Common use of Records Reviews Clause in Contracts

Records Reviews. As a component of the FFMP, GSK shall also review various types of records to assess sales personnel interactions with HCPs and HCIs in order to identify potential or actual compliance violations. For each Reporting Period, GSK shall develop and implement a plan for conducting Records Reviews associated with at least three Government Reimbursed Products and a sampling of the personnel supporting those products in regions across the country (as agreed with the OIG for each Reporting Period.) 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 GSK’s products provided by GSK, 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, GSK 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 personnel interactions with HCPs and HCIs (including records from the electronic call reporting system used by sales personnel (which includes call notes), sales communications from managers, sample distribution records, and expense reports); (2) requests for medical information about, or inquiries relating to, Government Reimbursed Products; (3) message recall studies or other similar records (such as Verbatims) purporting to reflect the details of sales personnel interactions with HCPs and HCIs; (4) sales personnel e-mails and other electronic records; and (5) recorded results of the Observations of sales representatives and applicable notes or information from the sales personnel managers.

Records Reviews. As a component of the FFMP, GSK Par shall also review various types of records to assess sales personnel interactions with HCPs and HCIs with respect to Relevant Government Reimbursed Products in order to identify potential or actual compliance violations. For each Reporting Period, GSK Par shall develop and implement a plan for conducting Records Reviews associated with at least up to three Relevant Government Reimbursed Products and a sampling of the personnel supporting those products in regions across the country (as agreed with the OIG for each Reporting Period.) The OIG shall have the discretion to identify the up to three Relevant Government Reimbursed Products to be reviewed for each Reporting Period. The OIG will select the products based on information about GSKPar’s products provided by GSKPar, upon request by the Par Corporate Integrity Agreement 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 Relevant Government Reimbursed Products to be reviewed within the first 30 days of the Reporting Period, GSK Par shall select the three products one product to be reviewed. These Records Reviews shall include the monitoring and review of: (1) records and systems relating to sales personnel interactions with HCPs and HCIs (including records from the electronic any call reporting system used by sales personnel (which includes call notespersonnel), including sales communications from managers, coaching reports, sample distribution records, and expense reports); (2) requests for medical information about, or inquiries relating to, Relevant Government Reimbursed Products; (3) message recall studies or other similar records (such as Verbatims) purporting to reflect the details of sales personnel interactions with HCPs and HCIs; (4) sales personnel e-mails and other electronic records; and (5) recorded results of the Observations of sales representatives and applicable notes or information from the sales personnel managers.

Records Reviews. As a component of the FFMP, GSK BIPI shall also review various types of records to assess sales personnel representatives’ interactions with HCPs and HCIs in order to identify potential or actual compliance violations. For each Reporting Period, GSK BIPI shall develop and implement a plan for conducting Records Reviews associated with at least three Government Reimbursed Products and a sampling of the personnel supporting representatives promoting those products in regions across the country (as agreed with the OIG for each Reporting Period.) 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 GSKBIPI’s products provided by GSKBIPI, 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, GSK BIPI 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 personnel representatives’ interactions with HCPs and HCIs (including records from the electronic call reporting detailing system used by for the particular sales personnel (which includes call notes)representative, sales communications from managers, sample distribution records, and expense reports); (2) requests for medical information about, or inquiries relating to, Government Reimbursed Products; (3) tutorials and preceptorships; 4) message recall studies or other similar records (such as Verbatims) purporting to reflect the details of sales personnel representatives’ interactions with HCPs and HCIs; (45) sales personnel representative call notes; 6) sales representatives’ e-mails and other electronic records; and (57) recorded results of the Observations of sales representatives and applicable notes or information from the sales personnel representatives’ managers.

Records Reviews. As a component of the FFMPSMMP, GSK shall Shire also review reviews various types of records to assess sales personnel representatives’ interactions with HCPs and HCIs in order to identify potential or actual compliance violations. For each Reporting Period, GSK Shire shall develop and implement a plan for conducting Records Reviews associated with at least three Government Reimbursed Products and a sampling of the personnel supporting representatives promoting those products in regions across every separate region of the country (as agreed with the OIG for each Reporting Period.) The United States. OIG shall have the discretion to identify the three Government Reimbursed Products to Shire North American Group, Inc. Corporate Integrity Agreement be reviewed for each Reporting Period. The OIG will select the products based on information about GSKShire’s products provided by GSK, upon request by the OIG Shire 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, GSK Shire shall select the three products to be reviewed. These Records Reviews shall include the monitoring and review of: (1a) records and systems relating to sales personnel representatives’ interactions with HCPs and HCIs (including records from any available electronic detailing system(s) for the electronic call reporting system used by particular sales personnel (which includes call notes)representatives, sales communications from managers, sample distribution records, and expense reports); (2b) requests for medical information aboutfor, or inquiries relating to, medical information about Government Reimbursed Products; (3c) message recall studies or other similar records (such as Verbatims) purporting to reflect the details of sales personnel representatives’ interactions with HCPs and HCIs; (4d) sales personnel representative call notes; e) sales representatives’ e-mails and other electronic records; f) records of promotional materials provided by sales personnel to HCPs and (5HCIs; and g) recorded results of the Observations of sales representatives and applicable notes or information from the sales personnel representatives’ managers.

Records Reviews. As a component of the FFMP, GSK Baxano Surgical shall also review various types of records to assess sales personnel representatives’ interactions with HCPs and HCIs in order to identify potential or actual compliance violations. For each Reporting Period, GSK Baxano Surgical shall develop and implement a plan for conducting Records Reviews associated with at least up to three Government Reimbursed Products and a sampling of the personnel supporting representatives promoting those products in regions across the country (as agreed with the OIG for each Reporting Period.) 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 GSKBaxano Surgical’s products provided by GSKBaxano Surgical, 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, GSK Baxano Surgical shall select the up to three products to be reviewed. These Records Reviews shall include the monitoring and review ofof the following records, to the extent that the records exist: (1) records and systems relating to sales personnel representatives’ interactions with HCPs and HCIs (including records from the electronic call reporting detailing system used by for the particular sales personnel (which includes call notes)representative, sales communications from managers, sample distribution records, and expense reports); (2) requests for medical information about, or inquiries relating to, Government Reimbursed Products; (3) tutorials and preceptorships; 4) message recall studies or other similar records (such as Verbatims) purporting to reflect the details of sales personnel representatives’ interactions with HCPs and HCIs; (45) sales personnel representative call notes; 6) sales representatives’ e-mails and other electronic records; and (57) recorded results of the Observations of sales representatives and applicable notes or information from the sales personnel representatives’ managers.

Records Reviews. As a component of the FFMP, GSK Novartis shall also review various types of records to assess sales personnel representatives’ interactions with HCPs and HCIs in order and to identify potential or actual compliance violations. For each Reporting Period, GSK Novartis shall develop and implement a plan for conducting Records Reviews associated with at least three Government Reimbursed Products and a sampling of the personnel supporting representatives promoting those products in regions across the country (as agreed with the OIG for each Reporting Period.) 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 GSK’s Novartis’ products provided by GSKNovartis, upon request by the OIG no later than 60 90 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, GSK Novartis 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 personnel representatives’ interactions with HCPs and HCIs (including records from the electronic call reporting system used by sales personnel (which includes call notes), sales communications from managers, sample distribution records, sales representative corporate charge card expense records, and expense reportsaggregate spend records concerning sales representatives’ interactions with HCPs); (2) requests for medical information about, or inquiries relating to, Government Reimbursed Productsto medical information; (3) message recall studies or other similar records (such as Verbatims) purporting to reflect the details of sales personnel representatives’ interactions with HCPs and HCIs; (4) sales personnel representative call notes or other Novartis records reflecting the details of sales representative visits with HCPs or HCIs; 5) sales representatives’ e-mails and other electronic records; and (56) recorded results of the Observations of sales representatives and applicable notes or information from the sales personnel representatives’ managers.

Records Reviews. As a component of the FFMP, GSK Forest shall also review various types of records to assess sales personnel representatives’ interactions with HCPs and HCIs in order and to identify potential or actual compliance or legal violations. For each Reporting Period, GSK Forest shall develop and implement a plan for conducting Records Reviews associated with at least three Government Reimbursed Products and a sampling of the personnel supporting those products in regions across the country (as agreed with the OIG for each Reporting Period.) Products. 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 GSKForest’s products provided by GSKForest, 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, GSK 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 personnel representatives’ interactions with HCPs and HCIs relating to promotional speaker program activities, samples, meals, and other events or items (including records from the electronic call reporting detailing system used by sales personnel (which includes such as call notes)) for the particular sales representative, sales communications from managers, sample distribution records, and expense reports); (2) requests for medical information about, or inquiries relating to, Government Reimbursed Productsthrough the MIC Department; (3) preceptorships; 4) message recall studies or other similar records (such as Verbatims) purporting to reflect the details of sales personnel representatives’ interactions with HCPs and HCIs; (45) sales personnel representatives’ e-mails and other electronic records; and (56) recorded results of the Observations Observations, if any, of the sales representatives and applicable notes or information from the sales personnel representatives’ managers.