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CELLECTGEN, INC. FINANCIAL CONFLICT OF INTEREST (FCOI) POLICY
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SCOPE: Company Wide. The Government Awards Compliance Program (Program) covers all projects conducted with government funds in CellectGen (Company) and is applicable to all employees, sub recipients, consultants, or any other covered organizations or persons involved in governmental awards.


PURPOSE: The purpose of this policy is to document the requirements and responsibilities associated with identifying and managing financial conflicts of interest to safeguard the integrity of Company research and to comply with federal regulations.

This policy has been developed to address and comply with the specific federal agency requirements as defined in the 2011 Revised Financial Conflict of Interest Regulation, Promoting Objectivity in Research (42 CFR part 50 subpart F, “Promoting Objectivity in Research). This regulation was developed to promote objectivity in research by establishing standards that provide a reasonable expectation ensuring the design, conduct and reporting of research funded under National Institutes of Health (NIH) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. An electronic version of the regulation is found at http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf.

This FCOI Policy serves to:

Investigators (as defined below) who fail to fully and truthfully disclose actual or perceived conflicts of interest or fail to comply with any plan for managing and/or eliminating the conflicts are subject to ordinary disciplinary processes of CellectGen, up to and including termination of employment. Such actions of an Investigator also will be considered in deliberations on contract renewal and promotions.


DEFINITIONS:
Conflict Monitoring: The President & CEO reviews financial conflict of interest (FCOI) disclosures and works with the Grants Manager (GM) and Investigator to formulate a management plan.

Conflict Management Plan (“CMP”): The document specifying the actions to be taken to manage a Financial Conflict of Interest. It can include reducing, managing, or eliminating the financial conflict of interest, to ensure to the extent possible that the design, conduct, and reporting of research will be free from bias. The Management Plan may also include a retrospective review and mitigation report, if necessary.

External Partner: A consultant, subcontractor, or sub-recipient performing work under a Government Award who is not employed by Company.

Government Award: Government grants and cost reimbursement contracts including research grants or contracts, and other types of government financial assistance (e.g., cooperative agreements, loans, loan guarantees, property, donated supplies, and direct appropriations) that Company receives directly from government agencies or indirectly from pass through entities. (At Company, Government Awards are commonly referred to as “Sponsored Projects.”) Government Awards do not include procurement contracts, payments for health care services provided under government health care programs (e.g., Medicare, Medicaid) or Medical Education and Research Costs (MERC)).

Financial Conflict of Interest (FCOI): A significant financial interest that could directly and significantly affect the design, conduct, or reporting of a research study or other government funded project, or the performance of duties and responsibilities performed on behalf of Company.
Immediate Family Member: A spouse, domestic partner, child or step-child, parent or step-parent, or sibling or step-sibling.

Investigator:
  1. For PHS-funded research: the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.
  2. For other Government Awards: project staff directly involved in management of the project or who hold key responsibilities on the Government Award. Typically, these would be individuals specifically named to a Government Award or whose participation is key to the success of the project.

Institutional Responsibilities: An Investigator’s professional responsibilities on behalf of Company, which may include, but is not limited to: research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Public Health Service (PHS): A division of the Department of Health and Human Services, consisting of the following agencies: Agency for Healthcare Research and Quality (AHRQ), Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), and Substance Abuse and Mental Health Services Administration (SAMHSA).

Research: A systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research.

Remuneration: Salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorships).

Financial Interest: Anything of monetary value or potential monetary value received from a non-Company domestic or foreign source that reasonably appears to be related to the individual’s duties and responsibilities including, but not limited to payment from a non-Company source, travel, stock, or intellectual property.

Significant Financial Interest (“SFI”):
  1. A financial interest consisting of one or more of the following interests of the Investigator or their Immediate Family Member that reasonably appears to be related to the Investigator’s Institutional Responsibilities:
  2. Investigators must disclose the occurrence of any reimbursed or sponsored travel related to their Institutional Responsibilities. The disclosure will include, at a minimum, the following details: (i) the purpose of the trip; (ii) the identity of the sponsor/organizer; (iii) the destination; and (iv) the trip duration. (This disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.)
  3. A significant financial interest does not include the following:


POLICY:
It is the policy of Company to comply with the Financial Conflict of Interest Rules (“FCOI Rules”) to ensure that the work performed under Government Awards is carried out in a manner that is free from any bias which may result from financial conflicts of interest. All Investigators for Government Awards must disclose any Significant Financial Interests (SFI) to Company. Investigators must complete or update a disclosure survey at least annually during the period of the award and must disclose any new SFI’s within thirty days of discovering or acquiring the SFI. Investigators also must ensure that the disclosure survey is completed or updated no later than the time of application for a Government Award.

If Company determines that a SFI constitutes a Financial Conflict of Interest (“FCOI”), Company will establish and monitor a Conflict Management Plan (“CMP”) to manage or eliminate the conflict of interest. The Company’s Grants Manager (GM) will be the conflict of interest official responsible for managing the conflict of interest process for Government Awards. No Government Award funds may be expended unless the GM has determined that no FCOI exists or that any FCOI is manageable in accordance with the terms of a CMP that has been adopted and implemented in accordance with the procedures set forth in this policy.

Duty to Cooperate: If the GM requests additional information from an Investigator to assess whether a SFI constitutes a FCOI, (including but not limited to documents relating to the SFI), the Investigator must cooperate with the request. If a CMP is implemented in connection with a SFI, the Investigator must comply with the CMP. Compliance with the requirements of this policy is a condition of employment with Company for employed Investigators and a condition of participating in Government Award projects as an External Partner. Failure to comply may result in appropriate sanctions.

Training: The NIH Financial Conflict of Interest tutorial was designed by the National Institutes of Health (NIH) to provide education training on what constitutes FCOI. This course is required for anyone involved with an NIH funded project, which includes all Investigators, consultants and employees of Company engaged in NIH-funded research or its compliance.

The course is accessible at http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm or CITI COI training found at https://about.citiprogram.org/en/homepage/. Upon completion of the training, a certificate of completion must be turned into the GM. You should retain a copy for your records. This training is required prior to engaging in research relating to any NIH-funded grant or as deemed necessary by the Company due to changes in the FCOI policy, non-compliance of the Investigator/Key Personnel or new to the Company. Investigators must complete training regarding this policy and the applicable regulations at the following times: (i) upon becoming an Investigator for Company; (ii) before performing work under a Government Award; (iii) when this policy is revised to alter the responsibilities of an Investigator; and (iv) at a minimum, the FCOI training shall be taken every four (4) years.

Public Posting of Policy: This policy will be posted on a publicly accessible Internet site for Company.

Reporting of Financial Conflicts of Interest for PHS-Funded Projects: Before the expenditure of any funds under a PHS-funded project and within sixty days of subsequently identifying a Financial Conflict of Interest, the SPA Manager will report all Financial Conflicts of Interest that have not been eliminated to the PHS awarding component and will ensure that an appropriate Conflict Management Plan has been implemented. The report will include the elements required under the PHS FCOI Rules. For subsequently identified FCOI’s, the SPA Manager will conduct a retrospective review to determine whether the PHS-funded project was affected by the financial conflict of interest, and if bias is found, will submit a mitigation report to the PHS awarding component. The SPA Manager also will provide an annual FCOI report that addresses the status of any previously reported FCOI’s and CMP’s related to an ongoing PHS-funded project.

External Partners: Any individual or organization acting as a consultant, subcontractor, or subrecipient (“External Partner”) to Company on a PHS-funded award must either: (1) have a FCOI policy that meets the requirements of the PHS FCOI Rules or (2) follow this policy.


PROCEDURE:
  1. It shall be the responsibility of the Principal Investigator of a Research project to identify all Investigators who have a SFI requiring disclosure under this policy and to ensure that a SFI Disclosure Form is prepared and submitted. In addition, the Principal Investigator shall be responsible for ensuring that annual updates and disclosures of new or increased financial interests are disclosed.
  2. Every individual having a SFI requiring disclosure under this policy shall prepare a fully-completed SFI Disclosure Form that shall be submitted to the GM. An initial review of the SFI Disclosure Form will be conducted by the GM to determine whether a potential for conflict of interest exists. If it is determined that there is a potential conflict of interest, then steps will be taken to determine what measures are needed to address the SFI identified in the SFI Disclosure Form. A CMP may be required to outline the terms, conditions and restrictions, if any, to ensure compliance with this policy. The CMP may require one or more of the following actions (but not limited to) to be taken in order to manage, reduce or eliminate any actual or potential conflict of interest:
  3. All CMPs are required to be signed by the Investigator and the CEO. Compliance of the CMP shall be monitored by the GM.
  4. Before the expenditure of funds under a Government Award, Investigators must complete the training on Company’s Government Awards FCOI Policy. All external investigators must complete FCOI training required under the policy (see Training section).
  5. Training must be documented by submitting the Government Award FCOI Training Certification form to Company GM. The required training is valid for four years; however, Investigators are required to certify annually that they understand and have complied with their responsibilities under Company’s Government Awards FCOI Policy.
  6. After the training is completed, the Investigator will complete the Government Award FCOI Questionnaire. This survey must be completed no later than the time of application for a Government Award and before any funds are expended. It also must be updated as required by the policy.
  7. The principal investigator/project director will complete the Government Award Approval form, which requires verification that those meeting the definition of Investigator and External Partners have been informed of the requirement to comply with this policy.
  8. The Investigator must report and update their Government Award FCOI Questionnaire when he/she is a recipient of sponsored travel. The Investigator will disclose: the purpose of the trip; the name of the entity that paid for the travel; the travel destination; the duration of the trip; the dates of the travel; and if known, the approximate value of the Sponsored Travel.
  9. If the GM determines a FCOI exists, he/she will create a draft CMP. The draft CMP will be presented to the CEO for consideration and approval. The CEO will act as the Conflict of Interest Committee for purposes of Government Awards.
  10. The actions taken by the RCOC will be documented in the FCOI meeting minutes. The GM will ensure that CMP’s are properly implemented and will monitor compliance with CMP’s on an ongoing basis. The GM and CEO will review the status of established CMP’s at intervals determined by the CEO and indicated in the CMP, and will have oversight responsibility for the enforcement of CMPs and compliance with this policy.
  11. Each Investigator under a CMP must comply fully and promptly with the CMP, and each person identified in the CMP as having responsibility for monitoring compliance with the CMP must carefully and fully monitor that compliance.
  12. For PHS-funded projects, GM will disclose the FCOI and CMP to the PHS awarding component before the expenditure of any federal funds. Company will make FCOI information available to those who submit a request by sending an email to info@cellectgen.com.
  13. Records of Investigator SFI Disclosure forms, and of actions taken to manage actual or potential conflicts of interest, shall be retained by the Company for four (4) years from the date the final expenditure report is submitted to the NIH, or as required by 45 CFR 74.53(b) and 92.42(b) for different situations.
  14. GM and CEO will regularly evaluate compliance with this policy and will review the effectiveness of GM’s conflict of interest management program, including a review of the implementation and effectiveness of these procedures.


Annual Reporting and After-Acquired Significant Financial Interests – All Investigators shall provide annual SFI Disclosure reports or more frequently if required by the CMP. Any Investigator who acquires a new or increased SFI shall promptly submit a new SFI Disclosure Form within 30 days of discovering or acquiring the new SFI. It is the Principal Investigator’s responsibility to ensure that any newly acquired Investigator on a research project submits the required SFI report to the GM.

Violations of FCOI Policy – Investigators are expected to comply fully and promptly with this policy. Whenever a person has violated this policy, including failure to make a required disclosure of financial interests or failure to comply with a requirement of the management plan, the CFO shall make recommendations to the President regarding the impositions of sanctions or disciplinary proceedings against the violating individual.

In addition, the Company shall follow Federal regulations regarding the notification of the sponsoring agency in the event an Investigator has failed to comply with this policy. The federal agency may take its own action as it deems appropriate, including the suspension of the funding for the Investigator until the matter is resolved.

Sub-recipient Requirements – Sub-award recipients must comply with this policy or provide certification that their organization is in compliance with the Federal policy, 2011 Revised Financial Conflict of Interest Regulation, Promoting Objectivity in Research (42 CFR part 50 subpart F) and that their portion of the research project, as detailed in their sub-award agreement, is in compliance with their institutional policies. If a SFI is identified by the sub-award recipient, they are required to notify the GM of the existence of the conflicting interest within 30 days of the identification of the interest. In addition, the sub-award recipient must certify and assure that any reported conflicting interest has been managed, reduced or eliminated in accordance with federal regulations.

Federal Reporting – The Finance Department is responsible for the reporting disposition of matters involving disclosures of SFI in accordance with applicable federal requirements. The following reports are required by the NIH:
  1. Initial report – prior to the Company’s expenditure of any funds under a NIH-funded research project, the Company must provide to the NIH an FCOI report regarding any Investigator SFI found by the Company to be a financial conflict of interest in accordance with the regulation.
  2. During on-going NIH-funded research projects – the Company shall submit an FCOI report within 60 days after its determination that a new FCOI exists. If a FCOI was not disclosed timely, the Company shall submit a FCOI report to the NIH within 60 days of the discovery, as well as complete a retrospective review within 120 days of discovery of noncompliance.
  3. Annual FCOI report – For any FCOI previously reported to the NIH, the Company shall provide an annual FCOI report addressing the status of the FCOI and any changes to its related management plan.



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