Common use of IRO Review of Inquiries Reflected in Inquiries Database Clause in Contracts

IRO Review of Inquiries Reflected in Inquiries Database. The IRO shall select and review a random sample of 50 Inquiries from among the Inquiries reflected in the Inquiries Database for each Reporting Period. Forty of the Inquiries reviewed by the IRO shall be Inquiries for which GSK conducted an Off-Label Review, and the other ten shall be Inquiries for which GSK did not conduct an Off-Label Review. For each Inquiry reviewed, the IRO shall determine: a) Whether each item of information listed above in Section III.A.1 is reflected in the Inquiries Database for each reviewed Inquiry; and b) For each Inquiry for which the Compliance Officer conducted an Off- Label Review, the basis for suspecting that improper off-label promotion may have occurred; the steps undertaken as part of the Off- Label Review; the findings of the Compliance Officer as a result of the Off-Label Review; and any follow-up actions taken by GSK based on the Off-Label Review findings.

IRO Review of Inquiries Reflected in Inquiries Database. The IRO shall select and review a random sample of 50 Inquiries from among the Inquiries reflected in the Inquiries Database for each Reporting Period. Forty of the Inquiries reviewed by the IRO shall be Inquiries for which GSK Amgen conducted an Off-Label Review, and the other ten shall be Inquiries for which GSK Amgen did not conduct an Off-Label Review. For each Inquiry reviewed, the IRO shall determine: a) Whether each item of information listed above in Section III.A.1 is reflected in the Inquiries Database for each reviewed Inquiry; and b) For each Inquiry for which the Chief Compliance Officer or designee conducted an Off- Off-Label Review, the basis for suspecting that improper off-label promotion may have occurred; the steps undertaken as part of the Off- Off-Label Review; the findings of the Chief Compliance Officer or designee as a result of the Off-Label Review; and any follow-up actions taken by GSK Amgen based on the Off-Label Review findings.

IRO Review of Inquiries Reflected in Inquiries Database. The IRO shall select and review a random sample of 50 Inquiries from among the Inquiries reflected in the Inquiries Database for each Reporting Period. Forty of the Inquiries reviewed by the IRO shall be Inquiries for which GSK Endo conducted an Off-Label Improper Promotion Review, and the other ten 10 shall be Inquiries for which GSK Endo did not conduct an Off-Label Improper Promotion Review. For each Inquiry reviewed, the IRO shall determine: a) Whether each item of information listed above in Section III.A.1 IV.A.1 is reflected in the Inquiries Database for each reviewed Inquiry; and b) For each Inquiry for which the Compliance Officer conducted an Off- Label Improper Promotion Review, the basis for suspecting that improper off-off- label promotion may have occurred; the steps undertaken as part of the Off- Label Improper Promotion Review; the findings of the Compliance Officer as a result of the Off-Label Improper Promotion Review; and any follow-up actions taken by GSK Endo based on the Off-Label Improper Promotion Review findings.

IRO Review of Inquiries Reflected in Inquiries Database. The IRO shall select and review a random sample of 50 Inquiries from among the Inquiries reflected in the Inquiries Database for each Reporting Period. Forty of the Inquiries reviewed by the IRO shall be Inquiries for which GSK Novartis conducted an Off-Label Review, and the other ten 10 shall be Inquiries for which GSK Novartis did not conduct an Off-Label Review. If Novartis conducted an Off-Label Review on fewer than 40 Inquiries, additional Inquiries may be selected for which an Off-Label Review was not conducted to reach a total of 50 Inquiries. For each Inquiry reviewed, the IRO shall determine: a) Whether each item of information listed above in Section III.A.1 III.A. 1 is reflected in the Inquiries Database for each reviewed Inquiry; and b) For each Inquiry for which the Chief Compliance Officer or designee conducted an Off- Off-Label Review, the basis for suspecting that improper off-label promotion may have occurred; the steps undertaken as part of the Off- Off-Label Review; the findings of the Chief Compliance Officer or designee as a result of the Off-Label Review; and any follow-up actions taken by GSK Novartis based on the Off-Label Review findings.

IRO Review of Inquiries Reflected in Inquiries Database. The IRO shall select and review a random sample of 50 60 Inquiries from among the Inquiries reflected in the Inquiries Database for each Reporting Period. Forty Forty-five of the Inquiries reviewed by the IRO shall be Inquiries for which GSK Cephalon conducted an Off-Label Review, and the other ten 15 shall be Inquiries for which GSK Cephalon did not conduct an Off-Label Review. For each Inquiry reviewed, the IRO shall determine: a) Whether each item of information listed above in Section III.A.1 III.A. 1 is reflected in the Inquiries Database for each reviewed Inquiry; and b) For each Inquiry for which the Compliance Officer or other appropriate personnel conducted an Off- Off-Label Review, the basis for suspecting that improper off-label promotion may have occurred; the steps undertaken as part of the Off- Off-Label Review; the findings of the Compliance Officer or other appropriate personnel as a result of the Off-Label Review; and any follow-up actions taken by GSK Cephalon based on the Off-Label Review findings.

IRO Review of Inquiries Reflected in Inquiries Database. The IRO shall select and review a random sample of 50 Inquiries from among the Inquiries reflected in the Inquiries Database for each Reporting Period. Forty of the Inquiries reviewed by the IRO shall be Inquiries for which GSK Allergan conducted an Off-Label Review, and the other ten 10 shall be Inquiries for which GSK Allergan did not conduct an Off-Label Review. For each Inquiry reviewed, the IRO shall determine: a) Whether each item of information listed above in Section III.A.1 is reflected in the Inquiries Database for each reviewed Inquiry; and b) For each Inquiry for which the Chief Compliance Officer conducted an Off- Off-Label Review, the basis for suspecting that improper off-label promotion may have occurred; the steps undertaken as part of the Off- Off-Label Review; the findings of the Chief Compliance Officer as a result of the Off-Label Review; and any follow-up actions taken by GSK Allergan based on the Off-Label Review findings.