definiens: means the section of the Canadian G overnment known as Health Canada and includes, among other departments, the Veterinary Drugs Direc torate, the Therapeutic Product Directorate and the Health Products and Food Branch Inspectorate or any succes sor agency thereto which may regulate pharmaceutica l products ; means any and all rights in patents, patent applications, formulae, trademarks, trademark applications, trade - names, Inventions, co pyrights, industrial designs, trade secrets, and kn ow how including all biological, chemical, biochemical, to xicological, pharmacological and metabolic material and information and data relating thereto and formulati on, clinical, analytical and stability information and data which have actual or potential commercial value and are not available in the public domain ; means any and all information, results, data, innovation, improvement, development, discovery, computer program, device, trade secret, method, know - how, process, technique or the like, w hether 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 Finished Produ ct, Components, Active Material, and work - in - process produced or held by Corden for the manufact ure of the Product ; has the meaning specified in Section 10.3 ; means Intellectu al Property generated or derived by KindredBio or any of its Affiliates before entering into this Agr eement or independent of this Agreement, or by Cord en or any of its Affiliates while performing services under t he MDA ( including the Manufacturing Process ) or any Manufacturing Services or otherwise generated or de rived by Corden or any of its Affiliates, which Int ellectual Property is directly related to, specific to, or de pendent upon, the Active Material or the Product ; has the meaning specified in Section 8.4(e ) ; has the meaning specified in Sectio n 5.5(b ) ; means a defect in the Product that was not, and could not reasonably be expected to have been, found by exercise of ordinary care by fo llowing the Specifications or by visual inspection of the Product at Delivery ; means the Product ordered under a pu rchase order that is not delivered on the Delivery Date ; has the meaning specified in Section 10.3 ; means the process validated under the MDA for the manufacture of the Product and any changes thereto agreed upon by the Parties in writing ; 4 -