definiens: means the annual report as described in Title 21 of the United States Code ofFederal Regulations, Section 314.81(b)(2 ) ; means the annual product review report as described in Title21 of the United States Code of Federal Regulations, Section 211.180(e);- 1 - [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filedseparately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of1934, as amended . means ( i ) with respect to [COMPANY], the Laws of the jurisdiction where theManufacturing Site is located ; and ( ii ) with respect to Customer and the Products, the Laws of alljurisdictions where the Products are manufactured, distributed and marketed as such are agreedand understood by the parties in this Agreement ; means any governmental or regulatory authority, department, body or agency or anycourt, tribunal, bureau, commission or other similar body, whether federal, state, provincial, county or municipal ; means the quantity of unlabelled, unpacked vials derived from one productioncycle and is equivalent to approximately [ * ] vials ; means the unlabelled unpacked vials resulting from the filling process ; means a day other than a Saturday, Sunday or a day that is a statutory holidayin Italy and/or in the United Kingdom ; means current good manufacturing practices as described in : ( a ) Parts 210 and 211 ofTitle 21 of the United States ' Code of Federal Regulations ; and ( b ) EC Directive 2001/83 / EC andits any subsequent amendment, together with the latest FDA and EMA guidance pertaining tomanufacturing and quality control practice, all as updated, amended and revised from time totime ; means, collectively, all packaging components, raw materials and ingredients(including labels, product inserts and other labelling for the Products ), required to be used inorder to produce the Products in accordance with the Specifications, other than the ActiveMaterials ; means the mutual obligations of the parties relating to the non - disclosure of confidential information between [COMPANY] and Customer as set out in theTechnology Transfer Agreement ; shall have the meaning ascribed thereto in Section 6.1(a ) ; means the date of delivery of Product at the Manufacturing Site, as confirmed byPatheon pursuant to Section 5.1(b ) ; means the European Medicines Agency ; shall mean the equipment described in the Technology Transfer Agreement ; means the United States government department known as the Food and DrugAdministration ; has the meaning specified in Section 5.1(b);- 2 - [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filedseparately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of1934, as amended . includes, without limitation, rights in patents, patent applications, formulae, trade - marks, trade - mark applications, trade - names, Inventions, copyright and industrialdesigns ; trade secrets and know how ; means information relating to any innovation, improvement, development, discovery, computer program, device, trade secret, method, know - how, process, technique or the like, whether or not written or otherwise fixed in any form or medium, regardless of the media on whichit is contained and whether or not patentable or copyrightable ; means all inventories of Components and work - in - process produced or held byPatheon in connection with the manufacture of the Products but, for greater certainty, does notinclude the Active Materials ; means all laws, statutes, ordinances, regulations, rules, by - laws, judgments, decrees ororders of any Authority ; means the manufacturing, quality control, quality assurance andstability testing, packaging and related services, as contemplated in this Agreement, required toproduce Products from Active Materials and Components ; means Intellectual Property generatedor derived by [COMPANY] in the course of performing any Manufacturing Services or otherwisegenerated or derived by [COMPANY] in connection with the conduct of its business which IntellectualProperty is not specific to, or dependent upon, Customer ’s Active Material or Product including, without limitation, Inventions and Intellectual Property which may have application tomanufacturing processes or the formulation or development of drug products, drug productdosage forms or drug delivery systems beyond the specific requirements of the Product(s ) ; means [COMPANY] ’s Affiliate facility, owned and operated by [COMPANY] ItaliaS.p . A, that is located at at 2ª Trav . SX via Morolense 5, Ferentino ( FR ) – ITALY ; means all Components and other materials used in the manufacture of the Productother than Active Materials ; means the price measured in EURO ( € ) to be charged by [COMPANY] regarding Productmanufactured and supplied hereunder as delivered to Customer, and is comprised of the fees forthe Manufacturing Services, and the costs for Components and Materials which Price is fullydescribed in Schedule B ; means the products listed on Schedule A hereto ; means the agreement between the parties hereto setting out the qualityassurance standards to be applicable to the Manufacturing Services provided by [COMPANY] asmay be required under the laws of the jurisdiction(s ) governing the Manufacturing Site or theProduct pursuant to the terms of this Agreement, attached hereto- 3 - [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filedseparately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of1934, as amended.as Schedule F ; It is agreed and understood in case of any discrepancy between the provisions ofthis Agreement and those included within the Quality Agreement, the latter shall prevail as for thequality and regulatory aspects