MEDICAL EDUCATION GRANTS SOBI TERMS AND CONDITIONS
1. Program. Organization has filed a grant application with Sobi wherein it has requested financial support for a continuing medical education program (“Program”). Organization shall only use the funds contributed by Sobi hereunder to support the Program and to provide the medical education grant benefits as each are described in more detail in this application and supporting documentation.
2. Funding. In the event Sobi approves the Program grant, any funding Sobi provides shall be paid only to the Organization.
No other funds shall be paid by Sobi to the Organization or to any individual in connection with the Program. The Organization may not, under any circumstances, use this funding to i) defray its ordinary or customary operating expenses or to reduce a recipient's otherwise budgeted operational expenses; ii) fund payments for consulting or other services or goods unrelated to the Program; iii) support the costs of honoraria, travel, lodging or other personal expenses of non-faculty patients or HCPs attending or participating in the Program; iv) compensate non-faculty patients or HCPs for time spent at an educational activity apart from the Program; v) fund salaries of hospital nurses, residents, or other healthcare professionals, or any other routine administrative costs of a healthcare professional (except for certain fellowship programs); vi) pay for activities that should be covered by fee-for-service contracts such as consulting services, advisory boards, etc.; or vii) pay for recreational activities.
Organization represents and warrants that none of the above funding will be used for any purpose prohibited by law or by the PhRMA Code on Interactions with Healthcare Professionals.
Sobi does not fund educational grants contingent on prescribing, purchasing, referring, arranging for, or ordering of, Sobi products or to induce the prescription, purchase, referral, arrangement for, or ordering of, Sobi products in the future.. Sobi funding is not provided or intended to encourage Organization, or its members, to order, prescribe or recommend Sobi products. Sobi funding is also not intended as a price term or offered in lieu of a price concession or intended to encourage off-label use
Organization represents and warrants that it has offered the opportunity to fund the medical grant Program, to other potential grant funders and that the grant funding opportunity was not intended only for Sobi.
4. No Tangible Benefits. Sobi may not receive complimentary exhibit space or any other type of tangible benefit in exchange for providing funding of a Program, except that Sobi may be recognized as a provider of grant funds, as appropriate, at the educational activity.
5. Statement of Purpose. Organization represents that the Program is for scientific and educational purposes and that it will include meaningful opportunity for debate and discussion. The content of the Program shall be non-promotional in nature and tone. Any discussion during the Program of Sobi or other company products shall be objective, balanced and scientifically rigorous. Any discussions of investigational compounds, or unapproved uses of approved products, shall be accompanied by appropriate disclosure that such uses are not FDA approved.
6. Control of Content or Activity. Organization shall be solely responsible for control of the planning and content of the Program. Sobi will not direct or influence the content, organization, operation, content, materials, faculty, speakers, presenters, moderators, audience, or venue of the Program, or selection of Program faculty or Program invitees. The grant recipient will take responsibility for and control over the identification of educational needs; determination of educational objectives; selection of content, faculty or other persons and organizations that will be in a position to control the content of the activity, educational methods, materials, target audience and venue; evaluations; and presentation of content.
7. Transparency. Organization understands that state and federal transparency laws, including but not limited to those under the Affordable Care Act, (including the Sunshine Act or “Open Payments” which is the program implementing the National Physician Payment Transparency Program) may require Sobi to provide information about any of its educational grants, including the identity of the organizations it funds and program participants, to state and federal authorities, who may make certain of this information public. Organization expressly permits Sobi to make such required disclosures. Organization agrees to provide Sobi with written records and other information to comply with any applicable transparency requirements that Sobi may have, upon reasonable advanced notice.
8. Acknowledgment of Support; License to Use Sobi’s Name. Organization shall disclose to the attendees at the time of the Program, or in the publication of the Program: (i) Sobi’s financial support or funding of the Program; (ii) any significant relationships between Organization and Sobi, and between the individual presenters or moderators or other person who is in a position to control the content of the educational activity and Sobi; and (iii) whether any unapproved uses of products will be discussed.
To satisfy the acknowledgement requirement, Sobi grants to Organization a limited, non- exclusive and non-transferable license to use Sobi’s name, logos, trademarks and/or service marks solely in connection with materials for the Program and only for the purpose of complying with the terms of this Agreement and/or providing any agreed upon grant benefits.
9. Relationship between the Parties. Sobi’s business is separate and apart from any that may be operated by Organization. Neither party has the authority to act for the other and neither party is responsible for any obligations or expenses of the other, except as established by this Agreement.
10. Audit. Upon reasonable notice and at reasonable times, Sobi shall have the right, at its expense, to audit and examine all contracts, documents, correspondence, account and expense records, and any other material, which relate to the Program, subject to any confidentiality agreements to which Organization may be bound.
11. Compliance with Law. The parties shall comply with all applicable laws and regulations, including, without limitation, the Federal Food, Drug, and Cosmetic Act, the Anti-Kickback Statute, and the Transparency Reporting Provisions of Section 6002 of the Affordable Care Act (the “Sunshine Act”). In the event Sobi believes Organization has violated any law, Sobi will notify Organization and this Agreement shall immediately be considered void. Upon voiding, the entire funding provided in Section 2 shall be immediately returned to Sobi.
12. Exclusion/Debarment. Organization represents and warrants that it is not: (i) excluded from any Federal health care program as outlined in Sections 1128 and 1156 the Social Security Act (see the Office of Inspector General of the Department of Health and Human Services List of Excluded Individuals/Entities at http://oig.hhs.gov/exclusions/index.asp); (ii) debarred by the Food and Drug Administration under 21 U.S.C. § 338a (see the FDA Office of Regulatory Affairs Debarment List at http://www.fda.gov/ICECI/EnforcementActions/FDADebarmentList/ucm2005408.htm); (iii) otherwise excluded from contracting with the federal government (see the Excluded Parties Listing System); and iv) debarred by the ACCME or a similar recognized accrediting organization.
Additionally, Organization represents and warrants that it is not i) an individual, group practice, or physician owned clinic (including those grants made at the request of an HCP in his/her individual capacity); ii) a managed care organization or prescription benefits manager; or iii) an organization where an HCP has a proprietary or ownership interest in the organization.
13. This Agreement does not obligate Sobi to provide any medical grant funding in the event that Sobi, in its sole discretion, determines that the application does not meet Sobi’s requirements for the provision of medical grant funding. Notwithstanding the foregoing, in the event Organization’s application is approved, Organization and Sobi may enter into a separate written agreement setting forth the terms of the medical grant funding to be provided by Sobi. In the event of conflict between this Agreement and such written agreement, the provisions of the written agreement shall prevail with respect to Organization’s medical grant funding.
The undersigned hereby represents and certifies that he/she is an authorized representative of the Organization and has provided complete and accurate information in this application. By signing this application, Organization agrees to comply with all of the terms and conditions set forth below in the event Sobi approves the above medical grant request. Organization further understands and agrees that its failure to comply with any of the following terms and conditions may result in termination of Sobi’s medical grant funding.
