Education Grants

Charitable Contributions

Transparency

DePuy EMEA is committed to Our Credo, which guides us to provide high quality products and services to health care professionals and patients and to support the communities in which we work and live.

We recognise that medical science evolves rapidly with new information becoming available constantly. As part of the health care system, we also understand the need to support health care professionals in their pursuit of the most current education to provide the best patient care possible. There is further need to support patients, caregivers and communities to ensure that they have the information and products required to live healthy, quality, and productive lives. As such, we are proud to have the opportunity to support educational programmes and community programmes through educational grants and charitable contributions, respectively.

We hold ourselves accountable to the highest standards to ensure that we are providing educational grants and charitable contributions in an appropriate manner. There are a number of policies and guidance documents from various external regulatory and policy-making organisations that form the basis for the development of our company's guiding principles used to evaluate grant and charitable request submissions.

Our primary focus is making life-changing, long-term differences in human health and disease management for those who may be helped by the products and services we provide. The purpose of our disclosure of the process for educational grants and charitable contributions is to demonstrate our ongoing commitment to this endeavor. It is our hope that this disclosure will help HCP’s to understand better the evaluation method and volume of programmes that we support in the interest of advancing patient care and supporting local communities.

Educational Grants Process

DePuy EMEA understands the need to comprehend all aspects of disease management and treatment and that both health care professionals and patients benefit from a wide variety of learning formats that employ generally accepted adult learning techniques.

DePuy EMEA is proud to be able to provide grants to support educational activities and programmes that help health care professionals enhance the care of their patients. We prioritise support in areas of scientific interest to the company that are intended to contribute to improvement in health care provider knowledge.

Our organisation follows a defined and specific process to ensure that our procedures for making educational grants are in agreement with appropriate guidelines and policies. The guidance we use to evaluate our support of various educational programmes is based on recognised standards.

• Educational grants may be given to support bona fide educational activities directed toward health care professionals or patients and may include funding for accredited/certified continuing education, fellowships, and patient education.
• Independent, company-supported educational activities are intended to benefit health care professionals and the patients they serve through the dissemination of information that contributes to the practice of medicine.
• DePuy EMEA does not control or influence the content of programmes or the selection of the speakers, authors, or faculty planners. This guideline applies equally to all educational activities involving any health care professional, or customer who is in a position to influence the purchase of DePuy EMEA products.

DePuy EMEA provides grant funds which must be used for the purpose defined within the original request. Each grant request is evaluated for completeness based on four basic components:

1. An assessment documenting why the education is necessary
2. An agenda or brochure describing the schedule of events
3. A detailed budget identifying all sources of funding and how grant funds will be used
4. Evidence of accreditation to provide continuing education credit and/or tax exempt status

Educational grants must be provided in accordance with the guidance documents of Eucomed and/or other relevant industry standards.

DePuy EMEA.'s Medical Affairs, Compliance, or other relevant departments have responsibility for the monitoring and recordkeeping of independent educational programmes supported by DePuy EMEA, including budget, staff and interactions with educational providers. In addition, DePuy EMEA has:

• Written policies and procedures relating to the submission, review and approval of grant requests and interactions with educational providers, so as to comply with applicable requirements of the guidelines mentioned above;
• An internal, multidisciplinary review process for evaluation of educational grant requests which includes our Medical Education, Medical Affairs, Clinical Research, Health Care Compliance, Regulatory Affairs and Law departments, as necessary;
• Appropriate measures to ensure that support of educational programmes are scientifically and clinically justified, and the programme is not intended to be promotional in nature. DePuy EMEA may consider the following factors:
  1. The demonstrated scientific and clinical need for the programme;
  2. Whether the proposed programme is sponsored solely by DePuy EMEA or if our funding represents a significant proportion of the programme budget;
  3. 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.

Frequently Asked Questions

1. Why is the DePuy logo required to be displayed in association with the grant?

   DePuy EMEA 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 believe that being transparent with this information is the appropriate action to demonstrate our commitment to providing the highest quality health care products and services, including support for medical education.

2. What types of grants does DePuy EMEA support?
   • Fellowship: Educational programmes for health care providers such as physicians, nurses, and/or pharmacists that provide continuing education credits.
   • Educational Event Support: A condition for funding, to the extent DePuy EMEA products are discussed as part of such funded activities, DePuy EMEA requires that such discussion be done in a manner consistent with the FDA and CE approved labeling and I.F.U.
3. Who is the "grant requestor(s)"?

   This is the organisation requesting the independent educational grant from DePuy EMEA and is typically an accredited/educational provider or similar organisation responsible for designing and conducting an educational activity. The accredited/educational provider is the organisation that signs the letter of agreement/contract with DePuy EMEA and has ownership of the educational activity, controlling all aspects of the activity/programme. Individual health care professionals or private health care professional practices are not eligible to receive grant funding.

4. 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 programme. For posting purposes, the title of the education activity is obtained from the information provided with the grant submission.

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

   The total amount approved for funding is based on the grant request and the grant committee's funding decision. This may be full or partial funding and can be of an equal or lesser amount than requested in the grant application. This amount is specified in the letter of agreement/contract and will be assessed for Fair Market Value and appropriate.

   The accredited/educational provider has complete control over the distribution of funds received from DePuy EMEA and the choice of co-sponsor(s).

   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 and company policies. A grant can only be approved for funding after it has undergone a rigorous review. The funding amount may be divided into partial payments that are stated in the letter of agreement/contract between the accredited/educational provider and DePuy EMEA.

6. Are the volume of requests and the number of approvals generally consistent over the course of a calendar year?

   The number of grant requests DePuy EMEA 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 DePuy EMEA. In addition, changes in the availability of DePuy EMEA funds affect the volume and funding available for grants.

7. What is the difference between a charitable contribution and an educational grant?
   • Educational grants are provided for bona fide educational activities
   • Fellowship: Educational programmes for health care providers such as physicians, nurses, and/or pharmacists that provide continuing education credits.

   Charitable contributions describe donation requests that are used for purposes other than health care professional education initiatives. Charitable contributions may be cash or product donations.

   • A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a nonprofit organisation to support a specific community-based (or regional/national) programme, project, or event (cash donation at a fund raising event).
   • A product donation is provided through specific product giving programmes to non-government organisations generally responding to disasters, medical relief efforts and basic health care needs in under-served communities.
8. How are programmes that are jointly supported by DePuy EMEA and another business reported?

   As each business is a separate legal entity, the individual company that signs the letter of agreement and provides the funds directly to the requesting organisation will report programmes.

9. 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, DePuy EMEA requires that unused funds already disbursed to the educational provider/sponsor be returned to our organisation.

Charitable Contributions Process Statement and FAQs

"We are responsible to the communities in which we live and work and to the world community as well. We must be good citizens - support good works and charities and bear our fair share of taxes. We must encourage civic improvements and better health and education. We must maintain in good order the property we are privileged to use protecting the environment and natural resources." Our Credo

A charitable contribution includes cash or product donations. A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a non-profit organisation to support a specific community-based (or regional/national) programme, project, or event. A product donation is provided through specific product giving programmes to non-government organisations generally responding to disasters, medical relief efforts and basic health care needs in under-served communities.

All requests must be submitted in writing on charity headed paper and are reviewed by a multidisciplinary committee, which may include Medical Affairs, Health Care Compliance, Public Affairs, Human Resources, and Legal, as necessary. Recipients must have charitable status with an appropriate registered charity number. Requests should include the organisation's mission statement, tax status, project/event description, description of how the funds will be used, project budget (if applicable) and annual operating budget (if applicable).

The following types of requests are generally not eligible for charitable contributions:

• Organisations that do not have a valid charitable tax-exempt status
• Scholarships to individuals
• Direct contributions to individuals or physician practices
• Loans
• Trips or tours
• Endowments of any kind
• Sectarian and religious organisations that do not serve the general public on a nondenominational basis
• Capital requests (building funds, endowments, multi-year commitments)
• Political, fraternal or athletic groups

Product contributions must be used in the manner defined below:

• Product contributions will only be placed with licensed medical and health care professionals;
• Product contributions cannot be transferred in exchange for money, other property or services;
• Product contributions cannot be used for research, experimental, or demonstration purposes;
• Product contributions cannot be billed to any third party payor (public or private);
• For purposes of disclosure and reporting, product contributions are valued at the Company's list price.

Charitable Contributions FAQs

1. Why is charitable contribution process being disclosed?

   DePuy EMEA is proud to have the privilege of providing charitable contributions to various community organisations. We believe that being transparent with this information is the appropriate action to demonstrate our commitment to providing the highest quality health care products and services.

2. How is the total amount of the charitable contribution determined and distributed?

   The amount approved for funding is a result of the charitable contribution review process. Funding amounts may be based on project/event budgets, fair market value, organisational geographic scope, and merits of the request. This may be of an equal or lesser amount than requested in the application. The organisation has complete control over the distribution of funds received from DePuy EMEA.

3. What is the difference between a charitable contribution and an educational grant?

   An Educational Grant falls into one of the following categories:

   • Accredited Continuing Education: Educational programmes for health care providers such as physicians, nurses, and/or pharmacists that provide continuing education credits.
   • Non-Accredited Professional Educational Activities: Educational programmes for health care providers such as physicians, nurses, and pharmacists that do not provide continuing education credits. As a condition for funding, to the extent DePuy EMEA products are discussed as part of such funded activities, DePuy EMEA requires that such discussion be done in a manner consistent with the approved labeling and uses.

   Charitable contributions describe donation requests that are used for purposes other than health care professional education initiatives. Charitable contributions may be cash or product donations.

   • A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a nonprofit organisation to support a specific community-based (or regional/national) programme, project, or event. As noted above, employee payroll deductions remitted by the company to a charitable organisation are not reported as a contribution by the company.
   • A product donation is provided through specific product giving programmes to non-government organisations generally responding to disasters, medical relief efforts and basic health care needs in under-served communities.
4. Are the volume of requests and the number of approvals generally consistent over the course of a calendar year?

   The number of contribution requests DePuy EMEA receives varies throughout the year. The quantity, timing, and nature of requests are determined by the needs of the organisations submitting proposals to DePuy EMEA, which is determined by the requestors' needs. In addition, changes in the availability of DePuy EMEA funds affect the volume and value available for contributions.

Criteria for Grant Denials

Educational grant requests are reviewed through a rigorous review process. Processes have been designed and implemented so that no single individual may authorize educational grant support alone. In accordance with government guidance, it is inappropriate for individuals responsible for sales and marketing to be involved in educational grant-making decisions. Grant reviewers typically include personnel from Medical Affairs, Medical Education, Regulatory Affairs, Health Care Compliance, and/or Legal departments, as necessary.

Numerous educational grant requests can be received by DePuy EMEA each year. Unfortunately, not all educational grants that are submitted for consideration can be funded.

DePuy EMEA abides by rules developed by several regulatory and policy-making organisations. These rules provide guidance on several parameters. For example:

• Grants should not take into account the volume or value of purchases made by, or anticipated from, a potential grant recipient;
• Accredited educational activities should be independent and without influence from commercial supporters;
• Educational grants may only be provided to recognized institutions, organisations, or societies; no funding may be provided by industry directly to an individual or medical practice;
• Presentations must give a balanced view of therapeutic options and not a specific proprietary business interest (product) of a commercial sponsor; and
• Any gift items provided to participating practitioners must provide educational value to the patient or healthcare professional.

DePuy EMEA uses established policies to evaluate each submission on its own merits. Funds are not provided as "unrestricted educational grants," which implies that recipients may use the financial support for a purpose other than what was originally intended. Although DePuy EMEA only provides restricted educational grants, it is assumed that programme content is developed in an independent manner by the requestor. It is expected that a provider should develop accredited medical education activities without interference, direct or nuanced, from a commercial supporter.

To ensure that the purpose of the educational activity is clearly understood, all grant requests include several key components to be provided within the written grant application when submitting a grant request to our organisation.

Each grant request submission is evaluated on four common components:

• The needs assessment documenting why the activity is necessary and how the proposed activity will address the educational need or gap
• A proposed or final agenda and/or brochure
• A detailed budget outlining how the funds will be utilized
• A statement of accreditation and/or tax exempt status

Unfortunately, educational grants may be denied for a variety of reasons. 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 the manufacturer
• 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 organisation exceed fair market values (i.e., faculty honoraria, venue costs, or administrative fees)
• Limited funds available in DePuy EMEA's educational budget
• Recent funding of similar educational activity

DePuy EMEA is proud to assist with the educational needs of health professionals through educational grants. We do so with intent to place the health and welfare of the patient ahead of economic self-interest.

More information about reporting of grants and contributions can be found at www.jnj.com