Settlement Agreement, dated July 14, 2022, by and among OPKO Health, Inc., BioReference Health, LLC, the United States of America, acting through the United States Department of Justice and on behalf of the Office of Inspector General of the Department of Health and Human Services, and the Defense Health Agency, acting on behalf of the TRICARE Program, the Commonwealth of Massachusetts, the State of Connecticut and Jean Marie Crowley

A.    Defendant OPKO Health, Inc. (“OPKO”) is a Delaware corporation with principal executive offices at 4400 Biscayne Blvd., Miami, FL 33137. OPKO Health is a publicly traded, diversified health care company whose diagnostics business includes BioReference Health, LLC.

B.    Defendant BioReference Health, LLC (“BioReference”) is a Delaware limited liability company that provides laboratory services nationwide. BioReference was known as BioReference Laboratories, Inc., a New Jersey Corporation, until March 10, 2022. BioReference is a wholly owned subsidiary of OPKO. OPKO completed its acquisition of BioReference on August 20, 2015.

C.    On April 25, 2019, Relator filed a qui tam action in the United States District Court for the District of Massachusetts captioned United States ex rel. Crowley v. BioReference Laboratories, Inc. and OPKO Health, Inc., No. 19-cv-10981, pursuant to the qui tam provisions

of the False Claims Act, 31 U.S.C. § 3730(b), the Massachusetts False Claims Act, M.G.L. c. 12, § 5A et seq., and the Connecticut False Claims Act, Conn. Gen. Stat. § 4-274, et seq. (the “Civil Action”). Relator alleges that Defendants violated the federal False Claims Act, the Connecticut False Claims Act, and the Massachusetts False Claims Act by: (1) paying unlawful remuneration to physician groups that referred testing to BioReference, in violation of the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b); and (2) submitting claims for designated health services referred in violation of the federal physician self-referral law (commonly referred to as the “Stark Law,”), 42 U.S.C. § 1395nn.

D.    The United States, the Commonwealth, and Connecticut contend that Defendants submitted or caused to be submitted fee-for-service claims for payment to the Medicare Program, Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395lll (“Medicare”); the Medicaid Program, 42 U.S.C. §§ 1396-1396w-5 (“Medicaid”); and the TRICARE Program, 10 U.S.C. §§ 1071-1110b (“TRICARE”) (collectively, “Federal Health Care Programs”).

E.    The United States contends that it has certain civil claims against Defendants for submitting or causing the submission of false claims for payment to Federal Health Care Programs that were tainted by violations of the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), and/or the Stark Law, 42 U.S.C. § 1395nn.

F.    The Commonwealth and Connecticut contend that they have certain civil claims against Defendants for submitting or causing the submission of false claims for payment to MassHealth and Connecticut Medicaid that were tainted by violations of the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), the Stark Law, 42 U.S.C. § 1395nn, the Massachusetts Anti-Kickback Law, M.G.L. c. 175H § 3, and/or the Connecticut Anti-Kickback Law, Conn. Gen. Stat. § 53a-161d(a). The Commonwealth and Connecticut contend that MassHealth and Connecticut Medicaid require that enrolled providers comply with federal and state law, including the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), the Stark Law, 42 U.S.C. §

1395nn, the Massachusetts Anti-Kickback Law, M.G.L. c. 175H § 3, and/or the Connecticut Anti-Kickback Law, Conn. Gen. Stat. § 53a-161d(a).

G.    Defendants admit, acknowledge, and accept responsibility for the following facts. For the physicians, physician groups, and time periods set forth in a separate letter dated June 29, 2022, which is incorporated herein by reference (the “Practice List”), BioReference made payments to the physicians and physicians’ groups, from January 1, 2013 through March 31, 2021, for office space rentals for amounts that exceeded fair market value. BioReference used the rented office space for its Patient Service Centers (“PSCs”), where BioReference collected patients’ blood samples. BioReference analyzed referrals from nearby health care providers—including many of the physician-lessors identified in the Practice List—when deciding whether to open, maintain, or close PSCs. When BioReference entered into the rental arrangements set forth in the Practice List and determined the payments it would make to physicians and physicians’ groups for the office space rentals, in some cases BioReference (i) inaccurately measured the amount of space that BioReference would use exclusively, and (ii) included a disproportionate share of the common spaces in the calculations of office space for which BioReference made payments. OPKO and BioReference conducted internal audits between 2017 and 2019 that identified certain physician-lessors to whom BioReference made lease payments in excess of fair market value. Defendants did not report or return any overpayments to the Federal Health Care Programs. This conduct is referred to below as the “Covered Conduct.” *

H.    With the exception of the Covered Conduct, Defendants expressly deny the allegations of the Relator as set forth in the Civil Action.

7.    Defendants have agreed to pay Relator’s reasonable expenses, fees, and costs related to the Civil Action, as contemplated by 31 U.S.C. §§ 3730(d) and (h)(2) and comparable state law provisions, and will do so subject to terms set forth in a separate agreement being entered into by Relator and Defendants. Moreover, Defendants and Relator have resolved Relator’s claims under 31 U.S.C. § 3730(h) and M.G.L. ch. 12 § 5J relating to the Civil Action subject to the terms set forth in a separate agreement.

8.    Subject to the exceptions in Paragraph 14 (concerning reserved claims) below, and upon the United States’ receipt of the Federal Settlement Amount plus interest due under Paragraph 1, the United States releases Defendants, their predecessors, their current and former parents, divisions, subsidiaries, successors, and assigns (collectively, the “Defendant Releasees”) from any civil or administrative monetary claim the United States has 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; the civil onetary provisions of the Stark Law at 42 U.S.C. §§ 1395nn(g)(3) and (g)(4); or the common law theories of payment by mistake, unjust enrichment, and fraud.

a)    Any liability arising under Title 26, U.S. Code (Internal Revenue Code) or Title IX (Chapters 58 - 65C) of the Massachusetts General Laws;

b)    Any liability arising under the laws and regulations that are administered and enforced by the State of Connecticut Department of Revenue Services;

c)    Any criminal liability;

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

e)    Except as explicitly stated in this Agreement, any administrative liability to the State of Connecticut Department of Social Services (“DSS”), or enforcement right of the State of Connecticut (or its agencies), including suspension from Connecticut Medicaid;

f)    Except as explicitly stated in this Agreement, any civil or administrative liability that any person or entity has or may have to the State of Connecticut or to individual consumers or state program payors under any statute, regulation or rule

not expressly covered by the release in Paragraph 10 above, including, but not limited to, any and all of the following claims: (i) State or federal antitrust violations; (ii) claims involving unfair and/or deceptive acts and practices and/or violations of consumer protection laws;

g)    Any liability to the United States, the Commonwealth or the State of Connecticut (or their agencies) for any conduct other than the Covered Conduct;

h)    Any liability based upon obligations created by this Agreement;

i)    Any liability of individuals;

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

k)    Any liability for failure to deliver goods or services due; and

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

15.    Relator and her heirs, successors, attorneys, agents, and assigns shall not object to this Agreement but agree and confirm that this Agreement, the Federal Settlement Amount, the Commonwealth Settlement Amount, and the Connecticut Settlement Amount are fair, adequate, and reasonable under all the circumstances, pursuant to 31 U.S.C. § 3730(c)(2)(B) and applicable state law. For the avoidance of doubt, Relator and her heirs, successors, attorneys, agents, and assigns hereby waive the right to challenge the fairness, adequacy, or reasonableness of the Agreement, the Federal Settlement Amount, the Commonwealth Settlement Amount, and the Connecticut Settlement Amount, and waive the opportunity for a hearing on any objection to this Agreement, the Federal Settlement Amount, the Commonwealth Settlement Amount, and the Connecticut Settlement Amount pursuant to 31 U.S.C. § 3730(c)(2)(B) and applicable state law. Conditioned upon Relator’s receipt of the Relator’s Share, Relator and her 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. Conditioned upon Relator’s receipt of the Commonwealth Relator’s Share, Relator and her heirs, successors, attorneys, agents, and assigns fully and finally release, waive, and forever discharge the Commonwealth, its agencies, officers, agents, employees, and servants, from any claims arising from the filing of the Civil Action or under M.G.L. c. 12, § 5A, and from any claims to a share of the proceeds of this Agreement and/or the Civil Action. Conditioned upon Relator’s receipt of the Connecticut Relator’s Share, Relator and her heirs, successors, attorneys, agents, and assigns fully and finally release, waive, and forever discharge Connecticut, its agencies, officers, agents, employees, and servants, from any claims arising from the filing of the Civil Action or under Conn. Gen. Stat. § 4-275, and from any claims to a share of the proceeds of this Agreement and/or the Civil Action.

16.    Conditioned upon Relator’s execution of this Agreement and the separate
agreements referenced in Paragraph 7, and dismissal with prejudice as to Relator of the Civil Action against Defendants as set forth more fully in Paragraph 25, Defendant Releasee Entities, to the full extent of their legal authority to do so, release Relator Releasors, jointly and severally, from any and all claims and potential claims, whether known or unknown, from the beginning of time until the Effective Date of this Agreement, including but not limited to (i) all claims related to Relator’s qui tam complaint in the Civil Action; (ii) claims against Relator under the False Claims Act, 31 U.S.C. §§ 3729-3733, or the False Claims Acts of the Commonwealth or the State of Connecticut; (iii) any employment claims; and (iv) any common law and/or statutory claims, with the express exception of any potential claims concerning conduct that post-dates the Effective Date of this Agreement. Defendant Releasee Entities represent and warrant that they are not currently aware of any legal claim that could lawfully be brought at this time against Relator

Releasors other than those encompassed within the Covered Conduct and the Civil Action, for which a full release is herein granted.

17.    Defendants waive and shall not assert any defenses Defendants 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.

18.    Defendants fully and finally release 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 Defendants have 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 or the United States’ investigation or prosecution thereof.

19.    Defendants fully and finally release the Commonwealth, its agencies, officers, agents, employees, and servants, from any claims (including attorneys’ fees, costs, and expenses of every kind and however denominated) that Defendants have asserted, could have asserted, or may assert in the future against the Commonwealth, its agencies, officers, agents, employees, and servants, related to the Covered Conduct or the Commonwealth’s investigation or prosecution thereof.

20.    Defendants fully and finally release Connecticut, its agencies, officers, agents, employees, and servants, from any claims (including attorneys’ fees, costs, and expenses of every kind and however denominated) that Defendants have asserted, could have asserted, or may assert in the future against Connecticut, its agencies, officers, agents, employees, and servants, related to the Covered Conduct or the Connecticut’s investigation or prosecution thereof.

21.    The Federal, Commonwealth, or Connecticut Settlement Amounts shall not be decreased as a result of the denial of claims for payment now being withheld from payment by any Medicare contractor (e.g., Medicare Administrative Contractor, fiscal intermediary, carrier), TRICARE, or any state payer, related to the Covered Conduct; and Defendants agree not to resubmit to any Medicare contractor, TRICARE, or any state payer any previously denied claims related to the Covered Conduct, agrees not to appeal any such denials of claims, and agrees to withdraw any such pending appeals.

22.    Defendants agree to the following:

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

5)    the payments 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 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 paragraph 22.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 Defendants.

b) Future Treatment of Unallowable Costs: Unallowable Costs shall be separately determined and accounted for in nonreimbursable cost centers 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 their subsidiaries or affiliates to the Medicare, Medicaid, TRICARE, 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 it 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 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 from Defendants 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.

d)    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 their 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.

e) 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.

23.    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 24 (waiver for beneficiaries paragraph), below.

24.    Defendants agree that they 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.