Exhibit 10.1

SETTLEMENT AGREEMENT

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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”), and the Defense Health Agency (“DHA”), acting on behalf of the TRICARE Program (collectively, the “United States”); Merit Medical Systems, Inc. (“Merit” or “Defendant”); and Charles J. Wolf, M.D. (“Relator”), through their authorized representatives. Collectively, all of the above will be referred to as “the Parties.”

RECITALS

A.Merit, a publicly-held corporation with its principal place of business in South Jordan, Utah, is a medical device manufacturer that markets and sells its products throughout the United States. Among other things, Merit markets and sells embolotherapeutic devices used to treat arteriovenous malformations, symptomatic uterine fibroids, and hypervascular tumors.

B.In April 2016, Relator filed a qui tam action in the United States District Court for the District of New Jersey captioned United States ex rel. Wolf v. Merit Medical Systems, Inc., Civ. A. No. 16-1855 (D.N.J.), pursuant to the provisions of the False Claims Act, 31 U.S.C. § 3730(b) (the “Qui Tam Action”). The United States intervened in the Qui Tam Action on June 12, 2020.

C.The United States contends that Merit caused to be submitted 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”).

D.The United States contends that it has certain civil claims against Merit arising from the following conduct from September 1, 2010, to March 31, 2017, by which Merit caused the submission of false or fraudulent claims to Medicare, Medicaid, and TRICARE:

The United States contends that under an internal program known as the Local Advertising Program, Merit offered and paid physicians, medical practices, and hospitals (collectively, “Healthcare Providers”) millions of dollars in free advertising assistance, practice development, practice support, and purported unrestricted “educational” grants to induce the Healthcare Providers to purchase and use Merit products in medical procedures performed on federal healthcare program beneficiaries, in violation of the Anti-Kickback Statute (“AKS”), 42 U.S.C. § 1320a-7b(b).

The United States further contends that Merit executives and sales personnel selected which Healthcare Providers would benefit from Merit’s Local Advertising Program payments, as reward for past sales, to induce future sales, and to steer business to Merit and away from Merit’s competitors. In its subsidized advertising, Merit promoted the targeted Healthcare Providers by name, provided contact information for those Healthcare Providers, and did not mention Merit or Merit products. The United States contends that before agreeing to make the Local Advertising Program payments to benefit a targeted Healthcare Provider, Merit often estimated the “projected revenue” that it expected to receive from the Healthcare Provider’s purchase of Merit products, and after making the payments, Merit often tracked the return on investment (ROI) based on the Healthcare Provider’s purchase of Merit products.

Merit and its executives claimed that the purpose of the Local Advertising Program was to increase patient awareness of uterine fibroid embolization. In fact, the United States contends, Merit used the Local Advertising Program payments to induce its targeted Healthcare Providers to use Merit products by providing them financial support and patient referrals. In internal communications, Merit described using the Local Advertising Program payments as “leverage,” a “bargaining chip,” or as part of a “deal” to secure Merit business from Healthcare Providers.  The

United States contends that Merit disregarded warnings that its conduct may violate the AKS, including from its Chief Compliance Officer.

The conduct set forth in Paragraph D is referred to below as the “Covered Conduct.”

E.Merit denies the allegations and contentions of the United States and the Relator.  This Settlement Agreement is neither an admission of liability by Merit nor a concession by the United States that its claims are not well founded.  

F.Relator claims entitlement under 31 U.S.C. § 3730(d) to a share of the proceeds of this Settlement Agreement and to Relator’s reasonable expenses, attorneys’ fees, and costs.

G.Merit has entered into, or will be entering into, separate settlement agreements described below in Paragraph 1(b) (“Medicaid State Settlement Agreements”) with the states (“Medicaid Participating States”) in settlement of the conduct released in those separate Medicaid State Settlement Agreements.  Relator claims entitlement under 31 U.S.C. § 3730(d), and State equivalents, to a share of the proceeds of the Medicaid State Settlement Agreements.

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 agree and covenant as follows:

TERMS AND CONDITIONS

1.Merit shall pay to the United States and the Medicaid Participating States the sum of Eighteen Million Dollars ($18,000,000.00) plus interest at the rate of 0.75% per annum, calculated monthly, from July 8, 2020, and continuing until and including the date of payment (“Total Settlement Amount”).  The Total Settlement Amount shall be paid, subject to the provisions of Paragraph 14 below, as follows:

a.Merit shall pay to the United States the sum of Fifteen Million Two Hundred Ten Thousand Dollars ($15,210,000.00), of which Seven Million Six Hundred Five Thousand

Dollars ($7,605,000.00) is restitution, plus accrued interest as set forth above (“Federal Settlement Amount”), no later than fourteen (14) calendar days after the Effective Date of this Agreement by electronic funds transfer pursuant to written instructions to be provided by the United States Attorney’s Office for the District of New Jersey.

b.Merit shall collectively pay to the Medicaid Participating States the total sum of Two Million Seven Hundred Ninety Thousand Dollars ($2,790,000.00), of which One Million Three Hundred Ninety-Five Thousand Dollars ($1,395,000.00) is restitution, plus accrued interest as set forth above (“State Settlement Amount”), pursuant to written instructions from the National Association of Medicaid Fraud Control Units (“NAMFCU”) State Team and under the terms and conditions of the separate agreements that Merit has entered into, or will enter into, with the Medicaid Participating States.

2.Conditioned upon the United States receiving the Federal Settlement Amount from Merit and as soon as feasible after receipt, the United States shall pay Two Million Six Hundred Fifty Thousand Dollars ($2,650,000.00) to Relator by electronic funds transfer to the trust account of Joseph Greenwald & Laake, P.A.

3.The Defendant and Relator and their heirs, successors, attorneys, agents, and assigns each retain all of their rights pursuant to 31 U.S.C. § 3730(d) on the issue of Relator’s expenses, fees, and costs, and have not reached agreement on those issues to date. Relator and Defendant further agree that, should the Parties be unable to reach an agreement on amounts, Relator may file a motion for attorney’s fees, costs and expenses in the District Court within sixty (60) days of the date of dismissal of the Civil Action. The Parties agree that the United States District Court for the District of New Jersey shall retain and have continuing jurisdiction with regard to any disputes over the amounts for expenses, attorney’s fees and costs.

4.Subject to the exceptions in Paragraph 8 (concerning excluded claims) below, and conditioned upon Merit’s full payment of the Total Settlement Amount and Merit’s full and timely compliance with Paragraph 17 below, the United States releases Merit and Merit’s current and former parent corporations, direct and indirect subsidiaries, and brother and sister corporations (collectively, the “Released Parties”) 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; or the common law theories of payment by mistake, unjust enrichment, and fraud.

5.Subject to Paragraph 3 and conditioned upon Merit’s full payment of the Total Settlement Amount, Relator, for himself and for his heirs, successors, attorneys, agents, and assigns, releases, remises, and forever discharges Merit, together with its current and former employees, officers, owners, directors, shareholders, attorneys, agents, insurers, parents, subsidiaries, predecessors, successors, assigns, and affiliated and related entities (collectively, the “Merit Releasees”) from any claims, rights, demands, controversies, allegations, causes of action, suits, obligations, judgments, debts, duties, and all other liabilities of any kind or nature whatsoever, known or unknown, suspected or unsuspected, accrued or not accrued, fixed or contingent, in law or in equity, in contract or in tort, under common law, under any federal or state statute or regulation (including without limitation any civil monetary claim the Relator has on behalf of the United States for the Covered Conduct under the False Claims Act, 31 U.S.C. §§ 3729-33), and whether or not asserted, that Relator or his respective heirs, successors, attorneys, agents, affiliates, and assigns otherwise would have standing to bring, have asserted, could have asserted, or may assert in the future against Merit or any of the Merit Releasees, from the beginning of time to the Effective Date of this Agreement.

6.The Relator covenants and warrants that the Relator and his attorneys and agents will within thirty (30) days of the Effective Date of this Agreement return to Merit and provide written certification that the Relator and his attorneys and agents have returned to Merit (a) all documents, records, files, data and other information that Relator obtained from Merit during his employment, or otherwise constitutes or contains the property of Merit, including but not limited to confidential or proprietary information, (b) all electronic equipment and electronic information storage devices (e.g., computers, cellular phones, PDAs, zip drives, thumb drives, disks, etc.) that constitutes or contains property of Merit, and (c) Merit credit cards, office keys, and any other property of Merit that the Relator and his attorneys and agents obtained or that were made available to the Relator as a consequence of the Relator’s employment with Merit and/or that constitute or contain the rightful property of Merit, and that all electronic copies of the above have been permanently deleted from Relator’s computers, electronic equipment, storage devices, and cloud-storage accounts.  Merit agrees to retain all material returned under this paragraph until the Relator’s claims pursuant to 31 U.S.C. § 3730(d) for expenses, fees, and costs, as described in paragraph 3, have been fully resolved.

7.In consideration of the obligations of Merit in this Agreement and the Corporate Integrity Agreement (CIA) entered into between OIG-HHS and Merit, and conditioned upon Merit’s full payment of the Total Settlement Amount and Merit’s full and timely compliance with Paragraph 17 below, the OIG-HHS agrees to release and refrain from instituting, directing, or maintaining any administrative action seeking exclusion from Medicare, Medicaid, and other Federal healthcare programs (as defined in 42 U.S.C. § 1320a-7b(f)) against Merit 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 this Paragraph and in Paragraph 8 (concerning excluded claims), below.  The OIG-HHS

expressly reserves all rights to comply with any statutory obligations to exclude Merit from Medicare, Medicaid, and other Federal healthcare 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 8, below.

8.Notwithstanding the releases given in paragraphs 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:

9.Relator and his 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). Conditioned upon Relator’s receipt of the payment described in Paragraph 2, Relator and his 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 Qui Tam Action or under 31 U.S.C. § 3730, and from any claims to a share of the proceeds of this Agreement and/or the Qui Tam Action.

10.Merit waives and shall not assert any defenses that Merit 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.

11.Each Released Party, listed in Paragraph 4, 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 the Released Party 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.

12.Merit fully and finally releases the Relator from any claims (including attorneys’ fees, costs, and expenses of every kind and however denominated) that Merit has asserted, could have asserted, or may assert in the future against the Relator, related to the Covered Conduct and the Relator’s investigation and prosecution thereof, the pursuit and filing of the Civil Action, and any all claims brought pursuant to the qui tam complaint, and amended complaint.

13.The Total Settlement Amount 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 carrier or payer, or any state payer, related to the Covered Conduct; and Merit agrees not to resubmit to any Medicare contractor, TRICARE carrier or payer, 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.

14.Merit agrees to the following:

a.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. §§ 1395-1395lll-1 and 1396-1396w-5; and the regulations and official program directives promulgated thereunder) incurred by or on behalf of Merit, its present or former officers, directors, employees, shareholders, and agents in connection with:

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”) (collectively, “Unallowable Costs”).  However, nothing in paragraph 14(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 Merit.

b.Future Treatment of Unallowable Costs: Unallowable Costs shall be separately determined and accounted for by Merit, and Merit 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 Merit or any of its subsidiaries or affiliates to the Medicare, Medicaid, TRICARE, or FEHBP Programs.

c.Treatment of Unallowable Costs Previously Submitted for Payment: Merit further agrees that within ninety (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 Merit 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. Merit agrees that the United States, at a minimum, shall be entitled to recoup from Merit 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 Merit or any of its subsidiaries or affiliates on the effect of inclusion of Unallowable Costs (as defined in this Paragraph) on Merit 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 Merit’s books and records to determine that no Unallowable Costs have been claimed in accordance with the provisions of this Paragraph.

15.This Agreement is intended to be for the benefit of the Parties, the Released Parties (as to Paragraph 4), and the Merit Releasees (as to Paragraph 5) only. The Parties do not release any claims against any other person or entity, except to the extent provided for in Paragraph 16 (waiver for beneficiaries paragraph), below.

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

17.Within three (3) business days of the Effective Date of this Agreement:

a.The United States and Merit shall sign and file a Joint Stipulation of Dismissal with Prejudice pursuant to Federal Rule of Civil Procedure 41(a)(1) in Merit Medical Systems, Inc. v. United States of America et al., No. 19-mc-211 (D.N.J.);

b.Merit shall sign and file a Notice of Dismissal with Prejudice pursuant to Federal Rule of Civil Procedure 41(a)(1) in Merit Medical Systems, Inc. v. Barr et al., No. 2:20-cv-6468 (D.N.J.); and

c.The United States and Merit shall sign and file a Joint Motion to Dismiss with Prejudice pursuant to Federal Rule of Appellate Procedure 42(b) in Merit Medical Systems, Inc. v. United States of America, No. 20-1449 (4th Cir.).

18.Upon receipt of the Total Settlement Amount and upon Merit’s full and timely compliance with Paragraph 17 above, the United States and Relator shall promptly sign and file in the Qui Tam Action a Notice of Dismissal of the Qui Tam Action pursuant to Rule 41(a)(1) as follows:

a.The Notice of Dismissal shall be with prejudice as to the United States’ and Relator’s claims in the Qui Tam Action as to the Covered Conduct and consistent with the terms and conditions of this Agreement.

b.The Notice of Dismissal shall be without prejudice to the United States and with prejudice to the Relator as to any other claims in the Qui Tam Action except for those reserved by Relator and his attorneys in Paragraph 3.

19.Except for those reserved by Relator and his attorneys in Paragraph 3, each Party shall bear its own legal and other costs incurred in connection with the Qui Tam Action and the three actions referenced above in Paragraph 17, including the preparation and performance of this Agreement.

20.Each party and signatory to this Agreement represents that it freely and voluntarily enters into this Agreement without any degree of duress or compulsion.

21.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 New Jersey. 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.

22.This Agreement constitutes the complete agreement between the Parties. This Agreement may not be amended except by written consent of the Parties.

23.The undersigned counsel represent and warrant that they are fully authorized to execute this Agreement on behalf of the persons and entities indicated below.

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

25.This Agreement is binding on Merit’s successors, transferees, heirs, and assigns.

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

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

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

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[Signature Pages Follow]

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THE UNITED STATES OF AMERICA

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DATED: October 13, 2020BY:/s/ Christopher Terranova​ ​​ ​

CHRISTOPHER TERRANOVA

Trial Attorney

Commercial Litigation Branch, Civil Division

United States Department of Justice

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DATED: October 13, 2010BY:/s/ Andrew A. Caffrey, III​ ​​ ​

ANDREW A. CAFFREY, III

Assistant United States Attorney

United States Attorney’s Office

District of New Jersey

APPROVED:

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/s/ Lee M. Cortex, Jr.​ ​​ ​​ ​​ ​

LEE M. CORTES, JR.

Chief, Health Care Fraud Unit

United States Attorney’s Office

District of New Jersey

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APPROVED:

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/s/ Rachael A. Honig​ ​​ ​​ ​​ ​

RACHAEL A. HONIG

Attorney for the United States, Acting under Authority Conferred by 28 U.S.C. § 515

United States Attorney’s Office

District of New Jersey

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DATED: October 13, 2020BY:/s/ Lisa M. Re​ ​​ ​​ ​​ ​

LISA M. RE

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

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DATED: October 13, 2020BY:/s/ Salvatore M. Maida​ ​​ ​

SALVATORE M. MAIDA

General Counsel

Defense Health Agency

United States Department of Defense

MERIT

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DATED: October 13, 2020BY:/s/ Fred Lampropoulos​ ​​ ​

FRED LAMPROPOULOS

Chairman and Chief Executive Officer

Merit Medical Systems, Inc.

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DATED: October 13, 2020BY:/s/ Michael R. Pauze​ ​​ ​​ ​

MICHAEL R. PAUZÉ

King & Spalding LLP

Counsel for Merit Medical Systems, Inc.

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DATED: October 13, 2020BY:/s/ Lawrence S. Lustberg​ ​​ ​

LAWRENCE S. LUSTBERG

Gibbons P.C.

Counsel for Merit Medical Systems, Inc.

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RELATOR

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DATED: October 13, 2020BY:/s/ Charles J. Wolf, M.D.​ ​​ ​

CHARLES J. WOLF, M.D.

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DATED: October 13, 2002BY:/s/ Jay P. Holland​ ​​ ​​ ​

/s/ Veronica B. Nannis​ ​​ ​

JAY P. HOLLAND

VERONICA B. NANNIS

Joseph Greenwald & Laake, PA

Counsel for Relator

Exhibit 10.2

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CORPORATE INTEGRITY AGREEMENT BETWEEN THE

OFFICE OF INSPECTOR GENERAL OF THE

DEPARTMENT OF HEALTH AND HUMAN SERVICES AND

MERIT MEDICAL SYSTEMS, INC.

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Merit Medical Systems, Inc. (Merit) hereby enters into this Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) of the United States Department of Health and Human Services (HHS) to promote compliance with the statutes, regulations, and written directives of Medicare, Medicaid, and all other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(f)) (Federal health care program requirements) and with the statutes, regulations, and written directives of the Food and Drug Administration (FDA requirements). Contemporaneously with this CIA, Merit is entering into a Settlement Agreement with the United States.

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Merit represents that it has an established corporate compliance program (Compliance Program) which preceded the execution of this CIA. The Compliance Program includes a Compliance Officer, Compliance Committee, written policies and procedures, education and training programs, and a disclosure program. Merit will continue to operate its Compliance Program throughout the term of this CIA.

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Merit Medical Systems, Inc. CIA

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Notwithstanding the above, the term “Covered Persons” does not include part-time or per diem employees, contractors, subcontractors, agents, or other persons who are not reasonably expected to work more than 160 hours during a Reporting Period, except that any such individuals shall become “Covered Persons” at the point when they do work more than 160 hours during a Reporting Period.

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Merit Medical Systems, Inc. CIA

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a third party and supported by Merit, including but not limited to, continuing medical education (CME), disease awareness, or sponsorship of symposia at medical conferences.

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Merit shall establish and maintain a Compliance Program that includes the following elements:

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Merit Medical Systems, Inc. CIA

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Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA.

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Merit shall report to OIG, in writing, any changes in the identity of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five business days after such a change.

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Merit shall report to OIG, in writing, any actions or changes that would affect the Compliance Committee’s ability to perform the duties necessary to meet the obligations in this CIA, within 15 business days after such a change.

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The Audit Committee shall, at a minimum, be responsible for the following:

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Merit Medical Systems, Inc. CIA

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At minimum, the resolution shall include the following language:

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“The Audit Committee has made a reasonable inquiry into the operations of Merit’s Compliance Program including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Audit Committee has concluded that, to the best of its knowledge, Merit

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Merit Medical Systems, Inc. CIA

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has implemented an effective Compliance Program to meet Federal health care program requirements, FDA requirements, and the obligations of the Corporate Integrity Agreement.”

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If the Audit Committee is unable to provide such a conclusion in the resolution, the Audit Committee shall include in the resolution a written explanation of the reasons why it is unable to provide the conclusion and the steps it is taking to implement an effective Compliance Program at Merit.

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Merit shall report to OIG, in writing, any changes in the composition of the Audit Committee, or any actions or changes that would affect the Audit Committee’s ability to perform the duties necessary to meet the obligations in this CIA, within 15 business days after such a change.

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“I have been trained on and understand the compliance requirements and responsibilities as they relate to [insert name of department], an area under my supervision. My job responsibilities include ensuring compliance with regard to the ​ ​[insert name of the department] with all applicable Federal health care program requirements, FDA requirements, obligations of the Corporate Integrity Agreement, and Merit policies, and I have taken steps to promote such compliance. To the best of my knowledge, the

​ ​ [insert name of department] of Merit is in compliance with all applicable Federal health care program requirements, FDA requirements, and the obligations of the Corporate Integrity Agreement. I understand that this certification is being provided to and relied upon by the United States.”

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If any Certifying Employee is unable to provide such a certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above.

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Merit Medical Systems, Inc. CIA

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Within 90 days after the Effective Date, Merit shall develop and implement a written process for Certifying Employees to follow for the purpose of completing the certification required by this section (e.g., reports that must be reviewed, assessments that must be completed, sub-certifications that must be obtained, etc. prior to the Certifying Employee making the required certification).

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§§ 3729-3733); and (ii) all applicable FDA requirements;

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Merit Medical Systems, Inc. CIA

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from Merit (including, separately, from sales representatives, or through other channels);

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Merit Medical Systems, Inc. CIA

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At least annually (and more frequently, if appropriate), Merit shall assess and update, as necessary, the Policies and Procedures. Any new or revised Policies and Procedures shall be made available to all Covered Persons.

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All Policies and Procedures shall be made available to OIG upon request.

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Merit Medical Systems, Inc. CIA

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New members of the Board of Directors shall receive the Board Training described above within 30 days after becoming a member or within 120 days after the Effective Date, whichever is later.

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III.C.2 has been provided as required.

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Within 120 days after the Effective Date, Merit shall develop and implement a centralized annual risk assessment and internal review process to identify and address risks associated with each Government Reimbursed Product, including risks associated with the Covered Functions. The Compliance Committee shall be responsible for implementation and oversight of the risk assessment and internal review process. The risk assessment and internal review process shall be conducted annually and shall require Merit to: (1) identify and prioritize risks, (2) develop internal audit work plans related to the identified risk areas, (3) implement the internal audit work plans, (4) develop corrective action plans in response to the results of any internal audits performed, and (5) track the implementation of the corrective action plans in order to assess the effectiveness of such plans. Merit shall maintain the risk assessment and internal review process for the term of the CIA.

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Merit Medical Systems, Inc. CIA

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(those exchanged between the IRO and Merit) related to the reviews.

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Merit Medical Systems, Inc. CIA

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the requirements specified in Appendix A to this CIA. The IRO’s certification shall include a summary of current and prior engagements between Merit and IRO.

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Within 90 days after the Effective Date, Merit shall establish a Disclosure Program that includes a mechanism (e.g., a toll free compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with Merit’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement believed by the individual to be a potential violation of criminal, civil, or administrative law. Merit shall appropriately publicize the existence of the Disclosure Program and the disclosure mechanism (e.g., via periodic e- mails to employees, or by posting the information in prominent common areas).

The Disclosure Program shall emphasize a nonretribution, nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Merit’s Covered Persons shall be expected to report suspected violations of any Federal health care program or FDA requirements to the Compliance Officer or other appropriate individual designated by Merit. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that he or she has obtained all of the information necessary to determine whether a further review should be conducted. For any disclosure that is sufficiently specific so that it reasonably: (1) permits a determination of the appropriateness of the alleged improper practice; and (2) provides an opportunity for taking corrective action, Merit shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted.

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The Compliance Officer (or designee) shall maintain a disclosure log and shall record all disclosures, whether or not related to a potential violation of criminal, civil or administrative law related to Federal health care programs or FDA requirements, in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a summary of each disclosure received (whether anonymous or not), the individual or department responsible for reviewing the disclosure, the status of the review, and any corrective action taken in response to the review.

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Merit Medical Systems, Inc. CIA

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Nothing in this Section III.G affects Merit’s responsibility to refrain from (and liability for) billing Federal health care programs for items or services furnished, ordered, or prescribed by an excluded person. Merit understands that items or services furnished, ordered, or prescribed by excluded persons are not payable by Federal health care

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Merit Medical Systems, Inc. CIA

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programs and that Merit may be liable for overpayments and/or criminal, civil, and administrative sanctions for employing or contracting with an excluded person regardless of whether Merit meets the requirements of Section III.G.

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Within 30 days after discovery, Merit shall notify OIG, in writing, of any ongoing investigation or legal proceeding known to Merit conducted or brought by a governmental entity or its agents involving an allegation that Merit has committed a crime or has engaged in fraudulent activities. This notification shall include a description of the allegation, the identity of the investigating or prosecuting agency, and the status of such investigation or legal proceeding. Merit also shall provide written notice to OIG within 30 days after the resolution of the matter and describe the findings and/or results of the investigation or proceeding, if any.

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Merit Medical Systems, Inc. CIA

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to any Federal health care program for which penalties or exclusion may be authorized;

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A Reportable Event may be the result of an isolated event or a series of occurrences.

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Within 30 days after the date of any written report, correspondence, or communication between Merit and the FDA that materially discusses Merit’s or a Covered Person’s actual or potential unlawful or improper promotion of Merit’s products (including any improper dissemination of information about off-label indications), Merit shall provide a copy of the report, correspondence, or communication to OIG. Merit shall also provide written notice to OIG within 30 days after the resolution of any such

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Merit Medical Systems, Inc. CIA

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disclosed improper promotional matter, and shall provide OIG with a description of the findings and/or results of the matter, if any.

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Within 120 days following the Effective Date, Merit shall establish and implement the following requirements relating to: (1) arrangements with HCPs to serve as presenters on behalf of Merit or participate in training programs related to the safe and effective use of Government Reimbursed Products (Speaker Programs); and (2) arrangements for marketing or other promotional activity that Merit performs with or on behalf of one or more HCPs or HCIs involving a Government Reimbursed Product (Co-Marketing).

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Merit Medical Systems, Inc. CIA

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other Merit personnel that a speaker program complied with Merit requirements, or in the event of non-compliance, Merit shall require the identification of the policy violation and ensure appropriate follow up activity to address the violation.

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Within 120 days after the Effective Date, Merit shall establish a comprehensive Field Force Monitoring Program (FFMP) to evaluate and monitor its sales personnel’s interactions with HCPs and HCIs. The FFMP shall be a formalized process designed to directly and indirectly observe the appropriateness of sales personnel’s interactions with HCPs and HCIs and to identify potential improper conduct. As described in more detail below, the FFMP shall include: (1) direct field observations (Observations) of sales personnel and (2) the monitoring and review of other records relating to sales personnel’s interactions with HCPs and HCIs (Records Reviews).

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Merit Medical Systems, Inc. CIA

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At the completion of each Observation, Monitoring Personnel shall prepare a report which includes:

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Monitoring Personnel shall conduct at least 5 Observations during each Reporting Period. Monitoring Personnel shall have access to all relevant records and information necessary to assess sales representatives’ interactions with HCPs and HCIs and to identify potential or actual compliance violations.

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Merit Medical Systems, Inc. CIA

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Within 120 days after the Effective Date, Merit shall develop policies, procedures, and systems to implement the requirements outlined below relating to the following types of activities: (1) consultant arrangement activities; and (2) grant and charitable contribution activities involving HCPs and HCIs.

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Merit Medical Systems, Inc. CIA

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shall be referred to herein as Consultants. Within 90 days of the Effective date, Merit shall:

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Merit Medical Systems, Inc. CIA

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Consultant is engaged and that, as applicable, Merit receives the work product generated by the Consultant.

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Merit Medical Systems, Inc. CIA

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In the event that, after the Effective Date, Merit proposes to (a) sell any or all of its business, business units or locations (whether through a sale of assets, sale of stock or other type of transaction) that are subject to this CIA; or (b) purchases or establishes a new business, business unit or location related to or engaged in any of the Covered Functions, the CIA shall be binding on the purchaser of any business, business unit or location. Any such new business, business unit or location (and all Covered Persons at each new business, business unit or location) shall be subject to the applicable requirements of this CIA, unless otherwise determined and agreed to in writing by OIG. Merit shall give notice of such sale or purchase to OIG within 30 days following the closing of the transaction.

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If, in advance of a proposed sale or a proposed purchase, Merit wishes to obtain a determination by OIG that the proposed purchaser or the proposed acquisition will not be subject to the requirements of the CIA, Merit must notify OIG in writing of the proposed sale or purchase at least 30 days in advance. This notification shall include a description of the business, business unit, or location to be sold or purchased, a brief description of the terms of the transaction and, in the case of a proposed sale, the name and contact information of the prospective purchaser.

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Within 150 days after the Effective Date, Merit shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include:

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Merit Medical Systems, Inc. CIA

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Merit Medical Systems, Inc. CIA

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Merit shall submit a written report to OIG on its compliance with the CIA requirements for each of the five Reporting Periods (Annual Report). Each Annual Report shall include, at a minimum, the following information:

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Merit Medical Systems, Inc. CIA

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Merit Medical Systems, Inc. CIA

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identified during the Reporting Period;

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The first Annual Report shall be received by OIG no later than 60 days after the end of the first Reporting Period. Subsequent Annual Reports shall be received by OIG no later than the anniversary date of the due date of the first Annual Report.

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Merit Medical Systems, Inc. CIA

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Merit shall clearly identify any portions of its submissions that it believes are trade secrets, or information that is commercial or financial and privileged or confidential, and therefore potentially exempt from disclosure under the Freedom of Information Act (FOIA), 5 U.S.C. § 552. Merit shall refrain from identifying any information as exempt from disclosure if that information does not meet the criteria for exemption from disclosure under FOIA.

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Unless otherwise stated in writing after the Effective Date, all notifications and reports required under this CIA shall be submitted to the following entities:

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OIG:

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Administrative and Civil Remedies Branch Office of Counsel to the Inspector General Office of Inspector General

U.S. Department of Health and Human Services Cohen Building, Room 5527

330 Independence Avenue, S.W. Washington, DC 20201

Telephone: 202.619.2078

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Merit Medical Systems, Inc. CIA

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Facsimile: 202.205.0604 Merit:

David Lewis

1600 West Merit Parkway South Jordan, UT 84095 Telephone: (801) 316-3835

Email Address: David.Lewis@merit.com

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Unless otherwise specified, all notifications and reports required by this CIA may be made by electronic mail, overnight mail, hand delivery, or other means, provided that there is proof that such notification was received. Upon request by OIG, Merit may be required to provide OIG with an additional copy of each notification or report required by this CIA in OIG’s requested format (electronic or paper).

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In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy Merit’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of Merit’s locations for the purpose of verifying and evaluating: (a) Merit’s compliance with the terms of this CIA and (b) Merit’s compliance with Federal health care program requirements and with all applicable FDA requirements. The documentation described above shall be made available by Merit to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of Merit’s owners, employees, contractors and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Merit shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. Merit’s owners, employees, contractors and directors may elect to be interviewed with or without a representative of Merit present.

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Merit Medical Systems, Inc. CIA

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Merit shall maintain for inspection all documents and records relating to reimbursement from the Federal health care programs and to compliance with this CIA for six years (or longer if otherwise required by law) from the Effective Date.

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Consistent with HHS’s FOIA procedures, set forth in 45 C.F.R. Part 5, OIG shall make a reasonable effort to notify Merit prior to any release by OIG of information submitted by Merit pursuant to its obligations under this CIA and identified upon submission by Merit as trade secrets, or information that is commercial or financial and privileged or confidential, under the FOIA rules. With respect to such releases, Merit shall have the rights set forth at 45 C.F.R. § 5.42 (a).

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Merit is expected to fully and timely comply with all of its CIA obligations.

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As a contractual remedy, Merit and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.

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Merit Medical Systems, Inc. CIA

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Merit Medical Systems, Inc. CIA

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accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.

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Merit may, in advance of the due date, submit a timely written request for an extension of time to perform any act or file any notification or report required by this CIA. Notwithstanding any other provision in this Section, if OIG grants the timely written request with respect to an act, notification, or report, Stipulated Penalties for failure to perform the act or file the notification or report shall not begin to accrue until one day after Merit fails to meet the revised deadline set by OIG. Notwithstanding any other provision in this Section, if OIG denies such a timely written request, Stipulated

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Merit Medical Systems, Inc. CIA

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Penalties for failure to perform the act or file the notification or report shall not begin to accrue until three business days after Merit receives OIG’s written denial of such request or the original due date, whichever is later. A “timely written request” is defined as a request in writing received by OIG at least five business days prior to the date by which any act is due to be performed or any notification or report is due to be filed.

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(b) OIG’s exercise of its contractual right to demand payment of the Stipulated Penalties (this notification is referred to as the “Demand Letter”).

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means:

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Merit Medical Systems, Inc. CIA

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III.E and Appendix B; or

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Merit Medical Systems, Inc. CIA

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determination to exclude Merit (this letter shall be referred to hereinafter as the “Exclusion Letter”). Subject to the Dispute Resolution provisions in Section X.E, below, the exclusion shall go into effect 30 days after the date of Merit’s receipt of the Exclusion Letter. The exclusion shall have national effect. Reinstatement to program participation is not automatic. At the end of the period of exclusion, Merit may apply for reinstatement by submitting a written request for reinstatement in accordance with the provisions at 42 C.F.R. §§ 1001.3001-.3004.

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C.F.R. § 1005.2-1005.21. Notwithstanding the language in 42 C.F.R. § 1005.2(c), the request for a hearing involving Stipulated Penalties shall be made within 10 days after receipt of the Demand Letter and the request for a hearing involving exclusion shall be made within 25 days after receipt of the Exclusion Letter. The procedures relating to the filing of a request for a hearing can be found at http://www.hhs.gov/dab/divisions/civil/procedures/divisionprocedures.html.

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Merit Medical Systems, Inc. CIA

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For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for Merit, only after a DAB decision in favor of OIG. Merit’s election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude Merit upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that Merit may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. Merit shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of Merit, Merit shall be reinstated effective on the date of the original exclusion.

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Merit and OIG agree as follows:

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Merit Medical Systems, Inc. CIA

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Merit Medical Systems, Inc. CIA

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ON BEHALF OF MERIT MEDICAL SYSTEMS, INC.

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/s/ Fred LampropoulosOctober 13, 2020​ ​

FRED LAMPROPOULOSDATE

Chief Executive Officer Merit Medical Systems, Inc.

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/s/ Seth Lundy

/s/ Michael PauzeOctober 13, 2020​ ​

SETH LUNDYDATE

MICHAEL PAUZE

Counsel for Merit Medical Systems, Inc. King & Spalding LLP

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Merit Medical Systems, Inc. CIA

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ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES

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/s/ Lisa M. Re ​ ​October 13, 2020 ​ ​

LISA M. REDATE

Assistant Inspector General for Legal Affairs Office of Inspector General

U.S. Department of Health and Human Services

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/s/ Madeline J. Bainer​ ​October 13, 2020 ​ ​

MADELINE J. BAINERDATE

Senior Counsel

Administrative and Civil Remedies Branch Office of Counsel to the Inspector General

U.S. Department of Health and Human Services

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APPENDIX A

INDEPENDENT REVIEW ORGANIZATION

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This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

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The IRO shall:

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The IRO shall:

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Merit shall ensure that the IRO has access to all records and personnel necessary to complete the reviews listed in III.E of this CIA and that all records furnished to the IRO are accurate and complete.

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The IRO must perform each component of the IRO Reviews in a professionally independent and objective fashion, as defined in the most recent Government Auditing Standards issued by the U.S. Government Accountability Office.

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qualifications, independence or performance of its responsibilities in order to resolve the concerns identified by OIG. If, following OIG’s review of any information provided by Merit regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Merit in writing that Merit shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. Merit must engage a new IRO within 60 days of its receipt of OIG’s written notice. The final determination as to whether or not to require Merit to engage a new IRO shall be made at the sole discretion of OIG.

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APPENDIX B

IRO REVIEWS

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As specified more fully below, Merit shall retain an IRO to perform engagements to assist Merit in assessing and evaluating certain of its systems, processes, policies, and procedures related to Merit’s Covered Functions (IRO Review). The IRO Review shall consist of two components—a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. Merit may engage, at its discretion, a single entity to perform both components of the IRO Reviews, provided that the entity has the necessary expertise and capabilities to perform both.

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If there are no material changes in Merit's systems, processes, policies, and procedures relating to Covered Functions, the IRO shall perform the Systems Review of certain systems, processes, policies and procedures relating to Covered Functions (as set forth below) for the first and fourth Reporting Periods. If Merit materially changes its systems, processes, policies, and procedures relating to Covered Functions, the IRO shall perform a Systems Review for the Reporting Period(s) in which such changes were made in addition to conducting the Review as set forth above. The additional Systems Review(s) shall consist of: (1) an identification of the material changes, and (2) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each Reporting Period of the CIA.

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The Systems Review shall be a review of Merit's systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) relating to Covered Functions. More specifically, the IRO shall review Merit's systems, processes, policies, and procedures associated with the following (hereafter “Reviewed Policies and Procedures”):

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belonging to specified medical specialties or types of clinical practice may receive Evaluation Product from Merit (including, separately, from sales representatives, or through other channels);

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The IRO shall prepare a report based upon each Systems Review performed. For each of the Reviewed Policies and Procedures identified in Section B above, the report shall include the following items:

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The Transactions Review shall include a review of: (1) a sample of consultant or other fee-for-service arrangements entered into with HCPs (including all events and expenses related to such engagements or arrangements), (2) a sample of Co-Marketing Activity agreements, (3) a sample of medical education grants and charitable contributions, and (4) a sample of Payments. The IRO shall report on all aspects of its reviews in the Transactions Review Report.

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Activity was completed prior to the initiation of the Consulting Activity;

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charitable contributions involving HCPs or HCIs provided by Merit. For each Reporting Period, the IRO shall review a sample of the greater of 10% or 5 Grants and Contributions to HCPs or HCIs.

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was provided to sponsor an event, the IRO shall assess whether the event, in fact, occurred.)

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required written approvals for the activity were obtained in accordance with Merit's policies.)

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Exhibit 99.1

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FOR IMMEDIATE RELEASE

MERIT MEDICAL SYSTEMS FINALIZES RESOLUTION WITH THE GOVERNMENT

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SOUTH JORDAN, Utah, October 13, 2020 -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, announced today that it has finalized its settlement with the U.S. Department of Justice and the U.S. Department of Health and Human Services.  In order to avoid distraction from its core mission, and the cost of litigating the matter to success, Merit agreed to pay $18 million to the federal government and certain states.  The settlement agreement does not constitute a finding of wrongdoing by Merit or its management, and it expressly recognizes that Merit denies the allegations.

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Merit looks forward to continuing to focus each day on its mission:  To be the most customer-focused company in healthcare.

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ABOUT MERIT

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Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 500 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.

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CONTACTS:

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Teresa Johnson

Corporate Communications
(801) 208-4295 (office)

tjohnson@merit.com

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Patrick McCarty
Investor Relations
(801) 208-4581 (office)

patrick.mccarty@merit.com

FORWARD-LOOKING STATEMENTS

Statements contained in this release which are not purely historical, including, without limitation, statements regarding the anticipated resolution of an ongoing investigation being conducted by the DOJ, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties such as those described in Merit’s Annual Report on Form 10-K for the year ended December 31, 2019 (as amended by an Amendment No. 1 to Annual Report on Form 10-K/A, the “Annual Report on Form 10-K”) and subsequent filings with the Securities and Exchange Commission. Such risks and uncertainties include inherent risks and uncertainties relating to risks and uncertainties associated with the COVID-19 pandemic; risks relating to Merit’s potential inability to successfully manage growth through acquisitions generally, including the inability to effectively integrate acquired operations or products or commercialize technology developed internally or acquired through completed, proposed or future transactions; negative changes in economic and industry conditions in the United States or other countries; expenditures relating to research, development, testing and regulatory approval or clearance of Merit’s products and risks that such products may not be developed successfully or approved for commercial use; governmental scrutiny and regulation of the medical device industry, including governmental inquiries, investigations and proceedings involving Merit; litigation and other judicial proceedings affecting Merit; restrictions on Merit’s liquidity or business operations resulting from its debt agreements; infringement of Merit’s technology or the assertion that Merit’s technology infringes the rights of other parties; actions of activist shareholders; product recalls and product liability claims; changes in customer purchasing patterns or the mix of products Merit sells; risks and uncertainties associated with Merit’s information technology systems, including the potential for breaches of security and evolving regulations regarding privacy and data protection; increases in the prices of commodity components; the potential of fines, penalties or other adverse consequences if Merit’s employees or agents violate the U.S. Foreign Corrupt Practices Act or other laws or regulations; laws and regulations targeting fraud and abuse in the healthcare industry; potential for significant adverse changes in governing regulations, including reforms to the procedures for approval or clearance of Merit’s products by the U.S. Food & Drug Administration or comparable regulatory authorities in other jurisdictions; changes in tax laws and regulations in the United States or other countries; termination or interruption of relationships with Merit’s suppliers, or failure of such suppliers to perform; fluctuations in exchange rates; uncertainties relating to the LIBOR calculation method and the expected discontinuation of LIBOR; concentration of a substantial portion of Merit’s revenues among a few products and procedures; development of new products and technology that could render Merit’s existing or future products obsolete; market acceptance of new products; volatility in the market price of Merit’s common stock; modification or limitation of governmental or private insurance reimbursement policies; changes in healthcare policies or markets related to healthcare reform initiatives; failure to comply with applicable environmental laws; changes in key personnel; work stoppage or transportation risks; introduction of products in a timely fashion; price and product competition; availability of labor and materials; fluctuations in and obsolescence of inventory; and other factors referenced in the Annual Report on Form 10-K and other materials filed with the Securities and Exchange Commission. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results, and Merit assumes no obligation to update or disclose revisions to those estimates.

2