PDMA AND SAMPLE ACCOUNTABILITY Sample Clauses

PDMA AND SAMPLE ACCOUNTABILITY. The Sales Force shall be responsible for strict adherence to the PDMA and the Customer sample accountability policies and procedures. Innovex shall provide immediate assistance to Customer in connection with investigation of discrepancies, thefts, significant losses and suspected falsification of sample records. Innovex agrees to produce any written sample records that are maintained by Innovex, within two business days after Customer request. [Optional] ITMS, CALL REPORTING AND SAMPLE ACCOUNTABILITY. Innovex shall provide the Innovex Territory Management System, including automated call reporting and sample accountability functions. Innovex shall have primary responsibility for Sales Force compliance with the requirements of the FDA Final Rule implementing the PDMA (21 CFR Parts 203 & 205), including, but not limited to (a) a sample accountability and tracking system for use by the Sales Representatives; (b) verification of licensed practitioners; (c) annual physical inventories and reconciliation reports; (d) monitoring and investigation of discrepancies, significant losses, thefts and falsification of sample records; (e) notification and reporting to FDA, in conjunction with Customer; (f) a sample distribution security and audit system, including conducting random and for cause audits of sales representatives by personnel independent of the sales force; and (g) training the Sales Force regarding the foregoing. Innovex agrees to produce any written sample records that are maintained by Innovex, within two business days after Customer request. Innovex shall equip the Sales Force with computer hardware and software, and shall bear the cost of database and system administration, licenses, access to data/replication lines, help desk support, and training of the Sales Force in proper use of the computers and software. CUSTOMER RESPONSIBILITIES AND OBLIGATIONS [Description of Customer responsibilities for training and sales meetings, sample accountability systems and call reporting may be significantly different if Innovex is engaged to provide training and/or SFA. The content of the Work Order should be modified to fit the agreed proposal as accepted by Customer]
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PDMA AND SAMPLE ACCOUNTABILITY. Samples of the Customer Products shall be distributed to the Sales Representatives in quantities and in a manner determined by Customer and at Customer's expense. Customer shall be responsible for the cost of sample storage facilities, if necessary to comply with Customer instructions. Customer shall have primary responsibility for compliance with the requirements of the FDA Final Rule implementing the PDMA (21 CFR Parts 203 & 205), including, but not limited to (a) a sample accountability and tracking system for use by the Sales Representatives; (b) verification of licensed practitioners; (c) annual physical inventories and reconciliation reports; (d) monitoring and investigation of discrepancies, significant losses, thefts and falsification of sample records; (e) notification and reporting to FDA; (f) a sample distribution security and audit system, including conducting random and for cause audits of sales representatives by personnel independent of the sales force; and (g) training the Sales Force regarding the foregoing. Customer and Innovex shall cooperate in connection with PDMA compliance investigations and audits. Customer will provide to Innovex for review and comment, a copy of any PDMA compliance report in connection with the Sales Force, prior to filing with the FDA. Customer will provide Innovex with results of annual Sales Representative sample inventories. [revise this section if Innovex provides ITMS and/or sample accountability]
PDMA AND SAMPLE ACCOUNTABILITY. The Sales Force shall be responsible for strict adherence to the PDMA and the Kos sample accountability policies and procedures. Innovex shall provide immediate assistance to Kos in connection with investigation of discrepancies, thefts, significant losses and suspected falsification of sample records. Innovex agrees to produce any written sample records that are maintained by Innovex, within two business days after Kos request
PDMA AND SAMPLE ACCOUNTABILITY. Samples of the Kos Products shall be distributed to the Sales Representatives in quantities and in a manner determined by Kos and at Kos's expense. Kos shall have primary responsibility for compliance with the requirements of the FDA Final Rule implementing the PDMA (21 CFR Parts 203 & 205), including, but not limited to (a) a sample accountability and tracking system for use by the Sales Representatives; (b) verification of licensed practitioners; (c) annual physical inventories and reconciliation reports; (d) monitoring and investigation of discrepancies, significant losses, thefts and falsification of sample records; (e) notification and reporting to FDA; (f) a sample distribution security and audit system, including conducting random and for cause audits of sales representatives by personnel independent of the sales force; and (g) training the Sales Force regarding the foregoing. Kos and Innovex shall cooperate in connection with PDMA compliance investigations and audits; provided, however, that Kos compensates Innovex for such cooperation on a time and materials basis. Kos will provide to Innovex for review and comment, a copy of any PDMA compliance report in connection with the Sales Force, prior to filing with the FDA. Kos will provide Innovex with results of annual Sales Representative sample inventories. Kos shall be responsible for the cost of independent random audits of Innovex Representatives, to be coordinated with Innovex.

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