Commercial Support Letter of Agreement

COMMERCIAL SUPPORT LETTER OF AGREEMENT FOR A CONTINUING MEDICAL EDUCATION ACTIVITY Introduction Accredited providers of continuing medical education activities have a responsibility to assure that activities that are certified for credit meet the criteria and standards of the Accreditation Council for Continuing Medical Education (ACCME) Accreditation Council for Pharmacy Education (ACPE) and the American Nurses Credentialing Center (ANCC) and other accreditations. Compliance with the standards for commercial support of continuing education is an integral part of the process. One of the key factors related to the use of commercial support is the execution of a commercial support letter of agreement (CSLOA) between the accredited provider and the commercial interest (grantor) providing funding to support the activity. The purpose of the CSLOA is to document the independence of the accredited provider from any influence of the commercial interest in the development and conduct of the educational activity and to establish the terms and conditions under which the educational grant will be received.

This commercial support letter of agreement between USF Health’s Office of Continuing Professional Development (accredited provider) and (commercial interest) contains the purposes, terms and conditions for which an educational grant in support of a continuing educational activity is made.

(This form must be typed or printed legibly) Title of Activity: Location: Commercial Interest (Company Name/Branch): Address: City, State, Zip: Telephone: Fax: Contact Person:

The above company wishes to provide support for the named continuing education activity by means of (indicate which option):

1. Unrestricted educational grant for support of the activity in the amount of $

2. Restricted grant to reimburse expenses for: A. Speaker(s) 1. 2. To include: All expenses ______Travel only ______Honorarium Only ______

B. Support for catering functions (specify): In the amount of $

C. Other in-kind support (e.g., equipment loan, brochure distribution, etc.)

Educational Partner(s): (Name) (Contact person)

(Phone) (Fax) (E-mail)

Revised 6/07, 3/08, 1/9/13 CONDITIONS

1. Statement of Purpose: Program is for scientific and educational purposes only and will not promote the commercial interests products, directly or indirectly.

2. Control of Content & Selection of Presenters & Moderators: Accredited provider is solely responsible for control of content and selection of presenters and moderators. The commercial interest agrees not to attempt to direct the content of the program.

3. Disclosure of Financial Relationships: Accredited provider will assure meaningful disclosure to the audience, at the time of the program, of (a) commercial support and (b) any significant financial relationship between the accredited provider and the commercial interest or between individual speakers, moderators, planning committee, staff or authors and the commercial interest related to the content of the activity.

4. Involvement in Content: There will be no “scripting”, emphasis, or direction of content by the commercial interest or its agents. There will be no content review by the commercial interest.

5. Ancillary Promotional Activities: No promotional activities will be permitted in the same room as the educational activity. No product advertisements will be permitted in the activity room or in the activity syllabus.

6. Objectivity & Balance: The accredited provider will make every effort to assure that data regarding the commercial interest’s products (or competing products) are objectively selected and presented with favorable and unfavorable information and balanced discussion of prevailing information on the product(s) and /or alternative treatments based on scientific evidence.

7. Limitations on Data: The accredited provider will assure, to the extent possible, meaningful disclosure of limitations on data, e.g., ongoing research, interim analyses, preliminary data or unsupported opinion.

8. Discussion of "Off-Label" or Unapproved Uses: The accredited provider will require that presenters disclose to the provider when a product is not approved in the United States for the use under discussion and such information will be disclosed to the learner.

9. Opportunities for Debate: The accredited provider will assure meaningful opportunities for questioning or scientific debate.

10. Independence of accredited provider in the use of Contributed Funds:

a. Funds should be in the form of an educational grant made payable to USF HPCC (USF Health Professions Conferencing Corporation) - Program # . Tax ID # 16-1765073.

Checks should be mailed to: USF Health, Office of Continuing Professional Development, 12901 Bruce B. Downs Blvd., MDC 46 Tampa, FL 33612-4799

b. All other support associated with the accredited educational activity (e.g., distributing brochures, in-kind donations) must be given with the full knowledge and approval of USF Health.

c. No other funds from the commercial interest will be paid to the program director, faculty or others Revised 6/07, 3/08, 1/9/13 involved with the accredited activity (i.e.: additional honoraria, extra social events) The commercial interest agrees to abide by all requirements of: 1) the ACCME, ACPE and/or ANCC Standards for Commercial Support of Continuing Medical Education (appended); 2) applicable laws; and 3) the PhRMA Code.

The accredited provider and all educational partners agree to: 1) abide by the ACCME, ACPE and ANCC Standards for Commercial Support of Continuing Medical Education, 2) acknowledge commercial support in activity brochures, syllabi, and other materials, and 3) upon request, furnish the commercial interest a report concerning the expenditure of the funds provided.

11. Entire Agreement: This agreement constitutes the sole and only agreement of the parties and supersedes any prior understandings, or written or oral agreements between the parties with respect to the subject matter of this agreement.

AGREED

Commercial Interest Representative (name)

Signature Date

Associate VP/Associate Dean, USF Health OCPD (name) Deborah Sutherland, Ph.D.

Signature Date

Revised 6/07, 3/08, 1/9/13 Revised 6/07, 3/08, 1/9/13