partnership, corporation, company or other entity or combination thereof or the power to direct the management of such person, firm, trust, corporation or other entity or combination thereof.
1.8“Applicable Laws” means all applicable ordinances, rules, regulations, laws, guidelines, guidance, requirements and court orders of any kind whatsoever of any Regulatory Authority applicable to a Party’s activities hereunder, as amended from time to time, including cGMP (if applicable) of the USA FDA, and the International Conference on Harmonization (ICH) guidelines and regulations, and other regulatory jurisdictions as agreed to by both parties.
1.9“Background IP” shall mean IPR (a) controlled by a Party prior to and during the existence of this Agreement or (b) that is or has been developed independently of this Agreement. For the purposes of this definition, control means possession of the right, whether directly or indirectly, and whether by ownership, license or otherwise, to assign, or grant a license, sub-license or other right to or under, such intellectual property or know-how without violating the terms of any agreement or other arrangement with any third party.
1.10“Batch” means a specific quantity of Product that is intended to have uniform character and quality within specified limits and is produced according to a single manufacturing order during the same cycle of manufacture.
1.10“Change Order” means a written description of a change in the Services, the Product to be manufactured or the prices of such Services that makes reference to the specific Work Order to which such changes are being made.
1.11“Certificate of Analysis” shall mean a CDMO document which provides test procedures, methods and results, and corresponding Specifications, for analysis for a specific Batch or lot of material and is dated and signed by personnel who represent the CDMO Quality Unit which is responsible for the testing.
1.12“cGMP” means current good manufacturing practices, including the regulations promulgated by the FDA under the United States Food, Drug and Cosmetic Act, 21 C.F.R. Part 210 et seq., as amended from time to time, applicable guidance documents issued by the FDA, EC Directive 2003/94/EC and European Medicines Agency guidance documents, applicable documents developed by the International Conference on Harmonization (ICH) to the extent that they are applicable to the Product and the Parties hereunder, and other Regulatory Authorities, as agreed to by the Parties, applicable to the manufacture and testing of pharmaceutical materials under Applicable Laws.
1.13“Commercially Reasonable Efforts” means, with respect to the activities of CDMO in the performance of the Services, the efforts and resources typically used by contract manufacturing organizations that are comparable in size to CDMO in the performance of such services to achieve a desired result.
1.14“Confidential Information” means, any and all non-public, proprietary and confidential information, trade secrets, know-how, inventions, including without limitation, patent applications, samples, biological materials, chemical compounds, techniques, methods, works of authorship, models, technical, business and financial information, including third party information, relating to the Disclosing Party, processes related to the current, future, and proposed products or services of the Disclosing Party, including without limitation its respective information concerning research, experimental work, development, design details and specifications, engineering, financing, purchasing, manufacturing, customers, investors, employees, business and contractual relationships, business forecasts, and marketing plans, information derived through observation or examination of the Disclosing Party’s