definiens: shall have the meaning ascribed thereto in Section 5.9(a ) ; shall have the meaning ascribed thereto in the introductory paragraph of thisAgreement ; shall mean all the equipment listed in Schedule D attached hereto as well as any othermanufacturing or inspection equipment owned by [COMPANY] ( or provided by any third party for thebenefit of [COMPANY] ) that is used for the fulfilment of the Manufacturing and Support Serviceshereunder ; shall have the meaning ascribed thereto in the introductory paragraph of thisAgreement ; means, as that term is defined in INCOTERMS 2010 ; means the manufacturing facility of [COMPANY], at Kingfisher Drive, Covingham, Swindon, Wiltshire, SN3 5BZ, United Kingdom, and where manufacturing of the Products under thisAgreement shall take place ; means the United States Food and Drug Administration ; shall mean the United States Food, Drug & Cosmetic Act, as amended fromtime to time, and the regulations promulgated pursuant thereto ; means a finished pack of Product, as further described in Schedule A ; has the meaning specified in Section 5.2(b ) ; has the meaning specified in the recitals to this Agreement;- 7 - shall mean all improving modifications or adaptations to any of the patentsor know - how relating to the Product, whether patentable or not, which might reasonably be ofcommercial interest to either Party in the design, manufacture, supply or use of the Product andwhich may be made, acquired by or disclosed to [COMPANY] or [COMPANY] during the Term of thisAgreement ; includes, without limitation, rights in patents, patent applications, formulae, trade - marks, trade - mark applications, trade - names, trade secrets, inventions, copyrights, industrialdesigns, know - how ; means all inventories of Materials and work - in - process produced or held by [COMPANY] inconnection with the manufacture of the Products ; means the manufacturing, quality control, qualityassurance and stability testing, packaging and related services, as contemplated in this Agreement, either required to produce Products from the Materials or requested to be completed by [COMPANY] ; means Marketing Authorisation for the Product at the Facility pursuant to Directive 65/65EEC ( as amended by following provisions including Directive 2001/83 / EC ) or any implementationof it or its equivalent under the laws of a relevant Member State, or the approved NDA orequivalent thereof ; means the reasonable costs required to repair the Facility and return it into auseable area based on the repair of materials damaged by the installation or removal of Equipment