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Medical Educational Grant Process

LEO Pharma understands the need to comprehend all aspects of disease management and treatment and that both healthcare professionals and patients benefit from a wide variety of learning formats that employ generally accepted adult learning techniques. LEO Pharma is proud to be able to provide grants to support educational activities and programs that help healthcare professionals enhance the care of their patients. We prioritize support in areas of scientific interest to the company that are intended to contribute to improvement in healthcare provider knowledge.

We follow a defined and specific process to ensure that our procedures for making medical educational grants are in agreement with appropriate guidelines and policies. The guidance we use to evaluate our support of various educational programs is based on recognized standards.

Medical Educational grants may be given to support bona fide educational activities directed toward healthcare professionals. Independent, company-supported educational activities are intended to benefit healthcare professionals and the patients they serve through the dissemination of information that contributes to the practice of medicine.

LEO Pharma Inc. (US) does not control or influence the content of programs or the selection of the speakers, authors, or faculty planners. LEO Pharma Inc. (US) does not provide "unrestricted educational grants" and grant funds must be used for the purpose defined within the original request.

Educational grants must be provided in accordance with the LEO Pharma policies and procedures and with the U.S. Food and Drug Administration's Guidance on Industry-Supported Scientific and Educational Activities. They must also be consistent with the Accreditation Council for Continuing Medical Education Standards for Commercial Support (www.accme.org) ("ACCME Standards"), the American Medical Association Ethical Guidelines for Gifts to Physicians from Industry (www.ama-assn.org) ("AMA Guidelines"), the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health care Professionals (www.phrma.org) ("PhRMA Code") and/or other relevant industry standards.

Who may apply?

Organizations eligible to apply for Medical Education Grants

Continuing Medical Education (CE)	Non-Accredited Continuing Education (NCE)
Academic Institutions	Academic Institutions
Hospitals	Hospitals
Medical Societies	Medical Societies
Professional Associations	Professional Associations
Government Agencies	Patient Advocacy Organizations

What type of Medical Education Grants applications will be considered?

There are three (3) types of Medical Education Grants eligible for LEO Pharma US funding:

1. Accredited Medical Education Activities
2. Non-Accredited Educational Activities for Healthcare Providers (HCP) and Allied Health Professionals
3. Patient Education materials and/or programs

¹Accredited Continuing Education includes educational programs for healthcare providers such as physicians, nurses, and/or pharmacists that provide continuing education credits.
²Non-Accredited Professional Educational Activities include educational programs for healthcare providers such as physicians, nurses, and pharmacists that do not provide continuing education credits
³Patient Education includes printed/online educational materials or live educational events produced for people living with a particular disease or condition.

Are there any criteria that guide use of the Medical Education Grant monies?

Yes, you need to be aware of the various exclusions. You may not use LEO Pharma Medical Education Grant funds for:

• Food and beverage expenses at non-CE-certified programs [?].
• Promotional activities related to LEO Pharma products.
• Development of treatment guidelines.
• Normal organizational overhead, staff training, or provision of medical care.
• Gifts and/or incentives for attendees of non-CE-certified educational programs.
• Travel, lodging, or honorarium for a healthcare professional to present a paper or poster.
• Educational activities for which attendee (patient or healthcare professional) travel and/or lodging are paid by the meeting organizers. This includes attendee scholarships and travel vouchers.
• Marketing sponsorships or exhibit opportunities. Educational grant requests that include marketing sponsorship or exhibit opportunities will be denied.
• LEO Pharma does not currently support process improvement or quality improvement initiatives.

You also need to be mindful of other restrictive considerations:

• For non-CE-certified healthcare professional education and patient education programs, content related to LEO Pharma products must be within FDA-approved labeling. US Prescribing Information for LEO Pharma products can be accessed at http://www.leo-pharma.us/Home/Products/LEO-Pharma-Products.aspx.
• Accredited education may discuss off-label information, but the nature of the off-label information must be disclosed to the audience at the time of presentation.
• LEO Pharma reserves the right to restrict financial support of independent professional education to activities certified by academic medical centers, hospitals, medical societies, professional medical associations or governmental agencies. Accredited providers may choose to collaborate with an educational partner for submission of grant applications.
• Faculty names for certified professional activities are not required to be included in the submission of a grant application.

Who reviews the Medical Education Grant application?

LEO Pharma has written policies and procedures relating to the submission, review and approval of grant requests and interactions with educational providers. The LEO Pharma Inc. (US) Grant Committee oversees a multidisciplinary review process for evaluation of educational grant requests which includes our Medical Strategy & Scientific Affairs, Health Care Compliance and Legal departments.

LEO Pharma Inc. (US) Medical Strategy & Scientific Affairs Department has primary responsibility for the monitoring and recordkeeping of independent educational programs supported by LEO Pharma Inc. including budget, staff and interactions with educational providers. Grant-related questions must be submitted to usgrants@leo-pharma.com.

What general criteria are used to review Medical Education Grant applications?

LEO Pharma is proud to have the privilege of providing educational grants to support independent educational activities, which are intended to contribute to better patient care. We provide grants with intent to place the health and welfare of the patient ahead of economic self-interest, and our grant review process is designed to advance patient care through education of healthcare professionals and patients.

LEO Pharma Inc. takes appropriate measures to ensure that support of educational programs is scientifically and clinically justified, and that the program is not promotional in nature. LEO Pharma may also consider the following factors:

• The demonstrated scientific and clinical need for the program;
• Whether the proposed program is sponsored solely by LEO Pharma, or if our funding represents a significant proportion of the program budget;
• The grant requestor's history and whether prior educational activities appeared to be conducted in an independent and unbiased manner and not influenced by support from industry sponsors.

Who is the "grant requestor(s)"?

This is the organization requesting the independent educational grant from LEO Pharma and is typically an accredited/educational provider or similar organization responsible for designing and conducting an educational activity. The accredited/educational provider is the organization that signs the letter of agreement/contract with LEO Pharma Inc. (US) and has ownership of the educational activity, controlling all aspects of the activity/program. The accredited/educational provider has complete control over the distribution of funds received from LEO Pharma Inc. (US) and the choice of co-sponsor(s).

Medical Education Companies and Logistics Companies are not eligible to receive grant funding. Individual healthcare professionals or private healthcare professional practices are also ineligible to receive grant funding.

Who decides the name/title of an educational activity?

The grant requestor and/or accredited continuing education provider is in complete control of all aspects of their educational activity including the title, scope of activity, faculty and audience selection, content, distribution and evaluation of the program.

What is a co-sponsor?

To be consistent with accepted industry standards (Accreditation Council for Continuing Medical Education, American Nurses Credentialing Center, and American College of Physician Executives), a continuing education provider may specify a co-sponsor in the letter of agreement. This does not include organizations retained by the provider in a subcontracting relationship that supply administrative or logistical services.

How is the total amount of the grant determined and distributed?

Every grant request received undergoes a thorough review, which follows a well-defined process to ensure that appropriate funding is made according to accepted standards (i.e., U.S. Food and Drug Administration, Accreditation Council for Continuing Medical Education, Office of Inspector General, and Pharmaceutical Research and Manufacturers of America) and company policies. A grant can only be approved for funding after it has undergone a rigorous review.

The total amount approved for funding is based on the grant request, the availability of funds and the grant committee's funding decision. Decisions may include full or partial funding, funding of an equal or lesser amount than requested in the grant application or the funding divided into partial payments.

Is the volume of requests and the number of approvals generally consistent over the course of a calendar year?

The number of grant requests LEO Pharma Inc. (US) receives varies throughout the year. The quantity, timing, and nature of requests are determined by the needs of accredited providers/educational sponsors submitting proposals to LEO Pharma Inc. (US). In addition, changes in the availability of LEO Pharma Inc. (US) funds affect the volume and dollars available for grants.

What happens when the grant recipient does not require, or use, all of the funds originally specified for an activity?

An educational provider/sponsor may reconcile their budget following an activity and find that they have unused funds remaining. As established in the written agreement and in accordance with our policy, LEO Pharma Inc. (US) requires that unused funds already disbursed to the educational provider/sponsor be returned to our organization.

What is the difference between a charitable contribution and a medical educational grant?

Educational grants are provided for bona fide educational activities and fall into three (3) categories: Accredited Continuing Education, Non-Accredited Professional Educational and Patient Education.

Charitable donations describe donation requests that are used for purposes other than healthcare professional education initiatives. Charitable donations may be cash, in kind or product donations.

• A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a 501 (c) (3) nonprofit organization to support a specific community-based (or regional/national) program, project, or event (e.g., a cash donation at a fund raising event).
• An �in kind� charitable contribution is a donation of goods, services, space, etc. that is philanthropic in nature and provided to a 501 (c) (3) nonprofit organization to support a specific community-based (or regional/national) program, project, or event.
• At this point in time, LEO Pharma Inc. (US) does not consider requests for product donations. When/if product donations become available, the donation will be provided through specific product giving programs to non-government organizations generally responding to disasters, medical relief efforts and basic healthcare needs in under-served communities.

Who reviews the Medical Education Grant application?

All requests are reviewed by a multidisciplinary committee, which includes Medical Strategy and Scientific Affairs, Health Care Compliance and Legal. Recipients must be tax-exempt organizations with an appropriate federal tax-exempt status.

Will our organization be contacted if our medical education support request is approved or denied?

Yes

Why might requests for medical educational grants be denied?

The primary criterion used by reviewers is that there must be a bona fide educational purpose that should result in improved patient care. Examples of reasons for denial of educational grants may include:

• Vague or incomplete grant applications
• Requests that appear to promote a medical practice or office
• Support for educational activities that are outside the therapeutic scope of legitimate scientific or clinical interests of LEO Pharma
• Funds to offset travel costs of attendees at an educational activity, other than a qualifying resident or fellow in training
• Grants to specifically promote an individual product
• Activities that include topics in a non-accredited environment that are designed to encourage unapproved uses of products
• Events that include a social activity or entertainment that overshadow the educational activity
• Requests that stipulate support is required in order to maintain access to health facilities, maintaining existing business relationships, or other quid pro quo
• All or parts of the proposed budget submitted by the requesting organization exceed fair market values (i.e., faculty honoraria, venue costs, or administrative fees).
• Limited funds available in LEO Pharma's educational budget
• Recent funding of similar educational activity

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