Common use of Stipulated Penalties for Failure to Comply with Certain Obligations Clause in Contracts

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a Compliance Officer; (b) a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) written Policies and Procedures; (f) the development of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails to engage and use an IRO as required by Section III.E and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails to submit any IRO Review report in accordance with the requirements of Section III.E and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior stating the specific grounds for its determination that Indivior has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 of this Section.

Appears in 2 contracts

Samples: Corporate Integrity Agreement (Indivior PLC), Corporate Integrity Agreement (Indivior PLC)

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Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior KDMC and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior KDMC fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) the management certification obligations and the development and implementation of d. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) e. written Policies and Procedures; (f) the development of a written training plan and f. the training and education of Covered Persons Persons, Relevant Covered Persons, Arrangements Covered Persons, Board Members, and NGC members; (g) a risk assessment Executive Management; g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements described in Sections III.F.1 and mitigation process; (h) III.F.2; h. a Disclosure Program; (i) i. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) j. notification of Government investigations or legal proceedings;; and (l) k. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior KDMC fails to engage and use an IRO IRO, as required by in Section III.E III.E, Appendix A, Appendix B, and Appendix B.C. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior KDMC fails to timely submit (a) engage and use a complete Implementation Report or Annual ReportPeer Review Consultant, (b) a certification to OIG as required in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.III.D. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior KDMC fails to engage and use the Physician Executive(s), as required in Section III.A.6. 5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day KDMC fails to engage and use a Medical Director of the Cardiac Catheterization Laboratory, as required in Section III.A.7. 6. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day KDMC fails to engage and use the Board Compliance Expert, as required in Section III.A.4. 7. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day KDMC fails to submit the Implementation Report or any IRO Review report Annual Reports to OIG in accordance with the requirements of Section V by the deadlines for submission. 8. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day KDMC fails to submit the Compliance Program Review Report, as required in Section III.A.4.a.v for the first, third, and fifth Reporting Periods. 9. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day KDMC fails to submit the Systems Review Report by the Peer Review Consultant, the annual Monitoring Reports by the Peer Review Consultant, the annual Interventional Cardiac Procedures Review Report, Arrangements Review Report, or Unallowable Cost Review Report in accordance with the requirements of Section III.D, Section III.E and Appendix B.Appendices B and C by the deadlines for submission. 510. A Stipulated Penalty of $1,500 for each day Indivior KDMC fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior KDMC fails to grant access.) 611. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior KDMC as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 812. A Stipulated Penalty of $1,000 for each day Indivior KDMC fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior KDMC stating the specific grounds for its determination that Indivior KDMC has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior KDMC shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior KDMC receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-11 of this Section.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Progenity and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Progenity fails to establish, implement or comply with any of the following obligations as described in Section Sections III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3.; (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) e. written Policies and Procedures; (f) f. the development of a written training plan and the training and education of Covered Persons Persons, Arrangements Covered Persons, and NGC Board members; (g) g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements; h. a risk assessment and mitigation internal review process; (h) i. a Disclosure Program; (i) j. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings; (l) l. policies and procedures regarding the repayment of Overpayments; and m. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Progenity fails to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix B.A, Appendix B, or Appendix C. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Progenity fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Progenity fails to submit any IRO Arrangements Review report Report in accordance with the requirements of Section III.E and Appendix B. 5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C. 6. A Stipulated Penalty of $1,500 for each day Indivior Progenity fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Progenity fails to grant access.) 67. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Progenity as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 78. A Stipulated Penalty of $2,500 for each day Indivior Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.E., and for each day Indivior Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; andA. 89. A Stipulated Penalty of $1,000 for each day Indivior Progenity fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Progenity stating the specific grounds for its determination that Indivior Progenity has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Progenity shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Progenity receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-8 of this Section.

Appears in 2 contracts

Samples: Corporate Integrity Agreement (Progenity, Inc.), Corporate Integrity Agreement (Progenity, Inc.)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy1. Unless otherwise specified herein, Indivior and OIG hereby agree that failure to comply with certain obligations as set forth in any Breach of any term of this CIA may lead shall be subject to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A a Stipulated Penalty of $2,500 (which per day. a. The Stipulated Penalty shall begin to accrue on the day after that the date the obligation became due) per obligation Breach occurs and shall continue to accrue for each day Indivior that the Provider fails to establish, implement or comply with any the term of this CIA giving rise to the following obligations as described in Section III:Breach. If the Provider cures the Breach, Stipulated Penalties shall cease accruing on the date that the Provider cures the Breach. (a) a Compliance Officer; (b) a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) the management certification obligations and the development and implementation of a written process b. The penalty shall be assessable for Certifying Employees, as required by Section III.A.4; (e) written Policies and Procedures; (f) the development of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting each Breach of any Payment-related informationterm of this CIA, independent of any other Breach of this CIA. 2. A In addition to any other penalty that may be assessed under the terms of this CIA, Provider’s failure to cooperate, respond or respond completely or timely, in connection with any request made by OMIG, or its duly authorized representative under Section VII – OMIG’s Inspection, Audit and Review Rights shall be subject to a Stipulated Penalty of $2,500 (which 1,500 per day. a. The Stipulated Penalty shall begin to accrue on the day after that the date the obligation became due) Breach occurs and shall continue to accrue for each day Indivior that the Provider fails to engage and use an IRO as required by Section III.E and Appendix B.comply with the term of this CIA giving rise to the Breach. If the Provider cures the Breach, Stipulated Penalties shall cease accruing on the date that the Provider cures the Breach. b. The penalty shall be assessable for each Breach of any term of this CIA, independent of any other Breach of this CIA. 3. A Stipulated Penalty of $2,500 (which 50,000 shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails to submit any IRO Review report in accordance with the requirements of Section III.E and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior fails to grant access.) 6. A Stipulated Penalty of $50,000 be imposed for each false certification submitted by or on behalf of Indivior Provider as part of its Implementation Report, any Annual ReportReports, additional documentation to a report (as requested by OIGOMIG), or as otherwise required by this CIA. In addition to any other remedy available to OMIG under the terms of this CIA, a false certification may also subject the person making the false certification to criminal prosecution for a misdemeanor or felony under the New York State Penal Law. 74. A Stipulated Penalty of $2,500 50,000 shall be imposed for each day Indivior fails false statement made by or on behalf of Provider under this CIA. Stipulated Penalties for false statements will apply to grant each false statement. In addition to any other remedy also available to OMIG under the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior fails to comply fully and adequately with any obligation terms of this CIA. OIG shall provide notice , a false statement may subject the person making the false statement to Indivior stating criminal prosecution for a misdemeanor or felony under the specific grounds for its determination that Indivior has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior receives this notice from OIG of the failure to complyNew York State Penal Law.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 of this Section.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Ensign Group and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Ensign Group fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) the management certification obligations and the development and implementation of d. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) e. written Policies and Procedures; (f) the development of a written training plan and f. the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard of Directors; (g) a risk assessment and mitigation process; (h) g. a Disclosure Program; (i) h. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) i. notification of Government investigations or legal proceedings;; and (l) j. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Ensign Group fails to engage and use an IRO IRO, as required by in Section III.E III.D, Appendix A, Appendix B, and Appendix B.C. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Ensign Group fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Ensign Group fails to submit any IRO MDS Review Report, Therapy Systems Assessment Report, or Unallowable Cost Review Report or any response to such report in accordance with the requirements of Section III.E III.D, Appendix B, and Appendix B.C. 5. A Stipulated Penalty of $1,500 for each day Indivior Ensign Group fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Ensign Group fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Ensign Group as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Ensign Group fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Ensign Group stating the specific grounds for its determination that Indivior Ensign Group has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Ensign Group shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Ensign Group receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 2 contracts

Samples: Corporate Integrity Agreement (Ensign Group, Inc), Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior RMC and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior RMC fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) the management certification obligations and the development and implementation of d. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) e. written Policies and Procedures; (f) the development of a written training plan and f. the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) a risk assessment and mitigation process; (h) g. a Disclosure Program; (i) h. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) i. notification of Government investigations or legal proceedings;; and (l) j. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior RMC fails to engage and use an IRO IRO, as required by in Section III.E III.D, Appendix A, and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior RMC fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior RMC fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior RMC fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior RMC fails to grant access.) 6. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior RMC as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior RMC fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior RMC stating the specific grounds for its determination that Indivior RMC has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior RMC shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior RMC receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior LHC and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior LHC fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) the management certification obligations and the development and implementation of d. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct and Ethics; (e) e. written Policies and Procedures; (f) the development of a written training plan and f. the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) a risk assessment and mitigation process; (h) g. a Disclosure Program; (i) h. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) i. notification of Government investigations or legal proceedings;; and (l) j. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior LHC fails to engage and use an IRO IRO, as required by in Section III.E III.D, Appendix A, and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior LHC fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior LHC fails to submit any IRO Internal Audit Review, Claims Review report Report or Unallowable Cost Review Report in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior LHC fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior LHC fails to grant access.) 6. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior LHC as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior LHC fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior LHC stating the specific grounds for its determination that Indivior LHC has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior LHC shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior LHC receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 2 contracts

Samples: Corporate Integrity Agreement (LHC Group, Inc), Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior GSK and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior GSK fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board compliance obligations and obligations, including the engagement of a Compliance Expert, resolution from the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3Board; (d) d. the management accountability and certification obligations and the development and implementation of obligations; e. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) f. written Policies and Procedures; (f) the development of a written training plan and g. the training and education of Covered Persons Persons, Relevant Covered Persons, Management, and NGC membersBoard Members; (g) h. a risk assessment and mitigation processTRACER program; (h) i. a Disclosure Program; (i) j. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction k. an employee and Financial Recoupment Programsexecutive incentive compensation and recoupment program as required by Section III.H and Appendix E; (k) l. notification of Government investigations or legal proceedings; (l) proceedings as required by Section XXX.X; GlaxoSmithKline LLC Corporate Integrity Agreement m. reporting of Reportable Events; (m) Events as required in Section III.J; n. notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification FDA as required by Section III.K; o. a program for FFMP as required by Section III.L; p. a program for Non-Promotional Monitoring Program as required by Section III.M; q. notifications to HCPs HCPs, HCIs, and HCIsPayers as required by Section III.N; and (q) and r. posting of any Payment-related information.Payments as required by Section III.O. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior GSK fails to engage and use an IRO as required by in Section III.E and Appendix B.Appendices A-C. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior GSK fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Report to OIG in accordance with the requirements of Section V, V of the CIA or (c) a complete response to any request of Appendix D by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior GSK fails to submit any IRO Review report (including the IRO Initial Report) in accordance with the requirements of Section Sections III.E and Appendix B.III.V and Appendices A-C. 5. A Stipulated Penalty of $1,500 for each day Indivior fails to grant access as required in Section VII. 2,500 (This Stipulated Penalty which shall begin to accrue on the day after the date Indivior fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 the obligation became due) for each day Indivior GSK fails to grant the IRO access to all records establish and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior fails to comply fully and adequately with implement any obligation of this CIA. OIG shall provide notice to Indivior stating the specific grounds for its determination that Indivior has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior receives this notice from OIG of the failure to comply.) A Stipulated Penalty following obligations as described in this Subsection shall not be demanded for any violation for which OIG has sought Section III of Appendix D: a. a Stipulated Penalty under Subsections 1- 7 GMS Compliance Officer; b. a GMS Compliance Committee; c. the Board compliance obligations, including the resolution from GlaxoSmithKline LLC Corporate Integrity Agreement the Board; d. a written Code of this Section.Conduct;

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior CHSI and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior CHSI fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Corporate Compliance and Privacy Officer, Corporate Compliance Directors, and/or Facility Compliance Officers; (b) b. a Corporate Compliance CommitteeWork Group; and/or Facility Compliance Committees; (c) c. the NGC Board of Directors compliance obligations and the engagement obligations; Community Health Systems, Inc. Corporate Integrity Agreement d. a written Code of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3Conduct; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) e. written Policies and Procedures; (f) the development of a written training plan and f. the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) a risk assessment and mitigation process; (h) g. a Disclosure Program; (i) h. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) i. notification of Government investigations or legal proceedings;; and (l) j. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CHSI fails to engage and use an IRO IRO, as required by in Section III.E III.E, Appendix A, and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CHSI fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CHSI fails to submit any IRO Inpatient Medical Necessity and Appropriateness Review report Report, Unallowable Cost Review Report, or Arrangements Review Report in accordance with the requirements of Section III.E III.E, Appendix B, and Appendix B.C. 5. A Stipulated Penalty of $1,500 for each day Indivior CHSI fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior CHSI fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior CHSI as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.. Community Health Systems, Inc. Corporate Integrity Agreement 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior CHSI fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior CHSI stating the specific grounds for its determination that Indivior CHSI has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior CHSI shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior CHSI receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 2 contracts

Samples: Corporate Integrity Agreement (Quorum Health Corp), Corporate Integrity Agreement (Community Health Systems Inc)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Rehab and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Rehab fails to establish, establish and implement or comply with any of the following obligations as described in Section IIISections III and IV: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) d. the management certification obligations and the development and implementation of obligations; e. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) f. written Policies and Procedures; (f) g. the development and/or implementation of a written training plan and Training Plan for the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) h. a risk assessment and mitigation processprocess as required in Section III.E; (h) i. a Disclosure Program; (i) j. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings; (l) l. policies and procedures regarding the repayment of Overpayments; m. the repayment of Overpayments as required by Section III.I; n. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting o. disclosure of any Payment-related informationchanges to business units or locations. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Rehab fails to engage and use an IRO IRO, as required by in Section III.E III.D, Appendix A, and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Rehab fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Rehab fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior Rehab fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Rehab fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Rehab as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Rehab fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Rehab stating the specific grounds for its determination that Indivior Rehab has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Rehab shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Xxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Post Acute Medical and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Post Acute Medical fails to establish, implement or comply with any of the following obligations as described in Section Sections III: (a) a. a Compliance Officer;Officer;‌ (b) b. a Compliance Committee;Committee;‌ (c) c. the NGC Manager’s compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3;obligations;‌ (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;III.A.4;‌ (e) e. written Policies and Procedures;Procedures;‌ (f) f. the development of a written training plan and the training and education of Covered Persons Persons, Arrangements Covered Persons, and NGC members;Manager;‌ (g) g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;‌ h. a risk assessment and mitigation process;internal review process;‌ (h) i. a Disclosure Program;Program;‌ (i) j. Ineligible Persons screening and removal requirements;requirements;‌ (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings;proceedings;‌ (l) l. policies and procedures regarding the repayment of Overpayments; and‌ m. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.Events.‌ 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Post Acute Medical fails to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix B.A, or Appendix B.‌ 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Post Acute Medical fails to timely submit (a) a complete Implementation Report or Report, Annual Report, (b) a or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Post Acute Medical fails to submit any IRO Arrangements Review report Report in accordance with the requirements of Section Section‌‌ III.E and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior Post Acute Medical fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Post Acute Medical fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Post Acute Medical as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.CIA.‌ 7. A Stipulated Penalty of $2,500 for each day Indivior Post Acute Medical fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.D, and for each day Indivior Post Acute Medical fails to furnish to the IRO accurate and complete records to the IROrecords, as required by Section III.E and Appendix A; andA.‌ 8. A Stipulated Penalty of $1,000 for each day Indivior Post Acute Medical fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Post Acute Medical stating the specific grounds for its determination that Indivior Post Acute Medical has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Post Acute Medical shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Post Acute Medical receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.Section.‌

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior the Friendship Entities and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior fails the Friendship Entities fail to establish, establish and implement or comply with any of the following obligations as described in Section IIISections III and IV: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, Review and the preparation of a Compliance Program Review Report, as required by Section III.A.3.; (d) d. the management certification obligations and the development and implementation of obligations; e. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) f. written Policies and Procedures; (f) g. the development and/or implementation of a written training plan and Training Plan for the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) h. a risk assessment and mitigation processinternal review process as required by Section III.E; (h) i. a Disclosure Program; (i) j. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings; (l) l. policies and procedures regarding the repayment of Overpayments; m. the repayment of Overpayments as required by Section III.I and Appendix B; n. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting o. disclosure of any Payment-related informationchanges to business units or locations. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails the Friendship Entities fail to engage and use an IRO IRO, as required by Section III.E and III.D, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails the Friendship Entities fail to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails the Friendship Entities fail to submit any IRO Claims Review report or Additional Items Review Report in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior fails the Friendship Entities fail to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior fails the Friendship Entities fail to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior the Friendship Entities as part of its their Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior fails the Friendship Entities fail to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior the Friendship Entities stating the specific grounds for its determination that Indivior has the Friendship Entities have failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior the Friendship Entities shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior receives the Friendship Entities receive this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Good Shepherd and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Good Shepherd fails to establish, establish and implement or comply with any of the following obligations as described in Section IIISections III and IV: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) c. the management certification obligations and the development and implementation of obligations; d. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) e. written Policies and Procedures; (f) f. the development and/or implementation of a written training plan and Training Plan for the training and education of Covered Persons Persons, and NGC members; (g) Relevant Covered Persons; g. a risk assessment and mitigation processinternal review process as required by Section III.E; (h) h. a Disclosure Program; (i) i. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) j. notification of Government investigations or legal proceedings; (l) k. policies and procedures regarding the repayment of Overpayments; l. the repayment of Overpayments as required by Section III.I; m. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting n. disclosure of any Payment-related informationchanges to business units or locations. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Good Shepherd fails to engage and use an IRO IRO, as required by in Section III.E III.D, Appendix A, and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Good Shepherd fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Good Shepherd fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior Good Shepherd fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Good Shepherd fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Good Shepherd as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 10,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Good Shepherd fails to grant cooperate and otherwise satisfy any of the IRO access to all records obligations and personnel necessary to complete the reviews required by requirements as described in Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; andIII.K. 8. A Stipulated Penalty of $1,000 for each day Indivior Good Shepherd fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Good Shepherd stating the specific grounds for its determination that Indivior Good Shepherd has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Good Shepherd shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Good Shepherd receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Good Shepherd and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Good Shepherd fails to establish, establish and implement or comply with any of the following obligations as described in Section IIISections III and IV: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) c. the management certification obligations and the development and implementation of obligations; d. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) e. written Policies and Procedures; (f) f. the development and/or implementation of a written training plan and Training Plan for the training and education of Covered Persons and NGC members; (g) Relevant Covered Persons; g. a risk assessment and mitigation processinternal review process as required by Section III.E; (h) h. a Disclosure Program; (i) i. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) j. notification of Government investigations or legal proceedings; (l) k. policies and procedures regarding the repayment of Overpayments; l. the repayment of Overpayments as required by Section III.I; m. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting n. disclosure of any Payment-related informationchanges to business units or locations. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Good Shepherd fails to engage and use an IRO IRO, as required by in Section III.E III.D, Appendix A, and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Good Shepherd fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Good Shepherd fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior Good Shepherd fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Good Shepherd fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Good Shepherd as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 10,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Good Shepherd fails to grant cooperate and otherwise satisfy any of the IRO access to all records obligations and personnel necessary to complete the reviews required by requirements as described in Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; andIII.K. 8. A Stipulated Penalty of $1,000 for each day Indivior Good Shepherd fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Good Shepherd stating the specific grounds for its determination that Indivior Good Shepherd has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Good Shepherd shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Good Shepherd receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xxxxxxxxxx-Xxxxxxx Xxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Xxxxxxxxxx-Xxxxxxx Xxxxxx fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) c. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4obligations; (e) d. written Policies and Procedures; (f) the development of a written training plan and the e. training and education of Covered Persons and NGC membersPersons; (g) f. a risk assessment and mitigation internal review process;; Xxxxxxxxxx–Zwanger Xxxxxx – Corporate Integrity Agreement (h) g. a Disclosure Program; (i) h. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) i. notification of Government investigations or legal proceedings; (l) j. policies and procedures regarding the repayment of Overpayments; and k. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxxxxxxx-Xxxxxxx Xxxxxx fails to engage and use an IRO IRO, as required by Section III.E and III.D, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxxxxxxx-Xxxxxxx Xxxxxx fails to timely submit (a) a complete Implementation Report, Annual Report or Annual Report, (b) a any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxxxxxxx-Xxxxxxx Xxxxxx fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior stating the specific grounds for its determination that Indivior has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior PHC and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior PHC fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) the management certification obligations and the development and implementation of d. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) e. written Policies and Procedures; (f) the development of a written training plan and f. the training and education of Covered Persons Persons, Arrangements Covered Persons, and NGC members; (g) a risk assessment Board Members; g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements described in Sections III.D.1 and mitigation process; (h) III.D.2; h. a Disclosure Program; (i) i. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) j. notification of Government investigations or legal proceedings;; and (l) k. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior PHC fails to engage and use an IRO IRO, as required by in Section III.E III.E, Appendix A, and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior PHC fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior PHC fails to submit any IRO the annual Arrangements Review report Report or Unallowable Cost Review Report in accordance with the requirements of Section III.E and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior PHC fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior PHC fails to grant access.) 6. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior PHC as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior PHC fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior PHC stating the specific grounds for its determination that Indivior PHC has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior PHC shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior PHC receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Amedisys and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Amedisys fails to establish, implement or comply with have in place any of the following obligations as described in Section III:: Amedisys, Inc. and Amedisys Specialized Medical Services, Inc. Corporate Integrity Agreement 24 (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) the management certification obligations and the development and implementation of c. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) d. written Policies and Procedures; (f) the development of e. a written training plan and the training and education of requirement that Covered Persons and NGC members;be trained; and (g) a risk assessment and mitigation process; (h) f. a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Amedisys fails to engage and use retain an IRO IRO, as required by in Section III.E and Appendix B.III.D. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Amedisys fails to timely submit (a) a complete meet any of the deadlines for the submission of the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG. 4. A Stipulated Penalty of $2,500 2,000 (which shall begin to accrue on the day after the date the obligation became duefailure to comply began) for each day Indivior fails Amedisys employs or contracts with an Ineligible Person and that person: (a) has responsibility for, or involvement with, Amedisys’ business operations related to submit the Federal health care programs; or (b) is in a position for which the person’s salary or the items or services rendered, ordered, or prescribed by the person are paid in whole or part, directly or indirectly, by Federal health care programs or otherwise with Federal funds (the Stipulated Penalty described in this Subsection shall not be demanded for any IRO Review report time period during which Amedisys can demonstrate that it did not discover the person’s exclusion or other ineligibility after making a reasonable inquiry (as described in accordance with Section III.F) as to the requirements status of Section III.E and Appendix B.the person). 5. A Stipulated Penalty of $1,500 for each day Indivior Amedisys fails to grant access to the information or documentation as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Amedisys fails to grant access.)) Amedisys, Inc. and Amedisys Specialized Medical Services, Inc. Corporate Integrity Agreement 25 6. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior Amedisys as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), ) or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Amedisys fails to comply fully and adequately with any obligation of this CIA. In its notice to Amedisys, OIG shall provide notice to Indivior stating state the specific grounds for its determination that Indivior Amedisys has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Amedisys shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Amedisys receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Amedisys Inc)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xx. Xxxxxxxx and Fleckner, P.C. and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a Compliance Officer; (b) a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) written Policies and Procedures; (f) the development of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails Xx. Xxxxxxxx and Fleckner,‌ P.C. fail to engage establish, implement or comply with any of the following obligations as described in Section III: a. post a notice in accordance with the requirements of Section III.A; b. complete the training required for Xx. Xxxxxxxx and use an IRO Fleckner, P.C. and Covered Persons and maintain training records, in accordance with the requirements of Section III.B; c. screen Covered Persons in accordance with the requirements of Section III.E; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.E; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.E;‌‌ d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.F;‌ e. repay any Overpayments as required by Section III.E III.G and Appendix B.B;‌ 3f. report a Reportable Event in accordance with Section III.H;‌ g. provide to OIG the certifications required by Section III.I relating to any third party xxxxxx engaged by Xx. Xxxxxxxx and Xxxxxxxx, P.C. during the term of the IA.‌ 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails Xx. Xxxxxxxx and Fleckner,‌ P.C. fail to timely submit (a) a complete Implementation Report or Annual Reportengage and use an IRO, (b) a certification to OIG in accordance with the requirements of as required by Section VIII.D, Appendix A, or (c) a complete response to any request for information from OIG.Appendix B. 43. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails Xx. Xxxxxxxx and Fleckner,‌ P.C. fail to submit a complete Implementation Report, Annual Report, Quarterly Drug Inventory Report, or any IRO Review report certification to OIG in accordance with the requirements of Section III.E V by the deadlines for submission. 4. A Stipulated Penalty of $1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Xx. Xxxxxxxx and Fleckner,‌ P.C. fail to submit any Quarterly Claims Review Report in accordance with the requirements of Section III.D and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B. 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior fails Xx. Xxxxxxxx and Fleckner, P.C. fail to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Xx. Xxxxxxxx and Xxxxxxxx, P.C. fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Xx. Xxxxxxxx and Xxxxxxxx, P.C. as part of its their‌ Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIA.IA.‌ 7. A Stipulated Penalty of $2,500 1,000 for each day Indivior fails Xx. Xxxxxxxx and Fleckner, P.C. fail to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.D, and for each day Indivior fails Xx. Xxxxxxxx and Xxxxxxxx,‌ P.C. fail to furnish accurate and complete records to the IRO, as required by Section III.E III.D and Appendix A; andA. 8. A Stipulated Penalty of $1,000 for each day Indivior fails Xx. Xxxxxxxx and Fleckner, P.C. fail to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior Xx. Xxxxxxxx and Fleckner, P.C. stating the specific grounds for its determination that Indivior has Xx. Xxxxxxxx and Fleckner, P.C. have failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Indivior shall take to comply with the CIAXx. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 of this Section.Xxxxxxxx and Fleckner,‌

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior UHS and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior UHS fails to establish, implement implement, or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) d. a Quality of Care Review Program; e. a Dashboard; f. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) g. written Policies and Procedures; (f) h. the development of a written training plan and the training and education of Covered Persons and NGC membersBoard Members; (g) i. retention of a Monitor; j. a risk assessment and mitigation internal review process; (h) k. a Disclosure Program; (i) l. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) m. notification of Government investigations or legal proceedings; (l) n. policies and procedures regarding the repayment of Overpayments; and o. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior UHS fails to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior UHS fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a Annual Reports, or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $1,500 for each day UHS fails to grant access as required in Section VII (This Stipulated Penalty shall begin to accrue on the date UHS fails to grant access.). 5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior UHS fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior B or fails to grant access repay any Overpayment identified by the IRO, as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior fails to grant access.)by Appendix B. 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior UHS as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior UHS fails to pay a Monitor, as required in Section III.D.5. 8. A Stipulated Penalty of $2,500 for each day UHS fails to comply fully and adequately with any of its obligations with respect to the Monitor, including but not limited to the obligation to grant the Monitor access, as set forth in Section III.D.2, and the obligation to adequately and timely respond to any written recommendation of the Monitor, as set forth in Section III.D.6. OIG shall provide notice to UHS stating the specific grounds for its determination that UHS has failed to comply fully and adequately with the CIA obligation(s) at issue and steps UHS shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 days after UHS receives this notice from OIG of the failure to comply.) 9. A Stipulated Penalty of $2,500 for each day UHS fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.E, and for each day Indivior UHS fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; andA. 810. A Stipulated Penalty of $1,000 for each day Indivior UHS fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior UHS stating the specific grounds for its determination that Indivior UHS has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior UHS shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior UHS receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-9 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Universal Health Services Inc)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior InterMune and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior InterMune fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) the NGC compliance obligations and the engagement c. a written Code of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3Conduct; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) d. written Policies and Procedures; (f) the development of a written training plan and e. the training and education of Covered Persons and NGC membersPersons; (g) a risk assessment and mitigation process; (h) f. a Disclosure Program; (i) g. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification h. Notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) i. notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIsregarding off-label related matters; and (q) posting j. a review of any Payment-related informationrecords reflecting the content of detailing sessions. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior InterMune fails to engage and use an IRO IRO, as required by in Section III.E III.D and Appendix Appendices A and B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior InterMune fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior InterMune fails to submit the annual Report associated with any IRO Review report of the Reviews in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior InterMune fails to grant access to the information or documentation as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior InterMune fails to grant access.) 6. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior InterMune as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior InterMune fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior InterMune, stating the specific grounds for its determination that Indivior InterMune has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior InterMune shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior InterMune receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Intermune Inc)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior CHSI and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior CHSI fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Corporate Compliance and Privacy Officer, Corporate Compliance Directors, and/or Facility Compliance Officers; (b) b. a Corporate Compliance CommitteeWork Group; and/or Facility Compliance Committees; (c) c. the NGC Board of Directors compliance obligations and the engagement obligations; Community Health Systems, Inc. Corporate Integrity Agreement, Amended d. a written Code of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3Conduct; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) e. written Policies and Procedures; (f) the development of a written training plan and f. the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) a risk assessment and mitigation process; (h) g. a Disclosure Program; (i) h. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) i. notification of Government investigations or legal proceedings;; and (l) j. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CHSI fails to engage and use an IRO IRO, as required by in Section III.E III.E, Appendix A, and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CHSI fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CHSI fails to submit any IRO Claims Review report Report, Unallowable Cost Review Report, or Arrangements Review Report in accordance with the requirements of Section III.E III.E, Appendix B, and Appendix B.C. 5. A Stipulated Penalty of $1,500 for each day Indivior CHSI fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior CHSI fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior CHSI as part of its Implementation Report, any Annual Report, Community Health Systems, Inc. Corporate Integrity Agreement, Amended additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior CHSI fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior CHSI stating the specific grounds for its determination that Indivior CHSI has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior CHSI shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior CHSI receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Community Health Systems Inc)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior VITAS and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as "Stipulated Penalties") in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior VITAS fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Governing Body compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4obligations; (e) e. written Policies and Procedures; (f) the development of a written training plan and the f. training and education of Covered Persons and NGC membersGoverning Body Members; (g) g. a risk assessment and mitigation internal review process; (h) h. a Disclosure Program; (i) i. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) j. notification of Government investigations or legal proceedings; (l) k. policies and procedures regarding the repayment of Overpayments; and l. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.. Vitas Corporate Integrity Agreement 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior VITAS fails to engage and use an IRO IRO, as required by Section III.E and III.D, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior VITAS fails to timely submit (a) a complete Implementation Report, Annual Report or Annual Report, (b) a any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior VITAS fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior VITAS fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior VITAS fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior VITAS as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior VITAS fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior VITAS stating the specific grounds for its determination that Indivior VITAS has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior VITAS shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior VITAS receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.. Vitas Corporate Integrity Agreement

Appears in 1 contract

Samples: Corporate Integrity Agreement (Chemed Corp)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Cephalon and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Cephalon fails to establish, implement implement, or comply with accomplish any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3Board resolution; (d) the management certification obligations and the development and implementation of d. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) e. written Policies and Procedures; (f) the development of a written training plan and f. the training and education of Covered Persons and NGC membersPersons; (g) g. a risk assessment and mitigation processDisclosure Program as required by Section III.E; (h) a Disclosure Program; (i) h. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) i. notification of Government investigations or legal proceedings; (l) reporting j. notification of Reportable Eventscommunications with FDA regarding off-label matters; k. Message Recall Studies (m) notification of written communications with FDAor alternative information permitted by Section III.J); (n) the l. a program for FFMP; (o) the NPMP; (p) m. notification to HCPs and HCIsany health care providers or entities as required by Section III.L; andor (q) n. posting of any Payment-related information.Payments as required by Section III.M. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Cephalon fails to engage and use an IRO IRO, as required by in Section III.E III.D and Appendix Appendices A-B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Cephalon fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Cephalon fails to submit any the annual IRO Review report Report(s) in accordance with the requirements of Section III.E Sections III.D and V.B.6 and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior Cephalon fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Cephalon fails to grant access.) 6. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior Cephalon as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Cephalon fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Cephalon, stating the specific grounds for its determination that Indivior Cephalon has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Cephalon shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Cephalon receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Cephalon Inc)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Gambro and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Gambro fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) the NGC compliance obligations and the engagement c. a written Standards of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3Business Conduct; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) d. written Policies and Procedures; (f) the development of a written training plan and e. the training and education of Covered Persons and NGC membersPersons; (g) a risk assessment and mitigation process; (h) f. a Disclosure Program; (i) g. Ineligible Persons screening and removal requirements;; and (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification h. Notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Gambro fails to engage and use an IRO IRO, as required by in Section III.E and Appendix B.X. Xxxxxx Healthcare, Inc. Corporate Integrity Agreement 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Gambro fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Gambro fails to submit any IRO the annual Claims Review report Report, the Unallowable Cost Review Report, the annual Stat Labs Billing Review Report, or the annual Heightened Arrangements Review Report in accordance with the requirements of Section III.E Sections III.D and Appendix B.E and Appendixes B, C, D, and E. 5. A Stipulated Penalty of $1,500 for each day Indivior Gambro fails to grant access to the information or documentation as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Gambro fails to grant access.) 6. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior Gambro as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Gambro fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Gambro, stating the specific grounds for its determination that Indivior Gambro has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Gambro shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Gambro receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Davita Inc)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Sava and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.provisions.‌ 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Sava fails to establish, implement implement, or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee;Committee;‌ (c) c. the NGC Board of Directors compliance obligations and the engagement obligations;‌ d. a Quality of Care Review Program;‌ e. a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3;Dashboard;‌ (d) f. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;Employees;‌ (e) g. written Policies and Procedures;Procedures;‌ (f) h. the development of a written training plan and the training and education of Covered Persons and NGC members;Board Members;‌ (g) i. retention of a Monitor;‌ j. a risk assessment and mitigation process;internal review process;‌ (h) k. a Disclosure Program;Program;‌ (i) l. Ineligible Persons screening and removal requirements;requirements;‌ (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) m. notification of Government investigations or legal proceedings;proceedings;‌ (l) n. policies and procedures regarding the repayment of Overpayments; and‌ o. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.Events.‌ 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Sava fails to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix B.B, or Appendix C.‌ 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Sava fails to timely submit (a) a complete Implementation any‌ Claims Review Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section VIII.E and Appendix C or fails to repay any Overpayment identified by the IRO, or (c) a complete response to any request for information from OIG.as required by Appendix C; 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Sava fails to submit a complete Implementation Report, Annual Reports, or any IRO Review report certification to OIG in accordance with the requirements of Section III.E and Appendix B.V by the deadlines for submission.‌ 5. A Stipulated Penalty of $1,500 for each day Indivior Sava fails to grant access as required in Section VII. VII (This Stipulated Penalty shall begin to accrue on the date Indivior Sava fails to grant access.)access.).‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Sava as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.CIA.‌ 7. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Sava fails to pay a Monitor, as required in Section III.D.5.‌ 8. A Stipulated Penalty of $2,500 for each day Indivior Sava fails to comply fully and adequately with any of its obligations with respect to the Monitor, including but not limited to the obligation to grant the Monitor access, as set forth in Section III.D.2, and the obligation to adequately and timely respond to any written recommendation of the Monitor, as set forth in Section III.D.6. OIG shall provide notice to Sava stating the specific grounds for its determination that Sava has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Sava shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 days after Sava receives this notice from OIG of the failure to comply.)‌ 9. A Stipulated Penalty of $2,500 for each day Sava fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.E, and for each day Indivior Sava fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; andB.‌ 810. A Stipulated Penalty of $1,000 for each day Indivior Sava fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Sava stating the specific grounds for its determination that Indivior Sava has failed to comply fully and and‌ adequately with the CIA obligation(s) at issue and steps Indivior Sava shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Sava receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-9 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xx. Xxxxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA (unless a timely written request for an extension has been submitted and approved in accordance with Section B below) may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a Compliance Officer; (b) a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) written Policies and Procedures; (f) the development of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 750 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xx. Xxxxxxxx fails to to: a. designate and maintain a Compliance Contact in accordance with the requirements of Section III.A; b. establish and/or post a notice in accordance with the requirements of Section III.B; c. implement, distribute, or update the procedures required by Section III.C; d. establish and implement a training program in accordance with the requirements of Section III.D; e. engage and use an IRO as required by in accordance with the requirements of Section III.E, Appendix A, and Appendix B; f. submit the IRO’s annual Claims Review Report in accordance with the requirements of Section III.E and Appendix B.B; 3g. obtain and maintain the following documentation: written procedures certifications in accordance with the requirements of Section III.C, training certification(s) in accordance with the requirements of Section III.D, and documentation of screening and disclosure requirements in accordance with the requirements of Section III.F; h. screen Covered Persons in accordance with the requirements of Section III.F; or require Covered Persons to disclose if they are debarred, excluded, suspended or are otherwise considered an Ineligible Person in accordance with the requirements of Section III.F; i. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.G; j. provide to OIG the certifications required by Section III.J relating to any third party xxxxxx engaged by Xx. Xxxxxxxx during the term of the IA; or k. report a Reportable Event. 2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xx. Xxxxxxxx fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 43. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) 750 for each day Indivior fails to submit any IRO Review report in accordance with the requirements of Section III.E and Appendix B. 5Xx. A Stipulated Penalty of $1,500 for each day Indivior Xxxxxxxx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Xx. Xxxxxxxx fails to grant access.) 64. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior Xx. Xxxxxxxx as part of its Implementation Report, any Annual ReportReports, additional documentation to a report (as requested by OIG), or as otherwise required by this CIAIA. 75. A Stipulated Penalty of $2,500 750 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8Xx. A Stipulated Penalty of $1,000 for each day Indivior Xxxxxxxx fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior Xx. Xxxxxxxx stating the specific grounds for its determination that Indivior Xx. Xxxxxxxx has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Indivior Xx. Xxxxxxxx shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Xx. Xxxxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-4 of this Section.

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Xxxxxx fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. post a Compliance Officer;notice in accordance with the requirements of Section III.A;‌ (b) a Compliance Committee;b. complete the training required for Xxxxxx and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;‌ (c) c. screen Covered Persons in accordance with the NGC compliance obligations and requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the engagement requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;‌ d. notify OIG of a Compliance Expertgovernment investigation or legal proceeding, in accordance with the performance requirements of a Compliance Program Review, and the preparation of a Compliance Program Review Report, Section III.E;‌ e. repay any Overpayments as required by Section III.A.3;III.F and Appendix B;‌ (d) f. report a Reportable Event in accordance with Section III.G; or‌ g. provide to OIG the management certification obligations and the development and implementation of a written process for Certifying Employees, as certifications required by Section III.A.4; (e) written Policies and Procedures; (f) III.H relating to any third party xxxxxx engaged by Xxxxxx during the development term of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.IA.‌ 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxxx fails to engage and use an IRO IRO, as required by Section III.E and III.C, Appendix B.A, or Appendix B.‌ 3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxxx fails to timely submit (a) a complete Implementation Report or Report, Annual Report, (b) a or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxxx fails to submit any IRO Quarterly Claims Review report Report or Quarterly Drug Inventory Review Report in accordance with the requirements of Section III.E III.C and Appendix B.B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.‌ 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior Xxxxxx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Xxxxxx fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Xxxxxx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIA.IA.‌ 7. A Stipulated Penalty of $2,500 1,000 for each day Indivior Xxxxxx fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.C, and for each day Indivior Xxxxxx fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A; andA.‌ 8. A Stipulated Penalty of $1,000 for each day Indivior Xxxxxx fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior Xxxxxx stating the specific grounds for its determination that Indivior Xxxxxx has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Indivior the Xxxxxx shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Xxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.Section.‌

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior WBH and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior WBH fails to establish, implement or comply with any of the following obligations as described in Section III:Sections III:‌ (a) a. a Compliance Officer;Officer;‌ (b) b. a Compliance Committee;Committee;‌ (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3;obligations;‌ (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;III.A.4.;‌ (e) e. written Policies and Procedures;Procedures;‌ (f) f. the development of a written training plan and the training and education of Covered Persons Persons, Arrangements Covered Persons, and NGC members;Board Members;‌ (g) g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;‌ h. a risk assessment and mitigation process;internal review process;‌ (h) i. a Disclosure Program;Program;‌ (i) j. Ineligible Persons screening and removal requirements;requirements;‌ (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings;proceedings;‌ (l) l. policies and procedures regarding the repayment of Overpayments; and‌ m. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.Events‌ 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior WBH fails to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix B.A or Appendix B.‌ 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior WBH fails to timely submit (a) a complete Implementation Report or Report, Annual Report, (b) a or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior WBH fails to submit any IRO Arrangements Review report Report in accordance with the requirements of Section III.E and Appendix B.B.‌ 5. A Stipulated Penalty of $1,500 for each day Indivior WBH fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior WBH fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior stating the specific grounds for its determination that Indivior has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 of this Section.access.)‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Mid Xxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Mid Xxxxxx fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) the management certification obligations and the development and implementation of d. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) e. written Policies and Procedures; (f) the development of a written training plan and f. the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) a risk assessment and mitigation process; (h) g. a Disclosure Program; (i) h. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) i. notification of Government government investigations or legal proceedings;; and (l) j. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Mid Xxxxxx fails to engage and use an IRO IRO, as required by in Section III.E III.D, Appendix A, Appendix B, and Appendix B.C. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Mid Xxxxxx fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Mid Xxxxxx fails to submit any IRO Claims Review report Report or Surgical Procedures Quality Review Report in accordance with the requirements of Section III.E III.D, Appendix A, Appendix B, and Appendix B.C. 5. A Stipulated Penalty of $1,500 for each day Indivior Mid Xxxxxx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Mid Xxxxxx fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Mid Xxxxxx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Mid Xxxxxx fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior stating the specific grounds for its determination that Indivior has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Xxx Xxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1–6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior FHG and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior FHG fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. appoint a Compliance Officer; (b) a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, Officer as required by Section III.A.3;III.A;‌ (d) b. written Policies and Procedures required by Section III.B;‌ c. post a notice in accordance with the management certification obligations requirements of Section III.C;‌ d. complete the training required for Covered Persons and maintain training records, in accordance with the development requirements of Section III.D;‌ e. screen Covered Persons in accordance with the requirements of Section III.F or require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.F; and implementation maintain documentation of screening and disclosure requirements in accordance with the requirements of Section III.F;‌ f. notify OIG of a written process for Certifying Employeesgovernment investigation or legal proceeding, in accordance with the requirements of Section III.G;‌‌ g. establish policies and procedures regarding the repayment of Overpayments;‌ h. repay any Overpayments as required by Section III.A.4;III.H and Appendix B;‌ (e) written Policies and Procedures;i. report a Reportable Event in accordance with Section III.I; or‌ (f) j. provide to OIG the development certifications required by Section III.J relating to any third party xxxxxx engaged by FHG during the term of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.IA.‌ 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior FHG fails to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix B.A or Appendix B.‌ 3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior FHG fails to timely submit (a) a complete Implementation Report or Report, Annual Report, (b) a or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior FHG fails to submit any IRO Quarterly Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B.B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.‌ 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior FHG fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior FHG fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior FHG as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIA.IA.‌ 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior FHG fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior FHG stating the specific grounds for its determination that Indivior FHG has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Indivior the FHG shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior FHG receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.Section.‌‌

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior CareMed and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the business day after the date the obligation became due) per obligation for each day Indivior CareMed fails to establish, establish and implement or comply with any of the following obligations as described in Section IIISections III and IV: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) d. the management certification obligations and the development and implementation of obligations; e. a written process for Certifying Employees, as required by Section III.A.4Code of Ethics; (e) f. written Policies and Procedures; (f) g. the development and/or implementation of a written training plan and Training Plan for the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) h. a risk assessment and mitigation processprocess as required in Section III.E; (h) i. a Disclosure Program; (i) j. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings; (l) l. policies and procedures regarding the repayment of Overpayments; m. the repayment of Overpayments as required by Section III.I; n. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting o. disclosure of any Payment-related informationchanges to business units or locations. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the business day after the date the obligation became due) for each day Indivior CareMed fails to engage and use an IRO IRO, as required by in Section III.E III.D, Appendix A, and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the business day after the date the obligation became due) for each day Indivior CareMed fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the business day after the date the obligation became due) for each day Indivior CareMed fails to submit any IRO Claims Review report Report or Restocking Review Report in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior CareMed fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior CareMed fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior CareMed as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior CareMed fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior CareMed stating the specific grounds for its determination that Indivior CareMed has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior CareMed shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior CareMed receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (PharMerica CORP)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior CSI and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior CSI fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4obligations; (e) e. written Policies and Procedures; (f) the development of a written training plan and the f. training and education of Covered Persons and NGC membersmembers of the Board; (g) g. annual budget plan and needs assessment processes for Consulting Activities; h. a risk assessment and mitigation internal review process; (h) i. a Disclosure Program; (i) j. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings; (l) l. the Field Force Monitoring Program; m. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIsn. Co-Marketing Activities Requirements; and (q) posting o. Reporting of any Payment-related informationPhysician Payments requirements. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CSI fails to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CSI fails to timely submit (a) a complete Implementation Report, Annual Report or Annual Report, (b) a any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CSI fails to submit any IRO Systems Review report Report or Transactions Review Report in accordance with the requirements of Section III.E and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior CSI fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior CSI fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior CSI as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior CSI fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior CSI stating the specific grounds for its determination that Indivior CSI has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior CSI shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior CSI receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Cardiovascular Systems Inc)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Baptist and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Baptist fails to establish, establish and implement or comply with any of the following obligations as described in Section IIISections III and IV: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) the management certification obligations and the development and implementation of d. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) e. written Policies and Procedures; (f) the development of a written training plan and f. the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) a risk assessment and mitigation process; (h) g. a Disclosure Program; (i) h. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) i. notification of Government investigations or legal proceedings; (l) j. repayment of Overpayments; k. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and, (q) posting l. disclosure of any Payment-related informationchanges to business units or locations. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Baptist fails to engage and use an IRO IRO, as required by in Section III.E III.D, Appendix A, and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Baptist fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Baptist fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior Baptist fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Baptist fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Baptist as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Baptist fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Baptist stating the specific grounds for its determination that Indivior Baptist has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Baptist shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Baptist receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior the DIG Entities and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior the DIG Entities fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Directors’ compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) the management certification obligations and the development and implementation of d. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) e. written Policies and Procedures; (f) the development of a written training plan and f. the training and education of Covered Persons Persons, Arrangements Covered Persons, and NGC members; (g) a risk assessment Relevant Covered Persons; g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements described in Sections III.D.1 and mitigation process; (h) III.D.2; h. a Disclosure Program; (i) i. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) j. notification of Government investigations or legal proceedings;; and (l) k. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior the DIG Entities fails to engage and use an IRO IRO, as required by in Section III.E III.E, Appendix A, Appendix B, and Appendix B.C. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior the DIG Entities fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior the DIG Entities fails to submit any IRO the annual Arrangements Review report Report, Claims Review Report, or Unallowable Cost Review Report in accordance with the requirements of Section III.E III.E, Appendix B, and Appendix B.C. 5. A Stipulated Penalty of $1,500 for each day Indivior the DIG Entities fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior the DIG Entities fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior the DIG Entities as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior fails the DIG Entities fail to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior the DIG Entities stating the specific grounds for its determination that Indivior the DIG Entities has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior the DIG Entities shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior DIG Entities receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior ResMed and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior ResMed fails to establish, implement or comply with any of the following obligations as described in Section Sections III: (a) a. a Compliance Officer;Officer;‌ (b) b. a Compliance Committee;Committee;‌ (c) c. the NGC Board compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3;III.A.3;‌ (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;III.A.4;‌ (e) e. written Policies and Procedures;Procedures;‌ (f) f. the development of a written training plan and the training and education of Covered Persons Persons, Arrangements Covered Persons, and NGC members;Board members;‌ (g) g. the Focus Arrangements Procedures, Invoiced Sales Procedures and/or Focus Arrangements Requirements;‌ h. a risk assessment and mitigation process;internal review process;‌ (h) i. a Disclosure Program;Program;‌ (i) j. Ineligible Persons screening and removal requirements;requirements;‌ (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings;; and‌ (l) l. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.Events‌ 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior ResMed fails to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix B.A, or Appendix B.‌ 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior ResMed fails to timely submit submit‌‌ (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior ResMed fails to submit any IRO Arrangements Review report Report in accordance with the requirements of Section III.E and Appendix B.B.‌ 5. A Stipulated Penalty of $1,500 for each day Indivior ResMed fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior ResMed fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior ResMed as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.CIA.‌ 7. A Stipulated Penalty of $2,500 for each day Indivior ResMed fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.D, and for each day Indivior ResMed fails to furnish to the IRO accurate and complete records to the IROrecords, as required by Section III.E and Appendix A; andA.‌ 8. A Stipulated Penalty of $1,000 for each day Indivior ResMed fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior ResMed stating the specific grounds for its determination that Indivior ResMed has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior ResMed shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior ResMed receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.Section.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Kindred, RehabCare and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Kindred and/or RehabCare, as applicable, fails to establish, establish and implement or comply with any of the following obligations as described in Section IIISections III and IV: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) d. the management certification obligations and the development and implementation of obligations; e. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) f. written Policies and Procedures; (f) g. the development and/or implementation of a written training plan and Training Plan for the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) h. a risk assessment and mitigation processinternal review process as required by Section III.E; (h) i. a Disclosure Program; (i) j. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings; (l) l. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting m. disclosure of any Payment-related informationchanges to Kindred’s contract therapy business units or locations. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Kindred and/or RehabCare, as applicable, fails to engage and use an IRO IRO, as required by Section III.E and III.D, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Kindred and/or RehabCare, as applicable, fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Kindred and/or RehabCare, as applicable, fails to submit any IRO Review report in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior Kindred and/or RehabCare, as applicable, fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Kindred fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Kindred and/or RehabCare, as applicable, as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Kindred and/or RehabCare, as applicable, fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Kindred stating the specific grounds for its determination that Indivior Kindred and/or RehabCare, as applicable, has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Kindred shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Kindred receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Kindred Healthcare, Inc)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior the GIS Parties and OIG hereby agree that failure to to‌‌ comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior fails the GIS Parties fail to establish, implement or comply with any of the following obligations as described in Section Sections III: (a) a a. Compliance Officer;Officers;‌ (b) a b. Compliance Committee;Committees;‌ (c) c. the NGC Boards of Directors’ compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3;obligations;‌ (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;obligations;‌ (e) e. written Policies and Procedures;Procedures;‌ (f) the development of a written training plan and the f. training and education of Covered Persons Persons, Arrangements Covered Persons, and NGC members;Board Members;‌ (g) g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;‌ h. a risk assessment and mitigation process;internal review process;‌ (h) i. a Disclosure Program;Program;‌ (i) j. Ineligible Persons screening and removal requirements;requirements;‌ (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings;proceedings;‌‌‌ (l) l. policies and procedures regarding the repayment of Overpayments; and‌ m. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.Events.‌ 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails the GIS Parties fail to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix B.A, or Appendix B.‌ 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails the GIS Parties fail to timely submit (a) a complete Implementation Report or Report, Annual Report, (b) a or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails the GIS Parties fail to submit any IRO Arrangements Review report Report in accordance with the requirements of Section III.E and Appendix B.B.‌ 5. A Stipulated Penalty of $1,500 for each day Indivior fails the GIS Parties fail to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior fails the GIS Parties fail to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior the GIS Parties as part of its their Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.CIA.‌ 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior fails the GIS Parties fail to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior the GIS Parties stating the specific grounds for its determination that Indivior has the GIS Parties have failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior the GIS Parties shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior receives the GIS Parties receive this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.Section.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Lundbeck and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.provisions.‌ 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Lundbeck fails to establish, establish,‌ implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4obligations; (e) e. written Policies and Procedures; (f) f. the development of a written training plan and the training and education of Covered Persons and NGC membersBoard Members; (g) g. a risk assessment and mitigation internal review process; (h) h. a Disclosure Program; (i) i. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) j. notification of Government investigations or legal proceedings; (l) k. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.l. the Independent Charity PAP policies, procedures, and practices required by Section XXX.X. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Lundbeck fails to engage and use an IRO as required by Section III.E and III.E, Appendix B.A, or Appendix B.‌ 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Lundbeck fails to timely submit (a) a complete Implementation Report, Annual Report or Annual Report, (b) a any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Lundbeck fails to submit any IRO Review report in accordance with the requirements of Section III.E and Appendix B.B.‌ 5. A Stipulated Penalty of $1,500 for each day Indivior Lundbeck fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Lundbeck fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Lundbeck as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or otherwise required by this CIA.CIA.‌ 7. A Stipulated Penalty of $2,500 for each day Indivior Lundbeck fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.E, and for each day Indivior Lundbeck fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; andA.‌ 8. A Stipulated Penalty of $1,000 for each day Indivior Lundbeck fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Lundbeck stating the specific grounds for its determination that Indivior Lundbeck has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Lundbeck shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Lundbeck receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 of this Section.Section.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Rotech and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Rotech fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) the NGC compliance obligations and the engagement c. a written Code of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3Conduct; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) d. written Policies and Procedures; (f) the development of a written training plan and e. the training and education of Covered Persons and NGC membersPersons; (g) a risk assessment and mitigation process; (h) f. a Disclosure Program; (i) g. Ineligible Persons screening and removal requirements;; and (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) h. notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Rotech fails to engage and use an IRO IRO, as required by in Section III.E III.D and Appendix B.A. Rotech Healthcare Inc. Corporate Integrity Agreement 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Rotech fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Rotech fails to submit any IRO the annual Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior Rotech fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Rotech fails to grant access.) 6. A Stipulated Penalty of $50,000 20,000 for each false certification submitted by or on behalf of Indivior Rotech as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior Rotech fails to grant comply with the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, Board of Directors resolution obligations as required by Section III.E and Appendix A; andIII.A.3; 8. A Stipulated Penalty of $1,000 for each day Indivior Rotech fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Rotech stating the specific grounds for its determination that Indivior Rotech has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Rotech shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Rotech receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Rotech Healthcare Inc)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior CRMC and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior CRMC fails to establish, implement or comply with any of the following obligations as described in Section Sections III: (a) a. a Compliance Officer;Officer;‌ (b) b. a Compliance Committee;Committee;‌ (c) c. the NGC Board compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3;obligations;‌ (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;III.A.4;‌ (e) e. written Policies and Procedures;Procedures;‌ (f) f. the development of a written training plan and the training and education of Covered Persons Persons, Arrangements Covered Persons, and NGC members;Board members;‌ (g) g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;‌ h. a risk assessment and mitigation process;internal review process;‌ (h) i. a Disclosure Program;Program;‌ (i) j. Ineligible Persons screening and removal requirements;requirements;‌ (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings;proceedings;‌ (l) l. policies and procedures regarding the repayment of Overpayments; and‌ m. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.Events‌ 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CRMC fails to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix B.A, or Appendix B.‌ 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CRMC fails to timely submit submit‌‌ (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CRMC fails to submit any IRO Arrangements Review report Report in accordance with the requirements of Section III.E and Appendix B.B.‌ 5. A Stipulated Penalty of $1,500 for each day Indivior CRMC fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior CRMC fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior CRMC as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.CIA.‌ 7. A Stipulated Penalty of $2,500 for each day Indivior CRMC fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.D, and for each day Indivior CRMC fails to furnish to the IRO accurate and complete records to the IROrecords, as required by Section III.E and Appendix A; andA.‌ 8. A Stipulated Penalty of $1,000 for each day Indivior CRMC fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior CRMC stating the specific grounds for its determination that Indivior CRMC has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior CRMC shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior CRMC receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.Section.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xx. Xxxxxxxx and OIG hereby agree that failure to to‌‌ comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Xx. Xxxxxxxx fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. post a Compliance Officer;notice in accordance with the requirements of Section III.A;‌ (b) a Compliance Committee;b. complete the training required for Xx. Xxxxxxxx and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;‌ (c) c. screen Covered Persons in accordance with the NGC compliance obligations and requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the engagement requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;‌ d. notify OIG of a Compliance Expertgovernment investigation or legal proceeding, in accordance with the performance requirements of a Compliance Program Review, and the preparation of a Compliance Program Review Report, Section III.E;‌ e. repay any Overpayments as required by Section III.A.3;III.F and Appendix B;‌ (d) f. report a Reportable Event in accordance with Section III.G; or‌ g. provide to OIG the management certification obligations and the development and implementation of a written process for Certifying Employees, as certifications required by Section III.A.4; (e) written Policies and Procedures; (f) III.H relating to any third-party xxxxxx engaged by Xx. Xxxxxxxx during the development term of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.IA.‌ 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xx. Xxxxxxxx fails to engage and use an IRO IRO, as required by Section III.E and III.C, Appendix B.A, or Appendix B.‌ 3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xx. Xxxxxxxx fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.OIG.‌ 4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xx. Xxxxxxxx fails to submit any IRO Quarterly Claims Review report Report in accordance with the requirements of Section III.E Section‌ III.C and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B. 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior Xx. Xxxxxxxx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Xx. Xxxxxxxx fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Xx. Xxxxxxxx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIA.IA.‌ 7. A Stipulated Penalty of $2,500 1,000 for each day Indivior Xx. Xxxxxxxx fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.C, and for each day Indivior Xx. Xxxxxxxx fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A; andA.‌ 8. A Stipulated Penalty of $1,000 for each day Indivior Xx. Xxxxxxxx fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior Xx. Xxxxxxxx stating the specific grounds for its determination that Indivior Xx. Xxxxxxxx has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Indivior the Xx. Xxxxxxxx shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Xx. Xxxxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.Section.‌

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Hanflink and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Hanflink fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. post a Compliance Officer;notice in accordance with the requirements of Section III.A;‌ (b) a Compliance Committee;b. complete the training required for Hanflink and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;‌ (c) c. screen Covered Persons in accordance with the NGC compliance obligations and requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the engagement requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;‌ d. notify OIG of a Compliance Expertgovernment investigation or legal proceeding, in accordance with the performance requirements of a Compliance Program Review, and the preparation of a Compliance Program Review Report, Section III.E;‌ e. repay any Overpayments as required by Section III.A.3;III.F and Appendix B;‌ (d) f. report a Reportable Event in accordance with Section III.G; or‌ g. provide to OIG the management certification obligations and the development and implementation of a written process for Certifying Employees, as certifications required by Section III.A.4; (e) written Policies and Procedures; (f) III.H relating to any third party xxxxxx engaged by Hanflink during the development term of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.IA.‌ 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Hanflink fails to engage and use an IRO IRO, as required by Section III.E and III.C, Appendix B.A, or Appendix B.‌ 3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Hanflink fails to timely submit (a) a complete Implementation Report or Report, Annual Report, (b) a or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Hanflink fails to submit any IRO Quarterly Claims Review report Report in accordance with the requirements of Section III.E III.C and Appendix B.B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.‌ 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior Hanflink fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Hanflink fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Hanflink as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIA.IA.‌ 7. A Stipulated Penalty of $2,500 1,000 for each day Indivior Hanflink fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.C, and for each day Indivior Hanflink fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A; andA.‌ 8. A Stipulated Penalty of $1,000 for each day Indivior Hanflink fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior Hanflink stating the specific grounds for its determination that Indivior Hanflink has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Indivior the Hanflink shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Hanflink receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.Section.‌

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior HOTC and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior HOTC fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) the management certification obligations and the development and implementation of d. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) e. written Policies and Procedures; (f) the development of a written training plan and f. the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) a risk assessment and mitigation process; (h) g. a Disclosure Program; (i) h. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) i. notification of Government investigations or legal proceedings;; and (l) j. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior HOTC fails to engage and use an IRO IRO, as required by in Section III.E III.D, Appendix A, and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior HOTC fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior HOTC fails to submit any IRO Eligibility Review report Report or Unallowable Cost Review Report in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior HOTC fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior HOTC fails to grant access.) 6. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior HOTC as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior HOTC fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior HOTC stating the specific grounds for its determination that Indivior HOTC has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior HOTC shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior HOTC receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior EGS and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior EGS fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) the management certification obligations and the development and implementation of d. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) e. written Policies and Procedures; (f) the development of a written training plan and f. the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) g. a risk assessment and mitigation processField Force Monitoring Program; (h) h. a Risk Assessment and Mitigation Program; i. a Disclosure Program; (i) j. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings;; and (l) l. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior EGS fails to engage and use an IRO IRO, as required by in Section III.E III.G, Appendix A, and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior EGS fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior EGS fails to submit any IRO Review report Report in accordance with the requirements of Section III.E III.G and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior EGS fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior EGS fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior EGS as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior EGS fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior EGS stating the specific grounds for its determination that Indivior EGS has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior EGS shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior EGS receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior CHSI and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior CHSI fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Corporate Compliance and Privacy Officer;, Corporate Compliance Directors, and/or Facility Compliance Officers;‌ (b) b. a Corporate Compliance Committee;Work Group; and/or Facility Compliance Committees;‌ (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3;obligations;‌ (d) the management certification obligations and the development and implementation of d. a written process for Certifying Employees, as required by Section III.A.4;Code of Conduct;‌ (e) e. written Policies and Procedures;Procedures;‌ (f) the development of a written training plan and f. the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC members;Board Members;‌ (g) a risk assessment and mitigation process; (h) g. a Disclosure Program;Program;‌ (i) h. Ineligible Persons screening and removal requirements;requirements;‌ (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) i. notification of Government investigations or legal proceedings;; and‌ (l) j. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.Events.‌ 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CHSI fails to engage and use an IRO IRO, as required by in Section III.E III.E, Appendix A, and Appendix B.B.‌ 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CHSI fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CHSI fails to submit any IRO Claims Review report Report, Unallowable Cost Review Report, or Arrangements Review Report in accordance with the requirements of Section III.E III.E, Appendix B, and Appendix B.C.‌ 5. A Stipulated Penalty of $1,500 for each day Indivior CHSI fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior CHSI fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior as part of its Implementation Report, any Annual Report, certification‌ additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.CIA.‌ 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior CHSI fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior CHSI stating the specific grounds for its determination that Indivior CHSI has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior CHSI shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior CHSI receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Xxxxx fails to establish, establish and implement or comply with any of the following obligations as described in Section IIISections III and IV: (a) a. a Compliance Officer;Officer;‌ (b) b. a Compliance Committee;Committee;‌ (c) c. the NGC Board of Directors compliance obligations obligations;‌ d. the management certification obligations;‌ e. a written Code of Conduct;‌ f. written Policies and Procedures;‌‌ g. the engagement development and/or implementation of a Compliance ExpertTraining Plan for the training of Covered Persons, the performance of a Compliance Program ReviewArrangements Covered Persons, and Board Members;‌ h. the preparation of Focus Arrangements Procedures and/or Focus Arrangements Requirements described in Sections III.D.1 and III.D.2;‌ i. a Compliance Program Review Report, risk assessment and internal review process as required by Section III.A.3;III.F;‌ (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) written Policies and Procedures; (f) the development of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) j. a Disclosure Program;Program;‌ (i) k. Ineligible Persons screening and removal requirements;requirements;‌ (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) l. notification of Government investigations or legal proceedings;proceedings;‌ (l) m. policies and procedures regarding the repayment of Overpayments;‌ n. the repayment of Overpayments as required by Section III.J and Appendix B;‌ o. reporting of Reportable Events;; and‌ (m) notification p. disclosure of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification changes to HCPs and HCIs; and (q) posting of any Payment-related information.business units or locations.‌ 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxx fails to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix B.A, or Appendix B.‌ 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxx fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxx fails to submit any IRO Arrangements Review report Report in accordance with the requirements of Section III.E and Appendix B.B.‌‌ 5. A Stipulated Penalty of $1,500 for each day Indivior Xxxxx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Xxxxx fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Xxxxx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.CIA.‌ 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Xxxxx fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Xxxxx stating the specific grounds for its determination that Indivior Xxxxx has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Xxxxx shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Xxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.Section.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior APM, Park Center, Xxxxxx, and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior fails APM, Park Center, and Xxxxxx fail to establish, implement or comply with any of the following obligations as described in Section Sections III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) c. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4obligations; (e) d. written Policies and Procedures; (f) e. the development of a written training plan and the training and education of Covered Persons Persons, and NGC membersArrangements Covered Persons; (g) f. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;‌ g. a risk assessment and mitigation process;internal review process;‌ (h) h. a Disclosure Program;Program;‌ (i) i. Ineligible Persons screening and removal requirements;requirements;‌ (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) j. notification of Government investigations or legal proceedings;proceedings;‌ (l) k. policies and procedures regarding the repayment of Overpayments; and‌ l. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.Events‌ 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails APM, Park Center, and Xxxxxx fail to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix B.A, Appendix B, or Appendix C.‌ 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails APM, Park Center, and Xxxxxx fail to timely submit (a) a complete Implementation Report or Report, Annual Report, (b) a or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails APM, Park Center, and Xxxxxx fail to submit any IRO Arrangements Review report Report in accordance with the requirements of Section III.E and Appendix B.B.‌ 5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day APM, Park Center, and Xxxxxx fail to submit any Claims Review Report in accordance with the requirements of Section‌‌ III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C. 6. A Stipulated Penalty of $1,500 for each day Indivior fails APM, Park Center, and Xxxxxx fail to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior fails APM, Park Center, and Xxxxxx fail to grant access.)access.)‌ 67. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior APM, Park Center, and Xxxxxx as part of its their Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.CIA.‌ 78. A Stipulated Penalty of $2,500 for each day Indivior fails APM, Park Center, and Xxxxxx fail to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.E., and for each day Indivior fails APM, Park Center, and Xxxxxx fail to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; andA.‌ 89. A Stipulated Penalty of $1,000 for each day Indivior fails APM, Park Center, and Xxxxxx fail to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior APM, Park Center, and Xxxxxx stating the specific grounds for its determination that Indivior has APM, Park Center, and Xxxxxx have failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior APM, Park Center, and Xxxxxx shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior receives APM, Park Center, and Xxxxxx receive this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-8 of this Section.Section.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior ABC and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior ABC fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. a Chief Compliance Officer;‌ b. a Compliance Officer;Committee;‌ (b) a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a a‌ Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3.; (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;III.A.4.;‌ (e) e. written Policies and Procedures;Procedures;‌ (f) f. the development of a written training plan and the training and education of Covered Persons and NGC members;Board Members;‌ (g) g. a risk assessment and mitigation process;internal review process;‌ (h) h. a Disclosure Program;Program;‌ (i) i. Ineligible Persons screening and removal requirements;requirements;‌ (j) j. the establishment of Incentive Compensation Restriction and Financial Recoupment Programs;Programs;‌ (k) k. notification of Government investigations or legal proceedings;proceedings;‌ (l) l. policies and procedures regarding the repayment of Overpayments;‌ m. reporting of Reportable Events;Events;‌ (m) n. notification of written communications with FDA;; and‌ (n) the FFMP; (o) the NPMP; (p) o. notification to HCPs and HCIs; and (q) posting of any Payment-related information.health care providers.‌ 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior ABC fails to engage and use an IRO as required by Section III.E and Appendix B.B.‌ 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior ABC fails to timely submit (a) a complete Implementation Report, Annual Report or Annual Report, (b) a any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior ABC fails to submit any IRO Review report in accordance with the requirements of Section III.E and Appendix B.B.‌ 5. A Stipulated Penalty of $1,500 for each day Indivior ABC fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior ABC fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior ABC as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or otherwise required by this CIA.CIA.‌ 7. A Stipulated Penalty of $2,500 for each day Indivior ABC fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior ABC fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; andand‌ 8. A Stipulated Penalty of $1,000 for each day Indivior ABC fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior ABC stating the specific grounds for its determination that Indivior ABC has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior ABC shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior ABC receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 of this Section.Section.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior the U.S. Healthcare Parties and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior fails the U.S. Healthcare Parties or the Xxxxx Entities, as applicable, fail to establish, implement implement, or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) c. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4obligations; (e) d. written Policies and Procedures; (f) the development of a written training plan and the e. training and education of Covered Persons and NGC membersPersons; (g) f. a risk assessment and mitigation internal review process; (h) g. a Disclosure Program; (i) h. the prohibition on Third-Party Internet-Based Lead Generation Activities; i. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) j. notification of Government investigations or legal proceedings; (l) k. policies and procedures regarding the repayment of Overpayments; and l. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails the U.S. Healthcare Parties fail to engage and use an IRO IRO, as required by Section III.E and III.D, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails the U.S. Healthcare Parties fail to timely submit (a) a complete Implementation Report or Report, Annual Report, (b) a or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails the U.S. Healthcare Parties fail to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior stating the specific grounds for its determination that Indivior has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior PGS and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior PGS fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and obligations; d. the engagement of a Compliance Expert, the performance of a Compliance Program Review, Review and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) e. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4obligations; (e) f. written Policies and Procedures; (f) the development of a written training plan and the g. training and education of Covered Persons and NGC membersBoard Members; (g) h. a risk assessment and mitigation internal review process; (h) i. a Disclosure Program; (i) j. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings; (l) l. policies and procedures regarding the repayment of Overpayments; and m. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior PGS fails to engage and use an IRO IRO, as required by Section III.E and III.D, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior PGS fails to timely submit (a) a complete Implementation Report, Annual Report or Annual Report, (b) a any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior PGS fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior PGS fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior PGS fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior PGS as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior PGS fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior PGS stating the specific grounds for its determination that Indivior PGS has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior PGS shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior PGS receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Vascular Access Centers and OIG hereby agree that that‌‌ failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Vascular Access Centers fails to establish, implement or comply with any of the following obligations as described in Section III:III:‌ (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC General Partner’s compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, Review and the preparation of a Compliance Program Review Report, as required by Section III.A.3.; (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) e. written Policies and Procedures; (f) f. the development of a written training plan and the training and education of Covered Persons Persons, Arrangements Covered Persons, and NGC membersGeneral Partners; (g) g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements; h. a risk assessment and mitigation process;internal review process;‌ (h) i. a Disclosure Program;Program;‌ (i) j. Ineligible Persons screening and removal requirements;requirements;‌ (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings;proceedings;‌ (l) l. policies and procedures regarding the repayment of Overpayments; and‌ m. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.Events.‌ 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Vascular Access Centers fails to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix B.A, Appendix B, or Appendix C.‌ 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Vascular Access Centers fails to timely submit (a) a complete Implementation Report or Report, Annual Report, (b) a or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Vascular Access Centers fails to submit any IRO Arrangements Review report Report in accordance with the requirements of Section III.E and Appendix B.B.‌ 5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Vascular Access Centers fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.‌ 6. A Stipulated Penalty of $1,500 for each day Indivior Vascular Access Centers fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Vascular Access Centers fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior stating the specific grounds for its determination that Indivior has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 of this Section.access.)‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior LHMC and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior LHMC fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. post a Compliance Officernotice in accordance with the requirements of Section III.A; (b) a Compliance Committeeb. complete the training required for LHMC and Covered Persons and maintain training records, in accordance with the requirements of Section III.B; (c) c. screen Covered Persons in accordance with the NGC compliance obligations and requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the engagement requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D; d. notify OIG of a Compliance Expertgovernment investigation or legal proceeding, in accordance with the performance requirements of a Compliance Program Review, and the preparation of a Compliance Program Review Report, Section III.E; e. repay any Overpayments as required by Section III.A.3III.F and Appendix B; (d) f. report a Reportable Event in accordance with Section III.G; or g. provide to OIG the management certification obligations and the development and implementation of a written process for Certifying Employees, as certifications required by Section III.A.4; (e) written Policies and Procedures; (f) III.H relating to any third-party xxxxxx engaged by LHMC during the development term of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related informationIA. 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior LHMC fails to engage and use an IRO IRO, as required by Section III.E and III.C, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior LHMC fails to timely submit submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG. 4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior LHMC fails to submit any IRO Quarterly Claims Review report Report in accordance with the requirements of Section III.E III.C and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B. 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior LHMC fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior LHMC fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior LHMC as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIAIA. 7. A Stipulated Penalty of $2,500 1,000 for each day Indivior LHMC fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.C, and for each day Indivior LHMC fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A; andA. 8. A Stipulated Penalty of $1,000 for each day Indivior LHMC fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior LHMC stating the specific grounds for its determination that Indivior LHMC has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Indivior the LHMC shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior LHMC receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior PCMC and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior PCMC fails to establish, implement or comply with any of the following obligations as described in Section Sections III: (a) a. a Compliance Officer;Officer;‌ (b) b. a Compliance Committee;Committee;‌ (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3;III.A.3;‌ (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;obligations;‌ (e) e. written Policies and Procedures;Procedures;‌ (f) the development of a written training plan and the f. training and education of Covered Persons Persons, Arrangements Covered Persons, and NGC members;Board Members;‌ (g) g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;‌ h. a risk assessment and mitigation process;internal review process;‌ (h) i. a Disclosure Program;Program;‌ (i) j. Ineligible Persons screening and removal requirements;requirements;‌ (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings;proceedings;‌ (l) l. policies and procedures regarding the repayment of Overpayments; and‌ m. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.Events‌ 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior PCMC fails to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix B.A, or Appendix B.‌ 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior PCMC fails to timely submit (a) a complete Implementation Report or Report, Annual Report, (b) a or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior PCMC fails to submit any IRO Arrangements Review report Report in accordance with the requirements of Section III.E and Appendix B.B.‌ 5. A Stipulated Penalty of $1,500 for each day Indivior PCMC fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior PCMC fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior PCMC as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.CIA.‌ 7. A Stipulated Penalty of $2,500 10,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior PCMC fails to grant cooperate and otherwise satisfy any of the IRO access to all records obligations and personnel necessary to complete the reviews required by requirements as described in Section III.E III.K.7 and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; andIII.L.‌ 8. A Stipulated Penalty of $1,000 for each day Indivior PCMC fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior PCMC stating the specific grounds for its determination that Indivior PCMC has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior PCMC shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior PCMC receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.Section.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a Compliance Officer; (b) a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) written Policies and Procedures; (f) the development of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxxx fails to: a. post a notice in accordance with the requirements of Section III.A;‌ b. complete the training required for Xxxxxx and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;‌ c. screen Covered Persons in accordance with the requirements of Section III.D; or require Covered Persons to engage disclose if they are excluded in accordance with the requirements of Section III.D; and use an IRO maintain documentation of screening and disclosure requirements in accordance with the requirements of Section III.D;‌ d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E;‌ e. repay any Overpayments as required by Section III.E III.F and Appendix B.B; or‌ 3f. report a Reportable Event in accordance with Section III.G.‌ 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxxx fails to timely submit (a) a complete Implementation Report or Annual Reportengage and use an IRO, (b) a certification to OIG in accordance with the requirements of as required by Section VIII.C, Appendix A, or (c) a complete response to any request for information from OIG.Appendix B. 43. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxxx fails to submit a complete Implementation Report, Annual Report, or any IRO Review report certification to OIG in accordance with the requirements of Section III.E V by the deadlines for submission.‌‌‌ 4. A Stipulated Penalty of $1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Xxxxxx fails to submit any Quarterly Claims Review Report in accordance with the requirements of Section III.C and Appendix B.B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.‌ 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior Xxxxxx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Xxxxxx fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Xxxxxx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIA.IA.‌ 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Xxxxxx fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior Xxxxxx stating the specific grounds for its determination that Indivior Xxxxxx has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Indivior the Xxxxxx shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Xxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.Section.‌

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior eTEL-Rx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior eTEL-Rx fails to establish, establish and implement or comply with any of the following obligations as described in Section III:: eTEL-Rx Corporate Integrity Agreement (a) a. a Compliance Officer; (b) b. a Compliance Committeewritten Code of Conduct; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) c. written Policies and Procedures; (f) the development of a written training plan and d. the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) a risk assessment and mitigation process; (h) e. a Disclosure Program; (i) f. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) g. notification of Government investigations or legal proceedings;; and (l) h. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior eTEL-Rx fails to engage and use an IRO IRO, as required by in Section III.E III.D, Appendix A, and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior eTEL-Rx fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior eTEL-Rx fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior eTEL-Rx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior eTEL-Rx fails to grant access.) 6. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior eTEL-Rx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.. eTEL-Rx Corporate Integrity Agreement 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior eTEL-Rx fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior eTEL-Rx stating the specific grounds for its determination that Indivior eTEL-Rx has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior eTEL-Rx shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior eTEL-Rx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xx. Xxxxxxxxxx-AFAS and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a Compliance Officer; (b) a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) written Policies and Procedures; (f) the development of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xx. Xxxxxxxxxx-AFAS fails to: a. post a notice in accordance with the requirements of Section III.A;‌ b. complete the training required for Xx. Xxxxxxxxxx-AFAS and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;‌ c. screen Covered Persons in accordance with the requirements of Section III.D; require Covered Persons to engage and use an IRO disclose if they are excluded in accordance with the requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;‌ d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E;‌ e. repay any Overpayments as required by Section III.E III.F and Appendix B.B; or‌ f. report a Reportable Event in accordance with Section III.G.‌ h. provide to OIG the certifications required by Section III.H relating to any third party xxxxxx engaged by Xx. Xxxxxxxxxx- AFAS during the term of the IA.‌ 32. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xx. Xxxxxxxxxx-AFAS fails to timely submit (a) a complete Implementation Report or Annual Reportengage and use an IRO, (b) a certification to OIG in accordance with the requirements of as required by Section VIII.C, Appendix A, or (c) a complete response to any request for information from OIG.Appendix B.‌ 43. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xx. Xxxxxxxxxx-AFAS fails to submit a complete Implementation Report, Annual Report, or any IRO Review report certification to OIG in accordance with the requirements of Section III.E V by the deadlines for submission.‌ 4. A Stipulated Penalty of $1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Xx. Xxxxxxxxxx-AFAS fails to submit any Quarterly Claims Review Report in accordance with the requirements of Section III.C and Appendix B.B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.‌ 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior Xx. Xxxxxxxxxx-AFAS fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Xx. Xxxxxxxxxx-AFAS fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Xx. Xxxxxxxxxx-AFAS as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIA.IA.‌ 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Xx. Xxxxxxxxxx-AFAS fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior Xx. Xxxxxxxxxx-AFAS stating the specific grounds for its determination that Indivior Xx. Xxxxxxxxxx-AFAS has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Indivior the Xx. Xxxxxxxxxx-AFAS shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Xx. Xxxxxxxxxx-AFAS receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.Section.‌

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Txxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Txxxx fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a a. Chief Compliance Officer; (b) a b. Regional Compliance Officers; c. Hospital Compliance Officers; d. Ethics and Compliance Department; e. Clinical Quality Department; f. Corporate Compliance Committee; (c) the NGC compliance obligations g. Regional and the engagement of a Hospital Compliance ExpertCommittees; h. Quality, the performance of a Compliance Program ReviewCompliance, and Ethics Committee of the preparation Board of a Compliance Program Review Report, as required by Section III.A.3Directors; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) i. written Policies and Procedures; (f) the development of a written ; j. training plan and the training and education of Covered Persons Persons, Billing and NGC members; (g) a risk assessment Reimbursement Covered Persons, Arrangements Covered Persons, and mitigation process; (h) Clinical Quality Covered Persons; k. a Disclosure Program; (i) l. Ineligible Persons screening and removal requirements;; and (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification m. Notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Txxxx fails to engage and use an IRO IRO, as required by in Section III.E III.D and Appendix B.Appendices A-E. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Txxxx fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Txxxx fails to submit any the IRO Review report Reports in accordance with the requirements of Section III.E III.D and Appendix B.Appendices A-E. 5. A Stipulated Penalty of $1,500 for each day Indivior Txxxx fails to grant access to the information or documentation as required in Section VIIVII or any other provision under the CIA. (This Stipulated Penalty shall begin to accrue on the date Indivior Txxxx fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Txxxx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Txxxx fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Txxxx, stating the specific grounds for its determination that Indivior Txxxx has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Txxxx shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Txxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Tenet Healthcare Corp)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior LCPCC and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior LCPCC fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. post a Compliance Officernotice in accordance with the requirements of Section III.A;‌ b. complete the training required for LCPCC and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;‌ c. screen Covered Persons in accordance with the requirements of Section III.D; require Covered Persons to disclose if they‌ are excluded in accordance with the requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D; (b) a Compliance Committee; (c) the NGC compliance obligations and the engagement d. notify OIG of a Compliance Expertgovernment investigation or legal proceeding, in accordance with the performance requirements of a Compliance Program Review, and the preparation of a Compliance Program Review Report, Section III.E;‌ e. repay any Overpayments as required by Section III.A.3;III.F and Appendix B; or‌ (d) the management certification obligations and the development and implementation of f. report a written process for Certifying Employees, as required by Reportable Event in accordance with Section III.A.4; (e) written Policies and Procedures; (f) the development of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.III.G.‌ 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior LCPCC fails to engage and use an IRO IRO, as required by Section III.E and III.C, Appendix B.A, or Appendix B.‌ 3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior LCPCC fails to timely submit (a) a complete Implementation Report or Report, Annual Report, (b) a or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior LCPCC fails to submit any IRO Quarterly Claims Review report Report in accordance with the requirements of Section III.E III.C and Appendix B.B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.‌ 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior LCPCC fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior LCPCC fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior LCPCC as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIA.IA.‌ 7. A Stipulated Penalty of $2,500 1,000 for each day Indivior fails LCPCCfails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior stating the specific grounds for its determination that Indivior has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 of this Section.listed in‌

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xxxxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Klurfeld fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. appoint a Compliance Officer; (b) a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, Officer as required by Section III.A.3III.A; (d) b. written Policies and Procedures required by Section III.B; c. post a notice in accordance with the management certification obligations requirements of Section III.C; d. complete the training required for Covered Persons and maintain training records, in accordance with the development and implementation requirements of Section III.D; e. screen Covered Persons in accordance with the requirements of Section III.F; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.F; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.F; f. notify OIG of a written process for Certifying Employeesgovernment investigation or legal proceeding, in accordance with the requirements of Section III.G; g. establish policies and procedures regarding the repayment of Overpayments; h. repay any Overpayments as required by Section III.A.4; (e) written Policies III.H and Procedures; (f) the development of Appendix B; or i. report a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications Event in accordance with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.Section III.I. 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Klurfeld fails to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix A or Appendix B. 3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Klurfeld fails to timely submit submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG. 4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Klurfeld fails to submit any IRO Quarterly Claims Review report Report in accordance with the requirements of Section III.E and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B. 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior Xxxxxxxx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Xxxxxxxx fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Klurfeld as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIAIA. 7. A Stipulated Penalty of $2,500 1,000 for each day Indivior Xxxxxxxx fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior stating the specific grounds for its determination that Indivior has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 of this Section.listed in

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Diversicare and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Diversicare fails to establish, implement or comply with any of the following obligations as described in Section III:III:‌‌ (a) a. a Compliance Officer; (b) b. Compliance Directors c. a Compliance Committee; (c) d. the NGC Board compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, Review and the preparation of a Compliance Program Review Report, as required by Section III.A.3III.A.4; (d) e. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4III.A.5; (e) f. written Policies and Procedures; (f) g. the development of a written training plan and the training and education of Covered Persons and NGC Board members; (g) h. a risk assessment and mitigation internal review process; (h) i. a Disclosure Program; (i) j. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings; (l) l. policies and procedures regarding the repayment of Overpayments; and m. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Diversicare fails to engage and use an IRO IRO, as required by Section III.E III.D, and Appendix B.Appendices A through C.‌‌ 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Diversicare fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.OIG.‌ 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Diversicare fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B.Appendices B and C or fails to repay any Overpayment identified by the IRO, as required by Appendices B and C.‌ 5. A Stipulated Penalty of $1,500 for each day Indivior Diversicare fails to grant access as required in Section VII. VII (This Stipulated Penalty shall begin to accrue on the date Indivior Diversicare fails to grant access.)access.).‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Diversicare as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or otherwise required by this CIA.CIA.‌ 7. A Stipulated Penalty of $2,500 for each day Indivior Diversicare fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.D, and for each day Indivior Diversicare fails to furnish accurate and complete records to the IRO, as required by Section III.E III.D and Appendix A; andA.‌ 8. A Stipulated Penalty of $1,000 for each day Indivior Diversicare fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Diversicare stating the specific grounds for its determination that Indivior Diversicare has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Diversicare shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Diversicare receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.Section.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xx. Xxxxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a Compliance Officer; (b) a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) written Policies and Procedures; (f) the development of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xx. Xxxxxxxx fails to: a. post a notice in accordance with the requirements of Section III.A;‌ b. complete the training required for Xx. Xxxxxxxx and Covered Persons and maintain training certifications, in accordance with the requirements of Section III.B;‌ c. screen Covered Persons in accordance with the requirements of Section III.D; or require Covered Persons to engage disclose if‌ they are debarred, excluded, or suspended in accordance with the requirements of Section III.D; and use an IRO maintain documentation of screening and disclosure requirements in accordance with the requirements of Section III.D; d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E;‌ e. repay any Overpayments as required by Section III.E III.F and Appendix B.B;‌ 3f. report a Reportable Event in accordance with Section III.G.; or‌ g. disclose any changes to locations or business under Section IV.‌‌ 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xx. Xxxxxxxx fails to timely submit (a) a complete Implementation Report or Annual Reportengage and use an IRO, (b) a certification to OIG in accordance with the requirements of as required by Section VIII.C, Appendix A, or (c) a complete response to any request for information from OIG.Appendix B.‌ 43. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xx. Xxxxxxxx fails to submit the Implementation Report, any IRO Quarterly Claims Review report Report or any Annual Report to OIG in accordance with the requirements of Section III.E and Appendix B.V by the deadlines for submission.‌ 54. A Stipulated Penalty of $1,500 1,000 for each day Indivior Xx. Xxxxxxxx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Xx. Xxxxxxxx fails to grant access.)access.)‌ 65. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Xx. Xxxxxxxx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIA.IA.‌ 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 86. A Stipulated Penalty of $1,000 for each day Indivior Xx. Xxxxxxxx fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior Xx. Xxxxxxxx stating the specific grounds for its determination that Indivior Xx. Xxxxxxxx has failed failed‌ to comply fully and adequately with the CIA IA obligation(s) at issue and steps Indivior the Xx. Xxxxxxxx shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Xx. Xxxxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-5 of this Section.

Appears in 1 contract

Samples: Integrity Agreement

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Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior MPG and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.provisions.‌‌ 1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior MPG fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. post a Compliance Officer;notice in accordance with the requirements of Section III.A;‌ (b) a Compliance Committee;b. complete the training required for MPG and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;‌ (c) c. screen Covered Persons in accordance with the NGC compliance obligations and requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the engagement requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;‌ d. notify OIG of a Compliance Expertgovernment investigation or legal proceeding, in accordance with the performance requirements of a Compliance Program Review, and the preparation of a Compliance Program Review Report, Section III.E;‌ e. repay any Overpayments as required by Section III.A.3;III.F and Appendix B; or‌ (d) the management certification obligations and the development and implementation of f. report a written process for Certifying Employees, as required by Reportable Event in accordance with Section III.A.4; (e) written Policies and Procedures; (f) the development of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.III.G.‌ 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior MPG fails to engage and use an IRO IRO, as required by Section III.E and III.C, Appendix B.A, or Appendix B.‌ 3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior MPG fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in in‌ accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.OIG.‌‌ 4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior MPG fails to submit any IRO Quarterly Claims Review report Report in accordance with the requirements of Section III.E III.C and Appendix B.B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.‌ 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior MPG fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior MPG fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior MPG and/or Xxxxxx Xxxx, M.D. as part of its the Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIA.IA.‌ 7. A Stipulated Penalty of $2,500 1,000 for each day Indivior MPG fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.C, and for each day Indivior MPG fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A; andA.‌ 8. A Stipulated Penalty of $1,000 for each day Indivior MPG fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior MPG stating the specific grounds for its determination that Indivior MPG has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Indivior the MPG shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior MPG receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.Section.‌

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xxxxx Xxxxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Xxxxx Pharmacy fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. post a Compliance Officernotice in accordance with the requirements of Section III.A; (b) a Compliance Committeeb. complete the training required for Xxxxx Pharmacy and Covered Persons and maintain training records, in accordance with the requirements of Section III.B; (c) c. screen Covered Persons in accordance with the NGC compliance obligations and requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the engagement requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D; d. notify OIG of a Compliance Expertgovernment investigation or legal proceeding, in accordance with the performance requirements of a Compliance Program Review, and the preparation of a Compliance Program Review Report, Section III.E; e. repay any Overpayments as required by Section III.A.3III.F and Appendix B; (d) f. report a Reportable Event in accordance with Section III.G; or g. provide to OIG the management certification obligations and the development and implementation of a written process for Certifying Employees, as certifications required by Section III.A.4; (e) written Policies and Procedures; (f) III.H relating to any third-party xxxxxx engaged by Xxxxx Xxxxxxxx during the development term of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related informationIA. 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxx Pharmacy fails to engage and use an IRO IRO, as required by Section III.E and III.C, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxx Pharmacy fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG. 4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxx Pharmacy fails to submit any IRO Quarterly Claims Review report Report in accordance with the requirements of Section III.E III.C and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B. 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior Xxxxx Pharmacy fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Xxxxx Pharmacy fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Xxxxx Xxxxxxxx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIAIA. 7. A Stipulated Penalty of $2,500 1,000 for each day Indivior Xxxxx Pharmacy fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.C, and for each day Indivior Xxxxx Pharmacy fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A; andA. 8. A Stipulated Penalty of $1,000 for each day Indivior Xxxxx Pharmacy fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior Xxxxx Pharmacy stating the specific grounds for its determination that Indivior Xxxxx Xxxxxxxx has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Indivior the Xxxxx Pharmacy shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Xxxxx Xxxxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xxx Xxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Kai Heart fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) the management certification obligations and the development and implementation of d. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) e. written Policies and Procedures; (f) the development of a written training plan and f. the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) a risk assessment and mitigation process; (h) g. a Disclosure Program; (i) h. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) i. notification of Government investigations or legal proceedings;; and (l) j. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Kai Heart fails to engage and use an IRO IRO, as required by in Section III.E III.D, Appendix A, and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Kai Heart fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Kai Heart fails to submit any IRO Claims Review report Report or Unallowable Cost Review Report in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior Kai Heart fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Kai Heart fails to grant access.) 6. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior Kai Heart as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Kai Heart fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Kai Heart stating the specific grounds for its determination that Indivior Kai Heart has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Kai Heart shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Xxx Xxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xx. Xxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Xx. Xxxxxx fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. post a Compliance Officer;notice in accordance with the requirements of Section III.A;‌ (b) a Compliance Committee;b. complete the training required for Covered Persons and maintain training records, in accordance with the requirements of Section III.B;‌ (c) c. screen Covered Persons in accordance with the NGC compliance obligations and requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the engagement requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;‌ d. notify OIG of a Compliance Expertgovernment investigation or legal proceeding, in accordance with the performance requirements of a Compliance Program Review, and the preparation of a Compliance Program Review Report, Section III.E;‌ e. repay any Overpayments as required by Section III.A.3;III.F and Appendix B; or‌ (d) the management certification obligations and the development and implementation of f. report a written process for Certifying Employees, as required by Reportable Event in accordance with Section III.A.4; (e) written Policies and Procedures; (f) the development of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.III.G.‌ 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xx. Xxxxxx fails to engage and use an IRO IRO, as required by Section III.E and III.C, Appendix B.A, or Appendix B.‌ 3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xx. Xxxxxx fails to timely submit (a) a complete Implementation Report or Report, Annual Report, (b) a or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xx. Xxxxxx fails to submit any IRO Quarterly Claims Review report Report in accordance with the requirements of Section III.E III.C‌ and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B. 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior fails Xx. Xxxxxx or MRA fail to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior fails Xx. Xxxxxx or MRA fail to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Xx. Xxxxxx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIA.IA.‌ 7. A Stipulated Penalty of $2,500 1,000 for each day Indivior Xx. Xxxxxx fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.C, and for each day Indivior Xx. Xxxxxx fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A; andA.‌ 8. A Stipulated Penalty of $1,000 for each day Indivior Xx. Xxxxxx fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior Xx. Xxxxxx stating the specific grounds for its determination that Indivior Xx. Xxxxxx has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Indivior the Xx. Xxxxxx shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Xx. Xxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.Section.‌

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Biomet, Biomet Orthopedics and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Biomet or Biomet Orthopedics fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) the NGC compliance obligations and the engagement c. a written Code of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3Conduct; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) d. written Policies and Procedures; (f) the development of a written training plan and e. the training and education of Covered Persons and NGC membersPersons; (g) a risk assessment and mitigation process; (h) f. a Disclosure Program; (i) g. Ineligible Persons screening and removal requirements;; and (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification h. Notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Biomet Orthopedics fails to engage establish and use an IRO as required by Section III.E implement the Arrangements Procedures and/or Arrangements Requirements described in Sections III.D.1 and Appendix B.III.D.2. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Biomet Orthopedics fails to timely submit (a) a complete Implementation Report or Annual Reportengage an IRO, (b) a certification to OIG as required in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.III.E and Appendix B. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails Biomet and Biomet Orthopedics fail to submit any IRO Review report the Implementation Report, documentation required under Section V.B, or the Annual Reports to OIG in accordance with the requirements of Section III.E and Appendix B.V by the deadlines for submission. 5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Biomet Orthopedics fails to submit the annual Arrangements Review Report in accordance with the requirements of Section III.E. 6. A Stipulated Penalty of $1,500 for each day Indivior Biomet or Biomet Orthopedics fails to grant access to the information or documentation as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Biomet fails to grant access.) 67. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior Biomet or Biomet Orthopedics as part of its their Implementation Report, any Annual ReportReports, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Biomet or Biomet Orthopedics fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Biomet or Biomet Orthopedics, stating the specific grounds for its determination that Indivior Biomet or Biomet Orthopedics has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Biomet or Biomet Orthopedics shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Biomet receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Biolectron, Inc.)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior 21st Century and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior 21st Century fails to establish, establish and implement or comply with any of the following obligations as described in Section IIISections III and IV: (a) a. a Chief Compliance Officer; (b) b. Regional Compliance Officers; c. a Compliance Committee; (c) d. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, Review and the preparation of a Compliance Program Review Report, as required by Section III.A.3;. (d) e. the management certification obligations and the development and implementation of obligations; f. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) g. written Policies and Procedures; (f) h. the development and/or implementation of a written training plan and Training Plan for the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) i. a risk assessment and mitigation processinternal review process as required by Section III.E; (h) j. a Disclosure Program; (i) k. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) l. notification of Government investigations or legal proceedings; (l) m. policies and procedures regarding the repayment of Overpayments; n. the repayment of Overpayments as required by Section III.I and Appendix B; o. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting p. disclosure of any Payment-related informationchanges to business units or locations. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior 21st Century fails to engage and use an IRO IRO, as required by Section III.E and III.D, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior 21st Century fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior 21st Century fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior 21st Century fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior 21st Century fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior 21st Century as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior 21st Century fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior 21st Century stating the specific grounds for its determination that Indivior 21st Century has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior 21st Century shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior 21st Century receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (21st Century Oncology Holdings, Inc.)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xxxx Clinic and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Xxxx Clinic fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. post a Compliance Officernotice in accordance with the requirements of Section III.A; (b) a Compliance Committeeb. complete the training required for Xxxx Clinic and Covered Persons and maintain training records, in accordance with the requirements of Section III.B; (c) c. screen Covered Persons in accordance with the NGC compliance obligations and requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the engagement requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D; d. notify OIG of a Compliance Expertgovernment investigation or legal proceeding, in accordance with the performance requirements of a Compliance Program Review, and the preparation of a Compliance Program Review Report, Section III.E; e. repay any Overpayments as required by Section III.A.3; (d) the management certification obligations III.F and the development and implementation of Appendix B; or f. report a written process for Certifying Employees, as required by Reportable Event in accordance with Section III.A.4; (e) written Policies and Procedures; (f) the development of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.III.G. 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxx Clinic fails to engage and use an IRO IRO, as required by Section III.E and III.C, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxx Clinic fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG. 4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxx Clinic fails to submit any IRO Quarterly Claims Review report Report in accordance with the requirements of Section III.E III.C and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B. 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior Xxxx Clinic fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Xxxx Clinic fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Xxxx Clinic as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIAIA. 7. A Stipulated Penalty of $2,500 1,000 for each day Indivior Xxxx Clinic fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.C, and for each day Indivior Xxxx Clinic fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A; andA. 8. A Stipulated Penalty of $1,000 for each day Indivior Xxxx Clinic fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior Xxxx Clinic stating the specific grounds for its determination that Indivior Xxxx Clinic has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Indivior the Xxxx Clinic shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Xxxx Clinic receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Cordant and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Cordant fails to establish, implement or comply with any of the following obligations as described in Section Sections III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) e. written Policies and Procedures; (f) f. the development of a written training plan and the training and education of Covered Persons Persons, Arrangements Covered Persons, and NGC Board members; (g) g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements; h. a risk assessment and mitigation internal review process; (h) i. a Disclosure Program; (i) j. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings; (l) l. policies and procedures regarding the repayment of Overpayments; and m. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Cordant fails to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Cordant fails to timely submit submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Cordant fails to submit any IRO Arrangements Review report Report in accordance with the requirements of Section III.E and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior Cordant fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Cordant fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Cordant as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior Cordant fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.D, and for each day Indivior Cordant fails to furnish to the IRO accurate and complete records to the IROrecords, as required by Section III.E and Appendix A; andA. 8. A Stipulated Penalty of $1,000 for each day Indivior Cordant fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Cordant stating the specific grounds for its determination that Indivior Cordant has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Cordant shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Cordant receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Xxxxxx fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Managers compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4obligations; (e) e. written Policies and Procedures; (f) the development of a written training plan and the f. training and education of Covered Persons and NGC membersBoard Members; (g) g. a risk assessment and mitigation internal review process; (h) h. a Disclosure Program; (i) i. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) j. notification of Government investigations or legal proceedings; (l) k. policies and procedures regarding the repayment of Overpayments; and l. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxxx fails to engage and use an IRO IRO, as required by Section III.E and III.D, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxxx fails to timely submit (a) a complete Implementation Report, Annual Report or Annual Report, (b) a any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxxx fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior Xxxxxx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Xxxxxx fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Xxxxxx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior stating the specific grounds for its determination that Indivior has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Vibra fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4obligations; (e) e. written Policies and Procedures; (f) the development of a written training plan and the f. training and education of Covered Persons and NGC membersBoard Members; (g) g. a risk assessment and mitigation internal review process; (h) h. a Disclosure Program; (i) i. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) j. notification of Government investigations or legal proceedings; (l) k. policies and procedures regarding the repayment of Overpayments; and l. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Vibra fails to engage and use an IRO IRO, as required by Section III.E and III.D, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Vibra fails to timely submit (a) a complete Implementation Report, Annual Report or Annual Report, (b) a any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Vibra fails to submit any IRO Claims Review report Report in accordance with section V.B.6 related to the requirements of Section III.E III.D and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior Vibra fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Vibra fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Vibra as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Xxxxx fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Xxxxx stating the specific grounds for its determination that Indivior Xxxxx has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Vibra shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Xxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior XXX and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior HOK fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. appoint a Compliance Officer; (b) a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, Officer as required by Section III.A.3;III.A;‌ (d) b. written Policies and Procedures required by Section III.B;‌ c. post a notice in accordance with the management certification obligations requirements of Section III.C;‌ d. complete the training required for Covered Persons and maintain training records, in accordance with the development and implementation requirements of Section III.D;‌ e. screen Covered Persons in accordance with the requirements of Section III.F; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.F; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.F;‌ f. notify OIG of a written process for Certifying Employeesgovernment investigation or legal proceeding, in accordance with the requirements of Section III.G;‌ g. establish policies and procedures regarding the repayment of Overpayments;‌ h. repay any Overpayments as required by Section III.A.4;III.H and Appendix B; or‌ (e) written Policies and Procedures; (f) the development of i. report a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications Event in accordance with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.Section III.I.‌ 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior HOK fails to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix B.A or Appendix B.‌ 3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior HOK fails to timely submit (a) a complete Implementation Report or Report, Annual Report, (b) a or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior HOK fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B.B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.‌ 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior HOK fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior HOK fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior HOK as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIA.IA.‌ 7. A Stipulated Penalty of $2,500 1,000 for each day Indivior HOK fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.E, and for each day Indivior HOK fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; andA.‌ 8. A Stipulated Penalty of $1,000 for each day Indivior HOK fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior HOK stating the specific grounds for its determination that Indivior HOK has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Indivior the HOK shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior HOK‌ receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Gamma and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Gamma fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer;Officer;‌ (b) b. a Compliance Committee;Committee;‌ (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3;obligations;‌ (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;obligations;‌ (e) e. written Policies and Procedures;Procedures;‌ (f) f. the development of a written training plan and the training and education of Covered Persons and NGC members;Board Members;‌ (g) g. a risk assessment and mitigation process;internal review process;‌ (h) h. a Disclosure Program;Program;‌ (i) i. Ineligible Persons screening and removal requirements;requirements;‌ (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) j. notification of Government investigations or legal proceedings;proceedings;‌ (l) k. policies and procedures regarding the repayment of Overpayments; and‌ l. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.Events.‌ 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Gamma fails to engage and use an IRO IRO, as required by Section III.E and III.D, Appendix B.A, or Appendix B.‌ 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Gamma fails to timely submit (a) a a‌ complete Implementation Report, Annual Report or Annual Report, (b) a any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Gamma fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B.B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.‌ 5. A Stipulated Penalty of $1,500 for each day Indivior Gamma fails to grant access as required in Section VII. VII (This Stipulated Penalty shall begin to accrue on the date Indivior Gamma fails to grant access.)access).‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Gamma as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.CIA.‌ 7. A Stipulated Penalty of $2,500 for each day Indivior Gamma fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.D, and for each day Indivior Gamma fails to furnish accurate and complete records to the IRO, as required by Section III.E III.D and Appendix A; andA.‌ 8. A Stipulated Penalty of $1,000 for each day Indivior Gamma fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Gamma stating the specific grounds for its determination that Indivior Gamma has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Gamma shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Gamma receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1–7 of this Section.Section.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior TPRC and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior TPRC fails to establish, implement or comply with any of the following obligations as described in Section Sections III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) e. written Policies and Procedures; (f) f. the development of a written training plan and the training and education of Covered Persons Persons, Ordering Providers, and NGC Board members; (g) g. the Urine Drug Testing Report, Urine Drug Testing Monthly Review, and the Urine Drug Testing Quarterly Review requirements in Section III.K; h. a risk assessment and mitigation internal review process; (h) i. a Disclosure Program; (i) j. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings; (l) l. policies and procedures regarding the repayment of Overpayments; and m. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior TPRC fails to engage and use an IRO IRO, as required by Section III.E and III.D, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior TPRC fails to timely submit submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior TPRC fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B or fails to repay any Overpayment identified by the IRO as required by Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior TPRC fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior TPRC fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior TPRC as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior TPRC fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.E., and for each day Indivior TPRC fails to furnish accurate and complete records to the IRO, as required by Section III.E III.D and Appendix A; andA. 8. A Stipulated Penalty of $1,000 for each day Indivior TPRC fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior TPRC stating the specific grounds for its determination that Indivior TPRC has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior TPRC shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior TPRC receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Odyssey and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Odyssey fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) the NGC compliance obligations and the engagement c. a written Code of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3Conduct; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) d. written Policies and Procedures; (f) the development of a written training plan and e. the training and education of Covered Persons and NGC membersPersons; (g) a risk assessment and mitigation process; (h) f. a Disclosure Program; (i) g. Ineligible Persons screening and removal requirements;; and (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification h. Notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Odyssey fails to engage and use an IRO IVO, as required by in Section III.E III.D and Appendix Appendices A and B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Odyssey fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Odyssey fails to submit any IRO the annual IVO Review report Report in accordance with the requirements of Section III.E III.D and Appendix Appendices A and B. 5. A Stipulated Penalty of $1,500 for each day Indivior Odyssey fails to grant access to the information or documentation as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Odyssey fails to grant access.) 6. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior Odyssey as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Odyssey fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Odyssey, stating the specific grounds for its determination that Indivior Odyssey has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Odyssey shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business 30 days after the date Indivior Odyssey receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Odyssey Healthcare Inc)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Jazz and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Jazz fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) the NGC compliance obligations and the engagement c. a written Code of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3Conduct; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) d. written Policies and Procedures; (f) the development of a written training plan and e. the training and education of Covered Persons and NGC membersPersons; (g) a risk assessment and mitigation process; (h) f. a Disclosure Program; (i) g. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) h. notification of Government investigations or legal proceedings; (l) reporting i. notification of Reportable Eventscommunications regarding off-label related matters; (m) notification j. a review of written communications with FDArecords reflecting the content of detailing sessions; (n) the FFMP; (o) the NPMP; (p) notification to HCPs k. monitoring and HCIsreview of Medical Information Requests; and (q) posting of any Payment-related information.l. the Field Sales Force Monitoring Program as described in Section III.L. Corporate Integrity Agreement Jazz Pharmaceuticals, Inc. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Jazz fails to engage and use an IRO IRO, as required by in Section III.E III.D and Appendix Appendices A and B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Jazz fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Jazz fails to submit the annual Report associated with any IRO Review report of the Reviews in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior Jazz fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Jazz fails to grant access.) 6. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior Jazz as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Jazz fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Jazz stating the specific grounds for its determination that Indivior Jazz has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Jazz shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Jazz receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Jazz Pharmaceuticals Inc)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior CBHA and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior CBHA fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. appoint a Compliance Officer; (b) a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, Officer as required by Section III.A.3;III.A;‌ (d) b. written Policies and Procedures required by Section III.B;‌ c. post a notice in accordance with the management certification obligations requirements of Section III.C;‌ d. complete the training required for Covered Persons and maintain training records, in accordance with the development and implementation requirements of Section III.D;‌ e. screen Covered Persons in accordance with the requirements of Section III.F; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.F; or maintain copies of print screens from search results‌ to demonstrate the required screening has been performed in accordance with the requirements of Section III.F;‌‌ f. notify OIG of a written process for Certifying Employeesgovernment investigation or legal proceeding, in accordance with the requirements of Section III.G;‌ g. establish policies and procedures regarding the repayment of Overpayments;‌ h. repay any Overpayments as required by Section III.A.4;III.H and Appendix B; or‌ (e) written Policies and Procedures; (f) the development of i. report a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications Event in accordance with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.Section III.I.‌ 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CBHA fails to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix B.A or Appendix B.‌ 3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CBHA fails to timely submit (a) a complete Implementation Report or Report, Annual Report, (b) a or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CBHA fails to submit any IRO Quarterly Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B.B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.‌ 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior CBHA fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior CBHA fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior CBHA and/or Xx. Xxxxxx Xxxx as part of its the Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIA.IA.‌ 7. A Stipulated Penalty of $2,500 1,000 for each day Indivior CBHA fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior stating the specific grounds for its determination that Indivior has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 of this Section.listed in‌

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Amedisys and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Amedisys fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors and Covered Administrators compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) the management certification obligations and the development and implementation of d. a written process for Certifying EmployeesCode of Conduct; Amedisys, as required by Section III.A.4;Inc. and Amedisys Holding, LLC Corporate Integrity Agreement (e) e. written Policies and Procedures; (f) the development of a written training plan and f. the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) a risk assessment and mitigation processg. the REM Program; (h) h. a Disclosure Program; (i) i. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) j. notification of Government investigations or legal proceedings;; and (l) k. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Amedisys fails to engage and use an IRO IRO, as required by in Section III.E III.E, Appendix A, and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Amedisys fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Amedisys fails to submit any IRO Claims Review report Report, the REM Program Review Report, or Unallowable Cost Review Report in accordance with the requirements of Section III.E and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior Amedisys fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Amedisys fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Amedisys as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.. Amedisys, Inc. and Amedisys Holding, LLC Corporate Integrity Agreement 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Amedisys fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Amedisys stating the specific grounds for its determination that Indivior Amedisys has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Amedisys shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Amedisys receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Amedisys Inc)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Forest and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Forest fails to establish, implement implement, or comply with accomplish any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. a resolution from the NGC compliance obligations and the engagement Board of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3Directors; (d) the management certification obligations and the development and implementation of d. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) e. written Policies and Procedures; (f) the development of a written training plan and f. the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) a risk assessment and mitigation process; (h) g. a Disclosure Program; (i) h. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) i. notification of Government investigations or legal proceedings; (l) j. reporting of Reportable Events;; Corporate Integrity Agreement Forest Laboratories, Inc. (m) k. notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) ; j. a Field Force Monitoring Program as required by XXX.X; k. a Non-Promotional Monitoring Program as required by III.K; k. notification to of HCPs and HCIsHCIs as required by Section III.L; and (q) l. posting of any Payment-related information.Payments as required by Section III.M. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Forest fails to engage and use a Compliance Expert as required in Section III.A.3 or an IRO as required by in Section III.E III.D and Appendix Appendices A-B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Forest fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Forest fails to submit any the annual IRO Review report Report(s) in accordance with the requirements of Section III.E III.D and Appendix Appendices A-B. 5. A Stipulated Penalty of $1,500 for each day Indivior Forest fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Forest fails to grant access.) 6. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior Forest as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Forest fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Forest, stating the specific grounds for its determination that Indivior Forest has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Forest shall take to comply with Corporate Integrity Agreement Forest Laboratories, Inc. the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Xxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Prime fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. a Corporate Compliance Officer;‌ b. Divisional Compliance Directors;‌ c. a Compliance Officer;Committee;‌ (b) a Compliance Committee; (c) d. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3;III.A.4.;‌ (d) e. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;III.A.5.;‌ (e) f. written Policies and Procedures;Procedures;‌ (f) g. the development of a written training plan and the training and education of Covered Persons and NGC members;Board Members;‌ (g) h. a risk assessment and mitigation process;internal review process;‌ (h) i. a Disclosure Program;Program;‌ (i) j. Ineligible Persons screening and removal requirements;requirements;‌ (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings;proceedings;‌ (l) l. policies and procedures regarding the repayment of Overpayments; and‌ m. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.Events.‌ 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Prime fails to engage and use an IRO IRO, as required by Section III.E and III.D, Appendix B.A, or Appendix B.‌ 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Prime fails to timely submit (a) a complete Implementation Report, Annual Report or Annual Report, (b) a any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Prime fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B.B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.‌ 5. A Stipulated Penalty of $1,500 for each day Indivior Prime fails to grant access as required in Section VII. VII (This Stipulated Penalty shall begin to accrue on the date Indivior Prime fails to grant access.)access.).‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Prime as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or otherwise required by this CIA.CIA.‌ 7. A Stipulated Penalty of $2,500 for each day Indivior Prime fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.D, and for each day Indivior Prime fails to furnish accurate and complete records to the IRO, as required by Section III.E III.D and Appendix A; andA.‌ 8. A Stipulated Penalty of $1,000 for each day Indivior Prime fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Prime stating the specific grounds for its determination that Indivior Prime has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Prime shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Prime receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.Section.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Rural/Metro Ohio and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Rural/Metro Ohio fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) the NGC compliance obligations and the engagement c. a written Code of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3Conduct; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) d. written Policies and Procedures; (f) the development of a written training plan and e. the training and education of Covered Persons and NGC membersRelevant Covered Persons; (g) a risk assessment and mitigation process; (h) f. a Disclosure Program; (i) g. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) h. notification of Government investigations or legal proceedings; and; (l) i. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Rural/Metro Ohio fails to engage and use an IRO IRO, as required by in Section III.E III.D, Appendix A, and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Rural/Metro Ohio fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Rural/Metro Ohio fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior fails to grant access as required in Section VII. 2,000 (This Stipulated Penalty which shall begin to accrue on the date Indivior fails the failure to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 comply began) for each day Indivior fails to grant the IRO access to all records Rural/Metro Ohio employs or contracts with an Ineligible Person and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records that person: (i) has responsibility for, or involvement with, Rural/Metro Ohio’s business operations related to the IRO, as required by Section III.E and Appendix AFederal health care programs; and 8. A Stipulated Penalty of $1,000 for each day Indivior fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior stating the specific grounds for its determination that Indivior has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 of this Section.or

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a Compliance Officer; (b) a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) written Policies and Procedures; (f) the development of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Qamar fails to: a. post a notice in accordance with the requirements of Section III.A; b. complete the training required for Qamar and Covered Persons and maintain training records, in accordance with the requirements of Section III.B; c. screen Covered Persons in accordance with the requirements of Section III.D; or require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.D; and maintain documentation of screening and disclosure requirements in accordance with the requirements of Section III.D; d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E; e. repay any Overpayments as required by Section III.F and Appendix B; or f. report a Reportable Event in accordance with Section III.G. g. engage and use an IRO as ICC in accordance with the requirements of Section III.B; h. provide to OIG the certifications required by Section III.E and Appendix B.III.H relating to any third party xxxxxx engaged by Xxxxx during the term of the IA. 32. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Qamar fails to timely submit (a) a complete Implementation Report or Annual Reportengage and use an IRO, (b) a certification to OIG in accordance with the requirements of as required by Section VIII.C, Appendix A, or (c) a complete response to any request for information from OIG.Appendix B. 43. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Qamar fails to submit a complete Implementation Report, Annual Report, or any IRO Review report certification to OIG in accordance with the requirements of Section III.E V by the deadlines for submission. 4. A Stipulated Penalty of $1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Qamar fails to submit any Quarterly Claims Review Report in accordance with the requirements of Section III.C and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B. 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior Qamar fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Qamar fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Qamar as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIAIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Xxxxx fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior Qamar stating the specific grounds for its determination that Indivior Xxxxx has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Indivior the Qamar shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Xxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Health Quest and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Health Quest fails to establish, implement implement, or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) e. written Policies and Procedures; (f) f. the development of a written training plan and the training and education of Covered Persons and NGC membersBoard Members; (g) g. a risk assessment and mitigation internal review process; (h) h. a Disclosure Program; (i) i. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) j. notification of Government investigations or legal proceedings; (l) k. policies and procedures regarding the repayment of Overpayments; and l. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Health Quest fails to engage and use an IRO IRO, as required by Section III.E and III.D, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Health Quest fails to timely submit (a) a complete Implementation Report or Report, Annual Report, (b) a or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Health Quest fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior Health Quest fails to grant access as required in Section VII. VII (This Stipulated Penalty shall begin to accrue on the date Indivior Health Quest fails to grant access.). 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Health Quest as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior Health Quest fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.D, and for each day Indivior Health Quest fails to furnish accurate and complete records to the IRO, as required by Section III.E III.D and Appendix A; andA. 8. A Stipulated Penalty of $1,000 for each day Indivior Health Quest fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Health Quest stating the specific grounds for its determination that Indivior Health Quest has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Health Quest shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Health Quest receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Golden and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Golden fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. appoint a Compliance Officer; (b) Officer and a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, Chief Clinical Officer as required by Section III.A.3;III.A;‌ (d) b. written Policies and Procedures required by Section III.B;‌ c. post a notice in accordance with the management certification obligations requirements of Section III.C;‌ d. complete the training required for Covered Persons and maintain training records, in accordance with the development and implementation requirements of Section III.D;‌ e. screen Covered Persons in accordance with the requirements of Section III.F; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.F; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.F;‌ f. notify OIG of a written process for Certifying Employeesgovernment investigation or legal proceeding, in accordance with the requirements of Section III.G;‌ g. establish policies and procedures regarding the repayment of Overpayments;‌ h. repay any Overpayments as required by Section III.A.4;III.H and Appendix B;‌ (e) written Policies and Procedures;i. report a Reportable Event in accordance with Section III.I; or‌ (f) j. provide to OIG the development certifications required by Section III.J relating to any third-party xxxxxx engaged by Golden during the term of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.IA.‌ 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Golden fails to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix B.A or Appendix B.‌ 3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Golden fails to timely submit submit‌ (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG. 4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Golden fails to submit any IRO Quarterly Claims Review report Report in accordance with the requirements of Section III.E and Appendix B.B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.‌ 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior Golden fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Golden fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Golden as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIA.IA.‌ 7. A Stipulated Penalty of $2,500 1,000 for each day Indivior Golden fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.E, and for each day Indivior Golden fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; andA.‌ 8. A Stipulated Penalty of $1,000 for each day Indivior Golden fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior Golden stating the specific grounds for its determination that Indivior Golden has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Indivior the Golden shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Golden receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.Section.‌

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xx. Xxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.provisions.‌ 1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Xx. Xxxxxx fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. post a Compliance Officer;notice in accordance with the requirements of Section III.A;‌ (b) a Compliance Committee;b. complete the training required for Xx. Xxxxxx and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;‌ (c) c. screen Covered Persons in accordance with the NGC compliance obligations and requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the engagement requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;‌ d. notify OIG of a Compliance Expertgovernment investigation or legal proceeding, in accordance with the performance requirements of a Compliance Program Review, and the preparation of a Compliance Program Review Report, Section III.E;‌ e. repay any Overpayments as required by Section III.A.3;III.F and Appendix B;‌ (d) f. report a Reportable Event in accordance with Section III.G; and‌ g. provide to OIG the management certification obligations and the development and implementation of a written process for Certifying Employees, as certifications required by Section III.A.4; (e) written Policies and Procedures; (f) III.H relating to any third-party xxxxxx engaged by Xx. Xxxxxx during the development term of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.IA.‌ 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xx. Xxxxxx fails to engage and use an IRO IRO, as required by Section III.E and III.C, Appendix B.A, or Appendix B.‌ 3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xx. Xxxxxx fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.OIG.‌ 4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xx. Xxxxxx fails to submit any IRO Quarterly Claims Review report Report in accordance with the requirements of Section III.E III.C and Appendix B.B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.‌ 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior Xx. Xxxxxx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Xx. Xxxxxx fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Xx. Xxxxxx as part of its the Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIA.IA.‌ 7. A Stipulated Penalty of $2,500 1,000 for each day Indivior Xx. Xxxxxx fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.C, and for each day Indivior Xx. Xxxxxx fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A; andA.‌ 8. A Stipulated Penalty of $1,000 for each day Indivior Xx. Xxxxxx fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior Xx. Xxxxxx stating the specific grounds for its determination that Indivior Xx. Xxxxxx has failed to comply fully and adequately with the CIA IA obligation(s) at issue and the steps Indivior Xx. Xxxxxx shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Xx. Xxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.Section.‌

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Practitioner and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Practitioner fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. post a Compliance Officernotice in accordance with the requirements of Section III.A; (b) a Compliance Committeeb. complete the training required for Practitioner and Covered Persons and maintain training records, in accordance with the requirements of Section III.B; (c) c. screen Covered Persons in accordance with the NGC compliance obligations and requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the engagement requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D; d. notify OIG of a Compliance Expertgovernment investigation or legal proceeding, in accordance with the performance requirements of a Compliance Program Review, and the preparation of a Compliance Program Review Report, Section III.E; e. repay any Overpayments as required by Section III.A.3;III.F and Appendix B; or (d) f. report a Reportable Event in accordance with Section III.G. g. provide to OIG the management certification obligations and the development and implementation of a written process for Certifying Employees, as certifications required by Section III.A.4; (e) written Policies and Procedures; (f) III.H relating to any third-party xxxxxx engaged by Practitioner during the development term of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related informationIA. 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Practitioner fails to engage and use an IRO IRO, as required by Section III.E and III.C, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Practitioner fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG. 4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Practitioner fails to submit any IRO Quarterly Claims Review report Report in accordance with the requirements of Section III.E III.C and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B. 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior Practitioner fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Practitioner fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Practitioner as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIAIA. 7. A Stipulated Penalty of $2,500 1,000 for each day Indivior Practitioner fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.C, and for each day Indivior Practitioner fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A; andA. 8. A Stipulated Penalty of $1,000 for each day Indivior Practitioner fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior Practitioner stating the specific grounds for its determination that Indivior Practitioner has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Indivior the Practitioner shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Practitioner receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior CareMed and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the business day after the date the obligation became due) per obligation for each day Indivior CareMed fails to establish, establish and implement or comply with any of the following obligations as described in Section IIISections III and IV: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) d. the management certification obligations and the development and implementation of obligations; e. a written process for Certifying Employees, as required by Section III.A.4Code of Ethics; (e) f. written Policies and Procedures; (f) g. the development and/or implementation of a written training plan and Training Plan for the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) h. a risk assessment and mitigation processprocess as required in Section III.E; (h) i. a Disclosure Program; (i) j. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings; Corporate Integrity Agreement between the Office of Inspector General and Sorkin’s Rx Ltd. d/b/a CareMed Pharmaceutical Services l. policies and procedures regarding the repayment of Overpayments; (l) m. the repayment of Overpayments as required by Section III.I; n. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting o. disclosure of any Payment-related informationchanges to business units or locations. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the business day after the date the obligation became due) for each day Indivior CareMed fails to engage and use an IRO IRO, as required by in Section III.E III.D, Appendix A, and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the business day after the date the obligation became due) for each day Indivior CareMed fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the business day after the date the obligation became due) for each day Indivior CareMed fails to submit any IRO Claims Review report Report or Restocking Review Report in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior CareMed fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior CareMed fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior CareMed as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior CareMed fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior CareMed stating the specific grounds for its determination that Indivior CareMed has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior CareMed shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior CareMed receives this notice from OIG of the failure to comply.) A Stipulated Penalty as Corporate Integrity Agreement between the Office of Inspector General and Sorkin’s Rx Ltd. d/b/a CareMed Pharmaceutical Services described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior I&L and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior I&L fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. post a Compliance Officer;notice in accordance with the requirements of Section III.A;‌ (b) a Compliance Committee;b. complete the training required for I&L and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;‌ (c) c. screen Covered Persons in accordance with the NGC compliance obligations and requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the engagement requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;‌ d. notify OIG of a Compliance Expertgovernment investigation or legal proceeding, in accordance with the performance requirements of a Compliance Program Review, and the preparation of a Compliance Program Review Report, Section III.E;‌ e. repay any Overpayments as required by Section III.A.3;III.F and Appendix B;‌ (d) f. report a Reportable Event in accordance with Section III.G; or‌ g. provide to OIG the management certification obligations and the development and implementation of a written process for Certifying Employees, as certifications required by Section III.A.4; (e) written Policies and Procedures; (f) III.H relating to any third party xxxxxx engaged by I&L during the development term of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.IA.‌ 2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior I&L fails to engage and use an IRO IRO, as required by Section III.E and III.C, Appendix B.A, or Appendix B.‌ 3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior I&L fails to timely submit (a) a complete Implementation Report or Report, Annual Report, (b) a or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior I&L fails to submit any IRO Quarterly Claims Review report Report or Quarterly Drug Inventory Review Report in accordance with the requirements of Section III.E III.C and Appendix B.B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.‌ 5. A Stipulated Penalty of $1,500 1,000 for each day Indivior I&L fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior I&L fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior I&L as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or as otherwise required by this CIA.IA.‌ 7. A Stipulated Penalty of $2,500 1,000 for each day Indivior I&L fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.C, and for each day Indivior I&L fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A; andA.‌ 8. A Stipulated Penalty of $1,000 for each day Indivior I&L fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Indivior I&L‌ stating the specific grounds for its determination that Indivior I&L has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Indivior the I&L shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior I&L receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.

Appears in 1 contract

Samples: Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior King and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.. Corporate Integrity Agreement King Pharmaceuticals, Inc. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior King fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) the NGC compliance obligations and the engagement c. a written Code of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3Conduct; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) d. written Policies and Procedures; (f) the development of a written training plan and e. the training and education of Covered Persons and NGC membersPersons; (g) a risk assessment and mitigation process; (h) f. a Disclosure Program; (i) g. Ineligible Persons screening and removal requirements;; and (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification h. Notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior King fails to engage and use an IRO IRO, as required by in Section III.E III.D and Appendix B.A. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior King fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior King fails to submit any IRO Review report the annual Engagement Report in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior King fails to grant access to Corporate Integrity Agreement King Pharmaceuticals, Inc. 28 the information or documentation as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior King fails to grant access.) 6. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior King as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior King fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior King, stating the specific grounds for its determination that Indivior King has failed to comply fully and adequately with the CIA obligation(s) at issue and the steps Indivior King shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior King receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (King Pharmaceuticals Inc)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Medco and HHS-OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Medco fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee c. a written Code of Conduct; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) d. written Policies and Procedures; Medco CIA e. the training of Covered Persons; (f) f. the development of a written training plan Arrangements Procedures and/or Focus Arrangements Requirements described in Sections III.D.l and the training and education of Covered Persons and NGC membersIII.D.2; (g) a risk assessment and mitigation process; (h) g. a Disclosure Program; (i) h. Ineligible Persons screening and removal requirements;; and (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification i. Notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Medco fails to engage and use an IRO IRO, as required by in Section III.E and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Medco fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Medco fails to submit any IRO the annual Focus Arrangements Review report Report and Unallowable Cost Review Report, if applicable, in accordance with the requirements of Section III.E and Appendix B.III.E. 5. A Stipulated Penalty of $1,500 for each day Indivior Medco fails to grant access to the information or documentation as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Medco fails to grant access.) 6. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior Medco as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Medco fails to comply fully and adequately with any obligation of this CIA. HHS-OIG shall provide notice to Indivior Medco, stating the specific grounds for its determination that Indivior Medco has failed to comply fully Medco CIA and adequately with the CIA obligation(s) at issue and steps Indivior Medco shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Medco receives this notice from HHS-OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which HHS-OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Medco Health Solutions Inc)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior HealthNet and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior HealthNet fails to establish, implement or comply with any of the following obligations as described in Section Sections III: (a) a. a Compliance Officer;Officer;‌ (b) b. a Compliance Committee;Committee;‌ (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3;obligations;‌ (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;obligations;‌ (e) e. written Policies and Procedures;Procedures;‌ (f) the development of a written training plan and the f. training and education of Covered Persons Persons, Arrangements Covered Persons, and NGC members;Board Members;‌ (g) g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;‌ h. a risk assessment and mitigation process;internal review process;‌ (h) i. a Disclosure Program;Program;‌ (i) j. Ineligible Persons screening and removal requirements;requirements;‌ (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings;proceedings;‌ (l) l. policies and procedures regarding the repayment of Overpayments; and‌ m. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.Events.‌ 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior HealthNet fails to engage and use an IRO IRO, as required by Section III.E and III.E, Appendix B.A, or Appendix B.‌ 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior HealthNet fails to timely submit (a) a a‌ complete Implementation Report or Report, Annual Report, (b) a or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior HealthNet fails to submit any IRO Arrangements Review report Report in accordance with the requirements of Section III.E and Appendix B.B.‌ 5. A Stipulated Penalty of $1,500 for each day Indivior HealthNet fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior HealthNet fails to grant access.)access.)‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior HealthNet as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.CIA.‌ 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior HealthNet fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior HealthNet stating the specific grounds for its determination that Indivior HealthNet has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior HealthNet shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior HealthNet receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.Section.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior TGS and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior TGS fails to establish, implement or comply with any of the following obligations as described in Section Sections III: (a) a. a Chief Compliance Officer; (b) a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) b. written Policies and Procedures; (f) the development of a written training plan and the c. training and education of Covered Persons Persons, and NGC membersArrangements Covered Persons; (g) d. the Focus Arrangements Procedures and/or Focus Arrangements Requirements; e. a risk assessment and mitigation internal review process; (h) f. a Disclosure Program; (i) g. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) h. notification of Government investigations or legal proceedings; (l) i. policies and procedures regarding the repayment of Overpayments; and j. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails to engage and use an IRO as required by Section III.E and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails to submit any IRO Review report in accordance with the requirements of Section III.E and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior TGS fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior TGS stating the specific grounds for its determination that Indivior TGS has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior TGS shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior TGS receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Toccoa and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.provisions.‌‌ 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Toccoa fails to establish, establish and implement or comply with any of the following obligations as described in Section IIISections III and IV: (a) a. a Compliance Officer;Officer;‌ (b) b. a Compliance Committee;Committee;‌ (c) c. the NGC Executive Committee compliance obligations obligations;‌ d. the management certification obligations;‌ e. a written Code of Conduct;‌ f. written Policies and Procedures;‌ g. the engagement development and/or implementation of a Compliance ExpertTraining Plan for the training of Covered Persons, the performance of a Compliance Program ReviewRelevant Covered Persons, and the preparation of Board Members;‌‌ h. a Compliance Program Review Report, risk assessment and internal review process as required by Section III.A.3;III.E;‌ (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) written Policies and Procedures; (f) the development of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) i. a Disclosure Program;Program;‌ (i) j. Ineligible Persons screening and removal requirements;requirements;‌ (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings;proceedings;‌ (l) l. policies and procedures regarding the repayment of Overpayments;‌ m. the repayment of Overpayments as required by Section III.I and Appendix B;‌ n. reporting of Reportable Events;; and‌ (m) notification o. disclosure of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification changes to HCPs and HCIs; and (q) posting business units or locations or of any Payment-related information.new employment or contractual arrangements.‌ 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Toccoa fails to engage and use an IRO IRO, as required by Section III.E and III.D, Appendix B.A, or Appendix B.‌ 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Toccoa fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.‌ 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Toccoa fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B.B.‌ 5. A Stipulated Penalty of $1,500 for each day Indivior Toccoa fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Toccoa fails to grant access.)access.)‌‌ 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Toccoa as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.CIA.‌ 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Toccoa fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Toccoa stating the specific grounds for its determination that Indivior Toccoa has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Toccoa shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Toccoa receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.Section.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xxxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Xxxxxxx fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) e. written Policies and Procedures; (f) f. the development of a written training plan and the training and education of Covered Persons and NGC Board members; (g) g. a risk assessment and mitigation internal review process; (h) h. a Disclosure Program; (i) i. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) j. notification of Government investigations or legal proceedings; (l) k. policies and procedures regarding the repayment of Overpayments; l. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.m. cooperation as required by Section XXX.X. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxxxx fails to engage and use an IRO IRO, as required by Section III.E and III.D, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxxxx fails to timely submit submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Xxxxxxx fails to submit any IRO Claims Review report Report in accordance with the requirements of Section III.E III.D and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior Xxxxxxx fails to grant access as required in Section VII. VII (This Stipulated Penalty shall begin to accrue on the date Indivior Xxxxxxx fails to grant access.). 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Xxxxxxx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior Xxxxxxx fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.D, and for each day Indivior Xxxxxxx fails to furnish accurate and complete records to the IRO, as required by Section III.E III.D and Appendix A; andA. 8. A Stipulated Penalty of $1,000 for each day Indivior Xxxxxxx fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Xxxxxxx stating the specific grounds for its determination that Indivior Xxxxxxx has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Xxxxxxx shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Xxxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 1-7 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Xxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Prime fails to establish, implement or comply with any of the following obligations as described in Section Sections III: (a) a. a Corporate Compliance Officer or Deputy Compliance Officers;‌ b. a Compliance Officer;Committee;‌ (b) a Compliance Committee; (c) c. the NGC Board compliance obligations and obligations, the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3;III.A.4.;‌ (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;III.A.5;‌ (e) e. written Policies and Procedures;Procedures;‌ (f) f. the development of a written training plan and the training and education of Covered Persons Persons, Arrangements Covered Persons, and NGC members;Board members;‌ (g) g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;‌ h. a risk assessment and mitigation process;internal review process;‌ (h) i. a Disclosure Program;Program;‌ (i) j. Ineligible Persons screening and removal requirements;requirements;‌ (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) k. notification of Government investigations or legal proceedings;proceedings;‌ (l) l. policies and procedures regarding the repayment of Overpayments; and‌‌ m. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.Events.‌ 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Prime fails to engage and use an IRO IRO, as required by Section III.E III.E, and Appendix B.Appendices A through D.‌ 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Prime fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.OIG.‌ 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Prime fails to submit any IRO Arrangements Review report Report in accordance with the requirements of Section III.E and Appendix B.B.‌ 5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Prime fails to submit any Claims Review Report or Inpatient Medical Necessity Review Report in accordance with the requirements of Section III.E and Appendices C and D, respectively, or fails to repay any Overpayment identified by the IRO as required by Appendices C and D.‌ 6. A Stipulated Penalty of $1,500 for each day Indivior Prime fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Prime fails to grant access.)access.)‌ 67. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior Prime as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.CIA.‌ 78. A Stipulated Penalty of $2,500 for each day Indivior Prime fails to grant the IRO access to all records and personnel necessary to complete the reviews required by listed in Section III.E III.E., and for each day Indivior Prime fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; andA.‌ 89. A Stipulated Penalty of $1,000 for each day Indivior Prime fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Prime stating the specific grounds for its determination that Indivior Prime has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Prime shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Prime receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-8 of this Section.Section.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior CVS Caremark and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior CVS Caremark fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board Committee compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3obligations; (d) the management certification obligations and the development and implementation of d. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) e. written Policies and Procedures; (f) the development of a written training plan and f. the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) a risk assessment and mitigation process; (h) g. a Disclosure Program; (i) h. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) i. notification of Government government investigations or legal proceedings; (l) j. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.k. reporting under Section XXX.X. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CVS Caremark fails to engage and use an IRO IRO, as required by in Section III.E III.D and Appendix Appendices A and B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CVS Caremark fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CVS Caremark fails to submit any IRO Third-Party Liability Claims Review report Report or PBM Platform Controls Assessment Report in accordance with the requirements of Section III.E III.D and Appendix B.Appendices B and C. 5. A Stipulated Penalty of $1,500 for each day Indivior CVS Caremark fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior CVS Caremark fails to grant access.) 6. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior CVS Caremark as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior CVS Caremark fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior CVS Caremark stating the specific grounds for its determination that Indivior CVS Caremark has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior CVS Caremark shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior CVS Caremark receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1–6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Maximus and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Maximus fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) the NGC compliance obligations and the engagement c. a written Code of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3Conduct; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) d. written Policies and Procedures; (f) the development of a written training plan and e. the training and education of Covered Persons and NGC membersPersons; (g) a risk assessment and mitigation process; (h) f. a Disclosure Program; (i) g. Ineligible Persons screening and removal requirements;; and (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) h. notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Maximus fails to engage and use pay an IRO invoice of OAS within 30 days of the receipt from OAS as required by in Section III.E and Appendix B.III.D. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Maximus fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Maximus fails to notify affected parties of a Potential Problem with Consulting Contract in accordance with requirements of Section III.H 5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Maximus fails to submit any IRO the annual Consulting Contract Review report in accordance with the requirements of Section III.E and Appendix B.III.D. 56. A Stipulated Penalty of $1,500 for each day Indivior Maximus fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Maximus fails to grant access.) 67. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior Maximus as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Maximus fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Maximus stating the specific grounds for its determination that Indivior Maximus has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Maximus shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Maximus receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Maximus Inc)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior CVS and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior CVS fails to establish, establish and implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) the NGC compliance obligations and the engagement c. a written Code of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3Conduct; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) d. written Policies and Procedures; (f) the development of a written training plan and e. the training and education of Covered Persons and NGC membersPersons; (g) a risk assessment and mitigation process; (h) f. a Disclosure Program; (i) g. Ineligible Persons screening and removal requirements;; and CVS Caremark Corporate Integrity Agreement (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification h. Notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CVS fails to engage and use an IRO IRO, as required by in Section III.E III.D and Appendix B.A. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CVS fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior CVS fails to submit any IRO the annual Government Reimbursement Review report Report in accordance with the requirements of Section III.E III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior CVS fails to grant access to the information or documentation as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior CVS fails to grant access.) 6. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior CVS as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior CVS fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior CVS, stating the specific grounds for its determination that Indivior CVS has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior CVS shall take to comply with the this CIA. (This Stipulated Penalty shall begin to accrue 10 business ten (10) days after the date Indivior CVS receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior Forest and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior Forest fails to establish, implement implement, or comply with accomplish any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. a resolution from the NGC compliance obligations and the engagement Board of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3Directors; (d) the management certification obligations and the development and implementation of d. a written process for Certifying Employees, as required by Section III.A.4Code of Conduct; (e) e. written Policies and Procedures; (f) the development of a written training plan and f. the training and education of Covered Persons Persons, Relevant Covered Persons, and NGC membersBoard Members; (g) a risk assessment and mitigation process; (h) g. a Disclosure Program; (i) h. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) i. notification of Government investigations or legal proceedings; (l) j. reporting of Reportable Events; (m) k. notification of written communications with FDA; (n) the FFMPl. a Field Force Monitoring Program as required by III.J; (o) the NPMPm. a Non-Promotional Monitoring Program as required by III.K; (p) n. notification to of HCPs and HCIsHCIs as required by Section III.L; and (q) o. posting of any Payment-related information.Payments as required by Section 111.M. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Forest fails to engage and use a Compliance Expert as required in Section III.A.3 or an IRO as required by in Section III.E III.D and Appendix Appendices A-B. 3. A Stipulated Penalty of $2,500 ({which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Forest fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior Forest fails to submit any the annual IRO Review report Report(s) in accordance with the requirements of Section III.E MD and Appendix Appendices A-B. 5. A Stipulated Penalty of $1,500 for each day Indivior Forest fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior Forest fails to grant access.) 6. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Indivior Forest as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior Forest fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior Forest, stating the specific grounds for its determination that Indivior Forest has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior Forest shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior Forest receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 1-6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Forest Laboratories Inc)

Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Indivior United Therapeutics and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior United Therapeutics fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a. a Compliance Officer; (b) b. a Compliance Committee; (c) c. the NGC Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, Review and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4obligations; (e) e. written Policies and Procedures; (f) the development of a written training plan and the f. training and education of Covered Persons and NGC membersBoard Members; (g) g. a risk assessment and mitigation internal review process; (h) h. a Disclosure Program; (i) i. Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) j. notification of Government investigations or legal proceedings; (l) k. reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information.l. the Independent Charity PAP processes, policies, and procedures required by Section III.J. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior United Therapeutics fails to engage and use an IRO as required by Section III.E and III.E, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior United Therapeutics fails to timely submit (a) a complete Implementation Report, Annual Report or Annual Report, (b) a any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior United Therapeutics fails to submit any IRO Review report in accordance with the requirements of Section III.E and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior United Therapeutics fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior United Therapeutics fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior United Therapeutics as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior United Therapeutics fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior United Therapeutics stating the specific grounds for its determination that Indivior United Therapeutics has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior United Therapeutics shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior United Therapeutics receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 6 of this Section.

Appears in 1 contract

Samples: Corporate Integrity Agreement (UNITED THERAPEUTICS Corp)

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