Development and License Agreement研发及许可协议完整篇doc.docx

Development and License Agreement研发及许可协议完整篇doc.docx

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DevelopmentandLicenseAgreement研发及许可协议完整篇doc

DevelopmentandLicenseAgreement研发及许可协议-

Asusedherein,thefollowingtermswillhavethefollowingmeanings:

1.1AFFILIATEmeansanyentitythatdirectlyorindirectlyOwns,isOwnedbyorisundercommonOwnershipwith,apartytothisAgreement,whereOwnorOwnershipmeansdirectorindirectpossessionofatleastfiftypercent（50%）oftheoutstandingvotingsecuritiesofacorporationoracomparableownershipinanyothertypeofentity,provided,however,thatifthelawofthejurisdictioninwhichsuchentityoperatesdoesnotallowfiftypercent（50%）orgreaterownershipbyapartytothisAgreement,suchownershipinterestshallbeatleastfortypercent（40%）.ThetermAffiliateshallnotincludeDDD,Inc.,_________,priortothetimeCCCdeliversnoticetoAAAdesignatingDDDasitsAffiliate.

1.2BUDGETmeanstheannualbudgetapprovedbythepartiesfromtimetotimepursuanttoARTICLE3.3（d）.

1.3COSTOFGOODSSOLDmeansthemanufacturingcostofProductsoldbyCCC,itsAffiliatesandsublicensees,calculatedinaccordancewithreasonablecostaccountingmethodsofsuchparties,providedthatsuchmethodscomplywithgenerallyacceptedaccountingprinciplesandthefurtherprovisionsofthisARTICLE1.3.CostofGoodsSoldshallconsistofdirectlaborandmaterialsandareasonableallocationofindirectlabor,facilitiesexpense（includingdepreciationovertheexpectedlifeofthebuildingsandequipment）,andadministrationcosts.CostofGoodsSoldshallexcludecostsassociatedwithprocessdevelopment,initialProductbatchesforregulatoryapproval,plantstart-upcosts,excesscapacity,ThirdPartyroyalties,oranycostsforwhichprovisionhasbeenmadeinthedefinitionofNetSales.IntheeventofanytransferofProductamongCCC,itsAffiliatesorsublicensees,theCostofGoodsSoldshallexcludeanyprofitorothermark-upbyanysuchparties.

1.4COVER（includingvariationsthereofsuchasCovered,Coverage,orCovering）shallmeanthatthemanufacture,useorsaleofaparticularproductwouldinfringeaValidClaimofanissuedpatentintheabsenceofrightsundersuchpatent.ThedeterminationofwhetheraproductisCoveredbyparticularpatentrightsshallbemadeonacountrybycountrybasis.

1.5DEVELOPMENTCOSTSmeanthecostsincurredbyAAAorforitsaccountaftertheEffectiveDatewhichareconsistentwiththeDevelopmentPlanandarespecificallyattributabletothedevelopmentofProducts.SuchcostsshallmeanthedirectcostsandtheindirectcostsofallAAAdevelopmentpersonnelandanythirdpartycosts,allofthemincurredtofurthertheProductdevelopmentprogram.IndirectcostsrelatedtotheDevelopmentPlanshallincludebutnotbelimitedtosalaries,employeebenefits,useoffacilitiesandequipment,personnel,travelmaterialsandsupplies,whichshallbeabsorbedintotheDevelopmentCostsbasedongenerallyacceptedaccountingprinciplesandmethodsapprovedbyCCC,suchapprovalnottobeunreasonablywithheld.

1.6DEVELOPMENTPLANmeanstheplanforthedevelopmentofProductsapprovedfromtimetotimepursuanttoARTICLE3.3.TheinitialDevelopmentPlan,reflectingthemutualobjectivesofthepartieswithrespecttothesequenceofeventsleadinguptothefilingofregulatorysubmissions,hasbeenagreedtobythepartiesasoftheEffectiveDate.

1.7EUROPEANUNIONorEUmeansthefollowingcountries:

Austria,Belgium,Denmark,Finland,France,Germany,Greece,Ireland,Italy,TheNetherlands,Portugal,Spain,Sweden,andtheUnitedKingdom.

1.8FIRSTCOMMERCIALSALEmeansthefirstsale,inanyparticularcountry,byCCCoritsAffiliatesorsublicenseesofProductforusebythegeneralpublicafterrequiredmarketingandpricingapprovalhasbeengrantedbythegoverninghealthauthorityofthatcountry.

1.9GENERICALLYEQUIVALENTPRODUCTshallmeanaproductmarketedbyaThirdParty,notunderlicensefromCCC,whichcontainsasanactiveingredientaninfluenzaneuraminidaseinhibitorthecompositionofmatterofwhichiswithinthescopeofaAAAPatentRightoraJointPatentRight.

1.10AAAKNOW-HOWmeansallproprietaryinventions,technology,tradesecrets,clinicalandpreclinicalresults,andanyphysical,chemicalorbiologicalmaterial,orotherinformationexcludingAAAPatentRightsandJointPatentRights,ownedoracquiredwithrighttosublicenseduringthetermofthisAgreementbyAAAoranyAffiliateofAAA,whicharenecessaryorusefultoCCCinthedevelopment,formulation,manufacture,useorsaleofProducts.

1.11AAAPATENTRIGHTSmeantherightsunderpatentsandpatentapplications,bothforeignanddomestic,which（a）Coveraninfluenzaneuraminidaseinhibitor,oritsmanufacture,formulationoruse,includingintermediatesforthemanufactureorusethereof,（b）arebasedonaninventionmadeatanytimepriortothefifthanniversaryoftheEffectiveDateand（c）areownedbyorlicensedtoAAAoranyAAAAffiliatewiththerighttosublicense.Notwithstandingtheforegoing,AAAPatentRightsshallexcludeJointPatentRightsbutshallincludeAAAPatents,whicharedefinedasthosepatentsandpatentapplicationsownedbyorlicensedtoAAAoranyAAAAffiliatewiththerighttosublicensethatareencompassedwithinAAAPatentRights.SetforthasExhibitAisalistoftheAAAPatentsasoftheEffectiveDate.SuchExhibitshallbeupdatednomorefrequentlythanannuallyuponCCC’srequest.

1.12IND（ORINVESTIGATIONALNEWDRUGAPPLICATION）meansanapplicationasdefinedintheUnitedStatesFood,DrugandCosmeticActandapplicableregulationspromulgatedthereundertotheUnitedStatesFoodandDrugAdministration（theFDA）ortheequivalentapplicationtotheequivalentagencyinanyothercountryorgroupofcountries,thefilingofwhichisnecessarytocommenceclinicaltestingofProductsinhumans.

1.13JOINTPATENTRIGHTSmeantherightsunderpatentsandpatentapplications,bothforeignanddomestic,which（a）Coveraninfluenzaneuraminidaseinhibitor,oritsmanufacturingformulationoruse,includingintermediatesforthemanufactureorusethereof,（b）arebasedonaninventionmadeatanytimepriortothefifthanniversaryoftheEffectiveDate,and（c）areownedjointlybyAAAandCCC.ExhibitAshallbeamendedtoincludeJointPatentswhensuchpatentapplicationsarefirstfiled.

1.14NDA（ORNEWDRUGAPPLICATION）meansanapplicationasdefinedintheUnitedStatesFood,DrugandCosmeticActandapplicableregulationspromulgatedthereundertotheUnitedStatesFDAortheequivalentapplicationtotheequivalentagencyinanyothercountryorgroupofcountries,thefilingofwhichisnecessarytocommencecommercialsaleofProducts.

1.15NETSALESmeansthegrosssalesinvoicedbyCCC,itsAffiliatesorsublicenseesforProducttoThirdPartiesotherthansublicensees,lessdeductionsofreturns（includingwithdrawalsandrecalls）,rebates（pricereductions,includingMedicaidandsimilartypesofrebates,e.g.chargebacks）,volume（quantity）discounts,discountsgrantedatthetimeofinvoicing,salestaxesandothertaxesdirectlylinkedtoandincludedinthegrosssalesamountascomputedonaproductbyproductbasisforthecountriesconcerned（hereinafterreferredtoasAdjustedGrossSales）.

FromtheAdjustedGrossSalesthereshallbealumpsumdeductionof

[]forthosesales-relateddeductionswhicharenotaccountedforonaproductbyproductbasis（e.g.,outwardfreights,transportationinsurance,packagingmaterialsfordispatchofgoods,customduties,discountsgrantedlaterthanatthetimeofinvoicing,cashdiscountsandotherdirectsalesexpenses）.

InthecaseofProductsbeingsoldaspartofacombinationproductcontainingtheProductandoneormoreothertherapeuticallyactiveingredients,thepartiesshallnegotiateanappropriateroyaltyadjustmenttoreflecttherelativesignificanceofeachsuchingredient,basedontheestimatedfairmarketvalueofeachsuchtherapeuticallyactiveingredient.

Notwithstandingtheforegoing,amountsreceivedbyCCCoritsAffiliatesorsublicenseesforthesaleofLicensedProductsamongCCCanditsAffiliatesorsublicenseesforresaleshallnotbeincludedinthecomputationofNetSaleshereunder.

1.16PHASEIIICLINICALTRIALmeansanyclinicaltrialprimarilydesignedtoserveasapivotal,well-controlledstudyuponwhichapprovalofanNDAwillbebased,includingsuchastudyreferredtoordenominatedasaPhaseII/IIIstudyintheUnitedStatesortheequivalentelsewhere.

1.17PRODUCT（S）meansanypharmaceuticalproductcontaininganinfluenzaneuraminidaseinhibitorCoveredbyaAAAPatentRight,aCCCPatentRightoraJointPatentRight.

1.18PROPRIETARYINFORMATIONmeans,subjecttothelimitationssetforthinARTICLE12.1hereof,allinformationdisclosedbyapartyheretototheotherpartypursuanttothisAgreement.Inparticular,ProprietaryInformationshallbedeemedtoinclude,butisnotlimitedto,informationrelatingtoresearchanddevelopmentprogramsandresults,therapeuticcandidatesandproducts,clinicalandpreclinicaldata,tradesecrets,businessstrategy,patentapplications,licenses,suppliers,manufacturers,productandmarketingstrategy,customers,marketdata,personnelandconsultants.

1.19CCCKNOW-HOWmeansallproprietaryinventions,technology,tradesecrets,clinicalandpreclinicalresults,andanyphysical,chemicalorbiologicalmaterial,orotherinformationexcludingCCCPatentRightsandJointPatentRights,ownedoracquiredwithrighttosublicenseduringthetermofthisAgreementbyCCCoranyAffiliateofCCC,whicharenecessaryorusefultoCCCinthedevelopment,formulation,manufacture,useorsal