IRO Review of the Distribution of Samples of Par Relevant Government Reimbursed Products Sample Clauses

IRO Review of the Distribution of Samples of Par Relevant Government Reimbursed Products. The IRO shall conduct a review and assessment of the distribution of samples of Relevant Government Reimbursed Products to HCPs and HCIs. Par shall provide the IRO with: i) a list of Relevant Government Reimbursed Products for which Par distributed samples during the Reporting Period; ii) information about the FDA-approved uses for each such product; and iii) information about Par’s Sample Distribution Policies and Procedures. Par shall also provide the IRO with information about the reviews of Sample Distribution Policies and Procedures that Par conducted during the Reporting Period as set forth in Section III.B.2.i of the CIA and any modifications to the Sample Distribution Policies and Procedures made as a result of Par’s reviews. For each Relevant Government Reimbursed Product for which Par distributed samples during the Reporting Period, the IRO shall randomly select a sample of 50 separate instances in which Par provided samples of the product to HCPs or HCIs. Each such instance shall be known as a “Sampling Event.” For each Sampling Event, the IRO shall review all documents and information relating to the distribution of the sample to the HCP or HCI. The reviewed materials shall include materials about the following: 1) the quantity, dosage, and form of the Par product provided to the HCP or HCI; 2) the identity and type of medical specialty or clinical practice of the HCP or HCI; 3) which individual Par sales personnel or other Par personnel provided the sample to the HCP or HCI; and 4) the manner and mechanism through which the sample was requested (e.g., sample request form, letter, or call to Par). For each Sampling Event, the IRO shall evaluate whether the sample was provided to an HCP or HCI whose medical specialty or clinical practice is consistent with the uses of the Relevant Government Reimbursed Product approved by the FDA and whether the sample was distributed by an Par representative in a manner consistent with Par’s sample distribution policy for the product(s) provided during the Sampling Event. To the extent that a sample was provided to an HCP or HCI by a Par representative other than a sales personnel, the IRO shall contact the HCP or HCI by letter. The letter shall request that the HCP or HCI: 1) verify that he/she/it received the quantity and type of samples identified by the IRO as the Sampling Event; 2) verify that he/she/it requested the samples provided during the Sampling Event; 3) explain or confirm its type of medical spec...
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