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

CALIFORNIA COMPREHENSIVE COMPLIANCE PROGRAM POLICY

INTRODUCTION

I. Purpose and Scope

Medicis Pharmaceutical Corporation (“Medicis” or the “Company”) conducts a wide range of activities in the pharmaceutical marketplace, including research, medical education, marketing, and selling.  A variety of legal and ethical standards, many of which are unique to the health care industry, apply to these activities.  The Company and its senior executives and managers are committed to conducting its affairs in accordance with these standards.  Compliance with these standards constitutes an important measure of job performance.  Failure to comply may constitute grounds for dismissal.  This California Comprehensive Compliance Program Policy (“CA Policy”) is intended to guide you in performing legitimate prescription drug and medical device marketing and promotional activities with California medical or health care professionals (“CA Professionals”).  The CA Policy applies to all Medicis employees who interact with CA Professionals regarding the Company’s drug and medical device products.

It is the responsibility of all Medicis employees to remain current in their understanding of, and to comply with, all Company policies including this CA Policy.  In discharging this responsibility, employees are encouraged to seek guidance in advance of engaging in any questioned interaction.  The Company’s Regional Managers and Vice Presidents of Sales are available to their respective employees to answer questions about the CA Policy.  Medicis employees should first contact their Regional Manager.  If your questions or concerns are not resolved by the Regional Manager, please contact the appropriate Vice President of Sales.  In the event that questions remain unanswered, Company Legal and Compliance personnel should be consulted.  If necessary, Company Legal and Compliance personnel should be consulted in the first instance. 

The Company has appointed a Chief Compliance Officer, Seth Rodner.  The Chief Compliance Officer is available to the Regional Managers, and to the Vice Presidents of Sales, to help answer your questions.  Questions or concerns may be addressed to the Chief Compliance Officer directly (telephone: 602-296-2655; email: srodner@medicis.com), or by utilizing the Company’s reporting hotline (toll-free telephone: 866-222-1274; email: reportinghotline@medicis.com).  

This CA Policy is only one element of the Medicis Corporate Compliance Program.  In addition to this policy, the Company’s Corporate Compliance Program includes, but is not limited to, the Company’s Good Promotional Practices―Dermatology and Ucyclyd (“Derm GPPs”); Good Promotional Practices―Aesthetics (“Aesthetics GPPs”); Code of Business Conduct and Ethics; Code of Compliance Conduct; Dermatology Customer Interaction Standards; Professional Field Sales Drug Sample Manual; Prescription Drug Marketing Act Annual Training Handbook; Employee Complaint Procedures for Accounting and Auditing Matters; and 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.  With regard to other applicable guidelines under the Company’s Corporate Compliance Program, where there are discrepancies, 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 sales and promotion of the Company’s products.  The failure of any Medicis employee to comply with the Company’s policies, including the GPPs, may result in disciplinary action, including but not limited to termination.   It is the responsibility of managers at all levels to help ensure that the employees under their supervision meet these obligations, and it is the responsibility and affirmative obligation of all employees to take all necessary steps to prevent, detect, and report violations of any applicable laws, regulations, industry codes of practice, or Company policies. 

As a reminder, all activities should also be reviewed for compliance with other areas of the law not covered here, including, for example, FDA requirements for product promotion.  Separate compliance policies apply to employees of Medicis Pharmaceutical Corporation, Medicis Aesthetics employees, and Medicis, The Dermatology Company employees, who interact with medical or health care professionals outside of the state of California because the applicable legal and regulatory standards differ, necessitating separate compliance policies.

II. Overview of Legal and Regulatory Standards

There are a number of specific laws and third-party guidelines that potentially apply to marketing practices.  Violations of these laws can lead to fines, imprisonment, or exclusion from health care programs.  A brief summary of the laws and guidelines follows.  Additional requirements may apply. 

Anti-Kickback Laws.  The federal anti-kickback laws make it illegal to pay or receive remuneration of any kind to induce:  (1) a referral for items and services covered under a federal health care program, or (2) the purchase or recommendation of items or services covered under federal health care programs.  This prohibition is very broad, and can apply to the giving or receiving of anything of value, including not only cash and “kickbacks,” but also free items or services or the opportunity to earn money.   Because the anti-kickback laws are so broad, “safe harbors” were created to recognize certain legitimate promotional and marketing activities.  Safe harbors describe remuneration for specific activities that are safe from government challenge.     States have enacted similar laws that apply to goods or services covered by state health care programs, and some state laws extend to goods or services covered by even private insurance (so-called “all payer states”).  The anti-kickback laws are a potential issue whenever anything of value is provided to CA Professionals or other persons in a position to influence the prescribing or utilization of Medicis products.  This CA Policy sets forth guidelines to ensure that these laws are not violated.

False Claims and Other Billing Standards.  Numerous federal and state laws prohibit the submission of “false” or “fraudulent” claims to government programs or other insurers.  Although Medicis typically does not submit claims to payers, false claims laws have been applied to pharmaceutical manufacturers based on actions that allegedly “caused” a health care professional to submit false or tainted claims, including payment of an alleged “kickback” or improper inducement.  You should be particularly careful about providing any advice relating to reimbursement for our products.

California.  Some states, including California, have enacted special dollar limits on all things of value, including but not limited to gifts or meals, provided to healthcare  professionals, or enacted special government disclosure requirements.    With regard to California, Medicis complies with the following specific limitations effective July 1, 2005:

Each calendar year, the total annual dollar value of gifts, meals, promotional materials, items, or activities permitted to be provided to an individual CA Professional pursuant to this CA Policy may not exceed $3,500 ($6,000 for Medicis Aesthetics Inc. customers due to the value of medical device related programs), subject to the following exclusions:

• Drug Samples;
• Financial Support for Continuing Medical Education Forums;
• Financial Support for Health Educational Scholarships; or
• Fair Market Value Payments made for legitimate Professional Services including, without limitation, consulting services or speaking/training services.

CA Professional means any of the following:

• A person licensed by California state law to prescribe drugs for human patients.
• A medical student attending a medical school located in California.
• A member of a drug formulary committee residing or employed in California.

For purposes of determining the total value of items and activities provided to a CA Professional, the total value is assessed from the perspective of the CA Professional and is a cumulative total throughout the calendar year, regardless of whether the gifts, meals, promotional materials, items, or activities are provided by one or multiple Medicis employees.

Industry Codes of Practice.  The following industry organizations have issued guidelines that are followed by Medicis.

• PhRMA Code and OIG Guidance.  Effective July 1, 2002, the Executive Committee of the Pharmaceutical Research and Manufacturers of America adopted a new Code on Interactions with Healthcare Professionals (the “PhRMA Code”).  The Code states that any interaction between the industry and health care professionals should focus on providing scientific and educational information and supporting scientific and medical research to maximize patient benefits.  The Code provides guidance in areas including: entertainment, speaker training programs, grants, continuing education, consultants, and educational and health care practice related items.  The Department of Health and Human Services Office of Inspector General (OIG), in its guidance for pharmaceutical manufacturers, recommends the PhRMA Code as “… a good starting point …” for a compliance program policy.  The OIG Guidance, finalized on April 28, 2003, contains advice to pharmaceutical companies about to how to comply with the federal anti-kickback laws.  Accordingly, Medicis follows the guidelines in the PhRMA Code and the OIG Guidance.
• AdvaMed Code.  On September 3, 2003, the Advanced Medical Technology Association (“AdvaMed”) issued a Code of Ethics on Interactions with Health Care Professionals (the “AdvaMed Code”).  The AdvaMed Code is effective January 1, 2004.  AdvaMed is dedicated to the advancement of medical science, the improvement of patient care, and in particular the contribution that high quality, cost-effective health care technology can make toward achieving those goals.  The AdvaMed Code encourages ethical business practices and socially responsible industry conduct related to interactions with health care professionals.  The AdvaMed Code provides guidance in areas including entertainment, speaker training programs, grants, continuing education, training, consultants, and educational and health care practice-related items to help ensure compliance with applicable laws and regulations.
• AMA Guidelines on Gifts to Physicians from Industry.  In December 1990, the American Medical Association adopted its Guidelines on Gifts to Physicians from Industry (“AMA Guidelines”), which later were adopted, for the most part, by drug and medical equipment manufacturers and trade associations.  For purposes of the AMA Guidelines, “gifts” include virtually all items or services of value provided to physicians. 
• ACCME Standards.  The Accreditation Council for Continuing Medical Education has issued Standards for Commercial Support of Continuing Medical Education (the “ACCME Standards”).  Under the ACCME Standards, the CME program sponsor must retain responsibility for the content, quality, and scientific integrity of an accredited educational program and for all materials provided in connection with the program.  Manufacturer support for the program must be disclosed.  These standards generally track the rules for CME sponsor independence in FDA’s Guidance on Industry-Supported Scientific and Educational Activities.

III. General Rules for Analysis of Promotional Arrangements

Because there are a wide variety of promotional and marketing arrangements, some of which may not be specifically addressed by these policies, the following factors should be considered by all Medicis employees when evaluating particular programs or activities involving CA Professionals:

• Nature of Activity.  Only legitimate marketing and promotional activities (e.g., educational programs) are permitted. 
• Type of CA Professionals.  The more that the CA Professional has the ability to influence the use of Medicis products (i.e. a high-prescriber), the closer review the relationship should receive.
• Amount of Funding.  The greater the value provided to a CA Professional, the greater the degree of care that must be taken when considering the arrangement.
• Fair Market Value.  Whenever an arrangement involves the payment for items or services, the amount of payment must be consistent with the fair market value of the items or services provided.
• Direct and Indirect Compensation.  These policies apply to compensation that is provided directly to a CA Professional by Medicis as well as to compensation provided indirectly or through a third party.
• No “Magic Words.”  All remuneration to CA Professionals must comply with these policies, regardless of the form or description of the payment.  Simply calling a payment a “grant,” “consulting arrangement,” or any other term does not justify an otherwise inappropriate arrangement.
• Documentation and Recordkeeping.  Medicis representatives must maintain documentation of compensation provided to CA Professionals that accurately reflects the reality of the transaction and records the legitimate services provided to Medicis.
• No Exception for “Pilot” Programs.  The fact that an inappropriate arrangement is isolated or limited in scope is not a sufficient justification for the relationship.

In adopting this CA Policy, Medicis recognizes that not all companies with which we compete will necessarily adhere to the same standards.  If you become aware of practices of competitors that conflict with our standards and potentially place Medicis at a significant competitive disadvantage, please review these situations with the applicable Vice President of Sales.  They will bring meritorious complaints to the Compliance Department.  Competitors’ practices, however, do not justify a deviation by Medicis from the Company’s stated policies.

SPECIFIC POLICIES

IV. Contacts with Health Care Professionals

A.  Meals, Entertainment, and Recreational Activities

This CA Policy complies with and is in accordance with industry codes of practice.  Accordingly, appropriate business courtesies associated with informational or educational presentations may be offered to health care practitioners (e.g., a modest meal).  When Medicis sponsors informational presentations, occasional modest meals may be offered, so long as those meals occur in a place and manner conducive to informational communication that provides scientific or educational value.  Geographic location is a factor in determining the modesty of the meal.  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 health care professional’s spouse or other guests may not be invited, even if not paid for by Medicis, unless they would independently qualify as a health care professional for whom the informational presentation is appropriate.

Providing only entertainment or recreational activities, such as golf outings, or tickets to sporting events or concerts, is generally not appropriate.  Exceptions such as entertainment or recreational activities that are incidental to a meeting in which a healthcare provider is providing a legitimate service to the Company (e.g., consultant or advisory board meeting), are of modest value, and are offered only occasionally, may be appropriate under certain circumstances.  Such incidental courtesies must be pre-cleared with the Compliance Department.

Providing modest food items, such as bagels or pizza, for the staff of a medical office is permitted so long as a Medicis representative is, at the same time, also providing or discussing scientific or medical information  (e.g., Lunch & Learn).  “Dine and Dash” programs where food is dropped off and there is no presentation or exchange of medical/scientific information are never appropriate.

With regard to other applicable guidelines under the Company’s Corporate Compliance Program, where there are discrepancies, the more detailed policies (i.e. the GPPs) govern, and employees are responsible for complying entirely with the GPPs.  Medicis employees should consult GPPs 9, “Occasional Meals in Connection with Information Presentations,” and 10, “General Prohibition Against Entertainment and Recreational Activities,” for more specific guidance.

B. Practice-Related or Patient Care-Related Items

This CA Policy complies with and is in accordance with industry codes of practice.  Accordingly, gifts to CA Professionals are permitted only if the item primarily entails a patient benefit and is of moderate value or is a practice related item of minimal value.  These principles apply to items distributed in connection with speaker programs and consultant meetings, as well as in connection with sales calls.

No Quid Pro Quo and No Cash.  Gifts are not permitted if they are conditioned on the CA Professional’s using, prescribing, or recommending Medicis products.  Payments in cash or cash equivalents (e.g., gift certificates) may never be offered, except as compensation for bona fide consulting services (discussed elsewhere) that have been memorialized in writing.

Value and Nature of Items.  Items that primarily benefit patients may be offered to CA Professionals if the items are modest in value and are offered only on an occasional basis.  A “modest value” means items that generally have a fair market value of $100 or less.  Items that are designed to further the professional’s practice of medicine may be offered on an occasional basis, provided that they are of minimal value (i.e. $20 or less). Items that may be appropriate include “reminder items,” such as pens and notepads with the Medicis logo, and other similar products.  Items intended for the personal benefit of a CA Professional, such as artwork, may not be offered, even if they are of minimal value (e.g., golf balls).  It is permitted to provide product samples for patients’ use in accordance with the requirements of the Prescription Drug Marketing Act (PDMA).

With regard to other applicable guidelines under the Company’s Corporate Compliance Program, where there are discrepancies, the more detailed policies (i.e. the GPPs) govern, and employees are responsible for full compliance with the GPPs.  Medicis employees should consult GPP 8, “Practice-Related or Patient Care-Related Items Provided to Customers,” for more specific guidance.

C. Promotional Giveaways

Under no circumstances may Medicis employees or representatives offer gifts, trips, prizes, or the like, as part of a sweepstakes or similar promotion to any CA Professional as an inducement for them to purchase Medicis products or services, or for purchasing specified volumes of Medicis products or services.  Any sweepstakes or similar programs must be reviewed and approved in advance by the Compliance Department.

D. Examples in Questions and Answers

Q:        What is acceptable to give to CA Professionals?
A:         Examples of what you may give physicians and other health care professionals on an occasional basis include:

• Practice-related promotional items, such as pens and notepads, where such items are of minimal value.
• Medical educational materials (e.g., medical textbooks, including those on CD/ROM; medical journal subscriptions; or stethoscopes).
• Product samples in accordance with the PDMA, the PhRMA Code, and OIG Guidance.
• Occasional, modest food items in conjunction with scientific or educational presentations or discussions.

Q:        What is not acceptable?
A:         Cash gifts are never allowed, nor are items that do not primarily entail a benefit to patients, or that are not practice related, even if the item is of nominal value.

Q:        Can Medicis representatives provide a CA Professional with a free stethoscope or medical text?
A:         Yes.  Educational materials or medical equipment primarily used for patient treatment or benefit may be provided to a CA Professional on an occasional basis if they are of modest value. More expensive items, such as medical textbooks or stethoscopes, should be made only on an infrequent or occasional basis to the same CA Professional.

Q:       Can Medicis take a CA Professional to dinner as part of a sales call?
A:         Yes, but only in cases in which a Medicis employee or a speaker is providing substantial scientific or educational information which may include a discussion regarding Medicis’ products.  In such cases, the meal must be modest in value and the nature and location of the meal must be conducive to the exchange of information.

Q:        Can Medicis provide $250 to fund a CA Professional’s office Christmas party?
A:         No.  Items may not be provided to CA Professionals unless they primarily entail a patient benefit, or are practice related, and are of modest or minimal value, respectively. Items under $100 in fair market value generally are considered modest.  Cash gifts are never allowed unless the payment constitutes compensation for a bona fide consulting service that has been memorialized beforehand in writing.  A cash gift for a Christmas party would not meet these criteria.

Q:       What are the guidelines on distributing Medicis’ product-specific materials?
A:         Medicis produces its own product-specific educational and marketing materials.  Materials that are promotional in nature (make efficacy or safety claims) must go through Medicis’s Final Approved Copy (FAC) approval process.  Medicis, or its promotional representatives, may distribute only those materials approved for use in California directly to CA Professionals.  Similarly, Medicis may provide these approved materials to CA Professionals for distribution to patients.  These activities may be different from Medicis’s normal marketing and promotional activities in order to conform to specific California statutes and regulations.

Q:        What constitutes a “modest meal”?
A:         A modest meal would be an average meal in a restaurant of average cost as measured by local community standards.  Examples of meals that would not be considered modest: a $50 ¼ ounce of Russian caviar or a $50 glass of French wine would not constitute an average meal. 

 

V.  Medicis Employees and Product Promotion

FDA and other rules that govern the content and presentation of product promotion are covered in the FAC process.  The FAC process is Medicis’s internal review process pursuant to which all draft marketing materials are reviewed for compliance with applicable FDA regulatory requirements.  Nevertheless, because the activities covered by FDA rules and other rules on product promotion can raise fraud and abuse issues, these rules are reviewed briefly here.

Under FDA’s rules for advertising and promotion, statements to health care providers must be within the approved prescribing information and limited to approved claims.  Medicis’ personnel may not minimize the risks associated with company products. Medicis employees must make sure that the sum total of any presentation to a health care professional on a given product is fairly balanced and includes disclosure of the product’s risks as well as the benefits associated with its use.  Therefore, Medicis employees must have available a copy of the current full prescribing information (“PI”) for each product discussed with a health care professional.

All promotional materials (including sales aids, flashcards, reprints and patient education pieces) must have prior approval from Medicis.  Medicis employees are responsible for ensuring that they always use the most current approved promotional materials and related full prescribing information.  Approved materials that Medicis employees provide to CA Professionals may not be underlined, highlighted, annotated, or otherwise marked up by any Medicis employee or representative.

Comparisons of safety, effectiveness, and/or tolerability between products, and related superiority claims, may generally be made only if supported by head-to-head clinical trials.  Such comparisons may not generally be made on the basis of comparing prescribing information to prescribing information, or on the basis of results from two separate trials not performed at the same time under the same protocol.  Medicis employees may not make comparative or superiority claims regarding competitive products unless they are specifically instructed to do so by the applicable Product Manager and/or Sales Training session.  Medicis employees may not promote a new product, or a new indication for an existing product, to CA Professionals unless, and until, they receive official notice from the applicable Vice President of Sales.

With regard to other applicable guidelines under the Company’s Corporate Compliance Program, where there are discrepancies, the more detailed policies (i.e. the GPPs) govern, and employees are responsible for full compliance with the GPPs.  Medicis employees should consult the applicable GPPs for more specific guidance.

VI. Consulting and Advisory Services

A. General Considerations

Medicis only enters into bona fide consulting and service agreements with a  limited number of CA Professionals.  It is appropriate for consultants who provide bona fide services to be offered reasonable compensation for such services.  They may also 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 contract specifies the nature of the services and the basis of payment for those service, (3) the services are provided, (4) compensation paid to the consultant is consistent with the fair market value of the services provided, and (5) Medicis documents everything specified in (1) through (4) above.  The written agreement must be approved by Compliance and executed prior to the provision of services and any payment for the services.  Time spent merely listening to detailing presentations or viewing or listening to marketing information on web sites or through other media is not a bona fide consulting service for which consulting fees may be paid.  In addition, payment  cannot be made to consultants to provide access to health care 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 Professionals for prescribing Medicis products.  The amount to be paid to a consultant must not be determined in a manner that takes account of the past, present, or future volume or value of business generated by the consultant for Medicis (e.g., prescriptions written by a CA Professional).  The documentation associated with a Consulting Agreement should memorialize the fact that there is no connection between the compensation provided and the prescribing of Medicis’ products.  Compensation should be paid with a company check.  Cash or personal checks should not be used.  Before submitting requests for a Consulting Agreement to the Compliance Department, approval from the appropriate Sales or Marketing supervisor must be obtained.  Once approval has been received, Consulting Agreements may be obtained from the Compliance Department.

With regard to other applicable guidelines under the Company’s Corporate Compliance Program, where there are discrepancies, the more detailed policies (i.e. the GPPs) govern, and employees are responsible for complying entirely with the GPPs.  Medicis employees should consult GPP 20, “Healthcare Professional Consultant/Advisory Board Meetings,” for more specific guidance.

B. Preceptorships

Medicis may enter into preceptorship arrangements with a CA Professional on a limited basis.  Under these programs, a CA Professional is compensated by Medicis to act as a preceptor for Medicis sales personnel and to allow the employee to spend up to a day observing how the CA Professional conducts his or her practice.  All of the policies applicable to other Healthcare Provider Agreements apply to Preceptorship Agreements (e.g., need for a written agreement, fees based on fair market value of a CA Professional’s time, etc.).  Once approval for a paid preceptorship has been received from the Director of Sales Training, written Preceptorship Agreements may be obtained from the Compliance Department.  Preceptorship Agreements may only be entered into infrequently.  The amount of preceptorships per year for any individual CA Professional or Medicis representative shall be determined by sales training officials and shall be based on the bona fide need for training purposes in accordance with GPP 30, “Sales Representative Training/Preceptorships.”  Sales Training tracks preceptorships to ensure compliance.

Patient Privacy.   The CA Professional must agree to explain his or her participation in the preceptorship program to patients, and to obtain their written authorization prior to allowing any Medicis representative to observe interactions with patients in which any patient identifiable information may be disclosed to any Medicis representative.

With regard to other applicable guidelines under the Company’s Corporate Compliance Program, where there are discrepancies, the more detailed policies (i.e. the GPPs) govern, and employees are responsible for full compliance with the GPPs.  Medicis employees should consult GPP 30, “Sales Representative Training/Preceptorships,” for more specific guidance.

C. Consulting and Advisory Services Agreement Checklist

The following checklist is provided for informational purposes and will be helpful prior to entering into a consulting arrangement.

If the answer to any of these questions is “no,” the arrangement must be restructured.

            With regard to other applicable guidelines under the Company’s Corporate Compliance Program, where there are discrepancies, the more detailed policies (i.e. the GPPs) govern, and employees are responsible for full compliance with the GPPs.  Medicis employees should consult GPP 20, “Healthcare Professional Consultant/Advisory Board Meetings,” for more specific guidance.

 

D. Speaker Events

Medicis may engage individuals to act as speakers with respect to the company’s products.  Promotional speaker programs are those in which Medicis has control or influence with respect to the content of the program, and the speaker is essentially acting as a promotional agent for Medicis.  Statements made by promotional speakers are generally attributable to Medicis and, therefore, must comply with FDA rules for product promotion, including, but not limited to, strictly conforming to the prescribing information.  By contrast, an independent speaker program is one in which Medicis does not have control or influence with respect to the content of the program or the selection of the speaker and is usually handled by an Educational Grant Agreement (discussed below).

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 of services, etc.).  If a meeting is held to train speakers, the rules outlined above for consultant meetings must be followed.  The opportunity to be a speaker or compensation for speaker services, must never be offered to a provider with “strings attached.”  Among other things, speakers may not be selected in consideration of, or as a reward for, prescribing, using, or recommending Medicis products. 

All paid Speaker Agreements must receive approval in advance by the appropriate supervisor in Sales or Marketing management.  Once approval is received, a Speaker Agreement may be obtained from the Compliance Department to memorialize the arrangement.

With regard to other applicable guidelines under the Company’s Corporate Compliance Program, where there are discrepancies, the more detailed policies (i.e. the GPPs) govern, and employees are responsible for full compliance with the GPPs.  Medicis employees should consult GPP 18, “Speaker Programs:  FDA-Regulated Promotional Programs,” for more specific guidance.

E. Consultant/Advisory Board Meetings

The following provisions apply to meetings of CA Professionals performing consulting or advisory board services:

            Purpose and Conduct of Meeting.  Consultant or advisory board meetings must be designed to obtain genuine feedback from the health care professional.  Promotion of any Medicis product, even within the scope of the approved labeling, is prohibited as part of a consultant/advisory board meeting.  There are limited acceptable purposes for conducting meetings, such as to obtain information on how a drug should be most effectively marketed for a particular approved indication, or to obtain information on potential areas of clinical research for a particular drug.  The meeting should be only as long as reasonably necessary to perform the service and to accommodate reasonable travel arrangements.  Incidental recreational activities are permissible, provided that such activities are clearly subordinate to the purpose of the meeting and modest in value (i.e. not in excess of $100 per healthcare professional).  The number of health care professionals retained for consulting or advisory board services, and the number of meetings held, should be limited to and based on the Company’s legitimate business needs. 

Medicis employees and representatives may attend such meetings only if appropriate in light of the activities scheduled to take place and the topics presented. For example, consulting, advisory, and feedback type meetings that are limited strictly to medical issues shall be conducted and coordinated by Medical Affairs in accordance with Medical Affairs Standard Operating Procedures for such activities; Marketing shall not be involved in such medical meetings and shall not be present at such meetings unless approved in advance by Compliance.

On the other hand, it is not uncommon for consulting, advisory, and feedback type meetings to include discussions of both medical and marketing issues.  In many instances, these issues will be intertwined.  For example, Marketing may be interested in learning about how physicians view the Company’s medical data for a product in order to assist in the development of promotional materials; this will necessarily involve probing the physicians’ understanding of the data and may require the involvement of Medical Affairs to assist in this interaction.  In contrast, there may be certain discussions at such meetings that are focused strictly on medical issues that do not have overlapping marketing issues.  For example, Medical Affairs may be interested in obtaining feedback regarding the design of a clinical trial.  It is not appropriate for Marketing to be involved in discussions related to clinical trial design and Marketing should not be present in the meeting room when such discussions take place. 

Questions regarding the issue of Medical and Marketing separation should be addressed to the  Compliance Department in advance of the meeting.

Venue, Travel, Entertainment, and Meals.  It is appropriate to reimburse consultants/advisory board members for necessary and reasonable business expenses actually incurred, such as  travel, and modest meals and accommodations.  A facility suitable for the purpose of the meeting should be selected.  Any ancillary activities should be incidental and designed to facilitate further discussion among participants and company representatives.  All expense reimbursements must be in substantial accordance with Medicis’ policy on corporate travel and reimbursement.  Specific guidance as to reasonable travel reimbursement and meals may be obtained from the Travel Department.

Medicis does not cover travel expenses for spouses or other guests of consultants/advisory board members.  A spouse or guest may share lodging, however, with the CA Professional if there is no additional charge or if any additional expense is paid by him or her.  Medicis may cover travel expenses for a spouse or guest who is also a physician, other health care provider or member of the CA Professional’s staff, so long as the participation by the spouse or guest provides an actual benefit to Medicis under an independent Physician Agreement. 

Additional Considerations.  A written agenda should be prepared and disseminated to invitees in advance of the meeting. Periods devoted to feedback from the consultants/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.  A written summary of the recommendations/feedback, a copy of the agenda, a list of attendees, and minutes of the meeting must be sent to the Compliance Department  after the meeting. Healthcare Provider Agreements may be obtained from the Compliance Department.

With regard to other applicable guidelines under the Company’s Corporate Compliance Program, where there are discrepancies, the more detailed policies (i.e. the GPPs) govern, and employees are responsible for full compliance with the GPPs.  Medicis employees should consult GPP 20, “Healthcare Professional Consultant/Advisory Board Meetings,” for more specific guidance.

F. Educational and Research Grants

            Medicis may provide grants to support bona fide educational activities  CA Professionals, including medical students, residents, fellows, and others in training as well as to support independent research initiatives of legitimate interest to the company.  Educational and research grants may include grants to independent continuing medical education (“CME”) providers, fellowships, grants to support similar programs or the dissemination of educational materials to practitioners or patients (e.g., as part of disease management programs), and support for CA Professional-initiated clinical research of interest and value to Medicis.  Grants may only be made to support specific educational activities, and may not be made for non-educational purposes.  Medicis may not use educational grants as a mechanism to induce CA Professionals to prescribe company products.  Educational grants are usually made to independent third-party organizations without restrictions or conditions with respect to content or faculty.  Such grants should not generally be provided to CA Professionals. 

Third party requests for educational grants must in the first instance be directed to Medical Affairs.  Once approval has been received from Medical Affairs, an Educational
Grant Agreement may be obtained from the Compliance Department.

VII. Drug Samples

Medicis employees engage in routine sampling of products to licensed CA Professionals; all such activities related to drug sampling must be performed in accordance with Medicis’s Professional Field Sales Drug Sample Manual.  The purpose of sampling programs is to familiarize CA Professionals and patients with the use of Medicis products.  Sampling programs must be limited to amounts reasonably necessary to achieve these purposes and must comply with the requirements of the PDMA, OIG Guidance and the PhRMA Code.  Among other things, the PDMA requires that physicians must request samples, in advance, in a writing, that includes: the physician’s name, address, professional designation, and signature; the identity and quantity of products for which samples are requested; the name of the manufacturer; and the date of the request.  Representatives must also obtain a written receipt for any samples delivered.  Signatures by office staff or Medicis employees on behalf of a physician are not acceptable substitutes for a physician’s signature.  The rules for providing samples to nurse practitioners or physician’s assistants vary state by state. 

Drug samples cannot be offered for sale, purchase, or trade, or sold, purchased, or traded under any circumstances.  Medicis employees may only receive samples from a source directly authorized by Medicis.  Medicis representatives must keep an accurate inventory of the samples that they receive and distribute.  Samples must be properly stored at all times, and any theft or  loss of samples must be immediately reported.  Falsification of any record relating to samples will result in termination of employment.  Additional training regarding sampling and the PDMA is provided for each Medicis employee, as applicable.

VIII. Charitable Contributions and Patient Assistance Programs

Medicis routinely provides contributions to charitable organizations and, in rare instances, to individuals engaged in genuine charitable missions for the support of that mission. Charitable contributions may not be made with the purpose of inducing CA Professional (s) to recommend, prescribe, or use Medicis products or be contingent on the performance of services. In addition to monetary charitable contributions, Medicis may donate certain products directly to indigent patients through patient assistance programs.  Where a patient assistance program makes Medicis products available for use by indigent patients (either directly or through their CA Professional), the recipient and beneficiary of the free products should commit in writing not to submit claims to third-party insurance programs for the products.  Patient assistance programs should not operate as a mechanism to subsidize the operations or bad debts of customers.

Requests for charitable contributions must be reviewed and approved by the Compliance Department based on established criteria. 

With regard to other applicable guidelines under the Company’s Corporate Compliance Program, where there are discrepancies, the more detailed policies (i.e. the GPPs) govern, and employees are responsible for full compliance with the GPPs.  Medicis employees should consult GPP 19, “Contributions, Sponsorships, and Educational Grants,” for more specific guidance.

IX. Clinical Studies

Permissible Activities.  If, on an unsolicited basis, a CA Professional asks a question regarding participation in a Medicis-sponsored trial, or regarding Medicis support for an investigator-initiated trial, Sales or Marketing personnel may forward the question to R&D or Medical Affairs for a response.  Clinical Trial Agreements related to clinical research are the responsibility of the Research & Development Department.

Prohibited Activities.   Sales or Marketing personnel may not ask investigators for access to case report forms or for other information regarding a trial, or be provided such access or information by investigators.

X. Compensation

It is Medicis policy to ensure that compensation (including bonuses and salaries) and other financial incentives do not inappropriately motivate Medicis employees to engage in the improper promotion, sales, and marketing of Medicis’s products.  Therefore, Medicis’s compensation plan and incentive structure do not require or reward Medicis employees for promoting products outside of their approved, “on-label” uses.  Compliance with laws, regulations, and the Medicis Corporate Compliance Program, including with respect to the prohibition on off-label promotion, is considered in evaluating performance and setting compensation.  Any instance of off-label promotion subjects an employee to discipline up to and including termination.

XI. Screening for Excluded Persons

Medicis screens officers, directors, employees, contractors, and agents (“Screened Persons”) to identify and address relationships with any individuals or entities who are on the FDA, OIG, or General Services Administration Exclusion Lists (“Exclusion Lists”).  Medicis screens all Screened Persons against the Exclusion Lists prior to engaging their services and on an annual basis.  By policy, and as part of the hiring or contracting process, Medicis requires Screened Persons to disclose whether they have been excluded, debarred, suspended, or otherwise rendered ineligible (including criminal conviction under 42 U.S.C. § 1320a-7(a)) for participation in Federal health care programs or in Federal procurement or nonprocurement programs.  Furthermore, by policy, all Screened Persons are obligated on an ongoing basis to disclose immediately to Medicis any debarment, exclusion, suspension, or other event that makes that individual ineligible for participation in Federal health care programs or in Federal procurement or nonprocurement programs.  If any Screened Person becomes ineligible for participation in Federal health care programs or in Federal procurement or nonprocurement programs, Medicis shall remove the individual from responsibility for, or involvement with, Medicis’ business operations related to Federal health care programs and shall remove the individual from any position for which the individual’s compensation or the items or services furnished, ordered, or prescribed by the individual are paid in whole or in part, directly or indirectly, by Federal health care programs or otherwise with Federal funds at least until such time as the individual is reinstated for participation in Federal health care programs.  If a Screened Person is criminally charged with an offense that may render the individual ineligible for participation in Federal health care programs, Medicis shall take all appropriate actions to ensure that the responsibilities of that individual have not and shall not adversely affect the quality of care rendered to any beneficiary, patient, or resident, or the accuracy of any claims submitted to any Federal health care program.

Note:  This CA Policy is subject to revision at any time in the sole discretion of Medicis Pharmaceutical Corporation without notice.

Annual California Written Declaration of Compliance

On or before July 1, 2006, Medicis Pharmaceutical Corporation shall make the annual written declaration of compliance as required by Chapter 8 (commencing with Section 119400) to Part 15 of Division 104 of the California Health and Safety Code, in all material respects and to the extent applicable.  Medicis is not responsible for any unauthorized act, or failure to act, on its behalf.

Toll-Free Telephone Number

A copy or copies of the Medicis CA Comprehensive Compliance Program Policy and the written declaration of compliance may be obtained by calling 1-800-550-5115.