Regeneron Pharmaceuticals, Inc. Terms and Conditions of Funding

Patient Advocacy

  • Funding for Patient Advocacy Support will be made in accordance with one of the categories set forth below.

Charitable Contributions and Local Community Relations

  • You are a qualified organization tax exempt from federal income tax under Internal Revenue Code Sections 501(c)(3).
  • Regeneron shall pay all funds directly to you, and you shall bear the sole responsibility of paying any third parties with respect to the activity. Acceptance of the funding indicates your agreement to comply with these terms and conditions of funding.
  • The funding of the activity has not been determined in a manner that takes into account the volume or value of any business otherwise generated with Regeneron. The funding of the activity does not affect the purchase, use, recommending or arranging for the use of any product developed, marketed and/or manufactured by Regeneron, or the formulary status of any Regeneron product.
  • With respect to Local Community Relations, upon completion of the activity, you shall provide to Regeneron a written confirmation that the activity occurred. If the activity is cancelled prior to completion, you shall return the funding to Regeneron within thirty (30) days of such cancellation.
  • Regeneron may publicly disclose the amount, recipient(s) and/or description of the funding and activity, including with respect to funding provided to CMS-designated Teaching Hospitals under the National Physicians Payment Transparency Program, codified at 42 CFR Parts 402 and 403.
  • Approved funds cannot be re-purposed for uses other than for the approved request.
  • You shall acknowledge Regeneron's financial support in activity materials. Any use of the Regeneron logo shall be made upon approval and in accordance with any graphic standards provided by Regeneron.

Collaborations

  • Regeneron shall pay all funds directly to you or the designated third-party provider identified in the funding request, and you and/or such third-party provider shall bear the sole responsibility of paying any third parties with respect to the program. Regeneron shall not provide any other support for the program unless it is (i) consistent with any applicable legal requirements and industry guidelines and (ii) consistent with these terms and conditions. All funding must comply with these terms and conditions of funding, as well as the Letter of Agreement ("LOA"), which is issued when a request for funding is approved. You must agree to the terms and conditions of the LOA before any funding is issued.
  • The funding of the program has not been determined in a manner that takes into account the volume or value of any business otherwise generated with Regeneron. The funding of the program does not affect the purchase, use, recommending or arranging for the use of any product developed, marketed and/or manufactured by Regeneron, or the formulary status of any Regeneron product.
  • Upon completion of the program, you shall provide to Regeneron (i) a written confirmation that the program occurred, (ii) written confirmation that program was provided in accordance with the funding request, (iii) an itemized list of expenditures supported by the funding and any requested receipts, and (iv) at the request of Regeneron, supporting documentation and a copy of any program materials. Regeneron shall have the right, at its expense, to audit and examine documents and other records/materials that relate to the program.
    1. You represent and warrant that you are aware of and understand the reporting requirements under the National Physicians Payment Transparency Program, codified at 42 CFR Parts 402 and 403 (the "Sunshine Act").
    2. To the extent you make any direct or indirect payments or other transfers of value to Covered Recipients ("Covered Payments"), you shall track such Covered Payments in accordance with the requirements of the Sunshine Act.
    3. You shall provide to Regeneron detailed reports on each Covered Payment in the templates/format provided by Regeneron. You shall provide such reports on a monthly basis (and in no event later than forty-five (45) calendar days from making a Covered Payment). You will take all actions necessary to ensure that the information collected and submitted in each report is accurate and complete.
    4. You will supply Regeneron with any backup or other documentation requested by Regeneron in connection with any report. In addition you agree to maintain complete and accurate detailed supporting documentation evidencing all Covered Payments for a period of five (5) years and to make such documents available to Regeneron within twenty (20) calendar days of Regeneron's request.
    5. Capitalized terms used in this Paragraph 4 shall have the meanings ascribed to them in the Sunshine Act.
  • Regeneron may publicly disclose the amount, recipient(s) and/or description of the funding and program, including with respect to funding provided to CMS-designated Teaching Hospitals under the Sunshine Act.
  • Upon completion of the program, you shall promptly return any unused funds to Regeneron. If the program is modified or cancelled prior to completion, you shall return any unused funds together with a budget reconciliation to Regeneron within thirty (30) days of such modification or cancellation.
  • Approved funds cannot be re-purposed for uses other than for the approved request.
  • You shall be primarily responsible for designing and conducting the program, including the goals, activities and program messaging; provided, however, that the program shall comply with these terms and conditions and any applicable legal requirements and industry guidelines. Regeneron may provide resources or expertise to the program, including with respect to the creation and/or review of the materials and other program activities (e.g., providing comments, suggestions or feedback). Regeneron may also receive the right to use the materials or other outputs created pursuant to the program, and has the right to review such materials and outputs for accuracy and compliance with applicable legal requirements, industry guidelines and internal policies. The purpose of the program shall be to provide patient education and/or support.
  • You shall acknowledge Regeneron's financial support in all program invitations, syllabi and other written materials. At the program, there shall be written and/or oral disclosure to the program attendees of Regeneron's financial support, and any significant relationship between Regeneron and you or the presenters or moderators. Any use of the Regeneron logo shall be made upon approval and in accordance with any graphic standards provided by Regeneron.
  • The content and scope of the program shall be consistent with the title of the program, and there shall be opportunities during the program for discussion and questions.
  • You agree that the program, including development of the program and program materials, shall conform, as applicable, to the AMA Guidelines on Gifts to Physicians, U.S. Food and Drug Administration regulations and guidance, U.S. Department of Health and Human Services' Office of Inspector General guidance, and the PhRMA Code on Interactions with Healthcare Professionals

Displays & Exhibits

  • You shall provide Regeneron with exhibit space as described in the Exhibit Request Form or other funding request documentation provided to Regeneron.
  • Regeneron shall pay all funds directly to you or the designated third-party provider identified in the exhibit request. Regeneron shall not provide any other support for the program unless it is consistent with any applicable legal requirements and industry guidelines. Acceptance of the funding indicates your agreement to comply with these terms and conditions of funding.
  • The funding requested for the exhibit represents fair market value for the exhibit opportunity. The exhibit funding has not been determined in a manner that takes into account the volume or value of any business otherwise generated with Regeneron. The exhibit funding does not affect the purchase, use, recommending or arranging for the use of any product developed, marketed and/or manufactured by Regeneron, or the formulary status of any Regeneron product.
  • Upon completion of the program, you shall provide to Regeneron (i) a written confirmation that the program occurred, (ii) written confirmation that the exhibit opportunity was provided in full, and (iii) at the request of Regeneron, supporting documentation. If the program is modified or cancelled prior to completion, you shall return the exhibit funding to Regeneron within thirty (30) days of such modification or cancellation.
  • Regeneron may publicly disclose the amount, recipient(s) and/or description of the exhibit funding and program, including with respect to funding provided to CMS-designated Teaching Hospitals under the National Physicians Payment Transparency Program, codified at 42 CFR Parts 402 and 403.
  • You shall acknowledge Regeneron's exhibit support in program materials. Any use of the Regeneron logo shall be made upon approval and in accordance with any graphic standards provided by Regeneron.
  • You agree that the program, including development of the program and program materials, shall conform, as applicable, to the AMA Guidelines on Gifts to Physicians, the AMA Ethical Opinion on Continuing Medical Education, the ACCME Standards for Commercial Support, U.S. Food and Drug Administration regulations and guidance, U.S. Department of Health and Human Services' Office of Inspector General guidance, and the PhRMA Code on Interactions with Healthcare Professionals.
  • Requests for program funding outside of an exhibit opportunity must be submitted as a separate request (e.g. medical education request).

Educational Grants

  • Regeneron shall pay all funds directly to you or the designated third-party provider identified in the funding request, and you and/or such third-party provider shall bear the sole responsibility of paying any third parties with respect to the program. Regeneron shall not provide any other support for the program unless it is (i) at your written request and approval, (ii) consistent with any applicable legal requirements and industry guidelines and (iii) consistent with these terms and conditions. All educational grants must comply with these terms and conditions of funding, as well as the Letter of Agreement (“LOA”), which is issued when a request for funding is approved. You must agree to the terms and conditions of the LOA before any funding is issued.
  • The funding of the program has not been determined in a manner that takes into account the volume or value of any business otherwise generated with Regeneron. The funding of the program does not affect and is in no way related to the purchase, use, recommending or arranging for the use of any product developed, marketed and/or manufactured by Regeneron, or the formulary status of any Regeneron product.
  • Upon completion of the program, you shall provide to Regeneron (i) a written confirmation that the program occurred, (ii) written confirmation that the program was provided in accordance with the grant request, (iii) an itemized list of expenditures supported by the funding and any requested receipts, (iv) supporting documentation and a copy of any program materials, and (v) Outcomes documentation consistent with the Outcomes level stated in the application. Regeneron shall have the right, at its expense, to audit and examine documents and other records/materials that relate to the program.
    1. You represent and warrant that you are aware of and understand the reporting requirements under the National Physicians Payment Transparency Program, codified at 42 CFR Parts 402 and 403 (the “Sunshine Act”).
    2. To the extent you make any direct or indirect payments or other transfers of value to Covered Recipients (“Covered Payments”), you shall track such Covered Payments in accordance with the requirements of the Sunshine Act.
    3. You shall provide to Regeneron detailed reports on each Covered Payment in the templates/format provided by Regeneron. You shall provide such reports on a monthly basis (and in no event later than forty-five (45) calendar days from making a Covered Payment). You will take all actions necessary to ensure that the information collected and submitted in each report is accurate and complete.
    4. You will supply Regeneron with any backup or other documentation requested by Regeneron in connection with any report. In addition you agree to maintain complete and accurate detailed supporting documentation evidencing all Covered Payments for a period of five (5) years and to make such documents available to Regeneron within twenty (20) calendar days of Regeneron’s request.
    5. Capitalized terms used in this Paragraph 4 shall have the meanings ascribed to them in the Sunshine Act.
  • Regeneron may publicly disclose the amount, recipient(s) and/or description of the funding and program, including with respect to funding provided to CMS-designated Teaching Hospitals under the Sunshine Act.
  • Upon completion of the program, you shall promptly return any unused funds to Regeneron. If the program is modified or cancelled prior to completion, you shall return any unused funds together with a budget reconciliation to Regeneron within thirty (30) days of such modification or cancellation.
  • Approved funds cannot be re-purposed for uses other than for the approved request.
  • You shall be solely responsible for designing and conducting the program and for the program content; provided, however, that the program shall comply with these terms and conditions and any applicable legal requirements and industry guidelines. Regeneron shall have no control or influence whatsoever over the content of the program, provided that Regeneron may suggest broad topic areas and general educational needs for programs submitted in response to a Request for Proposal. The purpose of the program shall be patient education and/or support, medical education and/or the dissemination of scientific information. The program shall be free from commercial bias and shall not be designed to promote Regeneron products either directly or indirectly. You shall control the selection of presenters and moderators.
  • You shall develop the invitations and other materials advertising the program. You shall also determine the mailing/contact list to which invitations shall be sent for the program and the means of distributing them.
  • You shall acknowledge Regeneron’s financial support in all program invitations, syllabi and other written materials. Any use of the Regeneron logo shall be made upon approval and in accordance with any graphic standards provided by Regeneron.
  • The content of the program shall be consistent with the following principles, as applicable:
    1. The content and scope of the program shall be consistent with the title of the program.
    2. The program shall address all of the reasonable and relevant treatment options in the particular therapeutic area that is the subject of the program and shall not focus solely or unduly on a Regeneron product (unless it is the only reasonable treatment option for a particular disease or condition).
    3. Any discussion of Regeneron products, as well as any competing products and/or alternative treatments, shall be objective, balanced, scientifically rigorous and evidence-based. Any such discussion shall include both favorable and unfavorable information, including risk information, on all such products and treatments.
    4. There shall be meaningful disclosure to the program attendees of any limitations on data that is discussed (e.g., ongoing research, interim analyses, preliminary data or unsupported opinion).
    5. At the program, there shall be written and oral disclosure to the program attendees of (i) Regeneron’s financial support of the program, (ii) any significant relationship between Regeneron and you or the presenters or moderators and (iii) if applicable, the fact that product uses or other information discussed goes beyond the product labeling approved by the U.S. Food and Drug Administration.
    6. There shall be opportunities during the program for meaningful discussion, questions and scientific debate.
  • You agree that the program, including development of the program and program materials, shall conform, as applicable, to the AMA Guidelines on Gifts to Physicians, the AMA Ethical Opinion on Continuing Medical Education, the ACCME Standards for Commercial Support, U.S. Food and Drug Administration regulations and guidance, U.S. Department of Health and Human Services’ Office of Inspector General guidance, and the PhRMA Code on Interactions with Healthcare Professionals.

Scientific Conference Funding

  • Regeneron shall pay all funds directly to you or the designated third-party provider identified in the funding request, and you and/or such third-party provider shall bear the sole responsibility of paying any third parties with respect to the program. Regeneron shall not provide any other support for the program unless it is (i) at your written request and approval, (ii) consistent with any applicable legal requirements and industry guidelines and (iii) consistent with these terms and conditions. All funding must comply with these terms and conditions of funding, as well as the Letter of Funding, which is issued when a request for funding is approved. You must agree to the terms and conditions of the Letter of Funding before any funding is issued.
  • The funding of the program has not been determined in a manner that takes into account the volume or value of any business otherwise generated with Regeneron. The funding of the program does not affect the purchase, use, recommending or arranging for the use of any product developed, marketed and/or manufactured by Regeneron, or the formulary status of any Regeneron product.
  • Upon completion of the program, you shall provide to Regeneron (i) a written confirmation that the program occurred, (ii) written confirmation that the program was provided in accordance with the funding request, (iii) an itemized list of expenditures supported by the funding and any receipts, and iv) at the request of Regeneron, supporting documentation and a copy of any program materials. . Regeneron shall have the right, at its expense, to audit and examine documents and other records/materials that relate to the program.
    1. You represent and warrant that you are aware of and understand the reporting requirements under the National Physicians Payment Transparency Program, codified at 42 CFR Parts 402 and 403 (the "Sunshine Act").
    2. You agree that you will not use the funds to make any direct or indirect payments or other transfers of value to Covered Recipients ("Covered Payments") under the Sunshine Act.
    3. Capitalized terms used in this Paragraph 4 shall have the meanings ascribed to them in the Sunshine Act.
  • Regeneron may publicly disclose the amount, recipient(s) and/or description of the funding and program, including with respect to funding provided to CMS-designated Teaching Hospitals under the Sunshine Act.
  • Upon completion of the program, you shall promptly return any unused funds to Regeneron. If the program is modified or cancelled prior to completion, you shall return any unused funds together with a budget reconciliation to Regeneron within thirty (30) days of such modification or cancellation.
  • Approved funds cannot be re-purposed for uses other than for the approved request.
  • The program shall comply with these terms and conditions and any applicable legal requirements and industry guidelines. The purpose of the program shall be to educate research scientists, principal researchers, drug development professionals, academics, pre-doctoral students and/or doctoral students. The program shall not be designed to support the continuing professional development or education of healthcare professionals.
  • You shall acknowledge Regeneron's financial support in program materials. At the program, there shall be written and/or oral disclosure to the program attendees of Regeneron's financial support, and any significant relationship between Regeneron and you or the presenters or moderators. Any use of the Regeneron logo shall be made upon approval and in accordance with any graphic standards provided by Regeneron.
  • The content and scope of the program shall be consistent with the title of the program, and there shall be opportunities during the program for discussion and questions.

Sponsorships

  • Sponsorship opportunities shall detail the sponsorship recognition and/or benefits to be provided to Regeneron.
  • Regeneron shall pay all funds directly to you or the designated third-party provider identified in the funding request, and you and/or such third-party provider shall bear the sole responsibility of paying any third parties with respect to the program. Regeneron shall not provide any other support for the program unless it is (i) consistent with any applicable legal requirements and industry guidelines and (ii) consistent with these terms and conditions. Acceptance of the funding indicates your agreement to comply with these terms and conditions of funding.
  • The funding of the program has not been determined in a manner that takes into account the volume or value of any business otherwise generated with Regeneron. The funding of the program does not affect the purchase, use, recommending or arranging for the use of any product developed, marketed and/or manufactured by Regeneron, or the formulary status of any Regeneron product.
  • Upon completion of the program, you shall provide to Regeneron (i) a written confirmation that the program occurred, (ii) written confirmation that the sponsorship opportunity was provided in full, and (iii) at the request of Regeneron, supporting documentation. If the program is modified or cancelled prior to completion, you shall return the funding to Regeneron within thirty (30) days of such modification or cancellation.
  • Regeneron may publicly disclose the amount, recipient(s) and/or description of the funding and program, including with respect to funding provided to CMS-designated Teaching Hospitals under the National Physicians Payment Transparency Program, codified at 42 CFR Parts 402 and 403.
  • You shall acknowledge Regeneron's financial support in program materials. Any use of the Regeneron logo shall be made upon approval and in accordance with any graphic standards provided by Regeneron.
  • You agree that the program, including development of the program and program materials, shall conform, as applicable, to the AMA Guidelines on Gifts to Physicians, the AMA Ethical Opinion on Continuing Medical Education, the ACCME Standards for Commercial Support, U.S. Food and Drug Administration regulations and guidance, U.S. Department of Health and Human Services' Office of Inspector General guidance, and the PhRMA Code on Interactions with Healthcare Professionals.
  • Requests for program funding outside of a sponsorship opportunity must be submitted as a separate request (e.g. medical education request).