Relating to the Review of Consulting Activities. i. A description of each type of Consulting Activity reviewed, including the number of each type of Consulting Activity reviewed and an identification of the types of documents and information reviewed for each Consulting Activity; ii. For each Consulting Activity, the aggregate annual amount paid by Indivior to the associated HCP or HCI for all purposes; iii. The IRO’s findings and supporting rationale as to whether: a. a written agreement was in place for each Consulting Activity that describes the scope of work to be performed, the fees and expenses to be paid for each Consulting Activity, and the compliance obligations for the Consultant; b. the compensation to be paid for the Consulting Activity was determined in accordance with a centrally managed, pre-set rate structure set by Indivior and was consistent with any compensation limits for the Consulting Activity established by Indivior policies and procedures; c. the rate structure was established based on an independent FMV analysis; d. the Consulting Activity was approved by the Consultant Review Committee in accordance with Indivior Policies and procedures, including Policies and procedures relating to the identification, selection and approval of a given HCP or HCI and the completion of a needs assessment; e. Indivior collected and retained a record of the specific activity performed by the HCP or HCI and, if applicable, a copy of the work product generated in connection with the Consulting Activity; f. the activity undertaken by the Consultant and/or the work product generated was used by Indivior in a manner consistent with Consultant Review Committee approval completed prior to the initiation of the Consulting Activity; g. the aggregate amount paid by Indivior to the HCP or HCI exceeded the applicable cap established under Indivior’s Policies and procedures; h. the IRO identified any weaknesses in Indivior’s systems, processes, policies, procedures and/or practices relating to Consulting Activities; and i. the IRO has recommendations for improvements to Indivior’s systems, processes, policies, procedures and/or practices relating to Consulting Activities.
Appears in 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Relating to the Review of Consulting Activities. In connection with the review of Consulting Activities:
i. A description of each type of Consulting Activity reviewed, including the number of each type of Consulting Activity reviewed and an identification of the types of documents and information reviewed for each Consulting Activity;
ii. For each Consulting Activity, the aggregate annual amount paid Payments by Indivior Novartis to the associated HCP or HCI for all purposesand the amount of each Payment;
iii. The IRO’s findings and supporting rationale as to whether:
a. a written agreement was in place for each Consulting Activity that describes the scope of work to be performed, the fees and expenses to be paid for each Consulting Activity, and the compliance obligations for the Consultant;
b. the compensation to be paid for the Consulting Activity was determined in accordance with a centrally managed, pre-set rate structure set by Indivior and was consistent with any compensation limits for the Consulting Activity established by Indivior policies and proceduresNovartis;
c. the rate structure was established based on an independent FMV fair market value analysis;
d. the Consulting Activity was identified in the annual Consulting budgeting plan developed by Novartis;
e. a needs assessment that identifies the business need for the Consulting Activity and provides detail about the activity was prepared prior to the initiation of the Consulting Activity;
f. the Consulting Activity was reviewed and approved by the Consultant Review Committee in accordance with Indivior Novartis Policies and proceduresProcedures, including Policies and procedures Procedures relating to the identification, selection and approval of a given HCP or HCI and the completion of a needs assessmentHCI;
e. Indivior g. Novartis collected and retained a record of the specific activity performed by the HCP or HCI and, if applicable, a copy of the work product generated in connection with the Consulting Activity;
f. h. the activity undertaken by the Consultant and/or the work product generated was used by Indivior Novartis in a manner consistent with Consultant Review Committee approval the needs assessment that was completed prior to the initiation of the Consulting Activity;
g. i. the aggregate amount paid by Indivior Novartis to the HCP or HCI exceeded the applicable cap established under Indivior’s Novartis’ Policies and proceduresProcedures;
h. j. the IRO identified any weaknesses in Indivior’s Novartis’ systems, processes, policies, procedures and/or practices relating to Consulting Activities; and
i. k. the IRO has recommendations for improvements to Indivior’s Novartis’ systems, processes, policies, procedures and/or practices relating to Consulting Activities.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Relating to the Review of Consulting Activities. In connection with the review of Consulting Activities:
i. A description of each type of Consulting Activity reviewed, including the number of each type of Consulting Activity reviewed and an identification of the types of documents and information reviewed for each Consulting Activity;
ii. For each Consulting Activity, the aggregate annual amount paid by Indivior to the associated HCP or HCI for all purposes;
iii. The IRO’s findings and supporting rationale as to whether:
a. a written agreement was in place for each Consulting Activity that describes the scope of work to be performed, the fees and expenses to be paid for each Consulting Activity, and the compliance obligations for the Consultant;Consultant;
b. the compensation to be paid for the Consulting Activity was determined in accordance with a centrally managed, pre-set rate structure set by Indivior and was consistent with any compensation limits for the Consulting Activity established by Indivior policies and procedures;Insys;
c. the rate structure was established based on an independent a FMV analysis;analysis conducted by Insys;
d. the Consulting Activity was identified in the annual Consulting budgeting plan developed by Insys;
e. a needs assessment that identifies the business need for the Consulting Activity and provides detail about the activity was prepared prior to the initiation of the Consulting Activity;
f. the Consulting Activity was reviewed and approved by the Consultant Review Committee in accordance with Indivior Insys Policies and procedures, including Policies and procedures relating to the identification, selection and approval of a given HCP or HCI and the completion of a needs assessment;Procedures;
e. Indivior g. Insys collected and retained a record of the specific activity performed by the HCP or HCI and, if applicable, a copy of the work product generated in connection with the Consulting Activity;Activity;
f. h. the activity undertaken by the Consultant and/or the work product generated was used by Indivior Insys in a manner consistent with Consultant Review Committee approval the needs assessment that was completed prior to the initiation of the Consulting Activity;Activity;
g. the aggregate amount paid by Indivior to the HCP or HCI exceeded the applicable cap established under Indivior’s Policies and procedures;
h. i. the IRO identified any weaknesses in IndiviorInsys’s systems, processes, policies, procedures and/or practices relating to Consulting Activities; andand
i. j. the IRO has recommendations for improvements to IndiviorInsys’s systems, processes, policies, procedures and/or practices relating to Consulting Activities.Activities.
Appears in 1 contract
Samples: Corporate Integrity Agreement
