Common use of Records Reviews Clause in Contracts

Records Reviews. As a component of the FFMP, AstraZeneca shall also review various types of records to assess sales representatives’ interactions with HCPs and HCIs and to identify potential or actual compliance violations. For each Reporting Corporate Integrity Agreement AstraZeneca Period, AstraZeneca shall develop and implement a plan for conducting Records Reviews associated with at least three Government Reimbursed Products and a sampling of the representatives promoting those products in every separate region. The OIG shall have the discretion to identify the three Government Reimbursed Products to be reviewed for each Reporting Period. The OIG will select the products based on information about AstraZeneca’s products provided by AstraZeneca, upon request by the OIG no later than 60 days prior to the beginning of the Reporting Period, and other information known to the OIG. If the OIG does not identify the Government Reimbursed Products to be reviewed within the first 30 days of the Reporting Period, AstraZeneca shall select the three products to be reviewed. These Records Reviews shall include the monitoring and review of: 1) records and systems relating to sales representatives’ interactions with HCPs and HCIs relating to promotional speaker program activities, samples, meals, and other events or items (including records from the electronic detailing system for the particular sales representative, sales communications from managers, and expense reports); 2) requests for medical information (including through PIRs and the VSEC); 3) tutorials and preceptorships; 4) message recall studies or other similar records (such as Verbatims) purporting to reflect the details of sales representatives’ interactions with HCPs and HCIs;

Records Reviews. As a component of the FFMP, AstraZeneca Allergan shall also review various types of records to assess sales representatives’ interactions with HCPs and HCIs and to identify potential or actual compliance violations. For each Reporting Corporate Integrity Agreement AstraZeneca Period, AstraZeneca Allergan shall develop and implement a plan for conducting Records Reviews associated with at least three Government Reimbursed Products and a sampling of the representatives promoting those products in every separate region. The OIG shall have the discretion to identify the three Government Reimbursed Products to be reviewed for each Reporting Period. The OIG will select the products based on information about AstraZenecaAllergan’s products provided by AstraZenecaAllergan, upon request by the OIG no later than 60 days prior to the beginning of the Reporting Period, and other information known to the OIG. If the OIG does not identify the Government Reimbursed Products to be reviewed within the first 30 days of the Reporting Period, AstraZeneca Allergan shall select the three products to be reviewed. These For the first Reporting Period, the Records Reviews shall include the monitoring and review of: 1) records and systems in BEACON relating to sales representatives’ interactions with HCPs and HCIs relating to promotional speaker program activities, samples, mealsmeals and expenses, and other events or items (including records from the electronic detailing system for the particular sales representative, sales communications from managers, and expense reports)advisory boards; 2) requests for medical information (including through PIRs and the VSEC)information; 3) tutorials and preceptorshipssales representatives’ call notes; 4) sales representatives’ e-mails; and 5) recorded results of the Observations of sales representatives. For the second and subsequent Reporting Periods, the Records Reviews shall include the monitoring and review of: 1) records in BEACON relating to sales representatives’ interactions with HCPs and HCIs; 2) requests for medical information; 3) message recall studies or any other similar records (such as Verbatims) in Allergan’s possession purporting to reflect the details of sales representatives’ interactions with HCPs and HCIs;; 4) sales representative call notes; 5) sales representatives’ e-mails and any electronic records; and 6) recorded results of the Observations of sales representatives and other notes or information from the sales representatives’ managers relating to interactions between the sales representatives and HCPs and HCIs pertaining to the Government Reimbursed Product at issue.

Records Reviews. As a component of the FFMP, AstraZeneca Forest shall also review various types of records to assess sales representatives’ interactions with HCPs and HCIs and to identify potential or actual compliance or legal violations. For each Reporting Corporate Integrity Agreement AstraZeneca Period, AstraZeneca Forest shall develop and implement a plan for conducting Records Reviews associated with at least three Government Reimbursed Products and a sampling of the representatives promoting those products in every separate regionProducts. The OIG shall have the discretion to identify the three Government Reimbursed Products to be reviewed for each Reporting Period. The OIG will select the products based on information about AstraZenecaForest’s products provided by AstraZenecaForest, upon request by the OIG OIG, no later than 60 days prior to the beginning of the Reporting Period, Period and other information known to the OIG. If the OIG does not identify the Government Reimbursed Products to be reviewed within the first 30 days of the during a given Reporting Period, AstraZeneca Forest shall select the three products to be reviewed. The Records Reviews shall include a review of records relating to the activities of a sampling of sales representatives in each region who promoted one or more of the products under review. These Records Reviews shall include the monitoring and review ofof selected: 1) records and systems relating to sales representatives’ interactions with HCPs and HCIs relating to promotional speaker program activities, samples, meals, and other events or items (including records from the electronic detailing system (such as call notes) for the particular sales representative, sales communications from managers, and expense reports); 2) requests for medical information (including through PIRs and the VSEC)MIC Department; 3) tutorials and Corporate Integrity Agreement Forest Laboratories, Inc. preceptorships; 4) message recall studies or other similar records (such as Verbatims) purporting to reflect the details of sales representatives’ interactions with HCPs and HCIs;