United States (U.S.) Practice to Policy Health Grants Program Guidance for Applicants The United States Practice to Policy Program invites applicants to download and submit an application between May 8 th and June 30 th, 2017 This document has been created to help explain the process of Intercept Pharmaceutical s United States (U.S.) Practice to Policy Health Grants Program, and to assist eligible applicants in completing their application form appropriately. Program overview and application process 1. Purpose of the Practice to Policy Health Grants Program The Practice to Policy Program was launched to be able to support the liver community to address primary biliary cholangitis 1 (PBC), with two parallel programs for the U.S. and for Europe and Canada. The programs will provide financial support for short-term initiatives that are funded for up to one year. The projects supported under this program are independent of the use of any particular therapeutic agent. Applications will be judged according to the criteria given in section 13, and grants will be awarded to healthcare providers, organizations and institutions for projects that align to the following eligibility criteria: Eligibility criteria The Practice to Policy Health Grants Program encourages the development of innovative solutions that support high standards of primary biliary cholangitis (PBC) patient care. In 2017, Intercept is excited to offer grant support to local and national projects in PBC that activate and empower PBC patients and the community. This includes: Helping people with PBC understand and proactively engage in the management of their condition Activating healthcare professionals to address PBC with more urgency in their own practices or communities Implementing strategies that support people with PBC in adhering to their treatment regimens *Initiatives can be aimed either directly to people with PBC or healthcare professionals 1 Formerly known as primary biliary cirrhosis 1
Applicants Healthcare providers and organizations Academic institutions Policy organizations Patient organizations Please ensure you match the eligibility criteria before applying to this program. If you are seeking grants or other funding for medical education (either CME or IME), please visit: https://grants.interceptpharma.com. If you are interested in investigator-initiated research grants please visit: https://research.interceptpharma.com. 2. The process of applying for an award To apply for an award, complete the online application form. A PDF version of the application form is available on the website to help you prepare your application, but all applications must be submitted using the online form. 3. Applying for 100 percent of your project funding to come from Intercept Pharmaceuticals Intercept Pharmaceuticals will consider applications that are requesting 100 percent of their project funding through this program. Intercept will also consider projects that have secured alternative sources of funding. If your project has an alternative source of funding, there must be a set of measurable outcomes and deliverables to be achieved by the end of the Intercept award period. Intercept also requires that applicants disclose any additional sources and amounts of funding in the application form. 4. Applying for support for an ongoing project It is possible to apply for support for an ongoing project. However, the project for which the applicant is requesting funding must act as a standalone component of the organization or institution s activities. As part of the funding conditions, Intercept will require the methodology, results and learnings of the funded project to be disseminated through relevant channels. The existence of ongoing components of a project must not compromise the ability to communicate best practices developed via the Intercept award. Completing an application form 5. What to include in your application The application form provides a structure to follow. The outline below also indicates what should be included in your completed form: Applicant details (full name, job title, department, address, country and contact information) Applicants will need to upload: o Legal proof that they are part of their organization/institution (e.g. scanned copies of organization/institution ID card, payment slip, official document) o A letter of support for the project from their organization/institution (see section 8 for further information) 2
o Any letters of support from external stakeholders (where applicable) should also be submitted at this stage of the online application (see section 9 for further information) Overview of your organization/institution (size, objectives, vision) Project overview and objectives Information regarding your capacity to initiate and implement the project in a timely manner A clear methodology including: o Specific, measurable, achievable, realistic and time-sensitive project milestones and action steps required to meet project goals o Proposed process for collection and analysis of data o Deliverables o Demonstration of cost-effectiveness where applicable Clear details of the budget (refer to section 7 for further details) 6. Including references in your application Cite any statistics you provide appropriately and list all references within your application. 7. Completing the budget planner In order for your application to be considered, you must include full details of the amount of funding being requested, including a justification for all items in the budget table. Applications that provide a more detailed breakdown of exactly how funds are to be used will receive greater consideration. Applications without an appropriately completed budget table cannot be considered. The budget table must be completed in USD ($). Please find a sample template of the budget planner below. Sample budget table from the application form Project/resource costs Staffing (describe roles, grades and whole time equivalent (WTE)) Please note: Funding will only cover temporary staff required for the timelines of the project, where 100% of their time is resourced to the funded project. Capital expenditure i.e. for existing or new permanent staff will not be covered by funding. Production (e.g. of materials) Equipment (not capital expenditure for equipment which would be used after the project) Total cost of resource within project USD ($) Amount requested from Intercept USD ($) Justification for Intercept funding requested 3
Expenses and travel Other (specify if applicable) Other (specify if applicable) Total Please note: Intercept is unable to offer funding for: (i) activities that are not fundamental to the delivery of the project; (ii) entertainment; or (iii) costs associated with capital expenditure It is a requirement that any unused funds are returned to Intercept Cannot be more than 45% of an organization s total funding Capital expenditure is not permitted within the funding 8. Demonstrating support from your organization or institution All applications should be signed by a senior member of your organization. For applications submitted on behalf of an institution, we require applicants to demonstrate support in the form of a signed and dated letter from a senior staff member when submitting the application. The letter of support must be uploaded under section 2 of your online application form before the application deadline. Please ensure the letter is written in English, quotes the full name of the applicant, the project title, and states that the institution endorses the proposed project. 9. Demonstrating support from stakeholders associated with your project If you have gained endorsement from any relevant organizations, institutions or project stakeholders, please upload the documents under section 2 of your online application form before the application deadline. This should demonstrate that the stakeholder has considered and supports the potential impact of your project on its locality. 10. Ensuring application forms are complete Please ensure your application form is complete before submission. All received applications will be reviewed prior to official consideration to ensure quality and identify important missing information. Should any missing information be identified in advance of the judging meeting, the U.S. Practice to Policy Program team may contact you to seek clarification. If you do not submit the information quickly upon request, your application may be rejected. 11. Recalling a submitted application An application can be recalled on the condition that it is re-submitted by the application deadline of June 30, 2017. To recall an application, email us.icptpracticetopolicy@wisper-public-affairs.com. Judging of applications 12. The judging committee A judging committee will be responsible for voting on which applications should receive awards. This committee consists of two senior Intercept representatives and three external judges representing 4
perspectives from the medical and patient communities who are familiar with the objectives of the program. 13. The judging criteria Applications will be judged on the extent to which they satisfy the criteria outlined below: Alignment to the eligibility criteria (please refer to section 1 for criteria) Demonstration of a clear purpose and rationale for the project A clear methodology for the project, including: o Measurable objectives and outcomes based on coherent deliverables o Impact in terms of creating valuable insights, evidence and learning for the wider healthcare community o Carefully considered and realistic timelines and milestones A clear and justified budget table (see section 7 for further information) Demonstration of endorsement from your institution and any other institutions involved in the project Ability of applicant to deliver the project with an associated publication Successful applicants 14. Next steps for successful applicants Successful applicants will be notified in August 2017 and asked to sign an award agreement letter in line with the PhRMA Code on Interactions with Health Care Professionals and the PhRMA Principles on Interactions with Patient Organizations, as well as any applicable laws and regulations. The award agreement letter will outline: The total amount of the award The payment staging and conditions The core requirements of the award The responsibilities of each party Expectation for PhRMA Code compliance and compliance with any applicable laws and regulations Successful applicants will be required to engage with members of Intercept to provide an interim report on the project s progress at times to be determined. 15. Timeline for provision of funding The program will provide financial support between $10,000 and $20,000 for short-term initiatives that last up to 1 year. Upon confirmation of an award from the U.S. Practice to Policy Health Grants Program, Intercept will engage with the successful party to create a written agreement detailing project milestones and terms of payment release. 5
16. Publishing the details of awards Details of all successful projects from the U.S. Practice to Policy Health Grants Program may be included on the Intercept website (www.interceptpharma.com). Intercept reserves the right to utilize project materials, project summaries and presentations for the purpose of sharing best practices externally. 17. Commitments required from successful applicants It is a requirement that successful applicants: Provide Intercept with interim and final reports on their project detailing their methodologies and results Work with Intercept on a project winners event to present study results and showcase their best practices. This event will take place in late 2017/early 2018 via webinar or in person, and may include the use of video recordings or interview quotes. Successful applicants maintain the right to withdraw from participation in video recordings and interviews. Permit the sharing of their organization/institution details in addition to their funded project being highlighted on the Intercept U.S. Practice to Policy Health Grants Program website. Commit to the dissemination of their methodologies and results through the relevant channels, including but not limited to: publications, manuscripts and toolkits to ensure education around best practices within and beyond their organization/institution s network. Intellectual property rights would remain in the ownership of the project leads. It is Intercept s policy in line with transparent disclosure requirements that any publication acknowledges financial support from Intercept. Unsuccessful applicants 18. Feedback for unsuccessful applicants The judging panel will supply feedback for unsuccessful applicants within 6 weeks of the judging decision. 19. Re-applying for future programs Applicants who are unsuccessful in this application window are welcome to apply to future programs. For all specific application queries, please email the U.S. Practice to Policy Health Grants Program team at us.icptpracticetopolicy@wisper-public-affairs.com. We look forward to receiving your application! 6