Common use of Validation Review Clause in Contracts

Validation Review. In the event OIG has reason to believe that: (a) any of Novartis’ IRO Reviews 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). 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 Novartis’ final Annual Report shall be initiated no later than one year after Novartis’ final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify 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, 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. 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 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 Novartis’ IRO Reviews fail Arrangements Review or Claims Review fails to conform to the requirements of this CIA; or (b) the IRO’s findings or Arrangements Review results or Claims Review results are inaccurate, OIG may, at its sole discretion, conduct its own review to determine whether the applicable IRO Arrangements Review or Claims Review complied with the requirements of the CIA and/or the findings or Arrangements Review or Claims Review results are inaccurate (Validation Review). Novartis Home Bound shall pay for the reasonable cost of any such review performed by OIG or any of its designated agents. Any Validation Review of Reports an Arrangements Review or Claims Review submitted as part of Novartis’ Home Bound’s final Annual Report shall be initiated no later than one year after Novartis’ Home Bound’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Novartis Home Bound in writing of its intent to do so and provide a written an explanation of why the reasons OIG believes such has determined a review Validation Review is necessary. To resolve any concerns raised by Home Bound shall have 30 days following the date of the OIG, Novartis may request ’s written notice to submit a meeting with written response to OIG to: (a) discuss the results of any IRO Review submissions or findings; (b) present that includes any additional or relevant information to clarify the results of the IRO Arrangements Review or Claims Review or to correct the inaccuracy of the IRO Review; Arrangements Review or Claims Review and/or (c) propose alternatives to the proposed Validation Review. 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 Novartis prior to conducting a Validation Review. However, the 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 Novartis’ IRO Reviews fail 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). Novartis 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 Novartis’ Cephalon’s final Annual Report shall be initiated no later than one year after Novartis’ Cephalon’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Novartis 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, Novartis 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. Novartis 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 Novartis 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.

Validation Review. In the event OIG has reason to believe that: (a) any of Novartis’ Shire IRO Reviews fail 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). Novartis 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 Novartis’ Shire’s final Annual Report shall be initiated no later than one year after Novartis’ Xxxxx’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Novartis 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, Novartis 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. Novartis 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 Novartis 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.

Validation Review. In the event OIG has reason to believe that: : (a) any of Novartis’ IRO Reviews fail Quarterly Claims Review fails to conform to the requirements of this CIAIA; or (b) the IRO’s findings or Quarterly Claims Review results are inaccurate, OIG may, at its sole discretion, conduct its own review to determine whether the applicable IRO Quarterly Claims Review complied with the requirements of the CIA IA and/or the findings or Quarterly Claims Review results are inaccurate (Validation Review). Novartis Xxxxxxx 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 agents so long as part of Novartis’ final Annual Report shall be it is initiated no later than within one year after Novartis’ Krentel’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Novartis Xxxxxxx in writing of its intent to do so conduct a Validation Review and provide the reasons OIG has determined a written explanation of why OIG believes such a review Validation Review is necessary. To resolve any concerns raised by Xxxxxxx shall have up to 30 days following the date of the OIG, Novartis may request ’s written notice to submit a meeting with written response to OIG to: (a) discuss the results of any IRO Review submissions or findings; (b) present that includes any additional or relevant information to clarify the results of the IRO Quarterly Claims Review or to correct the inaccuracy of the IRO Review; Quarterly Claims Review and/or (c) to propose alternatives to the proposed Validation Review. 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 Quarterly Claims Review issues with Novartis 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 Novartis’ IRO Reviews fail 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). Novartis UMHS shall pay for the reasonable cost of any such review performed by OIG or any of its designated agents. Any Validation Review of Reports a Claims Review submitted as part of Novartis’ UMHS’s final Annual Report shall be initiated no later than one year after Novartis’ UMHS’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Novartis UMHS in writing of its intent to do so and provide a written an explanation of why the reasons OIG believes such has determined a review Validation Review is necessary. To resolve any concerns raised by UMHS shall have 30 days following the date of the OIG, Novartis may request ’s written notice to submit a meeting with written response to OIG to: (a) discuss the results of any IRO Review submissions or findings; (b) present that includes any additional or relevant information to clarify the results of the IRO Claims Review or to correct the inaccuracy of the IRO Review; Claims Review and/or (c) propose alternatives to the proposed Validation Review. 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 Novartis prior to conducting a Validation Review. However, the 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 the OIG has reason to believe that: (a) any of Novartis’ IRO Reviews fail the Verification Review or Unallowable Cost Review fails to conform to the requirements of this CIA; or (b) Odyssey and/or the IROIVO’s findings or Review results are inaccurate, the OIG may, at its sole discretion, conduct its own review to determine whether the applicable IRO Verification Review or Unallowable Cost Review complied with the requirements of the CIA and/or the findings or Review review results are inaccurate (“Validation Review”). Novartis shall Odyssey 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 Novartis’ final Annual Report shall be it is initiated no later than before one year after Novartis’ Odyssey’s final submission (as described in Section II) is received by the OIG. Prior to initiating a Validation Review, the OIG shall notify Novartis Odyssey 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, Novartis Odyssey may request a meeting with the OIG to: (a) to discuss the results of any IRO Verification Review or Unallowable Cost Review submissions or findings; (b) present any additional or relevant information to clarify the results of the IRO Verification Review or Unallowable Cost Review or to correct the inaccuracy inaccuracies of the IRO Verification Review or the Unallowable Cost Review; and/or (c) propose alternatives to the proposed Validation Review. Novartis Odyssey agrees to provide any additional information as may be requested by the OIG under this Section III.D.3 section in an expedited manner. The OIG will attempt in good faith to resolve any IRO Verification Review issues or Unallowable Cost Review with Novartis Odyssey 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.

Validation Review. In the event OIG has reason to believe that: (a) any of Novartis’ BIPI’s IRO Reviews fail 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). Novartis 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 Novartis’ BIPI’s final Annual Report shall be initiated no later than one year after Novartis’ XXXX’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Novartis 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, Novartis 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. Novartis 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 Novartis 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.

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

Validation Review. In the event OIG has reason to believe that: (a) any of Novartis’ Daiichi’s IRO Reviews fail 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). Novartis 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 Novartis’ Daiichi’s final Annual Report shall be initiated no later than one year after Novartis’ Daiichi’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Novartis 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, Novartis 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. Novartis 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 Novartis 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: that:‌ (a) any of Novartis’ IRO Reviews fail Quarterly Claims Review fails to conform to the requirements of this CIAIA; or (b) the IRO’s findings or Quarterly Claims Review results are inaccurate, OIG may, at its sole discretion, conduct its own review to determine whether the applicable IRO Quarterly Claims Review complied with the requirements of the CIA IA and/or the findings or Quarterly Claims Review results are inaccurate (Validation Review). Novartis Xx. Xxxxxxxx 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 a Quarterly Claims Review performed in the final Reporting Period of Novartis’ final Annual Report this IA shall be initiated no later than one year after Novartis’ Xx. Xxxxxxxx’x final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Novartis Xx. Xxxxxxxx in writing of its intent to do so and provide a written an explanation of why the reasons OIG believes such has determined a review Validation Review is necessary. To resolve any concerns raised by Xx. Xxxxxxxx shall have 30 days following the date of the OIG, Novartis may request ’s written notice to submit a meeting with written response to OIG to: (a) discuss the results of any IRO Review submissions or findings; (b) present that includes any additional or relevant information to clarify the results of the IRO Quarterly Claims Review or to correct the inaccuracy of the IRO Review; Quarterly Claims Review and/or (c) propose alternatives to the proposed Validation Review. 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 Novartis prior to conducting a Validation Review. However, the 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 Novartis’ IRO Reviews fail Baptist’s 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). Novartis 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 Novartis’ Baptist’s final Annual Report shall be initiated no later than one year after Novartis’ Baptist’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Novartis 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, Novartis 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. Novartis Xxxxxxx 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 Novartis 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.

Validation Review. In the event OIG has reason to believe that: (a) any of Novartis’ IRO Reviews fail 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 Corporate Integrity Agreement Forest Laboratories, Inc. and/or the findings or Review results are inaccurate (Validation Review). Novartis Forest 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 Novartis’ Forest’s final Annual Report shall be initiated no later than one year after Novartis’ Xxxxxx’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Novartis Forest 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, Novartis Xxxxxx 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. Novartis Xxxxxx 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 Novartis Forest 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.