Acucela Financial Conflict of Interest Compliance Policy

Effective: 1/1/2019
Author(s): Acucela Management Team

Questions or Comments relating to this policy should be addressed to Acucela, Tim Kerber at tkerber@acucela.com or to the Financial Conflict of Interest Compliance Administrator at FCOIAdmin@Acucela.com

Introduction and Company Overview

Acucela Inc. (Acucela) is a Washington based company committed to translating innovation into a diverse portfolio of drugs and devices to preserve and restore vision for millions of people worldwide (https://www.acucela.com/).

Acucela is currently developing vision care technology that might be used by National Aeronautics and Space Administration (NASA) for the space program. Acucela may receive funding through grants from External Funding Sources (EFS) such as Translational Research Institute (TRISH) for Space Health (https://www.nasa.gov/hrp/tri). As a recipient of this funding, it is Acucela' s desire and management's directive to fully comply with all Federal Regulations relating to institutions or individuals receiving government funding (such as those found at https://grants.nih.gov/grants/policy/coi/index.htm).

Acucela is also planning to commercialize a similar version of this technology that could potentially be used by eyecare professionals, healthcare providers, and individuals. Acucela is a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Company, Ltd., a publicly held company whose stock is listed on the Tokyo Stock Exchange (Tokyo 4596).

I. Policy

Acucela strives to create a research and product development climate that promotes objectivity in all matters relating to research and product development by establishing these standards and policies such that the design, conduct, and reporting of all grant funded (government or private) research and product development is free from bias resulting from a Financial Conflict of Interest (FCOI) (defined below). Acucela has named a FCOI Compliance Administrator (FCOI Administrator) to insure the company complies with this policy and to help manage any situations where non-compliance becomes an issue (See IV. Administrative section below).

Who is Affected by This Policy? This policy is applicable to each employee, consultant, advisor and/or company doing subcontractor work for Acucela (collectively Worker) who is planning to or is participating in research activity that is either partially or wholly supported by EFS's, such as government funded grants.

Each such Worker must:

  1. Disclose his or her Significant Financial Interests (SFI) (defined below) in non-Acucela entities that would appear to be related to the employee's professional responsibilities;
  2. Comply with a FCOI management plan, if a FCOI is identified; and
  3. Undergo FCOI training, at least once every four years.

Disclosure of SFI is essential for Acucela to determine if a FCOI exists and in cases of an FCOI, determine how it will be managed and reported in full compliance with government regulation. Non-disclosure of SFI or non-compliance with an FCOI management plan may subject the Worker to discipline including, without limitation, suspension or termination of employment and or termination of the contract with Acucela.

II. Definitions

A. Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of outside funded research/product development.

B. Significant Financial Interest (SFI) means a financial interest of a Worker (including the Worker's spouse and dependent children) that reasonably appears to be related to the Worker's Acucela responsibilities1 and exceeds $5,000 annually in the aggregate2;

  1. Including:
    • The Worker is receiving a salary or other payments for services (e.g., consulting fees or honoraria) exceeding $5,000 in the aggregate from a subcontracted company with Acucela in the twelve months preceding disclosure;
    • The Worker has equity interests (e.g., stocks, stock options or other ownership interests) in a subcontracted company with Acucela; or,
    • The Worker is receiving income from intellectual property rights owned by the Worker that is co-owned or comes from a subcontracted company with Acucela.
  2. Excluding:
    • Salary, royalties, stock options or other remuneration from Acucela;
    • Income from seminars, lectures, teaching engagements, service on advisory committees or review panels, derived from excluded sources3;
    • Income from investment vehicles, such as mutual funds and retirement accounts, if the Worker does not directly control the investment decisions; and,
    • Unlicensed intellectual property owned by the Worker that does not generate income. Note that Intellectual property owned by Acucela is excluded.

    1 Worker's professional responsibilities on behalf of Acucela means conducting research, submitting patent applications, publication, technical committee membership and, teaching as adjunct faculty at an Institute of higher education.

    2 SFI also includes travel. Specifically, externally funded, reimbursed or sponsored travel that would appear to be related to employee's Acucela responsibilities that is not funded by Acucela. Such travel must be disclosed (if the amount exceeds $5,000 annually) except when the expenses are covered by any of the excluded sources. The amount of the expenses does not need to be disclosed, just the fact that they exceed $5,000 annually.

    3 An excluded source means a source of remuneration that is excluded from disclosure. With reference to the SFI, excluded sources are: 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.

    III. Procedure

    What do Workers Need to Do (SFI Disclosure Procedure) Workers who are planning to or currently participating in research or product development activities for Acucela that are either partially or wholly supported by EFS must disclose their SFI in a timely fashion, either to a member of the Acucela Management Team (Management Team) or the FCOI Administrator by completing a SFI Disclosure Form.

    New Workers must complete the FCOI training within 10 days of employment or contract inception and complete a SFI Declaration Form within 30 days (and annually after that or within 30 days of a change in their SFI status, as outlined in this policy).

    The FCOI Administrator will determine whether the SFI constitutes an FCOI, based on guidance set by the Management Team, government regulations, and this policy. Consistent with the Protocol for Handling Financial Conflict of Interest, if the SFI is determined to be an FCOI, the Management Team (working with the FCOI Administrator) will take actions to discuss, determine, and approve the implementation of an FCOI management plan consistent with this policy and, furthermore, to promptly notify the Acucela' s EFS (e.g., TRISH) via a FCOI report within 30 days of development of the plan.

    As a part of the FCOI management plan, the Management Team will impose one or more corrective actions depending upon the situation, including (but not limited to) requiring certain disclosure in public presentations, situation oversight by the FCOI Administrator or external body appointed by the Management Team, or other actions as agreed to by Acucela and the outside funding source. Workers with an identified FCOI must comply with the FCOI management plan.

    IV. Administration

    The FCOI Administrator is responsible for administration and oversight of this policy. The FCOI Administrator will be a qualified person that will be selected by the Management Team with input from the major EFS (i.e. TRISH). The current FCOI Administrator and his/her contact information will be listed on the Acucela website.

    V. Protocol for Handling Financial Conflict of Interest

    1. Review of Disclosures
    All SFIs, including those submitted by a new Worker who joins an ongoing EFS project, will be reviewed by the FCOI Administrator. All disclosures should be submitted on a SFI Disclosure Form (see link above). The review will determine whether an SFI is related to the EFS research/project development project and therefore an FCOI.

    When an SFI that was not disclosed by a Worker in a timely manner is identified, the FCOI Administrator will determine if FCOI exists, develop and implement a management plan within thirty (30) days after the identification of the SFI. In addition, the FCOI Administrator will conduct a retrospective review of SFIs for the Worker(s) within one hundred twenty (120) days and document it.

    2. Management of FCOI
    For each disclosure that leads to determination of FCOI, the Management Team will discuss and approve the implementation of a management plan developed by the FCOI Administrator. Workers with an identified FCOI must comply with the management plan. The management plan will include the following elements at a minimum:

    1. The role and principal duties of the conflicted Worker in the research project;
    2. Conditions of the management plan;
    3. How the management plan is designed to safeguard objectivity in the research project;
    4. Confirmation of the Workers agreement to the management plan; and
    5. How the management plan will be monitored to ensure Worker compliance.

    3. Reporting FCOI to EFS Awarding Component (e.g. TRISH)
    At the Beginning of any EFS Event (i.e. new grant) and annually if the funding period is longer than one year in length, FCOI reports (or revised reports as a result of retrospective reviews) will be submitted to the EFS funding source and will include an overview of the grant(s) that include what Workers (including Acucela employees, sub-contractors, consultants, and advisors) are involved in the EFS project, records indicating their FCOI training and information relating to any potential financial conflicts (or lack of).

    If a Conflict is Discovered at any point during the funding period, the FCOI Administrator will submit an initial FCOI report to the EFS organization (e.g. TRISH). FCOIs identified during the period of award will be submitted to the EFS within sixty (30) days of identification, including for new Workers joining an ongoing Acucela EFS project.

    Additionally, after the initial notification of a FCOI, the FCOI Administrator will submit a regular status report to the EFS on the financial conflict, i.e., whether the financial conflict is still being managed or explains why the financial conflict no longer exists. These FCOI reports will also include a description of any changes to the management plan since the last FCOI report.

    4. Training for FCOI
    Acucela Workers that are doing work on EFS projects must undergo training with respect to this Policy and Acucela FCOI rules and regulations, as follows:

    1. When a new Worker joins Acucela (through employment or as a subcontractor, consultant or advisor);
    2. Within 10 days of starting to participate in Acucela EFS research/product development, and at least once every four years;
    3. When the Acucela FCOI Policy changes in a manner that effects Acucela EFS funded disclosure or compliance requirements; and,
    4. If Management Team determines that a Worker is not compliant with the FCOI Compliance Policy or an FCOI Management Plan.

    Acucela will use the NIH web-based training (http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm) for the FCOI training platform. Workers must save and submit the FCOI Certificate as proof of completion to the Management Team.

    Note: When the Worker is a sub-contractor, consultant, or advisor and their organization consists of more than one person (i.e. a large organization), the Management Team will select a representative(s) (a company executive), of each company to complete the FCOI training. It will be the responsibility of that person to insure the organization is in compliance with this FCOI Compliance Policy.

    5. Sanctions for Violation of Policy
    Disclosure of SFI is essential for Acucela to implement its FCOI Compliance Policy. If a Worker fails to comply with this policy (with regard for instance to the SFI disclosure requirement or implementation of an FCOI management plan), and appears to have biased the EFS research/product development project, the Management Team and FCOI Administrator will implement a mitigation plan and require that the Worker disclose the FCOI in each public presentation of the results of the research, and to remedy previously published presentations with an FCOI disclosure addendum. In addition, the Worker may be subject to employment/contract discipline including, without limitation, suspension or termination of employment or cancellation of the contract/agreement.

    In any case, the EFS agency will be promptly notified.

    6. Retention of Records
    Records of financial disclosures and any resulting action will be maintained for three (3) years from the date of submission of the final expenditures report.

    7. Sub-contractor, Consultant or Advisor Compliance
    When working with an external Worker (collective a sub-contractor, consultant, advisor), a written agreement will be put in place to clarify: (a) which organization's FCOI Compliance Policies are relevant to the organization and will be followed, and, (b) in either case, clarify the timeline for disclosure and reporting. Note: the Management Team is responsible for monitoring subcontractor's compliance with the Financial Conflict of Interest regulation, management plans, and for reporting all identified financial conflicts of interest.

    8. Public Accessibility
    The Acucela FCOI Compliance Policy is being made accessible on the Acucela web site.

    If a Worker holds financial interests that are determined to be FCOI, as required by this Acucela FCOI Compliance Policy, these will also be posted on the web site, as follows:

    1. Include the minimum elements required by the regulation;
    2. Update within sixty (60) days of a newly identified FCOI;
    3. Update annually; and
    4. Remain available for three (3) years.