IRO Engagement. 1. Good Shepherd shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the review in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.8 of the CIA or any additional information submitted by Good Shepherd in response to a request by OIG, whichever is later, OIG will notify Good Shepherd if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Good Shepherd may continue to engage the IRO. 2. If Good Shepherd engages a new IRO during the term of the CIA, this IRO shall also meet the requirements of this Appendix. If a new IRO is engaged, Good Shepherd shall submit the information identified in Section V.A.8 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Good Shepherd at the request of OIG, whichever is later, OIG will notify Good Shepherd if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Good Shepherd may continue to engage the IRO.
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Samples: Corporate Integrity Agreement, Corporate Integrity Agreement, Corporate Integrity Agreement
IRO Engagement. 1. Good Shepherd Aegerion shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the review in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.8 of the CIA or any additional information submitted by Good Shepherd Aegerion in response to a request by OIG, whichever is later, OIG will notify Good Shepherd Aegerion if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Good Shepherd Aegerion may continue to engage the IRO.
2. If Good Shepherd Aegerion engages a new IRO during the term of the CIA, this that IRO shall must also meet the requirements of this Appendix. If a new IRO is engaged, Good Shepherd Aegerion shall submit the information identified in Section V.A.8 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Good Shepherd Aegerion at the request of OIG, whichever is later, OIG will notify Good Shepherd Aegerion if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Good Shepherd Aegerion may continue to engage the IRO.
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Samples: Corporate Integrity Agreement (Novelion Therapeutics Inc.)
IRO Engagement. 1. Good Shepherd Amedisys shall engage an IRO (or IROs) that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the review in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.8 V.A.10 of the CIA or any additional information submitted by Good Shepherd Amedisys in response to a request by OIG, whichever is later, OIG will notify Good Shepherd Amedisys if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Good Shepherd Amedisys may continue to engage the IRO.
2. If Good Shepherd Amedisys engages a new IRO during the term of the CIA, this IRO shall also meet the requirements of this Appendix. If a new IRO is engaged, Good Shepherd Amedisys shall submit the information identified in Section V.A.8 V.A.10 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Good Shepherd Amedisys at the request of OIG, whichever is later, OIG will notify Good Shepherd Amedisys if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Good Shepherd Amedisys may continue to engage the IRO.
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