Follow Up Reviews and Reporting. In the event that a potential violation of GSK’s Policies and Procedures or of legal or compliance requirements, including but not limited to potential improper promotion, are identified during any aspect of the Non- Promotional Monitoring Program, GSK shall investigate the incident consistent with established Policies and Procedures for the handling of investigations and shall take all necessary and appropriate responsive action (including disciplinary action) and corrective action, including the disclosure of Reportable Events pursuant to Section III.J above, if applicable. Any compliance issues identified during any Non-Promotional Monitoring Program referenced above, and any corrective action, shall be recorded in the files of the
Follow Up Reviews and Reporting. In the event that a potential violation of Indivior’s Policies and Procedures or of legal or compliance requirements, including but not limited to potential improper promotion, are identified during any aspect of the NPMP, Indivior shall investigate the incident consistent with established policies and procedures for the handling of investigations and shall take all necessary and appropriate responsive action (including disciplinary action) and corrective action, including the disclosure of Reportable Events pursuant to Section III.J above, if applicable.
Follow Up Reviews and Reporting. In the event that a potential violation of AstraZeneca’s Policies and Procedures or of legal or compliance requirements, including but not limited to potential off-label promotion, are identified during any aspect of the Non-Promotional Monitoring Program, AstraZeneca shall investigate the incident consistent with established Policies and Procedures for the handling of investigations and shall take all necessary and appropriate responsive action (including disciplinary action) and corrective action, including the disclosure of Reportable Events pursuant to Section III.H above, if applicable. Any compliance issues identified during any Non-Promotional Monitoring Program referenced above, and any corrective action, shall be recorded in the files of the U.S. Compliance Department. AstraZeneca shall include a summary of the Non-Promotional Monitoring Program and the results of the Non-Promotional Monitoring Program as part of each Annual Report. As part of each Annual Report, AstraZeneca also shall provide the OIG with descriptions of any instances identified through the Non-Promotional Monitoring Program in which it was determined that improper promotion of Government Reimbursed Products occurred or the activities violated AstraZeneca’s requirements or Policies and Procedures, and a description of the action(s) that AstraZeneca took as a result of such determinations. AstraZeneca shall make the documents relating to the Non-Promotional Monitoring Program available to the OIG upon request.
Follow Up Reviews and Reporting. In the event that a potential violation of Par’s Policies and Procedures or of legal or compliance requirements, including but not limited to potential improper promotion, are identified during any aspect of the Non- Par Corporate Integrity Agreement Promotional Monitoring Program, Par shall investigate the incident consistent with established Policies and Procedures for the handling of investigations and shall take all necessary and appropriate responsive action (including disciplinary action) and corrective action, including the disclosure of Reportable Events pursuant to Section III.J above, if applicable. Any compliance issues identified during any Non-Promotional Monitoring Program referenced above, and any corrective action, shall be recorded in the files of the Compliance Department. Par shall include a summary of the Non-Promotional Monitoring Program and the results of the Non-Promotional Monitoring Program as part of each Annual Report. As part of each Annual Report, Par also shall provide the OIG with descriptions of any instances identified through the Non-Promotional Monitoring Program in which it was determined that improper promotion of Government Reimbursed Products occurred or the activities violated Par’s requirements or Policies and Procedures, and a description of the action(s) that Par took as a result of such determinations. Par shall make the documents relating to the Non-Promotional Monitoring Program available to the OIG upon request.
Follow Up Reviews and Reporting. In the event that a potential violation of ACell’s Policies and Procedures or of legal or compliance requirements, including but not limited to potential improper promotion, are identified during the NPMP, ACell shall investigate the incident consistent with established policies and procedures for the handling of investigations and shall take all necessary and appropriate responsive action (including disciplinary action) and corrective action, including the disclosure of Reportable Events pursuant to Section III.I above, if applicable. ACell, Inc. Corporate Integrity Agreement
Follow Up Reviews and Reporting. In the event that a potential violation of Aegerion’s Policies and Procedures or of legal or compliance requirements, including but not limited to potential improper promotion, is identified during any aspect of the NPMP, Aegerion shall investigate the incident consistent with established policies and procedures for the handling of investigations and shall take all necessary and appropriate responsive action (including disciplinary action) and corrective action, including the disclosure of Reportable Events pursuant to Section III.J above, if applicable. As required by Section V.B.17, Aegerion shall include a summary of the NPMP and the results of the NPMP as part of each Annual Report. As part of each Annual Report, Aegerion also shall provide OIG with descriptions of any instances identified through the NPMP in which it was determined that improper promotion of Government Reimbursed Products occurred or the activities violated Aegerion’s Policies and Procedures, and a description of the action(s) that Aegerion took as a result of such determinations. Aegerion shall make the documents relating to the NPMP available to OIG upon request.
Follow Up Reviews and Reporting. In the event that a potential violation of Avanir’s Policies and Procedures or of legal or compliance requirements, including but not limited to potential improper promotion of a Government Reimbursed Product, are identified during any aspect of the NPMP, Avanir shall investigate the incident consistent with established policies and procedures for the handling of investigations and shall take all necessary and appropriate responsive action (including disciplinary action) and corrective action, including the disclosure of Reportable Events pursuant to Section III.I above, if applicable. Avanir shall include a summary of the NPMP and the results of the NPMP as part of each Annual Report. As part of each Annual Report, Xxxxxx also shall provide OIG with descriptions of any instances identified through the NPMP in which it was determined that improper promotion of Government Reimbursed Products occurred or the activities violated Avanir’s Policies and Procedures, and a description of the action(s) that Xxxxxx took as a result of such determinations. Avanir shall make the documents relating to the NPMP available to OIG upon request.
Follow Up Reviews and Reporting. In the event that a potential violation of BIPI’s Policies and Procedures or of legal or compliance requirements, including but not limited to potential improper promotion, are identified during any aspect of the Non-Promotional Monitoring Program, BIPI shall investigate the incident consistent with established Policies and Procedures for the handling of investigations and shall take all necessary and appropriate responsive action (including disciplinary action) and corrective action, including the disclosure of Reportable Events pursuant to Section
Follow Up Reviews and Reporting. In the event that a potential violation of Daiichi’s Policies and Procedures or of legal or compliance requirements, including but not limited to potential improper promotion, are identified during any aspect of the NPMP, Daiichi shall investigate the incident consistent with established policies and procedures for the handling of investigations and shall take all necessary and appropriate responsive action (including disciplinary action) and corrective action, including the disclosure of Reportable Events pursuant to Section III.I above, if applicable. Daiichi shall include a summary of the NPMP and the results of the NPMP as part of each Annual Report. As part of each Annual Report, Daiichi also shall provide the OIG with descriptions of any instances identified through the NPMP in which it was determined that improper promotion of Government Reimbursed Products occurred or the activities violated Daiichi’s Policies and Procedures, and a description of the action(s) that Daiichi took as a result of such determinations. Daiichi shall make the documents relating to the NPMP available to the OIG upon request.
Follow Up Reviews and Reporting. In the event that a potential violation of Endo's Policies and Procedures or of legal or compliance requirements, including but not limited to potential improper promotion, are identified during any aspect of the NPMP, Endo shall investigate the incident consistent with established Policies and Procedures for the handling of investigations and shall take all necessary and appropriate responsive action (including disciplinary action) and corrective action, including the disclosure of Reportable Events pursuant to Section III.I above, if applicable. Any compliance issues identified during any portion of the NPMP referenced above, and any corrective action, shall be recorded in the files of the Compliance Department. EPI shall include a summary of the NPMP and the results of the NPMP as part of each Annual Report. As part of each Annual Report, EPI also shall provide the OIG with descriptions of any instances identified through the NPMP in which it was determined that improper promotion of Government Reimbursed Products occurred or the activities violated Endo's requirements or Policies and Procedures, and a description of the action(s) that Endo took as a result of such determinations. EPI shall make the documents relating to the NPMP available to the OIG upon request.
