definiens: means, collectively, allpackaging components, raw materials, and ingredients(including labels, product inserts and other labelling fortheProducts ), required tomanufacturetheProducts inaccordance with theSpecifications, other than theActive Materials;·Confidentiality Agreement " means that certain Mutual Confidential Disclosure Agreementbetween [COMPANY] andClient dated February 18,2010 ; will have the meaning ascribed thereto inthe ConfidentialityAgreement ; willhave themeaning ascribed thereto inSection 6.3(a);·Deficiencies · willhave themeaning ascribed thereto inSection 7.8(d);Exclusivity ObligationFDAFirm OrdersForce Majeure Evenf ' willhave themeaning ascribed thereto inSection 13.7 ; willhave themeaning ascribed thereto inSection 10.5 ; willhave themeaning ascribed thereto inSection 10.5 ; willhave themeaning ascribed thereto insection 5.2(a ) ; willhave themeaning ascribed thereto inSection 8.1 ; includes, without limitation, rights inpatents, patent applications, formulae, trade - marks, trade - mark applications, trade - names, Inventions, copyrights, industrialdesigns, trade secrets, andknow how ; means information about orrelating toany innovation, improvement, development, discovery, computer program, device, trade secret, method, know - how, process, technique orthelike, whether ornotwritten orotherwise fixed inanyform ormedium, regardless ofthemedia onwhich itiscontained andwhether ornotpatentable orcopyrightabie ; means allinventories ofComponents and work - in - process produced orheld byPatheon forthemanufacture oftheProducts but, forgreater certainty, does notinclude theActiveMaterials orBillBack Items ; willhave themeaning ascribed thereto inSection 5.2 ; means alllaws, statutes, ordinances, regulations, rules, by - laws, judgments, decrees ororders ofanyAuthority, including, butnotlimited to, theActandcGMPs ; means themanufacturing, quality control, quality assurance, stabilitytesting, packaging, and related services, setforth inthisAgreement, required tomanufactureProduct orProducts from Active Materials andComponents ; means the applicable facility where the Manufacturing Services areperformed that isowned and operated byPatheon that islocated ateither 2110 East GalbraithRoad, Cincinnati, Ohio 45237 - 1625, or111Consumers Drive, Whitby, Ontario L1N525Canada ;, means allComponents, BillBack Items, andother materials used tomanufacture theProduct other than Active Materials ; means themaximum value ofActive Materials thatmay becredited byPatheon under thisAgreement, assetforth onSchedule C ; willhave themeaning ascribed thereto inSection 8.2(a);·PatheonPatheon Competitor " means acorporation which : ( i)isinthebusiness ofmanufacturingpharmaceutical products forthird parties ; and ( ii)does notdirecJly orindirecJly own ormarketpharmaceutical products initsown name;-4- means Intellectual Property generated orderived byPatheonbefore performing anyManufacturing Services, Intellectual Property developed byPatheon whileperforming theManufacturing Services, orotherwise generated orderived byPatheon initsbusiness which Intellectual Property isnotspecific to, ordependent upon, Client 's Active MaterialorProduct including, without limitation, Inventions and Intellectual Property which may generallyapply tomanufacturing processes ortheformulation ordevelopment ofdrug products, drugproduct dosage forms ordrug delivery systems unrelated tothespecific requirements oftheProduct ( s);·Price " means theprice measured inUSDollars tobecharged byPatheon forperforming theManufacturing Services, and includes thecost ofComponents, certain cost items assetforth inSchedule B ; means theproduct(s ) listed onSchedule A ; willhave themeaning ascribed thereto inSection 10.2 ; means theseparate andbinding agreement between theparties selling outthequality assurance standards fortheManufacturing Services tobeperformed byPatheon forClient forthisAgreement ; willhave themeaning ascribed thereto inSection 6.2(a ) ; willhave themeaning ascribed thereto inSection 6.3(b ) ; means theFDA andanyother foreign regulatory agencies competent togrant marketing approvals forpharmaceutical products including theProducts intheTerritory ; means Radio Frequency Identification Devices which ( atpresent orinthefuture ) may beaffixed toProducts orMaterials toassist ininventory control, tracking, andidentification;·Shelf Life " means theminimum length oftime, assetforth intheapplicable Specifications, thataProduct remains stable without degrading tounacceptable levels ( assuch unacceptable levelsaresetforth intheapplicable Specifications willhave themeaning ascribed thereto inSection 2.2.2 ; means thefile, foreach Product, which isgiven byClient toPath eon inaccordance with theprocedures listed inSchedule Aandwhich contains documents relating toeacJh Product, including, without limitation:(a ) specifications forActive Materials andComponents;(b ) manufacturing specifications, directions, andprocesses;(c ) storage requirements;(d ) allenvironmental, health and safety information foreacJh theProduct including materialsafety data sheets ; and(e ) thefinished Product specifications, packaging specifications and shipping requirementsforeach Product, including, butnotlimited to, anyrequirements setforth intheapplicable-5 - regulatory filings made with the FDA orother Authority and provided byClient toPatheon;allasupdated, amended andrevised from time totime byClient inaccordance with theterms ofthisAgreement ; willhave themeaning ascribed thereto inSection 8.1 ; means theBulk Tablets andBollied and Labelled Tablets listed onScheduleA ; willhave themeaning ascribed thereto inSection 2.2.1 ( c ) ; will have the meaning ascribed thereto inSection2.2.1(c ) ; willhave themeaning ascribed thereto inSection 12.2 ; willhave themeaning ascribed thereto inSection 8.2(a ) ; means ( i)theUnited States anditscommonwealths, territories and possessions, and(ii)any additional country(ies ) andlor commonwealths, territories and possessions which Clientmay later designate initssole discretion inanaddendum tothisAgreement ; provided thatClientwillbear allincremental costs, including, butnotlimited tolabeling costs, associated with themanufacture ofanyProducts forsuch additional country(ies ) and/or commonwealths, territoriesandpossessions inamounts tobeagreed bytheparties ; means theIntellectual Property ofanythird party ; and means inthefirstyear ofthisAgreement theperiod from theCommencement Date uptoandincluding December 31ofthesame calendar year, andthereafter willmean acalendar year