Common use of Central Laboratory Auditing Clause in Contracts

Central Laboratory Auditing. The Sponsor shall have the ability, upon reasonable notice to QLAB, to visit QLAB and examine all systems, documents and other materials related to the study. If The Sponsor audits QLAB, the parties shall cooperate and work in good faith to resolve any unsatisfactory audit findings. In addition, QLAB shall reasonably cooperate with and shall allow the Food and Drug Administration (FDA) and other governmental agencies to visit QLAB and to examine all systems, documents and other materials related to the study. * AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON NOVEMBER 30, 2001 INFORMATION HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE SEC. FEES AND BILLING D.1 Scheduled Visit Fees Scheduled visit fees which include analytical testing by visit and reporting along with database configuration, maintenance and transfer, project management, and transportation costs are included in Exhibit C. D.2 Kit Construction Fees Kit construction fees which include the cost of visit specific collection kits and materials, as well as shippers, are included in the Provisional Services Budget. Sponsor will be invoiced for these costs at the time they are shipped to the investigator sites.

Central Laboratory Auditing. The Sponsor shall have the ability, upon reasonable notice to QLAB, to visit QLAB and examine all systems, documents and other materials related to the study. If The Sponsor audits QLAB, the parties shall cooperate and work in good faith to resolve any unsatisfactory audit findings. In addition, QLAB shall reasonably cooperate with and shall allow the Food and Drug Administration (FDA) and other governmental agencies to visit QLAB and to examine all systems, documents and other materials related to the study. * AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON NOVEMBER 30DECEMBER 7, 2001 INFORMATION HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE SEC. FEES AND BILLING D.1 Scheduled Visit Fees Scheduled visit fees which include analytical testing by visit and reporting along with database configuration, maintenance and transfer, project management, and transportation costs are included in Exhibit C. D.2 Kit Construction Fees Kit construction fees which include the cost of visit specific collection kits and materials, as well as shippers, are included in the Provisional Services Budget. Sponsor will be invoiced for these costs at the time they are shipped to the investigator sites.