Xxxx Assessment and Mitigation Process. GSK represents that prior to the Effective Date, GSK began to implement a standardized process to allow GSK compliance, legal, and business unit leaders to assess and identify risks associated with Government Reimbursed Products that have field force support in the United States (GSK Products). This program is referred to as the Targeted Risk-based Analysis Compliance Evaluations and Review (TRACER) program and is described in more detail in Appendix C. TRACER involves an annual evaluation and mitigation of risks associated with the marketing of the GSK Products. GSK shall maintain a TRACER process for the duration of the CIA.
Xxxx 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 (4) track the implementation of the risk mitigation plans to assess the effectiveness of such plans. Indivior shall maintain the RAMP for the term of the CIA.
Xxxx Assessment and Mitigation Process. Within 90 days after the Effective Date, Taro shall develop and implement a centralized annual risk assessment and internal review process to identify and address risks associated with Taro’s Government Reimbursed Products and with applicable Federal health care program requirements (including the requirements of the Federal Anti-Kickback Statute). 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 Government Reimbursed Product, including risks associated with Pricing and Contracting Functions, (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. Taro shall maintain the risk assessment and internal review process for the term of the CIA.
Xxxx Assessment and Mitigation Process. Amgen represents that prior to the Effective Date, it implemented a standardized annual risk assessment process that focuses on activities governed by Amgen’s Policies and Procedures (hereafter the “Activity- Based Risk Assessment”). The Activity-Based Risk Assessment is intended, among other objectives, to inform Healthcare Compliance Internal Audit and Healthcare Compliance Monitoring annual priorities. Furthermore, in 2012, Amgen initiated a pilot project to Corporate Integrity Agreement Amgen Inc. implement a standardized annual compliance process which is referred to herein as “Ra3” (Risk - Assess, Align, Address) which would allow Amgen compliance, regulatory and other personnel to identify and assess risk on a product-specific basis beginning in 2013. Ra3, which is described more fully in Appendix C, will assess information associated with safety, advertising, marketing and promotion of Government Reimbursed Products. The outcomes of Ra3 will be coordinated with outcomes of the Activity-Based Risk Assessment. Additionally, based on the outcomes of Ra3 and the Activity-Based Risk Assessment, Amgen will annually develop and implement specific plans and oversight activities designed to mitigate or reduce the identified risk, which plans may include additional auditing, monitoring, training, compliance support, legal oversight, issuance of new policies or procedures or the implementation of new or enhanced compliance controls. In addition to general categories of information described above, the Ra3 process shall, at a minimum, include a review of annual financial and budget-type information. For example, the Ra3 process shall include a review of information about prior year expenditures and proposed financial and strategic plans for engaging HCPs for advisory boards, speaker training and speaker programs, consultant meetings, and Research as well as prior year and proposed financial and strategic plans for Publications relating to Government Reimbursed Products. The Ra3 process shall also include a review of past and projected financial and strategic plans for Independent Medical Education activities and Donations. Amgen shall maintain the Ra3 process or a substantively equivalent process for all Government Reimbursed Products throughout the term of the CIA.
Xxxx Assessment and Mitigation Process. Endo Pharmaceuticals Inc. Corporate Integrity Agreement Within the first Reporting Period, Endo shall develop and begin to implement a standardized, centralized annual risk assessment and mitigation process (the “RAMP Program”), as further described in this Section III.D and Appendix B. The RAMP Program shall require compliance, legal and other relevant representatives as determined by Endo to assess and identify risks associated with Government Reimbursed Products that are marketed in the United States, including risks associated with the sales, marketing, and promotion of such products. The RAMP Program shall involve an evaluation, at least annually, of the risks associated with Government Reimbursed Products. Based on the outcomes of the risk-identification component of the RAMP Program, Endo and EPI 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. Endo and EPI 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. The RAMP Program shall be in effect no later than the first anniversary of the Effective Date of the CIA.
Xxxx Assessment and Mitigation Process. Within 150 days after the Effective Date, Mallinckrodt shall develop and implement a centralized annual risk assessment and internal review process to identify and address risks associated with each of its Government Reimbursed Products and with applicable Federal health care program requirements (including the requirements of the Federal Anti-Kickback Statute), including risks associated with the sales, marketing, and promotion of such products; the collection, calculation, verification and reporting of information for such products for purposes of the Medicaid Drug Rebate Program, the Medicare Program and the 340B Drug Pricing Program and the payment of rebates to the Medicaid Drug Rebate Program for such products; and risks associated with Mallinckrodt’s operation of any PAP and the company’s arrangements and interactions with any Independent Charity PAPs. The Compliance Committee shall be responsible for implementation and oversight of the risk assessment and internal review process. The risk assessment and internal review process shall be conducted annually and shall require Mallinckrodt to: (1) identify and prioritize risks, (2) develop internal audit work plans related to the identified risk areas, (3) implement the internal audit work plans, (4) develop corrective action plans in response to the results of any internal audits performed, and (5) track the implementation of the corrective action plans in order to assess the effectiveness of such plans. Mallinckrodt shall maintain the risk assessment and internal review process for the term of the CIA.
Xxxx 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 Jazz Pharmaceuticals plc Corporate Integrity Agreement 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.
Xxxx Assessment and Mitigation Process. Within 120 days after the Effective Date, Lundbeck shall develop and implement a centralized annual risk assessment and internal review process to identify and address risks associated with each of Lundbeck’s Government Reimbursed Products and with Corporate Integrity Agreement Lundbeck LLC 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 Lundbeck’s 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. Lundbeck shall maintain the risk assessment and internal review process for the term of the CIA.
Xxxx 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
Xxxx 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.
