Common use of Validation Review Clause in Contracts

Validation Review. In the event OIG has reason to believe that: (a) any of BIPI’s IRO 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). BIPI 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 BIPI’s final Annual Report shall be initiated no later than one year after XXXX’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify BIPI 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, XXXX 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 IRO Review or to correct the inaccuracy of the IRO Review; and/or (c) propose alternatives to the proposed Validation Review. XXXX agrees to provide any additional information as may be requested by OIG under this Section III.D.3 in an expedited manner. OIG will attempt in good faith to resolve any IRO Review issues with BIPI 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

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Validation Review. In the event OIG has reason to believe that: (a) any of BIPI’s Shire IRO Reviews Review fails to conform to the requirements of this CIA; or (b) the IRO’s findings or IRO 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 IRO Review results are inaccurate (Validation Review). BIPI Shire 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 BIPIShire’s final Annual Report shall be initiated no later than one year after XXXXXxxxx’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify BIPI Shire 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, XXXX Shire may request a meeting with OIG to: (a) discuss the results of any the IRO Review submissions or findings; (b) present any additional information to clarify the results of the IRO Review or to correct the inaccuracy of the IRO Review; and/or (c) propose alternatives to the proposed Validation Review. XXXX Xxxxx agrees to provide any additional information as may be requested by OIG under this Section III.D.3 III.E.3 in an expedited manner. OIG will attempt in good faith to resolve any IRO Review issues with BIPI Shire 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 of BIPI’s IRO Reviews Xxxxxx’x Arrangements Review fails to conform to the requirements of this CIA; or (b) the IRO’s findings or Arrangements Review results are inaccurate, OIG may, at its sole discretion, conduct its own review to determine whether the applicable IRO Arrangements Review complied with the requirements of the CIA and/or the findings or Arrangements Review results are inaccurate (Validation Review). BIPI Xxxxxx 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 BIPI’s Xxxxxx’x final Annual Report shall be initiated no later than one year after XXXX’s Xxxxxx’x final submission (as described in Section II) is II)is received by OIG. Prior to initiating a Validation Review, OIG shall notify BIPI Xxxxxx 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, XXXX Xxxxxx may request a meeting with OIG to: (a) discuss the results of any IRO Arrangements Review submissions or findings; (b) present any additional information to clarify the results of the IRO Arrangements Review or to correct the inaccuracy of the IRO Arrangements Review; and/or (c) propose alternatives to the proposed Validation Review. XXXX Xxxxxx agrees to provide any additional information as may be requested by OIG under this Section III.D.3 III.E.3. in an expedited manner. OIG will attempt in good faith to resolve any IRO Arrangements Review issues with BIPI Xxxxxx 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 (Wright Medical Group Inc)

Validation Review. In the event OIG has reason to believe that: (a) any of BIPI’s IRO Reviews 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). BIPI 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 BIPIBiovail’s final Annual Report shall be initiated no later than one year after XXXXBiovail’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify BIPI 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, XXXX Biovail 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 IRO applicable Review or to correct the inaccuracy of the IRO Review; and/or (c) propose alternatives to the proposed Validation Review. XXXX Biovail agrees to provide any additional information as may be requested by OIG under this Section III.D.3 III.E.3 in an expedited manner. OIG will attempt in good faith to resolve any IRO Review issues with BIPI 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)

Validation Review. In the event OIG has reason to believe that: (a) any of BIPI’s Novartis’ IRO Reviews fails fail 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). BIPI Novartis 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 BIPI’s Novartis’ final Annual Report shall be initiated no later than one year after XXXX’s Novartis’ final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify BIPI Novartis 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, XXXX Novartis 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 IRO Review or to correct the inaccuracy of the IRO Review; and/or (c) propose alternatives to the proposed Validation Review. XXXX Novartis agrees to provide any additional information as may be requested by OIG under this Section III.D.3 in an expedited manner. OIG will attempt in good faith to resolve any IRO Review issues with BIPI Novartis 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 of BIPIBaptist’s IRO Reviews Claims Review fails to conform to the requirements of this CIA; or or, (b) the IRO’s findings or Claims Review results are inaccurate, OIG may, at its sole discretion, conduct its own review to determine whether the applicable IRO Claims Review complied with the requirements of the CIA and/or the findings or Claims Review results are inaccurate (Validation Review). BIPI Baptist 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 BIPIBaptist’s final Annual Report shall be initiated no later than one year after XXXXBaptist’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify BIPI Baptist 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, XXXX Baptist may request a meeting with OIG to: (a) discuss the results of any IRO Claims Review submissions or findings; (b) present any additional information to clarify the results of the IRO Claims Review or to correct the inaccuracy of the IRO Claims Review; and/or and/or, (c) propose alternatives to the proposed Validation Review. XXXX Baptist agrees to provide any additional information as may be requested by OIG under this Section III.D.3 III.D.5 in an expedited manner. OIG will attempt in good faith to resolve any IRO Claims Review issues with BIPI Baptist 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 of BIPI’s the IRO 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 in question complied with the requirements of the CIA and/or the findings or Review results are inaccurate (Validation Review). BIPI Jazz 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 BIPIJazz’s final Annual Report shall be initiated no later than one year after XXXXJazz’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify BIPI Jazz 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, XXXX Jazz 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 IRO Review in question or to correct the inaccuracy of the IRO Review; and/or (c) propose alternatives to the proposed Validation Review. XXXX Jazz agrees to provide any additional information as may be requested by OIG under this Section III.D.3 in an expedited manner. OIG will attempt in good faith to resolve any IRO Review issues with BIPI Jazz 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 (Jazz Pharmaceuticals Inc)

Validation Review. In the event OIG has reason to believe that: (a) any of BIPIPar’s IRO 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). BIPI 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 BIPIPar’s final Annual Report shall be initiated no later than one year after XXXXPar’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify BIPI 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, XXXX 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 IRO Review or to correct the inaccuracy of the IRO Review; and/or (c) propose alternatives to the proposed Validation Review. XXXX Par agrees to provide any additional information as may be requested by OIG under this Section III.D.3 III.E.3 in an expedited manner. OIG will attempt in good faith to resolve any IRO Review issues with BIPI 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 of BIPIXxxxxxx’s IRO 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). BIPI Daiichi 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 BIPIXxxxxxx’s final Annual Report shall be initiated no later than one year after XXXXXxxxxxx’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify BIPI Daiichi 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, XXXX Xxxxxxx 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 IRO Review or to correct the inaccuracy of the IRO Review; and/or (c) propose alternatives to the proposed Validation Review. XXXX Xxxxxxx agrees to provide any additional information as may be requested by OIG under this Section III.D.3 III.E.4 in an expedited manner. OIG will attempt in good faith to resolve any IRO Review issues with BIPI Xxxxxxx 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

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Validation Review. In the event OIG has reason to believe that: (a) any of BIPIICH’s IRO Reviews Arrangements Review fails to conform to the requirements of this CIA; or (b) the IRO’s findings or Arrangements Review results are inaccurate, OIG may, at its sole discretion, conduct its own review to determine whether the applicable IRO Arrangements Review complied with the requirements of the CIA and/or the findings or Arrangements Review results are inaccurate (Validation Review). BIPI ICH 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 BIPIICH’s final Annual Report shall be initiated no later than one year after XXXXICH’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify BIPI ICH 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, XXXX ICH may request a meeting with OIG to: (a) discuss the results of any IRO Arrangements Review submissions or findings; (b) present any additional information to clarify the results of the IRO Arrangements Review or to correct the inaccuracy of the IRO Arrangements Review; and/or (c) propose alternatives to the proposed Validation Review. XXXX ICH agrees to provide any additional information as may be requested by OIG under this Section III.D.3 III.E.3 in an expedited manner. OIG will attempt in good faith to resolve any IRO Arrangements Review issues with BIPI ICH 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 of BIPI’s Shire IRO Reviews Review fails to conform to the requirements of this CIA; or (b) the IRO’s findings or IRO 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 IRO Review results are inaccurate (Validation Review). BIPI Shire 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 BIPIShire’s final Annual Report shall be initiated no later than one year after XXXXShire’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify BIPI Shire 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, XXXX Shire may request a meeting with OIG to: (a) discuss the results of any the IRO Review submissions or findings; (b) present any additional information to clarify the results of the IRO Review or to correct the inaccuracy of the IRO Review; and/or (c) propose alternatives to the proposed Validation Review. XXXX Shire agrees to provide any additional information as may be requested by OIG under this Section III.D.3 III.E.3 in an expedited manner. OIG will attempt in good faith to resolve any IRO Review issues with BIPI Shire 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 of BIPIDaiichi’s IRO 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). BIPI Daiichi 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 BIPIDaiichi’s final Annual Report shall be initiated no later than one year after XXXXDaiichi’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify BIPI Daiichi 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, XXXX Daiichi 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 IRO Review or to correct the inaccuracy of the IRO Review; and/or (c) propose alternatives to the proposed Validation Review. XXXX Daiichi agrees to provide any additional information as may be requested by OIG under this Section III.D.3 III.E.4 in an expedited manner. OIG will attempt in good faith to resolve any IRO Review issues with BIPI Daiichi 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 of BIPI’s IRO Reviews 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). BIPI Cephalon 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 BIPICephalon’s final Annual Report shall be initiated no later than one year after XXXXCephalon’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify BIPI Cephalon 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, XXXX Cephalon 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 IRO applicable Review or to correct the inaccuracy of the IRO Review; and/or (c) propose alternatives to the proposed Validation Review. XXXX Cephalon agrees to provide any additional information as may be requested by OIG under this Section III.D.3 in an expedited manner. OIG will attempt in good faith to resolve any IRO Review issues with BIPI Cephalon 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 (Cephalon Inc)

Validation Review. In the event OIG has reason to believe that: (a) any of BIPIPar’s IRO 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). BIPI 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 BIPIPar’s final Annual Report shall be initiated no later than one year after XXXXPar’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify BIPI 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, XXXX 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 IRO Review or to correct the inaccuracy of the IRO Review; and/or (c) propose alternatives to the proposed Validation Review. XXXX Par agrees to provide any additional information as may be requested by OIG under this Section III.D.3 III.E.3 in an expedited manner. OIG will attempt in good faith to resolve any IRO Review issues with BIPI 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

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