CMO agreementWord文件下载.docx

CMO agreementWord文件下载.docx

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14.MelroseParkandGrandIslandFacilities.40

15.MiscellaneousProvisions.44

SCHEDULE1.451

SCHEDULE1.66TERRITORIES55

SCHEDULE2.10OTHERSERVICES56

SCHEDULE4.1UNITCOSTFORABRAXANE258

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

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"

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

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

1.30"

IndemnifiableClaim"

1.31"

IndemnifiedParty"

1.32"

IndemnifyingParty"

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"

smanufacturingfacility（s）whetherownedorleasedlocatedat2020RubyStreet,MelrosePark,Illinois.

1.38"

MelroseParkLease"

1.39"

MHLW"

meansJapan'

sministryofHealth,LaborandWelfare（alsoknownas"

Korosho"

）oranysuccessoragencyofthegovernmentofJapan.

1.40"

MOHFW"

meansIndia'

sministryofHealth&

FamilyWelfareoranysuccessoragency.

1.41"

MicrobiologicTesting"

meansthemicrobiologictestingofthePr