applicabledocxWord格式文档下载.docx

applicabledocxWord格式文档下载.docx

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AAA"

）,andBBB,INC.,a_________（STATE）corporationwithitsprincipalofficeslocatedat_________（address）andBBB'

sAffiliates（together"

BBB"

）.

RECITALS

1.WHEREAS,AAAisengaged,amongotherthings,inthebusinessofdiscovering,developing,manufacturingandmarketingpharmaceuticalproductsforthetreatmentandpreventionofinfectiousdiseases;

2.WHEREAS,AAA'

sresearchforantifungalagentshasresultedinAAAowningpatents,patentapplicationsandknow-howrelatingtoanechinocandinBanalogknownasAAA_________（andanalogsthereof）;

3.WHEREAS,AAAhasbeendevelopingintravenousandoralformulationsofAAA_________andgeneratedregulatoryfilings,pre-clinicalandclinicaldataandotherinformationrelatedtoAAA_________;

4.WHEREAS,AAAisinterestedinexclusivelylicensingAAA_________toapharmaceuticalcompanycapableanddesirousofdevelopingandcommercializingbothparenteralandenteralpharmaceuticalproductsofAAA_________（and/oranalogs,saltsorprodrugsthereof）;

5.WHEREAS,BBBisaspecialtypharmaceuticalcompanywhichconcentratesinthedevelopmentandcommercializationofcompoundsintheareaofinfectiousdiseases;

6.WHEREAS,BBBhasthecapabilityandexpertisetodevelopandcommercializebothparenteralandenteralpharmaceuticalproducts.

7.WHEREAS,BBBisinterestedinexclusivelylicensingrightstoAAA_________fromAAAfortheworldwidedevelopmentandcommercializationofboththeparenteralandenteralproductsofAAA_________（and/oranalogs,saltsorprodrugsthereof）;

and

8.WHEREAS,subjecttothetermsandconditionssetforthinthisAgreement,AAAiswillingtoexclusivelylicensetoBBBandBBBdesirestoexclusivelylicensefromAAArightsrelatedtoAAA_________sothatBBBmaybeenabledtoproceedwiththefurtherdevelopmentandcommercializationofAAA_________;

NOW,THEREFORE,thePartieshereto,intendingtobelegallybound,herebyagreeasfollows:

SECTION1

DEFINITIONS

1.1DEFINITIONS.ForpurposesofthisAgreement,thefollowingtermsshallhavethemeaningssetforthbelow:

"

AFFILIATES"

shallmean,withrespecttoaPartytothisAgreement,anyPersonsdirectlyorindirectlycontrolling,controlledby,orundercommoncontrolwith,suchotherPerson.Forpurposeshereof,theterm"

controlled"

（includingtheterms"

controlledby"

and"

undercommoncontrolwith"

）,asusedwithrespecttoanyPerson,shallmeanthedirectorindirectabilityorpowertodirectorcausethedirectionofmanagementpoliciesofsuchPersonorotherwisedirecttheaffairsofsuchPerson,whetherthroughownershipofequityparticipation,votingsecurities,beneficialinterest,bycontractorotherwise.AffiliateshallspecificallyexcludethirdpartiestowhichBBBhasgrantedasublicensepursuanttoauthoritygrantedbythisAgreementwhereBBBhasnorelationshiptothesublicenseeotherthanalicensor-licenseerelationship.

APPLICATIONFORMARKETINGAUTHORIZATION"

shallmean（a）intheUnitedStatesanewdrugapplicationfiledwiththeFDApursuantto21U.S.C.Section357and21C.F.R.Section314（"

NDA"

）withrespecttotheProductand（b）inanycountryotherthantheUnitedStates,anequivalentapplicationorsetofapplicationsformarketingapprovalcomparabletoanNDAnecessarytomakeandsellProductcommerciallyinsuchcountry.（f）isindependentlydevelopedbyanemployeeoragentofthereceivingParty,subsequenttoreceiptofsuchinformationfromthedisclosingParty,asdemonstratedbycontemporaneouswrittenrecords.

CO-PROMOTE"

or"

CO-PROMOTION"

shallmeananarrangement,inoneormorejurisdictionswherepermitted,inwhich（i）thereisasingleregistrationholderfortheProduct;

（ii）asinglePartyresponsibleforthemanufactureofProduct;

（iii）asinglePartyestablishingthepriceofProduct;

（iv）asinglePartybookingsales;

（v）asingletrademarkbeingusedinconnectionwiththeProduct;

（vi）bothPartiespromoteandmarketsalesoftheProductinsuchjurisdiction（s）;

and（vii）eitherorbothnamesorlogosofthePartiesappearontheProduct.

DAMAGES"

shallmeananyandallcosts,losses,claims,liabilities,fines,penalties,damagesandexpenses,courtcosts,andreasonablefeesanddisbursementsofcounsel,consultantsandexpertwitnessesincurredbyaPartyhereto（includinganyinterestpaymentswhichmaybeimposedinconnectiontherewith）.

DATAEXCLUSIVITYPERIOD"

shallmeantheperiod,ifany,duringwhichtheFDA,orotherequivalentregulatoryagencyinthecaseofcountriesotherthantheUnitedStates,prohibitsreference,forpurposesofseekingRegulatoryApproval,toclinicalandotherdatacontainedintheRegulatoryApprovalpackage