Promotional and Product Services Systems Review Report. The IRO shall prepare a report based upon each Systems Review. For each of the Reviewed Policies and Procedures identified in Section II.A above, the report shall include the following items:
1) a description of the documentation (including policies) reviewed and any personnel interviewed;
2) a detailed description of Cephalon’s systems, policies, processes, and procedures relating to the items identified in Sections II.A.1-5 above, including a general description of Cephalon’s control and accountability systems (e.g., documentation and approval requirements, and tracking mechanisms) and written policies regarding the Reviewed Policies and Procedures;
3) a description of the manner in which the control and accountability systems and the written policies relating to the items identified in Sections II.A.1-5 above are made known or disseminated within Cephalon;
4) a detailed description of any system(s) used to track and respond to requests for information about Cephalon’s products (including the Inquiries Database);
5) a detailed description of Cephalon’s incentive compensation system for Covered Persons who are sales representatives, including a description of the bases upon which compensation is determined and the extent to which compensation is based on product performance. To the extent that Cephalon may establish compensation differently for individual products, the IRO shall report separately on each such type of compensation arrangement;
6) findings and supporting rationale regarding any weaknesses in Cephalon’s systems, processes, policies, and procedures relating to the Reviewed Policies and Procedures, if any; and
7) recommendations to improve any of the systems, policies, processes, or procedures relating to the Reviewed Policies and Procedures, if any.
Promotional and Product Services Systems Review Report. The IRO shall prepare a report based upon each Systems Review. For each of the Reviewed Policies and Procedures identified in Section II.A above, the report shall include the following items:
1) a description of the documentation (including policies) reviewed and any personnel interviewed;
2) a detailed description of AtriCure’s systems, policies, processes, and procedures relating to the items identified in Sections II.A.1-5 above, including a general description of AtriCure’s control and accountability systems (e.g., documentation and approval requirements, and tracking mechanisms) and written policies regarding the Reviewed Policies and Procedures;
Promotional and Product Services Systems Review Report. The IRO shall prepare a report based upon its Systems Review. For each of the Reviewed Policies and Practices identified in Section II.A above, the report shall include the following items:
a) a description of the documentation (including policies) reviewed and any personnel interviewed;
b) a detailed description of InterMune’s systems, policies, processes, and practices with regard to the items identified in Sections IIA.1-12 above, including a general description of InterMune’s control and accountability systems (e.g., documentation and approval requirements, tracking mechanisms) and written policies regarding the Reviewed Policies and Practices;
c) a description of the manner in ‘,which the control and accountability systems and the written policies relating to the items identified in Sections II.A.1-12 above are made known or disseminated within InterMune;
d) a detailed description of any system used to track and respond to requests for information about InterMune’s products that come to Medical Affairs;
e) a description of InterMune’s systems, policies, processes, and procedures for tracking expenditures associated with the Reviewed Policies and Practices or other promotional activities;
f) a general description of the disciplinary measures InterMune has established for failure to comply with its systems, processes, policies and procedures relating to the Reviewed Policies and Practices;
g) a detailed description of InterMune’s compensation system (including salaries and bonuses) for non-Overtime Eligible employees, including a description of the bases upon which compensation is determined and the extent to which compensation is based on product performance. To the extent that InterMune may establish compensation differently for individual products, the IRO shall report separately on each such type of compensation arrangement;
h) findings and supporting rationale regarding any weaknesses in InterMune’s systems, processes, policies, and practices relating to the Reviewed Policies and Practices, if any; and
i) recommendations to improve any of the systems, policies, processes, or practices relating to the Reviewed Policies and Practices, if any. Prior to the IRO’s submission of the report to the OIG, InterMune shall be provided with a copy of the report and an opportunity to respond to each comment made by the IRO. Provided it does not delay the timely filing of the Annual Reports, any responses by InterMune may be included in the IRO report submitted t...
Promotional and Product Services Systems Review Report. The IRO shall prepare a report which, for each of the Reviewed Policies and Practices identified in Section II.A above, shall include the following items:
1) a description of the documentation (including policies) reviewed and any personnel interviewed, and a list and description of the activities and efforts undertaken by Jazz to assist the IRO in connection with the Systems Review;
2) a detailed description of Jazz’s systems, policies, processes, and practices with regard to the items identified in Sections II.A.1-6 above, including a general description of Jazz’s control and accountability systems (e.g., documentation and approval requirements, tracking mechanisms) and written policies regarding the Reviewed Policies and Practices;
3) a description of the manner in which the control and accountability systems and the written policies relating to the items identified in Sections II.A.1-6 above are made known or disseminated within Jazz;
4) a detailed description of any system used to track and respond to requests for information about Jazz’s products (e.g., through the Inquiries Database);
5) a detailed description of Jazz’s compensation system (including salaries and bonuses) for non-Overtime Eligible employees, included a description of the bases upon which compensation is determined and the extent to which compensation is based on product performance. To the extent that Appendix B to CIA Jazz Pharmaceuticals, Inc. Jazz may establish compensation differently for individual products, the IRO shall report separately on each such type of compensation arrangements;
6) findings and supporting rationale regarding any weaknesses in Jazz’s systems, policies, processes, and practices relating to Reviewed Policies and Practices, if any; and
7) recommendations to improve any of the systems, policies, processes, or practices relating to the Reviewed Policies and Practices, if any. Prior to the IRO’s submission of the report to the OIG, Jazz shall be provided with a copy of the report and an opportunity to respond to each comment made by the IRO. Provided it does not delay the timely filing of the Annual Reports, any responses by Jazz may be included in the IRO report submitted to the OIG. Otherwise, any responses by Jazz to the IRO’s findings may be submitted separately to the OIG following the Annual Report submission.
