definiens: has the meaning set out in Clause 20.1 ; has the meaning set out in paragraph 1 of Part C Schedule 8 ; means any and all approvals ( including any applicable supplements, amendments, pre and post approvals, and approvals of applications for regulatory exclusivity ), licenses, registrations, orauthorisations of any federal, national, multinational, state, provincial or local regulatory agency, department, bureau, commission, council or other governmental entity necessary for the manufacture, distribution, use, testing, development, storage, import, export, transport, promotion, marketing and sale of a medicinal productin a country or countries ; means any governmental or regulatory authority responsible for assessing and / orgranting Regulatory Approvals ( including any ethics committees ) and shall meanmore than one such authority ; means on a country by country basis that a Third Party under applicable lawsconcerning the application for and grant of Marketing Approvals having jurisdiction over that country at therelevant time ( i ) is precluded from submitting a Marketing Approval Application for any Competitive Product ; or(ii ) in respect of any Competitive Product, is prohibited from relying upon [COMPANY] ’s, or its Affiliates ’ orSub - Licensee ’s product dossier or Regulatory Submission ( from which such party obtained a MarketingApproval ) concerning any Royalty Product, under any applicable abridged or streamlined procedure to obtain aMarketing Approval for such Competitive Product ; means in respect of a Royalty Product, the package or packages of data, pre - clinical and clinical trial data and materials, information, results, materials and samples ( including any Testand Regulatory Data and/or the drug master file or part thereof ) submitted to a Regulatory Authority in supportof a Marketing Approval Application or any other Regulatory Approval ; has the meaning set out in Clause 18.2.1(ii ) ; means all uses and applications without restriction ; has the meaning set out in Clause 2.2.13 ; CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT . THE COPY FILEDHEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST . OMISSIONS AREDESIGNATED [ * * * ] . A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THESECURITIES AND EXCHANGE COMMISSION