Common use of IRO Engagement Clause in Contracts

IRO Engagement. GSK shall engage an IRO (or IRO(s)) 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.11 of the CIA or any additional information submitted by GSK in response to a request by OIG, whichever is later, OIG will notify GSK if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK may continue to engage the IRO. If GSK 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, GSK shall submit the information identified in Section V.A.11 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 GSK at the request of OIG, whichever is later, OIG will notify GSK if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK may continue to engage the IRO.

Appears in 4 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement, Corporate Integrity Agreement

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IRO Engagement. GSK 1. Indivior shall engage an IRO (or IRO(s)) 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. E. Within 30 days after OIG receives the information identified in Section V.A.11 V.A.9 of the CIA or any additional information submitted by GSK Indivior in response to a request by OIG, whichever is later, OIG will notify GSK Indivior if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Indivior may continue to engage the IRO. 2. If GSK Indivior 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, GSK Indivior shall submit the information identified in Section V.A.11 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 GSK Indivior at the request of OIG, whichever is later, OIG will notify GSK Indivior if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Indivior may continue to engage the IRO.

Appears in 4 contracts

Samples: Corporate Integrity Agreement (Indivior PLC), Corporate Integrity Agreement (Indivior PLC), Corporate Integrity Agreement

IRO Engagement. GSK Gambro shall engage an IRO (or IRO(s)) 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 and/or objective fashion, as set forth in Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.11 written notice of the CIA or any additional information submitted by GSK in response to a request by OIG, whichever is lateridentity of the selected IRO, OIG will notify GSK Gambro if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Gambro may continue to engage the IRO. If GSK Gambro 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, GSK Gambro shall submit the information identified in Section V.A.11 of the CIA V.A.8 to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by GSK at written notice of the request identity of OIG, whichever is laterthe selected IRO, OIG will notify GSK Gambro if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Gambro may continue to engage the IRO.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement (Davita Inc)

IRO Engagement. GSK 1. Hill-Rom shall engage an IRO (or IRO(s)) 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.11 V.A.8 of the CIA or any additional information submitted by GSK Hill-Rom in response to a request by OIG, whichever is later, OIG will notify GSK Hill-Rom if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Hill-Rom may continue to engage the IRO. 2. If GSK Hill-Rom 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, GSK Hill-Rom shall submit the information identified in Section V.A.11 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 GSK Hill-Rom at the request of OIG, whichever is later, OIG will notify GSK Hill-Rom if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Hill-Rom may continue to engage the IRO.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement (Hill-Rom Holdings, Inc.)

IRO Engagement. GSK 1. Each Provider shall engage an IRO (or IRO(s)) 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.11 V.A.8 of the CIA or any additional information submitted by GSK the Provider in response to a request by OIG, whichever is later, OIG will notify GSK the Provider if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK the Provider may continue to engage the IRO. 2. If GSK the Provider 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, GSK the Provider shall submit the information identified in Section V.A.11 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 GSK the Provider at the request of OIG, whichever is later, OIG will notify GSK the Provider if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK the Provider may continue to engage the IRO.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

IRO Engagement. GSK ‌ 1. Xx. Xxxxxx shall engage an IRO (or IRO(s)) 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. E. Within 30 days after OIG receives the information identified in Section V.A.11 V.A.2 of the CIA IA or any additional information submitted by GSK Xx. Xxxxxx in response to a request by OIG, whichever is later, OIG will notify GSK Xx. Xxxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Xx. Xxxxxx may continue to engage the IROIRO.‌ 2. If GSK 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, GSK Xx. Xxxxxx shall submit the information identified in Section V.A.11 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 GSK Xx. Xxxxxx at the request of OIG, whichever is later, OIG will notify GSK Xx. Xxxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Xx. Xxxxxx may continue to engage the IRO.IRO.‌

Appears in 2 contracts

Samples: Integrity Agreement, Integrity Agreement

IRO Engagement. GSK 1. Xxxxxxxx shall engage an IRO (or IRO(s)) 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. E. Within 30 days after OIG receives the information identified in Section V.A.11 V.A.4 of the CIA IA or any additional information submitted by GSK Xxxxxxxx in response to a request by OIG, whichever is later, OIG will notify GSK Klurfeld if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Klurfeld may continue to engage the IRO. 2. If GSK Xxxxxxxx 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, GSK Xxxxxxxx shall submit the information identified in Section V.A.11 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 GSK Xxxxxxxx at the request of OIG, whichever is later, OIG will notify GSK Klurfeld if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Klurfeld may continue to engage the IRO.

Appears in 1 contract

Samples: Integrity Agreement

IRO Engagement. GSK 1. Rite Aid shall engage an IRO (or IRO(s)) 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. E. Within 30 days after OIG receives the information identified in Section V.A.11 V.A.7 of the CIA or any additional information submitted by GSK Rite Aid in response to a request by OIG, whichever is later, OIG will notify GSK Rite Aid if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Rite Aid may continue to engage the IRO. 2. If GSK Rite Aid 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, GSK Rite Aid shall submit the information identified in Section V.A.11 V.A.7 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 GSK Rite Aid at the request of OIG, whichever is later, OIG will notify GSK Rite Aid if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Rite Aid may continue to engage the IRO.

Appears in 1 contract

Samples: Corporate Integrity Agreement

IRO Engagement. GSK 1. The Parties shall engage an IRO (or IRO(s)) 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. E. Within 30 days after OIG receives the information identified in Section V.A.11 V.A.7 of the CIA or any additional information submitted by GSK the Parties in response to a request by OIG, whichever is later, OIG will notify GSK the Parties if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK the Parties may continue to engage the IRO. 2. If GSK engages the Parties engage 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, GSK the Parties shall submit the information identified in Section V.A.11 V.A.7 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 GSK the Parties at the request of OIG, whichever is later, OIG will notify GSK the Parties if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK the Parties may continue to engage the IRO.

Appears in 1 contract

Samples: Corporate Integrity Agreement

IRO Engagement. GSK 1. LFAC shall engage an IRO (or IRO(s)) 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. E. Within 30 days after OIG receives the information identified in Section V.A.11 V.A.2 of the CIA IA or any additional information submitted by GSK LFAC in response to a request by OIG, whichever is later, OIG will notify GSK LFAC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK LFAC may continue to engage the IRO. 2. If GSK LFAC 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, GSK LFAC shall submit the information identified in Section V.A.11 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 GSK LFAC at the request of OIG, whichever is later, OIG will notify GSK LFAC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK LFAC may continue to engage the IRO.

Appears in 1 contract

Samples: Integrity Agreement

IRO Engagement. GSK 1. LCCA shall engage an IRO (or IRO(s)) 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. E. Within 30 days after OIG receives the information identified in Section V.A.11 V.A.7 of the CIA or any additional information submitted by GSK LCCA in response to a request by OIG, whichever is later, OIG will notify GSK LCCA if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK LCCA may continue to engage the IRO. 2. If GSK LCCA 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, GSK LCCA shall submit the information identified in Section V.A.11 V.A.7 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 GSK LCCA at the request of OIG, whichever is later, OIG will notify GSK LCCA if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK LCCA may continue to engage the IRO.

Appears in 1 contract

Samples: Corporate Integrity Agreement

IRO Engagement. GSK 1. The Providers shall engage an IRO (or IRO(s)) 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.11 V.A.3 of the CIA IA or any additional information submitted by GSK the Providers in response to a request by OIG, whichever is later, OIG will notify GSK the Providers if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK the Providers may continue to engage the IRO. 2. If GSK engages the Providers engage 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, GSK the Providers shall submit the information identified in Section V.A.11 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 GSK the Providers at the request of OIG, whichever is later, OIG will notify GSK the Providers if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK the Providers may continue to engage the IRO.

Appears in 1 contract

Samples: Integrity Agreement

IRO Engagement. GSK 1. Novartis shall engage an IRO (or IRO(s)) that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the review its reviews 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.11 V.A.10 of the CIA or any additional information submitted by GSK Novartis in response to a request by OIG, whichever is later, OIG will notify GSK Novartis if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Novartis may continue to engage the IRO. 2. If GSK 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, GSK Novartis shall submit the information identified in Section V.A.11 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 GSK Novartis at the request of OIG, whichever is later, OIG will notify GSK Novartis if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Novartis may continue to engage the IRO.

Appears in 1 contract

Samples: Corporate Integrity Agreement

IRO Engagement. GSK ‌ 1. Amgen Inc. (Amgen) shall engage an IRO (or IRO(s)) 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. E. Within 30 days after OIG receives the information identified in Section V.A.11 V.A.9 of the CIA or any additional information submitted by GSK Amgen in response to a request by OIG, whichever is later, OIG will notify GSK Amgen if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Amgen may continue to engage the IROIRO.‌ 2. If GSK Amgen 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, GSK Amgen shall submit the information identified in Section V.A.11 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 GSK Amgen at the request of OIG, whichever is later, OIG will notify GSK Amgen if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Amgen may continue to engage the IRO.IRO.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

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IRO Engagement. GSK 1. Practitioner shall engage an IRO (or IRO(s)) 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. E. Within 30 days after OIG receives the information identified in Section V.A.11 V.A.2 of the CIA IA or any additional information submitted by GSK Practitioner in response to a request by OIG, whichever is later, OIG will notify GSK Practitioner if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Practitioner may continue to engage the IRO. 2. If GSK Practitioner 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, GSK Practitioner shall submit the information identified in Section V.A.11 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 GSK Practitioner at the request of OIG, whichever is later, OIG will notify GSK Practitioner if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Practitioner may continue to engage the IRO.

Appears in 1 contract

Samples: Integrity Agreement

IRO Engagement. GSK 1. The Providers shall engage an IRO (or IRO(s)) 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.11 V.A.5 of the CIA or any additional information submitted by GSK the Providers in response to a request by OIG, whichever is later, OIG will notify GSK the Providers if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK the Providers may continue to engage the IRO. 2. If GSK engages the Providers 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, GSK the Providers shall submit the information identified in Section V.A.11 V.A.5 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 GSK the Providers at the request of OIG, whichever is later, OIG will notify GSK the Providers if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK the Providers may continue to engage the IRO.

Appears in 1 contract

Samples: Corporate Integrity Agreement

IRO Engagement. GSK 1. Mid Xxxxxx shall engage an IRO (or IRO(s)) 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. D, below. Within 30 days after OIG receives the information identified in Section V.A.11 V.A.9 of the CIA or any additional information submitted by GSK Xxx Xxxxxx in response to a request by OIG, whichever is later, OIG will notify GSK Mid Xxxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Mid Xxxxxx may continue to engage the IRO. 2. If GSK Mid Xxxxxx 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, GSK Xxx Xxxxxx shall submit the information identified in Section V.A.11 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 GSK Xxx Xxxxxx at the request of OIG, whichever is later, OIG will notify GSK Mid Xxxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Mid Xxxxxx may continue to engage the IRO.

Appears in 1 contract

Samples: Corporate Integrity Agreement

IRO Engagement. GSK 1. Orthofix shall engage an IRO (one or IRO(s)) more IROs that possesses possess the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO IRO(s) 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.11 V.A.12 of the CIA or any additional information submitted by GSK Orthofix in response to a request by OIG, whichever is later, OIG will notify GSK Orthofix if the any IRO is unacceptable. Absent notification from OIG that the any IRO is unacceptable, GSK Orthofix may continue to engage the IRO. 2. If GSK Orthofix 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, GSK Orthofix shall submit the information identified in Section V.A.11 V.A.12 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 GSK Orthofix at the request of OIG, whichever is later, OIG will notify GSK Orthofix if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Orthofix may continue to engage the IRO.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Orthofix International N V)

IRO Engagement. GSK Amgen shall engage an IRO (or IRO(s)) 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.11 V.A.10 of the CIA or any additional information submitted by GSK Amgen in response to a request by OIG, whichever is later, OIG will notify GSK Amgen if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Amgen may continue to engage the IRO. If GSK Amgen 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, GSK Amgen shall submit the information identified in Section V.A.11 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 GSK Amgen at the request of OIG, whichever is later, OIG will notify GSK Amgen if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Amgen may continue to engage the IRO.

Appears in 1 contract

Samples: Corporate Integrity Agreement

IRO Engagement. GSK 1. FHG shall engage an IRO (or IRO(s)) 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.11 V.A.4 of the CIA IA or any additional information submitted by GSK FHG in response to a request by OIG, whichever is later, OIG will notify GSK FHG if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK FHG may continue to engage the IRO. 2. If GSK FHG 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, GSK FHG shall submit the information identified in Section V.A.11 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 GSK FHG at the request of OIG, whichever is later, OIG will notify GSK FHG if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK FHG may continue to engage the IRO.

Appears in 1 contract

Samples: Integrity Agreement

IRO Engagement. GSK 1. Novartis shall engage an IRO (or IRO(s)) 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. E. Within 30 days after OIG receives the information identified in Section V.A.11 V.A.9 of the CIA or any additional information submitted by GSK Novartis in response to a request by OIG, whichever is later, OIG will notify GSK Novartis if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Novartis may continue to engage the IRO. 2. If GSK Novartis 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, GSK Novartis shall submit the information identified in Section V.A.11 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 GSK Novartis at the request of OIG, whichever is later, OIG will notify GSK Novartis if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Novartis may continue to engage the IRO.

Appears in 1 contract

Samples: Corporate Integrity Agreement

IRO Engagement. GSK 1. Orthofix shall engage an IRO (one or IRO(s)) more IROs that possesses possess the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO IRO(s) 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.11 V.A.12 of the CIA or any additional information submitted by GSK Orthofix in response to a request by OIG, whichever is later, OIG will notify GSK Orthofix if the any IRO is unacceptable. Absent notification from OIG that the any IRO is unacceptable, GSK Orthofix may continue to engage the IRO. 2. If GSK Orthofix 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, GSK Xxxxxxxx shall submit the information identified in Section V.A.11 V.A.12 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 GSK Orthofix at the request of OIG, whichever is later, OIG will notify GSK Orthofix if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, GSK Orthofix may continue to engage the IRO.

Appears in 1 contract

Samples: Corporate Integrity Agreement

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