definiens: shall mean any Clinical Trial conducted after the first Marketing Authorisation forthe Drug Product has been obtained ; 1.60 shall have the meaning set out in Clause 8.2 ; 1.61 shall mean promotional, advertising, communication and educational materialsrelating to the Drug Product for use in connection with the marketing, promotion and sale of the Drug Productand includes promotional literature, product support materials and promotional giveaways ; 1.62 shall mean a study aimed at investigating the API liability to prolong the QT interval(incorporating a bioavailability study ) to be performed on the Granule Formulation by Entasis in collaborationwith NIAID prior to commencement of the Phase III MC Trial ; 1.63 means all regulatory documents and filings registered with a Drug Regulatory Authorityfor a Marketing Authorisation containing the administrative, safety, efficacy, quality, non - clinical and clinicaldata and CMC data for the Drug Product as it may change from time to time ; 1.64 shall mean a regulatory plan outlining the regulatory strategy for obtaining MarketingAuthorisations for the Drug Product and split of regulatory responsibilities of the Parties with the aim ofensuring equitable and affordable access to the Product for people in the DNDi Territory and the EntasisTerritory at the earliest possible date, as further described in Schedule 4 hereto and in Clause 5, as may beamended from time to time ; 1.65 or shall mean detailed, written instructions to achieve uniformity ofthe performance of a specific function, adopted within the organisation of each of the Parties ; 1.66 shall mean a Third Party appointed by either Entasis or DNDi or an Affiliate of Entasis or DNDi(other than a CSP ) to carry out Manufacturing and/or Commercialisation of the Drug Product in its Territory ora part thereof ; 1.67 or shall mean the set of potential characteristics and attributes for the DrugProduct, described in Schedule 5 hereto, and revised from time to time by mutual consent through the JSC ; 1.68 shall mean the period commencing after the Effective Date and unless terminated earlier inaccordance with the terms of this Agreement, expiring country by country of the DNDi Territory and theEntasis Territory until the longer of : ( i ) the expiry of any Patent Rights in such country ; or ( ii ) ten years fromthe first Marketing Authorisation for such Drug Product for the Field in such country