definiens: means the annual report to the FDA prepared by Client regarding the Product as described in Title 21of the United States Code of Federal Regulations, Section 314.81(b)(2 ) ; means the annual product review report prepared by [COMPANY] as described in Title 21of the United States Code of Federal Regulations, Section 211.180(e ) ; means the minimum volume of Product to be manufactured in any Year of this Agreement as set forthin Schedule B ; means all Laws to the extent applicable to the subject matter of, or the performance by the parties oftheir respective obligations under, this Agreement, including but not limited to ( i ) for [COMPANY], ( a ) the Federal Food, Drug, and Cosmetic Act, together with any regulation promulgated thereunder, including without limitation cGMPs and(b ) the Laws of the jurisdiction where services are provided under this Agreement ; and ( ii ) for Client and the Products, theLaws of all jurisdictions where the Products are manufactured, distributed, and marketed as these are agreed andunderstood by the parties in this Agreement ; means any governmental or regulatory authority, department, body or agency or any court, tribunal, bureau, commission or other similar body, whether federal, state, provincial, county or municipal ; means the expenses for all third party supplier fees for the purchase of columns, standards, tooling, PAPR or PPE suits ( where applicable ), RFID tags and supporting equipment, and other project specific items requiredsolely for [COMPANY] to perform the Manufacturing Services for Client, and which are not included as Components ; means a day other than a Saturday, Sunday or a day that is a statutory holiday in the Province of Ontario, Canada means current good manufacturing practices as described in : ( a)Division 2 of Part C of the Food and Drug Regulations ( Canada ) ; ( b)Parts 210 and 211 of Title 21 of the United States ’ Code of Federal Regulations ; and ( c)EC Directive 2003/94 / ECtogether with the latest Health Canada, FDA and EMA guidance documents pertaining to manufacturing and qualitycontrol practice, all as updated, amended and revised from time to time including, but not limited to, the FDA ’s guidancefor Industry, Manufacturing, Processing or Holding Active Pharmaceutical Ingredients ; means Intellectual Property generated or derived by Client before entering into thisAgreement, or by [COMPANY] while performing any Manufacturing Services or otherwise generated or derived by [COMPANY] inits business which Intellectual Property is specific to the development, manufacture, use, and/or sale of Client ’s Productor Active Materials that are the subject of the Manufacturing Services ( including, but not limited to, any new use, newformulation or any change in the method of producing, testing or storing any Product ), including but not limited to(i ) any regulatory filings, formulations, chemical compositions, or Specifications relating to the Products, and ( ii ) any andall Confidential Information of Client, including any -2 - Standard Form chemical structures, composition of matter rights, process technology and other Inventions owned or controlled byClient ; or means the report prepared by [COMPANY] that provides a list for all materials whichhave expired, have been rejected or no longer have forecasted production requirements for Client ’s products at theManufacturing Site