CMO agreementWord文件下载.docx
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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
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