California Compliance Program

Introduction

The promotion, marketing, and sale of pharmaceutical products are subject to an array of legal, regulatory, and ethical standards. Innovex is committed to strictly complying with all applicable laws and regulations and adhering to the highest ethical standards in the conduct of its marketing and promotional activities. Innovex understands that its failure to abide by these standards can put itself and its customers, who hold the marketing authorizations of the pharmaceutical products that Innovex promotes, at risk.

Customer Practices, PhRMA Code & OIG Guidelines

Except where doing so would be in conflict with the law, Innovex is committed to maintaining strict adherence to the dictates of its customers with regard to the promotion of their specific products. In California, Innovex will only follow such customer dictates if such are consistent with the PhRMA Code on Interactions with Healthcare Providers (the "PhRMA Code") and the Compliance Program Guidance for Pharmaceutical Manufacturers developed by the United States Department of Health and Human Services Office of the Inspector General (the "OIG Guidance"). Where a customer has not provided instructions as to any particular matter, Innovex will follow the PhRMA Code and the OIG Guidance.

Spending Limits

In the course of its interactions on healthcare providers on behalf of its customers, Innovex makes certain expenditures on gifts, promotional materials, or other items or activities provided to individual healthcare providers. As stated previously, all such expenditures are made in conformance with the particular customer's practice or the PhRMA Code and OIG Guidance as the case may be. Further, where Innovex is providing sales force services to a fee for service customer, Innovex will seek and follow that customer's instructions on an applicable annual limit on spending on any individual healthcare provider visited by Innovex on such customer's behalf. Where Innovex is providing a sales force on its own behalf or on behalf of an affiliate of Innovex, then Innovex shall spend no more than $1,500 in the aggregate on any one healthcare provider in California.

Monitoring & Reporting

Innovex is committed to regular monitoring of its field representatives' compliance with this program. Accordingly, Innovex will conduct random, periodic reviews of representative expense reports and make random, periodic field visits to look for any indication of non-compliance. Where non-compliance is found, Innovex will take appropriate action consistent with its human resources policies and practices. Innovex will make available to its customers records of all health care provider level spending so that such customers can consider such spending in determining compliance with its own compliance program. Any person with any information regarding any violations of these policies should report such to the Quintiles Business Ethics Office as follows:

• Call: +1 608 848 8810. Calls to this number may be made anonymously. The phone (including voice mail) cannot identify where the call originates.
• Fax: +1 608 848 8811 
• Email: business.ethics@quintiles.com (Not capable of anonymity)

Publishing the Program

Innovex will post this Comprehensive Marketing Compliance Program on its website and will update this program without prior notice where required due to changes in the PhRMA Code or the OIG Guidelines. Finally, Innovex will certify annually to its compliance with this Comprehensive Marketing Compliance Program. Copies of this Comprehensive Marketing Compliance Program may be obtained by calling the Innovex Legal Department toll-free at 1-800-770-5657, ex. 4784.

Version 1.0, 1 July 2005