Exhibit 10.15
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA

         
UNITED STATES OF AMERICA
  :    
 
       
v. 
  :   CRIMINAL NO.
 
       
ELI LILLY AND COMPANY
  :    

GUILTY PLEA AGREEMENT
     Under Federal Rule of Criminal Procedure 11(c)(1)(C), the government, the
defendant, Eli Lilly and Company (hereinafter “Eli Lilly”), and Eli Lilly’s
counsel enter into the following guilty plea agreement. Any reference to the
United States or the government in this agreement shall mean the Office of the
United States Attorney for the Eastern District of Pennsylvania and the Office
of Consumer Litigation of the Department of Justice.
     1. Eli Lilly agrees to plead guilty to Count One of an Information, waiving
prosecution by indictment, charging it with the introduction into interstate
commerce of drugs that were misbranded, a misdemeanor, in violation of 21 U.S.C.
§§ 331(a), 333(a)(1) and 352(f)(1), and not to contest forfeiture as set forth
in the notice of forfeiture seeking forfeiture of $100,000,000 in substitute
assets, in lieu of the drugs which were promoted illegally and are no longer
available, all arising from Eli Lilly’s illegal promotion of its drug Zyprexa in
the United States between September 1999 and March 31, 2001. Eli Lilly further
acknowledges its waiver of rights, as set forth in Exhibit A to this agreement.
     2. The parties agree that this plea agreement is made pursuant to
Fed.R.Crim.P. 11(c)(1)(C) and that the following specific sentence is the
appropriate disposition

 

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of this case. Taking into consideration the factors set forth in 18 U.S.C. §§
3553(a) and 3572, the agreed upon sentence is as follows:
          A. Eli Lilly agrees to pay the special assessment in the amount of
$125 on the date of sentencing.
          B. Eli Lilly agrees to pay $615,000,000 to resolve this Information,
of which $515,000,000 will be applied as a criminal fine, and $100,000,000 will
be applied as substitute assets to satisfy the forfeiture obligation described
in paragraph 2(C) below. Eli Lilly will pay these amounts within 10 business
days of the date of sentencing. Eli Lilly and the government agree that this
fine and forfeiture represent a fair and just resolution of all issues
associated with loss, fine and forfeiture calculations.
          C. Eli Lilly agrees that as a result of its acts or omissions, the
forfeitable property, that is the drugs which were promoted off-label, are no
longer available for forfeiture as the drugs cannot be located or have been
transferred, sold or deposited with a third party, or otherwise disposed of,
within the meaning of federal law. As a result, Eli Lilly agrees to the entry
and satisfaction of a judgment and preliminary order of forfeiture on the date
of the guilty plea, forfeiting to the United States the sum of $100,000,000 as
substitute assets for the pertinent drugs. Eli Lilly agrees that, within 10
business days of the date of sentencing, Eli Lilly will make payment to the
United States, by means of a wire transfer to the United States Marshal Service
or check payable to same, in the amount of $100,000,000, this amount
representing substitute assets of the offense for which it is pleading guilty,
subject to forfeiture in full satisfaction of the judgment and preliminary order
of forfeiture.

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          D. In light of the anticipated Corporate Integrity Agreement, Eli
Lilly will not be placed on probation.
     3. Eli Lilly and the United States intend to execute a separate civil
settlement agreement. Eli Lilly waives any and all defenses and objections in
this matter or in that civil proceeding which might be available under the
Double Jeopardy and Excessive Fines clauses of the Eighth Amendment. The parties
agree that, in light of the separate civil settlement agreement, and to avoid
unduly complicating and prolonging the sentencing process, the appropriate
disposition of this case does not include a restitution order.
     4. Eli Lilly waives any claim under the Hyde Amendment, 18 U.S.C. § 3006A
(Statutory Note), for attorney’s fees and other litigation expenses arising out
of the investigation or prosecution of this matter.
     5. Eli Lilly understands, agrees and has had explained to it by counsel
that the Court may impose the following statutory maximum sentence: a fine of
$200,000, or twice the gross gain or gross loss, whichever is greater; a special
assessment of $125; restitution as ordered by the Court; and a five-year term of
Court supervision; in addition, forfeiture may be ordered. Eli Lilly further
understands that the terms and conditions of any Court supervision may be
changed, and extended, by the Court if Eli Lilly violates any of the terms and
conditions of that supervision.
     6. With respect to Eli Lilly’s conduct:

  A.   The parties stipulate to the following facts and basis for the plea,
criminal fine and forfeiture:

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  (1)   Eli Lilly marketed Zyprexa, which was a drug within the meaning of 21
U.S.C. § 321(g)(1).     (2)   Shipments of a drug in interstate commerce must be
accompanied by labeling bearing adequate directions for use for each of the
drug’s intended uses.     (3)   In September 1996, Zyprexa was approved by FDA
for the short term management of the manifestations of psychotic disorders. In
March 2000, FDA approved the addition of the subheading “schizophrenia” to the
short term management of the manifestations of psychotic disorders. Also in
March 2000, FDA approved Zyprexa for the short-term treatment of acute manic
episodes associated with Bipolar I Disorder. In November 2000, FDA approved new
labeling for Zyprexa for the short term treatment of schizophrenia in place of
the management of the manifestations of psychotic disorders. Also in
November 2000, FDA approved Zyprexa for maintaining treatment response in
schizophrenic patients who had been stable for approximately eight weeks and
were then followed for a period of up to eight months.     (4)   Between
September 1999 and March 31, 2001, Eli Lilly promoted Zyprexa in elderly
populations as treatment for

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      dementia, including Alzheimer’s dementia. Zyprexa is not approved by the
FDA for treatment of dementia or Alzheimer’s dementia. Eli Lilly’s promotion of
Zyprexa for these additional intended uses violated 21 U.S.C. § 352(f)(1),
because Zyprexa’s labeling did not bear adequate directions for each of the
drug’s intended uses.

  B.   The United States contends that, as a matter of relevant conduct, the
conduct which forms the basis for this plea agreement, as set forth in
subsection (A) above, continued past March 31, 2001. Eli Lilly does not admit
that this conduct extended past March 31, 2001.

     7. Eli Lilly and the United States retain the right to withdraw from this
guilty plea agreement, and this plea agreement will be null and void, if the
civil settlement agreement and Corporate Integrity Agreement are not executed
prior to the filing of the Information.
     8. Except as provided herein, the United States agrees that, other than the
charges in the Information in this case, it will not bring any other criminal
charges against Eli Lilly, its present and former parents, affiliates,
divisions, and subsidiaries; their predecessors, successors and assigns for
conduct which (A) falls within the scope of the criminal investigation in the
Eastern District of Pennsylvania relating to Eli Lilly’s drug Zyprexa; or
(B) was known to the United States Attorney’s Office for the Eastern District of
Pennsylvania or the Office of Consumer Litigation of the Department of Justice
as of the date of the execution of this plea agreement, and which concerned the
sale, promotion, or marketing of Zyprexa in the United

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States. The non-prosecution provisions of this paragraph are binding on the
Office of the United States Attorney for the Eastern District of Pennsylvania,
the Office of Consumer Litigation of the Department of Justice, and the United
States Attorney’s Offices for each of the other 93 judicial districts of the
United States. The non-prosecution provisions are also binding on the Criminal
Division of the United States Department of Justice, except that the
investigation of Eli Lilly and its affiliates, divisions, and subsidiaries,
being conducted by the Fraud Section of the Criminal Division regarding possible
violations of the Foreign Corrupt Practices Act and related offenses in
connection with the sales and marketing of Eli Lilly’s products to foreign
customers is specifically excluded from the non-prosecution provisions and
release provided by this paragraph and agreement. Attached as Exhibit B is a
copy of the letter to Acting United States Attorney Laurie Magid from the
Assistant Attorney General, Criminal Division, Department of Justice,
authorizing this agreement.
     9. Eli Lilly understands that this guilty plea agreement does not bind any
other government agency, or any component of the Department of Justice except as
specified in paragraph 8 of this guilty plea agreement. Further, Eli Lilly
understands that the United States takes no position as to the proper tax
treatment of any of the payments made by Eli Lilly pursuant to this plea
agreement, the civil settlement agreement, or the Corporate Integrity Agreement
referenced in this plea agreement.
     10. Eli Lilly agrees to waive the statute of limitations, and any other
time-related defense, to the charge to which it is agreeing to plead guilty
under this plea agreement, provided that the guilty plea is accepted by the
Court.

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     11. Eli Lilly understands and agrees that, should it withdraw its plea or
if Eli Lilly’s guilty plea is not accepted by the Court for whatever reason, Eli
Lilly may thereafter be prosecuted for any criminal violation of which the
United States has knowledge arising out of this investigation, notwithstanding
the expiration of any applicable statute of limitations between the time period
when Eli Lilly signed this plea agreement and either Eli Lilly’s withdrawal of
its plea or the Court’s rejection of its plea. In that event, Eli Lilly agrees
that it will not raise the expiration of any statute of limitations as a defense
to any such prosecution, except to the extent that the statute of limitations
would have been a defense pursuant to the terms of a Tolling Agreement between
the parties effective October 7, 2008, all subsequent extensions of the Tolling
Agreement, and this paragraph.
     12. In exchange for the undertakings made by the government in entering
this plea agreement, Eli Lilly voluntarily and expressly waives all rights to
appeal or collaterally attack the defendant’s conviction, sentence, or any other
matter relating to this prosecution, whether such a right to appeal or
collateral attack arises under 18 U.S.C. § 3742, 28 U.S.C. § 1291, 28 U.S.C. §
2255, or any other provision of law. This waiver is not intended to bar the
assertion of constitutional claims that the relevant case law holds cannot be
waived.
     13. Eli Lilly also waives all rights, whether asserted directly or by a
representative, to request or receive from any department or agency of the
United States any records pertaining to the investigation or prosecution of this
case, including without limitation any records that may be sought under the
Freedom of Information Act, 5 U.S.C. § 552, or the Privacy Act, 5 U.S.C. § 552a.

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     14. Eli Lilly is satisfied with the legal representation provided by its
lawyers; Eli Lilly and its lawyers have fully discussed this guilty plea
agreement; and Eli Lilly is agreeing to plead guilty because Eli Lilly admits
that it is guilty of the misdemeanor described in paragraph 1.
     15. Eli Lilly will acknowledge acceptance of this guilty plea agreement by
the signature of its counsel and of an authorized corporate officer. Eli Lilly
shall provide to the government for attachment as Exhibit C to this plea
agreement a notarized resolution by Eli Lilly’s Board of Directors authorizing
the corporation to enter a plea of guilty, and authorizing a corporate officer
to execute this agreement.
     16. If acceptable to the Court, the parties agree to waive the presentence
investigation and report pursuant to Rule 32(c)(1) of the Federal Rules of
Criminal Procedure, and ask that Eli Lilly be sentenced at the time the guilty
plea is entered.
     17. It is agreed that the parties’ guilty plea agreement contains no
additional promises, agreements or understandings other than those set forth in
this written guilty plea agreement, and that no additional promises, agreements
or understandings will be entered into unless in writing and signed by all
parties.

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SIGNATURES FOR THE UNITED STATES
GREGORY G. KATSAS
Assistant Attorney General
Civil Division
United States Department of Justice

             
/s/ Eugene M. Thirolf
      /s/ Laurie Magid    
 
           
EUGENE M. THIROLF
      LAURIE MAGID    
Director, Office of Consumer Litigation
      Acting United States Attorney    
United States Department of Justice
           
 
           
/s/ Jeffrey I. Steger
      /s/ Linda Dale Hoffa    
 
           
JEFFREY I. STEGER
      LINDA DALE HOFFA    
Trial Attorney
      Chief, Criminal Division    
Office of Consumer Litigation
      Assistant United States Attorney    
United States Department of Justice
           
 
           
/s/ Ross S. Goldstein
      /s/ Catherine Votaw    
 
           
ROSS S. GOLDSTEIN
      CATHERINE VOTAW    
Trial Attorney
      Assistant United States Attorney    
Office of Consumer Litigation
           
United States Department of Justice
           
 
           
 
      /s/ Marilyn S. May    
 
           
 
      MARILYN S. MAY
Assistant United States Attorney    
 
           
DATE: 1-14-09
      /s/ Denise S. Wolf    
 
           
 
      DENISE S. WOLF
Assistant United States Attorney    

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SIGNATURE FOR ELI LILLY

             
DATE: 14 Jan. 2009
      /s/ Robert A. Armitage    
 
           
 
      ROBERT A. ARMITAGE    
 
      Senior Vice President and General Counsel    
 
      Eli Lilly and Company    

SIGNATURES OF ELI LILLY’S ATTORNEYS

             
DATE: 1/14/09
      /s/ Nina M. Gussack    
 
           
 
      NINA M. GUSSACK    
 
      Pepper Hamilton LLP    
 
      Counsel for Defendant    
 
           
DATE: 1/14/09
      /s/ Thomas M. Gallagher    
 
           
 
      THOMAS M. GALLAGHER    
 
      Pepper Hamilton LLP    
 
      Counsel for Defendant    
 
           
DATE: 1/14/09
      /s/ Paul E. Kalb    
 
           
 
      PAUL E. KALB    
 
      Sidley Austin LLP    
 
      Counsel for Defendant    
 
           
DATE: 1/14/09
      /s/ Bradford A. Berenson    
 
           
 
      BRADFORD A. BERENSON    
 
      Sidley Austin LLP    
 
      Counsel for Defendant    

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Exhibit A
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA

         
UNITED STATES OF AMERICA
  :    
 
       
v.
  :   CRIMINAL NO.
 
       
ELI LILLY AND COMPANY
  :    

ACKNOWLEDGMENT OF RIGHTS
     Eli Lilly and Company (“Eli Lilly”), through its properly authorized
officer, hereby acknowledges that it has certain rights that it will be giving
up by pleading guilty.

  1.   Eli Lilly understands that it does not have to plead guilty.     2.   Eli
Lilly may plead not guilty and insist upon a trial.     3.   At that trial, Eli
Lilly understands:

  a.   that Eli Lilly would have the right to be tried by a jury that would be
selected from the Eastern District of Pennsylvania and that along with its
attorney, Eli Lilly would have the right to participate in the selection of that
jury;     b.   that the jury could only convict Eli Lilly if all twelve jurors
agreed that they were convinced of Eli Lilly’s guilt beyond a reasonable doubt;
    c.   that the government would have the burden of proving Eli Lilly’s guilt
beyond a reasonable doubt and that Eli Lilly would not have to prove anything;  
  d.   that Eli Lilly would be presumed innocent unless and until such time as
the jury was convinced beyond a reasonable doubt that the government had proven
that Eli Lilly was guilty;     e.   that Eli Lilly would have the right to be
represented by a lawyer at this trial and at any appeal following the trial, and
that if Eli Lilly could not afford to hire a lawyer, the court would appoint one
for Eli Lilly free of charge;     f.   that through Eli Lilly’s lawyer Eli Lilly
would have the right to confront and cross-examine the witnesses against Eli
Lilly;

 

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  g.   that Eli Lilly could call witnesses to testify in its defense if Eli
Lilly wanted to, and Eli Lilly could subpoena witnesses for this purpose if Eli
Lilly wanted to; and     h.   that Eli Lilly would not have to call witnesses to
testify or otherwise present any defense if Eli Lilly did not want to, and that
if Eli Lilly did not present any evidence, the jury could not hold that against
Eli Lilly.

  4.   Eli Lilly understands that if Eli Lilly pleaded guilty, there will be no
trial and Eli Lilly would be giving up all of the rights listed above, as well
as any other rights associated with the trial process arising under statute,
common-law, or judicial precedent.     5.   Eli Lilly understands that if Eli
Lilly decides to enter a plea of guilty, the judge will ask Eli Lilly
representatives questions under oath, and that if any of those representatives
lie on behalf of Eli Lilly in answering those questions, those persons could be
prosecuted for the crime of perjury, that is, for lying under oath.     6.   Eli
Lilly understands that if Eli Lilly pleads guilty, Eli Lilly has waived its
right to appeal, except as set forth in appellate waiver provisions of the plea
agreement.     7.   Understanding that Eli Lilly has all these rights and that
by pleading guilty Eli Lilly is giving them up, Eli Lilly still wishes to plead
guilty.

     
/s/ Robert A. Armitage
   
 
ROBERT A. ARMITAGE
   
Senior Vice President and General Counsel
   
Eli Lilly and Company
   
 
   
/s/ Paul E. Kalb
   
 
PAUL E. KALB
   
Sidley Austin LLP
   
Counsel for Defendant
   

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Exhibit B

 

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  U.S. Department of Justice
 
   
(LOGO) [c49534c4953401.gif]
  Criminal Division
 
   
Acting Assistant Attorney General
  Washington, D.C. 20530
 
   
 
  JAN 9 2009

The Honorable Laurie Magid
Acting United States Attorney
Eastern District of Pennsylvania
Philadelphia, Pennsylvania 19106

     
Attention:
  Catherine Votaw
 
  Assistant United States Attorney
 
   
           Re:
  Global Non-prosecution Agreement for Eli Lilly and Company

Dear Ms. Magid:
     This is in response to your request for authorization to enter into a
global case disposition agreement with the business entity known as Eli Lilly
and Company.
     I hereby approve the terms of the Plea Agreement, including Paragraph 8, in
which the United States Attorney’s Offices and the Criminal Division of the
Department of Justice agree not to initiate further criminal prosecutions as set
out therein.
     You are authorized to make this approval a matter of record in this
proceeding.

     
 
  Sincerely,
 
   
 
  Matthew W. Friedrich
 
  Acting Assistant Attorney General

                  /s/ John C. Keeney      John C. Keeney       Deputy Assistant
Attorney General
Criminal Division