EFFECTIVE AND BINDING AGREEMENT. Indivior and OIG agree as follows: A. This CIA shall become final and binding on the date the final signature is obtained on the CIA. B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA. C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Indivior’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements. D. The undersigned Indivior signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity and that they are authorized to execute this CIA. E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior /▇▇▇▇ ▇. Re/ 7/23/2020 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
Appears in 2 contracts
Sources: Corporate Integrity Agreement (Indivior PLC), Corporate Integrity Agreement (Indivior PLC)
EFFECTIVE AND BINDING AGREEMENT. Indivior J&J and OIG ▇▇▇ agree as follows:
A. This CIA shall be binding on the successors, assigns, and transferees of J&J.
B. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Indivior’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. The undersigned Indivior J&J signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity capacities and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. THIS PAGE IS INTENTIONALLY LEFT BLANK. /▇▇▇▇ ▇. ▇▇▇▇▇▇/ 10/31/13 ▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE Chief Compliance Officer ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇ /▇▇▇▇ ▇▇▇▇▇▇, Esq./ 10/31/13 ▇▇▇▇ ▇▇▇▇▇▇, ESQ. DATE King & Spalding LLP Counsel for ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇ /▇▇▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇, Esq./ 10/31/13 ▇▇▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇, ESQ. DATE King & Spalding LLP Counsel for ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇ /▇▇▇▇▇▇ ▇▇▇▇▇, Esq./ 10/31/13 ▇▇▇▇▇▇ ▇▇▇▇▇, ESQ. DATE King & Spalding LLP Counsel for ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇ ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES /▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE 10/31/13 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior /▇▇▇▇ ▇. Re/ 7/23/2020 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 10/31/13 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, ▇ DATE Senior Counsel DATE Office of the Inspector General /▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 10-31-2013 _ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇, ▇ DATE Senior Counsel Office of the Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
Appears in 2 contracts
Sources: Corporate Integrity Agreement, Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior Rite Aid and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. B. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) IndiviorRite Aid’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. C. The undersigned Indivior Rite Aid signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity capacities and that they are authorized to execute this CIA.
E. D. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 July 9, 2024 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇. ▇▇▇▇▇ DATE Chief Integrity & Compliance Executive Officer Indivior, Inc. _/▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇July 9, 2024 ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. Counsel for Rite Aid /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 07/09/24 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ DATE Chief Counsel to the Inspector General Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇/ 2024.07.09 ▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior /▇▇▇▇ ▇. Re/ 7/23/2020 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Office of Counsel to the Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior United Therapeutics and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Indivior’s United Therapeutics’ responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. The undersigned Indivior United Therapeutics signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted signatures shall constitute acceptable, binding signatures for purposes of this CIA. //s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇ 12/14/2017 ▇▇▇/ 7/24/2020 ▇▇▇▇ ▇▇▇▇▇▇▇ DATE Chief Compliance Officer United Therapeutics Corporation /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /▇▇▇12/14/17 ▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US Sidley Austin LLP Counsel for Indivior /United Therapeutics Corporation /s/ ▇▇▇▇ ▇. Re/ 7/23/2020 Re 12/18/17 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services //s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 ▇ 12/18/2017 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel ▇ DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Office of Counsel to the Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
Appears in 1 contract
Sources: Corporate Integrity Agreement (UNITED THERAPEUTICS Corp)
EFFECTIVE AND BINDING AGREEMENT. Indivior Respironics and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Indivior’s Respironics’ responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. The undersigned Indivior Respironics signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇ ▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ President and Chief Executive Officer _ 8/22/2022 _ DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 _ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Vice President and Treasurer 8/22/2022 _ _ DATE /▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE /__ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior to Philips RS North America LLC _ 8/16/2022 _ DATE /▇▇▇▇ ▇. Re/ 7/23/2020 ▇▇/ _ 8/24/2022 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel DATE ▇▇▇_ 8/25/22 ▇▇▇▇▇ ▇▇▇▇▇▇, ▇ DATE Senior Counsel Administrative and Civil Remedies Branch Office of Counsel to the Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent APPENDIX A ARRANGEMENTS TRANSACTIONS REVIEW The Monitor shall perform all components of each Arrangements Transactions Review. The Arrangements Transactions Review Organization (IRO) required by Section III.E shall be performed annually and shall cover each of the CIAfive Reporting Periods.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior Mylan and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect affect: (1) IndiviorMylan’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for the failure to follow applicable Federal health care program or FDA requirements.
D. The undersigned Indivior Mylan signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 8/15/17 ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ DATE Head of Global Compliance Operations and Chief Compliance Officer, North America Mylan Inc. /▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 8/16/17 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇. ▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior Mylan Inc. and Mylan Specialty L.P. DATE OF THE DEPARTMENT OF HEALTH AND-HUMAN SERVICES /▇▇▇▇ ▇. Re/ 7/23/2020 8/16/17 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 8/16/17 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Office of Inspector General U.S. Department of Health and Human Services DATE /▇▇▇▇▇▇ ▇▇▇▇▇▇/ 8/14/17 ▇▇▇▇▇▇ ▇▇▇▇▇▇ Senior Counsel Office of Inspector General U.S. Department of Health and Human Services DATE This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.
Appears in 1 contract
EFFECTIVE AND BINDING AGREEMENT. Indivior Essilor and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) IndiviorEssilor’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. The undersigned Indivior Essilor signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇ ▇▇▇▇▇/ 2/25/22 _ ▇▇▇▇▇ ▇. ▇▇▇▇▇, ESQ. DATE General Counsel Essilor of America, Inc., and Esssilor Laboratories of America, Inc. /▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior/ April 1, Inc. /▇▇2022_ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ , ESQ. DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells , ESQ. Dentons US LLP Counsel for Indivior Essilor of America, Inc., and Esssilor Laboratories of America, Inc. /▇▇▇▇ ▇. Re/ 7/23/2020 ▇▇/ _ 03/07/2022 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/_ April 4, 2022_ ▇/ 7/24/2020 ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, ▇ DATE Senior Counsel DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Administrative and Civil Remedies Branch Office of Counsel to the Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
A. IRO Engagement
1. Essilor shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the review in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.8 of the CIA or any additional information submitted by Essilor in response to a request by OIG, whichever is later, OIG will notify Essilor if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Essilor may continue to engage the IRO.
2. If Essilor engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, ▇▇▇▇▇▇▇ shall submit the information identified in Section V.A.8 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by ▇▇▇▇▇▇▇ at the request of OIG, whichever is later, OIG will notify Essilor if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Essilor may continue to engage the IRO.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior Rockport and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. B. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) IndiviorRockport’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. C. The undersigned Indivior Rockport signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity capacities and that they are authorized to execute this CIA.
E. D. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 /_ 6/8/2023 ▇▇▇▇▇ ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ , M.D. DATE Chief Integrity & Compliance Executive Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇6/13/23 ▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior DATE Administrator /▇▇▇▇ ▇. Re/ 7/23/2020 Re/_ 2023.06.12 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, / _ 2023.06.14 ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
A. IRO Engagement
1. Rockport shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall not have a prohibited relationship to Rockport as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.9 of the CIA or any additional information submitted by Rockport in response to a request by OIG, whichever is later, OIG will notify Rockport if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Rockport may continue to engage the IRO.
2. If Rockport engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, Rockport shall submit the information identified in Section V.A.9 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Rockport at the request of OIG, whichever is later, OIG will notify Rockport if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Rockport may continue to engage the IRO.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior The Companies and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. B. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) IndiviorBioReference’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. C. The undersigned Indivior OPKO and BioReference signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity capacities and that they are authorized to execute this CIA.
E. D. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. Chief Legal Officer for BioReference Health, LLC DATE Executive Vice President, Administration OPKO Health, Inc. __6/29/2022 DATE /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇/__ HOPE ▇. ▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior BioReference Health, LLC and OPKO Health, Inc. /▇▇▇▇ ▇. Re/ 7/23/2020 7/1/2022 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇_July 14, Senior Counsel DATE ▇▇▇2022 ▇▇▇▇▇ ▇▇▇▇▇▇, ▇ DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior TEN and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. B. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) IndiviorTEN’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. C. The undersigned Indivior TEN signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity capacities and that they are authorized to execute this CIA.
E. D. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 _7-17-23 ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Executive Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior TEN Healthcare /▇▇▇▇ ▇. Re/ 7/23/2020 07/24/23 ▇▇▇▇ ▇. RE Re DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services Services /▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇/ 7/24/2020 07/25/2023 ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, ▇▇ DATE Senior Counsel DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Administrative and Civil Remedies Branch Office of Inspector General U.S. Department of Health and Human Services Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.
A. IRO Engagement
1. TEN shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the review in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.6 of the CIA or any additional information submitted by TEN in response to a request by OIG, whichever is later, OIG will notify TEN if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, TEN may continue to engage the IRO.
2. If TEN engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, TEN shall submit the information identified in Section V.A.6 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by TEN at the request of OIG, whichever is later, OIG will notify TEN if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, TEN may continue to engage the IRO.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior Novartis and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Indivior’s Novartis’ responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. The undersigned Indivior Novartis signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ _ June 30, 2020 ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇ DATE President, Novartis Corporation U.S. Country President /▇▇▇▇▇▇ (▇▇▇▇▇) /_ 6-30-20 ▇▇▇▇▇▇ ▇▇▇▇▇ DATE Vice President & Chief Integrity Compliance Officer, Novartis Pharmaceuticals Corporation U.S. Country Head, Ethics, Risk & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇_6/30/20 ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ , Esq. DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ’▇▇▇▇▇▇▇ , Esq. ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇ Lovells US LLP Counsel for Indivior Novartis Pharmaceuticals Corporation ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES /▇▇▇▇ ▇. Re/ 7/23/2020 6/30/2020 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 6/30/2020 _ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel SENIOR COUNSEL DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel ASSOCIATE COUNSEL Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Indivior’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. The undersigned Indivior signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 7/24/2020_ ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 7/24/20_ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior Indivior ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES /▇▇▇▇ ▇. Re/ 7/23/2020 _ 07/23/2020 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 _ 07/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior Cephalon and OIG agree as follows:
A. This CIA shall be binding on the successors, assigns, and transferees of Cephalon;
B. This CIA shall become final and binding on the date the final signature is obtained on the CIA.;
B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Indivior’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.;
D. The undersigned Indivior Cephalon signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent signatory represents that they are he is signing this CIA in their his official capacity and that they are he is authorized to execute this CIA.; and
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /ON BEHALF OF CEPHALON, INC. /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇. September 29, 2008 ▇▇▇▇▇▇/ 7/24/2020 ▇ ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Date Chief Integrity & Compliance Executive Officer Indivior, Cephalon Inc. /▇/s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇ September 29, 2008 ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ DATE Date Cephalon Chief Legal Compliance Officer Indivior, Inc. //s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇ September 29, ▇▇▇▇ ▇▇▇▇ ▇. ▇▇▇▇/ 7/24/2020 ▇▇▇▇▇ Date Counsel for Cephalon, Inc. /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇ September 29, 2008 ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇ Date Counsel for Cephalon, Inc. ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE September 29, 2008 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior /▇▇▇▇ ▇. Re/ 7/23/2020 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 ▇ Date Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services Dear Healthcare Provider: As you may be aware Cephalon, Inc. recently entered into a global civil, criminal, and administrative settlement with the United States and individual states in connection with its promotion of three Cephalon products. This letter provides you with additional information about the settlement, explains Cephalon’s commitments going forward, and provides you with access to information about those commitments. In general terms, the Government alleged that Cephalon unlawfully promoted three drugs (Actiq, Gabitril, and Provigil) for uses not approved by the Food & Drug Administration (FDA). To resolve these matters, Cephalon pled guilty to a misdemeanor criminal violation and agreed to pay a total of $425 million to the Federal Government and state Medicaid programs. In addition, Cephalon paid $6,150,000 in a companion settlement with the Connecticut Attorney General related to unfair trade practice laws. Additional information about the settlements may be found at the following websites [include a link to the USAO, Cephalon (▇▇▇▇ ▇. .▇▇▇▇▇▇▇▇.▇▇▇), Senior Counsel DATE and Attorney General of Connecticut’s websites.] As part of the federal settlement, Cephalon also entered a five-year corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The corporate integrity agreement is available at ▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/fraud/cia/index.html. Under this agreement, Cephalon agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by Cephalon’s representatives to Cephalon’s Compliance Department or the FDA. Please call or email Cephalon at ▇-▇▇▇-▇▇▇-▇▇▇▇ or ▇▇▇▇▇▇▇▇ ▇▇@▇▇▇▇▇▇▇▇.▇▇▇ if you have questions about the settlement referenced above or to report any instances in which you believe that a Cephalon representative inappropriately promoted a product or engaged in other questionable conduct. Alternatively, Senior Counsel Office you may report any such instances to the FDA’s Division of Inspector General U.S. Department of Health Drug Marketing, Advertising, and Human Services Communications at 301-796- 1200. You should direct medical questions or concerns about the products to Cephalon’s Medical Information department. We appreciate your time and attention. We are dedicated to ensuring that we bring you the scientific and medical information you need to make well-informed decisions about whether Cephalon products are right for your patients. Sincerely, Chief Executive Officer Cephalon, Inc. This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.
Appears in 1 contract
EFFECTIVE AND BINDING AGREEMENT. Indivior Aegerion and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect affect: (1) IndiviorAegerion’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or and FDA requirements.
D. The undersigned Indivior Aegerion signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. //s/ ▇▇▇▇▇▇▇ ▇▇▇▇ 9/18/17 ▇▇▇▇▇▇▇ ▇▇▇▇ DATE President and Chief Accounting Officer Aegerion Pharmaceuticals, Inc. /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇ 9/18/2017 ▇▇▇▇▇ ▇▇▇▇▇▇▇ DATE Vice President, Ethics and Compliance Officer Aegerion Pharmaceuticals, Inc. /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /9/18/2017 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇. ▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇ Ropes & ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior /Aegerion Pharmaceuticals, Inc. /s/ ▇▇▇▇ ▇. Re/ 7/23/2020 Re 9/22/17 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services //s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 ▇ 9/22/17 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel ▇ DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Office of Counsel to the Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
Appears in 1 contract
Sources: Corporate Integrity Agreement (Novelion Therapeutics Inc.)
EFFECTIVE AND BINDING AGREEMENT. Indivior Insys and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) IndiviorInsys’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. The undersigned Indivior Insys signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 6/5/19 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇ DATE Chief Financial Officer Insys Therapeutics, Inc. /▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇/ ▇/▇/▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ ▇, ESQ. DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ , ESQ ▇▇▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇ Lovells US LLP Counsel for Indivior Insys Therapeutics, Inc. /▇▇▇▇ ▇. Re/ 7/23/2020 ▇▇/ ▇▇▇▇ ▇. RE DATE ▇▇ Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Office of Inspector General U.S. Department of Health and Human Services DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services DATE APPENDIX A INDEPENDENT REVIEW ORGANIZATION This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
A. IRO Engagement
1. Insys shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the review in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.8 of the CIA or any additional information submitted by Insys in response to a request by OIG, whichever is later, OIG will notify Insys if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Insys may continue to engage the IRO.
2. If Insys engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, Insys shall submit the information identified in Section V.A.8 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Insys at the request of OIG, whichever is later, OIG will notify Insys if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Insys may continue to engage the IRO.
B. IRO Qualifications The IRO shall:
1. assign individuals to conduct the IRO Reviews who have expertise in the pharmaceutical industry and in all applicable Federal health care program and FDA requirements relating to the Covered Functions, including but not limited to expertise relating to marketing and promotional activities associated with pharmaceutical products and the Federal Anti-Kickback Statute and False Claims Act.
2. assign individuals to design and select the samples for the IRO Transactions Reviews who are knowledgeable about the appropriate statistical sampling techniques; and
3. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Indivior’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. The undersigned Indivior signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 7/24/2020_ ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 7/24/20_ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior /▇▇▇▇ ▇. Re/ 7/23/2020 _ 07/23/2020 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 _ 07/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior Merit and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) IndiviorMerit’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. The undersigned Indivior Merit signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Executive Officer IndiviorMerit Medical Systems, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior /▇▇▇▇ ▇. Re/ 7/23/2020 Merit Medical Systems, Inc. King & Spalding LLP ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, DATE Senior Counsel DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Administrative and Civil Remedies Branch Office of Counsel to the Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior ▇▇▇▇ and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) IndiviorTaro’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. The undersigned Indivior Taro signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity capacities and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇/_ _ September 28, 2021 _ ▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Executive Officer IndiviorTaro Pharmaceuticals, U.S.A., Inc. /▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior/_ _ September 28, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇2021 _ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇ LLP Counsel for Taro Pharmaceuticals U.S.A., Inc. /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/__ _ September 28, 2021 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇ ▇▇▇DATE ▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP L.L.P Counsel for Indivior Taro Pharmaceuticals U.S.A., Inc. /▇▇▇▇ ▇. Re/ 7/23/2020 ▇▇/_ _ September 29, 2021 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 /_ _ September 30, 2021 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel ▇ DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇ Senior Counsel Office of Counsel to the Inspector General Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
A. IRO Engagement
1. Taro shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the review in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.8 of the CIA or any additional information submitted by ▇▇▇▇ in response to a request by OIG, whichever is later, OIG will notify Taro if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Taro may continue to engage the IRO.
2. If ▇▇▇▇ engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, ▇▇▇▇ shall submit the information identified in Section V.A.8 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by ▇▇▇▇ at the request of OIG, whichever is later, OIG will notify Taro if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Taro may continue to engage the IRO.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior ▇▇▇▇▇▇ and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Indivior’s ▇▇▇▇▇▇’▇ responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. The undersigned Indivior ▇▇▇▇▇▇ signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity capacities and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior_ September 27, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇2021 _ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇Vice President and Chief Ethics, Risk & Compliance Officer, N.A. Sandoz Inc. /▇▇▇▇ ▇. ▇▇▇▇▇▇▇ ▇▇/ 9/28/2021 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ Lovells US & Bird LLP Counsel for Indivior Sandoz Inc. /▇▇▇▇ ▇. Re/ 7/23/2020 ▇▇/_ _ September 29, 2021 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 /_ _ September 30, 2021 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel ▇ DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇ Senior Counsel Office of Counsel to the Inspector General Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior Amgen and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) IndiviorAmgen’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. The undersigned Indivior Amgen signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity capacities and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇ Chief Compliance Officer Amgen Inc. DATE DLA ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ Counsel for Amgen Inc. DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior // ▇▇▇▇ ▇. Re/ 7/23/2020 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General General U.S. Department of Health and Human Services DATE /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel 4/24/2019 DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Office of Inspector General U.S. Department of Health and Human Services APPENDIX A INDEPENDENT REVIEW ORGANIZATION This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior Baxano Surgical and OIG agree as follows:
A. This CIA shall be binding on the successors, assigns, and transferees of Baxano Surgical;
B. This CIA shall become final and binding on the date the final signature is obtained on the CIA.;
B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Indivior’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.;
D. The undersigned Indivior Baxano Surgical signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent signatory represents that they are he is signing this CIA in their his official capacity and that they are he is authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇K▇▇ ▇▇▇▇▇ DATE June 10, 2013 President & Chief Executive Officer Baxano Surgical, Inc. /s/ S▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior /▇▇▇▇ ▇. Re/ 7/23/2020 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇ ▇. S▇▇▇▇▇▇▇/ 7/24/2020 ▇ ▇▇▇▇▇ DATE June 10, 2013 Chief Compliance Officer Baxano Surgical, Inc. /s/ P▇▇▇▇ ▇. ▇▇▇▇▇ P▇▇▇▇ ▇▇▇▇▇▇ DATE June 10, 2013 H▇▇▇▇ Lovells US LLP Counsel for Baxano Surgical, Senior Counsel DATE Inc. /s/ M▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ M▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ DATE June 10, 2013 H▇▇▇▇ Lovells US LLP Counsel for Baxano Surgical, Inc. R▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ DATE June 24, 2013 Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services /s/ M▇▇▇▇ ▇▇▇▇▇▇ M▇▇▇▇ ▇▇▇▇▇▇ DATE June 24, 2013 Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
Appears in 1 contract
Sources: Corporate Integrity Agreement (Baxano Surgical, Inc.)
EFFECTIVE AND BINDING AGREEMENT. Indivior Biotronik and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. B. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) IndiviorBiotronik’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. C. The undersigned Indivior Biotronik signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity and that they are authorized to execute this CIA.
E. D. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇/_ 8.26.2022 ▇▇▇▇ ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer IndiviorDATE: President, Biotronik, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇8/26/2022 ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /ESQ. DATE: ▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior Biotronik, Inc. /▇▇▇▇ ▇. Re/ 7/23/2020 8/26/2022 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ Berlin/ 8/26/2022 ▇▇/ 7/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel ▇ BERLIN DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Office of Inspector General U.S. Department of Health and Human Services APPENDIX A INDEPENDENT REVIEW ORGANIZATION This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.
A. IRO Engagement
1. Biotronik shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the review in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.7 of the CIA or any additional information submitted by Biotronik in response to a request by OIG, whichever is later, OIG will notify Biotronik if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Biotronik may continue to engage the IRO.
2. If Biotronik engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, Biotronik shall submit the information identified in Section V.A.7 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Biotronik at the request of OIG, whichever is later, OIG will notify Biotronik if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Biotronik may continue to engage the IRO.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior Life Spine and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) IndiviorLife Spine’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. The undersigned Indivior signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 3/11/2021 _ ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Executive Officer IndiviorLife Spine, Inc. /▇▇▇▇▇▇▇ ▇▇▇▇▇▇/ 3/11/2021 _ ▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer IndiviorGeneral Counsel Life Spine, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior /▇▇▇▇ ▇. Re/ 7/23/2020 _ 3/16/2021 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇ ▇. ▇▇▇ ▇▇▇▇▇/ 7/24/2020 3/17/2021 ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel ▇ DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Deputy Branch Chief Administrative and Civil Remedies Branch Office of Counsel to the Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior ▇▇▇▇▇▇ and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. OIG may agree to a suspension of Genova’s obligations under this CIA based on a certification by Genova that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Genova is relieved of its CIA obligations, Genova shall be required to notify OIG in writing at least 30 days in advance if Genova plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA will be reactivated or modified.
D. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) IndiviorGenova’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. E. The undersigned Indivior Genova signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity capacities and that they are authorized to execute this CIA.
E. F. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇_ _ 13APR20 ▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Executive Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇Genova Diagnostics ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE Counsel for ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ Green ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior /▇▇▇▇ ▇. Re/ 7/23/2020 _ 4/17/20 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, BERLIN DATE Senior Counsel DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Administrative and Civil Remedies Branch Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior Allergan and OIG agree as follows:
A. This CIA shall be binding on the successors, assigns, and transferees of Allergan;
B. This CIA shall become final and binding on the date the final signature is obtained on the CIA.;
B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Indivior’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.;
D. The undersigned Indivior Allergan signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent signatory represents that they are he is signing this CIA in their his official capacity and that they are he is authorized to execute this CIA.; and
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /ON BEHALF OF ALLERGAN, INC. /s/ ▇▇▇▇-▇▇▇▇▇ ▇▇▇▇▇▇▇ 8/30/10 ▇▇▇▇-▇▇▇▇▇ ▇▇▇▇▇▇▇ Date Chief Compliance Officer Allergan, Inc. /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇▇ 8/30/10 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇▇ Skadden, Arps, Slate, ▇▇▇▇▇▇▇ & ▇▇▇▇ LLP Date Counsel for Allergan, Inc. /s/ ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇ 8/30/10 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇ Date Skadden, Arps, Slate, ▇▇▇▇▇▇▇ & ▇▇▇▇ LLP Counsel for Allergan, Inc. /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇ 8/30/10 ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇ Date King & Spalding LLP Counsel for Allergan, Inc. ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇8/20/10 ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior /▇▇▇▇ ▇. Re/ 7/23/2020 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.
Appears in 1 contract
EFFECTIVE AND BINDING AGREEMENT. Indivior ▇▇▇▇▇ and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA.
C. B. All requirements and remedies set forth in this CIA IA are in addition to and do not affect affect: (1) Indivior’s ▇▇▇▇▇’▇ responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. C. The undersigned Indivior signatories represent Saini signatory represents and warrant warrants that they are [he/she] is authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacity and that they are authorized to execute this CIAIA.
E. D. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /▇▇. ▇▇▇▇ ▇. Saini, MD/ 3/23/2023 ▇▇ ▇▇▇▇ ▇. SAINI, M.D. DATE Carolina Heart and Leg Center /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇_ 3/23/2023 ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ DATE The ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior Firm, PLLC /▇▇▇▇ ▇. Re/ 7/23/2020 _ 5/26/2023 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 4/5/23 ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel ▇ DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.C of the CIAIA.
A. IRO Engagement
1. Saini shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the review in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.2 of the IA or any additional information submitted by ▇▇▇▇▇ in response to a request by OIG, whichever is later, OIG will notify Saini if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Saini may continue to engage the IRO.
2. If ▇▇▇▇▇ engages a new IRO during the term of the IA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, ▇▇▇▇▇ shall submit the information identified in Section V.A.2 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information, or any additional information submitted by ▇▇▇▇▇ at the request of OIG, whichever is later, OIG will notify Saini if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Saini may continue to engage the IRO.
Appears in 1 contract
Sources: Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior Provider and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. B. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) IndiviorProvider’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. C. The undersigned Indivior Provider signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity capacities and that they are authorized to execute this CIA.
E. D. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ President, CHC Holdings, LLC _ 9.13.22 DATE ▇▇▇▇ & ▇▇▇▇▇▇▇▇ LLP Counsel for ▇▇▇▇▇▇ Healthcare DATE /▇▇▇▇ ▇. ▇▇▇▇▇▇/_ ▇▇▇▇ ▇. ▇▇▇▇▇▇ ▇▇▇▇▇ ▇& ▇▇▇▇▇▇▇ Counsel for ▇▇▇▇▇▇ Lovells US LLP Counsel for Indivior Healthcare DATE /▇▇▇▇ ▇. Re/ 7/23/2020 ▇▇/ 09/26/2022 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /▇▇▇▇▇ ▇. ▇▇▇▇▇/ 9.26.2022 ▇▇/ 7/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel ▇ DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services APPENDIX A INDEPENDENT REVIEW ORGANIZATION This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
A. IRO Engagement
1. Provider shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall not have a prohibited relationship to Provider as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.8 of the CIA or any additional information submitted by Provider in response to a request by OIG, whichever is later, OIG will notify Provider if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Provider may continue to engage the IRO.
2. If Provider engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, Provider shall submit the information identified in Section V.A.8 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Provider at the request of OIG, whichever is later, OIG will notify Provider if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Provider may continue to engage the IRO.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior A. All terms and OIG agree as follows:
A. This conditions of the CIA not modified in this Amendment shall become final and binding remain in effect for the remainder of the five-year period of compliance obligations that began on the CIA’s Effective Date of July 3, 2017. The Effective Date of this Amendment shall be the date the final signature is obtained on the CIAsignatory signs this Amendment (Amendment Effective Date).
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Indivior’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. The undersigned Indivior FHS and ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ signatories represent and warrant that they are authorized to execute this CIAAmendment. The undersigned OIG signatories represent that they are signing this CIA Amendment in their official capacity capacities and that they are authorized to execute this CIAAmendment.
E. C. This CIA Amendment may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAAmendment. Electronically-transmitted Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAAmendment. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇/ _ 2/19/20 ▇▇▇/ 7/24/2020 ▇▇▇ ▇▇▇▇▇▇ DATE President Foundations Health Solutions, Inc. /▇▇▇▇ ▇. ▇▇▇▇▇▇/_ _ 2/19/20 ▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE Counsel for Foundations Health Solutions, Inc. ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ LLP /▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /▇_ _ 2/19/20 ▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇ DATE /▇▇▇▇ ▇. ▇▇▇▇▇▇/_ _ 2/19/20 ▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Counsel for ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇ Lovells US ▇▇▇▇▇▇ ▇▇▇▇ LLP Counsel for Indivior /▇▇▇▇ ▇. Re/ 7/23/2020 _ 2/28/2020 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇▇ ▇. ▇▇▇▇▇/ 3/2/2020 ▇▇/ 7/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel ▇ DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior Amgen and OIG agree as follows:
A. This CIA shall be binding on the successors, assigns, and transferees of Amgen;
B. This CIA shall become final and binding on the date the final signature is obtained on the CIA.;
B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Indivior’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.;
D. The undersigned Indivior Amgen signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent signatory represents that they are he is signing this CIA in their his official capacity and that they are he is authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an Corporate Integrity Agreement Amgen Inc. original and all of which constitute one and the same CIA. Electronically-transmitted Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. Corporate Integrity Agreement Amgen Inc. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ Senior Vice President & Chief Compliance Officer Amgen Inc. 12/12/12 DATE ▇/▇▇▇▇▇ ▇. O’Connor/ ▇▇▇▇▇ ▇. O’Connor Ropes & Gray LLP Counsel for Amgen Inc. 12/10/12 DATE /▇▇▇▇▇▇▇ ▇. ▇▇▇▇ ▇▇▇/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ Lovells US Ropes & Gray LLP Counsel for Indivior Amgen Inc. 12/10/12 DATE Corporate Integrity Agreement Amgen Inc. /▇▇▇▇▇▇ ▇. Re/ 7/23/2020 ▇▇▇▇▇▇▇/ ▇▇▇▇▇▇ ▇. RE DATE ▇▇▇▇▇▇▇ Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services 12/14/12 DATE /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, ▇ Senior Counsel Office of Inspector General U. S. Department of Health and Human Services 12/14/12 DATE /▇▇▇▇ ▇. ▇▇▇▇▇▇/ ▇▇▇▇ ▇. ▇▇▇▇▇▇, ▇ Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services 12/14/12 DATE Corporate Integrity Agreement Amgen Inc. This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior Mallinckrodt and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) IndiviorMallinckrodt’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. The undersigned Indivior Mallinckrodt signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity capacities and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer IndiviorMarch 3, Inc. /▇▇2022 ▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇ DATE Executive Vice President and Chief Legal Officer Mallinckrodt plc /▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior. Dunn/ March 3, Inc. /▇▇2022 ▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 . DUNN DATE ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ Skadden, Arps, Slate, ▇▇▇▇▇▇▇ ▇& ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior Mallinckrodt plc /▇▇▇▇ ▇. Re/ 7/23/2020 ▇▇/ 02/07/2022 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 3/3/2022 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel ▇ DATE ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇, ▇ Senior Counsel Office of Counsel to the Inspector General U.S. Department Office of Health and Human Services Inspector General This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior The Rush Organization and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. OIG may agree to a suspension of the obligations under this CIA that apply to the Rush Organization based on a certification by the Rush Organization it is: (1) no longer providing health care items or services that will be billed to any Federal health care program; (2) do not have any ownership or control interest, as defined in 42 U.S.C. The Rush Organization Corporate Integrity Agreement
D. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Indiviorthe Rush Organization’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. E. The undersigned Indivior Rush Organization signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity capacities and that they are authorized to execute this CIA.
E. F. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. Arizona Health Services, PLLC Osteo Relief Institute, Inc. /▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 8/28/2019 /▇▇▇▇▇▇▇ ▇▇▇▇▇/ 8-29-19 /▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 8/29/2019 8/29/19 /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇, MD/ ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. M.D. for 8/29/2019 /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior▇, Inc. D.C. for himself and Artemis Health Management, LLC 8/29/19 /▇▇▇▇▇▇ ▇▇▇▇▇▇/ ▇▇▇▇▇ ▇▇▇▇▇▇, D.C. for himself 8/29/19 /▇▇▇▇ ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇ ▇▇▇▇▇▇ 8/29/19 /▇▇▇▇ ▇. Re/ 9/04/2019 /▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior /▇▇▇▇ ▇. Re/ 7/23/2020 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Office of Inspector General U.S. Department of Health and Human Services 9/3/2019 APPENDIX A INDEPENDENT REVIEW ORGANIZATION This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.
A. IRO Engagement
1. The Rush Organization shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the review in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.7 of the CIA or any additional information submitted by the Rush Organization in response to a request by OIG, whichever is later, OIG will notify the Rush Organization if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, the Rush Organization may continue to engage the IRO.
2. If the Rush Organization engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, the Rush Organization shall submit the information identified in Section V.A.7 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by the Rush Organization at the request of OIG, whichever is later, OIG will notify the Rush Organization if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, the Rush Organization may continue to engage the IRO.
B. IRO Qualifications The IRO shall:
1. assign individuals to conduct the Claims Review who have expertise in the Medicare and state Medicaid program requirements applicable to the claims being reviewed;
2. assign individuals to design and select the Claims Review sample who are knowledgeable about the appropriate statistical sampling techniques;
3. assign individuals to conduct the coding review portions of the Claims Review who have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements);
4. assign licensed nurses or physicians with relevant education, training and specialized expertise (or other licensed health care professionals acting within their scope of practice and specialized expertise) to make the medical necessity determinations required by the Claims Review; and
5. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.
C. IRO Responsibilities The IRO shall:
1. perform each Claims Review in accordance with the specific requirements of the CIA;
2. follow all applicable Medicare and state Medicaid program rules and reimbursement guidelines in making assessments in the Claims Review;
3. request clarification from the appropriate authority (e.g., Medicare contractor), if in doubt of the application of a particular Medicare or state Medicaid program policy or regulation;
4. respond to all OIG inquires in a prompt, objective, and factual manner; and
5. prepare timely, clear, well-written reports that include all the information required by Appendix B to the CIA.
D. The Rush Organization’s Responsibilities The Rush Organization shall ensure that the IRO has access to all records and personnel necessary to complete the reviews listed in III.D of this CIA and that all records furnished to the IRO are accurate and complete.
E. IRO Independence and Objectivity The IRO must perform the Claims Review in a professionally independent and objective fashion, as defined in the most recent Government Auditing Standards issued by the U.S. Government Accountability Office.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior Sanofi and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) IndiviorSanofi’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. The undersigned Indivior Sanofi signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity capacities and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. ON BEHALF OF SANOFI US SERVICES, INC., SANOFI-AVENTIS U.S., LLC AND /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇/ ▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal NA Compliance Officer Indivior, Inc. _2/28/20 Date /▇▇▇▇▇▇ ▇▇▇/ ▇▇▇▇ ▇▇▇ DLA ▇▇▇▇/ 7/24/2020 ▇ Counsel for Sanofi _2/28/2020 Date /▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ / ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇ Lovells US LLP DLA ▇▇▇▇▇ Counsel for Indivior Sanofi _2/28/20 Date /▇▇▇▇ ▇. Re/ 7/23/2020 2/28/2020 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 2/28/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Date Senior Counsel Office of Counsel to the Inspector General U.S. Department of Health and Human Services APPENDIX A INDEPENDENT REVIEW ORGANIZATION This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
A. IRO Engagement
1. Sanofi shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the review in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.8 of the CIA or any additional information submitted by Sanofi in response to a request by OIG, whichever is later, OIG will notify Sanofi if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Sanofi may continue to engage the IRO.
2. If Sanofi engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, Sanofi shall submit the information identified in Section V.A.8 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Sanofi at the request of OIG, whichever is later, OIG will notify Sanofi if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Sanofi may continue to engage the IRO.
B. IRO Qualifications The IRO shall:
1. assign individuals to conduct the IRO Reviews who have expertise in the pharmaceutical industry and in all applicable Federal health care program and FDA requirements relating to the Covered Functions, including but not limited to expertise relating to marketing and promotional activities associated with pharmaceutical products and the Federal Anti-Kickback Statute and False Claims Act.
2. assign individuals to design and select the samples for the IRO Transactions Reviews who are knowledgeable about the appropriate statistical sampling techniques; and
3. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.
C. IRO Responsibilities The IRO shall:
1. perform each component of the IRO Reviews in accordance with the specific requirements of the CIA;
2. follow all applicable Federal health care program and FDA requirements in making assessments in the IRO Reviews;
3. respond to all OIG inquires in a prompt, objective, and factual manner; and
4. prepare timely, clear, well-written reports that include all the information required by Appendix B to the CIA.
D. Sanofi Responsibilities Sanofi 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.
Appears in 1 contract
Sources: Corporate Integrity Agreement
EFFECTIVE AND BINDING AGREEMENT. Indivior and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA..
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA..
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) IndiviorMerit’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements..
D. The undersigned Indivior Merit signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity and that they are authorized to execute this CIA..
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇ /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇LampropoulosOctober 13, 2020 ▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE LAMPROPOULOSDATE Chief Integrity & Compliance Executive Officer IndiviorMerit Medical Systems, Inc. /▇▇ /s/ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇/s/ ▇▇▇▇▇▇▇ DATE Chief Legal Officer IndiviorPauzeOctober 13, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ 2020 SETH LUNDYDATE ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior /Merit Medical Systems, Inc. King & Spalding LLP ▇▇▇▇ ▇. Re/ 7/23/2020 ▇▇▇▇ ▇. RE DATE REDATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, . BAINERDATE Senior Counsel Administrative and Civil Remedies Branch Office of Counsel to the Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA..
Appears in 1 contract
Sources: Corporate Integrity Agreement (Merit Medical Systems Inc)
EFFECTIVE AND BINDING AGREEMENT. Indivior ▇▇▇▇▇▇ and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA.
C. B. All requirements and remedies set forth in this CIA IA are in addition to and do not affect affect: (1) Indivior▇▇▇▇▇▇’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. C. The undersigned Indivior signatories represent ▇▇▇▇▇▇ signatory represents and warrant warrants that they are he is authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacity and that they are authorized to execute this CIA.IA.
E. D. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 , MD/ 8/5/22 ▇▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇, M.D. DATE Individually and on behalf of ▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior▇▇▇▇▇▇, M.D., Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇/__ __8/9/22_ _ ▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP & Associates, P.C. Counsel for Indivior ▇▇▇▇▇▇▇▇ (▇▇▇▇) ▇▇▇▇▇▇, M.D. and ▇▇▇▇ ▇▇▇▇▇▇, M.D., Inc. ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES /▇▇▇▇ ▇. Re/ 7/23/2020 8/12/2022 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇▇ ▇. ▇▇▇▇/_ _ 8/10/2022 ▇▇▇/ 7/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel ▇ DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Office of Inspector General U.S. Department of Health and Human Services APPENDIX A INDEPENDENT REVIEW ORGANIZATION This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.C of the CIAIA.
A. IRO Engagement
1. ▇▇▇▇▇▇ shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the review in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.2 of the IA or any additional information submitted by ▇▇▇▇▇▇ in response to a request by OIG, whichever is later, OIG will notify ▇▇▇▇▇▇ if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, ▇▇▇▇▇▇ may continue to engage the IRO.
2. If ▇▇▇▇▇▇ engages a new IRO during the term of the IA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, ▇▇▇▇▇▇ shall submit the information identified in Section V.A.2 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information, or any additional information submitted by ▇▇▇▇▇▇ at the request of OIG, whichever is later, OIG will notify Kamali if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, ▇▇▇▇▇▇ may continue to engage the IRO.
Appears in 1 contract
Sources: Integrity Agreement