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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