Common use of IRO Engagement Clause in Contracts

IRO Engagement. A. For each review, KDMC shall engage an IRO that possesses the qualifications set forth in Section II, below, to perform the responsibilities in Section III, below. Each IRO shall conduct its review in a professionally independent and objective fashion, as set forth in Section IV, below. The Legal IRO shall not have a prohibited relationship to KDMC. Within 30 days after OIG receives the information identified in Section V.A.13 of the CIA or any additional information submitted by KDMC in response to a request by OIG, whichever is later, OIG will notify KDMC if either IRO is unacceptable. Absent notification from OIG that an IRO is unacceptable, KDMC may continue to engage the IRO. B. If KDMC 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, KDMC shall submit the information identified in Section V.A.13 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 KDMC at the request of OIG, whichever is later, OIG will notify KDMC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, KDMC may continue to engage the IRO.

IRO Engagement. A. For each review, KDMC 1. The DIG Entities shall engage an entity or entities to serve as an IRO that possesses the qualifications set forth in Section IIParagraph B, below, to perform the responsibilities in Section IIIParagraph C, below. Each IRO The IRO(s) shall conduct its the review in a professionally independent and objective fashion, as set forth in Section IV, below. The Legal IRO shall not have a prohibited relationship to KDMC. Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.13 V.A.9 of the CIA or any additional information submitted by KDMC the DIG Entities in response to a request by OIG, whichever is later, OIG will notify KDMC the DIG Entities if either the IRO is unacceptable. Absent notification from OIG that an the IRO is unacceptable, KDMC the DIG Entities may continue to engage the IRO. B. 2. If KDMC engages the DIG Entities engage 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, KDMC the DIG Entities shall submit the information identified in Section V.A.13 V.A.9 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 KDMC the DIG Entities at the request of OIG, whichever is later, OIG will notify KDMC the DIG Entities if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, KDMC the DIG Entities may continue to engage the IRO.

IRO Engagement. A. For each review, KDMC 1. Xxxxx-JCA shall engage an IRO (or IROs) that possesses possess(es) the qualifications set forth in Section IIParagraph B, below, to perform the responsibilities in Section IIIParagraph C, below. Each IRO The IRO(s) shall conduct its review the reviews in a professionally independent and objective fashion, as set forth in Section IV, below. The Legal IRO shall not have a prohibited relationship to KDMC. Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.13 V.A.3 of the CIA IA or any additional information submitted by KDMC Xxxxx-XXX in response to a request by OIG, whichever is later, OIG will notify KDMC Xxxxx-JCA if either IRO is the IRO(s) are unacceptable. Absent notification from OIG that an IRO is the IRO(s) are unacceptable, KDMC Xxxxx-JCA may continue to engage the IROIRO(s). B. 2. If KDMC Xxxxx-JCA engages a new IRO during the term of the CIAIA, this IRO shall also meet the requirements of this Appendix. If a new IRO is engaged, KDMC Xxxxx-JCA shall submit the information identified in Section V.A.13 V.A.3 of the CIA IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information information, or any additional information submitted by KDMC Xxxxx-JCA at the request of OIG, whichever is later, OIG will notify KDMC Xxxxx-JCA if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, KDMC Xxxxx-JCA may continue to engage the IRO.

IRO Engagement. A. For each review, KDMC 1. Xx. Xxxxxx shall engage an IRO that possesses the qualifications set forth in Section IIParagraph B, below, to perform the responsibilities in Section IIIParagraph C, below. Each The IRO shall conduct its the review in a professionally independent and objective fashion, as set forth in Section IV, below. The Legal IRO shall not have a prohibited relationship to KDMC. Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.13 V.A.4 of the CIA IA or any additional information submitted by KDMC Xx. Xxxxxx in response to a request by OIG, whichever is later, OIG will notify KDMC Xx. Xxxxxx if either the IRO is unacceptable. Absent notification from OIG that an the IRO is unacceptable, KDMC Xx. Xxxxxx may continue to engage the IRO.IRO.‌ B. 2. If KDMC Xx. Xxxxxx engages a new IRO during the term of the CIAIA, this that IRO shall must also meet the requirements of this Appendix. If a new IRO is engaged, KDMC Xx. Xxxxxx shall submit the information identified in Section V.A.13 V.A.4 of the CIA IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by KDMC Xx. Xxxxxx at the request of OIG, whichever is later, OIG will notify KDMC Xx. Xxxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, KDMC Xx. Xxxxxx may continue to engage the IRO.IRO.‌

IRO Engagement. A. For each review, KDMC ‌ 1. Lan Apothecary shall engage an IRO that possesses the qualifications set forth in Section IIParagraph B, below, to perform the responsibilities in Section IIIParagraph C, below. Each The IRO shall conduct its the review in a professionally independent and objective fashion, as set forth in Section IV, below. The Legal IRO shall not have a prohibited relationship to KDMC. Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.13 V.A.2 of the CIA IA or any additional information submitted by KDMC Lan Apothecary in response to a request by OIG, whichever is later, OIG will notify KDMC Lan Apothecary if either the IRO is unacceptable. Absent notification from OIG that an the IRO is unacceptable, KDMC Lan Apothecary may continue to engage the IRO.IRO.‌ B. 2. If KDMC Lan Apothecary engages a new IRO during the term of the CIAIA, this that IRO shall must also meet the requirements of this Appendix. If a new IRO is engaged, KDMC Lan Apothecary shall submit the information identified in Section V.A.13 V.A.2 of the CIA IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information information, or any additional information submitted by KDMC Lan Apothecary at the request of OIG, whichever is later, OIG will notify KDMC Lan Apothecary if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, KDMC Lan Apothecary may continue to engage the IRO.IRO.‌

IRO Engagement. A. For each review, KDMC 1. SpecialCare shall engage an IRO that possesses possesses, or IROs that possess, the qualifications set forth in Section IIParagraph B, below, to perform the responsibilities in Section IIIParagraph C, below. Each IRO The IRO(s) shall conduct its review the reviews in a professionally independent and objective fashion, as set forth in Section IV, below. The Legal IRO shall not have a prohibited relationship to KDMC. Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.13 V.A.10 of the CIA or any additional information submitted by KDMC SpecialCare in response to a request by OIG, whichever is later, OIG will notify KDMC SpecialCare if either IRO is the IRO(s) is/are unacceptable. Absent notification from OIG that an IRO is the IRO(s) is/are unacceptable, KDMC SpecialCare may continue to engage the IROIRO(s). B. 2. If KDMC SpecialCare 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, KDMC SpecialCare shall submit the information identified in Section V.A.13 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 KDMC SpecialCare at the request of OIG, whichever is later, OIG will notify KDMC SpecialCare if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, KDMC SpecialCare may continue to engage the IRO.

IRO Engagement. A. For each review1. Novartis or, KDMC as applicable, NPC (hereafter in this Appendix B, “Novartis”) shall engage an IRO that possesses the qualifications set forth in Section IIB, below, to perform the responsibilities in Section IIIC, below. Each The IRO shall conduct its the review in a professionally independent and objective fashion, as set forth in Section IVE, below. The Legal IRO shall not have a prohibited relationship to KDMC. Within 30 days after OIG receives the information identified in Section V.A.13 of the CIA V.A.9 or any additional information submitted by KDMC Novartis in response to a request by OIG, whichever is later, OIG will notify KDMC Novartis if either the IRO is unacceptable. Absent notification from OIG that an the IRO is unacceptable, KDMC Novartis may continue to engage the IRO. B. 2. If KDMC Novartis 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, KDMC Novartis shall submit the information identified in Section V.A.13 V.A.9 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 KDMC Novartis at the request of OIG, whichever is later, OIG will notify KDMC Novartis if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, KDMC Novartis may continue to engage the IRO.