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Dec 22, 2016
16-20967-CR-WILLIAMS/SIMONTON
18U.S.C.j371
18U.S.C.j2
TEVA LLC,
D efendant.
IN FO RM A TIO N
specified:
G ENER AL ALLEGA TIO N S
RelevantStatutoa Backeround
Code,Sections78dd-1,etseq.(TCPA''),wasenactedbyCongressforthepurposeof,among
otherthings,m aking itunlaw fulto actcorruptly in furtherance ofan offer,prom ise,
authorization,orpaym entofm oney oranything ofvalue,directly orindirectly,to a foreign
ofticialforthe pum ose ofobtaining orretaining business for,ordirecting businessto,any
Person.
RelevantEntities and Individuals
2.
com pany with itsheadquartersin Petah Tikva,lsrael. Teva wasthe world'slargestm anufacturer
CorruptPracticesAct(FCPA''),Title15,United StatesCode,Sections78dd-1(a)and78m(b).
TEVA LLC (:ETEVA RUSSIA'')wasalimitedliabilitycompanyincomoratedin
the Russian Federation in 2010 and was a wholly-owned subsidiary ofTeva. TEVA RU SSIA,
and itspredecessorentities,operated on behalf,forthe benefit,and underthe controlofTeva,
and w asprincipally responsible forthe sale and m arketing ofTeva pharm aceuticalproducts in
Russia. TEVA RUSSIA w asan ttagent''ofan issuer,Teva,w ithin the m eaning ofthe FCPA ,
Title15,United StatesCode,Section78dd-l(a).
4.
TevalnternationalGroup(1T1G'')wasaunitofTevathatwasprincipally
ttem ployee,''and agent''ofan issuer,Teva,within the m eaning ofthe FCPA ,Title 15,United
StatesCode,Section78dd-1(a).
tl-l-eva Russia Executive,''a citizen ofthe Russian Federation whose identity is
known to the United Statesand the Com pany,w as a high-levelexecutive atTEV A RUSSIA
UnitedStatesCode,Section78dd-1(a).
tRussian Official,''a citizen ofthe Russian Federation w hose identity isknown to
the United Statesand the Com pany,w as a high-ranking governm entofficialin theRussian
Federation,who held officialpositionson governm entcom m ittees. By virtue ofhis official
position,Russian Officialhad the ability to influene m attersrelated to thepurchase of
pharm aceuticalproductsby the Russian governm ent,including purchasesm ade during annual
auctionsheld by the Russian M inistry ofHealth. Russian O fficialw asa itforeign official''within
themeaningoftheFCPA,Title15,UnitedStatesCode,78dd-l(t)(l)(A).
8.
Federation,the identity ofwhich is known to the U nited States and the Company. Russian
Com pany w asa distributor,m anufacturerand re-packagerofpharm aceuticalproductsin the
Russian Federation. Russian Com pany wasow ned,controlled and m anaged by Russian Official.
9.
prescriptionofCopaxone,whichpatientswererequiredtotakeasaonce-dailyinjection,costup
to tensofthousandsofdollars. During the relevanttim e period,Copaxone wasTeva'sm ost
profitable product.
program whereby the centralgovernm entw ould procure and supply to patientsthe necessary
m edicationsfortreating these illnessesand conditions.A m ong the covered illnessesw as
multiple sclerosisand treatm entby Copaxone. Since in oraround 2008,Russian governm ent
purchases ofCopaxone w ereprim arily m ade by theM inistry ofHealth atusually bi-annual
auctions.
12.
intluence the Russian governm entto purchase Copaxone through tenderoffers. Thepaym ents
werem ade through thehigh profitm arginsthatRussian Company earned as Teva'srepackager
and distributorofCopaxone forsalesto the Russian M inistry ofH ealth pursuantto the central
governm ent'sdrug purchase program .
14.
direction ofTeva Executive and others,soughtto increase sales ofCopaxone to the Russian
governm ent,including by doing businessw ith com panies ow ned and controlled by Russian
and another seniorT1G M anagerabouta recentm eeting w ith Russian Official,providing them
withttanideaofthecaliberoftheperson(bylcitingbelowjustafew ofhisformaltitlesand
personalachievem ents.''l Teva Russia Executive described Russian Official'sofficialposition
and explained thatRussian Offkialw asthe key lobbyistofphanna-related questionsand
issues''aswellas a Ekey contactperson forK nesset,''the lsraeliparliam ent. Teva Russia
Executive explained thatRussian O ffcialw asthe ktownerofthe localw holesaling com pany
gRussianCompanyl''alongwithseveralotherpharmaceuticalcompanies.TevaRussia
Executive's em ailfurthernoted thatRussian Oftscial'sktintluence in the industry''could benefit
Teva by,am ong otherthings,allow ing Teva to obtain Em ore speedy and straightforward
registrationofproducts.''TevaRussiaExecutivecautioned,however,thattttheresults(of
Russia'sl2008presidentialelectionscanaffectthestatusandscopeofgRussianOfticiall's
intluence-''
l6.
thathedsupportged)exploringanykindofinitiativewhichcouldstrengthenourpositionin
Russia-''
17.
dgtlransparencyof(RussianCompanylshouldbeconsideredlow....Participationof(Russian
Offkial)andprobablysomelocalgovernmentofficialsintheownershipstructureiswellknown.''
18.
with Russian Officialand a Russian Com pany executive in lsrael. Them eeting had been
arranged by Russian Com pany'sD irectorofSalesand M arketing.
l9.
M arketing em ailed Teva Executive to follow-up on m atters discussed during the m eeting. The
em ailreiterated thatRussian Com pany wasliinterested to participate in the delivery and
distribution ofCopaxone,''and explained thatthe Russian governm enthad already dddefined''the
governm ent'sorderforCopaxone for2009. The em ailalso m entioned possible Sfuture
6
beneficialforTevatograntthedistributionofCopaxoneto(RussianCompanylinfu11or
Partially-''
20.
em ployees,including Teva Executive,learned thatthe Russian Com pany executive was under
investigation in Russia forcorruption and thatTeva's risk insurance providerhad decided to stop
insuring transactionsw ith Russian Com pany.
21.
w ould grantRussian Com pany the rightto distribute Copaxone in Russia,intending thatRussian
O ftk ialwould use his offk ialposition and ability to intluenceto increase salesofCopaxone to
theRussian governm ent. From early 2009 untilin oraboutm id-2010,Teva em ployeesexplored
variouspossibilities forRussian Com pany to sellCopaxone.
22.
em ailed Teva Executive w ith inform ation abouta publictenderforthe purchase ofCopaxone
thathadbeenannouncedbytheRussianAcademyofMedicalSciencesCtRAMS'').Theemail
explained thatRussian Com pany's Etop m anagem enthasfirsthand relationsw ith RAM S''and
thatthe tenderoffered t1a very good chance to push furtherup Copaxonepositioning in Russia,
sinceRAM SanditsPresidenthave(a1significantroleininfluencingtheopinionofmedicaland
politicalstratum in Russia.''
seniorTlG executivewiththenote,tltlhisisaninterestingofferasthisis(RussianOfficiall's
dom ain/specialty. Pls look into thisand advise soonest.''
issue and w asalready dealing w ith a Russian Com pany employee who ttreportsdirectly to
(RussianOffkiall.''lnoraroundmid-2009,theRussiangovernmentannouncedanew strategy
forthe Russian Federation'sdom estic pharm aceuticalindustry,know n asttpharm a 2020.'' The
goals ofthe new strategy involved,am ong otherthings,an im portphase-outand changesto the
Executive,agreed w ith Russian Officialand otherson a plan forRussian Com pany to be Teva's
repackagerand distributorforCopaxone salesto the Russian governm ent. Russian Com pany
would repackage and distribute Copaxone on behalfofTeva. As setforth below,Teva hoped
thatRussian Officialwould use hispoliticalnetwork and offk ialinfluenceto benefitTeva to
supportm aintaining or increasing the am ountofCopaxone sold to the Russian governm ent.
8
27.
Russian Com pany begranted a largerdiscount. The TEV A RU SSIA m anageropposed giving
Russian Com pany kEany additionalconcessions,''butTeva Russia Executive wrote back,
suggesting thatTEVA RU SSIA should considerthe requestastthe costofbuilding a
relationshipwith(RussianOfficiall,''astlthisyear,therewasasubstantialincreaseinthe
Copaxonerequestsfrom theIItAM SI,''andTEVA RUSSIA ttmaybenefitfrom gRussian
Official'slsupportinotherareasaswell.''
ln oraround lateA ugust2010,TEV A RU SSG em ployeesprovided a draftofthe
proposed Copaxone repackaging and distribution agreem entbetween Teva and Russian
Company to Teva em ployees in lsrael.
tenderthisfall)andsupportingfastdevelopmentandintroductionofthelocalglatiramoids(they
callthem ,ofcourse,tcopaxone'sgenerics'l.'' ln theemail,theTEVA RUSSIA executivestated
thatthisEtand som e othernew factorsproduced a seriousthreats forthe Copaxone businessin
2011.55 A sa result,d
partnership w ith a robustinfluentiallocalplayerw as identified asthe proper
solution to the above challenges.'' The em ailstated thatthe partnerw asdsupposed to lobby
Copaxone in the state tender.'' He explained thatRussian Com pany tw asfound asthe right
companycapabletoassurekeepingCopaxone'sshareanditspriceandevenrgalisingthem both
uP.
executivesin Israelw ith additionalinfonnation supporting TEVA RU SSIA 'Srequest. The em ail
noted thatRussian Com pany washeaded by Russian Official,listed Russian O fficial'sofficial
positionson variousgovem m entcom m ittees,and explained thatttthe plan''w asto use Russian
O ftk ial'scontacts,including atthe M inistry ofHealth,to m aintain Copaxone'sshare ofthe
m arket,including by m inim izing the risk thata generic version ofCopaxone would beapproved
by the Russian governm ent,thereby reducing Teva'sm arketshare.
32.
seniorTeva executivesin Israelrequesting them to sign offon the agreem entw ith Russian
Com pany im m ediately.
10
RussiaExecutiveanddescribedameetinghehadjusthadwithRussianOm cial.Theemailsaid
thatRussian Om cialhad told him thatthe M inisterofHealth Kxhad returned from a vacation and
askedinthemorningiftherewasaconsrmationthattheentireproject...wouldtakeplace.''
TheemailexplainedthatRussian Ofticialwasconcem ed thatTevawould refusetoapprovethe
agreem entw ith Russian Com pany,and thatRussian Officialhad threatened thatboth the price
and the supply volum esw ould be purposefully tlowered'ifa partnership w ith him w asnot
established.''
On oraboutSeptem berl5,2010,Teva executives agreed to enterinto the
internalprocessto form ally enterinto the agreem entw ith Russian Com pany. Consistentwith
11
36.
diligence to be conducted.
O n oraboutOctober9,2010,in response to an inquiry aboutthe statusofdue
Russian Company,which included granting Russian Com pany the rightto repackage and
distribute Copaxone in the Russian Federation as wellasan incentive agreem entw ith paym ents
tied to increasing salestargets. Atthe sam etim e Teva entered into the distribution agreem ent
w ith Russian Com pany,Teva term inated an agreem entw ith the R ussian com pany thathad
distributed Copaxone atseveralpriorM inistry ofH ealth auctionsand agreed to pay that
com pany a substantialbonus''paym entaspartofthe tenuination.
40.
On oraboutN ovem ber 12,2010,the Russian M inistry ofH ealth aw arded Russian
Com pany the contractto supply the Russian governm entw ith glatiram eracetate foritstender.
12
41.
O n oraboutD ecem ber 13,2010,a TEVA RUSSG executive com m unicated via
em ailw ith a seniorm anageratRussian Com pany regarding m attersrelated to the recentlyawarded contractto supply Copaxone to the Russian governm ent.
42.
executive abouta m eeting the executive w asscheduled to have w ith Russian Ofticial. ln
preparing the executive forthem eeting,Teva Russia Executive explained Russian Official's
position and intluence in the Russian governm entand stated thattheEEstate channelisa key one
forhisbusinesses.''TevaRussiaExecutiveexplainedthatEtthedilemma(RussianOm ciallfaces
ishow to protecthispositionsunderconditions when state funded businessin Russia is
becom ing transparent.'' Am ong otherthings,Teva Russia Executive asked the seniorEM IA
executivetodpush(RussianOfticialltodemandmorefundingforCopaxone(1inearly2011''
andtottobtainhiscommitmentinprotectingCopaxone(accesstotheMinister(ofHealthland
(M inistryofHealthldecisionmakers,leveragingSenatecapabilitiesl-''
43.
by the Russian M inistry ofH eaIth to supply the governm entw ith Copaxone.
45.
Oftk ialand Russian Com pany in the m iddle of2013 asa resultofRussian Com pany'srefusalto
follow Teva'sdue diligence procedures.
46.
(Conspiracy to ViolatetheFCPA)
47.
(i)influencingactsanddecisionsofsuchforeignofficialinhisorherofficialcapacity;(ii)
inducing such foreign officialto do and om itto do acts in violation ofthe law fulduty ofsuch
official;(iii)securinganimproperadvantage;and(iv)inducingsuchforeignofficialtousehisor
herinfluence w ith a foreign governm entand agenciesand instnlm entalitiesthereofto affectand
Section 78dd-1(a).
O biectofthe Conspiracv
50.
accom plish the purposesofthe conspiracy included,am ong otherthings,the follow ing:
TEVA RU SSIA,through certain ofitsemployeesand agents,soughtto
have Teva enter into a distribution agreem entw ith Russian Com pany intending thatRussian
Officialwould exercise his influence to increase Copaxone sales.
b.
aboutRussian Com pany w hen Teva w asundertaking due diligence,including inform ation about
Russian Om cial'salleged involvem entin corruption related to Russian governm entdrug
procurem entauctions.
15
O vertA cts
ln furtheranceoftheconspiracyandtoachieveitspurposeandobject,atleastone
ofthecoconspiratorscom m itted,and caused to be com m itted,in the United States,and
elsewhere,the follow ing overtacts,am ong others:
Copaxoneto(RussianCompany)infullorpartially.''
On oraboutM arch 8,2009,Teva Executive sentan em ailto Teva Russia
Executive,an executive ofthe TEVA RUSSIA,and others,instructing Teva Russia Executive to
exploreentering into an agreem entw ith Russian Com pany to sellCopaxone in an upcom ing
Russian governm enttender.
O n oraboutA ugust5,2010,TevaRussia Executive sentan em ailto an
employee ofTEVA RUSSIA instructing him to grantRussian Company an increased profit
consideredtthecostofbuildingarelationshipwith(RussianOfficiall.''
d.
draftofthe proposed Copaxone distribution agreem entbetween Teva and Russian Com pany to
Teva em ployeesin lsrael.
O n oraboutSeptem ber 12,2010,a TEVA RU SSIA m anagerem ailed
Teva executives in Israelw ith additionalinform ation abouttheproposed distribution agreem ent,
noting thatRussian Com pany w asheaded by Russian O m cial,listing the officialpositions held
h.
TevaEM IA executive abouta m eeting the executive wasscheduled to have w ith Russian
Ofticial.Amongotherthings,TevaRussiaExecutiveaskedtheexecutivetopushgRussian
OfficialltodemandmorefundingforCopaxone(1inearly201l''andtottobtainhiscommitment
inprotectingCopaxone(accesstotheM inister(ofHealth)and(M inistryofHealthqdecision
makers,leveragingSenatecapabilitiesl.''
A llin violation ofTitle 18,U nited StatesCode,Section 371.
AN DREW W EISSM AN N
ChietlFraud Section
BY :
ROHA N A .V lR
R
JOIN A LEX ROM AN O
TrialAttorneys,Fraud Section
Crim inalDivision
United States Departm entofJustice
1400 N ew Y ork Ave.,N .W .
W ashington,D .C.20005
(202)598-2253
CA SE NO .
V:.
CourtDivision:(selectone)
X F
Mi
TL
ami
New Defendantts)
N umberofN ew Defendants
Ke
w/BWest
Yes
No
FTp Totalnumberofcounts
lqterpreter:
(YesorNo)
Llstlanguageand/ordialect
Thiscase willtake
No
daysforthe partiesto try.
(Checkonl
yone)
I
11
1l1
IV
V
0 to 5days
6 to 10 days
11to 20 days
21to 60 days
61daysand over
6:
lfyes:
Judge:
Petty
M inor
M isdem .
Felony
--
No
Case No.
(Attachcopy ofdispositiveorder)
Hasacomplaintbeen filedinthismatter?
lfyes:
M agistrateCaseN o.
(YesorNo)
No
Related M iscsllaneousnumbers:
Defendantts)lnfederalcustody asof
Defendantts)lnstatecustodyasof
Rule20 from the Districtof
lsthisapotentialdeathpenalty case?(YesorNo)
No
Yes
No
ROHAN A VIRG
*penaltySheetts)attached
TRIALATYORNEY DEPToFJvsrlcE
CRIMINAL Dlvlslcx
Rsv4/8/08
18 U.S.C.i 371
*M ax.Penalty:
Count#:2
*M ax.Penalty:
Cotmt#:
*M ax.Penalty:
Count#:
*M ax.Penalty:
Count#:
*M ax.Penalty:
AO 455(Rev.01/09)Waiverofanlndictment
CaseN o.
Teva LLC
Date:
12/22/2016
''
(Qkla t-t-L (,n
Defendant'
ssignature
/z' fx
Signatureofdefendant'
sattorney
Martin J.W einstein
Printednameofdefendant'
sattornev