definiens: shall have the meaning ascribed thereto in Section 5.9(a ) ; means the 1 day of November 2008 ; shall mean all the equipment listed in Schedule D attached hereto as well as any other manufacturing orinspection equipment owned by [COMPANY] ( or provided by any third party for the benefit of [COMPANY] ) that is used for thefulfilment of the Manufacturing Services hereunder ; means, as that term is defined in INCOTERMS 2000 ; means the manufacturing facility of [COMPANY], at Kingfisher Drive, Covingham, Swindon, Wiltshire, SN3 5BZ, United Kingdom, and where manufacturing of the Products under this Agreement shall take place ; means the United States Food and Drug Administration ; shall mean the United States Food, Drug & Cosmetic Act, as amended from time to time, and the regulationspromulgated pursuant thereto ; means a finished pack of Product, as further described in Schedule A ; has the meaning specified in Section 5.2(b ) ; - - 3 - -thst shall have the meaning ascribed thereto in Section 6.6 ; shall mean all improving modifications or adaptations to any of the patents or know - how relating tothe Product, whether patentable or not, which might reasonably be of commercial interest to either party in the design, manufacture, supply or use of the Product and which may be made, acquired by or disclosed to [COMPANY] or Zogenixduring the term of this Agreement ; shall have the meaning ascribed thereto in Section 7.1 ; includes, without limitation, rights in patents, patent applications, formulae, trade - marks, trade - mark applications, trade - names, trade secrets, inventions, copyrights, industrial designs, know - how ; means all inventories of Materials and work - in - process produced or held by [COMPANY] in connection with themanufacture of the Products ; means the manufacturing, quality control, quality assurance and stabilitytesting, packaging and related services, as contemplated in this Agreement, either required to produce Products from theMaterials or requested to be completed by [COMPANY] ; means Marketing Authorisation pursuant to Directive 65/65 EEC ( as amended by following provisions includingDirective 2001/83 / EC ) or any implementation of it or its equivalent under the laws of a relevant Member State, or theapproved NDA or equivalent thereof ; means the reasonable costs required to repair the Facility and return it into a useable area based on a replacement of any damaged materials