Risk Assessment and Mitigation Process. Within 120 days after the Effective Date, Indivior shall develop and implement a centralized annual risk assessment and mitigation process to identify and address risks associated with Indivior’s compliance with Federal health care program requirements and FDA requirements, including risks associated with the sales, marketing, and promotion of Government Reimbursed Products. The Compliance Committee shall be responsible for implementation and oversight of the risk assessment and mitigation process. The Risk Assessment and Mitigation Process (RAMP) shall require compliance, legal, and business unit leaders, at least annually, to: (1) evaluate and identify emerging risks (e.g., new products or activities) and assess relevant, material changes to previously identified RAMP risk areas, (2) prioritize, develop, update (as relevant), and implement specific risk mitigation plans related to the identified, prioritized risks, (3) implement the risk mitigation plans (which may include compliance auditing and monitoring activities), and
Risk Assessment and Mitigation Process. Within 120 days after the Effective Date, IHS shall develop and implement a centralized annual risk assessment and mitigation process to identify and address risks associated with Arrangements (as defined in Section III.C.1, above). The risk assessment and mitigation process should include: (1) a process for identifying and prioritizing risks;
Risk Assessment and Mitigation Process. Within 90 days after CPT Publication, EGS shall develop a standardized, centralized process to allow EGS in-house or outside legal counsel, compliance, and leaders of the relevant departments and functions to identify and assess risks associated with the sale, marketing, detailing, advertising, and promotion of Government Reimbursed Products, and to devise and implement specific measures to mitigate identified risks. This process shall focus on risks associated with Government Reimbursed Products, including, but not limited to, Promotional Functions and Advice Functions, related to compliance with Federal health care program requirements, the False Claims Act, and the Federal anti-kickback statute. EGS shall maintain the Risk Assessment and Mitigation Process for the duration of the CIA. The IRO shall perform a review of the effectiveness of the Risk Assessment and Mitigation Process at the OIG’s request.
Risk Assessment and Mitigation Process. Within 120 days after the Effective Date, Daiichi shall implement a standardized, centralized annual risk assessment and mitigation process (RAMP) as further described in this Section III.D and Appendix B. The RAMP shall require compliance, legal and business unit leaders, at least annually, to evaluate and identify risks associated with each Government Reimbursed Product, including risks associated with the sales, marketing, and promotion of such products. Based on the outcomes of the risk-identification component of the RAMP, Daiichi legal, compliance and other personnel shall centrally develop and implement specific plans designed to mitigate or reduce the identified risks. The risk mitigation plans shall be developed annually and a plan shall be developed for each Government Reimbursed Product. Daiichi shall implement the risk mitigation plans and shall track the implementation of the mitigation plans. The RAMP shall be reviewed by the IRO, and the IRO review of the process is described in more detail in Appendix B. Daiichi shall maintain the RAMP for the duration of the CIA.
Risk Assessment and Mitigation Process. No later than January 1, 2021, Sanofi shall develop and implement a centralized annual risk assessment and internal review process to identify and address risks associated with each of Sanofi’s Government Reimbursed Products and with applicable Federal health care program requirements. The risk assessment and internal review process shall require compliance, legal, and department leaders, at least annually, to: (1) identify and prioritize risks associated with each Government Reimbursed Product, including risks associated with the sales, marketing, and promotion of such products and risks associated with Sanofi’s operation of any Sanofi PAP and the company’s arrangements and interactions with any Independent Charity PAPs, (2) develop internal audit work plans related to the identified risk areas, (3) implement the internal audit work plans, (4) develop corrective action plans in response to the results of any internal audits performed, and (5) track the implementation of the corrective action plans in order to assess the effectiveness of such plans. Sanofi shall maintain the risk assessment and internal review process for the term of the CIA.
Risk Assessment and Mitigation Process. Shire shall implement a standardized, centralized annual risk assessment and mitigation process (RAMP), as further described in this Section III.D and Appendix B. The RAMP shall require compliance, legal and other relevant representatives, including personnel from the applicable business unit(s), to assess and identify risks associated with Government Reimbursed Products that have one or more sales representatives assigned in the United States during the Reporting Period, are marketed in the United States, and are subject to FDA requirements governing the marketing of such Government Reimbursed Products. The RAMP shall involve an evaluation, at least annually, of the risks associated with Government Reimbursed Products marketed in the United States. Based on the outcomes of the risk-identification component of the RAMP Program, Shire legal, compliance and other personnel shall centrally develop and implement specific plans designed to mitigate or reduce the identified risks. The risk mitigation plans shall be developed annually and a plan shall be developed for each Government Reimbursed Product. Shire shall mitigate risks associated with marketing the Government Reimbursed Products in the United States, taking into account each risk assessment and applicable Federal health care program and FDA requirements. Shire North American Group, Inc. Corporate Integrity Agreement
Risk Assessment and Mitigation Process. Within 90 days after the Effective Date, DaVita shall develop a standardized, centralized process to allow DaVita Dialysis’s in-house or outside legal counsel, compliance, and leaders of the relevant functions to: (1) identify and assess the risks associated with DaVita Dialysis’s compliance with Federal health care program requirements, the False Claims Act, and the Anti-Kickback Statute; and (2) determine what steps, if any, DaVita Dialysis should take to mitigate the identified risks. DaVita shall maintain the Risk Assessment and Mitigation Process for the duration of the CIA. DaVita HealthCare Partners Inc. Corporate Integrity Agreement
Risk Assessment and Mitigation Process. Within 120 days after the Effective Date, Jazz shall develop and implement a centralized annual risk assessment and internal review process to identify and address risks associated with each of Jazz’s Government Reimbursed Products and with applicable Federal health care program requirements. The risk assessment and internal review process shall require compliance, legal, and department leaders, at least annually, to: (1) identify and prioritize risks associated with each Government Reimbursed Product, including risks associated with the sales, marketing, and promotion of such products and risks associated with Jazz’s operation of any patient assistance program and the company’s arrangements and interactions with any Independent Charity PAPs, (2) develop audit work plans related to the identified risk areas, (3) implement the audit work plans, (4) develop corrective action plans in response to the results of any internal audits performed, and (5) track the implementation of the corrective action plans in order to assess the effectiveness of such plans. Jazz shall maintain the risk assessment and internal review process for the term of the CIA.
Risk Assessment and Mitigation Process. Within 120 days after the Effective Date, United Therapeutics shall develop and implement a centralized annual risk assessment and internal review process to identify and address risks associated with each of United Therapeutics’ Government Reimbursed Products and with applicable Federal health care program requirements. The risk assessment and internal review process shall require compliance, legal, and department leaders, at least annually, to: (1) identify and prioritize risks associated with each Government Reimbursed Product, including risks associated with the sales, marketing, and promotion of such products and risks associated with United Therapeutics’ operation of any patient assistance program and the company’s arrangements and interactions with any Independent Charity PAPs, (2) develop internal audit work plans related to the identified risk areas, (3) implement the internal audit work plans, (4) develop corrective action plans in response to the results of any internal audits performed, and (5) track the implementation of the corrective action plans in order to assess the effectiveness of such plans. United Therapeutics shall maintain the risk assessment and internal review process for the term of the CIA.
Risk Assessment and Mitigation Process. Within 120 days after the Effective Date, Aegerion shall implement a centralized annual risk assessment and mitigation process (RAMP) as further described in this Section III.D and Appendix B. The RAMP shall require compliance, legal and business unit leaders, at least annually, to evaluate and identify risks associated with Aegerion’s participation in Federal health care programs and the risks associated with each Government Reimbursed Product, including risks associated with the sales, marketing, and promotion of such products. Based on the outcomes of the risk-identification component of the RAMP, Aegerion legal, compliance and other personnel shall centrally develop and implement specific plans designed to mitigate or reduce the identified risks. The risk mitigation plans shall be developed annually and a plan shall be developed for each Government Reimbursed Product. Aegerion shall implement the risk mitigation plans and shall track the implementation of the mitigation plans. The RAMP shall be reviewed by the IRO, and the IRO review of the process is described in more detail in Appendix B. Aegerion shall maintain the RAMP for the duration of the CIA.
