Validation Review. In the event OIG has reason to believe that: (a) any IRO Review fails to conform to the requirements of this CIA; or (b) the IRO’s findings or Review results are inaccurate, OIG may, at its sole discretion, conduct its own review to determine whether the applicable IRO Review complied with the requirements of the CIA and/or the findings or Review results are inaccurate (Validation Review). Boston Scientific shall pay for the reasonable cost of any such review performed by OIG or any of its designated agents. Any Validation Review of Reports submitted as part of Boston Scientific’s final Annual Report shall be initiated no later than one year after Boston Scientific’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Boston Scientific of its intent to do so and provide a written explanation of why OIG believes such a review is necessary. To resolve any concerns raised by OIG, Boston Scientific may request a meeting with OIG to: (a) discuss the results of any Review submissions or findings; (b) present any additional information to clarify the results of the applicable Review or to correct the inaccuracy of the Review; and/or (c) propose alternatives to the proposed Validation Review. Boston Scientific agrees to provide any additional information as may be requested by OIG under this Section III.E.3 in an expedited manner. OIG will attempt in good faith to resolve any Review issues with Boston Scientific prior to conducting a Validation Review. However, the final determination as to whether or not to proceed with a Validation Review shall be made at the sole discretion of OIG. Boston Scientific Corp. Corporate Integrity Agreement
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Sources: Corporate Integrity Agreement (Boston Scientific Corp)
Validation Review. In the event OIG has reason to believe that: (a) any IRO Review fails to conform to the requirements of this CIA; or (b) the IRO’s findings or Review results are inaccurate, OIG may, at its sole discretion, conduct its own review to determine whether the applicable IRO Review complied with the requirements of the CIA and/or the findings or Review results are inaccurate (Validation Review). Boston Scientific Biovail shall pay for the reasonable cost of any such review performed by OIG or any of its designated agents. Any Validation Review of Reports submitted as part of Boston ScientificBiovail’s final Annual Report shall be initiated no later than one year after Boston ScientificBiovail’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Boston Scientific Biovail of its intent to do so and provide a written explanation of why OIG believes such a review is necessary. To resolve any concerns raised by OIG, Boston Scientific Biovail may request a meeting with OIG to: (a) discuss the results of any Review submissions or findings; (b) present any additional information to clarify the results of the applicable Review or to correct the inaccuracy of the Review; and/or (c) propose alternatives to the proposed Validation Review. Boston Scientific Biovail agrees to provide any additional information as may be requested by OIG under this Section III.E.3 in an expedited manner. OIG will attempt in good faith to resolve any Review issues with Boston Scientific Biovail prior to conducting a Validation Review. However, the final determination as to whether or not to proceed with a Validation Review shall be made at the sole discretion of OIG. Boston Scientific Corp. Corporate Integrity Agreement.
Appears in 1 contract
Sources: Corporate Integrity Agreement (Biovail Corp International)
Validation Review. In the event OIG has reason to believe that: (a) any IRO Review fails to conform to the requirements of this CIA; or (b) the IRO’s findings or Review results are inaccurate, OIG may, at its sole discretion, conduct its own review to determine whether the applicable IRO Review complied with the requirements of the CIA and/or the findings or Review results are inaccurate (Validation Review). Boston Scientific Allergan shall pay for the reasonable cost of any such review performed by OIG or any of its designated agents. Any Validation Review of Reports submitted as part of Boston ScientificAllergan’s final Annual Report shall be initiated no later than one year after Boston ScientificAllergan’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Boston Scientific Allergan of its intent to do so and provide a written explanation of why OIG believes such a review is necessary. To resolve any concerns raised by OIG, Boston Scientific Allergan may request a meeting with OIG to: (a) discuss the results of any Review submissions or findings; (b) present any additional information to clarify the results of the applicable Review or to correct the inaccuracy of the Review; and/or (c) propose alternatives to the proposed Validation Review. Boston Scientific Allergan agrees to provide any additional information as may be requested by OIG under this Section III.E.3 III.D.3 in an expedited manner. OIG will attempt in good faith to resolve any Review issues with Boston Scientific Allergan prior to conducting a Validation Review. However, the final determination as to whether or not to proceed with a Validation Review shall be made at the sole discretion of OIG. Boston Scientific Corp. Corporate Integrity Agreement.
Appears in 1 contract