CMO agreement.docx

CMO agreement.docx

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CMOagreement

AGREEMENT

1.Definitions（相关词语定义1·1——1·67）1

2.GenericoManufacturingandOtherServices.（制药公司）11

3.NewAlphaManufacturing.（生物科技公司）20

4.PriceandPayment.（价格及支付方式）22

5.RegulatoryApproval.（监管机构批准）23

6.RejectedProduct.（不合格产品）24

7.AdverseExperienceReporting.（药物不良反应）27

8.Recalls.（产品召回）27

9.ProductLiability.（产品责任）29

10.TermandTermination.（合同的期限）31

11.Confidentiality.（保密约定）33

12.Indemnification.（损失赔偿）36

13.ManagementFee.（设施管理费）40

14.MelroseParkandGrandIslandFacilities.40

15.MiscellaneousProvisions.44

SCHEDULE1.451

SCHEDULE1.66TERRITORIES55

SCHEDULE2.10OTHERSERVICES56

SCHEDULE4.1UNITCOSTFORABRAXANE258

NOW,THEREFORE,inconsiderationoftheaboveRecitals,themutualcovenantsandagreementscontainedherein,andothergoodandvaluableconsideration,thereceiptandsufficiencyofwhichareherebyacknowledged,thePartiesheretoherebyagreeasfollows:

1.Definitions（相关词语定义1·1——1·67）

ForpurposesofthisAgreement,inadditiontootherdefinedtermssetforthinthisAgreement,thetermssetforthbelowwillhavethefollowingmeanings:

1.1"Action"meansanyactualorthreatenedclaim,suit,demand,arbitration,hearing,inquiry,proceeding,complaint,chargeorinvestigationbyorbeforeanycourt,RegulatoryAuthorityorarbitrator.

1.2"Affiliate"means,withrespecttoanyPerson,anyentitycontrolling,controlledbyorunderthecommoncontrolofsuchPerson.SuchentitywillbeconsideredanAffiliateonlyforthetimeduringwhichsuchcontrolexists.ForthepurposeofthisAgreement,"control"（togetherwithitscorrelativemeanings"controlledby"or"undercommoncontrolwith"）meanshaving,directlyorindirectly,thepowertodirectorcausethedirectionofmanagementandpoliciesofsuchentity.ForpurposesofthisAgreement,noneofGholdcooranyofitssubsidiaries,includingGENERICO,shallbeconsideredanaffiliateofNEWALPHAoranyofitssubsidiaries,andnoneofNEWALPHAoranyofitssubsidiariesshallbeconsideredanaffiliateofGholdcooranyofitssubsidiaries,includingGENERICO.

1.3"AlternativeCompensationAmount"hasthemeaningsetforthinSection2.8（B）.

1.4"AnnualForecasts"means,for2008,theannualforecastsoftheaggregateunitsofProductandPipelineProductstobesuppliedbyGENERICOfromeachFacilitythatareattachedasPartAofSchedule1.4hereto,andforsubsequentyears,theannualforecastsoftheaggregateunitsofProductandPipelineProductsfromeachFacilityprovidedbyNEWALPHAtoGENERICOatleastthirty（30）

1

Note:

Redactedportionshavebeenmarkedwith（***）.TheredactedportionsaresubjecttoarequestforconfidentialtreatmentthathasbeenfiledwiththeSecuritiesandExchangeCommission.

dayspriortoJanuary1ofthatyear;provided,however,thattheforecastsprovidedbyNEWALPHAwithrespecttoeachyearsubsequentto2008shallnot,withouttheapprovalofGENERICO（whichapprovalshallnotbeunreasonablybewithheldordelayed）,provideforthesupplyofProductandPipelineProductsfromanyFacilitythatismorethan（***）oftheaggregateunitstobesuppliedfromthatFacilityreflectedintheestimatesfor2009,2010,2011and2012assetforthinPartBofSchedule1.4.The2009,2010,2011and2012estimatesshallnotbecome"AnnualForecasts"forpurposeshereofuntilprovidedbyNEWALPHAunderthetermsofthisAgreement.

1.5"Breach"hasthemeaningsetforthinSection10.2.

1.6"cGMP（s）"meanscurrentgoodmanufacturingpracticesestablishedundertheFDCAandtheregulationspromulgatedthereunder;andothercomparablelawsandregulationsofanycompetentRegulatoryAuthoritiesapplicabletomanufacturingactivitiesortheFacilityfortheProductandPipelineProducts,allasamendedfromtimetotime.

1.7"ChemicalIngredients"means,withrespecttotheProductoranyPipelineProduct,theactivepharmaceuticalingredient（s）andhumanalbuminintheProductorPipelineProduct,asapplicable.

1.8"ChemicalSolution"meansendproductobtainedafterNewAlphaManufacturing（otherthantheNewAlphaReviewandRelease）iscompletewithrespecttotheProductoranyPipelineProduct.

1.9"ChemicalTesting"meansin-processtestingofthechemicalpropertiesoftheProductoranyPipelineProductduringtheprocessofmanufacturingProductoranyPipelineProduct.

1.10"ClaimNotice"hasthemeaningsetforthinSection12.3.

1.11"Competitor"means（***）.

1.12"Components"meansallcontainers,closures,packagingcomponents,labelsandlabelingnecessaryforthemanufactureoftheProductoranyPipelineProductasfinishedgoods.

1.13"Damages"meansanyandalllosses,liabilities,obligations,costs,expenses,damagesorjudgmentsofanykindornaturewhatsoever（includingreasonableattorneys�,accountants'andexperts'fees,disbursementsofcounselandothercostsandexpenses）.

1.14"EMEA"meanstheEuropeanMedicinesEvaluationAgencyoranysuccessoragency.

1.15"EffectiveDate"meansthedatewritteninthepreambleofthisAgreement,assetforthabove.

1.16"EstimatedGenericoManufacturingPlan"meansNEWALPHA'sestimateoftheunitsoftheProductwithrespecttowhichNEWALPHAwillplacePurchaseOrdersduringeachmonthofeachrolling12-monthperiodduringtheTerm,whichestimatewillbedeliveredbyNEWALPHAtoGENERICOonamonthlybasis;provided,however,thatinnoeventwillagivenmonthlyestimatevarybymore

2

Note:

Redactedportionshavebeenmarkedwith（***）.TheredactedportionsaresubjecttoarequestforconfidentialtreatmentthathasbeenfiledwiththeSecuritiesandExchangeCommission.

than（***）fromthemonthlyestimateissuedinrespectoftheimmediatelyprecedingmonth.TheEstimatedGenericoManufacturingPlanshallinclude,withrespecttotheProduct,NEWALPHA'sestimatedrequirementsforcommercialsale,clinicalsupply,validation,stabilityorotherusesthereof,andforGenericoManufacturingateachFacility,duringeachmonthoftheapplicablerolling12-monthbasis.

1.17"Facility"means（i）theMelroseParkFacilityand（ii）theGrandIslandFacility.

1.18"FDA"meanstheUnitedStatesFoodandDrugAdministrationoranyothersuccessoragencyoftheUnitedStatesFederalGovernment.

1.19"FDAModernizationPlan"hasthemeaningsetforthinSection14.1（A）.

1.20"FDCA"meanstheFederalFood,Drug,andCosmeticAct（21U.S.C.Section301et.seq.）,asamendedfromtimetotime.

1.21"ForceMajeure"hasthemeaningsetforthinSection15.4（A）.

1.22"GENERICOIndemnifiedParties"hasthemeaningsetforthinSection12.2.

1.23"GenericoManufacture,""GenericoManufactured"and"GenericoManufacturing"meanstheacquisition,sampling,testingandreleaseofComponents,theacquisitionandsamplingofMaterialsandtestingofMaterialssuppliedbyGENERICOsuchaswaterforinjection（"WFI"）andnitrogen,thesamplingofChemicalIngredientsandthemanufacturing,lyophilization,packaging,labeling,filling,holding,MicrobiologicTestingoftheProductandPipelineProductsasmorefullysetforthonExhibitA.Fortheavoidanceofdoubt,GenericoManufacturingdoesnotincludeNewAlphaManufacturing.

1.24"GenericoProducts"meansalloftheexistingproductsbeingmanufacturedbyGENERICOfromtimetotime,includinganyvariationsofsuchproductsinformulation,dosage,deliverysystem,orthelike（but,fortheavoidanceofdoubt,innoeventwilltheGenericoProductsincludeanyproductincorporating"nab"technology）.

1.25"Gholdco"meansAbraxisBioScience,Inc.（formerlyknownasGenericoHoldings,Inc.andtoberenamedAPPPharmaceuticals,Inc.）,aDelawarecorporationandtheparentcompanyofGENERICO.

1.26"GrandIslandFacility"meansGENERICO'smanufacturingfacility（s）whetherownedorleasedlocatedat3159StaleyRoad,GrandIsland,NewYork.

1.27"GrandIslandLease"hasthemeaningsetforthinSection10.1.

1.28"HPFB"meanstheHealthProductsandFoodBranchofHealthCanadaoranysuccessoragencyoftheCanadiangovernment.

1.29"IHI"meanstheInternationalConferenceonHarmonisationofTechnicalRequirementsforRegistrationofPharmaceuticalsforHumanUseoranysuccessorthereto.

3

Note:

Redactedportionshavebeenmarkedwith（***）.TheredactedportionsaresubjecttoarequestforconfidentialtreatmentthathasbeenfiledwiththeSecuritiesandExchangeCommission.

1.30"IndemnifiableClaim"hasthemeaningsetforthinSection12.3.

1.31"IndemnifiedParty"hasthemeaningsetforthinSection12.3.

1.32"IndemnifyingParty"hasthemeaningsetforthinSection12.3.

1.33"LegalRequirement"meansanyfederal,stateorlocallaw,ordinance,regulation,permit,order,writ,judgment,injunction,decreeoraward,oranyrule,regulationorpublishedguidelinesoranystatementhavingtheeffectoflaw,promulgatedbyanyRegulatoryAuthority,includingcGMPs.

1.34"ManagementFee"hasthemeaningsetforthinSection13.

1.35"Materials"means,withrespecttotheProductoranyPipelineProduct,allinactiverawmaterialsandexcipients,excludinghumanalbumin,usedintheformulationoftheProductoranyPipelineProductnecessaryfortheirmanufactureasfinishedgoods.

1.36"MelroseParkEUPlan"hasthemeaningsetforthinSection14.2（A）.

1.37"MelroseParkFacility"meansGENERICO'smanufacturingfacility（s）whetherownedorleasedlocatedat2020RubyStreet,MelrosePark,Illinois.

1.38"MelroseParkLease"hasthemeaningsetforthinSection10.1.

1.39"MHLW"meansJapan'sministryofHealth,LaborandWelfare（alsoknownas"Korosho"）oranysuccessoragencyofthegovernmentofJapan.

1.40"MOHFW"meansIndia'sministryofHealth&FamilyWelfareoranysuccessoragency.

1.41"MicrobiologicTesting"meansthemicrobiologictestingofthePr