definiens: means the value to be attributed to the API for purposes 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 indirectly, a controlling interest in a party to this Agreement, 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 ; 1 USIDOCS 4846225vl { \ means a day other than a Saturday, Sunday or a day that is a statutory holiday in the Province of Ontario, Canada or the State of Massachusetts, United States ; means current good manufacturing practices as described 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 guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time ; means the date of commencement of manufacturing of the first commercial batches of Product pursuant to the first Finn Orders submitted by [COMPANY] under Section 5.2(b ) ; means, collectively, all packaging components, raw materials and ingredients ( including labels, product inserts and other labelling 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 information whether written or oral, technical or non - technical, including financial statements, reports, pricing, trade secrets, secret processes, formulas, customer data ( including customer lists ), and the like, that is disclosed to the other party ; shall have the meaning ascribed thereto in Section 5.7(a ) ; means November 1, 2003