Document:

ex10_1.htm

Exhibit 10.1

 

                            

U.S. Department of Justice

Carmen M. Ortiz

United States Attorney District of Massachusetts

                                                       

	
Main Reception: (617) 748-3100

	
John Joseph Moakley United States Courthouse

1 Courthouse Way

Suite 9200

Boston, Massachusetts 02210

 

December 8, 2010

 

	
Joshua S. Levy, Esq.

	
John C. Dodds, Esq

	
Ropes & Gray LLP

	
Morgan Lewis & Bockius LLP

	
800 Boylston Street

	
1701 Market Street

	
Boston, MA 02199-3600

	
Philadelphia, PA 19103

Re:  United States v. Elan Pharmaceuticals, Inc.

 

Dear Mr. Levy:

 

This letter sets forth the Agreement between the United States Attorney for the District of Massachusetts ("the U.S. Attorney") and the United States Department of Justice (collectively, the "United States") and your client, Elan Pharmaceuticals, Inc. (hereinafter "EPI"), in the above-referenced case. The Agreement is as follows:

 

1. Change of Plea

 

At the earliest practicable date, EPI shall waive indictment and plead guilty to the one-count Information attached hereto as Exhibit A. Count One of the Information charges that beginning in or about May 2000 and continuing until on or about April 28, 2004, EPI introduced for delivery into interstate commerce various quantities of a misbranded drug Zonegran, in violation of Title 21 U.S.C. §§ 331(a), 333(a)(1) and 352(f)(1) (introduction into interstate commerce of a misbranded drug). EPI expressly and unequivocally admits that it committed this offense. Defendant expressly and unequivocally further admits that it is in fact guilty of the offense, and agrees that it will not make any statements inconsistent with this explicit admission. EPI agrees to waive venue, to waive any applicable statutes of limitations, and to waive any legal or procedural defects in the Information.

 

2. Penalties

 

EPI faces the following maximum penalties on Count One of the Information (21 U.S.C. §§ 331(a), 333(a)(1) and 352(f)(1):

 

	
a.  

	
A fine of $200,000, or twice the gross gain derived from the offense or twice the gross loss to a person other than the defendant, whichever is

 

  

  

  

greatest. See 18 U.S.C. §§ 3571(c)(5), (d). Given EPI's gross gain of the misbranded drug Zonegran totaled approximately $80,875,222, the maximum possible fine in connection with this count is $161,750,444;

 

	
b.  

	
A term of probation of not more than five (5) years. See 18 U.S.C. § 3561(c)(2);

 

	
c.  

	
Restitution to any victims of the offense. See 18 U.S.C. §§ 3556, 3663;

 

	
d.  

	
Asset forfeiture; and

 

	
e.  

	
A mandatory special assessment of $125. See 18 U.S.C. § 3013(a)(1)(B)(iii).

 

3. Sentencing Guidelines

 

The parties agree that while the fine provisions of the United States Sentencing Guidelines ("U.S.S.G.") do not apply to misdemeanor violations of the Food, Drug, and Cosmetic Act, see U.S.S.G. § 8C2.1, the agreed-upon fine is consonant with those guidelines and takes into account EPI's conduct under 18 U.S.C. §§ 3553 and 3572, as follows:

 

	
a.  

	
The parties agree that the base fine is $80,875,222, which is the pecuniary gain to EPI from the offense. See U.S.S.G. §§ 8C2.4(a), 8C2.3.

 

	
b.  

	
Pursuant to U.S.S.G. § 8C2.5, the culpability score is six (6), which is determined as follows:

 

	
i.  

	
Base culpability score is five (5) pursuant to U.S.S.G. § 8C2.5(A);

 

	
ii.  

	
Add three (3) points pursuant to U.S.S.G. § 8C2.5(b)(3) in that the organization had 200 or more employees and tolerance of the offense by substantial authority personnel was pervasive throughout the organization; and

 

	
iii.  

	
Deduct two (2) points pursuant to U.S.S.G. § 8C2.5(g)(3) in recognition of EPI's full cooperation and clearly demonstrated recognition and affirmative acceptance of responsibility for its criminal conduct.

 

	
c.  

	
Pursuant to U.S.S.G. § 8C2.6, the appropriate multiplier range associated with a culpability score of six (6) is 1.20 to 2.40.

 

	
d.  

	
Thus, the Guideline Fine Range is $97,050,266 to $161,750,444. See U.S.S.G. §§ 8C2.7(a), (b); 18 U.S.C. §§ 3571(c), (d).

 

	
e.  

	
The parties agree that (1) disgorgement pursuant to U.S.S.G. § 8C2.9 is not necessary, and (2) there is no basis for a downward or upward departure or deviation under the United States Sentencing Guidelines.

 

  

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4. Agreed Disposition

 

The United States and EPI agree pursuant to Fed. R. Crim. P. 11(c)(1)(C) that the appropriate disposition of this case is as follows, and will result in imposition of a reasonable sentence that is sufficient, but not greater than necessary, taking into consideration all of the factors set forth in 18 U.S.C. §§ 3553(a), 3572:

 

	
a.  

	
a criminal fine in the amount of ninety-seven million fifty thousand two hundred sixty-six dollars ($97,050,266) to be paid no later than one week after the date of sentencing;

 

	
b.  

	
a mandatory special assessment of $125 pursuant to 18 U.S.C. § 3013, which shall be paid to the Clerk of Court on or before the date of sentencing;

 

	
c.  

	
criminal forfeiture in the amount of $3,600,000; and

 

	
d.  

	
In light of the pending civil action, United States of America ex rel. Chartock v. Elan Corporation, plc, et al., C.A. No. 04-11594-RWZ (D. Mass.) (the "Civil Action"), and the Civil Settlement Agreement between Elan Corporation plc ("Elan") and the United States relating to the Civil Action which is being signed contemporaneously with this plea agreement, (and is attached hereto as Exhibit B) which requires the payment of $102,890,517, plus interest, the parties agree that the complication and prolongation of the sentencing process that would result from an attempt to fashion a proper restitution order outweighs the need to provide restitution to potential victims in this case, especially where, as here: (1) any loss suffered by government payers will be compensated fully as defined in the Civil Settlement Agreement, which amount is subject to review and approval by the District Court in the Civil Action, and (2) given the numerous unknown individuals and insurance companies that purchased the products in question, tracing reimbursements to the various unknown insurance companies and patients and determining the apportionment of payment pertaining to the product at issue would be extraordinarily complicated, if not impossible. See 18 U.S.C. § 3663(a)(1)(B)(ii). Accordingly, the United States agrees that it will not seek a separate restitution order as to EPI as part of the resolution of the Information and the Parties agree that the appropriate disposition of this case does not include a restitution order.

 

The United States may, at its sole option, be released from its commitments under this Agreement, including, but not limited to, its agreement that this paragraph constitutes the appropriate disposition of this case, if at any time between Defendant's execution of this Agreement and sentencing, EPI:

 

	
a.  

	
fails to admit a complete factual basis for the plea;

 

  

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b.  

	
fails to truthfully admit its conduct in the offenses of conviction;

 

	
c.  

	
falsely denies, or frivolously contests, relevant conduct for which EPI is accountable under U.S.S.G. § 1B1.3;

 

	
d.  

	
gives false or misleading testimony in any proceeding relating to the criminal conduct charged in this case and any relevant conduct for which EPI is accountable under U.S.S.G. § 1B1.3;

 

	
e.  

	
engages in acts which form a basis for finding that EPI has obstructed or impeded the administration of justice under U.S.S.G. § 3C1.1;

 

	
f.  

	
commits a crime; or

 

	
g.  

	
attempts to withdraw its guilty plea.

 

EPI expressly understands that it may not withdraw its plea of guilty unless the Court rejects this Agreement under Fed. R. Crim. P. 11(c)(5).

 

5. No Further Prosecution of EPI

 

Pursuant to Fed. R. Crim. P. 11(c)(1)(A), the United States agrees that, other than the charges in the attached Information, it shall not further prosecute EPI for any additional federal criminal non-tax charges against Defendant with respect to conduct relating to the drug Zonegran which (a) falls within the scope of the Information; (b) was the subject of the grand jury investigation in the District of Massachusetts; or (c) pertains to facts currently known to the United States based upon EPI's conduct between the years 2000 and 2005 relating to the marketing and/or promotion of Zonegran, an Anti Epileptic medication, within the United States. This declination is expressly contingent upon:

 

	
a.  

	
the guilty plea of EPI to the Information attached hereto as Exhibit A being accepted by the Court and not withdrawn or otherwise challenged; and

 

	
b.  

	
EPI's performance of all of its material obligations as set forth in this Agreement and Elan's performance of all of its material obligations as set forth in the Civil Settlement Agreement attached as Exhibit B.

 

If EPI's guilty plea is not accepted by the Court or is withdrawn for any reason, or if EPI should fail to perform any material obligation under this Agreement, or if Elan should fail to perform any material obligation under the attached Civil Settlement Agreement, this declination of prosecution shall be null and void.

 

The United States expressly reserves the right to prosecute any individual, including but not limited to present and former officers, directors, employees, and agents of EPI, in connection with the conduct encompassed by this plea agreement, within the scope of the grand jury investigation, or known to the United States.

 

  

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6. Payment of Mandatory Special Assessment

 

EPI shall pay the mandatory special assessment to the Clerk of the Court on or before the date of sentencing.

 

7. Waiver of Right to Appeal and to Bring Other Challenge

 

	
a.  

	
EPI has conferred with its attorney and understands that it has the right to challenge its convictions in the United States Court of Appeals for the First Circuit ("direct appeal"). EPI also understands that it may, in some circumstances, be able to challenge its convictions in a future proceeding (such as, for example, in a collateral challenge pursuant to 28 U. S.C. § 2255 or 28 U.S.C. § 2241). EPI waives any right it has to challenge its conviction on direct appeal or in any future proceeding.

 

	
b.  

	
EPI has conferred with its attorney and understands that defendants ordinarily have a right to appeal their sentences and may sometimes challenge their sentences in future proceedings. EPI understands, however, that once the Court accepts this Rule 11(c)(1)(C) plea agreement, the Court is bound by the parties' agreed-upon sentence. EPI may not contest the agreed-upon sentence in an appeal or challenge the sentence in a future proceeding in federal court. Similarly, the Court has no authority to modify an agreed-upon sentence under 18 U.S.C. § 3582(c), even if the Sentencing Guidelines are later modified in a way that appears favorable to Defendant. Given that a defendant who agrees to a specific sentence cannot later challenge it, and also because EPI desires to obtain the benefits of this Agreement, EPI agrees that it will not challenge the sentence imposed in an appeal or other future proceeding, if the Court imposes the agreed-upon sentence. EPI also agrees that it will not seek to challenge the sentence in an appeal or future proceeding even if the Court rejects one or more positions advocated by any party at sentencing.

 

	
c.  

	
The United States agrees that it will not appeal the imposition by the Court of the sentence agreed to by the parties as set out in Paragraph 4, even if the Court rejects one or more positions advocated by a party at sentencing.

 

8. Probation Department Not Bound By Agreement

 

The sentencing disposition agreed upon by the parties and their respective calculations under the Sentencing Guidelines are not binding upon the United States Probation Office.

 

9. Forfeiture

 

EPI will forfeit to the United States assets subject to forfeiture pursuant to 21 U.S.C. § 334 and 28 U.S.C. § 2461(c) as a result of its guilty plea. EPI admits that the value of the quantities of Zonegran that it misbranded and distributed in violation of 21 U.S.C. §§ 331(a), 333(a)(1), and 352(f)(1) totaled at least $3,600,000 in United States currency. EPI acknowledges

 

  

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and agrees that the quantities of Zonegran that it distributed in violation of 21 U.S.C. §§ 331(a), 333(a)(1), and 352(f)(1) cannot be located upon exercise of due diligence, or have been transferred or sold to, or deposited with, a third party, placed beyond the jurisdiction of the Court, substantially diminished in value, or commingled with other property which cannot be divided without difficulty. Accordingly, EPI agrees that the United States is entitled to forfeit as "substitute assets" any other assets of EPI up to the value of the now missing directly forfeitable assets.

 

EPI agrees that it shall remit the amount of $3,600,000 in United States currency to the United States Marshals Service no later than one week after the date of sentencing pursuant to wire instructions provided by the United States Attorney's Office. EPI and the United States agree that this payment shall satisfy any and all forfeiture obligations that EPI may have as a result of its guilty plea. In the event that EPI fails to make such payment, the United States will proceed with forfeiture of any other property of EPI, up to the value of $3,600,000. EPI agrees to assist law enforcement agents and government attorneys in locating, liquidating, recovering, returning to the United States, and forfeiting all forfeitable assets, wherever located, and in whatever names the assets may be held. EPI shall promptly take whatever steps are deemed necessary by the U.S. Attorney and, as applicable, the United States Marshals Service, to transfer possession of, and clear title to, all forfeitable assets to the United States. Such steps may include, but are not limited to, executing and surrendering all title documents, and signing consent decrees of forfeiture, deeds, sworn statements relating the factual bases for forfeiture, and any other documents deemed necessary by the government to complete the criminal, civil, or administrative forfeiture proceedings which may be brought against the assets identified in this section and against any other forfeitable assets involved in or related to any of the criminal acts charged in the Information.

 

Forfeiture of substitute assets shall not be deemed an alteration of EPI's sentence. The forfeitures set forth herein shall not satisfy or offset any fine, restitution, cost of imprisonment, or other penalty imposed upon EPI, nor shall the forfeiture be used to offset EPI's tax liability or any other debt owed to the United States.

 

EPI agrees to consent to the entry of orders of forfeiture for the $3,600,000 in United States currency, and waives the requirements of Federal Rules of Criminal Procedure 32.2 and 43(a) regarding the notice of the forfeiture in the charging instrument, entry of a preliminary order of forfeiture, announcement of the forfeiture at sentencing, and incorporation of the forfeiture in the judgment. EPI acknowledges that it understands that the forfeiture of assets is part of the sentence that may be imposed in this case and waives any failure by the court to advise it of this, pursuant to Rule 11(b)(1)(J), at the time the guilty plea is accepted.

 

In addition to all other waivers or releases set forth in this Agreement, EPI hereby waives any and all claims arising from or relating to the forfeitures set forth in this section, including, without limitation, any claims arising under the Double Jeopardy Clause of the Fifth Amendment, or the Excessive Fines Clause of the Eighth Amendment, to the United States Constitution, or any other provision of state or federal law.

 

The United States District Court for the District of Massachusetts shall retain jurisdiction to enforce the provisions of this section pertaining to forfeiture.

 

  

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10. Fed. R. Crim. P. 11(c)(1)(C) Agreement

 

EPI's plea will be tendered pursuant to Fed. R. Crim. P. 11(c)(1)(C). EPI cannot withdraw its plea of guilty unless the sentencing judge rejects this Agreement or fails to impose a sentence consistent herewith. If the sentencing judge rejects this Agreement or fails to impose a sentence consistent herewith, this Agreement shall be null and void at the option of either the United States or EPI, with the exception of paragraph 12 (Waiver of Defenses) which shall remain in full effect.

 

EPI may seek sentencing by the Court immediately following the Rule 11 plea hearing. The United States does not object to the Court proceeding to sentence EPI immediately following the Rule 11 plea hearing or in the absence of a Presentence Report in this case. EPI understands that the decision whether to proceed immediately following the plea hearing with the sentencing proceeding, and to do so without a Presentence Report, is exclusively that of the United States District Court.

 

11. Civil and Administrative Liability

 

By entering into this Agreement, the Government does not compromise any civil or administrative liability, including but not limited to any False Claims Act or tax liability, which EPI may have incurred or may incur as a result of its conduct and its plea of guilty to the attached Information.

 

EPI and Elan's civil liability to the United States in connection with certain of the matters under investigation by the Government is resolved in the Civil Settlement Agreement with Elan, attached as Exhibit B, according to the terms set forth in that Agreement.

 

12. Waiver of Defenses

 

If EPI's guilty plea is not accepted by the Court for whatever reason, if EPI's guilty plea is later withdrawn or otherwise successfully challenged by EPI for whatever reason, or if EPI breaches this Agreement, EPI hereby waives, and agrees it will not interpose, any defense to any charges brought against it which it might otherwise have under the Constitution for pre-indictment delay, any statute of limitations, or the Speedy Trial Act, except any such defense that EPI may already have for conduct occurring before July 14, 2004, as further described in a tolling agreement dated September 17, 2010, attached hereto as Exhibit C. This waiver is effective provided that charges are filed within six months of the date on which such guilty plea is rejected, withdrawn, or successfully challenged, or a breach is declared by the United States.

 

13. Breach of Agreement

 

If the United States determines that EPI has failed to comply with any provision of this Agreement, or has committed any crime following its execution of this Agreement, the United States may, at its sole option, be released from its commitments under this Agreement in its entirety by notifying EPI, through counsel or otherwise, in writing. The United States may also pursue all remedies available under the law, even if it elects not to be released from its commitments under this Agreement. EPI recognizes that no such breach by it of an obligation

 

  

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under this Agreement shall give rise to grounds for withdrawal of its guilty plea. EPI understands that should it breach any provision of this Agreement, the United States will have the right to use against EPI before any grand jury, at any trial or hearing, or for sentencing purposes, any statements which may be made by EPI, and any information, materials, documents or objects which may be provided by it to the government subsequent to this Agreement, without any limitation.

 

EPI understands and agrees that this Rule 11(c)(1)(C) plea agreement and its agreed-upon criminal disposition:

 

	
a.  

	
are wholly dependant upon Elan and EPI's timely compliance with the provisions of the attached Civil Settlement Agreement, including the requirement in the agreement that Elan pay to the United States and to the various state Medicaid Programs the amount of $102,890,517, plus interest continuing until and including the day before complete payment is made in accord with the terms of the Civil Settlement Agreement; and that

 

	
b.  

	
failure by EPI to comply fully with the terms of this Agreement or the failure by Elan to comply fully with the attached Civil Settlement Agreement will constitute a breach of this Agreement, provided however, that a breach of the Corporate Integrity Agreement (the "CIA"), referred to in the Civil Settlement Agreement, does not constitute a breach of this Plea Agreement, and any disputes arising under the CIA shall be resolved exclusively through the dispute resolute provisions of the CIA.

 

In the event EPI at any time hereafter breaches any provision of this Agreement, EPI understands that (1) the United States will as of the date of that breach be relieved of any obligations it may have in this Agreement and the attached Civil Settlement Agreement, including but not limited to the promise not to further prosecute EPI as set forth in this Agreement; and (2) EPI will not be relieved of its obligation to make the payments set forth in this Agreement and Elan will not be relieved of its obligation to make the payments set forth in the attached Civil Settlement Agreement, nor will it be entitled to return of any monies already paid. Moreover, in the event of a breach, EPI understands and agrees that the United States may pursue any and all charges that might otherwise have been brought but for this Agreement, and EPI hereby waives, and agrees it will not interpose, any defense to any charges brought against it which it might otherwise have under the Constitution for pre-indictment delay, any statute of limitations, or the Speedy Trial Act, except any such defense that EPI may already have for conduct occurring before July 14, 2004.

 

14. Who Is Bound By Agreement

 

With respect to matters set forth in Paragraph 5, this Agreement is binding upon EPI and the Office of the United States Attorney for the District of Massachusetts, the United States Attorney's Offices for each of the other 93 judicial districts of the United States, and the Office of Consumer Litigation of the Department of Justice. The non-prosecution provisions in Paragraph 5 are also binding on the Criminal Division of the United States Department of Justice, with the exception of any investigations of EPI that are or may be conducted in the future

 

  

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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 EPI's products to foreign customers, which investigations are specifically excluded from the release in Paragraph 5. A copy of the letter to United States Attorney Carmen M. Ortiz on behalf of the Assistant Attorney General, Criminal Division, Department of Justice, authorizing this Agreement is attached as Exhibit D. EPI understands that this Agreement does not bind any state or local prosecutive authorities, the Tax Division of the U.S. Department of Justice or the Internal Revenue Service of the U.S. Department of the Treasury.

 

15. Corporate Authorization

 

EPI's acknowledgment of this Agreement and execution of this Agreement on behalf of the corporation is attached below. EPI shall provide to the U.S. Attorney and the Court a certified copy of a resolution of the governing authority of EPI affirming that it has authority to enter into the Plea Agreement and has (1) reviewed the Information in this case and the proposed Plea Agreement; (2) consulted with legal counsel in connection with the matter; (3) voted to enter into the proposed Plea Agreement; (4) voted to authorize EPI to plead guilty to the charge specified in the Information; and (5) voted to authorize the corporate officer identified below to execute the Plea Agreement and all other documents necessary to carry out the provisions of the Plea Agreement. A copy of the resolution is attached as Exhibit E. EPI agrees that either a duly authorized corporate officer or a duly authorized attorney for EPI, at the discretion of the Court, shall appear on behalf of EPI and enter the guilty plea and will also appear for the imposition of sentence.

 

16. Complete Agreement

 

This Agreement and the attachments hereto, together with the Side Letter Agreement, the Civil Settlement Agreement, the Corporate Integrity Agreement, the Escrow Agreement between Elan Corporation plc and the United States, and the Tolling Agreement between EPI, Elan and the United States Attorney dated September 17, 2010 (incorporating prior tolling agreements), set forth the complete and only agreements between the parties relating to the disposition of this case. No promises, representations or agreements have been made other than those set forth in this Agreement and its attachments, and the Civil Settlement Agreement and its attachments. This Agreement supersedes prior understandings, if any, of the parties, whether written or oral. This Agreement can be modified or supplemented only in a written memorandum signed by the parties or on the record in court.

 

If this letter accurately reflects the Agreement between the United States and your client, EPI, please have the authorized representative of EPI sign the Acknowledgment of Agreement below. Please also sign below as Witness. Return the original of this letter to Assistant U.S. Attorney Mary Elizabeth Carmody.

 

Very truly yours,

 

  

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         /s/ Carmen M. Ortiz

        CARMEN M. ORTIZ

        UNITED STATES ATTORNEY

        DISTRICT OF MASSACHUSETTS

 

 

	
By:  /s/ Mary Elizabeth Carmody

       MARY ELIZABETH CARMODY

       ANTON P. GIEDT

       Assistant U.S. Attorneys

       District of Massachusetts

 

       TONY WEST

       ASSISTANT ATTORNEY GENERAL

       CIVIL DIVISION

       U.S. DEPARTMENT OF JUSTICE

 

 

	
By:  /s/ Patrick H. Hearn

       PATRICK H. HEARN

       Trial Attorney

       Office of Consumer Litigation

       U.S. Department of Justice

  

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ACKNOWLEDGMENT OF AGREEMENT

 

The Officers and Members of the Board of Directors of Elan Pharmaceuticals, Inc. (the "Board") have authorized me to execute this Plea Agreement on behalf of Elan Pharmaceuticals, Inc., which is a wholly-owned subsidiary of Elan Corporation plc. The Board is authorized to act on behalf of Elan Pharmaceuticals, Inc. The Board has read this Plea Agreement, the attached criminal Information, and the Civil Settlement Agreement including all attachments in their entirety or has been advised of the contents thereof, and has discussed them fully in consultation with EPI's attorney. The Board acknowledges that these documents fully set forth EPI and Elan's agreement with the United States. The Board further states that no additional promises or representations have been made to EPI by any officials of the United States in connection with the disposition of this matter, other than those set forth in the Plea Agreement, the attached Civil Settlement Agreement and the Side Letter.

 

	
 

 

 

Dated:  12/13/10

 

 

	
/s/ Douglas Love

DOUGLAS LOVE

Director and Vice President

ELAN PHARMACEUTICALS, INC.

	
 

 

 

Dated:  12/13/10

 

 

	
/s/ Joshua S. Levy

JOSHUA S. LEVY, ESQ.

Ropes & Gray LLP

Counsel for Defendant

	
 

 

 

Dated:  12/13/10

	
/s/ John C. Dodds

JOHN C. DODDS, ESQ.

Morgan Lewis & Bockius LLP

Counsel for Defendant

 

-11-ex10_2.htm

Exhibit 10.2

SETTLEMENT AGREEMENT

 

I.  PARTIES

 

This Settlement Agreement (Agreement) is entered into among the United States of America, acting through the United States Department of Justice and on behalf of the Office of Inspector General (“OIG-HHS”) of the Department of Health and Human Services (“HHS”), the TRICARE Management Activity (“TMA”), and the United States Office of Personnel Management (“OPM”) (collectively the “United States”); Elan Corporation, plc. (“Elan”); and Lee R. Chartock, M.D. (“Relator”) (hereafter referred to as “the Parties”), through their authorized representatives.

 

II.  PREAMBLE

As a preamble to this Agreement, the Parties agree to the following:

 

A. Elan Corporation, plc is a publicly traded Irish corporation headquartered in Dublin, Ireland. Elan Pharmaceuticals, Inc. (“EPI”) is a Delaware corporation with a principal place of business in South San Francisco, California.  EPI is a wholly owned subsidiary of Elan.  At all relevant times, EPI distributed, marketed and sold pharmaceutical products in the United States, including an anti-epileptic drug (“AED”) sold under the trade name of Zonegran.  From April 2000 until April 27, 2004, EPI manufactured, marketed and sold Zonegran, at which time it divested Zonegran, the drug’s assets, the United States license to market and sell Zonegran, and the Zonegran sales force to Eisai Co., LTD. and Eisai, Inc. (collectively “Eisai”), although Elan continued to manufacture Zonegran for Eisai after April 2004.

 

B. On or about July 16, 2004, Lee R. Chartock, M.D. (“Relator”) filed a qui tam action in the United States District Court for the District of Massachusetts captioned United

 

  

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States, et al. ex rel. Lee R. Chartock, MD. v. Elan Corporation, plc, et al., Civ. Action No. 04- 11594-RWZ (hereinafter the “Civil Action”).

C. On such date as may be determined by the Court, EPI will enter a plea of guilty pursuant to Fed. R. Crim. P. 11(c)(1)(C) (the “Plea Agreement”) to an Information filed in United States of America v. Elan Pharmaceuticals, Inc., Criminal Action No. [to be assigned] (District of Massachusetts) (the “Criminal Action”) that will allege a violation of Title 21, United States Code, Sections 331(a), 333(a), and 352(f)(1), namely, the introduction into interstate commerce of a misbranded drug, Zonegran, in violation of the Food, Drug, and Cosmetic Act (“FDCA”).

 

D. Elan has entered into or will be entering into separate settlement agreements, described in Paragraph III. 1(b) below (hereinafter referred to as the “Medicaid State Settlement Agreements”) with certain states and the District of Columbia in settlement of the Covered Conduct.   States with which Elan executes a Medicaid State Settlement Agreement in the form to which Elan and the National Association of Medicaid Fraud Control Units (“NAMFCU”) Negotiating Team have agreed, or in a form otherwise agreed to by Elan and an individual State, shall be defined as “Medicaid Participating States.”

 

E. The United States alleges that Elan caused to be submitted claims for payment for Zonegran to the Medicaid Program, Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v. The United States further alleges that Elan caused claims for payment for Zonegran to be submitted to the TRICARE program, 10 U.S.C. §§ 1071-1109; and the Federal Employees Health Benefits Program (“FEHBP”), 5 U.S.C. §§ 8901-8914; and caused purchases

 

  

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of Zonegran by the Department of Veterans’ Affairs (“DVA”) (collectively, the “other Federal Health Care Programs”).

 

F. The United States contends that it and the Medicaid Participating States have certain civil claims, as specified in Paragraph III. 2, below, against Elan due to the following conduct:

 

During the period from April 1, 2000 through December 2005, EPI (a) knowingly marketed, sold and promoted Zonegran for certain uses that were not approved by the Food and Drug Administration (“FDA”) (i.e., “unapproved uses”), or benefitted from this conduct, and certain of these unapproved uses were not medically accepted indications as defined by 42 U.S.C. § 1396r-8(k)(6) (hereinafter “medically accepted indications”) for which the United States and state Medicaid programs provided coverage for Zonegran; (b) offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zonegran in violation of the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b).   As a result of the foregoing conduct, EPI knowingly caused false or fraudulent claims for Zonegran to be submitted to, or caused purchases by, Medicaid, the TRICARE and FEHB Programs, and the Veterans’ Administration.  (Hereinafter referred to as the “Covered Conduct.”)

 

G. The United States also contends that it has certain administrative claims against Elan, as specified in Paragraphs III. 4-6 below, due to the Covered Conduct.

 

H. This Agreement is made in compromise of disputed claims.  This Agreement is neither an admission of facts nor liability by Elan nor a concession by the United States that its claims are not well founded.  Elan expressly denies the allegations of the United States and the Relator set forth herein and in the Civil Action and denies that it or EPI have engaged in any wrongful conduct in connection with the Covered Conduct except as to such admissions as EPI makes in connection with its guilty plea under the Plea Agreement.  Neither this Agreement, its execution, nor the performance of any obligation under it, including any

 

  

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payment, nor the fact of settlement, is intended to be, or shall be understood as, an admission of liability or wrongdoing, or other expression reflecting upon the merits of the dispute by Elan.

 

I. To avoid the delay, expense, inconvenience and uncertainty of protracted litigation of these claims, the Parties mutually desire to reach a full and final settlement as set forth below.

 

III.  TERMS AND CONDITIONS

 

NOW, THEREFORE, in reliance on the representations contained herein and in consideration of the mutual promises, covenants, and obligations in this Agreement, and for good and valuable consideration, receipt of which is hereby acknowledged, the Parties agree as follows:

 

1. Elan agrees to pay to the United States and the Medicaid Participating States, collectively, the sum of $102,890,517, plus interest at the rate of 2.625% per annum from July 14, 2010 and continuing until and including the day before payment is made (collectively, the “Settlement Amount”).  The Settlement Amount shall constitute a debt immediately due and owing to the United States and the Medicaid Participating States on the Effective Date of this Agreement.  This debt shall be discharged by payments to the United States and the Medicaid Participating States, under the following terms and conditions:

 

a. Elan shall pay to the United States the sum of $59,491,477 plus accrued interest (“Federal Settlement Amount”).  The Federal Settlement Amount shall consist of $59,491,477, plus interest accrued on this amount at the rate of 2.625% per annum from July 14, 2010, continuing until and including the day before payment is made.  The Federal Settlement Amount shall be paid no later than seven (7) business days after (i) this Agreement is

 

  

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fully executed by the Parties and delivered to Elan’s attorneys; or (ii) the Court accepts a Fed. R. Crim. P. 11(c)(1)(C) guilty plea by EPI as described in Preamble Paragraph C in connection with the Criminal Action and imposes the agreed upon sentence, whichever occurs later.  The Federal Settlement Amount shall be paid by electronic funds transfer account pursuant to written instructions from the United States.

 

b. Elan shall pay to the Medicaid Participating States the sum of $43,399,040 plus accrued interest (“Medicaid State Settlement Amount”).  The Medicaid State Settlement Amount shall consist of the sum of $43,399,040 plus interest accrued thereon at a rate of 2.625% per annum from July 14, 2010, continuing until and including the day before payment is made.  The Medicaid State Settlement Amount shall be paid no later than seven (7) business days (i) this Agreement is fully executed by the Parties and delivered to Elan’s attorneys; or (ii) the Court accepts a Fed. R. Crim. P. 11(c)(1)(C) guilty plea by EPI as described in Preamble Paragraph C in connection with the Criminal Action and imposes the agreed upon sentence, whichever occurs later.  The Medicaid State Settlement Amount shall be paid by electronic funds transfer to an interest bearing account pursuant to written instructions from the NAMFCU Negotiating Team and under the terms and conditions of the Medicaid State Settlement Agreements that Elan will enter into with the Medicaid Participating States.

 

c. Contingent upon the United States receiving the Federal Settlement Amount from Elan, and as soon as feasible after receipt, the United States agrees to pay $10,708,466, plus accrued interest, to Relator by electronic funds transfer.

 

d. If EPI’s agreed upon guilty plea pursuant to Fed. R. Crim. P. 11(c)(1)(C) in the Criminal Action described in Preamble Paragraph C is not accepted by the

 

  

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Court or the Court does not impose the agreed upon sentence for whatever reason, this Agreement shall be null and void at the option of either the United States or Elan.  If either the United States or Elan exercises this option, which option shall be exercised by notifying all Parties, through counsel, in writing within five (5) business days of the Court’s decision, the Parties will not object and this Agreement will be rescinded.  If this Agreement is rescinded, Elan will not plead, argue, or otherwise raise any defenses under the theories of statute of limitations, laches, estoppels, or similar theories, to any civil or administrative claims, actions, or proceedings arising from the Covered Conduct that are brought by the United States within 90 calendar days of rescission, except to the extent such defenses were available on the day on which the qui tam Complaint, referenced in Preamble Paragraph B, above, was filed.

 

2. Subject to the exceptions in Paragraph 7 (concerning excluded claims), below, in consideration of the obligations of Elan set forth in this Agreement, and conditioned upon Elan’s full payment of the Settlement Amount, the United States (on behalf of itself, its officers, agents, agencies, and departments) agrees to release Elan, its predecessors, and its current and former divisions, parents, subsidiaries, successors and assigns, and their current and former directors, officers, and employees from any civil or administrative monetary claim the United States has or may have for the Covered Conduct under the False Claims Act, 31 U.S.C. §§ 3729-3733; the Civil Monetary Penalties Law, 42 U.S.C. § 1320a-7a; the Program Fraud Civil Remedies Act, 31 U.S.C. §§ 3801-3812; any statutory provision creating a cause of action for civil damages or civil penalties for which the Civil Division of the Department of Justice has actual and present authority to assert and compromise pursuant to 28 C.F.R. Part 0, Subpart I, 0.45(d) and common law claims for fraud, payment by mistake, disgorgement and unjust enrichment.

 

  

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3. In consideration of the obligations of Elan in this Agreement, and conditioned upon Elan’s full payment of the Settlement Amount in accordance with Paragraph 1, above, Relator, for himself, and for his respective heirs, successors, attorneys, agents, and assigns, hereby fully and finally releases and forever discharges Elan, its predecessors, and its divisions, parents, subsidiaries, related entities, officers, directors, trustees, agents, servants, employees, representatives, attorneys, consultants, successors, heirs, executors, administrators and assigns, individually and collectively, current or former (collectively, the “Elan Entities”), from: (a) any and all claims, claims for relief, actions, rights, causes of action, suits, debts, obligations, liabilities, demands, losses, damages (including treble damages and any civil penalties), punitive damages, costs and expenses of any kind, character or nature whatsoever, known or unknown, fixed or contingent, in law or in equity, in contract or tort, or under any state or federal statute or regulation or otherwise that Relator has standing to bring, which Relator may now have or claim to have against the Elan Entities, arising in any way out of or connected in any way with the facts, claims and circumstances alleged in, arising under, or arising from the filing of, the Civil Action, or from any other past activities and actions of the Elan Entities, or from any civil monetary claim the United States has or may have for the Covered Conduct under the False Claims Act, 31 U.S.C. §§ 3729-3733; and (b) conditioned upon receipt of payment for attorneys’ fees and costs as contemplated in Paragraph 9, any claims Relator or his attorneys may assert for expenses, attorneys’ fees, and costs under 31 U.S.C. § 3730(d) or any similar federal or state statute.  Relator also does not release the Medicaid Participating States from any claims that Relator has for a share of any settlement or judgment obtained by the Medicaid Participating States concerning the Covered Conduct.

 

  

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4. In consideration of the obligations of Elan set forth in this Agreement and the Corporate Integrity Agreement (“CIA”) entered into between OIG-HHS and Elan, conditioned upon Elan’s full payment of the Settlement Amount, OIG-HHS agrees to refrain from instituting, directing, or maintaining any administrative action seeking exclusion from Medicare, Medicaid, and all other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(f)) against (a) Elan and its subsidiaries and affiliates that are covered by the CIA (including EPI) under 42 U.S.C. § 1320a-7a (Civil Monetary Penalties Law) or 42 U.S.C. § 1320a-7(b)(7) (permissive exclusion for fraud, kickbacks, and other prohibited activity) for the Covered Conduct, except as reserved in Paragraph 7 (concerning excluded claims), below, and as reserved in this Paragraph; or (b) against EPI under 42 U.S.C. § 1320a-7(b)(1) (permissive exclusion for conviction relating to fraud) based on EPI’s agreement to plead guilty to the criminal charge in the Criminal Action as referenced above in Paragraph C, except as reserved in Paragraph 7 (concerning excluded claims), below, and as reserved in this Paragraph.  The OIG HHS expressly reserves all rights to comply with any statutory obligations to exclude Elan or EPI from the Medicare, Medicaid, and other Federal health care programs under 42 U.S.C. § 1320a-7(a) (mandatory exclusion) based upon the Covered Conduct.  Nothing in this Paragraph precludes the OIG-HHS from taking action against entities or persons, or for conduct and practices, for which claims have been reserved in Paragraph 7, below.

 

5. In consideration of the obligations of Elan set forth in this Agreement, conditioned upon Elan’s full payment of the Settlement Amount, TMA agrees to release and refrain from instituting, directing, or maintaining any administrative action seeking exclusion or suspension from the TRICARE Program against Elan under 32 C.F.R. § 199.9 for the Covered Conduct, except as reserved in Paragraph 7 (concerning excluded claims), below, and as reserved

 

  

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in this Paragraph.  TMA expressly reserves authority to exclude Elan under 32 C.F.R. §§ 199.9 (f)(1)(i)(A), (f)(1)(i)(B), and (f)(1)(iii), based upon the Covered Conduct.  Nothing in this Paragraph precludes TMA or the TRICARE Program from taking action against entities or persons, or for conduct and practices, for which claims have been reserved in Paragraph 7, below.

 

6. In consideration of the obligations of Elan in this Agreement, conditioned upon Elan’s full payment of the Settlement Amount, OPM agrees to release and refrain from instituting, directing, or maintaining any administrative action seeking exclusion from the FEHBP against Elan under 5 U.S.C. § 8902a or 5 C.F.R. Part 970 for the Covered Conduct, except as reserved in Paragraph 7 (concerning excluded claims), below, and except if excluded by the OIG-HHS pursuant to 42 U.S.C. § 1320a-7(a) or required by 5 U.S.C. § 8902a(b), or 5 C.F.R. Part 970.  Nothing in this Paragraph precludes OPM from taking action against entities or persons, or for conduct and practices, for which claims have been reserved in Paragraph 7, below.

 

7. Notwithstanding any term of this Agreement, specifically reserved and excluded from the scope and terms of this Agreement as to any entity or person (including Elan and Relator) are the following claims of the United States:

 

	
a.  

	
Any civil, criminal, or administrative liability arising under Title 26, U.S. Code (Internal Revenue Code);

 

	
b.  

	
Any criminal liability;

 

  

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c.  

	
Any civil, criminal, or administrative liability of any other Defendant to this action;

 

	
d.  

	
Except as explicitly stated in this Agreement, any administrative liability, including mandatory exclusion from Federal health care programs;

 

	
e.  

	
Any liability to the United States (or its agencies) for any conduct other than the Covered Conduct;

 

	
f.  

	
Any liability based upon such obligations as are created by this Agreement;

 

	
g.  

	
Any liability for express or implied warranty claims or other claims for defective or deficient products or services, including quality of goods and services;

 

	
h.  

	
Any liability for failure to deliver items or services due;

 

	
i.  

	
Any liability for personal injury or property damage or for other consequential damages arising from the Covered Conduct; or

 

	
j.  

	
Any liability of individuals (including current or former directors, officers, employees, or agents of Elan) who receive written notification that they are the target of a criminal investigation, are criminally indicted or charged, or are convicted, or who enter into a criminal plea agreement.

 

  

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8. Relator and his respective heirs, successors, attorneys, agents, and assigns agree not to object to this Agreement and agree and confirm that this Agreement is fair, adequate, and reasonable under all the circumstances, pursuant to 31 U.S.C. § 3730(c)(2)(B), and, conditioned upon receipt of Relator’s share, Relator, for himself individually, and for his heirs, successors, agents, and assigns, fully and finally releases, waives, and forever discharges the United States, its officers, agents, and employees, from any claims arising from or relating to 31 U.S.C. § 3730; from any claims arising from the filing of the Civil Action as to Elan; and from any other claims for a share of the Settlement Amount; and in full settlement of any claims Relator may have under this Agreement.  This Agreement does not resolve or in any manner affect any claims the United States has or may have against the Relator arising under Title 26, U.S. Code (Internal Revenue Code), or any claims arising under this Agreement.

 

9. Elan agrees to pay Relator’s attorneys’ fees and costs, as contemplated by 31 U.S.C. § 3730(d), in accordance with the terms set forth in a separate agreement being entered into by Elan and Relator simultaneously with the execution of this Settlement Agreement.

 

10. Elan waives and shall not assert any defenses it may have to any criminal prosecution or administrative action relating to the Covered Conduct that may be based in whole or in part on a contention that, under the Double Jeopardy Clause in the Fifth Amendment of the Constitution, or under the Excessive Fines Clause in the Eighth Amendment of the Constitution, this Agreement bars a remedy sought in such criminal prosecution or administrative action.  Nothing in this Paragraph or any other provision of this Agreement constitutes an agreement by the United States concerning the characterization of the Settlement Amount for purposes of the Internal Revenue laws, Title 26 of the United States Code.

 

  

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11. Elan fully and finally releases the United States, its agencies, employees, servants, and agents from any claims (including attorneys’ fees, costs, and expenses of every kind and however denominated) that Elan has asserted, could have asserted, or may assert in the future against the United States, its agencies, employees, servants, and agents, related to the Covered Conduct and the United States’ investigation and prosecution of the Civil Action.

 

12. In consideration of the obligations of the Relator set forth in this Agreement, Elan fully and finally releases, waives and forever discharges the Relator and his respective heirs, successors, assigns, agents and attorneys from any claims Elan has asserted or could have asserted, against the Relator, related to the Covered Conduct and the Relator’s investigation and prosecution of the Civil Action, except as they relate to a claim by Relator for reasonable attorneys’ fees and costs pursuant to 31 U.S.C. § 3730(d).

 

13. The Settlement Amount shall not be decreased as a result of the denial of claims for payment now being withheld from payment by any Medicare carrier or intermediary, Medicaid, TRICARE, or FEHBP carrier or payer, or any state payer, related to the Covered Conduct; and Elan agrees not to resubmit to any Medicare carrier or intermediary or Medicaid, TRICARE, or FEHBP carrier or payer, or any state payer any previously denied claims related to the Covered Conduct, and agrees not to appeal any such denials of claims.

 

14. Elan agrees to the following:

 

a. Unallowable Costs Defined: That all costs (as defined in the Federal Acquisition Regulations (“FAR”), 48 C.F.R. § 31.205-47; and in Titles XVIII and XIX of the Social Security Act, 42 U.S.C. §§ 1395-1395kkk-1 and 1396-1396w-5; and the regulations and official program directives promulgated thereunder) incurred by or on behalf of Elan, its

 

  

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present or former officers, directors, employees, shareholders, and agents in connection with the following shall be “Unallowable Costs” on government contracts and under the Medicare Program, Medicaid Program, TRICARE Program, and the FEHBP:

 

	
(1)  

	
the matters covered by this Agreement and the related plea agreement;

 

	
(2)  

	
the United States’ audit(s) and civil and criminal investigation(s) of the matters covered by this Agreement;

 

	
(3)  

	
Elan’s investigation, defense, and any corrective actions undertaken in response to the United States’ audit(s) and civil and criminal investigation(s) in connection with the matters covered by this Agreement (including attorneys’ fees);

 

	
(4)  

	
the negotiation and performance of this Agreement;

 

	
(5)  

	
the payments Elan makes to the United States or any State pursuant to this Agreement, or the Medicaid State Settlement Agreements and any payments that Elan may make to Relator including costs and attorney’s fees; and

 

	
(6)  

	
the negotiation of, and obligations undertaken pursuant to the CIA to : (i) retain an independent organization to perform annual reviews as described in Section III of the CIA; and (ii) prepare and submit reports to the OIG-HHS.  However, nothing in this paragraph 14.a.(6) that may apply to the obligations undertaken

 

  

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pursuant to the CIA affects the status of costs that are not allowable based on any other authority applicable to Elan.

 

b. Future Treatment of Unallowable Costs: If applicable, these Unallowable Costs shall be separately determined and accounted for by Elan, and Elan shall not charge such Unallowable Costs directly or indirectly to any contracts with the United States or any State Medicaid program, or seek payment for such Unallowable Costs through any cost report, cost statement, information statement, or payment request submitted by Elan or any of its subsidiaries or affiliates to the Medicare, Medicaid, TRICARE, or the FEHBP.

 

c. Treatment of Unallowable Costs Previously Submitted for  Payment: Elan further agrees that within 90 days of the Effective Date of this Agreement it shall, if applicable, identify to applicable Medicare and TRICARE fiscal intermediaries, carriers, and/or contractors, and Medicaid and FEHBP fiscal agents, any Unallowable Costs (as defined in this Paragraph) included in payments previously sought from the United States, or any State Medicaid program, including, but not limited to, payments sought in any cost reports, cost statements, information reports, or payment requests already submitted by Elan or any of its subsidiaries or affiliates, and shall request, and agree, that such cost reports, cost statements, information reports, or payment requests, even if already settled, be adjusted to account for the effect of the inclusion of the Unallowable Costs.  Elan agrees that the United States, at a minimum, shall be entitled to recoup from Elan any overpayment plus applicable interest and penalties as a result of the inclusion of such Unallowable Costs on previously-submitted cost reports, information reports, cost statements, or requests for payment.

 

  

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Any payments due after the adjustments have been made shall be paid to the United States pursuant to the direction of the Department of Justice and/or the affected agencies.  The United States reserves its rights to disagree with any calculations submitted by Elan or any of its subsidiaries or affiliates on the effect of inclusion of Unallowable Costs (as defined in this Paragraph) on Elan or any of its subsidiaries’ or affiliates’ cost reports, cost statements, or information reports.

 

d. Nothing in this Agreement shall constitute a waiver of the rights of the United States to audit, examine, or re-examine Elan’s books and records to determine that no Unallowable Costs have been claimed in accordance with the provisions of this Paragraph.

 

15. Elan agrees to cooperate fully and truthfully with the United States’ investigation relating to the Covered Conduct of individuals and entities not released in this Agreement.  Upon reasonable notice, Elan shall encourage, and agrees not to impair, the cooperation of its directors, officers, and employees, and shall use its best efforts to make available, and encourage the cooperation of former directors, officers, and employees for interviews and testimony, consistent with the rights and privileges of such individuals.  Elan agrees to furnish to the United States, upon reasonable request, complete and unredacted copies of all non-privileged documents and records in its possession, custody, or control concerning any investigation of the Covered Conduct that it has undertaken, or that has been performed by its counsel or other agent.

 

16. This Agreement is intended to be for the benefit of the Parties only.  The Parties do not release any claims against any other person or entity, except to the extent provided for in Paragraph 17 (waiver for beneficiaries paragraph), below or elsewhere in this Agreement.  Defendants Eisai Co., LTD and Eisai, Inc. are specifically excluded from this Agreement.

 

  

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17. Elan agrees that it waives and shall not seek payment for any of the health care billings covered by this Agreement from any health care beneficiaries or their parents, sponsors, legally responsible individuals, or third party payors based upon the claims defined as Covered Conduct.

 

18. Elan warrants that it has reviewed its financial situation and that it currently is solvent within the meaning of 11 U.S.C. §§ 547(b)(3) and 548(a)(1)(B)(ii)(I), and shall remain solvent following payment to the United States of the Settlement Amount.  Further, the Parties warrant that, in evaluating whether to execute this Agreement, they (a) have intended that the mutual promises, covenants, and obligations set forth herein constitute a contemporaneous exchange for new value given to Elan, within the meaning of 11 U.S.C. § 547(c)(1) and (b) conclude that these mutual promises, covenants, and obligations do, in fact, constitute such a contemporaneous exchange.  Further, the Parties warrant that the mutual promises, covenants, and obligations set forth herein are intended to and do, in fact, represent a reasonably equivalent exchange of value that is not intended to hinder, delay, or defraud any entity to which Elan was or became indebted to on or after the date of this transfer, within the meaning of 11 U.S.C. § 548(a)(1).

 

19. Upon receipt of the payments described in Paragraph III. 1, above, the United States shall promptly sign and file in the Civil Action a Notice of Intervention and the United States and Relator shall file a Joint Stipulation of Dismissal with prejudice of the Civil Action as to the Elan Entities consistent with the terms of this Agreement.

 

  

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20. Except as expressly provided to the contrary in this Agreement, each Party shall bear its own legal and other costs incurred in connection with this matter, including the preparation and performance of this Agreement.

 

21. The Parties each represent that this Agreement is freely and voluntarily entered into without any degree of duress or compulsion whatsoever.

 

22. This Agreement is governed by the laws of the United States.  The Parties agree that the exclusive jurisdiction and venue for any dispute arising between and among the Parties under this Agreement is the United States District Court for the District of Massachusetts.

 

23. For purposes of construction, this Agreement shall be deemed to have been drafted by all Parties to this Agreement and shall not, therefore, be construed against any Party for that reason in any subsequent dispute.

 

24. This Agreement constitutes the complete agreement between the Parties with respect to the issues covered by the Agreement.  This Agreement may not be amended except by written consent of the Parties.

 

25. The individuals signing this Agreement on behalf of Elan represent and warrant that they are authorized by Elan to execute this Agreement.  The individual(s) signing this Agreement on behalf of Relator represent and warrant that they are authorized by Relator to execute this Agreement.  The United States signatories represent that they are signing this Agreement in their official capacities and that they are authorized to execute this Agreement.

 

26. This Agreement may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same Agreement.

 

  

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27. This Agreement is binding on Elan’s successors, transferees, heirs, and assigns.

 

28. This Agreement is binding on Relator’s successors, transferees, heirs, and assigns.

 

29. All Parties consent to the United States’ disclosure of this Agreement, and information about this Agreement, to the public.

 

30. This Agreement is effective on the date of signature of the last signatory to the Agreement (Effective Date of this Agreement).  Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this Agreement.

 

  

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THE UNITED STATES OF AMERICA

 

 

	  	
        TONY WEST

        Assistant Attorney General

 

 

	
DATED:  12/15/10

	
BY:  /s/ Brian J. McCabe

        JOYCE R. BRANDA

        Director

        BRIAN J. McCABE

        Trial Attorney

        Commercial Litigation Branch, Civil Division

        United States Department of Justice

 

 

	  	
        CARMEN M. ORTIZ

        United States Attorney, District of Massachusetts

 

 

	
DATED:  12/15/10

	
BY:  /s/ Anton P. Giedt

        ANTON P. GIEDT

        Assistant United States Attorney

        Office of the United States Attorney

        for the District of Massachusetts

 

 

	
DATED:  12/15/10

	
BY:  /s/ Gregory E. Demske

        GREGORY E. DEMSKE

        Assistant Inspector General for Legal Affairs

        Office of Counsel to the Inspector General

        Office of Inspector General

        United States Department of Health and Human Services

 

 

  

Page 19 of 22

  

	
DATED:  30 Nov 2010

	
BY:  /s/ Laurel C. Gillespie

        LAUREL C. GILLESPIE

        Deputy General Counsel

        TRICARE Management Activity

        United States Department of Defense

 

 

	
DATED:  ________

	
BY:  ______________________________

        GARY J. KRUMP

        Deputy Assistant

        Secretary of Acquisition and Material Management

        United States Department of Veteran Affairs

 

 

	
DATED:  ________

	
BY:  ______________________________

        KATHLEEN MCGETTIGAN

        Deputy Assistant Director

        Center for Retirement and Insurance Services

        United States Office of Personnel Management

 

 

	
DATED:  11/24/10

	
BY:  /s/ Richard J. Griffin

        RICHARD J. GRIFFIN

        Deputy Inspector General

        Department of Veterans Affairs Office of Inspector General

        United States Department of Veteran Affairs

 

 

	
DATED:  12/8/10

	
BY:  /s/ Ronald W. Melton

        for SHIRLEY R. PATTERSON

        Acting Director

        Federal Employee Insurance Operations

        United States Office of Personnel Management

 

 

	
DATED:  12/9/10

	
BY:  /s/ J. David Cope

        J. DAVID COPE

        Assistant Inspector General for Legal Affairs

        United States Office of Personnel Management

  

Page 20 of 22

  

Elan – DEFENDANT

 

 

Elan Corporation, PLC

 

 

	
DATED:  12/13/10

	
BY:  /s/ John B. Moriarty, Jr.

        JOHN B. MORIARTY, JR.

        Senior Vice President and General Counsel

        ELAN CORPORATION, PLC

 

 

	
DATED:  12/13/10

	
BY:  /s/ Joshua Levy

        JOSHUA LEVY, Esquire

        Ropes & Gray, LLP

        Counsel to Elan Corporation, plc and Elan

         Pharmaceuticals, Inc.

 

 

	
DATED:  12/13/10

	
BY:  /s/ John C. Dodds

        JOHN C. DODDS, Esquire

        Morgan, Lewis & Bockius

        Counsel to Elan Corporation, plc and Elan

        Pharmaceuticals, Inc.

  

Page 21 of 22

  

Lee R. Chartock, M.D. – RELATOR

 

	
DATED:  12/14/10

	
BY:  /s/ Lee R. Chartock / RMT

        LEE R. CHARTOCK, M.D.

 

 

 

	
DATED:  12/14/10

	
BY:  /s/ Robert M. Thomas, Jr.

        ROBERT M. THOMAS, JR.

 

 

 

	
DATED:  12/14/10

	
BY:  /s/ Suzanne E. Durrell / RMT

        SUZANNE E. DURRELL

 

 

 

	
DATED:  12/14/10

	
BY:  /s/ Royston H. Delaney

        ROYSTON H. DELANEY

        Counsel for Relator Lee R. Chartock, M.D.

Page 22 of 22

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