) right und er any Contract with any Governmental Authority