Civil Settlement Agreement



 Exhibit 10.57A 
 SETTLEMENT AGREEMENT 
 I. PARTIES 
 This Settlement Agreement (the “Agreement”) is entered into among the United States of America, acting through its Department of Justice and
the United States Attorney’s Office for the Eastern District of New York, the Office of Inspector General of the Department of Health and Human Services (“HHS-OIG”), the United States Office of Personnel Management (“OPM”),
and the United States Department of Defense TRICARE Management Activity (“TMA”) (collectively the “United States”); Jazz Pharmaceuticals, Inc. (“JPI”) and Orphan Medical, Inc. (“Orphan”) (JPI and Orphan are
collectively referred to as “Defendants”); and Shelley Lauterbach (the “Relator”); through their authorized representatives. Collectively, all of the above will be referred to as “the Parties.” 
 II. PREAMBLE 
 As a preamble to this
Agreement, the Parties agree to the following: 
 A. WHEREAS, at all relevant times, Orphan and JPI distributed, marketed and sold
pharmaceutical products in the United States, including a drug it sold under the trade name Xyrem (registered as sodium oxybate); 
 B.
WHEREAS, on or about January 24, 2005, Relator, an individual resident of Alabama and former sales representative for Orphan, filed a qui tam action in the United States District Court for the Eastern District of New York
captioned United States of America and the States of California, Delaware, Florida, Hawaii, Illinois, Massachusetts, Nevada, New Mexico, Tennessee, Texas, Virginia, and the District of Columbia ex rel. Lauterbach v. Orphan Medical Inc. and
Dr. Peter Gleason, Civil Action No. CV 05-0387 (Feurstein, J.) (Matsumoto, M.J.) (hereinafter “the Civil Action”); 







 C. WHEREAS, on or about June 24, 2005, JPI acquired Orphan, and on or about January 1, 2006,
Orphan employees became employees of JPI; 
 D. WHEREAS, Orphan has agreed to enter into a plea agreement with the United States Attorney for
the Eastern District of New York (the “Plea Agreement”), under which, if the Plea Agreement is approved by the Court, Orphan will enter a plea of guilty, pursuant to Fed. R. Crim. P. 11, to an Information to be filed in United States of
America v. Orphan Medical Inc. (the “Federal Criminal Action”) that will allege that Orphan, together with others, did knowingly and intentionally introduce into interstate commerce, and cause the introduction into interstate commerce
of, with the intent to defraud and mislead, a drug, to wit: Xyrem, that was misbranded within the meaning of 21 U.S.C. § 352(f), in that Xyrem was being marketed for medical indications that were not approved by FDA when, as Orphan knew and
believed, Xyrem’s labeling lacked adequate directions for such uses and adequate warnings against such uses where such uses could be dangerous to the user’s health. 
 E. WHEREAS, JPI has agreed to enter into a non-prosecution agreement with the United States Attorney for the Eastern District of New York; 
 F. WHEREAS, Defendants have entered into or will be entering into separate settlement agreements, described in Paragraph 1 below, (hereinafter referred
to as the “Medicaid State Settlement Agreements”) with the states (hereinafter referred to as the “Medicaid Participating States”) in settlement of the Covered Conduct; 
 G. WHEREAS, the United States and the Medicaid Participating States allege that Orphan employees caused claims for payment for Xyrem to be submitted to
the Medicaid Programs, Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the “Medicaid Program”). The United States further alleges that Orphan employees caused claims for payment 

  

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for Xyrem to be submitted to the Medicare Program, Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395ggg (“Medicare”),
the TRICARE program, 10 U.S.C. §§ 1071-1110, which is administered by the Department of Defense through TMA (“TRICARE”), and the Federal Employees Health Benefits Program (“FEHBP”), and caused purchases of Xyrem by the
Department of Veterans Affairs (“DVA”); 
 H. WHEREAS, the United States and the Medicaid Participating States contend that they
have certain civil claims against Defendants, as specified in Paragraph 2 below, for engaging in the following conduct concerning the marketing, promotion, and sale of Xyrem (hereinafter referred to as the “Covered Conduct”): 

Between January 1, 2003 and December 31, 2005, Orphan employees knowingly and willfully promoted the sale and use of Xyrem for certain uses
for which the Food and Drug Administration (“FDA”) had not approved Xyrem (i.e., “unapproved” uses). These employees continued this conduct from January 1, 2006 through March 31, 2006. The promotion of Xyrem for
these unapproved uses violated the Food Drug and Cosmetic Act, 21 U.S.C. § 331(a), and these unapproved uses were not medically accepted indications for which the United States and State Medicaid programs reimbursed and as a result, Orphan and
JPI knowingly caused false and/or fraudulent claims to be submitted to the Medicare, Medicaid, TriCare, and FEHB Programs, and to be purchased by the VA. 
 I. WHEREAS, the United States contends that it has certain administrative claims against Defendants as specified in Paragraphs 4 through 6 below, for engaging in the Covered Conduct; 
 J. WHEREAS, this Agreement is neither an admission of facts nor liability by either Defendant (with the exception of such admissions that are made in
connection with any guilty plea by Orphan made in connection with the Federal Criminal Action) nor a concession by the United States that its claims are not well founded. 
  

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 K. WHEREAS, to avoid the delay, uncertainty, inconvenience, and expense of protracted litigation of the
above claims, the Parties reach a full and final settlement pursuant to the Terms and Conditions below. 
 III. TERMS AND CONDITIONS 

 1. Defendants agree to pay to the United States and the Medicaid Participating States the sum of $3.75 million plus four percent interest
annually pursuant to the payment schedule annexed hereto as Schedule A (the “Settlement Amount”). 
 a. Defendants’
payments to the United States (the “Federal Settlement Amount”) shall be made by electronic funds transfer in accordance with written instructions provided by the U.S. Attorney’s Office, Eastern District of New York 
 b. Defendants’ payments to the Medicaid Participating States (the “State Settlement Amount”) shall be made by electronic funds transfer
in accordance with the Medicaid State Settlement Agreement that Defendants will enter into with the Medicaid Participating States. In the event that the Medicaid State Settlement Agreement is not finalized when a payment to the Medicaid
Participating States becomes due, Defendants shall place that sum in an interest bearing escrow account. 
 c. Payments by the United States
and the Medicaid Participating States to Relator, as provided for by 31 U.S.C. § 3730(d)(1) and any analogous state statutes, are not included in this Agreement, and will be the subject of separate agreements. If the United States and Relator
are unable to reach an agreement regarding Relator’s share of the Settlement Amount, such disagreement will be resolved by proceedings in the United States District Court 

  

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for the Eastern District of New York. Payments made to Relator pursuant to 31 U.S.C. § 3730(d)(1) are contingent upon the United States and the Medicaid
Participating States receiving the Settlement Amount payments set forth in Schedule A. It is expressly understood and agreed that the United States and the Medicaid Participating States in no way promise, guarantee, nor are liable to Relator for the
collection or payment of any funds pursuant to this Agreement or the payment of Relator’s share except as provided herein for funds actually collected and received by the United States. 
 d. If, for any calendar year, JPI’s audited financial statements show net income, Defendants agree, within thirty days after the issuance of such
financial statements, to apply fifty percent of such net income to pay the portion of the Settlement Amount that is owed pursuant to this Agreement (see Schedule A), and those payments shall be applied to the payment schedule in reverse
chronological order (i.e., toward the amount owed in 2012 first, and then to the amount owed in 2011, etc.). These payments shall be apportioned between the federal and state settlement amounts on a pro rata basis. 
 e. In the event that JPI is acquired, in whole or in part, by another entity, the portion of the Settlement Amount that is owed pursuant to this
Agreement (see Schedule A) shall be due on or before the closing date of the acquisition. 
 f. Default: 
 i. Defendants shall be in default of this Agreement if they fail to pay any amount set forth in Paragraph 1 and Schedule A of this Agreement within five
(5) days after such payment is due. 
 ii. On the date of any such event of default, the United States agrees that it will provide
written notice of the default and an opportunity for Defendants to cure 

  

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said default within five (5) business days after receipt of the notice. Upon default, the full remaining unpaid balance (including all unpaid interest
and principal) will become immediately due and payable. Interest will accrue at the rate of 18% (eighteen percent) per annum compounded daily from the date of default on the remaining unpaid principal balance. 
 iii. Upon declaration of default, the United States may exercise, at its sole option, one or more of the following rights, as applicable:
(1) declare this Agreement breached, and proceed against Defendants for any claims under the Civil Action, including those to be released by this Agreement; (2) file an action for specific performance of the Agreement, excluding the
Corporate Integrity Agreement (the “CIA”) which will be separately enforced by HHS-OIG pursuant to its own terms; (3) offset the remaining unpaid balance, inclusive of interest, from any amounts due and owing to Defendants by any
department, agency, or agent of the United States at the time of default; (4) exercise any other right granted by law, or under the terms of this Agreement or the CIA, or recognizable at common law or in equity. Defendants agree not to contest
any offset imposed pursuant to this provision, either administratively or in any State or Federal court. In addition, Defendants shall pay the United States all reasonable costs of collection and enforcement of this Agreement, including
attorney’s fees and expenses. The United States reserves the option of referring such matters for private collection. 
 iv. in the
event of default, as defined in Paragraph 1 above, HHS-OIG may exclude Defendants from participating in all Federal health care programs until Defendants pay the Settlement Amount and reasonable costs as set forth above. HHS-OIG will provide written
notice of any such exclusion to Defendants. Defendants waive any further notice of the exclusion under 42 U.S.C. § 1320a-7(b)(7), and agree not to contest such exclusion either 

  

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administratively or in any state or federal court. Reinstatement to program participation is not automatic. If at the end of the period of exclusion
Defendants wish to apply for reinstatement, Defendants must submit a written requests for reinstatement to HHS-OIG in accordance with the provisions of 42 C.F.R. §§ 1001.3001-.3005. Defendants will not be reinstated unless and until
HHS-OIG approves such requests for reinstatement. 
 v. in the event of default, as defined in Paragraph 1 above, OPM may debar Defendants
from participating in the FEHB until Defendants pay the Settlement Amount and reasonable costs as set forth above. OPM will provide written notice of any such debarment to Defendants. Defendants waive any further notice of the debarment under 5
U.S.C. § 8902a(c)(5), and agree not to contest such exclusion either administratively or in any state or federal court. Reinstatement to program participation is not automatic. If at the end of the period of exclusion Defendants wish to apply
for reinstatement, Defendants must submit a written requests for reinstatement to OPM in accordance with the provisions of 42 C.F.R. §8902a(g)(4). Defendants will not be reinstated unless and until OPM approves such requests for reinstatement

 2. Subject to the exceptions in Paragraph 7 below, and in consideration of the obligations of Defendants in this Agreement, and
conditioned upon Defendants’ full payment of the Settlement Amount, and subject to Paragraph 22 below (concerning bankruptcy proceedings commenced within 91 days of the Effective Date of this Agreement or any payment made under this Agreement),
the United States (on behalf of itself, its officers, agents, agencies, and departments) agrees to release Defendants 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; or the common law theories of payment by mistake, unjust enrichment, and
fraud. No individuals are released by this Agreement. 
  

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 3. Subjects to the exceptions in Paragraph 7 below, and in consideration of the obligations of Defendants
in this Agreement and conditioned upon Defendants’ full payment of the Settlement Amount, Relator, for herself and for her heirs, successors, attorneys, agents, and assigns, agrees to release Defendants 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. 
 4. In consideration of the
obligations of JPI in this Agreement and the CIA entered into between HHS-OIG and JPI, conditioned upon Defendants’ full payment of the Settlement Amount, and subject to Paragraph 22 below (concerning bankruptcy proceedings commenced within 91
days of the Effective Date of this Agreement or any payment made under this Agreement), the HHS-OIG agrees to release and refrain from instituting, directing, or maintaining any administrative action seeking exclusion from Medicare, Medicaid, and
other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(f)) against JPI 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 activities) for the Covered Conduct, except as reserved in Paragraph 7 below, and as reserved in this Paragraph. The HHS-OIG expressly reserves all rights to comply with any statutory obligations to exclude JPI from 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 HHS-OIG from taking action against entities or persons, or for conduct and
practices, for which claims have been reserved in Paragraph 7 below. 
  

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 5. In consideration of the obligations of Defendants set forth in this Agreement, conditioned upon
Defendants’ full payment of the Settlement Amount and subject to Paragraph 22, below (concerning bankruptcy proceedings commenced within 91 days of the Effective Date of this Agreement or any payment made under this Agreement), TMA agrees to
release and refrain from instituting, directing, or maintaining any administrative action seeking exclusion from the TRICARE Program against JPI under 32 C.F.R. § 199.9 for the Covered Conduct, except as reserved in Paragraph 7 below and as
reserved in this Paragraph. TMA expressly reserves authority to exclude JPI from the TRICARE Program 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 Defendants in this Agreement, conditioned upon Defendants’ full payment of the Settlement Amount and subject to Paragraph 22 below (concerning bankruptcy proceedings
commenced within 91 days of the Effective Date of this Agreement or any payment made under this Agreement), OPM agrees to release and refrain from instituting, directing, or maintaining any administrative action seeking exclusion from the FEHBP
against JPI under 5 U.S.C. § 8902a or 5 C.F.R. Part 970 for the Covered Conduct, except as reserved in Paragraph 7 below and except if excluded by HHS-OIG pursuant to 42 U.S.C. § 1320a-7(a). 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. OPM further reserves the right to take administrative action against Orphan pursuant to 5 U.S.C. § 8902a and 5
C.F.R. Part 970 for the Covered Conduct. 
  

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 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 Defendants 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;

 c. Except as explicitly stated in this Agreement, any administrative liability, including mandatory exclusion from Federal health care
programs; 
 d. Any liability to the United States (or its agencies) for any conduct other than the Covered Conduct; 
 e. Any liability based upon such obligations as are created by this Agreement; 
 f. Any liability for express or implied warranty claims or other claims for defective or deficient products or services, including quality of goods and
services; 
 g. Any liability for failure to deliver goods or services due; 
 h. Any liability of individuals, including officers and employees.  
 8. Relator and her 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). 
 9. Relator, for herself
individually, and for her 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; and from any other claims for a share of the 

  

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Settlement Amount; and in full settlement of any claims Relator may have under this Agreement, with the exception of any claims by Relator pursuant to 31
U.S.C. § 3730(d)(1) for Relator’s share of the proceeds (discussed above in Paragraph 1(c)). 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. 
 10. Conditioned upon receipt of the payments described in
Paragraph 1, Relator, for herself, and for her heirs, successors, attorneys, agents, and assigns, hereby fully and finally releases and forever discharges Orphan, JPI, their 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, from any and all claims, claims for relief, actions, rights, causes of
actions, 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 the Relator has standing to bring, which Relator may now have or claim to have against Orphan or JPI, 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 Orphan or JPI, with the exception that Relator does not release Orphan
or JPI for any claims that Relator has (1) for expenses, attorney’s fees and costs pursuant to 31 U.S.C. §§ 3730(d) and (h), and (2) pursuant to 31 U.S.C. § 3730(h). Relator 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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 11. Defendants fully and finally release Relator and her attorneys, and their respective successors,
assigns, and agents, from any claims that they have asserted, could have asserted, or may assert in the future against Relator or her attorneys related to the Covered Conduct or related to the investigation and prosecution of the Covered Conduct by
Relator or her attorneys. 
 12. Defendants fully and finally release the United States, its agencies, employees, servants, and agents from
any claims (including attorney’s fees, costs, and expenses of every kind and however denominated) that Defendants 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 thereof. 
 13. JPI has provided
audited financial statements for the calendar year ended December 31, 2006 (which include Orphan as a consolidated subsidiary from June 24, 2005) (the “Financial Statements”) to the United States, and the United States has relied
on the accuracy and completeness of the Financial Statements in reaching this Agreement. JPI warrants that the Financial Statements are complete, accurate, and current as of the dates thereof. JPI has additionally provided unaudited financial
information to the United States, which JPI warrants as accurate and consistent with information provided to JPI’s Board of Directors and underwriters for JPI’s initial public offering. JPI has informed the United States that the unaudited
financial information contains estimates and projections as to future products, sales and operations, all of which are based on assumptions and contingencies that cannot be guaranteed. If the United States learns of asset(s) in which Defendants had
an interest at the date of either the Financial Statements or the unaudited financial information that were not disclosed therein, or if the United States learns of any misrepresentation by Defendants on, or in connection with, the Financial 

  

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Statements or unaudited financial information, and if such non-disclosure or misrepresentation changes the estimated net worth set forth in the Financial
Statements by seven hundred and fifty thousand dollars or more, the United States may at its option: (a) rescind this Agreement and file suit based on the Covered Conduct, or (b) let the Agreement stand and collect the full Settlement
Amount plus one hundred percent (100%) of the value of the net worth of Defendants previously undisclosed. Defendants agree not to contest any collection action undertaken by the United States pursuant to this provision. 
 14. In the event that the United States, pursuant to Paragraph 13 above, opts to rescind this Agreement, Defendants agree not to plead, argue, or
otherwise raise any defenses under the theories of statute of limitations, laches, estoppel, or similar theories, to any civil or administrative claims that (a) are filed by the United States within 90 calendar days of written notification to
JPI that this Agreement has been rescinded, and (b) relate to the Covered Conduct, except to the extent these defenses were available on March 15, 2007. 
 15. Defendants waive and shall not assert any defenses that they 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. 
 16. 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, 

  

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any other federal payer, or any state payer, related to the Covered Conduct; and Defendants shall not resubmit to any Medicare carrier or intermediary, any
other federal payer, or any state payer any previously denied claims related to the Covered Conduct, and shall not appeal any such denials of claims. 
 17. Defendants agree to the following: 
 a. Unallowable Costs Defined: that all costs (as defined in
the Federal Acquisition Regulation, 48 C.F.R. § 31.205-47; and in Titles XVIII and XIX of the Social Security Act, 42 U.S.C. §§ 1395-1395ggg and 1396-1396v; and the regulations and official program directives promulgated thereunder)
incurred by or on behalf of Defendants, their 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 Federal Employees Health Benefits Program: 
 (1) the matters covered by this Agreement and any
related plea agreement; 
 (2) the United States’ audit(s) and civil and any criminal investigation(s) of the matters covered by this
Agreement; 
 (3) Defendants’ investigation, defense, and corrective actions undertaken in response to the United States’ audit(s)
and civil and any criminal investigation(s) in connection with the matters covered by this Agreement (including attorney’s fees); 
 (4) the negotiation and performance of this Agreement and any plea agreement; 
  

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 (5) the payment Defendants make to the United States pursuant to this Agreement and any payments that
Defendants may make to Relator, including costs and attorneys fees; and 
 (6) the negotiation of, and obligations undertaken pursuant to the
CIA to: 
 (i) retain an independent review organization to perform annual reviews as described in Section III of the CIA; and 
 (ii) prepare and submit reports to HHS-OIG. However, nothing in this Paragraph that may apply to the obligations undertaken pursuant to the CIA affect
the status of costs not allowable under any other authority applicable to Defendants (all costs described or set forth in this Paragraph are hereafter “unallowable costs.”). 
 b. Future Treatment of Unallowable Costs: These unallowable costs shall be separately determined and accounted for by Defendants, and Defendants
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 Defendants or any of its subsidiaries or affiliates to the Medicare, Medicaid, TRICARE, the VA or FEHBP Programs. 
 c. Treatment of Unallowable Costs Previously Submitted for Payment: Defendants further agree that within 90 days of the Effective Date of this Agreement that they shall 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 

  

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statements, information reports, or payment requests already submitted by Defendants or any of their 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. Defendants agree that the United States, at a
minimum, shall be entitled to recoup 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.

 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 Defendants or any of its subsidiaries or affiliates on the effect of inclusion of unallowable costs (as defined in this
Paragraph) on Defendants or any of their 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 Defendants’ books and records to determine that no unallowable costs have been claimed in accordance with the provisions of
this Paragraph. 
 18. Defendants agree to cooperate fully and truthfully with the United States’ investigation of individuals and
entities not released in this Agreement, for the Covered Conduct. Upon reasonable notice, Defendants shall make reasonable efforts to facilitate access to, and encourage the cooperation of their directors, officers, and employees for interviews and
testimony, consistent with the rights and privileges of such individuals, and shall furnish to the United States, upon reasonable request, all non-privileged documents and records in its possession, custody, or control relating to the Covered
Conduct. 
  

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 19. 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. 
 20. Defendants waive 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. 
 21. Defendants warrant that they have reviewed their financial situation and that they currently are 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 constitute a contemporaneous exchange for new value given to Defendants, 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 that Defendants were or became indebted to on or after the date of this transfer, within the meaning of 11 U.S.C. § 548(a)(1). 
 22. If within 91 days of the Effective Date of this Agreement or of any payment made under this Agreement, Defendants commence, or a third party
commences, any case, proceeding, or other action under any law relating to bankruptcy, insolvency, reorganization, or relief of debtors (a) seeking to have any order for relief of Defendants’ debts, or seeking to adjudicate Defendants as
bankrupt or insolvent; or (b) seeking appointment of a receiver, trustee, custodian, or other similar official for Defendants or for all or any substantial part of Defendants’ assets, Defendants agree as follows: 
 a. Defendants’ obligations under this Agreement may not be avoided pursuant to 11 U.S.C. § 547, and Defendants shall not argue or otherwise
take the position in any such case, proceeding, or action that: (i) Defendants’ obligations under this Agreement may be avoided under 11 U.S.C. § 547; (ii) Defendants were insolvent at the time this Agreement was entered into, or
became insolvent as a result of the payment made to the United States; or (iii) the mutual promises, covenants, and obligations set forth in this Agreement do not constitute a contemporaneous exchange for new value given to Defendants.

  

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 b. If Defendants’ obligations under this Agreement are avoided for any reason, including, but not
limited to, through the exercise of a trustee’s avoidance powers under the Bankruptcy Code, the United States, at its sole option, may rescind the releases in this Agreement, and bring any civil and/or administrative claim, action, or
proceeding against Defendants for the claims that would otherwise be covered by the releases provided in Paragraphs 2 and 4 through 6 above. Defendants agree that (i) any such claims, actions, or proceedings brought by the United States
(including any proceedings to exclude Defendants from participation in Medicare, Medicaid, or other Federal health care programs) are not subject to an “automatic stay” pursuant to 11 U.S.C. § 362(a) as a result of the action, case,
or proceeding described in the first clause of this Paragraph, and Defendants shall not argue or otherwise contend that the United States’ claims, actions, or proceedings are subject to an automatic stay; (ii) Defendants shall not plead,
argue, or otherwise raise any defenses under the theories of statute of limitations, laches, estoppel, or similar theories, to any such civil or administrative claims, actions, or proceeding that are brought by the United States within 120 

  

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calendar days of written notification to Defendants that the releases have been rescinded pursuant to this Paragraph, except to the extent such defenses were
available on March 15, 2007; and (iii) the United States has a valid claim against Defendants in the amount of $3.75 million dollars plus interest and applicable penalties under the False Claims Act, and the United States may pursue its
claim in the case, action, or proceeding referenced in the first clause of this Paragraph, as well as in any other case, action, or proceeding. 
 c. Defendants acknowledge that its agreements in this Paragraph are provided in exchange for valuable consideration provided in this Agreement. 
 23. 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. 
 24. Defendants represent that this Agreement is freely and voluntarily entered into without any degree of duress or compulsion
whatsoever. 
 25. Relator represents that this Agreement is freely and voluntarily entered into without any degree of duress or compulsion
whatsoever. 
 26. 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 Eastern District of New York, except that disputes arising under the CIA shall be resolved exclusively under the dispute
resolution provisions in the CIA. The Parties agree that, in the event the following three claims are not resolved, the United States District Court for the Eastern District of New York shall retain jurisdiction over them: (a) claims made by
Relator for a share of the Settlement Amount pursuant to 31 U.S.C. § 3730(d)(1); (b) claims by Relator for reasonable attorneys’ fees and costs pursuant to 31 U.S.C. § 3730(d)(1); and (c) claims by Relator against Defendants
brought pursuant to 31 U.S.C. § 3730(h). 
  

 -19- 








 27. This Agreement constitutes the complete agreement between the Parties. This Agreement may not be
amended except by written consent of the Parties. 
 28. Upon receipt of the initial payments described in Paragraph 1 above, and after the
three claims raised in Paragraph 26 are resolved, the United States and Relator shall promptly sign and file in the Civil Action a Joint Stipulation of Dismissal with prejudice of the Civil Action pursuant to the terms of the Agreement. 

29. The individuals signing this Agreement on behalf of Defendants represent and warrant that they are authorized by Defendants to execute this
Agreement. The individual signing this Agreement on behalf of Relator represents and warrants that she is 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. 
 30. This Agreement may be executed in counterparts, each of which
constitutes an original and all of which constitute one and the same Agreement. 
 31. This Agreement is binding on Defendants’
successors, transferees, heirs, and assigns. 
 32. This Agreement is binding on Relator’s successors, transferees, heirs, and assigns.

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

  

 -20- 








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

 -21- 








 THE UNITED STATES OF AMERICA 
  

											
		 		 		 		 	 ROSLYNN R. MAUSKOPF
	 	
		 		 		 		 	 United States Attorney
	 	
		 		 		 		 	 Eastern District of New York
	 	
						
	 DATED: 7/13/07
	 		 		 	BY:	 	 /s/ Paul Kaufman
	 	
		 		 		 		 	PAUL KAUFMAN	 	
		 		 		 		 	Assistant United States Attorney	 	
		 		 		 		 	Chief, Civil Health Care Fraud	 	
		 		 		 		 	United States Attorney’s Office	 	
		 		 		 		 	Eastern District of New York	 	
						
	DATED: 7/13/07	 		 		 	BY:	 	 /s/ Brian McCabe
	 	
		 		 		 		 	BRIAN McCABE	 	
		 		 		 		 	Trial Attorney	 	
		 		 		 		 	Commercial Litigation Branch	 	
		 		 		 		 	Civil Division	 	
		 		 		 		 	United States Department of Justice	 	
						
	DATED: 7/13/07	 		 		 	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	 	
		 		 		 		 		 	
						
	DATED: 7/11/07	 		 		 	BY:	 	 /s/ Laurel C. Gillespie
	 	
		 		 		 		 	LAUREL C. GILLESPIE	 	
		 		 		 		 	Deputy General Counsel	 	
		 		 		 		 	TRICARE Management Activity	 	
		 		 		 		 	United States Department of Defense	 	

  

 -22- 









											
						
	 DATED: 7/12/07
	 		 		 	BY:	 	 /s/ Kathleen McGettigan
	 	
		 		 		 		 	KATHLEEN McGETTIGAN	 	
		 		 		 		 	Deputy Associate Director	 	
		 		 		 		 	 Center for Retirement and
 Insurance
Services
	 	
		 		 		 		 	 United States Office of
 Personnel Management
	 	
						
	 DATED: 7/12/07
	 		 		 	BY:	 	 /s/ J. David Cope
	 	
		 		 		 		 	J. DAVID COPE	 	
		 		 		 		 	Assistant Inspector General
For Legal Affairs	 	
		 		 		 		 	United States Office of Personnel Management	 	

  

 -23- 








 JPI AND ORPHAN — Defendants 
  

											
	DATED: 7/13/07	 		 		 	BY:	 	 /s/ Samuel R. Saks, M.D.
	 	
		 		 		 		 	SAMUEL R. SAKS, M.D.	 	
		 		 		 		 	Chief Executive Officer JPI Pharmaceuticals, Inc.	 	
						
	DATED: 7/13/07	 		 		 	BY:	 	 /s/ Robert Myers
	 	
		 		 		 		 	ROBERT MYERS	 	
		 		 		 		 	President	 	
		 		 		 		 	Orphan Medical Inc.	 	
						
	DATED: 7/13/07	 		 		 	BY:	 	 /s/ J. Sedwick Sollers III, Esq.
	 	
		 		 		 		 	J. SEDWICK SOLLERS III, Esq.	 	
		 		 		 		 	MARK A. JENSEN, Esq.	 	
		 		 		 		 	King & Spalding LLP.	 	
		 		 		 		 	Counsel for JPI Pharmaceuticals, Inc. and
Orphan Medical Inc.	 	

  

 -24- 








 RELATOR 
  

											
	 DATED: 7/11/07
	 		 		 	BY:	 	 /s/ Shelly Lauterbach
	 	
		 		 		 		 	SHELLY LAUTERBACH	 	
		 		 		 		 	Relator	 	
						
	 DATED: 7/12/07
	 		 		 	BY:	 	 /s/ Erika A. Kelton
	 	
		 		 		 		 	ERIKA A. KELTON, Esq.	 	
		 		 		 		 	Phillips and Cohen LLP	 	
		 		 		 		 	Counsel for Relator	 	

  

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 Settlement – JPI and Orphan 








 SCHEDULE A 
 Federal Settlement Amount 
  

										
	 	 	Total	 	PortionPaid In Accordance
With Restitution Agreement
(Federal Criminal
Action)1	 	 Portion Paid In Accordance
With The
Civil
 Settlement Agreement

	 7/20/07
	 	$	169,004	 	$	61,344	 	$	107,659
	 1/15/08
	 	$	338,007	 	$	122,689	 	$	215,318
	 1/15/09
	 	$	422,509	 	$	153,361	 	$	269,148
	 1/15/10
	 	$	507,011	 	$	184,033	 	$	322,978
	 1/15/11
	 	$	507,011	 	$	184,033	 	$	322,978
	 1/15/12
	 	 	1,436,530	 	$	521,427	 	$	915,103

 State Settlement Amount 
  

										
	 	 	Total	 	Portion Paid In Accordance
With Restitution Agreement
(Federal Criminal
Action	 	 Portion Paid In Accordance
With The
Civil
 Settlement Agreement

	 7/20/07
	 	$	45,896	 	$	16,659	 	$	29,237
	 1/15/08
	 	$	91,792	 	$	33,318	 	$	58,474
	 1/15/09
	 	$	114,740	 	$	41,648	 	$	73,092
	 1/15/10
	 	$	137,689	 	$	49,978	 	$	87,711
	 1/15/11
	 	$	137,689	 	$	49,978	 	$	87,711
	 1/15/12
	 	$	390,118	 	$	141,604	 	$	248,514



	 1
	 Defendants are obligated to make the payments in this column pursuant to the Plea Agreement and
Non-prosecution agreement in the Federal Criminal Action. While these payments are therefore accounted for in both the Federal Criminal Action and this Agreement, Defendants are obligated to make them once. 


  

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 Settlement – JPI and Orphan