definiens: means the United States Food and Drug Adminis tration ; means the receipt by [COMPANY] of c onfirmation from the FDA that the FDA approves Chesapeake to Manufacture Finished Products on the licence concerning Finished Products granted to [COMPANY] by the FDA ; means final approval for sale of Fi nished Products given by the relevant Regulatory Authority or Regulatory Authori ties and/or by [COMPANY], and in the event that such approval is given by Pro therics and one or more Regulatory Authorities, the last such approval so g iven ; means the products specified in schedule 1 ; means any and all tr ade marks, rights in designs, get - up, business names, copyrights, future copyrigh ts and patents ( whether registered or not and any -2- applications to register or rights to apply for reg istration of any of the foregoing ), rights in inventions, know - how, trade s ecrets and other confidential information and all other intellectual property rig hts of a similar or corresponding nature, which may now or in the futur e subsist in any part of the world ; means all materials, components and rea gents, other than Bulk Products and Buffer, used by Chesapeake in the Manu facture of Finished Products ; means the manufacture of Finished Pro ducts from Bulk Products through their sterile filtration, filling and freez e - drying and the testing, packing and labelling thereof, and a nd shall be construed accordingly ; means the United Kingdom Medicines Control Ag ency ; means a pack containing the number of Vials of Finished Products set out in the Specification, whi ch such Vials shall be packed in accordance with the Technical Agreement ; means all technical informati on and data relating to the Bulk Products, Finished Products and Specification, and the contents of the Technical Agreement ; means a ce rtificate of release in the form attached to this agreement as schedule 5 ; has the same meaning as in Europ ean Directive 75/319 / EEC ; means the FDA, the MCA and E MEA ; means an inspection by any Regulatory Authority of the Facility or of Chesapeake 's processes and/or equipm ent used in Manufacture or in the storage of Finished Products, or any part or co mponent thereof ; means Vials rejected by Chesapeake or Pro therics for containing Finished Products not conforming to the Specificati on and/or not Manufactured, stored, handled or transported in accordance with t his agreement and the Technical Agreement ; means the second anniversary of the Effective Date ; means the specification for the Fin ished Products appended to this agreement as schedule 2 ; means, in respect of any Batch, the number of Vials comprising such Batch as would be produced by utilising all Bulk Pr oducts supplied by [COMPANY] for use in the Manufacture of the Finished Products comprising such Batch and were such quantity of such Bulk Products as Prother ics specifies pursuant to clause 3.3 to be included therein in the course of such Manufacture, less the number of Vials within such Batch as are used by Ch esapeake in conducting sterility tests in accordance with the Technical Ag reement, as specified in schedule 8 ; -3- means the agreed spe cification for Manufacture of the same date as the date hereof, a copy o f which is appended to this agreement as schedule 3 ; means the per iod of six ( 6 ) months following the Effective Date ; means Value Added Tax or any other tax of a similar nature that may be substituted for or levi ed in addition to it, in each case at the rate current from time to time ; means the type of vial to be used i n packing Finished Products as part of Manufacture, as provided by the Technical Agreement, containing the appropriate quantity of the relevant Finished Product ; means water complyin g with the United States Environmental Protection Agency National P rimary Drinking Water Regulations or comparable regulations of t he European Union, purified by distillation and by reverse osmosis and containing no added substances ; and means, in respect of any Batch, th e number of Vials of Finished Products Manufactured in accordance with t his agreement net of Rejects and which are potentially available for sa le by [COMPANY] in the course of its business