OIG Removal of IRO In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK to engage a new IRO in accordance with Paragraph A of this Appendix. GSK must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the final determination as to whether or not to require GSK to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Review shall consist of two components - a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSK’s systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform the Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second and fifth IRO Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIA.
