definiens: means the value to be attributed to the API for p urposes of Section 2.3 of this Agreement, as set out in Schedule D hereto ; or means the materials listed on Schedule C hereto ; means : ( a ) a business entity which owns, directly or indirectl y, a controlling interest in a party to this Agreem ent, by stock ownership or otherwise ; or ( b ) a business entity which is owned by a party to this Agreement, either directly or indirectly, by stock ownership or otherwise ; or ( c ) a business entity, the majority ownership of which is directly or indirectly common to the majority ownership of a part to this Agreement ; means a day other than a Saturday, Sunday or a day that is a statutory holiday in the Province of Ontario, Canada, the State of Massachus etts, United States, the State of Ohio, United Stat es or the Commonwealth of Puerto Rico ; 2 means current good manufacturing practices as des cribed in : ( a ) Division 2 of Part C of the Food and Drug Regulations ( Canada ) ; and, ( b ) Parts 210 and 211 of Title 21 of the United States ' Code of Federal Regulations ; together with the latest Health Canada and FDA guid ance documents pertaining to manufacturing and quality control practice, all as updated, amended a nd revised from time to time ; means, collectively, all packaging components, ra w materials and ingredients ( including labels, product inserts and other labell ing for the Products ), required to be used in order to produce the Products in accordance with [COMPANY] 's Technical Information, other than the API ; means a party 's technology, data, know - how or inf ormation whether written or oral, technical or non - technical, includ ing financial statements, reports, pricing, trade s ecrets, secret processes, formulas, customer data ( includin g customer lists ), and the like, that is disclosed to the other party ; shall have the meaning ascribed thereto in Sectio n 5.7(a ) ; means November 6, 2007 ; means ex - works, as that term is defined in INCOTER MS 2000 ; means the United States government department kno wn as the Food and Drug Administration ; has the meaning specified in Section 5.2(b ) ; means the section of the Canadian government know n as Health Canada and includes, among other departments, the Therapeutic Products Directorate and the Health Products and Food Branch Inspectorate ; includes, without limitation, xxxhts in patents, patent applications, formulae, trade - marks, trade - mark applications, trade - names, trade secrets, Inventions, copyright, industrial designs, know - how and, with respect to [COMPANY], Se pracor 's Technical Information ; means information relating to any innovation, imp rovement, development, discovery, computer program, device, trade secret, method, kno w - how, process, technique or the like, whether or not written or otherwise fixed in any form or mediu m, regardless of the media on which it is contained and whether or not patentable or copyrightable ; means all inventories of Components and work - in - p rocess produced or held by [COMPANY] in connection with the manufacture of the Products but, for greater certainty, does not include the API ; has the meaning specified in Section 2.2 ; xxxxx ( x ) xx xxxxxxx xx Xxxxxxx Xxx ., Xxxxxxx'x f acilities located at 2100 Syntex Court, Mississauga, Xxxxxxx, Xxxxxx, ( xx ) xx xxxxxxx xx XXX, XXX'x xxxxxxxxxx located at 2110 East Galbraith Road, Cincinnati, Ohio 45000 -0000, XXX, ( iii ) in respect xx XXXX, XXXX'x xxxxxxxxxx xxxxxxx xt State Road # 670, Km . 2.7, Bo . Coto Norte, Manatí, Puerto Rico 00674, and ( iv ) any additional facility owned by [COMPANY] Inc. or its Affiliates where Manufacturing Services are to be performed as agreed to by the parties in writing