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Case 1:12-cr-00026-SGW Document 5

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CLERK'
SAT
OFFICE tl.s.Dl:T.cour
ABINGnONIVA
.
FILED

IN TH E UNITED STATES DISTR IC T C O URT


FO R TH E W ESTERN DISTR ICT O F VIR GINIA
A BIN G DO N D IVISIO N
UNITED STATES

#At 2?2212
JULA
3Y:

criminalxo./-'/JJ7N&
:

ABBO TT LABO R ATO W ES

PLEA AGREEM ENT

ABBOTT LABORATORIES (ElN:36-0698440)(''


ABBOTT'')hasentered into aPlea
Agreementwith theUnited StatesofAmerica,by counsel,pursuantto Rule 1l(c)(1)(C)ofthe
FederalRulesofCriminalProcedure (d(Fed.R.Crim.P.''). The terms and conditionsofthis
agreem entare asfollow s:

CHARGE TO W HICH ABBOTT IS PLEADING GUILTY AND W AIVER OF


RIG H TS

AB BOTT w illenter a plea of guilty to Count One of the Inform ation charging itw ith

violating Title 21,Unitd States Code,Sections 331(a),333(a)(l),352(a) and 352(941)by


introducing and delivering forintroduction into interstate com m erce and causing the introduction
and delivery for introduction into interstate com m erce from lllinois and Puerto Rico to various
locationsthroughoutthe United States,including the W estern D istrict of Virginia,of Depakote,
Depakote ER and Depakote Sprinkle thatwere m isbranded.
The parties agree and stipulate that the m axim um statutory penalty is a fine of

$800,000,000.00 (twice the gross gain),pursuantto Title 18,United States Code,Section


3571(d),plusaperiodofprobationofupto fiveyears,pursuanttoTitle 18,United StatesCode,
Section 3561(c)(2). ln addition,ABBOTT'S assetsmay be subjectto forfeiture. ABBOTT
understandsthatfeesmay beimposed to pay forprobation and thatthere willbe a $125 special

assessmentforCountOne,pursuanttoTitle 18,United StatesCode,Section 3013(a)(l)(B)(iii).


ABBOTT'Sattorneyshave inform ed itofthe nature ofthe charge and the elem ents ofthe charge
thatm ustbe proved by the United States beyond a reasonable doubtbefore A BBO TT could be
found guilty ascharged.
AB BOTT acknow ledgesthatA BBOTT hashad al1ofitsrightsexplained to it. A BBO TT

expressly recognizesthat,as a corgoration,ABBOTT may have the following constitutional


rightsandthatbyvoluntarilypleadlngguiltyABBOTT knowinglywaivesandgivesupthese
valuableconstitutlonalrights:

Therighttopleadnotguiltyandgersistinthatplea.

The rightto a speedy and publicJul'


y trial.
The rightto assistance ofcounselatthattrialand in any subsequentappeal.
The rightto rem ain silentattrial.
The rightto testify attrial.
The rightto confrontand cross-exam ine w itnesses.
Plea Agreement

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AuthorizedCorporateOm cer'
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The rightto presentevidence and w itnesses.


The rightto com pulsory processofthe court.
The rightto com pelthe attendance ofw itnessesattrial.
The rightto be presum ed innocent.
Therightto aunanim ous guilty verdict.
The rightto appeala guilty verdict.
ABBOTT is pleading guilty as described above because A BBOTT is in fact guilty and
because A BBOTT believes it is in its best interest to do so and not because of any threats or
prom ises,otherthan the tenns ofthe Plea A greem ent,described herein,in exchange for its plea
of guilty. ABBOTT agrees that aIl of the m atters set forth in the lnfonnation are true and
correct.

ABBOTT understandsthatthe plea is being entered in accordance w ith Fed.R.Crim .P.

l1(c)(1)(C).
SENTKNCING XROVISJONS
Based upon the evidence currently known to the United States,the parties agree thatthe
2011 version ofthe United States Sentencing Com m ission G uidelines M anualisthe appropriate

GuidelinesManualtoutilize.AccordinjtoU.S.S.G.j8C2.1,theorganizationalfineprovisions
donotapplytothecountofconviction lnthiscase,which isamisdemeanorunder21U.S.C.j
333(a)(l).
Thepartiesagreethatthefineshallbe$500,000,000.00(fivehundredmilliondollars).

Thepartiesagreeandstipulatethataterm ofgrobationforfiveyearswillbeimposed
subjecttomodificationassetforth inthesection ofthlsPleaAgreementtitled EGSUCCESSION
ISSUES.'' ABBOTT understands and agrees that if its probation is revoked, it m ay be

resentenced and atotalaggregatefineup to the statutorymaximum of$800,000,000.00 (eight


hundredmilliondollars)maybeimposed.
The parties agree thatifthe Courtrefusesto acceptthe Plea Agreem entw ith the agreed-

ujonsentence,thisPleaAgreementwillbenullandvoid,andABBOTTwillbefreetowithdraw

thls guilty plea. ln the event the Courtrefuses to acceptthe Plea A greem ent w ith the agreed-

uponsentenceandABBOTTwithdrawsthisguiltyplea,nothinginthisPleaAjreementshallbe

deemed awaiveroftheprovisionsofFederalRule ofEvidence (GtFed.R.Ev1d.'')4l0 andthe


UnitedStateswillmoveto dismissthelnformationwithoutprejudicetotheUnited States'right
to proceed crim inally againstABBOTT orany otherentity orindividualon any charge.
FINA N CIA L O BLIGA TIO N S
The parties agree and understand that any of the m oney paid pursuant to this Plea
Agreem entw illbe returned if,and only if,the Courtrefuses to acceptthe Plea Agreem entw ith
the agreed-upon sentence and, as a result, ABBOTT w ithdraws its guilty plea. If the Court

rejectsthe plea agreement,theUnited Stateswillreturn allmoneypaid by ABBOTT,without


interest,not m ore than 3 days afterA BBOTT w ithdraw s its guilty plea and notifies the United
States Attorney'sO ffice forthe W estern D istrictofVirginia,in writing,thatitw ishesto have the
m oney returned.

PleaAgreement

UnitedStatesv.AbbottLaboratories

AuthorizedCorporateOm cer'
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a.

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Crim inalR esolution Paym ents

Notm ore than 3 days afterthe entry of ABBOTT'S guilty plea,A BBO TT w illm ake the
follow ing disbursem ents:

(1) $125.00 (one hundred twentyfive dollars)to the Clerk,


U.S.D istrictCourt,Abingdon,Virginla,as paym entof the special
assessm ent;

(2)

$500,000,000.00 (five hundred million dollars) to the

Clerk,U .S.District Court,A bingdon,Virginia,as paym entofthe


fine;

(3)

$1,500,000.00 (onemillion fivehundred thousand dollars)

to the V irginia M edicaid Fraud Control Unit's Program lncom e


Fund;and

(4) $198,500,000.00 (one hundred ninety-eight million five


hundred thousand dollars),made payable to the United States
D epartm ent of the Treasury, as directed by the United States
Attorney'sOffice aspaym entofaforfeiture.
b.

Forfeiture

ABBOTT agrees to forfeit $198,500,000.00 (one hundred ninety-eight million five

hundred thousand dollars),and agreesto sign any documentation necessary to accomplish the
forfeiture. A BBO TT agrees to forfeita1linterest ln these funds and to take whatever steps are
necessary to pass clear title of this sum to the United States. These steps include butare not
lim ited to m aking the sum available to the United States, as directed by the United States.
ABBOTT agreesnotto t5le a claim in any forfeiture proceeding orto contest,in any m anner,the
forfeiture of said assets. A BBOTT understands and agrees that forfeiture of this property is
proportionate to the degree and nature ofthe offense. A BBOTT freely and know ingly w aives
any and a11 constitutional and statutory challenges to any forfeiture carried out in accordance
with this Plea A greem ent on any grounds,including that the forfeiture constitutes an excessive
fine orpunishm ent. A BBO TT furtherunderstands and agreesthatthis forfeiture is separate and
distinctfrom ,and isnotin the nature of,orin lieu of,any m onetary penalty thatm ay be im posed
by the court.
C.

R estitution

The parties agree and stipulate, pursuant to 18 U.S.C. j 3663(a)(l)(B)(ii), that no


restitution should be ordered.
4.

AD DITIO NA L OBLIGA TIO N S

Unlessthe CourtrejectsthisPleaAgreementand,asaresult,ABBOTT withdrawsits

plea,ABBOTT agreesto:(1)acceptresponsibilityforitsconduct;(2)notattempttowithdraw
itsguiltyplea;(3)notdenythatitcommittedthecrlmestowhichithaspledguilty;(4)notmake
oradoptanyargumentsorobjectionstothepresentenceinvestigationreportthatareinconsistent
PleaAgreement

UnitedStat
esv.AbbottLaborat
ories

Authorized CorporateOffcer'sIniti s.
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withthisPleaAgreement'
,(5)comply with itsobligationsundertheCivilSettlementAgreement
(attached as AttachmentD);and (6)enterinto a Corporate lntegrity Agreement(attached as
AttachmentE).
ABBOTT willnot(1)makeanypublicstatementor(2)make any statementortakeany
position in litigation in w hich any United States departm entor agency is a party,contradicting

any statementoffactsetforth intheAgreed StatementofFacts(attached asAttachmentB). lf


ABBOTT m akes a public statem ent that in w hole or in part contradicts a statem ent of fact
contained in the A greed Statem entofFacts,A BBO TT m ay avoid being in violation ofthis Plea
Agreem entby promptly publicly repudiating such statem ent. Forthe purposes ofthis paragraph,
the term Etpublic statem ent''m eans any statem entm ade or authorized by A BBOTT'S directors,
officers,m anagem entem ployees,orattorneys and includes,but is not lim ited to,a statem entin

(1)apressrelease,(2)publicrelationsmaterial,or(3)ABBOTT website.Notwithstanding the


above,anyABBOTT entity mayavailitselfofany legalorfactualargumentsavailableto it(1)
indefendinglitigationbroughtbyapartyotherthantheUnitedStatesor(2)inanyinvestigation
orproceeding brought by a state entity or by the United States Congress. This paragraph does
not apply to any statem entm ade by any individualin the course ofany actualor contem plated
crim inal,regulatory,adm inistrative or civilcase initiated by any governm entalorprivate party
againstsuch individual.
5.

W A IV ER OF W GH T TO A PPEA L A ND C O LLA TER ALLY ATTA CK TH E


JU DG M ENT AN D SEN TENC E IM PO SED BY TH E CO U RT

lfthe Courtacceptsthis Plea Agreem ent,A BBO TT agreesthatA BBO TT w illnotappeal


the conviction orsentence im posed. A BBOTT isknowingly and voluntarily w aiving any rightto
appealand is voluntarily w illing to rely on the Courtin sentencing it,pursuantto the term s of

Fed.R.Crim.P.1l(c)(l)(C). ABBOTT expresslywaivesitsrightto appealasto any and all


issues in this m atter and waives any right it m ay have to collaterally attack, in any future
proceeding, any order issued in this m atler,unless such appeal or collateral attack cannot be
w aived,by law . A BBO TT understands the United States expressly reserves al1of its rights to
appeal,butifthe United States initiates a directappealofthe sentence im posed,A BBO TT m ay
t5le a cross-appealofthatsam e sentence. A BBOTT agrees and understands if itfiles any court

document(exceptforanappealorcollateralattack based on an issuethatcannotbewaived,by


law)seekingtodisturb,inanyway,anyorderimposedinthecasesuchaction shallconstitutea
failure to comply w ith a provision ofthisagreem ent.
6.

REM ED IES FO R FAILUR E TO CO M PLY W ITH A NY PRO V ISIO N O F TH E


PLEA A G REEM ENT O R O VER ALL R ESO LUTIO N

ABBOTT understandsthatif:(l)ABBOTT attemptstowithdraw itsplea(intheabsence


oftheCourtrefusingtoacceptthePleaAgreement)orfailstocomplywithanyprovisionofthis
PleaAgreementpriorto thecompletion oftheterm ofprobation;(2)ABBOTT'Sconviction is
setaside,forany reason;(3)ABBOTT failsto execute al1required paperwork priorto the

impositionofjudgment;and/or(4)ABBOTT failstocomglywithitsobligationsundertheCivil
SettlementAgreement(attachedasAttachmentD)theUnltedStatesmay,atitselection,pursue
any or allof the following remedies: (a) declare this Plea Agreement void;(b) file,by
Plea Agreement

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indictm entorinform ation,any chargeswhich w ere filed and/orcould have been filed concerning

themattersinvolved inthe instantinvestigation;(c)refuseto abide by any stipulationsand/or


recommendationscontained in thisPleaAgreement;(d)notbeboundby any obligation ofthe
United States setforth in this Plea A greem ent,including,butnotIim ited to,those obligationsset

forthinthesectionofthisPleaAgreementtitledtICOM PLETION OFPROSECUTION;''and(e)


take any other action provided for underthis Plea A greem entorby statute,regulation or court
rule.
The rem edies setforth above are cumulative and not m utually exclusive. lfthe United
Statespursues any ofits perm issible rem ediesassetforth in thisPlea Agreem ent,A BBOTT w ill
stillbe bound by its obligations underthis Plea Agreem ent. ABBOTT hereby waives its right
under Fed.R.Crim .P.7 to be proceeded againstby indictm entand consentsto the filing ofan
inform ation against it concerning any charges filed pursuant to this section of the Plea
A greem ent. ABBOTT hereby w aives any statute oflim itationsargum entasto any such charges.
7.

INFOR M ATION AC CESS W A IVER

A BBO TT agrees to w aive a1lrights,w hether asserted directly or by a representative,to


requestorreceive from any departm entoragency ofthe United States any records pertaining to
the investigation orprosecution ofthiscase,including w ithoutlim itation any recordsthatm ay be

soughtundertheFreedom oflnformation Act,5 U.S.C.j 552,orthePrivacy Actof1974,5


U.S.C.j552a.
8.

D ESTRUC TIO N OF ITEM S O BTA INED BY LAW ENFO R CEM EN T

By signing this Piea A greem ent, ABBOTT consents to the destruction of all item s
obtained by 1aw enforcem entagents during the course ofthe investigation. How ever,A BBOTT
expressly agrees that,w ithin 30 days of being inform ed by the United States Attorney's O ffice
thatrecords and/orother item sobtained from A BBOTT are available forrem oval,itw illrem ove,
atits cost,a1lsuch recordsand/orother item s from the prem ises designated by the U nited States
A ttorney'sOffice.
9.

A TTOR NEY C LIENT PR IV ILEG E

N othing in this Plea Agreem ent shall be construed to require A BBOTT to w aive any
attorney-clientprivilege orwork-productprotection.

10.

COM PLETION OF PROSECUTION

Pursuantto Fed.R.Crim.P.1l(c)(l)(A),so long asABBOTT complieswith al1ofits


obligationsunderthe Plea A greem ent,the United States agreesthat,otherthan the charge in the
attached lnform ation,it shallnot further prosecute ABBOTT or its present or form er parents,

affiliates,divisions,orsubsidiariesortheirpredecessors,successors,orassigns for:(a)any
additionalfederalcrim inalchargesorforfeiture action w ith respectto the conductcovered by the

lnformation'
,or(b)anyviolationsoflaw thatwerethesubjectmatteroftheinvestigationbythe
United States A ttorney's Office for the W estern District of Virginia and the United States
z

plea Agreement

unttedstatesv.AbbottLaboratories

Authorized CorporateOf#cer'sInitials:
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Departm ent of Justice Consum er Protection Branch or based on facts currently known to the
United States Attorney's Office for the W estern District of Virginia and the United States
Departm entof Justice Consum erProtection Branch regarding the sale,prom otion,orm arketing
of D epakote, Depakote ER, Depakote Sprinkle, D epacon or D epakene in the United States
occurring on orbefore'M ay 7,2012.
N othing in this Plea A greem ent affects the adm inistrative,civil,crim inal,or other tax
liability ofany entity or individualand this Plea Agreem entdoes notbind the lnternalRevenue
Service of the Departm ent of Treasury,the Tax Division of the United States Departm ent of
Justice,orany othergovernm entagency w ith respectto theresolution ofany tax issue.
The non-prosecution provisions in this Plea Agreem ent are not binding on the U nited
States with respectto any investigations of ABBOTT,its subsidiaries,affiliates,or parent that
are or m ay be conducted in the future by the Fraud Section of the Crim inal D ivision of the
United States D epartm ent of Justice regarding possible violations of the Foreign Corrupt
PracticesA ctand related offenses.
11.

LIM ITATIO N O F A GR EEM ENT

This Plea Agreem ent is lim ited to the United States Departm entofJustice and does not
bind any otherfederal,state orlocalauthority.
12.

EFFECTIVE REPRESEN TA TIO N

A BBOTT has discussed the tenms of the foregoing Plea A greem ent and al1 m atters

pertainingtothechargesagainstitwith itsattorneysand isfullysatisfiedwithitsattorneysand


its attorneys' advice. At this tim e, ABBO TT has no dissatisfaction or com plaint w lth its
attorneys'representation. A BBOTT agrees to m ake known to the Courtno laterthan atthe tim e
of sentencing any dissatisfaction or com plaint A BBOTT m ay have with its attorneys'
representation.
13.

SU CCESSIO N ISSU ES

ABBOTT haspublicly announced and representsto the Courtthatitplansto separate into


tw o publicly traded com panies,one a diversified m edicalproducts com pany,which m ay retain

the ABBOTT name,(icDiversified Company'') and the othera research-based pharmaceutical


company (tpharmaceuticalCompany'')which willnotbea subsidiaryorcorporate affiliate of
ABBOTT (thisseparationishereinafterreferredtoasthetTransaction''andtheltEffective
Time''shallbethedateandtimethattheTransactionbecomeseffective).Theconductforwhich
ABBOTT w as investigated and that led to this Plea A greem ent relates solely to ABBOTT'S
research-based pharm aceutical products business and not to its diversified m edical products
business. Upon com pletion of the Transaction, the assets of ABBOTT'S research-based
pharm aceutical products business w ill be transferred, conveyed and/or assigned by it to the

PharmaceuticalCompany and ABBOTT shallno lonjer be involved in the marketing or


prom otion of research-based pharm aceutical products ln the United States. As part of the
Transaction,A BBO TT agrees that it willinclude the follow ing in a contract or agreem entw ith
the Pharm aceuticalCom pany relating to the transfer,conveyance orassignmentofthe assets of
Plea Agreement

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ories

AuthorizedCorporateOfficer's1 -lals
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the research-based pharmaceuticalproducts businessto the PharmaceuticalCompany:(a) a


provision stating thatthe Pharm aceutical Com pany agrees that the conditions ofprobation and
allother provisions of this Plea Agreem ent are fully binding on the Pharm aceutical Com pany

and (b)aprovision stating thatthe PharmaceuticalCompany willbe deemed to carry aprior


convictionforpurposesofTitle21,United StatesCode,Section333(a)(2),andwaivesanyright
itm ay have to arguethatitdoes nothave such priorconviction.

ln the eventthe Transaction takesplace and the PharmaceuticalCom pany agrees to (a)
and (b)inthe lastsentenceoftheprecedingparagraph,theUnitedStatesDepartmentofJustice
and ABBOTT agree to the follow ing:
A . The Pharm aceuticalCom pany w illbe deem ed the successorin interest,for
purposes ofthis Plea A greem ent,and allofABBOTT'S obligationsunder

thisPleaAjreement,including any and alIconditionsofprobation,will

B.

becom e obllgations of the Pharm aceutical Com pany as of the Effective


Tim e ofthe Transaction. The term ofprobation shallbe m odified to three
years from the Effective Tim e. A s of the Effective Tim e, neither
ABBOTT nor the D iversified Com pany w illhave any further obligations
underthisPlea A greem ent. The Pharm aceuticalCom pany w illbe the only
entity that will have any further obligations under this Plea A greem ent,
including any and allconditions of probation,w hich w illbe term inated
with respectto ABBOTT. A ny violation of this Plea A greem ent or any
term ofprobation thatoccurs afterthe Effective Tim e shallnot be a basis
to im pose any sanction on ABBOTT,the D iversified Com pany,orany of
their subsidiaries afterthe Effective Tim e. A fter the Effective Tim e,aIl
releases that run to the benefitof A BBOTT,including those set forth in
the section of this Plea Agreem ent titled CCO M PLETION O F
PRO SECUTION ,'' w ill continue to apply fully to ABBOTT, the
Diversised Com pany,the Pharm aceuticalCom pany and theirsubsidiaries'
,
ABBOTT w illbe deem ed to no longer carry a conviction by the United
States Departm entofJustice and the U nited States D epartm ent ofJustice
agrees it w ill not use the conviction of ABBOTT pursuant to this plea
agreem ent:
l.
ln any future calculation of the Crim inalH istory Category under
the U nited States Sentencing Guidelines in any future sentencing
ofA BBOTT orthe D iversified Com pany;or

As a prior conviction for purposes of 21 U.S.C.jj 331 and


333(a)(2) in any future criminalcase against ABBOTT or the
Diversified Com pany. The United States Departm ent of Justice
waivesany rightitm ighthave to argue thateitherA BBO TT orthe
Diversified Com pany has such a conviction forsuch purposes.
The Pharm aceutical Com pany's certification, resolution, and reporting
requirem ents willcoverABBOTT'Sconductforany tim e period forwhich
A BBOTT did not subm it a certificate, resolution or report because the
Effective Tim e occurred priorto the due date ofthe certificate,resolution
orreport.

Plea Agreement

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AuthorizedCorporateOfficer'sInitials:
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For purposes of this Plea Agreem ent and the conditions of probation, the term
ttlkesponsible Entity'' refers to the corporate entity that bears the obligations of this Plea

Agreement,includinj theconditionsofprobation. ABBOTT shallbetheResponsibleEntity


untilthe Effective Tlm e and Pharm aceuticalCom pany shallbe the Responsible Entity after the
Effective Tim e.
14.

C O NDITIO N S O F PR OBA TIO N

Thepartiesagreethatthe followingwillbe includedastheonlyconditionsofprobation:

A.
B.

Alldehnitionssetforth in thePleaAgreementshallbe incorporated by


referenceandareincludedintheconditionsofprobation.
The Responsible Ak///yshallmakethefollowing reportstotheprobation
t?/
.
#*ce:
.

1.

Annual Chief Executive Offjccr (''CEO '') Certification: On an


annualbasis,the Responsible A'
n/j/y '
s CEO shallconducta review

of the effectiveness of the Responsible lb/ffy's Compliance


Program as itrelates to the marketing,promotion,and sale of
pharmaceutical products during the preceding twelve-m onth

period. Thereview shallconsistofareview ofupdatesandreports


by the Responsible Akf/y'
s Chief Compliance OA ccr and/or a
representative#om theResponsible fn/f.y'
s US.Pharmaceutical
.

Compliance Com m ittee aboutthe Responsible fn///.p'


s Compliance

Program and the effectiveness of that program during the


preceding twelve-month period. Based on the review described
above,the Responsible Entity '
s CEO shallsubm itto theprobation

tp
//icc a signed certscationstating that,to the bestof hisorher
know ledge,during thepreceding twelve-monthperiod:
a.
The Responsible Ak/if.p's Compliance Program continued

to includethecompliancepoliciesandproceduressetforth
in the section of this Plea Agreement titled
''COM PLM N CE M EASURES,''and

To the extent that a Reportable Event (as that term is


dehned below)hasbeen determined to haveoccurred,the
Responsible fk//fy hasfully compliedwith theReportable
EventreportingrequirementsofthisPleaAgreement.
The CEO 's certfcation shallsummarize the review described
above that he or she conducted to provide the required

certi
flcation.

AnnualBoard tpfDirectors Resolution:On an annualbasis,the


Responsible fk/l-p'
s Board of Directors (''
Board') or a

designated Committee of the Board of Directors ('iBoard


Committee''
) shallconduct a review of the effectiveness of the
Responsible Akp'f.y's Compliance Program as it relates to the

marketing,promotion,and sale ofpharmaceuticalproducts.This


review shallconsistof updates and reports by the Responsible
PleaAgreement
UnitedStatesv.AbbottLaboratories

Authorized Corporate O-/.


#
'cw 'sInitials:

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A'
n//
.p'
sChiefcomplianceOA ccrand/oravepresentative#om the
Responsible A'
n/jf.p'
s U S.PharmaceuticalCompliance Comm ittee
about the Responsible fp/f.y '
s Compliance Program and the

effectivenessof thatprogram during thepreceding twelve-month


period. Based on the review described above, the Responsible

Ak//fy'
s Board shallsubmitto theprobation tp
f/icc a resolution
adoptedby theBoardstatingthat,tothebestofitsknowledge,the
Responsible Akp'
/'
p has had in e//cfpolicies and procedures
designed to prevent the Responsible Akfjf
y from violating 21
U S.C.#f 331(a) or (k) by directly or indirectly causing the
introductionordeliveryforintroduction into interstatecommerce
of any pharmaceuticalproductthatwtz.
misbranded within the
meaning of 21 US.C.f JJJ orby directly orindirectly causing
.

any pharmaceuticalproductto be m isbranded within the m eaning

of 21 US.C.# JJJ while such productwtu heldfor sale a#er


shi
pmentof itorany of its components in interstate commerce.
The Board's resolution shall sum marize the review described
above that it,or the Board Comm ittee,conducted to provide the

required statement. .
JJ the Board is unable to provide this
statement,itshallsubm ita resolution explaining the reasons w/l
y

itisunabletoprovide/77s'
xstatementabouttheeffectivenessofthe
Responsible fn/j/y '
s ComplianceProgram.

Renortable Events: F#een days ajter the end of each calendar


quarter (thatis,by January 15forthe calendar quarter ending
December3l,Aprill5forthecalendarquarterending March 3l,
July 15forthecalendarquarterendingJune 30,and October15
forthe calendarquarterending September30)and 10daysprior
to thetermination ofprobation ('TinalReport'),theResponsible
Ak/j/p shallsubmita reportto the probation t
pf/zcc in writing
.

stating whether any Reportable Events have been determ ined to

have occurred during thepreceding calendarquarter(or,in the


case of the FinalReport,during theperiod since the calendar
quarterlastcovered by aregularquarterly report)andproviding
updated informationaboutReportableEventsthatoccurredduring
any prior calendar quarters. ,4 Reportable Event is any m atter

thata reasonableperson would consideraprobable violation of


theFoo4 Drug,andCosmeticAct(''FDCA'),21US.C.jf33l(a)
or $),related to the misbranding of a pharmaceuticalproduct
withinthe meaning of21 US.C.f 352. W ReportableEventmay
betheresultofan isolated eventoraseriesofoccurrences. The
reporting of a Reportable Eventshallnotbe considered by the
Probation OA ccrasa nerJ.
violation of thetermsofprobation.
lnstead,otherfactorswillbetaken intoaccount,including,butnot
limited to, whether the Reportable Event violated policies the
company has adopted, whether the company provided training
Plea Agreement
United Statesv.AbbottLaboratories

Authorized Corporate O-f


-/ic'
dr'sInitias:

Page9 of l5

Case 1:12-cr-00026-SGW Document 5

Filed 05/07/12 Page 10 of 16 Pageid#: 21

addressingthesubjectmatteroftheReportableEvent,whetherthe
Reportable Event wtzx an isolated or system ic occurrence, the
company 's response to the Reportable Event, and any remedial

actionstaken ajterthecompany Iearned of theReportableEvent.


Any Reportable Event determined to have occurred by the
Responsible Ak//y shall be promptly reported to the Responsible
.

EW///.y'
sChiefExecutiveOfhcer.

Thehrstsetofannualcertfcationsandreportsshallbesubmitted
notmore than 350 days tz/ier the Responsible Ab//
y issentenced
andshallcovertheperiodoftimecommencingonemonthpriorto
thedateofsentencing tothedateofsubmissionofthecertscation
and report. Each subsequent set of annual reports and
certfcationsshallbedueoneyearthereafterand coverthe one
yearperiod thatfollows the year covered in theprior annual
reportsandcertscations.
Theprobation tp
f/icc may shareany information itreceivesfrom
the Responsible AW/fy with the United StatesAttorney 's Of#ce.
For the purpose of this Plea Agreementand the conditions of
probation,thefollowingtermsshallhavethefollowing meaning.
.
a. Theterm ''ChiefComplianceO//ccr''refersto theperson
atthe Responsible Ak/f/y with ultimate responsibilityfor
-

developing and implementing policies, procedures, and


practices designed to ensure compliance with the FD CA
and FDA 's regulations and guidance documents relating to

the marketing,promotion, and sale of pharmaceutical


products. During the term of probation, the Chief
Compliance OA ccrshallbe a memberof the Responsible
EW///.'
p's senior m anagem ent and the Responsible Ab///-p 's
U S. Pharm aceutical Compliance Com mittee. Not m ore

than//l/r@ (30)daysfrom theimpositionofsentenceinthis


matter,the Responsible Fa///y shallnot# the probation
tpf/zcc in writing of the name of the Responsible Ak/@ 's
ChiefcomplianceOA ccrandprovideawrittendescription
of thatperson'
sresponsibilitieswithrespecttocomplying
with the FD CA and FDA '
s regulatl
bns and guidance
documents relating to the marketing,promotion, and sale

ofpharmaceuticalproducts. TheResponsibleAW//f
.pshall,
inwriting,reporttotheprobationtp
//c:any changesinthe
identity of or any materialchanges in the position and
responsibilities of the Chief Compliance Ofhcer. This
reportshallbe provided w///p /i
-/iccn (15)daysJ-/prsuch
-

a change.
The term ''U S.Pharmaceutical Compliance Comm ittee''

referstothecommitteeestablished ortobeestablishedby
the Responsible A'
n//y to, in conjunction with the Chief
.

PleaAgreement
UnitedStatesr.AbbottLaboratories

AuthorizedCorporateOffcer'sInitials:
Page 10 of 15

Case 1:12-cr-00026-SGW Document 5

Filed 05/07/12 Page 11 of 16 Pageid#: 22

Compliance Ofhcer, assist in the implementation and


enhancementof the Compliance Program 'spolicies and

procedures relating to compliance with the FD CA and


FDA 's regulations and guidance docum ents concerning the

marketing, promotion, and sale of pharmaceutical


products. During the term of probation,this committee
shall,ata m inimum,include the Responsible f/7///y''
sChief
Compliance O//3cerandothermembersoftheResponsible
.

Ak/jy''
s senior management with responsibilities

concerning the marketing,promotion, and sale of the


Responsible Ak//f.p's pharm aceuticalproducts. N otm ore
than f/p/rf.p(30)daysfrom theimpositionofsentenceinthis

matter,the Responsible Ak//fy shallnotf.


,
v theprobation
tp
//zcc in writing of thenames of theResponsibleA'
zi/j/.
p'
,
s
senior m anagers on the U S.Pharm aceutical Compliance

Committee and provide a written description of ///c/


'r
responsibilities with respect to complying with the FD CA
and FDA '
s regulations and guidance documents relating to

the marketing, promotion, and sale of pharmaceutical


products. The Responsible Zk//y shall, in writing,report
.

totheprobationtpf/3ceany changesintheidentity oforany


materialchanges in the position and responsibilities of
these senior managers. FJ//'
5' report shall be provided

withinhfteen(15)daysajtersuchachange.
The term ''Compliance Program ''refers to thepolicies,
procedures, practices, and other measures that the
Responsible fnfry has established or will establish to
address rpgz//tz/tpr.p compliance issues, relating to the

marketing,promotionandsaleofpharmaceuticalproducts,
including the Responsible A'
n/f/y '
s compliance with FD CA
and FDA regulationsand guidance documents.

The term 'pharmaceutical products'' means drugs


marketed,promoteJ or sold in the United States and

intended for use in the diagnosis, cure, mitigation,


treatment,orprevention of disease in humans or drugs
intendedtotz
//cc/thestructureoranyfunctionofthebody
ofhumans.21U.S.C.J32l(g)(l)(B)(f (C).
The Responsible fk//y shallnotcommitanyfederalhealth carefraud
offense,any offense under Titles21or42 of the United StatesCode,or
anyfelony during theterm ofprobatl
bn. The commission of an tp
f/nlc
shallnotbeconsidered by theProbation OA ccrasa pprJ.
violation of
thetermsofprobation. Instea4 otherfactorswillbetaken into account,
including,butnotIimited to,whether the offense violated policies the
company has adopted,whether the company provided training addressing

thesubjectmatterof theoffense,whethertheoffensewtzx
an isolated or
Plea Agreement
United Statesv.AbbottLaboratories

Xlf//ltlrizf!flCorporateOxifb
drX O ifi J
Page 11of15

Case 1:12-cr-00026-SGW Document 5

Filed 05/07/12 Page 12 of 16 Pageid#: 23

systemic occurrence, the company'


s response to the offense,and any
remedialactions taken tz/crthecompanylearnedoftheoffense.
Within 7 days of hling, the Responsible AW///.y shall submit to the
probation tpf/3cc a copy of each Securities and Exchange Commission
Form 1O-Q.
-

15.

CO M PLIA NCE M EA SU RES

A BBO TT agreesthat,priorto entering itsplea ofguilty,asthe Responsible Entity ithas


instituted a Com pliance Program , under which policies, procedures, practices, and other
m easures are setforth to address,am ong otherm atters,regulatory com pliance issuesw ith respect
to the m arketing,prom otion and sale ofpharm aceuticalproducts in the United States,including

compliance with the Food, Drug and Cosmetic Act (tCFDCA'') and Food and Drug
Administration ($$FDA'') regulations and guidance documents. The Responsible Entity's
Com pliance Program includes the policiesand proceduresrelating to pharm aceuticalproducts as
setforth below :
A.
TheResponsibleEntityrequiresthatthecompensation(includingthrough

salaries,bonuses,andcontests)ofitsUnitedStatessalesrepresentativesbe
designed to ensure that financial incentives do not inappropriately
m otivate such individuals to engage in off-label m arketing, prom otion,
and salesofthe Responsible Entity'spharm aceuticalproducts.
B.

TheResponsible EntityrequiresContinuing MedicalEducation (tiCM E'')


grant-m aking decisions to be approved by the Responsible Entity's
financial or other organizations separate from sales and m arketing, and
requires financial support to be provided only to program s that foster
increased understanding of scientific,clinical or healthcare issues.The
Responsible Entity requires a third-party CM E provider to m aintain full
responsibility for, and control over, the selection of content, faculty,
educationalm ethods,m aterialsand venue forCM E program s.
The Responsible Entity requires m edicalinform ation lettersto be accurate
and unbiased. The Responsible Entity's policies and procedures prohibit

thepromptinjofrequestsformedicalinformationletters;and
D.

The Responslble Entity requires clinicaltrials funded or controlled by the


Responsible Entity to be approved by ABBOTT'S m edical and/or
scientitsc organizations and that the scientific research and any resulting
publications foster increased understanding of scientific, clinical or
healthcare issues. The Responsible Entity's policies and procedures
requirethatitw illnotapprove scientific research purely forthe purpose of
developing an article or reprint for sales representative use. The
Responsible Entity requires all investigators to disclose the Responsible
Entity's supportfor their research and financialrelationships betw een the

Responsible Entity and investigators (including any interest in any


Responsible Entity product). The Responsible Entity has a publication
policy designed to ensure that the Responsible Entity develops
publications in a consistent and transparent m anner, reporting com plete
Plea Agreement

Unit
edSmtesv.AbbottLaboratories

Authorized CorporateOm cer'sInitials.


Page 12 of 15

Case 1:12-cr-00026-SGW Document 5

Filed 05/07/12 Page 13 of 16 Pageid#: 24

and accurate results,presented objectively and with discussion of the


strengths and lim itations of the study. The Responsible Entity requires
that a person can be considered an ''author''only if he or she has m ade
substantial contributions to the conception and design of the study,
acquisition oranalysis of data and has finalapprovalofthe version to be

published. The Resgonsible Entity requires acknowledgement in a1l


related scientific publlcations of its role as the funding source of all

researchandclinicaltrialsinitiatedbytheResponsibleEntity.

The Responsible Entity agrees to m aintain the pollcies and procedures set forth above
through thecom pletion ofthe term ofprobation.

16.

EFFECT OF ABBOTT'S SIGNATURE

A BBOTT understands that its A uthorized Corporate Officer's signature on this Plea
A greem ent constitutes a binding offer by it to enter into this Plea A greem ent. A BBOTT
understands that the U nited States has not accepted A BBOTT'S offer until the authorized
representative ofthe United Stateshassigned the Plea A greement.
G ENER AL UN DER STAND IN G S

ABBOTT understands thata presentence investigation w illbe conducted and sentencing


recom m endations independent of the United States Attorney's Office will be m ade by the
presentence preparer.
ABBOTT understandsthe U nited States and A BBOTT willbe freeto allocute ordescribe
the nature ofthisoffense and the evidence in this case.
ABBOTT understands the United States and A BBO TT retain the right,notw ithstanding
any provision in this Plea A greem ent, to inform the Probation Office and the Court of alI
relevantfacts,to address the Courtw ith respectto the nature and seriousness ofthe offense,to
respond to any questions raised by the Court,to correct any inaccuracies or inadequacies in the
presentence report,ifareportisprepared,and to respond to any statem entsm ade to the Court.
ABBOTT w illingly stipulatesthatthere is a sufficientfactualbasis forthe Courtto accept
the plea.
ABBOTT understands thatthis Plea Agreem entdoes notapply to any crim es orcharges
notaddressed in thisPlea Agreem ent.
ABBOTT hasnotbeen coerced,threatened,orprom ised anything otherthan the term sof
thisPlea A greem ent,described above,in exchange forits plea of guilty. A BBO TT understands
thatits attorneys w illbe free to argue any m itigating factors on itsbehalfto the extentthey are
not inconsistent w ith the term s of this Plea A greem ent. A BBOTT understands thatA BBO TT
w ill have an opportunity to have a representative address the Court prior to sentence being
im posed.

This writing and the Agreed Statement of Facts (attached as Attachment B),Civil
SettlementAgreement(attached asAttachmentD),Corporate lntegrity Agreement(attached as
AttachmentE),andAgreedOrderofFodkiture(attachedasAttachmentC)arethecompleteand
only agreem ents between the United States and A BBOTT concerning resolution of this m atter.

In addition,ABBOTT hasno objection to the filingofthe Information (AttachmentA)(which


PleaAgreement

UnitedStatesv.AbbottLaboratories

AuthorizedCsr#tlrfl/dOflicer'
,
:Initials:
Page 13 of l5

Case 1:12-cr-00026-SGW Document 5

Filed 05/07/12 Page 14 of 16 Pageid#: 25

willincorporatetheAgreed StatementofFacts). Theagreementsand documentslisted inthis


paragraph set forth the entire understanding between the parties and constitute the com plete
agreementbetween the United States Attorney forthe W estern D istrictofV irginia and ABBOTT
and no otheradditionaltet'm soragreem ents shallbe entered exceptand unlessthose otherterm s
or agreem ents are in writing and signed by the parties. These agreem ents supersede all prior
understandings, prom ises, agreem ents, or conditions, if any, between the United States and
A BBOTT. A BBOTT consentsto public disclosure of aIlofthe agreem entsand otherdocum ents
referenced in thisparagraph.
A BBO TT has consulted w ith itsattorneys and fully understandsitsrights. ABBOTT has
read this Plea A greem ent and carefully review ed every partof itw ith its attorneys. ABBOTT
understands this Plea Agreem entand A BBOTT voluntarily agrees to it. Being aw are of a11of
the possible consequences ofits plea,ABBOTT has independently decided to enter thisplea of
its own free w illand is affirm ing thatagreem enton this date by the signature of its A uthorized
Corporate Officerbelow .
The Authorized Corporate Officer, by her signature below , hereby certifies to the
follow ing:

(1)

She is fully authorized to enterinto this plea agreementon behalf of

A BBO TT;

(2)

Shehasreadthe entirePleaAgreementanddocumentsreferencedherein

and discussed them with A BBOTT'S Board ofDirectors;

(3)

ABBOTT understandsa1lthetermsofthePleaAgreementandthoseterms

correctlyretlecttheresultsofqleanegotiations;
(4)

ABBOTT is fully satlsfied with ABBOTT'S attorneys' representation

during al1phasesofthiscase;

(5)

ABBOTT isfreelyandvoluntarilypleadingguiltyinthiscase;

(6) ABBOTTispleadingjuiltyassetforthinthisPleaAgreementbecauseit
isguilty ofthe crim e to which ltisentering itsplea;and

(7)

ABBOTT understandsthatitiswaiving itsrightto appealthejudgment

and conviction in thiscase.


ABBOTT acknowledges its acceptance of this Plea A greem ent by the signature of its
counsel and A uthorized Corporate Officer. A copy of a certification by A BBO TT'S Board of
D irectors authorizing the A uthorized Corporate O fficerto execute this Plea A greem ent and al1
otherdocum entsto resolve thism atteron behalfofABBOTT is attached.

Date:wI?!/>
Laura J.Schum acher
Executive V ice-president,G eneralCounsel,and Secretary
ofAbbottLaboratories
A uthorized Corporate Officer
A BBO TT LA BORATORIES

Counsel has fully explained to the Board of D irectors of ABBOTT the facts and
circum stances of the case;all rights with respect to the offense charged in the Inform ation;
1

Plea Agreement

UnitedStatesv.AbbottLaboratories

Authorized f7t?r#/F//dOfficer'.
NInit' ,
$1
Page 14 of 15

Case 1:12-cr-00026-SGW Document 5

Filed 05/07/12 Page 15 of 16 Pageid#: 26

possible defensesto the offense charjed in the Information;allrights with respectto the
applicability ofthe Sentencin! Guidellnes;and the consequences ofentering into this Plea
Agreem ent and entering a gullty plea. W e have reviewed the entire Plea Agreem ent and
docum ents referenced herein w ith m y client,through its Authorized Cop orate Om cer. ln our

judgment,ABBOTT understands the terms and conditions ofthe Plea Agreement,and we

believe ABBOTT'S decision to enter into the Plea Agreement is knowing and voluntary.

ABBOTT'Sexecution ofand entry into thePleaAgreem entlsdone w ith ourconsent.

Date: 3- 7 1=

Ilate:

J-/z1/-.
'

-;

;.Q7

n eodore V.W ells,Esquire


Paul,W eiss,RiR ind,W halon & Garrison
CounselforAbO ttLabpr
atories
jj.y...'
;.
j
j
(
,
f
/,
lz

M arkFilip,Esquire
Kirkland & EllisLLP

:7
1

%.

CounselforAbbottLaM ratories

Date! a-/,//,

Timothy 7.Heaphy
United StatesAttom ey
W estern DistrictofV irginia
Rick A.M ountcastle,A ssistantUnited StatesAttorney

RandyRamseyer,AssistantUnitedSlatesAttomey

CarolW allack,TrialAttorney,U.S.Dept.OfJustlce
Lauren > 11,TrialAttom ey,U.S.Dept.OfJustice
Jil1Furm an,Asst.D ia ctor,Consum erProtetion Branch

PleaAgreement

Unitedstatesv,AbbottLaboratories

AuthorizedCorporateOm cer'
.
:Initias:
Page l5of15

Case 1:12-cr-00026-SGW Document 5

Filed 05/07/12 Page 16 of 16 Pageid#: 27

CERTIFICATE

1,John A.Berry,do hereby cedify thatlam a dul


y appointed and qualKed M sistant
Secretal ofAbbottLaboratories and ading as such;thatAbbottLaboratories is a
corporation dul
y organized and validly existing underthe laws ofthe State ofIllinois w i
th
its principaloffice at100 A bbottPark Road,Abboq Park,Lake County.Illinois;thatIam

akeeperofitsbooksandrecordsanditscorqorateseal;thatthefollowingresolutionisa
true,com plete and corred copy ofthe resolutlon adopted ata regularm eeting ofits
Board ofDiredors on April27,2012*
,thatsaid m eeting was duly called,a quorum was
presentthere at;andthatthatsuchresolution isstillin elect:

RESOLVED,thatthe ExecutiveM ce Presi


dent,GeneralCounseland Secretary
i
s hereby authorized to enterorcause to be entered on behal
fofthis Corporation:the

Plea Agreement civilsettlementagreementswiththe federalgovem mentand the


coordinating states,a corporate lntegrityAgreementwith the HHS Omce ofInspedor
General,and allotherdocum ents necessae orappropriate to efed uate the seqlem ent
ofaIIaspeds ofthe investigation ofthe Corporation'ssales and marketing pradi s for
Depakote from 1998 to 2008 by the United States Departm entofJustice atany tim e on
oraqerthe date ofthis m eeting.
IN W ITNESS W HEREO F,Ihave a xed my nam e as AssistantSecretary and

havecausedthecorporatesealofAbbottLaboratoriestobehereunto amxedasofthis
3O dayofApril,2012.
&c'v''rsw

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PleaAgreement
UnitedStatesv.AbbottLaboratories

Attached BoardResolution