IRO Systems Review. The Systems Review shall be a review of Merit's systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) relating to Covered Functions. More specifically, the IRO shall review Merit's systems, processes, policies, and procedures associated with the following (hereafter “Reviewed Policies and Procedures”):
IRO Systems Review. The Systems Review shall be a review of Jazz’s systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) relating to select Contribution and Assistance Related Functions. Where practical, Jazz personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by Jazz pursuant to the preceding sentence. More specifically, the IRO shall review Jazz’s systems, processes, policies, and procedures associated with the following (hereafter “Reviewed Policies and Procedures”):
IRO Systems Review. A. Description of Reviewed Policies and Procedures The Systems Review shall be a review of systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of the J&J Pharmaceutical Affiliates relating to certain of the Covered Functions. Where practical, J&J Pharmaceutical Affiliates personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by the J&J Pharmaceutical Affiliates in accordance with the preceding sentence. Specifically, the IRO shall review systems, processes, policies, and procedures of the J&J Pharmaceutical Affiliates associated with the following (hereafter “Reviewed Policies and Procedures”):
IRO Systems Review. The Systems Review shall be a review of Merit's systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) relating to Covered Functions. More specifically, the IRO shall review Merit's systems, processes, policies, and procedures associated with the following (hereafter “Reviewed Policies and Procedures”):
IRO Systems Review. The IRO Systems Review shall be a review of systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Sandoz relating to Pricing and Contracting Functions and other systems as described below. Where practical, Sandoz personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by Sandoz in accordance with the preceding sentence. Specifically, the IRO shall review systems, processes, policies, and procedures of Sandoz associated with the following (hereafter “Reviewed Policies and Procedures”):
IRO Systems Review. The Systems Review shall be a review of Amgen’s systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) relating to Patient Assistance Related Functions and the Independent Charity PAP Review Program. Where practical, Amgen personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by Amgen pursuant to the preceding sentence. More specifically, the IRO shall review Amgen’s systems, processes, policies, and procedures associated with the following (hereafter “Reviewed Policies and Procedures”):
IRO Systems Review. The Systems Review shall be a review of Endo’s systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) relating to certain Covered Functions and the RAMP Program. Where practical, Endo personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by Endo pursuant to the preceding sentence. More specifically, the IRO shall review Endo’s systems, processes, policies, and procedures associated with the following (hereafter “Reviewed Policies and Procedures”):
IRO Systems Review. The Systems Review shall be a review of PSI’s systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) relating to Patient Assistance Related Functions in effect during the applicable Reporting Period. Where practical, PSI personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by PSI pursuant to the preceding sentence. More specifically, the IRO shall review PSI’s systems, processes, policies, and procedures associated with the following (hereafter “Reviewed Policies and Procedures”) in effect during the applicable Reporting Period:
IRO Systems Review. The Systems Review shall be a review of United Therapeutics’ systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) relating to select Contribution and Assistance Related Functions. Where practical, United Therapeutics personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by United Therapeutics pursuant to the preceding sentence. More specifically, the IRO shall review United Therapeutics’ systems, processes, policies, and procedures associated with the following (hereafter “Reviewed Policies and Procedures”):
IRO Systems Review. The Systems Review shall be a review of CSI’s systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) relating to Covered Functions. More specifically, the IRO shall review CSI’s systems, processes, policies, and procedures associated with the following (hereafter “Reviewed Policies and Procedures”):
