definiens: means any and all approvals, licenses, registrations, clearances, or authorizations of any nat ional, supra -national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, that are necessary for the commercial manufacture, distribution, use, and sale of a Licensed Product for human therapeu tic, prophylactic, or palliative use in a particular jurisdiction, provided that Regulatory Approvals shall exclude pricing and reimbursement approvals 1.42 means any multinational, federal, regional, state and/or local government aut hority ( including public, quasi -public and private bodies contracted, certified or authorized by such governmental bodies ) in a country or other jurisdiction with authority to regulate, approve, license, inspect, review or otherwise control or supervise th e manufacture, sale, labeling, use, marketing, distribution, import, export, price or reimbursement for API or final Drug Product, including but not limited to the FDA, MHLW, and their counterparts in the European Union and other countries outside the Terr itory