JANUARY 24, 2021
Financial Conflict of Interest Policy
The purpose of this Conflict of Interest Policy (the “Policy”) is to outline the policies and procedures regarding conflict of interests and potential conflicts of interest in conducting research at Codagenix, Inc. (the “Policy”). It is the policy of Codagenix Inc. (“the Company”) to ensure that investigators, employees and others involved with research at the Company avoid situations in which personal interests may affect, or have the appearance of affecting, their professional judgment in exercising their duties or responsibilities, or in conducting or reporting research in compliance with applicable federal laws when participating in research funded by the Public Health Service (PHS).
This Policy is designed to comply with PHS regulations (42 CFR Part 50 Subpart F, Promoting Objectivity in Research, 45 CFR Part 94, Responsible Prospective Contractors). These standards and procedures are intended to ensure that the design, conduct, or reporting of research funded under PHS grants, cooperative agreements, or contracts will be free from bias resulting from Investigator and others Financial Conflict of Interest. The Company’s Conflict of Interest Policy implements the requirements of these federal regulations.
Applies to Covered Persons
This Policy applies to Investigators and employees that are involved in PHS-funded Research, including in PHS-funded research projects that are awarded after December 2020 or are applying for PHS funding after December 2020.
All Investigators must complete a disclosure all Significant Financial Interest or Positional Interests:
- within 30 days of acquiring or discovering a new Significant Financial Interest, and
- before each submission of application for funds or study approval.
By the time a proposal is submitted to PHS, all Covered Persons requesting PHS funding—whether grant, cooperative agreement, or contract—are required to have submitted to the Conflict of Interest Official a Financial Interest Disclosure Form. This form shall be part of the package submitted for review and approval. These completed forms either indicate that the Covered Person has no significant financial interests or includes a listing of known SFIs and those of any Family member in entities whose financial interests would reasonably appear to be affected by the research for which PHS funding is sought. Financial disclosures must be updated by all Covered Persons on an annual basis during the award period or as new reportable SFIs are obtained, whichever occurs first.
- Must complete training as described in this Policy.
- Must complete and submit to the Conflict of Interest Officer a Financial Interest Disclosure Form prior to working on PHS-funded projects or otherwise described in this Policy.
- Must update the Financial Interest Disclosure Form annually or within 30 days of a change in financial status (acquisition of new financial interest), whichever occurs first or otherwise described in this Policy.
- Must follow management plan as prescribed by the Conflict of Interest Official as described in this Policy.
- Must complete and submit to the Conflict of Interest Official a Financial Interest Disclosure Form prior to working on PHS funded projects.
- Sub-recipient organization will certify that it has a compliant conflict of interest policy in place which meets the requirements of the Policy or that it will abide by this Policy.
- Sub-recipient organization will certify that the investigators, personnel, contractors and other will complete required training as described in this Policy.
Conflict of Interest Official:
- Solicits and reviews all Financial Interest Disclosure Forms from Covered Persons to determine whether a Potential Conflict of Interest exists for Covered Research.
- Provides required information concerning Financial Conflict of Interest to the expenditure of PHS funds, and must update such information at least annually and within 60 days of changes to Statement of Financial Interest Disclosure forms, whichever occurs first.
- Assists in the development and implementation of management plans to Manage Financial Conflicts of Interest to include: role and principal duties; how the management plan is designed to safeguard objectivity in the Research; confirm that Investigator or other Covered Person agrees with the FCOI Management Plan; and how the FCOI Management Plan will be monitored.
- Maintain records under this Policy.
- Maintains this Policy on the Company’s external website and other information related to Financial Conflicts of Interest as required by the PHS or other funding source.
- Files reports as required by funding source and this Policy.
- Oversees and ensures compliance of this Policy.
SFI Review Process
The Conflict of Interest Officer reviews each Conflict of Interest or SFI received from Covered Persons in a timely manner. If necessary, the CO collects additional information from the disclosing individual and/or from other individuals who possess relevant information. The CO determines whether the disclosed a disclosed Significant Financial Interest or Positional Interest represents a Conflict of Interest, and whether a management plan is required. In conducting this review, the CO considers factors such as the value of the individual’s financial interest and how it could affect their ability to objectively complete their research with the Company. If a significant financial interest is deemed to be a financial conflict of interest, the CO will develop a management plan in consultation with the Investigator. The goal of the management plan is to reduce or eliminate the financial conflict of interest, which can include reducing or eliminating the financial conflict of interest and to ensure that the design, conduct and reporting of research will be free from bias. The Conflict of Interest Official shall take such actions as necessary to ensure that a perceived or actual Conflict of Interest will be Managed, reduced, or eliminated, and shall inform the Covered Person of his or her conflicts management plan.
The management plan may include, but is not limited to: (1) requiring the individual to recuse him/herself from particular decisions or activities related to the research, (2) requiring the individual to inform certain persons or institutions about the conflict of interest and the management plan (e.g. relevant review bodies, research sponsors, co-investigators, journals to which manuscripts about the research are submitted, media, etc.), (3) requiring others to review decisions in which the individual participates, (4) requiring the individual to reduce, modify or eliminate a financial interest (e.g. divesting ownership, restricting the sale or exercise of stock and stock options, and deferring or waiving royalties or milestone payments), or (5) requiring the individual to vacate a position.
Potential action could include:
- No Investigator involved in industry-sponsored Human Subject Research shall be permitted to have an Equity Interest in the sponsor of such research, or engage in insider trading activities. There is no minimum level of Equity Interest permitted.
- Positional and Significant Financial Interests shall generally be disclosed to human research subjects in the informed consent process and/or publication.
- The Conflict of Interest Official may impose additional conditions to Manage any Conflict of Interest.
- The Conflict of Interest Official will report all Conflicts of Interest which result in management plan and/or disclosure to Human Research Subjects in the informed consent process to the Chief Executive Officer at Company.
- Retrospective review to evaluate of Research.
- Reporting of Significant Financial Conflict of Interest.
Company will review and follow requirements of reporting Conflicts of Interest consistent with the funding source and will collaborate with the contracting entity or federal agency related to such review and reporting requirements. The Company will comply with federal regulations regarding reporting of Financial Conflicts of Interest and timely and promptly report to the funding source. The Company will comply with federal FCOI regulations regarding making publicly available information on identified Financial Conflict of Interest held by Covered Persons on PHS-funded Research projects.
The Company complies with federal regulations regarding maintaining records relating to all disclosures of financial interests and the Company’s review of, and response to, such disclosures. Relevant records under this Policy shall be retained for 7 years or 3 years from the date the final expenditures report is submitted related to PHS-funded Research.
All disclosures or information obtained in reviewing a potential FCOI is kept confidential, except where disclosure is required by federal regulations.
Covered Persons shall receive training regarding Conflict of Interests prior to engaging in PHS-funded Research and at least every 4 years.
Failure to comply with this Policy includes failing to submit a required disclosure, providing false information, omitting required information, failing to maintain confidentiality, failure to carry out duties prescribed by these policies, and refusal or failure to comply with a management plan adopted under these policies. A failure to comply with these policies may result in a decision by the Conflict of Interest Officer to suspend the research project or to refuse to approve a new research project for the individual who fails to comply.
A failure to comply is also subject to: (1) formal admonition, (2) ineligibility of the individual to apply for federal research grants, (3) additional sanctions per research funding agency (such as requiring investigator financial conflict of interest training), up to and including sponsor suspension of function per application federal regulations (note: the Company will comply with federal financial conflict of interest requirements regarding non-compliance retrospective review and corrective action), and/or (4) termination of employment.
For the purposes of this procedure, the following definitions apply:
Conflict of Interest means a Covered Person or a Family Member of such individual has, directly or indirectly, a significant Financial Interest or Positional Interest that could affect the design, conduct, reporting, evaluation, approval or oversight of a research study.
Company Responsibilities means the Investigator’s responsibilities associated with his or her Company appointment or position, such as research, teaching, administration, and internal and external professional committee service.
Covered Person means all employees and Investigators involved in PHS-funded Research at the Company.
Disclosure of Significant Financial Interests means an Investigator’s disclosure of Significant Financial Interests to the Conflict of Interest Official at Company or otherwise under this Policy.
Financial Interest means anything of monetary value, whether or not the value is readily ascertainable, held directly or indirectly by a Covered Person and/or Family Member, including but not limited to the following:
- Equity Interest means any interest in the profits of or other ownership interest in any entity or enterprise, whether public or private, including stock and other equity securities, and any right to acquire any of the foregoing such as an option, warrant or other convertible security.
- Compensation means income or other payments for services, including, but not limited to salary and other services not otherwise identified as salary gifts, consulting fees, honoraria, paid authorship, dividends, loan, or other consideration with value, such as significant product discounts.
- Intellectual Property Interest means any personal propriety interest or right held or claimed directly or indirectly by a Covered Person or a Family member, including but not limited to, a proprietary interest or right in an invention, technology, know-how, a patent, patent application, trademark, licensing agreement, trade secret, or copyright.
- Reimbursed Travel means any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Covered Person and not reimbursed to the Covered Person so that the exact monetary value may not be readily available) related to Company responsibilities.
Family Member means spouse or domestic partner and dependent children (e.g., biological, half, step, or adopted children) of the Covered Person.
Human Subject Research shall mean Research governed under the Common Rule that involves a Human Subject.
A Human Subject means a living individual about whom an Investigator obtains either (1) data through intervention or interaction with the individual, or (2) identifiable private information.
Insider Trading refers to the federal laws making it illegal to trade stocks while in possession of information not available to the general public or to inform other traders of such information. (Public announcements and publishing render research information available to the general public.) The Securities and Exchange Commission has prosecuted researchers who have tipped off friends, relatives, and business associates regarding initial results of clinical trials prior to publication.
Investigator means the Project Director (PD) or Principal Investigator (PI) 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, including collaborators or consultants.
Manage means taking action to address a financial conflict of interest, which can include reducing 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, including but not limiting to change in personnel and modification of Research plan.
PD/PI means a project director or principal investigator.
Positional Interest means that a Covered Person or a Family Member is an officer, director or trustee, consultant (including a medical director), or employee of an entity with which Company has or is considering a transaction or arrangement.
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Sub-recipient means any party that has entered into an Agreement with the Company as a sub-grantee, subcontractor, collaborator, contractor, or consultant.
Significant Financial Interest (or SFI) means a Financial Interest means one or more of the following Financial Interests received, held, or owned directly or indirectly by a Covered Person and/or a Family Member, that when aggregated, exceeds the following thresholds:
For Human Subjects Research, any Financial Interest is a Significant Financial Interest.
For all Research other than Human Subjects Research, any Financial Interest (including Compensation, an Equity Interest, Intellectual Property Interest, or Reimbursed Travel), which alone or in the aggregate, exceeds the following thresholds:
Publicly Traded Entity:
- Equity Interest: Any Equity Interest in a publicly-traded company exceeding $5,000, valued as of the date of disclosure.
- Compensation: Any Compensation from a publicly-traded company exceeding $5,000 received in the 12 months preceding the date of disclosure.
Non-Publicly Traded Entity:
- Equity Interest: Any Equity Interest in a non-publicly traded company, valued as of the date of disclosure.
- Compensation: Any Compensation from a non-publicly traded company exceeding $5,000 received in the 12 months preceding the date of disclosure.
Intellectual Property Interests: Any Intellectual Property Interest upon receipt of income from such Interest, regardless of value.
Reimbursed Travel: Any amount of Reimbursed Travel received in the 12 months preceding the date of disclosure.