Guide to Grants at EMD Serono Effective: April 1, 2010

1. Guide to Grants at EMD Serono Effective: April 1, 2010

2. Topic Introduction Types of Grants Descriptions of Types of Grants Requirements for Medical Education Grants Medical Education for HCPs Research Fellowships Medical Education for Patients Requirements for Charitable Contributions Requirements for Sponsorships Requirements for Display/Exhibit Space General Information for All Grants Slide Number 3 5 6 12 13 23 26 33 36 39 42 Table of Contents

3. Introduction • Since launching our online grant management system in July 2007, we have listened to your comments, feedback and suggestions on how to improve our on-line system. • This “Guide to Grants at EMD Serono” was created to give applicants clear guidance on eligibility requirements, criteria for certain categories of grants, and types of activities which are fundable. • Please continue to give us your comments, feedback and suggestions. We want to hear from you. Our contact information appears on the last page.

4. Our Commitment EMD Serono is aware of the growing need for support for medical education, sponsorship, charitable contributions, and exhibits/displays. We understand that continuing medical education is the foundation for healthcare providers to provide quality, effective and safe healthcare to their patients. As part of our commitment to meeting unmet needs, EMD Serono supports activities that improve patient care and provide valuable information to the medical community.

5. Types of Grants • EMD Serono provides grants for a wide variety of activities Independent Medical Grants (i.e. Investigator-Sponsored Trials) Medical Education Charitable Contributions Sponsorships Apply via online system www.img.emdserono.com Exhibits/Displays Community Service Apply via online Grant System www.grants.emdserono.com Apply via manual submission

6. Descriptions of Types of Grants Medical Education • Medical Education Grants are grants to support a specific educational activity developed for either: (1) healthcare professionals (HCPs) or (2) patients. • Examples: • Accredited medical education program for HCPs, such as CME programs. • Effective July 1, 2009 EMD Serono will no longer fund unaccredited medical education programs. • Research Fellowships at teaching or research institutions. • Patient education programs organized by patient advocacy groups.

7. Descriptions of Types of Grants Charitable Contributions • Charitable Contributions are grants to support the general activities (as opposed to a specific educational activity) of 501(c)(3) organizations engaged in healthcare-related charitable purposes. • Examples: • Donations to patient advocacy group’s fundraising campaign to cover operating expenses. • Annual fund campaign of a healthcare-related foundation.

8. Descriptions of Types of Grants Sponsorships • Sponsorships are grants to support healthcare-related events and programs. • Examples: • Tier sponsorship (gold, silver, bronze) of an industry conference, a medical society’s annual meeting or an advocacy group’s meeting. • Sponsorship of medical-related fundraising walks and bike-a-thons (sponsorships are given to organizations only; they are not given to individuals participating in fundraisers).

9. Descriptions of Types of Grants Exhibits/Displays • Exhibits/Displays are payments of an exhibit fee for exhibit space or a display table (with no “sponsorship” element attached) at an industry conference or seminar. • Examples: • Exhibit space at a healthcare conference. • A display table at an industry seminar.

10. Descriptions of Types of Grants Independent Medical Grants Independent Medical Grants (i.e. Investigator-Sponsored Trials) are unsolicited requests for funding and/or clinical supplies (e.g. drugs) to conduct an independent scientific investigation usually, but not necessarily, associated with a drug. Requests for these grants are handled via a manual submission process. Contact Dawne Green or Janet Griffin at (781) 982-9000 or Dawne.Green@emdserono.com or Janet.Griffin@emdserono.com for submission information.

11. Descriptions of Types of Grants Community Service • Community Service Grants are charitable contributions and sponsorships to organizations that are not related to healthcare. • Example: • Donation to a local food pantry. • Sponsor uniforms for local little league team. Requests for these grants are handled via a manual submission process. Contact EMD Serono’s Corporate Communications Group at 800-283-8088.

12. Requirements for Medical Education Grants Medical Education for HCPs

13. Requirements for Medical Education Grants Medical Education for HCPs 1. Accredited Medical Education Programs • An “accredited” medical education activity is an independent educational activity that is certified for continuing education credit by an accredited provider. • Effective July 1, 2009 EMD Serono will no longer fund unaccredited medical education programs. • For accredited activities, the CME provider must be the requestor of the grant and the activity must be accredited by an accredited provider such as ACCME, ACPE, ANCC, AMA or a similar recognized accrediting organization which utilizes the equivalent of the ACCME Standards for Commercial Support.

14. Requirements for Medical Education Grants Medical Education for HCPs (cont.) 2. Eligibility – An individual HCP is not eligible to apply for any type of medical education grant. All grant recipients must not discriminate by age, race, sex, religion, sexual orientation, or disability. In addition, the following restrictions on eligibility apply: • Accredited Medical Education Activity for HCPs • The accredited provider must apply for the grant funding and is responsible for the program. • None of the following organizations may apply for this type of grant: (a) physician group practice, (b) physician-owned clinic, (c) managed care organization, and (d) pharmacy benefit managers.

15. Requirements for Medical Education Grants Medical Education for HCPs (cont.) 2. Eligibility (cont.) • Research Fellowships • The academic or training institution hosting the research fellow must apply for the research fellowship. • None of the following may apply for this type of grant: individual medical students, residents, fellows, or other healthcare professionals in-training. • Fellowship funding can not be used to send Residents, Fellows or other HCPs to medical conferences, congresses or industry meetings.

16. Requirements for Medical Education Grants Medical Education for HCPs (cont.) 3. Purpose • All medical educational grants must have a clearly defined, legitimate scientific or medical purpose and must provide a benefit to a broad audience of healthcare providers. 4. Format • The education may take the form of a live presentation, satellite symposia, internet-based presentation, videotape, teleconference, print medium (e.g. monographs, newsletters), publications, or other format. The recipient, content and audience for anything other than a live presentation must be similar to the recipient, content and audience for a live presentation. The materials cannot promote a particular healthcare provider. EMD Serono will only fund accredited medical education programs for HCPs.

17. Requirements for Medical Education Grants Medical Education for HCPs (cont.) 5. Meeting An Unmet Need • All medical education grant requests must demonstrate the ability to meet unmet educational needs of the target audience and encourage the improvement of patient outcomes. 6. Needs Assessment • The needs assessment for the program should be well-developed, current and clearly identify the relevant educational gaps. 7. Learning Objectives • The learning objectives for the program should be clearly defined, realistic and aligned with the needs assessment. The learning objectives should also be measurable and optimally tied to measuring change in knowledge, competence or performance.

18. Requirements for Medical Education Grants Medical Education for HCPs (cont.) 8. Agenda • The agenda should be consistent with the learning objectives of the program. Any time devoted to meals, entertainment, or recreation must be clearly subordinate to the time for education. 9. Content of Program • The program should be scientifically rigorous, balanced and unbiased. Responsibility for and control over the identification of educational needs, determination of educational objectives, selection of content, faculty, educational methods, materials and venue, evaluations, and presentation of content belong to the accredited provider in accordance with the medical education providers’ guidelines. EMD Serono will not provide any advice or guidance on content to the accredited provider, even if asked.

19. Requirements for Medical Education Grants Medical Education for HCPs (cont.) 10. Faculty • The proposed faculty should be identified and appropriate for the content and educational objectives. EMD Serono will not provide any advice or guidance on faculty to the accredited provider, even if asked. 11. Attendance • Professional education programs must be open to healthcare professionals from a broad community. Programs may not be limited to physicians from a single hospital or a restricted number of practices. 12. Venue • The venue must be appropriate for the dissemination of medical and scientific information. • Luxury hotels and resort properties are not appropriate venues for medical education programs.

20. Requirements for Medical Education Grants Medical Education for HCPs (cont.) 13. Budget • The budget for the activity should present a cost-effective approach to achieving the learning objectives. • The budget must not include any costs of honoraria, travel, lodging, or other personal expenses of non-faculty HCPs attending any professional education program. • EMD Serono will not separately promote, publicize or otherwise take advantage of any option to be identified as the sponsor of a meal.

21. Requirements for Medical Education Grants Medical Education for HCPs (cont.) 13. Budget (cont.) • The budget must not include any costs for activities that are conducted essentially for a recipient’s operational purposes or to reduce a recipient’s otherwise budgeted operational expenses. • Specifically, the budget must not include funds for an organization’s annual accreditation fee. • However, the budget may include administrative costs in connection with issuing CME certificates to attendees. Such costs may be listed under “Other Expenses” in the Budget section of the online grant application. • Unused funds must be returned to EMD Serono.

22. Requirements for Medical Education Grants Medical Education for HCPs (cont.) 14. Meals • All meals and receptions must be open to all attendees of the program (i.e. funds may not be used to fund a faculty-only meal or reception). • All meals and receptions must be modest in nature and conducive to discussions among attendees. • The amount of time at meals and receptions must be clearly subordinate to the amount of time spent at the educational activities of the meeting.

23. Requirements for Medical Education Grants Research Fellowships

24. Requirements for Medical Education Grants Research Fellowships 1. Eligibility: • The academic or training institution at which medical students, residents, fellows, and other healthcare professionals in-training are being trained must apply for the fellowship. • Research fellows must be selected by the institution at which they are being trained or by another independent selection organization. • None of the following may apply for this type of grant: individual medical students, residents, fellows, or other healthcare professionals in-training.

25. Requirements for Medical Education Grants Research Fellowships (cont.) 2. Use of Funds: • Fellowship grants may be used by the recipient institution only for direct expenses associated with the fellowship and may not be used to subsidize the recipient’s routine business expenses. • If the fellowship position includes both billable services and research or teaching, the award must be made so as to fund only the activities devoted to non-billable teaching or research. • Fellowship grant funds may not be used to pay for salary for any portion of a position that bills for services. • Fellowship grant funds may not be used to pay for attendance at a medical conference, congress or industry meeting.

26. Requirements for Medical Education Grants Medical Education for Patients

27. Requirements for Medical Education Grants Medical Education for Patients 1. Eligibility: • Individual HCPs may not apply for this type of grant. 2. Purpose • All medical educational grants must have a clearly defined, legitimate scientific or medical purpose and must provide a benefit to a broad audience of patients. 3. Format • The education may take the form of a live presentation, internet-based presentation, satellite symposia, videotape, teleconference, print medium (e.g. monographs, newsletters), publications, or other format. The recipient, content and audience for anything other than a live presentation must be similar to the recipient, content and audience for a live presentation. The materials cannot promote a particular healthcare provider.

28. Requirements for Medical Education Grants Medical Education for Patients (cont.) 4. Meeting An Unmet Need • All medical education grant requests must demonstrate the ability to meet unmet educational needs of the target audience and encourage the improvement of patient outcomes. 5. Needs Assessment • The needs assessment for the program should be well-developed, current and clearly identify the relevant educational gaps. 6. Learning Objectives • The learning objectives for the program should be clearly defined, realistic and aligned with the needs assessment. The learning objectives should also be measurable and optimally tied to improved patient care.

29. Requirements for Medical Education Grants Medical Education for Patients (cont.) 7. Agenda • The agenda should be consistent with the learning objectives of the program. Any time devoted to meals, entertainment, or recreation must be clearly subordinate to the time for education. 8. Content of Program • The program should be medically relevant, balanced and unbiased. Responsibility for and control over the identification of educational needs, determination of educational objectives, selection of content, faculty, educational methods, materials and venue, evaluations, and presentation of content belong to the provider in accordance with any applicable providers’ guidelines. EMD Serono will not provide any advice or guidance to the provider, even if asked.

30. Requirements for Medical Education Grants Medical Education for Patients (cont.) 9. Faculty • The proposed faculty should be appropriate for the content and educational objectives. 10. Attendance • Patient education programs must be open to patients from a broad community and may not be restricted to patients currently prescribed EMD Serono products. 11. Venue • The venue must be appropriate for the dissemination of medical and scientific information. Luxury hotels and resort properties are not appropriate venues for patient education programs. • Patient education programs may not be held in the offices of an individual HCP, physician group practice, or physician-owned clinic.

31. Requirements for Medical Education Grants Medical Education for Patients (cont.) 12. Budget • The budget for the activity should present a cost-effective approach to achieving the learning objectives. • The budget must not include any costs of honoraria, travel, lodging, or other personal expenses of any patients attending the activity. • The budget must not include any costs for activities that are conducted essentially for a recipient’s operational purposes or to reduce a recipient’s otherwise budgeted operational expenses. • EMD Serono will not separately promote, publicize or otherwise take advantage of any option to be identified as the sponsor of a meal. • Unused funds must be returned to EMD Serono.

32. Requirements for Medical Education Grants Medical Education for Patients (cont.) 13. Meals • All meals and receptions must be open to all attendees of the program (i.e. funds may not be used to fund a faculty-only meal or reception). • All meals and receptions must be modest in nature and conducive to discussions among attendees. • The amount of time at meals and receptions must be clearly subordinate to the amount of time spent at the educational activities of the meeting.

33. Requirements for Charitable Contributions Charitable Contributions

34. Requirements for Charitable Contributions Charitable Contributions 1. Eligibility: • The organization must be a registered tax-exempt organization under section 501(c)(3) of the Internal Revenue Code. • None of the following organizations or people may apply for a charitable contribution: (a) physician group practice, (b) physician-owned clinic, (c) managed care organization, (d) pharmacy benefit managers, (e) foundations or charitable organizations controlled by or closely affiliated with these organizations or individual healthcare providers, (f) college alumni associations, (g) religious organizations for sectarian religious purposes (secular programs of faith-based organizations that meet criteria will be considered) and (h) individuals who are fundraising for any scientific or medical-related activities (e.g. leading a team in a walk-a-thon).

35. Requirements for Charitable Contributions Charitable Contributions (cont.) 2. Nature of Request • Charitable contributions generally should be in connection with a general fundraising effort, rather than in response to a request directed only to EMD Serono. • Charitable contributions must serve a clearly defined legitimate charitable purpose and EMD Serono may only receive an incidental benefit from any such contributions. 3. Unsolicited • Charitable contributions will not be made to a charitable organization in response to a direct request from an individual physician, pharmacist, or healthcare professional. That is, EMD Serono will not contribute to the “favorite charity” of a healthcare professional at the individual’s request.

36. Requirements for Sponsorships Sponsorships

37. Requirements for Sponsorships Sponsorships 1. Eligibility: • Unlike charitable contributions, sponsorships are not limited to 501(c)(3) organizations. • None of the following organizations or people may apply for a sponsorship: (a) physician group practice, (b) physician-owned clinic, (c) managed care organization, (d) pharmacy benefit managers, (e) foundations or charitable organizations controlled by or closely affiliated with these organizations or individual healthcare providers, (f) college alumni associations, (g) religious organizations for sectarian religious purposes (secular programs of faith-based organizations that meet criteria will be considered) and (h) individuals who are fundraising for any scientific or medical-related activities (e.g. leading a team in a walk-a-thon).

38. Requirements for Sponsorships Sponsorships (cont.) 2. Nature of Request • Sponsorships must be for clearly identified events or activities and must be in exchange for a commercial benefit (e.g. gold sponsor of meeting). 3. Unsolicited • Sponsorships will not be made in response to a direct request from an individual physician, pharmacist, or healthcare professional. That is, EMD Serono will not contribute to the “favorite charity” of a healthcare professional at the individual’s request.

39. Requirements for Exhibit/Display Space Requests Exhibit/Display Space

40. Requirements for Exhibit/Display Space Requests Exhibit/Display Space Requests 1. Eligibility: • Unlike charitable contributions, exhibit/display space requests are not limited to 501(c)(3) organizations. • None of the following organizations or people may apply for an exhibit/display: (a) physician group practice, (b) physician-owned clinic, (c) managed care organization, (d) pharmacy benefit managers, (e) foundations or charitable organizations controlled by or closely affiliated with these organizations or individual healthcare providers, (f) college alumni associations, (g) religious organizations for sectarian religious purposes (secular programs of faith-based organizations that meet criteria will be considered) and (h) individuals who are fundraising for any scientific or medical-related activities (e.g. leading a team in a walk-a-thon).

41. Requirements for Exhibit/Display Space Requests Exhibit/Display Space Requests (cont.) 2. Nature of Request • Exhibit/Display space requests must be for exhibit or display space only (with no “sponsorship” element attached; e.g., exhibit booth space at an industry conference or seminar). 3. Unsolicited • Exhibit/Display space funding will not be made in response to a direct request from an individual physician, pharmacist, or healthcare professional. That is, EMD Serono will not contribute to the “favorite charity” of a healthcare professional at the individual’s request.

42. General Information for all Grants General Information

43. General Information for all Grants General Information 1. Processing Time • All grant requests (medical education, charitable contributions, sponsorships, and exhibit/display space) must be submitted at least 45 calendar days before the date of the program or event. Grant requests made less than 45 days before the program or event will be automatically rejected. • EMD Serono will not approve any grant request made after the date of a program or event. 2. Review of Application • All grant requests are reviewed for merit, audience scope, compliance with legal, ethical and professional obligations, as well as fiscal responsibility.

44. General Information for all Grants General Information (cont.) 3. Funding Decisions • Submission of an application does not mean that EMD Serono, Inc. has agreed to provide you any funding. • Funding decisions are made only after a review of your complete application. • All funding decisions are final and cannot be appealed. • Pursuant to our Grant Policy, we are not permitted to provide a reason for denial of a grant request, except when the denial is because funding in a specific therapeutic area has been exhausted.

45. General Information for all Grants General Information (cont.) 4. Additional Criteria for All Grants • All grant requests for medical education, charitable contributions, sponsorships, and exhibit/display space must adhere to and be compliant with: • Office of Inspector General (OIG) Guidelines • Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support • Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals • American Medical Association (AMA) Ethical Guidelines for Gifts to Physicians from Industry and other relevant guidelines and regulations • All State laws • These guidelines are available under the “Resource” link of our Grant System. The guidelines help to ensure that activities are developed independent of commercial interests and are fairly balanced, scientifically rigorous and evidence based.

46. Neurology Multiple Sclerosis Parkinson’s Metabolic Endocrinology Growth and Growth Disorders HIV and Wasting Reproductive Health Oncology Therapeutic cancer vaccines (aka specific active immunotherapies) Anti-Integrins in cancer Aurora Kinase Inhibition in cancer Mek inhibition in cancer General Information for all Grants General Information (cont.) • 5. Areas of Educational Interest • While EMD Serono will consider funding activities in many therapeutic areas, priority will be given to those in the following areas of educational interest:

47. General Information for all Grants General Information (cont.) 6. Written Grant Agreements for Medical Education Grants • All recipients of medical education grants for HCPs and patients must enter into a written grant agreement with EMD Serono. • For accredited education programs for HCPs, the written agreement must be signed by the CME provider and any educational partners. • The agreement will specify that EMD Serono is the source of the commercial support for the educational grant.

48. General Information for all Grants General Information (cont.) 7. Availability of Funds • It is difficult for EMD Serono to predict the volume of quality grant requests it will receive throughout the year in any given therapeutic area. As a result, the funding in some of our educational areas of interest may be exhausted sooner than others. • We recognize the amount of time and effort it takes to prepare a quality grant application and understand the frustration of being denied simply because funding in a specific therapeutic area is no longer available. Out of respect for your time and resources, we will put an announcement on our Grant Website when funding in a specific therapeutic area is exhausted.

49. General Information for all Grants General Information (cont.) 8. Reconciliation • EMD Serono requires all recipients of medical education, sponsorship grants and exhibit/display space funding to reconcile their grants to ensure that funds provided were used solely for the purpose stated in the grant request. Reconciliation is not required for charitable contributions. • One day after the funded activity, you will receive an email asking for a reconciliation. You will have 45 calendar days to complete the reconciliation process. • If you do not reconcile within 45 days, you will be prevented from submitting any additional grant requests until reconciliation is completed • If you need more time to provide a reconciliation, contact the Medical Education grant coordinator at megrants@emdserono.com or the Charitable Contribution and Sponsorship grant coordinator at csgrants@emdserono.com.

50. General Information for all Grants General Information (cont.) 9. Firewall Certification • EMD Serono prohibits providers and educational partners (including parent or sister companies) from both performing promotional services for EMD Serono and providing or accrediting independent medical education, unless an adequate firewall is in place. • Grant applicants for continuing medical education (CME) programs must certify that they meet the following firewall criteria: • Maintain separate employees/contractors for promotional services and independent medical education services. • Maintain separate legal entities for both types of services. • Maintain separation of promotional/independent medical education information and content, including, but not limited to, prohibition on sharing substantive information, physical separation of functions, and information technology safeguards. • Undergo routine and regular compliance training and audits. • Internally monitor compliance with company policies and applicable laws and regulations.