Common use of Field Force Monitoring and Review Efforts Clause in Contracts

Field Force Monitoring and Review Efforts. To the extent not already accomplished, within 120 days after the Effective Date, AstraZeneca shall establish a comprehensive Field Force Monitoring Program (FFMP) to evaluate and monitor its sales representatives’ interactions with HCPs and HCIs. The FFMP shall be a formalized process designed to directly and indirectly observe the appropriateness of sales representatives’ interactions with HCPs and HCIs and to identify potential off-label promotional activities or other improper conduct. As described in more detail below, the FFMP shall include: 1) a Speaker Monitoring Program; 2) direct field observations (Observations) of sales representatives; and 3) the monitoring and review of other records relating to sales representatives’ interactions with HCPs and HCIs (Records Reviews). Corporate Integrity Agreement AstraZeneca Prior to the Effective Date, AstraZeneca provided electronic tablet notebooks (the Tablet PC System) to all of its field-based sales representatives. These electronic notebooks are part of a centralized, electronic system to be used by sales representatives in connection with the detailing of HCPs (detailing system). AstraZeneca shall maintain the Tablet PC System or another electronic detailing system that includes the controls described in this paragraph throughout the term of the CIA. The detailing system shall continue to include controls designed to ensure compliance with Federal health care program and FDA requirements and shall permit the tracking of detailing-related activities, including the submission of Inquiries (as defined above in Section III.B.3.g) and the distribution of samples of Government Reimbursed Products to HCPs. The detailing system shall continue to include a centralized mechanism through which sales representatives may submit Inquiries to Medical Affairs. With regard to the distribution of samples, the detailing system and its controls shall prevent the delivery of samples of particular Government Reimbursed Products to HCPs that AstraZeneca has identified as belonging to a specialty group that is unlikely to prescribe the particular Government Reimbursed Product for a use consistent with the FDA-approved label for the product.