definiens: means, in respect of each part y, any company, partnership or other entity which directly or indirect ly controls, is controlled by or is under the common control with such p arty ; means a batch of Finished Products ; mean s comprehensive histories, produced by Chesapeake, of the Manufacture of each Batch ; means any day ( excluding Sa turdays and Sundays ) on which banks generally are open in the City of Lo ndon for the transaction of normal banking business ; means all business, commercial, economic, financial, operational, administrative, ma rketing, planning and staff information relating to a party or its int erests ; means the solution supplied by Pr otherics to be used for wetting filters used in Manufacture ; -1- means [COMPANY] ' bulk formulated p roprietary antibody products from which Finished Products are Manufactured, supp lied by [COMPANY] to Chesapeake pursuant to this agreement ; means the Code of Federal Regulations, Part 21, Sections 210 and 211 and such other Sections thereof as are designated by th e title and promulgated under the United States Federal Food, Drug and Cosmetic Act, as are in effect from time to time ; means [COMPANY] ' system of evalua ting, notifying and documenting planned changes from previously accepte d practice and the impact thereof on the quality, safety and efficacy of Fini shed Products as regards the materials, components ( including without limitation packaging, labeling and Materials ), products, processes, computer systems, utilities or testing procedures, used or involved in or relating to the Manufacture, storage or delivery of Finished Products, whenever, howsoever and wherever in the course thereof they are relevant ; means the committee esta blished and appointed by [COMPANY] from time to time, which is responsible for operating Change Control ; means the date of this agreement ; means the European Medicines Evaluation Agen cy ; means a person to whom reference is made p ursuant to clause 13.2 and who is appointed as specified therein ; means the determination of a dispute or difference between the parties by an Expert, in accordance wit h clause 13 ; means Chesapeake 's facility for the ster ile filtration, filling and freeze - drying of pharmaceutical products at Camden Industrial Park, 0000 X