Common use of Validation Review Clause in Contracts

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). 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 Biovail’s final Annual Report shall be initiated no later than one year after Biovail’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify 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, 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. 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 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.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Biovail Corp International)

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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). Biovail Elan 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 BiovailElan’s final Annual Report shall be initiated no later than one year after BiovailElan’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Biovail Elan 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, Biovail Elan 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. Biovail Elan 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 Biovail Elan 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.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Elan Corp PLC)

Validation Review. In the event OIG has reason to believe that: (a) any of Par’s IRO Review Reviews 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). Biovail Par 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 BiovailPar’s final Annual Report shall be initiated no later than one year after BiovailPar’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Biovail Par 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, Biovail Xxx may request a meeting with OIG to: (a) discuss the results of any IRO Review submissions or findings; (b) present any additional information to clarify the results of the applicable IRO Review or to correct the inaccuracy of the IRO Review; and/or (c) propose alternatives to the proposed Validation Review. Biovail Par 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 IRO Review issues with Biovail Par 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.

Appears in 1 contract

Samples: Corporate Integrity Agreement

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). Biovail Lilly 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 BiovailLilly’s final Annual Report shall be initiated no later than one year after BiovailLilly’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Biovail Lilly 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, Biovail Lilly 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. Biovail Lilly 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 Biovail Lilly 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.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Lilly Eli & Co)

Validation Review. In the event the OIG has reason to believe that: (a) any IRO Review LifePoint's Billing Engagement fails to conform to the requirements of this CIA; or (b) LifePoint's or the IRO’s 's findings or Review Billing Engagement results are inaccurate, the OIG may, at its sole discretion, conduct its own review to determine whether the applicable IRO Review Billing Engagement complied with the requirements of the CIA and/or the findings or Review Billing Engagement results are inaccurate ("Validation Review"). Biovail shall LifePoint agrees to pay for the reasonable cost of any such review performed by the OIG or any of its designated agents. Any Validation Review of Reports submitted agents so long as part of Biovail’s it is initiated before one year after LifePoint's final Annual Report shall be initiated no later than one year after Biovail’s final submission (as described in Section II) and any additional information requested by the OIG is received by the OIG. Prior to initiating a Validation Review, the OIG shall notify Biovail LifePoint of its intent to do so and provide a written explanation of why the OIG believes such a review is necessary. To resolve any concerns raised by the OIG, Biovail LifePoint may request a meeting with the OIG to: (a) to discuss the results of any Review Billing Engagement submissions or findings; (b) present any additional or relevant information to clarify the results of the applicable Review Billing Engagement or to correct the inaccuracy of the ReviewBilling Engagement; and/or (c) propose alternatives to the proposed Validation Review. Biovail LifePoint agrees to provide any additional information as may be requested by the OIG under this Section III.E.3 section in an expedited manner. The OIG will attempt in good faith to resolve any Review Billing Engagement issues with Biovail LifePoint 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 the OIG.

Appears in 1 contract

Samples: The Corporate Integrity Agreement (Lifepoint Hospitals Inc)

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Validation Review. In the event OIG has reason to believe that: (a) any of Par’s IRO Review Reviews 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). Biovail Par 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 BiovailPar’s final Annual Report shall be initiated no later than one year after BiovailPar’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Biovail Par 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, Biovail Par may request a meeting with OIG to: (a) discuss the results of any IRO Review submissions or findings; (b) present any additional information to clarify the results of the applicable IRO Review or to correct the inaccuracy of the IRO Review; and/or (c) propose alternatives to the proposed Validation Review. Biovail Par 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 IRO Review issues with Biovail Par 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.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Validation Review. In the event OIG has reason to believe that: (a) that any of the IRO Review Reviews fails to conform to the requirements of this CIAAgreement; 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 Reviews complied with the requirements of the CIA Agreement and/or the findings or Review results are inaccurate (Validation Review). Biovail Txxxx 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 Biovail’s Txxxx’x final Annual Report shall must be initiated no later than one year after Biovail’s Txxxx’x final submission (as described in Section IIII of the CIA) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Biovail Txxxx 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, Biovail Txxxx may request a meeting with OIG to: (a) discuss the results of any IRO Review submissions or findings; (b) present any additional information to clarify the results of the applicable Review IRO Reviews or to correct the inaccuracy of the ReviewIRO Reviews; and/or (c) propose alternatives to the proposed Validation Review. Biovail Txxxx 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 IRO Review issues with Biovail Txxxx 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.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Tenet Healthcare 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). Biovail 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 BiovailAllergan’s final Annual Report shall be initiated no later than one year after BiovailAllergan’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Biovail 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, Biovail 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. Biovail 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 Biovail 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.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Allergan Inc)

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