U.S. Commercial Compliance Policy

Effective January 9, 2009

1. GENERAL

A. PURPOSE:

To assist Aptalis and its affiliates, ("the Company") employees, agents and contractors ("Company Personnel") in complying with government and industry guidance when dealing with Healthcare Professionals in the United States. For purposes of this Commercial Compliance Policy, the term “Healthcare Professional” shall mean persons in a position to prescribe, order, purchase, or influence the prescribing, ordering, or purchasing of Company products including, but not limited to, physicians, physician assistants, nurses, purchasing agents, formulary managers and pharmacists.

B. POLICY:

Interactions shall be focused on informing Healthcare Professionals about products, providing scientific and educational information, and supporting medical education. No grants, scholarships, subsidies, support, consulting contracts, or educational or practice related items may be offered to a Healthcare Professional in exchange for prescribing, ordering, or purchasing Company products, or for a commitment to prescribe, order, or purchase Company products. Company Personnel may not offer or provide anything in a manner or on conditions that would interfere with the independence of a Healthcare Professional's prescribing, ordering, or purchasing practices.

2. GIFTS AND BUSINESS COURTESIES

A. POLICY:

Company Personnel may, on occasion, offer items to Healthcare Professionals that meet all of the following criteria:

have a value of $100 or less (or as otherwise restricted by state law);
are designed primarily for the education of patients or Healthcare Professionals (unless otherwise approved in writing by the Legal Department); and
do not offer value to the Healthcare Professional outside of his or her professional responsibilities; and
are approved in advance in writing by the Legal Department.

Note: In addition to the criteria above, Company Personnel shall comply with all State laws.

B. GENERAL GUIDELINES:

Permitted Items.
1. Except as where otherwise prohibited by State law and if approved in advance by the Company, Company Personnel may, on occasion, offer items of value and business courtesies valued at less than $100, that satisfy the following criteria:
  1. the item is intended to help educate Healthcare Professionals such as a medical text book or copies of relevant clinical treatment guidelines; or
  2. the item is intended for patient education such as anatomical models or informational sheets and brochures; or
  3. the item is an educational item designed for use by patients to assist in the administration of their treatment or management of their conditions (e.g., starter kits) that are considered essential to proper treatment compliance.
2. Company Personnel may offer Product samples for patient use in accordance with the Prescription Drug Marketing Act.
Prohibited Items.
1. Company Personnel may not offer to any Healthcare Professional or their staff:
  1. gifts or payments in cash or cash equivalents of any kind (including, but not limited to, gift certificates), whether offered directly or indirectly, whether purchased with Company funds or with the Company Personnel's personal funds (except as compensation for services that meet the requirements under these Policies); and
  2. items intended for the personal benefit of Healthcare Professionals or their staff including, but not limited to, such items as music CDs, gift baskets, floral arrangements, artwork, or tickets to a sporting event; and
  3. items that do not advance disease or treatment education (such as pens, note pads, mugs and similar "reminder" items with Company or product logos); and
  4. funds to subsidize personal expenses for Healthcare Professional, their families or their staff (such as personal travel costs or entertainment).
Frequency. Gifts and business courtesies may not be offered any more often than occasionally, even if each individual item might otherwise appear to satisfy this Policy.

3. ENTERTAINMENT AND RECREATION

A. PURPOSE:

Entertainment and recreational items may not be provided to any Healthcare Professional or their staff. Prohibited items include, but are not limited to, lavish meals, tickets to the theater or sporting events, leisure or vacation trips, or seats at charity dinners or sporting events.

Note: An exception to this provision is provided for Healthcare Providers who are salaried employees of the Company.

4. INFORMATIONAL PRESENTATIONS

A. POLICY:

Company field sales representatives and their immediate managers may provide a modest meal incidental to an informational discussion that occurs in the Healthcare Professional’s office during the Healthcare Professional's working day. Other Company Personnel, other than field sales representatives and their immediate managers, may provide occasional meals incidental to an informational discussion that occurs outside the Healthcare Professional’s office and working day.

B. GENERAL GUIDELINES:

Nature of Presentations. Presentations shall provide scientific or educational information.
Meals. Occasionally, a modest meal may be provided to a Healthcare Provider and their staff by a field sales representative or their immediate manager, if the meal is provided in conjunction with an informational presentation and discussion that occurs in the Healthcare Professional's office, hospital, or other healthcare facility. Meals shall be modest as judged by local standards, and provided in a manner and location conducive to informational communication. Meals shall not be provided as part of an entertainment or recreational event. Meals to be eaten without a Company representative being present (e.g., meals dropped off at the Healthcare Professional’s office) may not be provided. Meals may not be provided to a Healthcare Professional's spouse or other guest, regardless of whether the Healthcare Professional pays for the spouse or guest, unless the spouse or guest would independently qualify as a Healthcare Professional for whom the informational presentation is appropriate.

5. GRANT FUNDING FOR CONTINUING MEDICAL EDUCATION ("CME")

A. POLICY:

Restricted grant funding to support bona fide CME events may be provided, however all CME grant funding decisions must:

be made by the Company’s Grant Committee, and
promote the safe and effective practice of medicine; and
be independent of outside influences; and
never take into consideration the amount of product that is purchased or will be purchased by the recipient of the grant or other funding; and
be made in accordance with the standards for commercial established by the Accreditation Council for Continuing Education, or other similar body that accredits CME.

B. GENERAL GUIDELINES:

Grant-making Authority. The Company’s Grants Committee shall select the CME events that will be funded by the Company. The Sales and Marketing Departments may not select or influence the selection of CME events to be funded by the Company.
Grant-making Criteria. CME grant decisions shall be based on objective criteria developed to ensure that the program funded by the Company is a bona fide educational program and that the financial support is not an inducement to prescribe, order, or recommend a particular Company medicine or course of treatment. Funding for CME may not be conditioned on the use or purchase of Company products.
To Whom Support May be Provided. Any financial support for CME shall be provided directly to the CME provider. The CME provider may use financial support received from the Company to reduce the overall CME registration fee for all, and not just selected, participants.
Meals. The Company may not provide meals at CME events. However, the CME provider may, at its own discretion, apply the financial support for CME paid by the Company to the CME provider to provide meals for all, and not just selected, participants.
Content, Faculty, Materials, Venue. The organizer of the CME, and not the Company, shall control the selection of content, faculty, educational methods, materials, and venue for any CME for which the Company provides financial support. The Company may not provide the CME provider with advice or guidance regarding the content or faculty for CME funded by the Company even if the provider requests the Company's input.
Compensation. The Company may not offer Healthcare Professionals compensation for time spent in participating at a CME event.
Travel, Lodging, and Personal Expenses. Except in the limited situation of support for medical students, residents, fellows, and other Healthcare Professionals in training attending certain selected educational conferences, the Company may not offer financial support for the cost of travel, lodging, or any personal expenses of Healthcare Professionals (who are not employees of the Company) attending CME events, whether directly to the individuals participating in the event or indirectly to the event sponsors.
Grant Agreements. All grant agreements related to the CME must be executed in advance of the CME.

6. THIRD-PARTY EDUCATIONAL OR PROFESSIONAL MEETINGS

A. POLICY:

Generally, the Company may provide grants for third-party educational or professional meetings to the meeting sponsors.

B. GENERAL GUIDELINES:

Conference or meeting. A conference or meeting is any activity, held at an appropriate location, where the gathering is primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse, and the main incentive for bringing attendees together is to further their knowledge on the topics being presented.
To Whom Support May be Provided. Any financial support shall be given directly to the conference's sponsor. The conference sponsor may use the funds received to reduce the overall conference registration fee for all, and not just selected, attendees.
Content, Faculty, Materials, Venue. Except at the Company's own medical conferences or meetings, the organizer of the conference or meeting, and not the Company, shall control the selection of content, faculty, education methods, materials, and venue in accordance with the organizer's guidelines.
Compensation. The Company may not offer Healthcare Professionals compensation (unless they are a Company employee) for time spent in attending a conference or meeting.
Travel, Lodging, and Personal Expenses. Except in the very limited situation of support for medical students, residents, fellows, and other Healthcare Professionals in training attending certain selected educational conferences (Subsection vi below), the Company may not offer financial support for the cost of travel, lodging, or any personal expenses of Healthcare Professionals (who are not Company employees) attending a conference, whether directly to the individuals participating in the event or indirectly to the event sponsors.
Healthcare Professionals in Training. Financial assistance for scholarships or other educational funds to permit medical students, residents, fellows, and other Healthcare Professionals in training to attend a conference may be offered if the selection of individuals who will receive the funds is made by the academic or training institution, and the event is a major educational, scientific, or policy-making meeting of a national, regional, or specialty medical association.

7. GRANT FUNDING FOR CLINICAL TRIALS AND RESEARCH

A. POLICY:

Generally, the Company may sponsor clinical trials and offer research grants to support bona fide research efforts that benefit the development of Company's products. A grant decision to offer such assistance shall:

be made by the Company’s Grant Committee; and
promote the practice of medicine; and
be independent of outside influences; and
never take into consideration the amount of product that is purchased or will be purchased by the recipient of the grant or other funding.

The Company may not offer clinical trials or research grants that condition payment for the research on outcome or referrals, or are conditioned upon the use or purchase of the Company's products.

B. GENERAL GUIDELINES::

Grant-making Authority. The Company’s Grant Committee shall select the clinical trials and research that will be funded by the Company. The Sales and Marketing Departments may not select or influence the selection of clinical trials and research to be funded by the Company.
Permitted Grants. The Company may sponsor clinical trials and offer research grants:
1. to support research efforts selected by the Company because the efforts will serve a legitimate need of the Company or the medical community, are not repetitive or needlessly duplicative of other research, and are subsidized in an amount that represents the fair market value of the research effort to the Company;
2. that are not intended or designed to result in increased utilization of Company products or services or increased billings for the Company's products to federal or state governments;
3. that select and support grantees based on an objective analysis of the value of the project and the skill and experience that the investigator will bring to the task; and
4. that provide for the selection of trial sites and participants based on an objective analysis of the goals of the research project.
Prohibited Conduct
1. Company Personnel shall not represent, promise, imply or suggest that research grant funding is available for, or may be awarded to, any Healthcare Professional based upon past or future sales, referrals, or any subjective criteria.

8. SPEAKING ARRANGEMENTS AND SPEAKER TRAINING SESSIONS

A. POLICY:

The Company's speaking arrangements with Healthcare Professionals shall promote the safe and effective practice of medicine and shall not be conditioned upon the prescription, order, purchase, or use of the Company's products. Company Personnel may not solicit, offer, or agree to any speaking arrangement that is conditioned upon, or includes remuneration for referrals or other business generated. All speaking agreements and speaker training sessions must be approved in writing in advance by the Legal Department.

B. GENERAL GUIDELINES:

Permitted Speaking Arrangements. A speaking arrangement may be offered if:
1. the services are provided in accordance with a written consulting agreement executed in advance, that specifies the nature of, and compensation for, all the services to be provided; and
2. the consulting agreement clarifies the distinct nature of the speaking activity from a CME event;
3. the compensation paid to the Healthcare Professional over the term of the agreement is set in advance, is consistent with fair market value in arms-length transactions and is not determined in a manner that takes into account the volume or value of any Company products prescribed, ordered, or purchased;
4. for an agreement that is intended to provide for the services of the Healthcare Professional on a periodic, sporadic, or part-time basis rather than on a full-time basis for the term of the agreement, the agreement delineates to the extent possible the schedule of such intervals, their length, and the exact charge for such intervals;
5. the arrangement has a legitimate, commercially reasonable business purpose clearly identified by the Company in advance of entering into the arrangement with the prospective speaker, and the Company actually needs, intends to utilize, and does appropriately utilize the services;
6. the Healthcare Professional was selected (1) based on his or her (a) general medical expertise and skills, or reputation, knowledge and experience in the relevant therapeutic area; and (b) communication skills; and (2) not in a manner that takes into account the volume or value of Company products prescribed, ordered, or purchased, or business generated between the parties;
7. the number of Healthcare Professionals retained and the aggregate services contracted for do not exceed the number that is reasonably necessary to accomplish the commercially reasonable business purpose of the services;
8. the speaking arrangement is not an inducement or reward for prescribing, ordering, or purchasing a particular Company medicine;
9. records are properly maintained regarding the speaking arrangement;
10. the venue and circumstances of any meeting with speakers are conducive to the speaking services, the primary focus of the meeting is the activities related to the services, and no recreational or entertainment activities are provided in conjunction with the meeting; and
11. for a speaker who is a Healthcare Professional also serving as a member of a committee that sets formularies or develops clinical guidelines, the Healthcare Professional is required to (1) disclose to the committee the existence and nature of his or her relationship with the Company (such disclosure requirement shall extend for at least two years beyond the termination of the speaking arrangement); and (2) follow the procedures established by the committee, which may include recusal from decisions relating to the Aptalis product for which he or she is providing, or has provided, speaking services.
Annual Compensation Cap. The total compensation paid to any individual Healthcare Professional under a speaking agreement shall be limited to an annual cap of $40,000 for National Speakers and $25,000 for all other speakers.
Travel, Lodging, and Meals. The Company may offer Healthcare Professionals who have entered into a written speaking agreement with the Company reimbursement for reasonable expenses actually incurred for travel, lodging, and meals.
Non-speakers. The Company may not compensate or reimburse for travel, lodging, or meals of non-speakers (i.e., spouses, children, guests, etc.).
Disclosures. Speakers shall clearly identify in their presentation materials that the Company is sponsoring the presentation, that they are presenting on behalf of the Company, and that they are presenting information that is consistent with FDA guidelines.
Meals for Attendees and Venue. A speaking activity may include modest meals offered to the attendees. Speaking activities shall occur in a venue and manner conducive to informational communication.
Compensation, Travel, Lodging, and Meals in connection with Speaker Training Sessions. Speaker training sessions may be provided to Healthcare Professionals as well as reasonable compensation for the Healthcare Professional's time, considering the value of the type of services provided. Compensation and reimbursement for reasonable travel, lodging, and meals may be offered to participants of speaker training sessions if:
1. the participant receives extensive training on Company drug products or other specific topic to be presented and on compliance with FDA regulatory requirements for communications;
2. the training will result in the participant providing a valuable service to the Company; and
3. the participant meets all the requirements of a permissible consulting arrangement under this Policy.
Venue of Speaker Training Sessions. Speaker training sessions shall be held in venues that are appropriate and conducive to informational communication and training about medical information. Speaker training sessions may not be held at resorts.
Training and Monitoring. The Company shall provide speakers with appropriate training on FDA requirements for communications on behalf of the Company about its medicines and periodically monitor speaker activities for compliance with such requirements.
Utilization of Speakers. Attendees of speaker training programs shall be required to sign a speaking agreement in advance, covering the services they will provide.

9. RETENTION OF HEALTHCARE PROFESSIONALS FOR CONSULTING AND OTHER PERSONAL SERVICE ARRANGEMENTS

A. POLICY:

The Company's consulting and other personal service arrangements with Healthcare Professionals shall promote the safe and effective practice of medicine and shall not be conditioned upon the prescription, order, purchase, or use of the Company's products. Compensation and reimbursement for travel, lodging, and other out-of-pocket expenses may not be offered based on token consulting or advisory arrangements. Company Personnel may not solicit, offer, or agree to consulting arrangements that are conditioned upon, or include remuneration for referrals or other business generated. All consulting agreements must be approved in writing in advance by the Legal Department.

B. GENERAL GUIDELINES:

Permitted Arrangements. Consulting and other personal service arrangements may be undertaken if:
1. the services are provided in accordance with a written agreement executed prior to the services being provided, that covers all, and specifies the nature of, the services to be provided, and the basis for payment for those services;
2. the aggregate compensation paid to the Healthcare professional over the term of the agreement is set in advance, is consistent with fair market value in arms-length transactions and is not determined in a manner that takes into account the volume or value of any Company products prescribed, ordered, or purchased for which payment may be made in whole or in part under Medicare, Medicaid or other Federal health care programs;
3. for an agreement that is intended to provide for the services of the Healthcare Professional on a periodic, sporadic, or part-time basis, rather than on a full-time basis for the term of the agreement, the agreement specifies exactly the schedule of such intervals, their precise length, and the exact charge for such intervals;
4. the services to be performed under the agreement do not involve the counseling or promotion of a business arrangement or other activity that violates any state or Federal law;
5. the arrangement has a legitimate, commercially reasonable business purpose clearly identified by the Company in advance of entering into the arrangement with the prospective consultant, and the Company actually needs, intends to utilize, and does appropriately utilize the services;
6. The consultant was selected (1) based on his or her (a) general medical expertise and skills; or (b) reputation, knowledge and experience in the relevant therapeutic area; and (2) not in a manner that takes into account the volume or value of Company products prescribed, ordered, or purchased, or business generated between the parties;
7. the number of consultants retained and the aggregate services contracted for do not exceed the number that is reasonably necessary to accomplish the commercially reasonable business purpose of the services;
8. the consulting arrangement is not an inducement or reward for prescribing, ordering, or purchasing a particular Company medicine;
9. records are properly maintained regarding the consulting arrangement;
10. the venue and circumstances of any meeting with consultants are conducive to the consulting services, the primary focus of the meeting is the activities related to the services, and no recreational or entertainment activities are provided in conjunction with the meeting; and
11. for a consultant who is a Healthcare Professional also serving as a member of a committee that sets formularies or develops clinical guidelines, the Healthcare Professional is required to (1) disclose to the committee the existence and nature of his or her relationship with the Company (such disclosure requirement shall extend for at least two years beyond the termination of the consulting arrangement); and (2) follow the procedures established by the committee, which may include recusal from decisions relating to the Aptalis product for which he or she is providing or has provided, consulting or other personal services.
Travel, Lodging, and Meals. Healthcare Professionals who have entered into a written consulting agreement with the Company may be reimbursed for reasonable expenses actually incurred for travel, lodging, and meals. Any such reimbursement must be approved in writing in advance by the Legal Department. Reimbursement for travel, lodging, or meals may not be offered to non-consultants (i.e., spouses, children, guests, etc.), including non-faculty and non-consultant Healthcare Professional attendees who participate in interactive sessions.
Meals with Healthcare Professional Consultants. Modest meals or reception may be offered during company-sponsored meetings with Healthcare Professional consultants.

10. FREE AND DISCOUNTED APTALIS PRODUCTS

A. POLICY:

For purposes of this Section 9, a discount means any reduction in the amount a customer is charged for an item (including rebates). A rebate means any discount, the terms of which are fixed and disclosed in writing to the customer in advance, but which is not given at the time of sale.

Free goods and discounts (other than appropriately labeled and tracked professional samples) may only be offered to Healthcare Professionals if the arrangement meets all the requirements of the Discounts Safe Harbor of the Federal Anti-kickback Statute (42 C.F.R. Section 1001.952(h)).
Any offer of free goods or discounts shall be made in accordance with a written contract or other written documentation that clearly and succinctly summarizes relevant pricing terms and conditions, and fully discloses the nature and value of any free goods or discounts.
The Company shall fully and accurately report any discount on the invoice, coupon, or statement submitted to the customer, and provide notice to the customer of its obligations to report such discount and to provide information upon request by the U.S. Secretary of Health and Human Services or a state agency.
Sales or shipments of Company products that might entitle the customer to receive free goods or discounts shall be accompanied by invoices that clearly notify the customer that the sale might involve a discount, and shall advise the customer of potential obligations to the government as set forth in Subsection iii.
At no time shall the Company or a Company Personnel impede a customer from meeting its reporting obligations to an authorized government agency or employee.
At no time shall any Company Personnel advise a customer: (a) that free goods or discounts received from the Company should not be fully and properly disclosed to an authorized government agency or employee upon request, or (b) to take any action that would conceal the nature and existence of the free goods or discounts from an authorized government agency or employee.
At no time shall any Company Personnel counsel any customer to bill for free goods, services, equipment, or discounted products in a manner that is unethical, illegal or prohibited by law, regulation, and/or Company policy.

B. GENERAL GUIDELINES:

Permitted Discounts. The Company may offer free goods and discounts of Company items and services only in the following circumstances:
1. Product samples may be provided in accordance with the Prescription Drug Marketing Act;
2. As provided for in Company-approved patient programs such as Comprehensive Care Program for CF™ and CareFirst for CF™ programs;
3. On a compassionate use basis;
4. A contractual agreement that provides discounts based on purchase assumptions, terms, and conditions that are clearly set forth in writing between the parties (including customers and buying groups) prior to the delivery of the free or discounted product;
5. As compensation for credit due to a customer in the context of returns, billing errors, or damaged product, but only upon the delivery of an invoice or other shipping documentation that sets forth the reason for the transaction and clearly advises the customer that the delivery involves a discount that may have to be reported to federal or state payers.
Prohibited Conduct. Company employees may not market, offer, sell, or otherwise distribute free goods and discounted products or services as a means to take inappropriate, illegal, or unethical advantage of federal, state, or private payer reimbursement, or in a manner that directly or indirectly encourages the customer to seek an inappropriate reimbursement for Company's products.

11. INFORMATION RELATING TO UNAPPROVED USES OF COMPANY PRODUCTS

A. POLICY:

The Company and Company Personnel shall not promote or encourage the use of Company products for unapproved uses, or enter into arrangements that otherwise promote or encourage use for unapproved uses. The Company's Medical Affairs and Scientific Affairs Departments and Clinical Science Liaisons may respond to unsolicited requests for information on an unapproved use.

B. GENERAL GUIDELINES:

In response to a question or request for information about an unapproved product use, Company Personnel (other than Medical Affairs, Scientific Affairs or Clinical Science Liaisons) shall refer the question or request for information to MedInfo or to a Clinical Science Liaison for a response.
Medical Affairs, Scientific Affairs and Clinical Science Liaisons may respond to unsolicited questions (meaning the Company Personnel did not encourage the Healthcare Professional to ask the question) related to unapproved uses of Company products as long as the information provided:
1. reports only the science;
2. is not misleading;
3. is specific to the question asked;
4. is fair and balanced; and
5. is consistent with FDA regulations governing dissemination of information on unapproved uses for marketed drugs.
In very limited circumstances, the Company’s Medical Affairs department may distribute information in compliance with FDA’s draft guidance (as may be later finalized) entitled: “Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices”.
Company Personnel shall never encourage, overtly or covertly, a Healthcare Professional to ask a question, or request information, on an unapproved product use.
Sales representatives shall only call on Healthcare Professionals that have the legitimate potential to prescribe or order the marketed product for an approved use.

12. USE OF PROMOTIONAL MATERIALS NOT APPROVED BY THE COMPANY

A. POLICY:

Company Personnel may only use promotional materials approved by the Company.

B. GENERAL GUIDELINES:

Company Personnel may only use promotional pieces approved by the Company. A Company employee shall never use any home-made marketing pieces, sales aids, or unapproved journal articles.
Promotional materials approved by the Company and provided to Healthcare Professionals by or on behalf of the Company shall (a) be accurate and not misleading; (b) make claims about a product only when properly substantiated; (c) reflect the balance between risks and benefits; and (d) be consistent with all other FDA requirements governing such communications.

13. USE OF NON-PATIENT IDENTIFIED PRESCRIBER DATA

A. POLICY:

Non-patient identified prescriber data may be used to facilitate communication with Healthcare Professionals if such use is done responsibly.

B. GENERAL GUIDELINES:

Company Personnel shall maintain the confidential nature of prescriber data.
Prescriber data of Healthcare Professionals who ask that their prescriber data not be made available to Company sales representatives shall not be disclosed to Company sales representatives.
Company Personnel shall participate in Company-sponsored training regarding the use of prescriber data.
Inquiries regarding the use of prescriber data shall be directed to the Legal Department. The Legal Department shall manage such inquiries in accordance with applicable Company policies.
Company Personnel who misuse prescriber data shall be subject to disciplinary action, including and up to termination.

14. TRAINING

A. POLICY:

Company Personnel who visit Healthcare Professionals on behalf of the Company shall receive training on:

applicable laws (including, including without limitation, the Medicare and Medicaid Anti-kickback Statute), regulations, and industry codes of practice (including the PhRMA Code); and
general science and product-specific information to ensure information provided to Healthcare Professionals is accurate, up-to date, and consistent with FDA standards.

B. GENERAL GUIDELINES:

Company Personnel who visit Healthcare Professionals on behalf of the Company shall participate in initial training and periodic retraining sessions.
Company Personnel who visit Healthcare Professionals on behalf of the Company shall be subject to periodic assessment by the Company to ensure adherence to Company policies and standards of conduct.

15. VIOLATIONS

All Company Personnel are expected to comply with this Policy and to report any suspected violations of this Policy to the Company’s Legal Department. Violations of this Policy will result in disciplinary action.

Aptalis certifies that the Company is in compliance with this Commercial Compliance Policy. To request a copy of the Commercial Compliance Policy and certification of compliance, please call 1-800-950-8085.