Common use of Engagement of Independent Review Organization Clause in Contracts

Engagement of Independent Review Organization. Within 120 days after the Effective Date, GSK shall engage an entity (or entities), such as an accounting, auditing, or consulting firm (hereinafter “Independent Review Organization” or “IRO”), to perform reviews to assist GSK in assessing and evaluating its Covered Functions. More specifically, the IRO(s) shall conduct reviews that assess GSK’s systems, processes, policies, procedures, and practices relating to the Covered Functions (including Research and Publication Practices and Authorship-Related Practices) and the TRACER program (collectively “IRO Reviews”). The applicable requirements relating to the IRO are outlined in Appendix A to this CIA, which is incorporated by reference. Each IRO engaged by GSK shall have expertise in applicable Federal health care program and FDA requirements as may be appropriate to the Review for which the IRO is retained including expertise in the pharmaceutical industry with regard to risk identification and mitigation in relation to pharmaceutical product marketing and promotion. Each IRO shall assess, along with GSK, GlaxoSmithKline LLC Corporate Integrity Agreement whether it can perform the engagement in a professionally independent and objective fashion, as appropriate to the nature of the review, taking into account any other business relationships or other engagements that may exist.