Corporate Integrity Agreement Sample Contracts

Envision Healthcare Corp – Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Envision Healthcare Corporation (December 19th, 2017)

Envision Healthcare Corporation (Envision) 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. SS 1320a-7b(f)) (Federal health care program requirements). Contemporaneously with this CIA, Envision is entering into a Settlement Agreement with the United States.

Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Vitas Hospice Services, L.L.C., Vitas Healthcare Corporation, Vitas Healthcare Corporation of California, Vitas Healthcare Corporation of Illinois, Vitas Healthcare Corporation of Florida, Vitas Healthcare Corporation of Ohio, Vitas Healthcare Corporation of Atlantic, Vitas Healthcare of Texas, L.P., Vitas Healthcare Corporation Midwest, and Vitas Healthcare Corporation of Georgia. (November 2nd, 2017)

VITAS Hospice Services, L.L.C., VITAS Healthcare Corporation, VITAS Healthcare Corporation of California, VITAS Healthcare Corporation of Illinois, VITAS Healthcare Corporation of Florida, VITAS Healthcare Corporation of Ohio, VITAS Healthcare Corporation of Atlantic, VITAS Healthcare of Texas, L.P., VITAS Healthcare Corporation Midwest, and VITAS Healthcare Corporation of Georgia (collectively, "VITAS"), hereby enter 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. SS 1320a-7b(f)) (Federal health care program requirements). Contemporaneously with this CIA, VITAS is entering into a Settlement Agreement with the United States.

QLT Inc. – Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Aegerion Pharmaceuticals, Inc. (September 22nd, 2017)

Aegerion Pharmaceuticals, Inc. (Aegerion) 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. SS 1320a-7b(f)) (Federal health care program requirements) and with the statutes, regulations, and written directives of the Food and Drug Administration (FDA requirements).

Mylan B.V. – Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Mylan Inc. And Mylan Specialty L.P. (August 21st, 2017)

Mylan Inc. and Mylan Specialty L.P. (collectively Mylan) hereby enter 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. SS 1320a-7b(f)) (Federal health care program requirements). Contemporaneously with this CIA, Mylan is entering into a Settlement Agreement with the United States.

CORPORATE INTEGRITY AGREEMENT BETWEEN THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES AND SORKIN'S RX LTD. T/a and/or D/B/a CAREMED PHARMACEUTICAL SERVICES (May 10th, 2017)

Sorkin's Rx Ltd. t/a and/or d/b/a CareMed Pharmaceutical Services (CareMed) 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. SS 1320a-7b(f)) (Federal health care program requirements). CareMed is a retail specialty pharmacy that does business with Federal health care programs.

Replidyne, Inc. – Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Cardiovascular Systems, Inc. (June 28th, 2016)

Cardiovascular Systems, Inc. (CSI) 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. SS 1320a-7b(f)) (Federal health care program requirements). Contemporaneously with this CIA, CSI is entering into a Settlement Agreement with the United States.

21st Century Oncology Holdings, Inc. – Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services And (December 22nd, 2015)
Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Davita Healthcare Partners Inc. (October 23rd, 2014)

DaVita HealthCare Partners Inc. and its U.S. wholly-owned and partially-owned subsidiaries and joint ventures in which DaVita HealthCare Partners Inc. owns an interest that provide dialysis services, whether directly or indirectly owned by DaVita HealthCare Partners Inc., with the exception of the joint ventures listed in Appendix E (collectively DaVita) 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. SS 1320a-7b(f)) (Federal health care program requirements). Contemporaneously with this CIA, DaVita is entering into a Settlement Agreement with the United States.

Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Amedisys, Inc. And Amedisys Holding, Llc (April 24th, 2014)

Amedisys, Inc. and Amedisys Holding, LLC (collectively, Amedisys) hereby enter 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. SS 1320a-7b(f)) (Federal health care program requirements). Contemporaneously with this CIA, Amedisys is entering into a Settlement Agreement with the United States.

CORPORATE INTEGRITY AGREEMENT Between the Office of Inspector General of the Department of Health and Human Services and Baxano Surgical, Inc. (July 3rd, 2013)

Baxano Surgical, Inc. ("Baxano Surgical") 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. SS 1320a-7b(f)) (Federal health care program requirements) and with the statutes, regulations, and written directives of the Food and Drug Administration (FDA requirements).

Orthofix International N.V. – Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Orthofix International, N.V. (June 7th, 2012)

Orthofix International, N.V. (Orthofix N.V.) 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 by Orthofix N.V. and its U.S. subsidiaries with the statutes, regulations, and written directives of Medicare, Medicaid, and all other Federal health care programs (as defined in 42 U.S.C. SS 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, Orthofix N.V. and its wholly owned subsidiary, Orthofix, Inc. (OFX) are entering into a settlement agreement with the United States. Further, it is anticipated that in the near future Blackstone Medical Inc. d/b/a Orthofix Spinal Implants (OSI), a wholly owned subsidiary of Orthofix, N.V., will be entering into a separate settlement agreement with the United States

Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Lhc Group, Inc. (September 30th, 2011)

A narrative explanation of the IRO's findings and supporting rationale (including reasons for errors, patterns noted, etc.)

Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Hill-Rom Holdings, Inc. (September 28th, 2011)

Hill-Rom Holdings, Inc. (Hill-Rom) 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. SS 1320a-7b(f)) (Federal health care program requirements). Contemporaneously with this CIA, Hill-Rom is entering into a Settlement Agreement with the United States. This CIA shall apply only to the U.S. operations of Hill-Rom that are subject to U.S. Federal health care program requirements.

Wright Medical Group, Inc. – AMENDMENT TO CORPORATE INTEGRITY AGREEMENT Between the Office of Inspector General of the Department of Health and Human Services and Wright Medical Technology, Inc. (September 15th, 2011)

Effective September 29, 2010, Wright Medical Technology, Inc. (Wright) entered into a Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) of the United States Department of Health and Human Services. Contemporaneously with the CIA, Wright entered into a Settlement Agreement and Deferred Prosecution Agreement (DPA) with the United States.

CORPORATE INTEGRITY AGREEMENT Between the Office of Inspector General of the Department of Health and Human Services and WellCare Health Plans, Inc. (August 3rd, 2011)

such a timely written request, Stipulated Penalties for failure to perform the act or file the notification or report shall not begin to accrue until three business days after WellCare 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.

Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Elan Corporation, Plc (February 24th, 2011)

Elan Corporation, plc 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. SS 1320a-7b(f)) (Federal health care program requirements) and with the statutes, regulations, and written directives of the Food and Drug Administration (FDA requirements). This CIA specifically applies to Elan Corporation, plc and all its corporate subsidiaries, or other Elan affiliates (as defined below) that engage or employ individuals who meet the definition of Covered Persons set forth below in Section II (collectively Elan). Contemporaneously with this CIA, Elan Corporation, plc is entering into a Settlement Agreement with the United States. Elan Corporation, plc will also enter into settlement agreements with various States

Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Exactech, Inc. (December 8th, 2010)

Exactech, Inc. (Exactech) 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. SS 1320a-7b(f)) (Federal health care program requirements). Contemporaneously with this CIA, Exactech is entering into a Settlement Agreement and Deferred Prosecution Agreement (DPA) with the United States. This CIA shall apply only to U.S. operations of Exactech that are subject to U.S. Federal health care program requirements.

Corporate Integrity Agreement (November 9th, 2010)

Forest Laboratories, Inc. 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 by Forest Laboratories, Inc., and its U.S. subsidiaries (Forest Pharmaceuticals, Inc., Forest Research Institute, Inc., FL Cincinnati Inc., Inwood Laboratories, Inc., and Cerexa, Inc.) (collectively "Forest") with the statutes, regulations, and written directives of Medicare, Medicaid, and all other Federal health care programs (as defined in 42 U.S.C. SS 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, Forest Laboratories, Inc. and Forest Pharmaceuticals, Inc. are entering into a Settlement Agreement and Release with the United States. Forest Laboratories, Inc. and Forest Pharmaceuticals, Inc. will also enter into set

Wright Medical Group, Inc. – CORPORATE INTEGRITY AGREEMENT Between the Office of Inspector General of the Department of Health and Human Services and Wright Medical Technology, Inc. (September 30th, 2010)

Wright Medical Technology, Inc. (Wright) 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. SS 1320a-7b(f)) (Federal health care program requirements). Contemporaneously with this CIA, Wright is entering into a Settlement Agreement and Deferred Prosecution Agreement (DPA) with the United States. This CIA shall apply only to U.S. operations of Wright that are subject to U.S. Federal health care program requirements.

Allergan – Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Allergan, Inc. (September 1st, 2010)

Allergan, Inc. (Allergan) 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. SS 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, Allergan is entering into a Settlement Agreement with the United States. Allergan will also enter into settlement agreements with various States (State Settlement Agreements) and Allergans agreement to this CIA is a condition precedent to those agreements.

CORPORATE INTEGRITY AGREEMENT Between the Office of Inspector General of the Department of Health and Human Services and Boston Scientific Corporation (February 26th, 2010)

Boston Scientific Corporation 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. SS 1320a-7b(f)) (Federal health care program requirements). Notwithstanding the fact that Boston Scientific Corporation (Boston Scientific) is the party to this CIA and responsible for ensuring its implementation, the undertakings in this CIA relate only to its Cardiac Rhythm Management business activities and the following related corporate entities: Guidant Corporation, Cardiac Pacemakers, Inc. and Guidant Sales Corporation (collectively, Guidant/CRM) and those persons who meet the definition of Covered Persons set forth below in Section II. Contemporaneously with this CIA, Boston Scientific is entering into a Settlement A

Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Biovail Corporation (February 26th, 2010)

Biovail Corporation 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. SS 1320a-7b(f)) (Federal health care program requirements) and with the statutes, regulations, and written directives of the Food and Drug Administration (FDA requirements). This CIA specifically applies to Biovail Corporation and all its corporate subsidiaries, affiliates, and other related corporate entities, including but not limited to BTA Pharmaceuticals, Inc. (collectively Biovail). Contemporaneously with this CIA, Biovail Corporation is entering into a Settlement Agreement with the United States.

Atricure – Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Atricure, Inc. (February 5th, 2010)

AtriCure, Inc. 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. SS 1320a-7b(f)) (Federal health care program requirements). Contemporaneously with this CIA, AtriCure is entering into a Settlement Agreement with the United States.

CORPORATE INTEGRITY AGREEMENT Between the Office of Inspector General of the Department of Health and Human Services and Spectranetics Corporation (December 29th, 2009)

The Spectranetics Corporation (Spectranetics) 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. SS 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, Spectranetics is entering into a Settlement Agreement with the United States.

CORPORATE INTEGRITY AGREEMENT Between the Office of Inspector General of the Department of Health and Human Services and Eli Lilly and Company (February 27th, 2009)

Eli Lilly and Company (Lilly) 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. SS 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, Lilly is entering into a Settlement Agreement with the United States. Lilly will also enter into settlement agreements with various States (State Settlement Agreement and Release) and Lillys agreement to this CIA is a condition precedent to those agreements.

Second Addendum to the Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Healthsouth Corporation (February 24th, 2009)

This Second Addendum sets forth additional corporate integrity obligations for HealthSouth. All other sections of HealthSouth's CIA and the First Addendum to the CIA will remain unchanged and in effect, unless specifically amended herein or upon the prior written consent of the OIG and HealthSouth.

First Addendum to the Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Healthsouth Corporation (February 24th, 2009)

This First Addendum to the CIA sets forth additional corporate integrity obligations for HealthSouth. All other sections of HealthSouths CIA will remain unchanged and in effect, unless specifically amended herein or upon the prior written consent of the OIG and HealthSouth.

Corporate Integrity Agreement (September 29th, 2008)

Cephalon, Inc. (Cephalon) 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. SS 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, Cephalon is entering into a Settlement Agreement with the United States. Cephalon will also enter into settlement agreements with various States (Related State Settlement Agreements) and Cephalons agreement to this CIA is a condition precedent to those agreements.

Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Amerigroup Corporation (August 14th, 2008)

Amerigroup Corporation and its subsidiaries (Amerigroup) hereby enter 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. SS 1320a-7b(f)) (Federal health care program requirements). Contemporaneously with this CIA, Amerigroup is entering into a Settlement Agreement with the United States and the State of Illinois.

Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Rotech Healthcare Inc. (May 21st, 2008)

Rotech Healthcare Inc. (Rotech) 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. SS 1320a-7b(f)) (Federal health care program requirements). Contemporaneously with this CIA, Rotech is entering into a Settlement Agreement with the United States.

Thoramet, Inc. – Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Biomet, Inc. (May 6th, 2008)

Contemporaneously with this CIA Biomet, Inc. (Biomet) and Biomet Orthopedics, Inc. (Biomet Orthopedics) entered into a Settlement Agreement with the United States and a Deferred Prosecution Agreement (DPA) with the United States Attorneys Office for the District of New Jersey. Biomet Orthopedics is a wholly owned subsidiary of Biomet engaged in the business of designing, manufacturing, marketing and selling joint reconstruction and replacement products. Biomet and Biomet Orthopedics hereby enter into this CIA with the Office of Inspector General (OIG) of the United States Department of Health and Human Services (HHS) to promote compliance by their officers, directors, employees, contractors, and agents with the statutes, regulations, and written directives of Medicare, Medicaid, and all other Federal health care programs (as defined in 42 U.S.C. SS 1320a-7b(f)) (Federal health care program requirements). This CIA shall apply only to U.S. operations of Biomet that are subject to U.S. Fe

CORPORATE INTEGRITY AGREEMENT Between the Office of Inspector General of the Department of Health and Human Services and Zimmer, Inc. (October 2nd, 2007)

Zimmer, Inc. and Zimmer Holding, Inc (collectively Zimmer) hereby enter into this CIA with the Office of Inspector General (OIG) of the United States Department of Health and Human Services (HHS) to promote compliance by its officers, directors, employees, contractors, and agents with the statutes, regulations, and written directives of Medicare, Medicaid, and all other Federal health care programs (as defined in 42 U.S.C. SS 1320a-7b(f)) (Federal health care program requirements). Contemporaneously with this CIA, Zimmer is entering into a Settlement Agreement and Deferred Prosecution Agreement (DPA) with the United States. This CIA shall apply only to U.S. operations of Zimmer that are subject to U.S. Federal health care program requirements.

Columbia Valley Healthcare Systems L P – Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Hca-The Healthcare Company (August 2nd, 2007)

HCAThe Healthcare Company (HCA) 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 by itself, its subsidiaries, and their employees, contractors, agents, and physicians with the requirements of Medicare, Medicaid and all other Federal health care programs (as defined in 42 U.S.C. ss. 1320a-7b(f))(hereinafter collectively referred to as the Federal health care programs.) This CIA shall be applicable only to those operations of HCA that are subject to United States law and regulations. HCAs compliance with the terms and conditions in this CIA shall constitute an element of HCAs present responsibility with regard to participation in the Federal health care programs. Whenever the term HCA is used in this CIA, it includes all of HCAs subsidiaries, as defined in this agreement. Contemporaneously with this CIA, HCA is entering into a Settlement

Corporate Integrity Agreement (July 25th, 2007)

New Relevant Covered Persons shall receive this training within 60 days after the beginning of their employment or becoming Relevant Covered Persons, or within 90 days after the Effective Date, whichever is later. A Maximus employee who has completed the Specific Training shall review a new Relevant Covered Person's work, to the extent that the work relates to the delivery of patient care items or services and/or the preparation or submission of claims for reimbursement from any Federal health care program, until such time as the new Relevant Covered Person completes his or her Specific Training.

Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and Jazz Pharmaceuticals, Inc. (July 18th, 2007)

Jazz Pharmaceuticals, Inc. (Jazz) 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. SS 1320a-7b(f)) (Federal health care program requirements) and the statutes, regulations, and written directives of the Food and Drug Administration (FDA) (FDA requirements). Contemporaneously with this CIA, Jazz is entering into a Settlement Agreement with the United States. Jazz will also enter into settlement agreements with various states and Jazzs agreement to this CIA is a condition precedent to those settlement agreements.