definiens: 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, andapprovals of applications for regulatory exclusivity ), licenses, registrations, or authorisations 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 product in a country orcountries ; means any governmental or regulatory authority responsible for assessing and/or granting Regulatory Approvals(including any ethics committees ) and shall mean more than one such authority ; means on a country by country basis that a Third Party under applicable laws concerning the application for and grantof Marketing Approvals having jurisdiction over that country at the relevant time ( i ) is precluded from submitting a Marketing Approval Applicationfor any Competitive Product ; or ( ii ) in respect of any Competitive Product, is prohibited from relying upon [COMPANY] ’s, or its Aﬃliates ’ or Sub - Licensee ’s or any Assignee Entity ’s product dossier or Regulatory Submission ( from which such party obtained a Marketing Approval ) concerningany Royalty Product, under any applicable abridged or streamlined procedure to obtain a Marketing Approval for such Competitive Product ; means in respect of a Royalty Product, the package or packages of data, pre - clinical and clinical trial data andmaterials, information, results, materials and samples ( including any Test and Regulatory Data and/or the drug master ﬁle or part thereof)submitted to a Regulatory Authority in support of a Marketing Approval Application or any other Regulatory Approval ; means the RQR8 Patent Rights and the [ * * * ] Existing Patent ; means all uses and applications without restriction ; has the meaning set out in Clause 2.2.13 ; means any product or therapy within the Retrostim Field : ( i ) which, were it not for the licence granted hereunder or theassignment to [COMPANY] ( or subsequent assignment or licence grant to an Assignee Entity ) of the Retrostim Patent Rights, would infringe theRetrostim Patent Rights ; and/or ( ii ) the manufacture of which product or therapy were it not for the licence granted hereunder or the assignmentto [COMPANY] ( or subsequent assignment or licence grant to an Assignee Entity ) of the Retrostim Patent Rights, would infringe the Retrostim PatentRights, and/or ( iii ) where the manufacture of any materials used in connection with the manufacture of such product or therapy, were it not forthe licence granted hereunder or the assignment to [COMPANY] ( or subsequent assignment or licence grant to an Assignee Entity ) of the RetrostimPatent Rights, would infringe the Retrostim Patent Rights ; means the program of research deﬁned in Schedule 1 under the title Retrostim Program as conducted prior to theAmendment Date ; means excluding Manufacturing Know - How, ( i ) those patent applications listed in Schedule 2 under the title RetrostimPatents and all Patent Rights derived therefrom ( ) ; ( ii ) the Know - How described in Schedule 2 under the titleRetrostim Know - How ; and ( iii ) the materials listed in Schedule 2 under the title Retrostim Materials together with all IP in the same ; or has the meaning set out in Clause 14.1 ; has the meaning set out in Clause 14.6 ; means any one of the Original Royalty Products, Additional Royalty Products or CAT19 Products, and shall be constructed to mean any combination of two or more of the Original Royalty Products, Additional Royalty Products and CAT19 Products, as the context requires ; means all uses and applications without restriction except for any uses or activities relating to any allogeneic T - cell therapy ( beingthe therapeutic transplantation of genetically engineered T - cell lymphocyte to a recipient patient from a genetically non - identical donor of thesame species ), including any activities of research, development or commercialisation of a therapeutic relating to any allogeneic T - cell therapy ; has the meaning set out in Clause 2.2.5 ; 12CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENTS, MARKED BY [ * * * ], HAS BEEN OMITTED BECAUSE IT IS NOTMATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED