EX-10.15





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


 








 




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;





 








 





	 	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




 









 








	 	 	 
	 

	 	U.S. Department of Justice
	 
	 	 
	

	 	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