Compliance Program

I. Introduction

Warner Chilcott is committed to ensuring that all of our dealings with our customers, employees, suppliers, competitors and the community are conducted with the utmost integrity, adhering to the highest standards of ethical and just conduct. Consistent with these values, Warner Chilcott is committed to achieving its goals by establishing and maintaining an effective comprehensive compliance program (the “Compliance Program”) in accordance with the April 2003 “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Guidance”) published by the United States Department of Health and Human Services, Office of the Inspector General (the “OIG”).

Below is an overview of Warner Chilcott’s Compliance Program. As recommended in the OIG Guidance, the Compliance Program has been designed to fit the specific compliance needs of Warner Chilcott. The effectiveness of the Compliance Program will be assessed regularly to determine the need to address and implement changes.

II. Overview of the Compliance Program

A. Leadership and Structure

Compliance Officer
The Compliance Officer is responsible for developing and overseeing the implementation of the Compliance Program. One of the Compliance Officer’s primary roles is to monitor compliance with internal standards and applicable laws. The Compliance Officer will report compliance-related issues directly to the Chief Executive Officer and/or the Board of Directors. In addition, the Compliance Officer has the authority to ensure the effectiveness of the Compliance Program by revising the Compliance Program as necessary.

Compliance Committee
Warner Chilcott has established a Compliance Committee comprised of high-level personnel from various business units to assist the Compliance Officer in the implementation and administration of the Compliance Program. The Compliance Officer will meet with the Compliance Committee on a periodic basis. The Compliance Committee along with members of management will work together with the Compliance Officer in developing corporate policies and will assist in ensuring that business activities meet the goals of the Compliance Program by enforcing standards, reporting misconduct, and making sure that all employees under their control are aware of and comply with all applicable laws and corporate policies.

B. Written Standards

Warner Chilcott’s general standards of conduct for director, officer and employee compliance with applicable laws, policies and procedures are set forth in Warner Chilcott’s Code of Business Conduct and Ethics (the “Code of Business Conduct”). In addition to the Code of Business Conduct, Warner Chilcott has established policies and procedures addressing substantive areas including, but not limited to, laws, rules and regulations governing operations and promotional activities. Policies and procedures have been adopted to address specific risk areas to pharmaceutical manufacturers identified by the OIG such as (i) data integrity pertaining to government reimbursement practices; (ii) kickbacks and other illegal remuneration; and (iii) compliance with laws regulating drug sampling. Policies and procedures related to promotional activities are designed to ensure that interactions with healthcare professionals are appropriate, ethical, and consistent with applicable laws and with the Pharmaceutical Research and Manufactures of America “Code of Interactions with Health Care Professionals,” as revised January 2004 (the “PhRMA Code”).

Warner Chilcott expects that directors, officers and employees comply with the Compliance Program, the ethical standards of the Code of Business Conduct and all written policies and procedures. Employees are required to acknowledge, upon hire and annually thereafter, their commitment to conduct all business activities in accordance with applicable laws, regulations and company policies.

C. Education and Training

Educating and training employees on their legal and ethical obligations under applicable laws, regulations, and policies is at the core of the Compliance Program. Warner Chilcott is committed to implementing training programs to effectively educate all employees on the standards and procedures applicable to their job responsibilities. All new employees receive compliance training as part of their initial training and are required to complete periodic compliance training. As new developments in applicable laws, regulations or policies and procedures occur, Warner Chilcott provides periodic training through live training sessions, web-based training or through the distribution of memoranda or publications to affected employees. Warner Chilcott regularly reviews and updates its training programs and identifies and implements additional areas of training as appropriate.

D. Internal Lines of Communication

Employees are responsible for ensuring that Warner Chilcott’s standards of conduct are met. This obligation requires that employees (i) seek compliance guidance when unclear about an ethical situation or specific conduct and (ii) report possible violations of laws, regulations or company policies. To facilitate these goals, Warner Chilcott encourages an environment of open communication and has established policies regarding confidentiality and non-retaliation. Employees should contact their supervisor, manager, the Compliance Officer, the Legal Department, any member of the Ethics Committee, or Human Resources regarding questions or information about the Compliance Program or to report potential violations. Further information regarding Warner Chilcott’s non-retaliation policy can be found in the Code of Business Conduct.

E. Auditing and Monitoring

Effectiveness of the Compliance Program is accomplished through continuous efforts to audit, monitor and evaluate compliance with polices and procedures. In accordance with the OIG Guidance, the nature of our reviews as well as the extent and frequency of compliance monitoring and auditing varies according to a variety of factors, including new regulatory requirements, changes in business practices, and other considerations. Warner Chilcott will utilize ongoing assessment of compliance programs to identify new and emerging risk areas and address these risks.

Employees also play an essential role in monitoring compliance on a day-to-day basis. Warner Chilcott requires its Chief Executive Officer, Chief Financial Officer, Executive Vice President Corporate Development, President Pharmaceuticals and all Senior Vice Presidents to certify annually that they are aware of and have complied with Warner Chilcott’s policies on ethical behavior and to list any violations or questionable activities they have witnessed or heard about or certify that they are not aware of any such activities.

F. Responding to Potential Violations

Adherence to the Code of Business Conduct is a condition of employment at Warner Chilcott. Any violation of Compliance Program requirements by directors, officers, managers and employees is subject to disciplinary action. Although each situation is considered on a case-by-case basis, Warner Chilcott consistently undertakes appropriate disciplinary action to address inappropriate conduct and to deter future violations. Employees are put on notice that failure to adhere to company policies may have consequences, up to and including termination of employment. In addition, if necessary, revisions to guidelines, policies, procedures or any function of the Compliance Program to prevent the reoccurrence of misconduct in the area will be implemented.

G. Corrective Action Procedures

A Compliance Program increases the likelihood of preventing, or at least detecting, unlawful and unethical behavior. However, the OIG Guidance recognizes that even an effective Compliance Program may not prevent all violations. As such, Warner Chilcott’s Compliance Program requires that we respond promptly to potential violations of law or company policy, take appropriate disciplinary action in a consistent manner, assess whether the violation is in part due to gaps in Warner Chilcott’s policies, practices, or internal controls, and take action to prevent future violations.

III. Annual Spending Limit

For purposes of complying with the California Health & Safety Code § 119400-119402 (effective July 1, 2005) Warner Chilcott has established, as part of its Compliance Program, an annual dollar limit for spending on gifts, promotional materials, items or activities that Warner Chilcott may provide to a medical or health care professional in California. The items or activities subject to this limit include primarily items that principally entail a patient benefit or are related to the healthcare professional’s practice (like medical textbooks, other medical literature, anatomical models, etc.), modest meals associated with a substantive discussion of a Warner Chilcott product, or a meeting or discussion about a medical, scientific or clinical matter. Any promotional items provided must comply with company policies, the PhRMA Code and OIG Guidance.

Warner Chilcott’s annual aggregate limit on covered promotional expenditures is $2,500 per covered medical or health care professional for annual periods commencing on July 1, 2005. This annual aggregate limit is based on an estimate of the maximum value of gifts, promotional materials and other items or activities that a medical or health care professional may receive in one year. The limit represents a maximum amount and is not necessarily a usual, customary, average or typical amount for medical or health care professionals and may be revised in the future based on a variety of factors.

IV. Conclusion

Warner Chilcott’s Compliance Program is part of its commitment to honest and ethical business dealings and corporate responsibility. In order to effectively reach these goals, the Compliance Officer will periodically review the Compliance Program and adapt to the characteristics of Warner Chilcott and the changing environment in which it operates.

This description of Warner Chilcott’s Compliance Program is as of July 1, 2005. Warner Chilcott will assess its Compliance Program at least annually for the purpose of declaring compliance with California Health & Safety Code § 119400-119402.

California Compliance Declaration

Warner Chilcott is committed to the development, manufacturing and marketing of pharmaceutical products in compliance with all applicable laws through an effective Compliance Program. To the best of our knowledge, and based on a good faith understanding of the statutory requirements, we have developed a Compliance Program consistent with California Health & Safety Code § 119400-119402. As of July 1, 2006, Warner Chilcott declares that it is, in all material respects, compliant with the Compliance Program as described above and California Health & Safety Code § 119400-119402.

As recommended in the OIG Guidance, we have developed a Compliance Program tailored to the size, organizational structure and resources of our company. While the OIG Guidance recognizes that even an effective compliance program may not completely eliminate all misconduct by individuals, our Compliance Program is reasonably designed to prevent and detect violations. Our expectation is that all directors, officers and employees will adhere to our Compliance Program. Our Compliance Program is dynamic, and in order to address evolving compliance needs, we will assess our Compliance Program at least annually and as part of this assessment, Warner Chilcott may modify aspects of its program to enhance the program’s effectiveness.

Warner Chilcott

Copies of this summary of the Compliance Program and declaration may be obtained by contacting Warner Chilcott at the following toll-free number: 1-800-521-8813.