definiens: means the department of the Canadian Government k nown as Health Canada and includes, among other relevant branches, the Therap eutic Products Directorate and the Health Products and Food Branch Inspectorate ; has the meaning specified in Section 8.1 ; includes, without limitation, rights in patents, patent applications, formulae, trademarks, trademark applications, trade - names, In ventions, copyrights, industrial designs, trade secrets, and know how ; means information about any innovation, improveme nt, development, discovery, computer program, device, trade secret, method, process, tec hnique or the like, whether or not written or other wise fixed in any form or medium, regardless of the medi a on which it is contained and whether or not patentable or copyrightable ; means, at a point in time, all inventories of Com ponents and work - in - process under [COMPANY] ’s care or control used for the manufacture or packaging of Product ; means all laws, statutes, ordinances, regulations, rules, by - laws, judgments, decrees or orders of any Authority ; has the meaning specified in Section 5.1(a ) ; means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set ou t in Appendix 1, for the manufacture of Product for distribution in the Territory ; means the facility located at 2110 East Galbraith Road, Cincinnati, OH 45237 where the Manufacturing Services will be performed ; has the meaning specified in Section 2.1 ; means, for each manufacturing campaign ordered, t he minimum number of units or batches of a Product that Client must p urchase, as set out in Appendix 1 ; has the meaning specified in Section 5.2(b ) ; means a business that derives greater than 50 % of its revenues from performing contract pharmaceutical or biopharmaceutical develo pment or commercial manufacturing services ; means Intellectual Property generated or derived by [COMPANY] or its Affiliates before performing any Manufacturing Serv ices, developed by [COMPANY] while performing the Manufacturing Services, or otherwise generated or d erived by [COMPANY] in its business which Intellectua l Property is not specific to, or dependent upon, the Product or Client Intellectual Property, including, without limitation, Inventions and Intellectual Pro perty which may apply to manufacturing processes or the formulation or development of drug products or drug delivery systems unrelated to the Product or Client Intellectual Property ; June 28, 2019 Confidential Manufacturing Services Agreement between [COMPANY] and PLx Page 6 of 38 17 CFR 240.24b-2, confidential information has been omitted in places marked and has been file d separately with the Securities and Exchange Commiss ion pursuant to a Confidential Treatment Applicatio n filed with the Commission