制造与供给协议英文版.docx
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制造与供给协议英文版.docx
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制造与供给协议英文版
TABLEOFCONTENTS
RECITALS:
序言
1. Definitions. 定义
2. GrantofRightstoProducts. 许可生产
3. Exclusivity 独家代理权
4. Manufacturing. 制造
5. Forecasts. 市场预测
6. PurchasePrice;Payment. 购买价格;支付款项
7. RegulatoryApprovals. 监管机构的批准
8. Indemnification. 相互保障对方
9. Confidentiality. 保密
10. InspectionActivity;CustomerComplaints;Recall. 质量检测;客户投诉;产品召回
11. Term. 协议期限
12. Termination. 协议的终止
13. ForceMajeure. 不可抗力
14. ManufacturingAudits; Inspection; Records. 制造商审计;检测;记录
15. Insurance. 保险
16. IndependentContractors. 承包商的独立地位
17. DisputeResolution. 纠纷解决
18. Assignment. 权利义务的转让
19. Notices. 通知
20. AmendmentandWaiver. 协议的变更和权利的放弃
21. Severability. 协议条款的可分割性
22. EntireAgreement. 协议条款的完整性
23. SectionHeadings. 小标题
24.Counterparts. 协议份数
RECITALS:
序言
A.PARTYAandPARTYBareeachengagedin,amongotherthings,thepreparation,manufacture,distributionandsaleofAAAproducts.
B.PARTYBdesirestomanufactureforPARTYAandtosupplyPARTYA’srequirementsofsuchproductsuponthetermsandsubjecttotheconditionssetforthherein. PARTYAlikewisedesirestoacquiresuchrightsanddesirestopurchasesuchproductsfromPARTYBuponthetermsandsubjecttotheconditionssetforthherein.
NOWTHEREFORE,thePartiesagreeasfollows:
1.Definitions. 定义
AsusedinthisAgreement(inadditiontootherdefinitionssetforthintheAgreement),thefollowingdefinitionsshallapply:
(a)“Affiliate”shallmeananyentitycontrolling,controlledbyorunderthecommoncontrolofPARTYAorPARTYB,asthecasemaybe. ForthepurposeofthisAgreement,“control”shallmeanthedirectorindirectownershipofatleastfifty(50%)percentoftheoutstandingsharesorothervotingrightsofthesubjectentityorpossession,directlyorindirectly,ofthepowertodirectorcausethedirectionofmanagementandpoliciesofsuchentity. ForpurposesofthisAgreement,XYZCo.Ltd.isdefinedasanaffiliateofPARTYB.
(b)“FDA”shallmeantheUnitedStatesFoodandDrugAdministrationoranysuccessorsthereto.
(c)“Parties”shallmeanPARTYAandPARTYB(“Party”meaningone
(1)oftheParties).
(d)“Products”shallmeantheAAAproductslistedonExhibitA(asmaybeamendedfromtimetotimebyagreement)suitableforhumanuse(“Product”hereinaftermeaningoneoftheProducts).
(e)“Regulatoryapproval”shallmeantheprocurementofanyregistration,permitandapprovalrequiredbyapplicablegovernmentauthoritiesforthemanufacture,importation,marketing,saleanddistributionoftheProducts.
(f)“Territory”shallmeanCCCarea,exceptBBBarea.
2.GrantofRightstoProducts. 许可生产
(a)PARTYBherebygrantstoPARTYAanditsAffiliatestherighttouseinthemanufactureofotherproducts,promote,market,detail,sellanddistributetheProducts.
(b)PARTYAmaypromote,market,detail,selland/ordistributetheProductsunderanytrademarkortrademarksasPARTYAoritsAffiliatesmayfromtimetotimechoose;provided,however,PARTYAshallnotuseoradoptanytrademarkoforconfusinglysimilartoanymarkofPARTYB. SuchtrademarksusedoradoptedbyPARTYAshallbeandremainthesolepropertyofPARTYA.
(c)Patents,Trademark(s),andTradeSecrets:
Eachpartywillretainexclusiverightstotheirowninvention(s).Ifeitherpartyisinterestedintheacquisitionoftheotherparty’srightsthenaseparatelicensingagreementwillbeexecutedasastand-alonedocument.
3.Exclusivity 独家权利
(a)PARTYAisherebygrantedexclusiverightsforsupplyingtheProductstocustomersintheTerritory.
(b)PARTYBshallrequireothercustomerspurchasingtheProducts(whetherasactiveingredientorasfinishedproduct)toagreenottosellsaidProductsintheTerritory.
4.Manufacturing.
(a)PARTYAshallpurchasefromPARTYBamanufacturingsourcefortheProducts(subjecttotheprovisionsofSection4(b)),andPARTYBshallmanufactureforandselltoPARTYA,suchquantitiesoftheProductsasPARTYAmayorderfromtimetotimeduringthetermofthisAgreement.
(b)PARTYBrepresentsandwarrantstoandcovenantswithPARTYAthat:
(i)AllProductssuppliedtoPARTYAhereundershallbeofgood,merchantableandusablequality,andmedicallysuitableforthepurposesforwhichsuchrespectiveProductisusedorsold,shallconformtothemutuallyagreedmanufacturingproceduresandtheSpecificationssetprovidedbyPARTYA.PARTYBshalluseitscommerciallyreasonablebesteffortstocomplywithanyreasonablerequestbyPARTYAforchangesintheSpecifications,manufacturingprocessandmaterials,andanychangeinanalyticaltestingmethodsrequestedbyPARTYA,theFDAoranyotherapplicableregulatoryagency;
(ii)PARTYBpossessesandshallatalltimesmaintaintherequiredlicenses,permits,consentsandapprovals,ifany,forthemanufacture,supplyandsaleoftheProducts,includingwithoutlimitationforthedistributionandsaleoftheProducts. AllProducts,andPARTYB’smanufactureanddistributionoftheProducts,shallconforminallrespectstotheapplicablelaws,regulationsandapprovalsgoverningthemanufacture,importation,distributionanduseoftheProducts. NeitherthemanufacturenorthedistributionoftheProductsascontemplatedherebywillinfringeanyexistingprocesspatentsoranyotherproprietaryrightsofthirdparties,andPARTYBhasnotreceivedanynoticeofanyclaimedinfringement(includingwithoutlimitationpatentinfringement)inconnectionwiththeProducts;
(iii)ThemanufactureoftheProductsshallbeinaccordancewithABCCONVENTION.Withoutlimitingthegeneralityoftheforegoing,allProductsshallbemanufacturedandtestedatamanufacturingfacilityapprovedbytheFDA,andtheProductsandthemanufacturethereofshallcomplywithallgovernmentalandregulatoryrequirements,includingwithoutlimitationthoseof,andapplicablein,theTerritory,andshallbeinaccordancewiththeSpecifications;
(iv)PARTYBwillretainsuchsamplesoftheProductsasarerequiredandspecifiedbyPARTYAtocomplywiththeretentionrequirementsassetforthintheABCCONVENTION,performstabilitytestingasdescribedandrequiredtoconformwiththeProductsstabilityprotocol,reporttoPARTYAanyconfirmedout-of-specificationtestresultswithrespecttodeliveredProductswithinthree(3)businessdays,andmakestabilityreportsandfindingsavailableforreasonableinspectionbyPARTYA.PARTYBshallretainallproductionrecordsoftheprocessingandmanufactureoftheProductsinaccordancewithregulatoryrequirements,includingwithoutlimitationABCCONVENTION;
(v)PARTYBshallinvestigateallmaterialabnormalitiesinprocessingandshareallinvestigativereportswithrespecttheretowithPARTYA;
(vi)PARTYBshallpromptlyinformPARTYAofanywithdrawal,recallactionsorFDAorotherregulatoryauditofitsfacilities,Productsorprocess,andshallprovidecopiestoPARTYAofallinspectionobservationreports,otherregulatorycommunicationsandPARTYB’sresponses,thatmayaffecttheProducts,itsmanufacture,orthecomplianceof PARTYB’sfacilitieswithregulatoryrequirements;
(vii)PARTYBshallprovideallnecessaryinformationrequiredtosatisfyregulatoryinquiries.However,PARTYBisundernoobligationtodiscloseproprietaryinformationoutsidethescopeofaregulatoryinquiryorrequirement.
(viii) PARTYBhasneverbeenandisnotcurrently:
(A)anindividualwhohasbeendebarredbytheFDApursuantto21U.S.C.§228a(a)or(b)(“DebarredIndividual”)fromprovidingservicesinanycapacitytoapersonthathasanapprovedorpendingdrugproductapplication,oranemployer,employeeorpartnerofsuchaDebarredIndividual;or,(B)acorporation,partnershiporassociationthathasbeendebarredbyFDApursuantto21U.S.C.§228a(a)or(b)(“DebarredEntity”)fromsubmittingorassistinginthesubmissionofadrugapplication,oranemployee,partner,shareholder,member,subsidiary,orAffiliateofaDebarredEntity. PARTYBhasnoknowledgeofanycircumstances,whichmayaffecttheaccuracyoftheforegoingrepresentation,includingwithoutlimitationanyFDAinvestigationsof,ordebarmentproceedingsagainst,PARTYBoranypersonorentityperformingservicesorrenderingassistance,whichisinanywayrelatedtoactivitiesundertakenpursuanttothisAgreement. PARTYBshallimmediatelynotifyPARTYAinwritingifPARTYB,atanytimeduringtheTerm,becomesawareofanysuchcircumstances.
(c)IfanyquantityofProduct(s)purchasedbyPARTYAfailstosatisfytherequirementsofthisAgreementorshallotherwisebedefective,PARTYAmayrejectthesamebygivingnoticetoPARTYBwithinforty-five(45)daysofPARTYA’sreceiptofsuchProduct(s). Thepartiesagreethattheproblemshallbeapproachedasacommonproblem.Eachpartyshallcommitallnecessaryresourcestoexpediteresolution.Uponnotification,PARTYBshallretestthelotinquestionandsharetheresultswithPARTYA.Ifthepartiesarestillnotinagreement,furtheranalysisshallbeperformedbyanindependenttestingfacilityacceptabletobothPARTYBandPARTYA.Ifthepartiescannotagree,thedisputeshallberesolvedasoutlinedinsectionSeventeen(b)(17b)ofthisAgreement.Intheeventofanysuchrejection,PARTYAshallbeentitledtoarefundorreplacement(asPARTYAdesignates)oftheaffectedProduct(s).
5.Forecasts.
(a)PARTYAshallprovidePARTYBwitharollingtwelve(12)monthforecastofPARTYA’santicipatedrequirementsoftheProducts,updatedeachquarterduringtheTerm. TherollingforecastshallbemadetoassistPARTYBinplanningitsproductionandshallbenonbinding. PARTYAshallplacefirmordersforthePro
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