Agios Global Policy: Funding & In-Kind Support of External Organizations PDF

Funding and In-kind Support of External Organizations GLOBAL POLICY WHAT IS THE PURPOSE OF THIS POLICY? Agios employees are responsible for complying with...

Funding and In-kind Support of External Organizations GLOBAL POLICY WHAT IS THE PURPOSE OF THIS POLICY? Agios employees are responsible for complying with this policy and with applicable Compliance Handbooks and The purpose of this policy is to set forth the principles for ensuring that any contractors or third parties engaged and minimum standards for providing funding and in-kind by them to act on Agios’ behalf are subject to a written support to qualified organizations, associations, institutions agreement approved by Legal and adhere to the principles or other entities so that Agios’ support is provided for in this policy and applicable Compliance Handbooks. legitimate purposes and in accordance with applicable law and industry standards. WHO CAN I CONTACT WITH QUESTIONS? WHAT DOES THIS POLICY APPLY TO? If you have any questions about how to comply with this policy, please contact a member of the Compliance team. This policy applies to all requests for funding and in-kind support for educational grants, investigator-sponsored trials (“ISTs”) donations to charitable organizations (including independent charity patient assistance programs), and REPORTING VIOLATIONS sponsorships. Any knowledge of a violation, or suspected This policy does not apply to requests for research with violation, of this policy must be reported. Reports third parties for pre-clinical or other research that are can be made to your manager, HR, Compliance addressed by separate Agios processes or agreements or or Legal. to the provision of Agios products for “compassionate use” Reports can also be made anonymously via the or “expanded access” programs. Agios Compliance Helpline: This policy also does not apply to personal volunteering by Agios employees or employee membership in an external  (800) 792-8135 organization. To ensure such activities are consistent with  www.agios.ethicspoint.com Agios policies and do not present a conflict of interest, please consult with a member of the Compliance team. Agios prohibits retaliation against anyone for reporting, in good faith, a suspected violation of the Code of Business Conduct and Ethics, WHO DOES THIS POLICY APPLY TO? a company policy or the law. This global policy applies to all Agios employees worldwide. This policy is intended to be read together with all applicable Compliance Handbooks (“Compliance Handbooks”) adopted TRAINING by Agios. Each Compliance Handbook establishes standards Appropriate Agios employees shall undergo periodic training intended to comply with applicable local laws, regulations, covering principles and minimum standards for providing and industry codes and guidelines (“applicable laws”), some funding and in-kind support set forth in this policy and of which may impose more stringent requirements than set related policies and procedures. Training should occur on a forth in this global policy. If there is a conflict between this schedule and in a format to be determined by Compliance. policy, a Compliance Handbook or an applicable law, Agios employees must comply with the strictest standard. In cases where Agios provides funding or in-kind support in another country, the local laws and regulations as well as the local compliance standards must be followed. For additional guidance regarding specific requests, please consult a member of the Compliance team. This document is confidential and proprietary and is the exclusive property of Agios. Page 1 of 5 It may not be reproduced in any form without prior written approval from Agios. Version 1.0 | Effective Date: January 1, 2022  Funding and In-kind Support of External Organizations GLOBAL POLICY POLICY 1.4. Process Agios will establish and maintain processes for the review, 1. GENERAL REQUIREMENTS approval and administration of external funding. Any From time to time, Agios may provide funding or in-kind requests for external funding should be routed through support to third-party organizations and institutions, in these processes, and Agios employees may not commit to an effort to further the Company’s mission of promoting public health and enhancing patient care. All such funding award funding without following the appropriate approval must be made in accordance with this policy and meet the process. Agios shall not award funding for activities or events requirements of applicable laws, which may have additional that have already occurred. requirements than those set forth herein. 1.5. Sufficient Documentation 1.1. No Rewards, Inducements, Discounts, or Off-Label All funding requests must be in writing (including by Promotion electronic submission) from an authorized representative No funding or in-kind support may be provided or offered, of the requester and must include sufficient documentation directly or indirectly, to any Healthcare Professional (“HCP”), and detail to enable Agios to make an informed decision as Healthcare Organization (“HCO”), or other individual to whether Agios’ support would comply with this policy. or organization to induce or reward the prescription, recommendation, purchase, supply or administration 1.6. Written Agreement/Acknowledgement of Agios products. Agios shall not measure or track the impact of funding or in-kind support on the prescription, All external funding activities must be documented in a recommendation, purchase, supply or administration of written agreement or acknowledgement using a template Agios products. Funding or in-kind support shall not be approved by Legal prior to issuing payment or providing in- used as price concessions or discounts on Agios products, kind support. The written agreement or acknowledgement or to secure any improper business advantage. must contain a clear description of the payment or in-kind support provided and its purpose, and where applicable, With the exception of sponsorships, external support is any tangible benefit received by Agios. non-promotional in nature and should not be used to inappropriately promote Agios products. In all instances, 1.7. Disclosure of Funding external support should not be used to support any activity that may result in off-label or inappropriate (e.g., unbalanced) Agios shall track and disclose any funding required to be promotion of Agios products. disclosed under applicable local laws and in accordance with its spend tracking procedures. Generally, funds must not be 1.2. Appropriate Recipients allocated specifically to the provision of meals, recreation, entertainment, or other expenses related to HCPs (although Payment may be made only to qualified organizations based on standard, objective criteria for bona fide purposes. Except Agios may separately provide meals at certain third-party where admissible under local requirements, Agios may not conferences or professional meetings, consistent with Global provide funding to individual HCPs or HCP-owned practice Policy on Interactions with Healthcare Professionals and groups. Agios may sponsor HCPs to attend events (e.g., Healthcare Organizations and any requirements established symposia, congresses and other educational or professional by the conference or meeting organizer). meetings) where legally permissible and subject to a legitimate scientific need (i.e., with the purpose of providing scientific 2. EDUCATIONAL GRANTS or educational information or informing HCPs about Agios Agios provides non-promotional funding to external products), consistent with Global Policy on Interactions with organizations, or HCPs outside the US where permitted Healthcare Professionals and Healthcare Organizations. by applicable law, to support bona fide educational and scientific activities that will benefit public health and improve 1.3. No Cash Payments patient care. Such educational grants are permissible only if Agios shall pay all funds by check, wire transfer or similar they are independent, delivered to an audience selected by means to the institution requesting the support, not to any the organization, and present information that is balanced, individual. Cash payments are not permitted. accurate and non-misleading. This document is confidential and proprietary and is the exclusive property of Agios. Page 2 of 5 It may not be reproduced in any form without prior written approval from Agios. Version 1.0 | Effective Date: January 1, 2022  Funding and In-kind Support of External Organizations GLOBAL POLICY 2.1. Continuing Medical Education for which it provides an educational grant, and Agios may not provide any advice or guidance even if asked. However, Agios may provide educational grants to support independent Agios may limit its funding of educational grants to topics or continuing medical education (“CME”) in order to help of interest to Agios. physicians and other medical professionals obtain information and insights that contribute to the improvement of patient 2.5. Use of Funds care. Agios may support accredited CME programs or unaccredited education programs in accordance with Funding for educational grants should be unrestricted, this policy, provided that such programs are conducted conveying full fund disbursement discretion to the requester. in accordance with the standards for commercial support Agios shall not offer financial support for: established by the Accreditation Council for Continuing Medical Education (“ACCME”) or other entity that may T he costs of travel, lodging or other personal expenses accredit the CME. Educational grants for CME should support of non-faculty HCPs attending an educational program, education on a full range of treatment options and not either directly to the individuals participating in the event promote a particular medicine. or indirectly to the event’s sponsor (except as expressly provided for Scholarships below or if permitted by applicable Educational grants may not be awarded to an organization laws and approved in advance in writing by Compliance); that has been debarred by the ACCME or other applicable accrediting entity, is on an exclusion list maintained by a T  ime spent by HCPs participating in the event; or, governmental authority for the relevant country, is owned The direct provision of meals, recreation, or entertainment or subject to a proprietary interest by an HCP, or has been for participants (although the sponsor may elect to apply involved in a recent Agios marketing or promotional strategy. Agios funding to the provision of a meal for all attendees). Educational grants to individual HCPs, where permitted by applicable law, must be approved in advance in writing 2.6. Promotional Activities by Compliance. Agios may not engage in any sales or promotional activities Agios may not provide meals at CME events. in the same space, or at the same time that an educational activity is taking place. Any promotional activities associated 2.2. Third-Party Educational or Professional Meetings with educational events (e.g., promotional exhibits or Agios may provide educational grants to organizations advertisements) must follow the sponsor’s rules, the ACCME for third-party scientific and educational conferences or Standards or other applicable local standards (for CME), and professional meetings where: be clearly separate from the educational content. T he gathering is primarily dedicated, in both time and 2.7. Awards, Fellowships and Scholarships effort, to promoting objective scientific and educational activities and discourse; and Agios may provide educational grant funding for Scholarships or Fellowships in accordance with this policy. The requester T he main incentive for bringing attendees together is to must be an academic institution, teaching hospital, medical further their knowledge on the topic being presented. school, or medical society or association that has a bona fide interest in advancing education and research, and the 2.3. Patient Education recipients of all Scholarships or Fellowships must be selected Agios may support educational grants for activities that by such institution, hospital, medical school, or medical provide scientific or medical education to the patient society with no involvement by Agios. The Scholarship or community. Fellowship must be open to all qualified candidates, and the application and selection process must be clearly defined and 2.4. Control of Educational Program published. Funding must be given directly to the academic or training institution and not to an individual candidate or Agios may not exercise any control over or influence the recipient. In addition, Fellowship funding must generally be operation, content, materials, faculty, speakers, presenters, used only for research activities of recipients and cannot moderators, audience or venue of any educational program be used to cover a salary for a position that bills services. This document is confidential and proprietary and is the exclusive property of Agios. Page 3 of 5 It may not be reproduced in any form without prior written approval from Agios. Version 1.0 | Effective Date: January 1, 2022  Funding and In-kind Support of External Organizations GLOBAL POLICY 3. INVESTIGATOR-SPONSORED TRIALS 3.4. Independence Agios may support ISTs and other research activities that are For all ISTs, the investigator or sponsor, as applicable, shall of legitimate scientific value either to Agios or to the medical maintain full discretion and responsibility for all aspects of and scientific community at large and are designed to provide the design, implementation and analysis of the study, for meaningful information or scientific data. Support for ISTs the publication and dissemination of the study data, and should generally be provided only for studies in therapeutic for all applicable regulatory submissions including protocol and scientific areas of interest to Agios. Examples of ISTs development. This is not intended to restrict appropriate that Agios may support include health economics studies, communications between Agios and the investigator or health outcomes research, retrospective studies, research sponsor that do not jeopardize the independence of the on unapproved uses involving approved Agios products or investigator or sponsor. unapproved Agios products, observational studies, non- interventional studies of diseases and other types of research 3.5. Written Agreement consistent with Agios’ policies. ISTs may not be funded unless the recipient has signed Agios may only provide support for ISTs for bona fide scientific a written agreement with Agios that has been approved questions. Agios may not provide support for studies intended by Legal. to familiarize HCPs with a new Agios product (rather than collect scientifically important information) or that seek to 4. DONATIONS - GENERAL replicate findings from a previous study (unless significant Agios may make donations to non-profit organizations questions remain about the scope or applicability of these recognized as charitable organizations for bona fide prior findings). charitable purposes, in amounts that are reasonable and 3.1. Form of Support justified. Donations may be made only to entities designated as non-profit organizations consistent with the relevant Agios may support ISTs in the form of financial funding, country’s requirements for such organizations. Donations Agios products or both. For ISTs for which Agios provides may not be made to an individual, physician group practice financial support, Agios shall provide support for actual study or physician management company, or to an organization costs, without markup by the Grant recipient. For ISTs for that has been involved in a recent Agios marketing or which Agios provides Agios product, Agios shall: (1) provide promotional strategy. the Agios product free-of-charge; (2) clearly designate the Agios product as “free commercial product”, “investigational 4.1. Benefit Received product” or a similar designation; (3) track and document all Donations may be made only for bona fide charitable Agios products requested and provided; and, (4) provide only purposes and must not include a tangible benefit to Agios. the quantity of Agios products required for the scope of the The Company may receive an ancillary benefit by being applicable study. recognized as a sponsor for transparency reasons. 3.2. Prohibited Grants 4.2. Institutional HCOs Agios may not support ISTs that: (1) involve ongoing or new research that does not have a study protocol or synopsis; Agios may make donations to charitable organizations or, (2) support purchases of capital equipment, payments to that are institutional HCOs (e.g., a hospital or its related employees or other administrative or capital expenditures foundation) if the payment is otherwise permitted under that are unrelated to the study. this policy. Donations to such charitable organizations generally should be made only in response to a general 3.3. No Product Purchase Conditions fundraising effort, rather than in response to a request directed only to Agios. Agios may not make the purchase of Agios products a condition for the funding of an IST. This document is confidential and proprietary and is the exclusive property of Agios. Page 4 of 5 It may not be reproduced in any form without prior written approval from Agios. Version 1.0 | Effective Date: January 1, 2022  Funding and In-kind Support of External Organizations GLOBAL POLICY 4.3. Requests from Individual HCPs A gios must have a legitimate business reason (e.g., advertising Agios products or otherwise advancing Agios’ Agios may not make donations to a charitable organization business interests) for providing a sponsorship and must in response to a direct request from an individual HCP (e.g., receive a tangible benefit. Receipt of recognition of support a donation to an HCP’s “favorite charity”). This rule does in program materials does not constitute a tangible benefit. not prohibit donations requested by an individual HCP as Any funding request lacking a tangible benefit will be a representative of an institutional HCO if such donation treated as a charitable donation. otherwise would be permitted under this policy. Agios shall not make a donation on behalf of an HCP to a charity in lieu S ponsorships must be broadly offered to other entities of payment for services. on the same terms and not exclusively presented to or tailored for Agios. 5. DONATIONS – INDEPENDENT CHARITY Events and activities supported through sponsorships must PATIENT ASSISTANCE PROGRAMS be consistent with Agios’ Global Policy on Interactions with In the United States, Agios may receive requests for donations Healthcare Professionals and Healthcare Organizations. from charitable organizations that operate programs to provide financial or other assistance to patients undergoing Payment for a sponsorship must represent a fair market treatment for a particular disease. Such Independent Charity value for the benefit received. Patient Assistance Programs (“PAPs”) operate independently Sponsorships may not be used as opportunities to provide from Agios and award assistance to patients based on their unrestricted funds to an organization, nor to entirely fund independently developed eligibility criteria. Agios may an organization’s proposed activity. provide donations to Independent Charity PAPs in accordance with the standards set forth in the applicable Compliance S ponsorship funding may not be used for specific Handbooks. educational programs unless separately approved in a manner consistent with Agios’ procedures on review and approval of educational grants. 6. SPONSORSHIPS Sponsorships are opportunities to provide funding or in- All sponsorships must be reviewed and approved in advance kind support in return for a tangible benefit to Agios (e.g., by the head of the sponsoring division (or his/her designee) opportunity to display or exhibit, provide literature to and by Compliance. attendees, etc.). Sponsorships can be provided to either a for-profit or non-profit organization and should not be 7. DEFINITIONS made to an HCP. Please see definitions in the Global Healthcare Compliance In addition to the general requirements outlined above, Glossary. sp onsor ships must me et the following additional requirements: This document is confidential and proprietary and is the exclusive property of Agios. Page 5 of 5 It may not be reproduced in any form without prior written approval from Agios. Version 1.0 | Effective Date: January 1, 2022