Grant # [Grant Number]

NON CME/CE

LETTER OF AGREEMENT

Between Grant Recipient ______and Novartis Pharmaceuticals Corporation

Title of Activity: ______

Location (if applicable): ______Date(s): ______

Sponsor: Novartis Pharmaceuticals Corporation, 59 Route 10, East Hanover, New Jersey 07936

Grant Recipient: ______

Address: ______

City, State, Zip: ______

Telephone: ______Fax: ______Contact Person: ______

Tax I.D. No. ______

Novartis Pharmaceuticals Corporation (“Novartis”) wishes to provide support for, the named activity by means of:

A grant in the amount of $ ______

1.  Statement of Purpose: The activity is for scientific and/or educational purposes only and will not promote Novartis’ products, directly or indirectly. This grant is not being given in exchange for any explicit or implicit agreement to purchase, prescribe, recommend, influence or provide favorable formulary status for any of Novartis’ products. The amount of the grant is based upon a budget provided to Novartis by the Grant Recipient reflecting a good faith estimate of the actual cost of the educational or scientific activity to be funded pursuant to this Letter of Agreement. The amount of the grant has not been determined in a manner that takes into account the volume or value of referrals or business, if any, generated between Novartis and the Grant Recipient or any of their respective officers, directors, employees, agents, affiliates, parents or subsidiaries.

2.  Control of Content & Selection of Presenters & Moderators: Activities for which Novartis provides grant support must be created independently of any commercial influence or bias. Grant Recipient is responsible for control of content and selection of presenters and moderators (if any). Novartis may not provide suggestions for topics and/or speakers. Novartis will not participate in the selection of speakers or content. Novartis will not have any control of the organization and/or operation of the educational activity. The Grant Recipient is responsible for identifying Conflicts of Interest of potential faculty and either resolving them or disqualifying those faculty member(s) for whom a resolution cannot be reached. Invitations and/or mailing lists pertaining to the activity will not be generated or distributed by Novartis and will not be generated by the Grant Recipient in a manner to reflect the sales or marketing goals of Novartis.

3.  Disclosure of Financial Relationships: 1.) Novartis shall have the right to disclose the financial support provided under this agreement by posting on its corporate website and/or sharing in different or additional forms as Novartis may reasonably choose or as may be required under state, federal or local laws, a Corporate Integrity Agreement or similar agreement, a listing of all medical education grants and charitable contributions processed by Novartis Pharmaceuticals Corporation provided to healthcare related organizations. The information to be disclosed (e.g. posted on the Novartis Corporate website) may include, but may not necessarily be limited to, the following: (a.) the ultimate recipient organization’s name, (b) a brief description of the program and (c) the amount of the grant. 2.) The Accredited Provider will ensure disclosure to the audience of (a) Novartis funding and (b) any relationship between the Accredited Provider and Novartis or between individual speakers or moderators and Novartis. 3.) The Accredited Provider will acknowledge support from Novartis in brochures, syllabi, and other activity materials.

4. Ancillary Promotional Activities: The activity to be funded cannot include commercial exhibits as part of the overall activity funded by this grant. No promotional activities will be permitted in the same room as a certified educational activity. The conduct of promotional activities is not a condition of the making of this grant.

5.  Objectivity & Balance: The activity will be independent, non-promotional, and free from commercial influence or bias. If Novartis products are mentioned in the course of this activity, the Grant Recipient will make every effort to ensure that data regarding Novartis’ products (and competing products) are objectively selected and presented, with favorable and unfavorable information and balanced discussion of prevailing information on the product(s) and/or alternate treatments. Generic names of products, rather than Brand names, will be utilized for all products mentioned in the program. The title of the activity will fairly and accurately represent the scope of the presentation. The activity will present discussion of multiple treatment options, and will not focus on a single product, except when options are so limited as to preclude meaningful discussion. The Grant Recipient will ensure, to the extent possible, disclosure of limitations of data, e.g., ongoing research, interim analyses, preliminary data, or unsupported opinion(s).

6. Discussion of Unapproved Uses: Grant Recipient will require that presenters disclose when a product is not approved in the United States for the use under discussion.

7. Opportunities for Debate: Grant Recipient will ensure opportunities for questioning and/or scientific debate, if appropriate for

event/program.

8. Independence of Grant Recipient in the Use of Contributed Funds and the Conduct of the Activity:

a.  Funds will be in the form of a grant made payable to the Grant Recipient. Novartis’ financial responsibility is limited to the amount of the grant set forth in this Letter of Agreement. Any claims for payment by subcontractors or third parties involved in the activity to be funded are the sole responsibility of the Grant Recipient

b.  All other support associated with this activity (e.g., distributing brochures, preparing slides) must be given with the full knowledge and approval of the Grant Recipient

c.  No additional funds from Novartis will be paid to the program director, faculty, or others involved with the activity (additional honoraria, extra social events, etc.). No funds from Novartis will be used to reimburse or defray the costs of travel, lodging, or other personal expenses of non-faculty healthcare professionals attending event/conference or other third-party scientific or educational conferences or professional meetings, whether directly to the individuals attending the conference or indirectly to the conference sponsor (except in the case of financial assistance for medical students, residents, fellows and other healthcare professionals in training provided that the selection of individuals who will receive the funds is made by the academic or training institution). In addition, no funds from Novartis will be used to compensate for the time spent by healthcare professionals attending the conference or meeting. The scheduling of meals and/or receptions, if any, in connection with the activity to be funded is at the sole discretion of the Grant Recipient. Meals and/or receptions, if any, will be modest and be conducive to discussions among faculty and attendees, and the amount of time at the meals or receptions will be clearly subordinate to the amount of time spent at the educational portion of the activity

9. Multiple Letters of Agreement: The Novartis Letter of Agreement needs to be signed by the Grant Recipient to proceed with this activity. Novartis will not sign a separate Letter of Agreement from the Grant Recipient.

10. Reconciliation of Expenses: Within ninety (90) calendar days of the conclusion of the program, the Accredited Provider will provide Novartis with the following: a report, consistent with the submitted grant proposal, outlining the measurement of the program in meeting the stated educational objectives of the program, the final agenda, and a reconciliation of actual expenses versus estimated expenses. If requested by Novartis, the grant recipient will issue a refund to Novartis for money not spent in the implementation of the program in a timely manner.

11. Compliance with Pertinent Standards: The Grant Recipient agrees to abide by all relevant standards including: (a) U.S. Food and Drug Administration's Guidance for Industry: Industry-Supported Scientific and Educational Activities; (b) PhRMA Code on Interactions with Healthcare Professionals (c) Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers, and all other relevant standards and guidelines. Novartis will not be responsible for any deviation or departure from relevant standards and guidelines that is the not the direct fault of Novartis.

12. Choice of Law: The parties agree that this Letter of Agreement will be governed by and interpreted under the laws of the State of New Jersey without regard to its conflict of laws rules.

13. Integrated Agreement: The parties agree that this Letter of Agreement sets forth the entire understanding regarding the subject matter hereof, supercedes all prior agreements or understandings, whether written or oral, between the Grant Recipient and Novartis and may only be modified upon the mutual written agreement of the Grant Recipient and Novartis.

14. List of Excluded Individuals/Entities: The Grant Recipient certifies that none of its employees or subcontractors is on the Office of Inspector General’s List of Excluded Individuals/ Entities or has been debarred, excluded or is otherwise ineligible to participate in any Federal healthcare program.

15. Novartis Grant Approval Process: Commitment to support the activities specified in this Letter of Agreement is not extended until the activity has been explicitly approved through the Novartis Grant Approval Process.

AGREED

Authorized Representative of Grant Recipient Novartis Pharmaceuticals Corporation

By: ______By: ______

(Print Name) (Print Name)

Title: ______Title: ______

Signature: ______Signature: ______

Date:______, 201____ Date: ______, 201 ____

NCME 001

Rev. January 24, 2011 Page 1