Common use of Validation Review Clause in Contracts

Validation Review. In the event OIG has reason to believe that: (a) any of 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 complied with the requirements of the CIA and/or the findings or Review results are inaccurate (Validation Review). J&J 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 J&J’s final Annual Report shall be initiated no later than one year after J&J’s final submission (as described in Section II.B) is received by OIG. Prior to initiating a Validation Review, OIG shall notify J&J 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, J&J 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. J&J 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 J&J 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.

Validation Review. In the event OIG has reason to believe that: (a) any of the IRO Reviews Claims Review fails to conform to the requirements of this CIA; 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). J&J CCH shall pay for the reasonable cost of any such review performed by OIG or any of its designated agents. Any Validation Review of reports Reports submitted as part of J&JCCH’s final Annual Report shall be initiated no later than one year after J&JCCH’s final submission (as described in Section II.BII) is received by OIG. Prior to initiating a Validation Review, OIG shall notify J&J CCH 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, J&J CCH 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 (c) propose alternatives to the proposed Validation Review. J&J CCH 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 IRO Claims Review issues with J&J CCH 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.

Validation Review. In the event OIG has reason to believe that: (a) any of the Xxxxxxx’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). J&J 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 Reports submitted as part of J&JXxxxxxx’s final Annual Report shall be initiated no later than one year after J&JXxxxxxx’s final submission (as described in Section II.BII) is received by OIG. Prior to initiating a Validation Review, OIG shall notify J&J 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, J&J 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. J&J Xxxxxxx agrees to provide any additional information as may be requested by OIG under this Section III.E.3 III.E.4 in an expedited manner. OIG will attempt in good faith to resolve any IRO Review issues with J&J 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.

Validation Review. In the event OIG has reason to believe that: (a) any of the Daiichi’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). J&J 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 Reports submitted as part of J&JDaiichi’s final Annual Report shall be initiated no later than one year after J&JDaiichi’s final submission (as described in Section II.BII) is received by OIG. Prior to initiating a Validation Review, OIG shall notify J&J 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, J&J 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. J&J Daiichi agrees to provide any additional information as may be requested by OIG under this Section III.E.3 III.E.4 in an expedited manner. OIG will attempt in good faith to resolve any IRO Review issues with J&J 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.

Validation Review. In the event OIG has reason to believe that: (a) any of the 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). J&J 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 Reports submitted as part of J&J’s Novartis’ final Annual Report shall be initiated no later than one year after J&J’s Novartis’ final submission (as described in Section II.BII) is received by OIG. Prior to initiating a Validation Review, OIG shall notify J&J 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, J&J 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. J&J Novartis 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 IRO Review issues with J&J 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.

Validation Review. In the event OIG has reason to believe that: (a) any of the 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). J&J 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 Reports submitted as part of J&JCephalon’s final Annual Report shall be initiated no later than one year after J&JCephalon’s final submission (as described in Section II.BII) is received by OIG. Prior to initiating a Validation Review, OIG shall notify J&J 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, J&J 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. J&J Cephalon 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 IRO Review issues with J&J 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.