Corporate Comprehensive Compliance Program (CCP) Statement

Hollister -Stier is committed to conducting business in an ethical manner and complying with State and Federal pharmaceutical compliance program guidelines. Our sales and marketing activities are intended to enhance the practice of medicine and benefit patients, and not interfere with the independent judgment of health care professionals.

With this in mind, our Comprehensive Compliance Program(CCP) was established in accordance with guidelines established by the Office of Inspector General of the United States Department of Health and Human Services (OIG HHS) and the most recent version of the “Code of Interactions with Healthcare Professionals” issued by the Pharmaceutical Research and Manufacturers of America (PhRMA). Our CCP is in accordance with regulations and State Bills (SB’s) that establish annual spending limits on promotional marketing materials and on items or gifts given to healthcare providers (e.g., California State Bill (SB 1765) effective July 1, 2005, and others). It is also in alignment with regulations which require a written code of conduct for practices which govern the marketing and sale of products, and require a comprehensive training program to regularly educate sales and marketing personnel, (e.g., Nevada State Bill (NVA.B.128) effective October 1, 2007).

An annual declaration of compliance with our CCP is published on our corporate website, and is updated based on the previous reporting year.

Our Comprehensive Compliance Program includes the following, but is not limited to:

• Policies, procedures and protocols that are written and revised as needed. These practices guide Hollister-Stier Laboratories and the conduct of our employees in our day-to-day operations.
• A Formal Corporate Compliance Program that includes a Corporate Compliance Committee consisting of Corporate Officers, designated staff members, and a full-time Compliance Officer who has the authority to report significant issues directly to the CEO and to the Board of Directors. The Compliance Officer is a senior executive staff member who is responsible for developing, implementing, operating and monitoring the compliance program. Our Corporate Compliance Officer regularly conducts monthly sales and marketing audits of gifts provided to healthcare providers, and investigates instances of non-compliance with our established marketing code of conduct.

The Corporate Compliance Committee's function is deliberation of major noncompliance and legal issues, and any related disciplinary decisions. The committee includes the following members:

•  President & CEO
•  CFO (Chief Financial Officer)
•  Corporate Legal Counsel
•  Director, Regulatory Affairs (the Corporate Compliance Officer)
•  Regulatory Affairs Specialist (Corporate Compliance Administration, Reports to Director, Regulatory Affairs)
• A communication plan has been developed which includes a toll free hotline, 1(800) 541-3782, accessible 24-hours a day, seven days a week, and an email mailbox corporate_compliance@hollister-stier.com, to field complaints and concerns from employees or others. Calls can be made anonymously and without fear of retribution. Reports of compliance violations may also be faxed to (509) 484-4320.
• Investigation of all suspected non-compliance offenses will be documented, reported and prompt corrective action taken as warranted. The Corporate Compliance Committee requires the company to report instances of noncompliance to law enforcement authorities “in appropriate circumstances”.
• A Code of Employee Conduct that articulates Hollister-Stier’s expectations of commitment to compliance by management, employees and agents.
•  Adoption of the Code on Interactions with Healthcare Professionals developed by the PhRMA (Pharmaceutical Research and Manufacturers of America) which incorporates applicable legal standards and principles of health care.
• Effective, ongoing training, education and certification programs for our employees regarding the Corporate Compliance Program.  Sales and Marketing employees receive additional training and certification to ensure that they have a good understanding of our marketing policies and of the legal framework governing sales activities.
• Internal monitoring and auditing of our compliance program and marketing practices on a routine basis to detect and prevent deviations from the CCP.
• Enforcement of standards with well-publicized disciplinary guidelines.

 Hollister-Stier Laboratories Marketing Practices

Hollister-Stier maintains its dedication to providing healthcare providers with the best possible products and services. To that end, we have established Sales and Marketing practices that will deliver valuable information to healthcare professionals and further enhance their knowledge of current health and treatment options for their patients.

Because compliance is a dynamic and changing process, we regularly assess and monitor our response to recent legislation and modify our Marketing program guidelines accordingly, while maintaining the highest service standard that meets our customer’s needs and expectations.

Hollister-Stier has set the following annual spending limits (maximum amount) to a cumulative annual dollar limit of $1800.00 per Medical and Healthcare Professional. Hollister-Stier reserves the right to revise this limit. The annual spending limit includes following example items:

• The value of gifts and promotional materials, including modest meals and activities that are provided by Hollister-Stier to healthcare professionals in connection with the promotion of our products.
• Medically-relevant items ($25.00 or less per item) such as: Physician desk reference books, medical textbooks or anatomical models, provided occasionally to the physician primarily for the benefit of the patient.
• Modest meals, receptions, etc., that are provided in connection with Hollister-Stier’s efforts to advance the healthcare professional’s knowledge in regard to the safety, efficacy and benefits of Hollister-Stier’s line of products.

Hollister-Stier excludes the following items from the annual spending limit listed above, consistent with our understanding of similar pharmaceutical marketing laws (e.g., California, Maine, Minnesota, Vermont, West Virginia, D.C., and others). Hollister-Stier’s annual spending limit does not include:

• Samples provided to physicians and healthcare providers intended for free distribution and benefit for their patients.
• Reminder items of small monetary value (under $25.00) such as pens, paper pads and calendars.
• Financial support for independent education, health education scholarships and medical education conferences.
• Payment for professional services including, but not limited to, professional speakers, advisors, consultants, market research and independent training services, that are based on the fair market value of the services provided.
• Miscellaneous items of minimal value such as diaries, physician and patient educational materials that are provided to the healthcare professional with the purpose of enhancing the patient’s knowledge of the disease state, disorder and treatment directions.

Compliance Declaration

 For the period from July 1, 2006 through June 30, 2007, Hollister-Stier Laboratories LLC asserts to the best of our knowledge and in all material respects, and based upon a good faith understanding of applicable statutory requirements, that we are in compliance with our Comprehensive Compliance guidelines established in 2005. We recognize that compliance is a dynamic concept that must be adapted to the specific characteristics of the individual company. With this in mind, the guidelines established are in effect, and compliance is monitored regularly to prevent and detect misconduct.

Hollister-Stier's Corporate Compliance Program (CCP) will be reassessed at least annually, and may be modified periodically, to enhance program effectiveness and to better address, detect and prevent any impropriety.

To obtain a printed copy of Hollister-Stier's statement of compliance or our Corporate Compliance Program, please call us toll free at 1(800) 541-3782.