Product Sales Agreement.docx

Product Sales Agreement.docx

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ProductSalesAgreement

PRODUCTSALESAGREEMENT

THISPRODUCTSALESAGREEMENT（this"Agreement"）madeasofthe21stday

ofDecember,2001,byandbetweenAesgen,Inc.,aDelawarecorporation,having

itsprincipalplaceofbusinessat2ResearchWay,ThirdLevelEast,Princeton,

NewJersey08540（"Aesgen"）andaaiPharma,Inc.,aDelawarecorporation,having

itsprincipalplaceofbusinessat2320ScientificParkDrive,Wilmington,North

Carolina28405（"AAI"）.

WHEREAS,Aesgenistheownerofdevelopmentprojectsrelatingto

certainproducts,including,butnotlimitedtotheabbreviatednewdrug

applicationswhichhavebeenfiledand/orapproved,asmorespecificallyset

forthbelow;and

WHEREAS,AAIdesirestopurchasefromAesgenandAesgendesirestosell

toAAIsuchproductsdevelopmentprojects,togetherwithalltheirattendant

rightsandobligations;and

WHEREAS,AAIhasagreedtoassumefromAesgencertainliabilitiesand

undertakecertainobligationsonbehalfofAesgen;

NOWTHEREFORE,inconsiderationofthemutualcovenantsandbenefits

containedinthisAgreement,thepartiesagreeasfollows:

1DEFINITIONS.Inadditiontothetermsdefinedelsewhereherein,thefollowingtermsshallbedefinedasfollows:

1.1"ANDA"shallmeananabbreviatednewdrugapplicationwhichis

submittedtotheFDAforapprovaltomanufactureand/orsellapharmaceutical

productintheUnitedStatespursuanttotheFDCAct

1.2"ANDAProducts"shallmean（i）AcyclovirCapsules（200mg）;（ii）

AcyclovirTablets（400mg,800mg,UD）;（iii）EtodolacCapsules（300mg,bottle

of100）;（iv）EtodolacTablets（400mg,bottleof100）;and（iv）Ketoconazole

Tablets（200mg,bottleof100,blisterpacks）.

1.3"cGMP"shallmeancurrentgoodmanufacturingpracticesassetforth

intheFDCAct.

1.4"DevelopmentProducts"shallmean（i）PentoxifyllineTablets（400

mg,bottleof100,5000,UD）and（ii）SelegilineTablets/Capsules（generic

dosageforms）.

1.5"FDA"shallmeantheUnitedStatesFoodandDrugAdministration.

1.6"FDCAct"shallmeantheFederalFood,DrugandCosmeticAct,21

U.S.C.ss.321etseq.,asamended,andtheregulationspromulgatedthereunder

fromtimetotime.

1.7"GovernmentalEntity"shallmeananyfederal,state,localor

non-U.S.governmentoranycourtofcompetentjurisdiction,legislature,

governmentalagency,administrativeagencyorcommissionorothergovernmentalauthorityorinstrumentality.

1.8"LOI"shallmeanthatcertainletterofintentexecutedbyand

betweenAesgenandAAIonoraboutApril20,2001.

1.9"MaterialAdverseEffect"meansamaterialadverseeffectonthe

business,assets,operations,prospectsorcondition,financialorotherwise,

relatingtotheANDAProductsandtheDevelopmentProducts,takenasawhole.

2TRANSFEROFTHEASSETS.

2.1SALEOFASSETS.Onthetermsandconditionssetforthinthis

Agreement,Aesgenagreestosell,assign,deliver,transferandconveyandAAI

agreestopurchase,acquireandacceptalloftheright,titleandinterestof

AesgeninandtotheProducts（asdefinedbelow）,andmoreparticularlythe

assetssetforthbelowinsubsections2.1.1through2.1.5（the"Assets"）,free

andclearofanyandallliensorencumbrances.

2.1.1THEPRODUCTS.AllofAesgen'sright,titleandinterestinandtotheANDAProductsandtheDevelopmentProducts（collectivelyreferredtoherein

asthe"Products"）.

2.1.2THEREGULATORYRECORDS.AllofAesgen'sright,titleandinterestinandtoanyandallregulatoryfiles（includingcorrespondencewithregulatory

authorities）,registrations,applications,approvals,licensesandpermitsrelatingtotheProducts,asoftheClosingDate,fromtheFDA,or,totheextenttheyexist,anyotherapplicableregulatoryauthorityinanycountry,ineachcasetotheextenttransferableinlightoflegal,regulatoryand,practicalconsiderations;

2.1.3THEINTELLECTUALPROPERTY.Alltrademarks,trademarkrights,licenses,inventions,processes,specifications,know-how,tradesecrets,goodwilland

copyrights,whicharecurrentlyownedbyAesgenandusedexclusivelyinconnectionwiththeProductsandsetforthonSchedule2.1.3.

2.1.4ACCRUEDROYALTIES.AllroyaltieswhichaccrueandbecomedueandowingfromMOVAtoAesgenfromthedateoftheexecutionoftheLOI,tobepaidin

accordancewithSection6.1.3below.

2.1.5THEINTANGIBLES.AlltherightsexclusivelyrelatingtotheAssetssetforthin2.1.1,2.1.2,2.1.3above,includingallclaims,counterclaims,credits,causes

ofaction,rightsofrecoveryandrightsofsetoff.

2.2EXCLUDEDASSETS.AAIacknowledgesandagreesthatitisnot

acquiringanyright,titleorinterestinortoanyotherassetsofAesgen

including,bywayofexample,thefollowingassets（"ExcludedAssets"）:

2.2.1CASH.AllofAesgen'scash,bankaccounts,certificatesofdepositandothercashequivalents.

2.2.2ACCOUNTSRECEIVABLE.ExceptassetforthinSection2.1.4above,allofAesgen'saccountsreceivable,whichshallincludeallreceivablesarisingfromor

relatingtoanyProductsatanytimepriortothecloseofbusinessontheClosingDate.

2.2.3REALESTATE.AnyrealestateownedorleasedbyAesgen.

2.2.4TAXRECORDSANDREFUNDS.AllofAesgen'staxreturnsandrecordsandanytaxrefundsortaxcreditsdueAesgenattributabletotheProductsfortaxperiodspriortotheClosingDate.

2.2.5OTHERASSETS.AllotherassetsofAesgenexceptfortheAssets.

2.3PRIOROBLIGATIONSOFAAI.Inconnectionwiththeterminationofthe

ProductTransfer,Manufacturing,MarketingandDistributionAgreementbetween

MOVAPharmaceuticalCorporation（"MOVA"）andAesgen（the"MOVAAgreement"）relatingtotheProducts,whichterminationshallbeeffectiveonApril22,2002（the"TerminationDate"）,AAIherebyacknowledgesthat,inaccordancewiththe

termsoftheMOVAAgreementanauditofMOVA'sbooksandrecordshasbeen

requestedbyAesgeninordertodeterminethefinalbalanceofoutstandingand

disputedamountsduetoMOVAundersaidMOVAAgreement（the"Audit"）.AspartialconsiderationforthetransferoftheAssets,AAIfurtheracknowledgesand

agreesthatAAIisandremainsobligated,responsibleandliabletoundertake

thefollowingactionsonbehalfofAesgen:

2.3.1AUDITCOSTS.TopayallAesgen'scostsassociatedwiththeAuditwhichareunreimbursedbyMOVAdirectlytotheauditorsconductingtheAudit;and

2.3.2INDEMNIFICATION.Toindemnify,defendandholdharmlessAesgen,anditsofficers,directors,employeesandagents,againstanyandallsuits,claims,causesofactionandliabilities,including,withoutlimitation,attorneys'fees,relatingtotheterminationoftheMOVAAgreement.

2.4ASSUMPTIONOFCERTAINLIABILITIES.Aspartialconsiderationforthe

transferoftheAssets,onthetermsandsubjecttotheconditionsofthis

Agreement,AAIshallassumeandagreetopay,performordischarge,whendue,

thefollowingdebts,obligationsandliabilitiesofAesgen（the"Assumed

Liabilities"）:

2.4.1AMOUNTSDUEMOVA.AAIshallbesolelyresponsibleforandthepaymentdirectlytoMOVAofanyandallamountsdeterminedbytheAudittobedueandowingfromAesgentoMOVAundertheMOVAAgreement.

2.4.2PRODUCTLIABILITY.Allliabilitiesarisingoutoforrelatingtoanyproductliability,breachofwarrantyorsimilarclaimforinjurytopersonor

property,regardlessofwhenasserted,whichresultedfromtheuseormisuseoftheProductsorotherwiserelatedtotheProducts,provided,however,thatAesgenshallindemnifyAAI,anditsofficers,directors,employeesandagentsagainstanyliabilitiesforsalesofProductsbyMOVAtothesameextentthatAesgenisindemnifiedagainstsuchliabilitiesbyMOVApursuanttotheMOVAAgreement.

2.4.3PRODUCTRETURNS.ExcepttotheextentsetforthinSection2.5.1,allliabilitiesarisingoutoforrelatingtothereturnofanyProductonoraftertheClosingDate,whetherornotsoldbyAesgenpriorto,on,oraftertheClosingDate.

2.4.4ADDITIONALLIABILITIES.Allotherliabilities,obligationsandcommitmentsofwhateverkindandnature,primaryorsecondary,directorindirect,

absoluteorcontingent,knownorunknown,whetherornotaccrued,arisingoutoforrelatingto,directlyorindirectly,theProductsortheAssetsortheownership,saleorleaseofanyoftheAssetsbutonlytotheextentrelatedtoanyperiodonoraftertheClosingDate.

2.5NOOTHERLIABILITIESASSUMED.Exceptasexpresslystatedin

Sections2.3and2.4,AAIshallnotassumeoragreetopay,performordischarge

anyofthedebts,obligationsandliabilitiesofAesgen.Withoutlimitingthe

foregoingAAIdoesnotassumeandwillnotbeliableforthefollowing（the

"ExcludedLiabilities"）.

2.5.1PRODUCTRECALLS.AllliabilitiesarisingoutoforrelatingtotherecallofaProductpursuanttoFDAregulationsorotherapplicablegovernmentalauthorityorreturnedbyanenduser,aftertheClosingDate,whichrecallorreturnisaresultof

adulteration,misbrandingorotherviolationoftheFDCActbyAesgenorMOVApriortotheClosingDate.

2.5.2OTHERLIABILITIES.ExceptasprovidedelsewhereinthisAgreement,anydebt,obligationorliabilityofAesgen,knownorunknown,liquidated,unliquidated,absoluteorcontingent,accruedorotherwisewhetherarisingfromcontract,tortorotherwiseandrelatingtotheProductspriortotheClosingDate.

3CONSIDERATION.

3.1AsfurtherconsiderationforthetransferoftheAssets,AAIagreestothefollowing:

3.1.1TERMINATEAGREEMENTS.OntheTerminationDate,AAIshall,togetherwithAesgen,terminatethefollowingagreementsbetweentheparties:

（i）theDevelopmentAgreementdatedasofApril4,1995,（ii）theLicenseAgreementforSelegilineHydrochlorideCapsulesdatedasofJune24,1996,and（iii）allancillary

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