A Guide to ShireSupport Updated: Spring 2013

1. A Guide towww.ShireSupport.com Updated: Spring 2013 Shire Pharmaceuticals-SP

2. www.ShireSupport.com • These slides provide an orientation on • Registration, Eligibility and Submission Process • Therapeutic Areas of Interest • Funding Types • Charitable Contributions • Sponsorship Requests • Independent Medical Education • Continuing Medical Education • Fellowship Funding • Travel Grants for HCPs in Training • Disclaimer: Massachusetts • Finances • Reminders • Contact Information

3. Registration and Submission Process • Step One • Become a registered user of www.ShireSupport.com • When registering please have the following materials available • Legal name of the organization as registered with the IRS • A signed PDF copy of the organization’s W9 form • Note: Electronic signatures are NOT acceptable • If applicable, a PDF copy of the organization’s non-profit determination letter from the IRS • Step Two • Select the request type • Medical Education Grants • Healthcare related Charitable Contributions and/or Sponsorship Requests • Step Three • Submit the request with attachments as applicable

4. Eligible Medical Schools Hospitals/Medical Centers Medical Associations/Medical Societies Patient Advocacy Organizations Medical Education Companies Not for Profit organizations 501(c)(3)(4)(6) Ineligible Individuals Private or group medical practice(s) An organization that has been debarred or is on the OIG exclusion list An organization that is partially or wholly owned by practicing healthcare professionals Registration Eligibility If you represent an organization located in Massachusetts, please refer to slides 14-15.

5. Therapeutic Areas of Interest • ADHD • Adult • ADHD is a chronic neurologically based disease. Therefore Shire’s educational goal is to fund education that provides specialists with the information and tools needed to improve the screening, diagnosis, treatment, and management of adult patients with ADHD. • Adolescents • ADHD is a chronic neurologically based disease. Therefore Shire’s educational goal is to fund education that provides specialists with the information and tools needed to improve the screening, diagnosis, treatment, and management of adolescent patients with ADHD. • Pediatric • ADHD is a chronic neurologically based disease. Therefore Shire’s educational goal is to improve the screening, diagnosis, treatment, and management of pediatric patients with ADHD.

6. Therapeutic Areas of Interest • Gastroenterology • Mild to Moderate Ulcerative Colitis • Mild to moderate ulcerative colitis is a disease characterized by inflammation and ulceration of the lining of the colon and rectum. Shire’s educational goal is to fund education that provides specialists with the information and tools needed to improve the screening, diagnosis, treatment, and management of patients with mild to moderate ulcerative colitis. • Motility/Chronic Constipation • Chronic constipation is characterized by infrequent and difficult passage of stools over a prolonged period and a range of bothersome symptoms. Shire’s educational goal is to fund education that provides specialists with the information and tools needed to improve the screening, diagnosis, treatment, and management of female patients with chronic constipation. • Renal • Hyperphosphatemia • Hyperphosphatemia is an abnormal concentration of phosphates in the blood. Shire’s educational goal is to fund education that provides specialists with the information and tools needed to improve the screening, diagnosis, treatment, and management of patients with hyperphosphatemia.

7. Charitable Contributions Sponsorship Requests

8. Definitions of Funding Types Notice to all requestors located in Massachusetts: due to the Massachusetts Pharmaceutical and Device Manufacturer Conduct Law, Shire is unable to fund requests for the financial support for the costs of travel, lodging, or other personal expenses of non-faculty health care practitioners attending any CME event, third-party scientific or educational conference, or professional meetings, either directly to the individuals participating in the event or indirectly to the event’s sponsor.  While Shire has information on the charitable section of this website relating to Fellows and Residents travel grants, any organizations located in Massachusetts are not eligible due to this law.

9. Definitions of Funding Types

10. Independent Medical Education Continuing Medical Education Fellowship Funding Requests Travel Grants for HCPs in Training

11. Independent Medical Education

12. Shire’s Expectations: Independent Medical Education • Aligned with Shire’s areas of interest and are developed independently of Shire personnel involvement. • Developed to address the educational gap identified through the needs assessment. The educational gap could be related to clinical practice, knowledge, or skills. • Intent is to meet the identified educational gap, be appropriate for the educational audience, and lead to improved patient outcomes. • Honoraria offered to healthcare professionals serving as faculty reflects fair market values. • Live educational activities will be held at modest locations, which provide an environment conducive to learning. • Modest meals or social events will not compete with or take precedence over the educational activity. • Educational activities will be implemented in accordance with Shire’s Letter of Agreement. • Organizations determined to be non-compliant will be precluded from requesting educational grant funding from Shire.

13. Educational interventions for healthcare professionals include, but are not limited to: Courses: Local, Regional, or National Fellowship Funding Affiliated with an accredited organization Internet CME: Live or Archived Journal CME Performance Improvement Initiatives Teleconferences Travel Grants for HCPs in Training Must be associated with a major scientific meetings Examples of requests that Shire will not consider: Activities developed for professional or staff development Activities intended to develop clinical guidelines or algorithms Activities focused on promoting Shire products Activities that include retroactive support Activities developed by or in partnership with an organization that is partially or wholly owned by practicing healthcare professionals Shire’s Expectations: Independent Medical Education

14. Disclaimer Massachusetts Based Organizations

15. Massachusetts Pharmaceutical and Device Manufacturer Conduct Law • Shire is unable to fund requests for the financial support for the costs of travel, lodging, or other personal expenses of non-faculty health care practitioners attending any CME event, third-party scientific or educational conferences, or professional meetings, either directly to the individuals participating in the event or indirectly to the event’s sponsor.   • While Shire has information on the Continuing Medical Education section of this website relating to Fellowship Funding and Travel Grants for HCPs in Training, organizations located in Massachusetts are not eligible due to this law.

16. Finances Funding Availability Ineligible Budget Items Reconciliations

17. Shire Pharmaceuticals-SP – 2013 Funding Availability

18. Shire’s Expectations: Ineligible Budget Items • Independent medical education budget line items must not include: • Prizes • Gifts or service awards • Funding for guests • Travel and/or lodging reimbursement out of proportion with the activity dates • Faculty dinners not aligned with content review • Operating expenses not specifically aligned with the educational activity • Expenses related to exhibits

19. Financial Reconciliation of Sponsorships • All sponsorships must be reconciled within 90 days of the activity date • Reconciliations are to be completed online at www.ShireSupport.com • What’s needed • Comparative budget to actual reconciliation • Program expenses for the entire initiative must be included (not just funding provided by Shire) • Documentation of the commercial support acknowledgement statement • Note that failure to reconcile this request may prevent future Charitable and/or Sponsorship funding to your organization.

20. Financial Reconciliation for Independent Medical Education • Reconciliations are due within 90 days of the activity date • Reconciliations are to be completed online at www.ShireSupport.com • Complete the online reconciliation form with • Attendance information • Comparative budget to actual reconciliation (Program expenses for the entire initiative; not just what Shire provided) • Total Funding received from all sources = registration income, educational grants, and funding provided by the hosting organization • The evaluation summary • Documentation of the commercial support acknowledgement statement, i.e. “This activity was supported by an independent medical educational grant from Shire.” • Refunds are only due if the amount is greater than $250 • Failure to reconcile educational grants may prevent future funding to your organization.

21. Some Reminders… • Funding requests must be aligned to a Shire Pharmaceuticals-SP therapeutic area of interest to be considered • Funding requests must be submitted online to www.ShireSupport.com by the requesting organization without assistance from Shire employees • Faxed, mailed, or e-mailed requests will not be reviewed • Funding requests must be in compliance with all applicable guidelines • Timelines • All requests – educational, charitable contributions, or sponsorships – must be submitted 60 days in advance • Decisions are communicated by e-mail within 45-60 days of the request date • Requests will not be reviewed or approved after the activity has begun or taken place • Submission, or past approvals, does not guarantee support • Declined requests cannot be resubmitted • If a request is inadvertently submitted in the wrong category ShireSupport personnel will provide appropriate direction • Independent medical education requests may not include sponsorship requests and vice versa • Questions? • ShireSupport@shire.com or ShireSupportCME@shire.com

22. Contact Information