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 the United States Attorneys Office for the District of Maryland; the Office of Inspector General (OIG-HHS) of the Department of Health and Human Services (HHS); TRICARE Management Activity (TRICARE); the United States Department of Veterans Affairs (VA); the United States Department of Defenses Defense Logistics Agency (DLA) and Department of the Army (DoD) (collectively the United States); the Relators as identified in Paragraph B of the Preamble to this Agreement; and Defendant, Novo Nordisk Inc. (Novo Nordisk) (hereinafter collectively referred to as "the Parties"), through their authorized representatives. II. PREAMBLE As a preamble to this Agreement, the Parties agree to the following: A. Novo Nordisk, a pharmaceutical company that produces pharmaceutical and

biological products for diabetes care, hemostasis management, hormone replacement, and growth hormone therapy, is a U.S. company and a subsidiary of Novo Nordisk U.S. Holdings, Inc., which in turn is a subsidiary of Novo Nordisk A/S. Novo Nordisk A/S is a publicly traded Danish corporation headquartered in Bagsvaerd, Denmark. Novo Nordisks United States corporate headquarters are located in Princeton, New Jersey. At all relevant times, Novo Nordisk distributed, marketed, and sold its pharmaceutical and biological products in the United States, including its hemostasis management drug, Factor VIIa recombinant, sold under the trade name NovoSeven.

B.

On or about October 31, 2008, Ian Black and Oscar Montiel, (Relators) filed a

qui tam action in the United States District Court for the District of Maryland captioned United States of America and the States of Arkansas, California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, Oklahoma, Rhode Island, Tennessee, Texas, Virginia, Wisconsin and the District of Columbia ex rel. Ian Black & Oscar Montiel v. Novo Nordisk, Inc.; and John Does 1-10, Civ. No. RDB-08-2900, under, inter alia, the qui tam provisions of the federal False Claims Act, 31 U.S.C. 3730(b) and applicable state statutes (hereinafter the Civil Action). Among other things, the Relators alleged in the Civil Action that Novo Nordisk engaged in the off-label promotion of NovoSeven for use in trauma patients. C. Novo Nordisk will be entering into separate settlement agreements, described in

Paragraph III.1(b) below (and hereinafter referenced as the Medicaid State Settlement Agreements), with certain states and the District of Columbia in settlement of the Covered Conduct, as defined in Paragraph II.F. States with which Novo Nordisk executes a Medicaid State Settlement Agreement in the form to which Novo Nordisk and the National Association of Medicaid Fraud Control Units (NAMFCU) have agreed or in a form otherwise agreed to by Novo Nordisk and an individual state, shall be defined as Medicaid Participating States. D. The United States and the Medicaid Participating States allege that Novo Nordisk

caused claims for payment for NovoSeven to be submitted to the Medicaid Program, Title XIX of the Social Security Act, 42 U.S.C. 1396-1396w-5 (the Medicaid Program). E. The United States further alleges that Novo Nordisk caused claims for payment

for NovoSeven to be submitted to the Medicare program, Title XVIII of the Social Security Act,

42 U.S.C. 1395-1395kkk; the TRICARE program, 10 U.S.C. 1071-1109; and caused purchases of NovoSeven by the VA; the DLA; and the DoD. F. The United States and the Medicaid Participating States allege, as specified in

Paragraph III.2 below, that they have certain civil claims against Novo Nordisk for engaging in the following conduct between January 2000 and December 31, 2010 (hereinafter referred to as the Covered Conduct): The United States and the Medicaid Participating States allege that Novo Nordisk knowingly promoted NovoSeven to physicians, other health care professionals, and certain military physicians within the Department of the Army (collectively Health Care Professionals) for certain uses that were not approved by the Food and Drug Administration (FDA) as safe and effective. Although NovoSeven is only approved by the FDA to treat certain bleeding disorders in hemophiliacs, patients with acquired hemophilia or patients with congenital Factor VII deficiency, the United States and the Medicaid Participating States allege that Novo Nordisk promoted NovoSeven to Health Care Professionals as a hemostatic agent that could stop bleeding in situations outside those approved indications, including but not limited to trauma, general surgery, cardiac surgery, liver surgery, liver transplants and intra-cerebral hemorrhage; and that some of the unapproved uses were not medically accepted indications for which the United States and State Medicaid programs provided coverage for NovoSeven. Additionally, the United States alleges that Novo Nordisk entered into Cooperative Research and Development Agreements (CRADAs) with military institutions, provided funding for trials conducted in part by military researchers, and made donations and other gifts to non-profit foundations on behalf of military physicians that caused the military to use NovoSeven in its trauma patients. The United States and the Medicaid Participating States allege that, as a result

of the conduct described above, Novo Nordisk knowingly caused false and/or fraudulent claims to be submitted to Medicare and Medicaid. The United States further alleges that, as a result of the conduct described above, Novo Nordisk caused false and/or fraudulent claims to be submitted to TRICARE and caused the Army, DLA and the VA to purchase NovoSeven for the unapproved uses. G. This Agreement is made in compromise of disputed claims. This Agreement is

neither an admission of facts or liability by Novo Nordisk nor a concession by the United States that its claims are not well founded. Novo Nordisk expressly denies the contentions and allegations of the United States and Relators as set forth herein and in the Civil Action and denies that it engaged in any wrongful conduct. Neither this Agreement or its execution, nor the performance of any obligation arising under it, including any 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 on the merits of the dispute by any party to this Agreement. H. Relators assert entitlement under 31 U.S.C. 3730(d) to a share of the proceeds

due to the United States under this Settlement Agreement and to Relators reasonable expenses, attorneys fees and costs. I. To avoid the delay, uncertainty, inconvenience, and expense of protracted

litigation of the above claims, and in consideration of the mutual promises and obligations of this Settlement Agreement, the Parties mutually desire to reach a full and final settlement pursuant to the Terms and Conditions below. III. TERMS AND CONDITIONS 1. (a) Novo Nordisk shall pay to the United States the sum of $21,425,790.59,

plus interest at the rate of 3 percent per annum on any unpaid balance from March 1, 2011 and continuing until and including the day before complete payment is made (the Federal Settlement Amount). The Federal Settlement Amount shall be paid by electronic fund transfer pursuant to written instructions to be provided by the United States Attorneys Office for the District of Maryland. Novo Nordisk agrees to make this electronic funds transfer no later than ten (10) business days after the Effective Date of this Settlement Agreement. (b) Novo Nordisk agrees to pay the states the sum of $3,574,209.41, plus

accrued interest at the rate of 3 percent per annum from March 1, 2011, and continuing until and including the day before complete payment is made. This sum shall be paid and allocated pursuant to the terms agreed upon by Novo Nordisk and the NAMFCU Negotiating Team and as set forth in the individual Medicaid State Settlement Agreements, and the portion owed to the Medicaid Participating States shall be the Medicaid State Settlement Amount. This Medicaid State Settlement Amount shall be paid by electronic funds transfer pursuant to the written payment instructions from the negotiating team for the Medicaid Participating States. (c) The Federal Settlement Amount and the Medicaid State Settlement Amount shall

hereinafter collectively be referred to as the Settlement Amount. (d) Conditioned upon the United States receiving the Federal Settlement Amount

from Novo Nordisk, the United States agrees to pay, as soon as feasible after receipt, the amount of 16.7% of the Federal Settlement Amount to Relators Ian Black and Oscar Montiel by electronic funds transfer. (e) The Relators have entered into a separate agreement concerning the allocation of

the Relators Share between themselves.

(f)

The Relators shall enter into a separate agreement with Novo Nordisk regarding

any payment of Relators attorneys fees and expenses or, if no such agreement is reached, shall submit a petition for fees and costs to the United States District Court for the District of Maryland. 2. Subject to the exceptions in Paragraph 6 below (concerning excluded claims), in

consideration of the obligations of Novo Nordisk in this Agreement, and conditioned upon Novo Nordisks full payment of the Settlement Amount, the United States (on behalf of itself, its officers, agents, agencies and departments) releases Novo Nordisk, its current and former parent corporations, subsidiaries, affiliates, divisions, transferees, and their predecessors, successors, and assigns and their current and former directors, officers, employees, agents, and servants (collectively referred to as Released Novo Entities and Individuals) 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 or present authority to assert and compromise pursuant to 28 C.F.R. Part 0, Subpart I, Section 0.45(d); or the common law theories of payment by mistake, unjust enrichment, fraud, and, if applicable, breach of contract. 3. Subject to the exceptions in Paragraph 6 below (concerning excluded claims), in

consideration of the obligations of Novo Nordisk in this Agreement and conditioned upon Novo Nordisks full payment of the Settlement Amount, Relators, for themselves and for their heirs, successors, transferees, attorneys, agents, and assigns, agree to dismiss with prejudice any

currently pending claims against Novo Nordisk and release the Novo Entities and Individuals from any civil monetary claim they have or may have on behalf of themselves or the United States against the Novo Entities and Individuals arising from the Covered Conduct, excepting, however, that Relators do not release Novo Nordisk for any claims under 31 U.S.C. 3730(d) for expenses or attorneys fees and costs. 4. In consideration of the obligations of Novo Nordisk set forth in this Agreement

and the Corporate Integrity Agreement (CIA) entered into between OIG-HHS and Novo Nordisk, and conditioned upon Novo Nordisks full payment of the Settlement Amount, the OIG-HHS 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 Novo Nordisk 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 6 (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 Novo Nordisk 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 OIG-HHS from taking action against entities or persons, or for conduct and practices, for which claims have been reserved in Paragraph 6 below. 5. In consideration of the obligations of Novo Nordisk as set forth in this

Agreement, and conditioned upon Novo Nordisks full payment of the Settlement Amount, TRICARE agrees to release and refrain from instituting, directing, or maintaining any

administrative action seeking exclusion from the TRICARE Program against Novo Nordisk under 32 C.F.R. 199.9 for the Covered Conduct, except as reserved in Paragraph 6 (concerning excluded claims) below, and as reserved in this Paragraph. TRICARE expressly reserves authority to exclude Novo Nordisk from the TRICARE Program under 32 C.F.R. 199.9 (f)(1)(i)(A), (f)(1)(i)(B), and (f)(1)(iii) (mandatory exclusion), based upon the Covered Conduct. Nothing in this Paragraph precludes TRICARE or the TRICARE Program from taking action against entities or persons, or for conduct and practices, for which claims have been reserved in Paragraph 6, below. 6. Notwithstanding the releases given in paragraphs 2, 4 and 5 of this Agreement, or

any other term of this Agreement, the following claims of the United States are specifically reserved and are not released: a. b. c. Any liability arising under Title 26, U.S. Code (Internal Revenue Code); Any criminal liability; Except as explicitly stated in this Agreement, any administrative liability, including suspension and debarment and/or 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. f. Any liability based upon obligations created by this Agreement; Any liability for express or implied warranty claims or other claims for

defective or deficient products or services, including quality of goods and services; or g. Any liability for personal injury or property damage or for other

consequential damages arising from the Covered Conduct. 7. Relators, their heirs, successors, attorneys, agents, and assigns shall not object to

this Agreement but 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 expressly waive the opportunity for a hearing on any objection to this Agreement pursuant to 31 U.S.C. 3730(c)(2)(B). Conditioned upon Relators receipt of the Relators Share, Relators, for themselves individually, and for their heirs, successors, attorneys, agents, and assigns fully and finally release, waive, and forever discharge the United States, its agencies, officers, agents, employees, and servants, from any claims arising from the filing of the Civil Action or under 31 U.S.C. 3730, and from any claims to a share of the proceeds of this Agreement and/or the Civil Action. This Agreement does not resolve or in any manner affect any claims the United States has or may have against the Relators arising under Title 26, U.S. Code (Internal Revenue Code), or any claims arising under this Agreement. 8. Novo Nordisk waives and shall not assert any defenses Novo Nordisk 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 of the Fifth Amendment of the Constitution, or under the Excessive Fines Clause of 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 Federal Settlement Amount or Medicaid State Settlement Amount for purposes of the Internal Revenue laws, Title 26 of the United States Code.

9.

Novo Nordisk fully and finally releases the United States, its agencies, officers,

agents, employees, and servants, from any claims (including attorneys fees, costs, and expenses of every kind and however denominated) that Novo Nordisk has asserted, could have asserted, or may assert in the future against the United States, its agencies, officers, agents, employees, and servants, related to the Covered Conduct and the United States investigation and prosecution thereof. 10. In consideration of the obligations of the Relator set forth in this Agreement,

Novo Nordisk, on behalf of itself, and the other Novo Released Entities and Individuals, fully and finally release, waive, and forever discharge the Relators and their heirs, successors, assigns, and agents from any claims or allegations that Novo Nordisk has asserted or could have asserted, arising from the Covered Conduct or the Civil Action, except as they relate to a statutory claim by Relators for reasonable attorneys fees and costs pursuant to 31 U.S.C. 3730(d). 11. The Federal Settlement Amount and Medicaid State 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 or any State payer or TRICARE, related to the Covered Conduct; and Novo Nordisk agrees not to resubmit to any Medicare carrier or intermediary or any State payer or TRICARE any previously denied claims related to the Covered Conduct, and agrees not to appeal any such denials of claims. 12. a. Novo Nordisk agrees to the following: Unallowable Costs Defined: 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. 1395-1395kkk-1 and 1396-1396w-5; and the regulations and official program

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directives promulgated thereunder) incurred by or on behalf of Novo Nordisk, its present or former officers, directors, employees, shareholders, and agents in connection with: (1) the matters covered by this Agreement; (2) the United States audit(s) and civil investigation(s) of the matters covered by this Agreement; (3) Novo Nordisks investigation, defense, and corrective actions undertaken in response to the United States audit(s) and civil investigation(s) in connection with the matters covered by this Agreement (including attorneys fees); (4) the negotiation and performance of this Agreement and the Medicaid State Settlement Agreements; (5) the payment Novo Nordisk makes to the United States or any State pursuant to this Agreement or the Medicaid State Settlement Agreements and any payments that Novo Nordisk may make to Relators, 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 the OIG-HHS

are unallowable costs for government contracting purposes and under the Medicare Program, Medicaid Program, TRICARE Program, and Federal Employees Health Benefits Program (FEHBP) (hereinafter referred to as Unallowable Costs). However, nothing in this paragraph

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12.a.(6) that may apply to the obligations undertaken pursuant to the CIA affects the status of costs that are not allowable based on any other authority applicable to Novo Nordisk. b. Future Treatment of Unallowable Costs: Unallowable Costs shall be separately

determined and accounted for in nonreimbursable cost centers by Novo Nordisk, and Novo Nordisk 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 Novo Nordisk or any of its subsidiaries or affiliates to the Medicare, Medicaid, TRICARE, FEHBP Programs, the DLA or the VA. c. Treatment of Unallowable Costs Previously Submitted for Payment: Novo

Nordisk further agrees that within 90 days of the Effective Date of this Agreement it shall identify to applicable Medicare and TRICARE fiscal intermediaries, carriers, and/or contractors, and Medicaid, 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 Novo Nordisk 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. Novo Nordisk agrees that the United States, at a minimum, shall be entitled to recoup from Novo Nordisk 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 Novo Nordisk or any of its subsidiaries or affiliates on the effect of inclusion of Unallowable Costs (as defined in this Paragraph) on Novo Nordisk 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 Novo Nordisks books and records to determine that no Unallowable Costs have been claimed in accordance with the provisions of this Paragraph. 13. Novo Nordisk expressly warrants that it has reviewed its financial situation and

that it is currently solvent within the meaning of 11 U.S.C. 547(b)(3) and 548 (a)(1)(B)(ii)(I), and will remain solvent following payment 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 Novo Nordisk, 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 which is not intended to hinder, delay, or defraud any entity to which Novo Nordisk was or became indebted to on or after the date of this transfer, within the meaning of 11 U.S.C. 548(a)(1). 14. Following the execution of this Settlement Agreement, the United States shall

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notify the Court that it is intervening in the Civil Action for the purposes of settlement and will attach the executed Agreement to the Notice of Intervention. Upon Novo Nordisks payment of the Federal Settlement Amount and payment of the Medicaid Settlement Amount (pursuant to the terms and conditions of the Medicaid State Settlement Agreements that Novo Nordisk will enter into with the Medicaid Participating States), the Parties shall promptly sign and file in the Civil Action a Joint Stipulation of Dismissal with prejudice of the Civil Action pursuant to Rule 41(a)(1) of the Federal Rules of Civil Procedure. 15. 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 Paragraphs 2, 3 and 16 of this Agreement. 16. Novo Nordisk 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. 17. 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. 18. Each party and signatory to this Agreement represents that it freely and

voluntarily enters into this Agreement without any degree of duress or compulsion. 19. This Agreement is governed by the laws of the United States. The exclusive

jurisdiction and venue for any dispute relating to this Agreement is the United States District Court for the District of Maryland, except that disputes arising under the CIA shall be resolved

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exclusively through the dispute resolution provisions set forth in the CIA. For purposes of construing this Agreement, 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. 20. This Agreement constitutes the complete agreement between the Parties. This

Agreement may not be amended except by written consent of the Parties. 21. The undersigned counsel represent and warrant that they are fully authorized to

execute this Agreement on behalf of the persons and entities indicated below. 22. This Agreement may be executed in counterparts, each of which constitutes an

original and all of which constitute one and the same Agreement. 23. assigns. 24. 25. This Agreement is binding on Relators successors, transferees, heirs, and assigns. All parties consent to the United States disclosure of this Agreement, and This Agreement is binding on Novo Nordisks successors, transferees, heirs, and

information about this Agreement, to the public. 26. 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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SIGNATURE PAGE THE UNITED STATES OF AMERICA

DATED: __________

BY: ______________________________ JOYCE R. BRANDA PATRICIA DAVIS ART COULTER Trial Attorneys Commercial Litigation Branch Civil Division United States Department of Justice

DATED: _________

BY: ______________________________ THOMAS F. CORCORAN TARRA DESHIELDS Assistant United States Attorneys United States Attorneys Office For the District of Maryland

DATED:

BY: ______________________________ 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:

BY: ______________________________ LAUREL C. GILLESPIE Deputy General Counsel TRICARE Management Activity United States Department of Defense

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DEFENDANT--- NOVO NORDISK INC.

DATED:

BY: _____________________________ For Novo Nordisk Inc. JAMES C. SHEHAN Corporate Vice President, Legal/Government & Quality Affairs

DATED:

BY: _____________________________ PAUL E. KALB JAY T. JORGENSEN Sidley Austin LLP Counsel for Novo Nordisk Inc.

OSCAR MONTIEL - Relator

DATED:

BY: _____________________________ Oscar Montiel

DATED:

BY: _____________________________ CHARLES SEIGEL LOREN JACOBSON Waters and Kraus Counsel for Oscar Montiel

IAN BLACK - Relator

DATED:

BY: _____________________________ Ian Black

DATED:

BY: _____________________________ DAN HARGROVE Hargrove and Rea Counsel for Ian Black 17