Code of Business Conduct and Ethics
Code of Compliance Conduct
Corporate Governance Guidelines
Audit Committee Charter
Compliance Committee Charter
Employee Development and Retention Committee Charter
Nominating and Governance Committee Charter
Stock Option and Compensation Committee Charter
Annual California Written Declaration of Compliance
California Comprehensive Compliance Program Policy

CALIFORNIA COMPREHENSIVE COMPLIANCE PROGRAM POLICY

I. Purpose and Scope

Medicis Pharmaceutical Corporation ("Medicis" or the "Company") requires that all of the Company’s business activities comply with all laws and regulations, industry codes of practice, and the Medicis Corporate Compliance Program ("Medicis CCP"). This California Comprehensive Compliance Program ("CA Policy"), which is a part of the Medicis CCP, is designed to guide the conduct of persons who engage in the marketing, sale, or other promotion of Medicis products to California-licensed medical or health professionals ("CA-licensed HCPs")1 on behalf of Medicis. This CA Policy applies to all officers, directors, employees, contract representatives, and contingent employees of Medicis ("Company Representatives"). Company Representatives are often the primary point of contact between the Company and CA-licensed HCPs. Therefore, Company Representatives must ensure that their individual behavior in relation to all business activities conforms to Medicis’s high standards for lawful, ethical, and socially responsible conduct. The failure of any Company Representative to comply with the Medicis CCP, including this CA Policy, may result in disciplinary action, up to and including termination.2

The Medicis CCP includes, but is not limited to: the Company’s Code of Compliance Conduct; Code of Business Conduct and Ethics; Good Promotional Practices?Dermatology and Ucyclyd, and Good Promotional Practices?Aesthetics (collectively "GPPs"); Good Medical Affairs Practices ("GMAPs"); California Comprehensive Compliance Program; State Law Compliance Policy (when effective); Employee Education Policy Concerning the Prevention and Detection of Fraud, Waste, and Abuse in Government Healthcare Programs: Compliance Policy Pursuant to the Deficit Reduction Act of 2005; Professional Field Representative Drug Sample Manual; and Aesthetics Sample Compliance Program Manual.

It is the obligation of all Company Representatives to know and comply with all applicable laws and regulations, industry codes of practice, and the Medicis CCP, including this CA Policy. In discharging this responsibility, Company Representatives are encouraged to seek guidance from any manager, the Human Resources Department, the Legal Department, or the Compliance Department (specifically, the Manager, Corporate Compliance) in advance of engaging in any questioned interaction. The Chief Compliance Officer ("CCO") is responsible for the CA Policy, including resolving any questions arising under the CA Policy. The Compliance Department shall regularly review and amend or supplement the CA Policy at any time the CCO deems necessary to reflect updated legal requirements, policies, and procedures. This regular review is intended to assure that the CA Policy is consistent with current laws and regulations, industry codes of practice, and the Medicis CCP, as well as other Company policies, procedures, and business requirements.

In the event that the CA Policy and other applicable guidelines under the Company’s CCP conflict, the more detailed policies (i.e. GPPs) govern, and employees are responsible for full compliance with the GPPs. The GPPs contain specific guidance related to the marketing, sale, and other promotion of the Company’s products. It is the responsibility of managers at all levels to help ensure that Company Representatives under their supervision meet these obligations.

II. Overview of Standards

California.

Under California law, pharmaceutical companies are required to adopt a "Comprehensive Compliance Program" that is in accordance with the Pharmaceutical Research Manufacturers of America ("PhRMA") Code on Interactions with Healthcare Professionals ("PhRMA Code") and the "Compliance Program Guidance for Pharmaceutical Manufacturers" issued by the Office of the Inspector General of the U.S. Department of Health and Human Services ("OIG"). The Comprehensive Compliance Program is required to include policies for compliance with the PhRMA Code; limits on gifts or incentives provided to CA-licensed HCPs; and a specific annual dollar limit on gifts, promotional materials, or items or activities that the pharmaceutical company may give or otherwise provide to a CA-licensed HCP.

Pursuant to California law, Medicis has established the following specific annual dollar limits:

Each calendar year, the total annual dollar limit on gifts, promotional materials, or items or activities that Medicis may give or otherwise provide to a CA-licensed HCP may not exceed: $3,500 for Medicis, The Dermatology Company customers and $6,000 for Medicis Aesthetics Inc. customers (due to the value of medical device-related programs), subject to the following exclusions:

  • Prescription drug and medical device samples;
  • Support for Continuing Medical Education ("CME") programs;
  • Scholarship and educational funds; and
  • Payments for legitimate professional services provided by a CA-licensed HCP, including but not limited to consulting and speaker services, that do not exceed the fair market value of the services rendered.

For purposes of determining the total value of gifts, promotional materials, or items or activities that Medicis may give or otherwise provide to a CA-licensed HCP, the total value is assessed from the perspective of the CA-licensed HCP and is a cumulative total throughout the calendar year, regardless of whether the gifts, promotional materials, or items or activities are provided by one or more Company Representatives.

Industry Codes.

Because the Company’s products may include both drugs and medical devices, applicable industry codes of practice may include the PhRMA Code and the Advanced Medical Technology Association ("AdvaMed") Code of Ethics on Interactions with Health Care Professionals ("AdvaMed Code"). The CA Policy, as well as the overall CCP, is designed to reflect the principles set forth in these codes, to the extent relevant.

The PhRMA Code and the AdvaMed Code encourage ethical business practices and socially responsible conduct related to interactions with healthcare professionals, including CA-licensed HCPs. The Codes provide that interactions with healthcare professionals should focus on providing scientific and educational information and should support scientific and medical research to maximize patient benefits. More specifically, the Codes provide guidance on: meals and entertainment, speaker training, educational grants, charitable contributions and sponsorships, consultants, and educational items.

The OIG Compliance Program Guidance states that industry codes of practice are a "useful starting point" for pharmaceutical companies in developing their compliance programs. The OIG Compliance Program Guidance states further that compliance with the PhRMA Code will "substantially reduce the risk of fraud and abuse" and demonstrates a good faith effort to comply with the law.

III. Interactions with CA-Licensed HCPs

For detailed guidance regarding meals, entertainment, and recreational activities, please consult the GPPs; the below information is a summary for purposes of this CA Policy.

A. Meals, Entertainment, and Recreational Activities

In accordance with industry codes of practice, when a Company Representative conducts an informational presentation or engages in an informational discussion with a CA-licensed HCP, an occasional modest meal may be offered, so long as the meal occurs in a place and manner conducive to informational communication that provides scientific or educational value. Furthermore, consistent with industry codes of practice, field-based sales representatives and their immediate managers may only provide an occasional, modest meal to a CA-licensed HCP within the healthcare professional’s office or in a hospital setting. In addition, offering "take-out" meals or meals to be eaten without a Company Representative being present (such as a "dine and dash" program) is not appropriate.

As a general rule, subject to geographic adjustments, a modest meal typically would not exceed $100 per person, including beverages, tax, and gratuity. Additionally, the value of the meal should be based on fair market value, not the cost to Medicis of providing it. The CA-licensed HCP’s spouse or other guest(s) may not be invited to participate at an event where a meal is served, even if the healthcare professional offers to pay for the meal, unless the guest would independently qualify as a healthcare professional for whom the informational presentation would be appropriate.

Company Representatives may not offer entertainment or recreational activities, such as golf outings, tickets to sporting events, or concert tickets, to CA-licensed HCPs. There is no exception to this prohibition, even in a context where CA-licensed HCPs are providing a legitimate service to the Company, such as when they act as a bona fide consultant to the Company. There are no "holiday," "out-of-pocket," "personal," or "friend" exceptions.

B. Educational Items and Prohibition on Non-Educational Items

For detailed guidance regarding educational items and the prohibition on non-educational items, please consult the GPPs; the below information is a summary for purposes of this CA Policy.

Consistent with industry codes of practice, Medicis does not permit the distribution of any items of value to CA-licensed HCPs unless the items advance disease or treatment education and are intended solely for the individual’s professional use. Accordingly, Company Representatives may offer appropriate educational items (e.g., medical textbooks, scientific journal subscriptions, and anatomical models for examination rooms) to CA-licensed HCPs on an occasional basis, provided that the items:

  • Are pre-approved by the Compliance Department;
  • Are not of substantial value (i.e. are valued at $100 or less); and
  • Do not have independent value outside of the individual’s professional medical practice.

Medicis may not provide non-educational items to CA-licensed HCPs, even in a context where those healthcare professionals are providing a legitimate service to the Company, such as when they act as a bona fide consultant to the Company. Except for the limited range of educational items described above, nothing of value may be given to a CA-licensed HCP for any reason, including but not limited to pens, notepads, paperweights, scrubs, calendars, umbrellas, sports bags, or purchasing storage space for patient product samples. The prohibition on non-educational items extends to offering non-educational items through sweepstakes or other forms of promotional giveaways (e.g., offering trips, prizes, or the like as part of a sweepstakes or similar promotion to CA-licensed HCPs). This prohibition applies irrespective of the cost of the item (there is no de minimis exception). There is no "holiday," "out-of-pocket," "personal," or "friend" exception. Finally, no Company Representative may use personal funds to provide anything of value to a CA-licensed HCP that is otherwise prohibited.

C. Consultants

For detailed guidance regarding consultants, please consult the GPPs; the below information is a summary for purposes of this CA Policy.

1. General Considerations

Medicis may enter into bona fide consulting and service agreements with a commercially reasonable number of CA-licensed HCPs. It is appropriate for consultants who provide bona fide services to be offered reasonable compensation based on fair market value for such services. They also may be offered reimbursement for reasonable travel, lodging, and meal expenses incurred as part of those services. An agreement is for bona fide services as long as: (1) Medicis has a legitimate need for the services, (2) a written agreement specifies the nature of the services and the basis of payment for those services, (3) the services are provided, (4) compensation paid to the consultant is consistent with the fair market value of the services provided in an arms-length transaction, and (5) Medicis documents everything specified in (1) through (4) above. Time spent merely listening to detailing presentations or viewing or listening to marketing information on websites or through other media is not a bona fide consulting service for which a CA-licensed HCP may be engaged. In addition, payment cannot be made to consultants to provide access to healthcare professionals.

Consultants should be selected because they possess special knowledge or expertise that is of value to Medicis, not because they are "high prescribers." Consulting and other service arrangements may not be used to make payments to CA-licensed HCPs for prescribing Medicis products. Accordingly, the amount to be paid to a consultant must not be determined in a manner that takes into account the past, present, or future volume or value of business generated by the consultant for Medicis.

2. Speaker Programs

Medicis may engage CA-licensed HCPs to make presentations on Company products ("Promotional Speaker Programs"). Promotional Speaker Programs are programs in which Medicis has control or influence with respect to the content of the program, and the speaker is educating and informing other healthcare professionals about the benefits, risks, and appropriate on-label uses of Medicis products. The general rules discussed above for consulting and other service arrangements apply to the engagement of promotional speakers (e.g., need for a written service agreement, payment based on fair market value, etc.). The opportunity to be engaged as a promotional speaker and compensation for speaker services must never be offered to a CA-licensed HCP as an inducement or reward for prescribing Medicis products.

3. Advisory Board Meetings

Medicis may engage CA-licensed HCPs to participate in consulting, advisory, or feedback-type meetings ("Advisory Board Meetings"). The purpose of the meeting cannot be to promote Medicis products to the attendees. The number of healthcare professionals engaged for Advisory Board Meetings, and the number of meetings held, should be limited to and based on the Company’s legitimate business needs. The general rules discussed above for consulting and other service arrangements apply to the engagement of healthcare professionals for Advisory Board Meetings (e.g., need for a written service agreement, payment based on fair market value, etc.).

A written agenda should be prepared and disseminated to invitees in advance of the meeting. Periods devoted to feedback from the advisory board members must comprise more than half of the total meeting time. A Medicis representative must keep notes of the recommendations made or feedback received during the meeting. Among other things, a copy of the agenda, a list of attendees, and thorough and complete meeting minutes must be provided to the Compliance Department after the meeting.

The venue for Advisory Board Meetings must not be overly lavish. This means that selected venues should not give the appearance to the general public that the venue or hotel is the attraction for the meeting as opposed to the business purpose of the meeting. By way of example, resort locations where the primary function of the property is something other than lodging or meeting space (e.g., ski-in, ski-out lodges; fishing retreats; or five-star hotel/spa facilities) are not appropriate venues. It is appropriate to reimburse CA-licensed HCPs engaged to participate in Advisory Board Meetings for the necessary and reasonable business expenses they actually incur, such as travel, modest meals, and accommodations. Medicis does not cover travel expenses for spouses or other guests of CA-licensed HCPs engaged to participate in an Advisory Board Meeting. A spouse or guest may participate in group meals provided that the cost of the meal(s) is paid for by the CA-licensed HCP and not by Medicis.

IV. Support for Continuing Medical Education

For detailed guidance regarding educational grants, please consult the GPPs or GMAPs (as applicable); the below information is a summary for purposes of this CA Policy.

Medicis’s support of patient care and the practice of medicine are demonstrated, in part, through its provision of grants for educational activities and organizations. Any request to support a continuing medical education program or other independent scientific exchange will be considered as an educational grant, and such programs must be conducted free of influence by Medicis. Educational grants may only be given to fund CME programs that are accredited by the Accreditation Council for Continuing Medical Education ("ACCME") or a comparable third-party accrediting organization to provide CME credit.

Company Representatives are prohibited from soliciting requests for educational grants. Unsolicited requests for educational grants received by Company Representatives should be forwarded directly to Medical Affairs for processing in accordance with the GMAPs. Medicis may not exercise any control over CME programs, including but not limited to the following: audience, location, date, speaker selection, presentation title or content, or educational content (including slides or other product information). Grants may not be provided directly to individuals nor may Company Representatives use educational grants as a mechanism to induce CA-licensed HCPs to prescribe Company products.

V. Samples

For detailed guidance related to samples, Company Representatives should consult the Professional Field Representative Drug Sample Manual or the Aesthetics Sample Compliance Program Manual (as applicable); the below is a summary for purposes of this CA Policy.

Field-based sales representatives and their immediate managers may provide samples of Medicis prescription drug and medical device products ("Samples") to CA-licensed HCPs in accordance with the Professional Field Representative Drug Sample Manual or the Aesthetics Sample Compliance Program Manual (as applicable). Samples may not be offered for sale, purchase, or trade, or be sold, purchased, or traded under any circumstances. Company Representatives must maintain an accurate inventory of the Samples they receive and distribute. In addition, Samples must be properly stored at all times; any theft or loss of Samples must be immediately reported to Field Compliance.

VI. Charitable Contributions and Sponsorships

For detailed guidance related to charitable contributions and sponsorships, Company Representatives should consult the GPPs; the below is a summary for purposes of this CA Policy.

Contributions. Contributions are a manifestation of Medicis’s commitment to being a socially responsible company and are intended to support worthwhile charitable, educational, or health-related causes in the geographic locations and healthcare communities in which Medicis operates.

Sponsorships. Medicis supports certain educational and scientific activities by providing sponsorships. Generally, a request for funding to assist with an educational conference or meeting or a request for support of a scientific or medical association will be considered to be a sponsorship. Sponsorships may be given to both tax exempt and non-exempt organizations. Sponsorships may be provided to recognized medical associations, societies, institutions, academies, congresses, or other organizations hosting third-party educational conferences or medical professional meetings.

Medicis may provide funding to enhance patient care, the practice of medicine, and the quality of life in the communities with which Medicis is affiliated. As a matter of social responsibility, Medicis provides contributions and sponsorships in support of charitable causes, research and education purposes, and not-for-profit healthcare and other health-related services. Contributions and sponsorships may not be made with the purpose of inducing CA-licensed HCPs to recommend, prescribe, or use Medicis products or be contingent on the performance of services. Accordingly, contributions and sponsorships must never be based on or linked to prescribing, formulary, purchasing, or reimbursement policies. Contributions and sponsorships are provided to eligible organizations in a manner that does not attempt to exercise control over the program. All contributions and sponsorships require the preparation and execution of a written agreement.

VII. Prescriber Data and Patient Data

For detailed guidance related to prescriber data and patient data, Company Representatives should consult the GPPs; the below is a summary for purposes of this CA Policy.

Medicis may use non-identified prescriber data to direct important safety and risk information to prescribers of a particular product, conduct research, track adverse events related to a particular product, or focus marketing activities on the healthcare professionals who would most likely benefit from information about a particular product. Medicis, however, respects and abides by the wishes of CA-licensed HCPs who request that their individually identified prescriber data not be provided to field-based sales representatives. This means that Medicis abides by any voluntary "opt-out" selection made by CA-licensed HCPs. If Company Representatives inadvertently come into contact with patient information during the conduct of their business activities, they should protect and dispose of the information pursuant to the procedures outlined in the GPPs.

VIII. Prevention, Detection, and Correction of Noncompliance

It is the obligation of all Company Representatives to comply with this CA policy and to prevent, detect, and report violations of any applicable laws and regulations, industry codes of practice, or the Medicis CCP, including this CA Policy. Violations or other compliance concerns should be reported to the Compliance Department. Reports may be made by contacting one of the following persons:

Sarah Scopel Devon Brogan Kunde
Chief Compliance Officer Manager, Corporate Compliance
Medicis Pharmaceutical Corp. Medicis Pharmaceutical Corp.
7720 North Dobson Road 7720 North Dobson Road
Scottsdale, AZ 85256 Scottsdale, AZ 85256
(480) 291-5816 (480) 291-5650
sscopel@medicis.com dkunde@medicis.com

Alternatively, reports may be made by utilizing the Company’s confidential reporting hotline:

Medicis Toll-free telephone hotline: (866) 222-1274
E-mail: reportinghotline@medicis.com

It is Medicis policy to investigate any suspected or known instances of non-compliance with the Medicis CCP, including this CA Policy. If an instance of non-compliance is determined to have occurred, Medicis will take corrective action as appropriate under the circumstances, which may include disciplinary action up to and including termination.

1 CA-licensed HCPs include persons licensed by California law to prescribe drugs or medical devices for human patients, medical students, and members of drug formulary committees.

2 Unless otherwise expressly specified in writing, all employment with Medicis is on an at-will basis. At-will employment means that all employment with Medicis is terminable with or without cause, and is terminable without prior notice. Nothing in this CA Policy shall be construed to convey any additional rights to any Medicis employee.