Common use of Reporting and Follow-up Clause in Contracts

Reporting and Follow-up. Personnel conducting the Speaker Program Audits, Observations, and Records Reviews shall have access to all relevant records and information necessary to assess potential or actual compliance violations. Results from the FFMP audits, including the identification of potential violations of policies and/or legal requirements, shall be compiled and reported to the Compliance Officer (or compliance personnel designee) for review and follow-up as appropriate. 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 off-label promotion, is identified during any aspect of the FFMP, 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 a Speaker Program Audit, GlaxoSmithKline LLC Corporate Integrity Agreement Observation and/or Records Review and any corrective action shall be recorded in the files of the Compliance Officer (or compliance personnel designee). GSK shall include a summary of the FFMP and the results of the FFMP as part of each Annual Report. As part of each Annual Report, GSK also shall provide the OIG with copies of the Observation report for any instances in which it was determined that improper promotion occurred and a description of the action(s) that GSK took as a result of such determinations. GSK shall make the Observation reports for all other Observations available to the OIG upon request.