Purpose and Scope

This policy is intended to comply with regulations regarding financial conflicts of interest and allow Seven Bridges to identify and manage any such conflicts its staff may be subject to. It applies to all staff members, and those outside consultants working on designated projects.

This policy shall be posted publicly on the Seven Bridges website, www.sbgenomics.com.

Disclosure

    1. All staff members as well as those outside consultants working on designated projects must disclose all Significant Financial Interests reasonably related to their responsibilities at Seven Bridges. A Significant Financial Interest is defined as the following:
      • With regard to any publicly traded entity, a Significant Financial Interest (SFI) exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. Included are payments and equity interests;
      • With regard to any non-publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the staff member or consultant (or the staff member or consultant’s spouse or dependent children) holds any equity interest; or
      • Intellectual property rights and interests, upon receipt of income related to such rights and interest.

Significant Financial Interests do not include the following:

      • Income from seminars, lectures, or teaching, and service on advisory or review panels for government agencies, institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with an institution of higher learning
      • Income from investment vehicles, such as mutual funds and retirement accounts, as long as the staff member or consultant does not directly control the investment decisions made in these vehicles
      • Income from or equity interest in Seven Bridges Genomics Inc., or any of its branches or subsidiaries.

If a staff member or consultant is unsure if an SFI is reasonably related to their responsibilities, they should contact the Chief Operating Officer (“COO”) for guidance.

  1. Disclosure shall be made via the Financial Conflict of Interest Disclosure Webform.
  2. Initial disclosures shall be made by each staff member or consultant within one week of training on the policy (see next section), and in any case prior to beginning work on any PHS-funded research.
  3. Subsequent disclosures shall be made (a) by any staff member or consultant within 30 days of discovering or acquiring a new Significant Financial Interest; and (b) annually by all staff members and consultants during the second half of August.
  4. It is the responsibility of the COO to solicit initial and annual disclosures. It is the responsibility of the individual staff member or consultant to make disclosures related to the acquisition or discover of new Significant Financial Interests, without prompting.
  5. Designated projects shall include any project funded by the Public Health Service (PHS), including the National Institutes of Health and NCI, and any other projects designated by the COO. Those outside consultants working on designated projects must agree in writing to abide by the terms of this policy and provide all required disclosures.

Training

  1. All staff members shall be trained on this policy within one week of joining the company. All outside consultants working on designated projects shall be trained on this policy prior to beginning work on the designated project.
  2. An refresher training for all staff shall be held every two years in the first half of August in even-numbered years, and within one week of any change to this policy that affects disclosure requirements.
  3. Any staff member found not to be in compliance with this policy or a conflict management plan established under this policy shall be trained within one week.
  4. Upon completion of training, all staff shall acknowledge training via this webform.

Review and Conflict Management

  1. All disclosures of Significant Financial Interests shall be reviewed by the COO.
  2. The COO shall determine whether the SFI:
    • is related to a project the staff member is working on, or the designated project in the case of outside consultants
    • is related to research funded by the Public Health Service (PHS), including the National Institutes of Health and NCI
    • determine if the FCOI creates a Financial Conflict of Interest (FCOI), defined as an SFI that could directly and significantly affect the design, conduct, or reporting of the project
  3. If the COO determines that an FCOI exists, the COO shall develop a Conflict Management Plan that shall specify the actions that have been, and shall be, taken to manage such financial conflict of interest. Examples of conditions or restrictions that might be imposed to manage a financial conflict of interest include, but are not limited to:
    • Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);
    • For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;
    • Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest;
    • Modification of the research plan;
    • Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
    • Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
    • Severance of relationships that create financial conflicts.
  4. The relevant staff member or outside consultant shall agree in writing to abide by the terms of the management plan.
  5. The COO shall monitor compliance with the management plan until completion of the project.

Records Retention

All disclosures, FCOI Reports, management plans, retrospective reviews, mitigation reports, and other records generated under this policy shall be retained for a minimum of 6 years, and in the case of PHS-funded research for at least 3 years from the date the final expenditures report is submitted to the relevant agency.

Enforcement and Sanctions

  1. The COO is responsible for ensuring that disclosures are made in a timely manner, and following up with any staff members or outside consultants who do not make disclosures by the indicated deadline.
  2. If a staff member is found not to have disclosed a Significant Financial Interest, either as part of their initial disclosure or subsequently, the COO shall refer the matter to the CEO, President, and CTO, who shall consider the nature of the failure to disclose to determine an appropriate sanction.
  3. The determination of sanctions shall take into account, but not necessarily be bound by, the following guidelines:
    • Unintentional or careless violations shall generally result in retraining on the this policy and may result in a verbal or written warning. Repeated or particularly flagrant violations may result in stronger sanctions.
    • Intentional violations regarding Significant Financial Interests not found to constitute Financial Conflicts of Interest shall generally result in a verbal warning or a written warning as well as retraining on this policy. Repeated or particularly flagrant violations may result in stronger sanctions.
    • Intentional violations regarding Significant Financial Interests found to constitute Financial Conflicts of Interest shall result in a written warning as well as retraining on the this policy. Depending on the nature of the interest and the conflict, stronger sanctions including suspension without pay or termination may also be imposed.
  4. If an outside consultant is found not to have disclosed a Significant Financial Interest, either as part of their initial disclosure or subsequently, the COO shall refer the matter to the CEO, President, and CTO, who shall consider the nature of the failure to disclose and the recourse available under the agreement with the outside consultant to determine an appropriate remedy.

Special Requirements for PHS-funded Research

The following procedures shall only apply to PHS-funded research, including any projects funded by the National Institutes of Health and NCI.

Reporting

  1. Prior to expenditure of any funds under a PHS-funded research project, Seven Bridges shall provide to the contact designated in the relevant contract or grant document an FCOI Report identifying any Financial Conflicts of Interest relating to the PHS-funded research.
  2. The FCOI Report shall include the following:
    • the Project number;
    • the PD/PI or Contact PD/PI if a multiple PD/PI model is used;
    • the name of the staff member or outside consultant with the financial conflict of interest;
    • the name of the entity with which the staff member or outside consultant has a financial conflict of interest;
    • the nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
    • the value of the financial interest (dollar ranges are permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value;
    • a description of how the financial interest relates to the PHS-funded research and the basis for Seven Bridges’ determination that the financial interest conflicts with such research; and
    • a description of the key elements of the Institution's management plan, including the role and principal duties of the conflicted Investigator in the research project; conditions of the management plan; how the management plan is designed to safeguard objectivity in the research project; confirmation of the Investigator's agreement to the management plan; how the management plan will be monitored to ensure Investigator compliance; and other information as needed.
    In addition to this, the COO shall include any other information necessary to enable the relevant government agency to understand the nature and extent of the financial conflict, and to assess the appropriateness of the management plan.
  3. For any Financial Conflict of Interest relating to PHS-funded research that is identified subsequent to the initial FCOI report, Seven Bridges shall provide to the contact designated in the relevant contract or grant document an FCOI Report identifying any FCOI, as described above, within 60 days.
  4. If any FCOI is identified concerning key personnel, as defined in the relevant contract or grant document, a public disclosure of the following information shall be posted on the Seven Bridges website at the same location as this policy is posted:
    • the staff member or outside consultant’s name;
    • the staff member or outside consultant’s title and role with respect to the research project;
    • the name of the entity in which the significant financial interest is held;
    • the nature of the significant financial interest;
    • and the approximate dollar value of the significant financial interest (dollar ranges are permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.
    The public disclosure shall be posted prior to the expenditure of funds, shall be updated at least annually during the course of the PHS-funded project as well as within 60 days of the identification of any new Financial Conflict of Interest, and shall remain available for three years following the most recent update.

Review of Improperly-Handled Financial Conflicts of Interest

The following procedures shall be carried out whenever a Financial Conflict of Interest is not identified or managed in a timely manner, including failure by the staff member or outside consultant to disclose a significant financial interest that is determined by the Institution to constitute a financial conflict of interest; failure by Seven Bridges to review or manage such a financial conflict of interest; or failure by the staff member or outside consultant to comply with a financial conflict of interest management plan:

  1. the President shall appoint a review panel consisting of three senior employees not reporting to the COO
  2. Within 120 days of the determination of noncompliance, the review panel shall complete a retrospective review of the staff member or outside consultants’ activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.
  3. The review panel shall document the retrospective review in a record including at least the following key elements:
    • Project number;
    • Project title;
    • PD/PI or contact PD/PI if a multiple PD/PI model is used;
    • Name of the staff member or outside consultant with the FCOI;
    • Name of the entity with which the staff member or outside consultant has a financial conflict of interest;
    • Reason(s) for the retrospective review;
    • Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);
    • Findings of the review; and
    • Conclusions of the review.
  4. Based on the results of the retrospective review, if appropriate, the President shall update the previously submitted FCOI Report, specifying the actions that will be taken to manage the FCOI going forward.
  5. If bias is found, the President is required to notify the contact designated in the relevant contract or grant document promptly and submit a mitigation report to the that contact. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and Seven Bridges’ plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable).
  6. Depending on the nature of the financial conflict of interest, the President may determine that additional interim measures are necessary with regard to the staff member or outside consultant’s participation in the PHS-funded research project between the date that the financial conflict of interest or the staff member or outside consultant’s noncompliance is determined and the completion of Seven Bridges’ retrospective review.