Conflict of Interest Statement or Policy Relating to PHS Grants
Last Updated: September 23, 2021
This policy is in addition to the Conflict of Interest Policy that applies to all directors, executives and employees and certain independent contractors of Life Biosciences LLC and its wholly- and partially- owned subsidiaries.
This policy governing financial conflict of interest applies to all Interested Parties who are PHS-sponsored investigators of the Company. Interested Parties must never place themselves in a position where their self-interest may conflict with their duties to the Company.
Any Interested Party who breaches this policy is subject to disciplinary action, up to and including discharge.
Interested Parties will:
a. have a duty of fidelity to the Company
b. avoid actual or appearance of a Financial Conflict of Interest
c. disclose to the Company potential Financial Conflicts of Interest
d. avoid conduct that would harm the Company, its business or reputation
e. never accept gifts or ‘Kickbacks’ from competitors or vendors of Company
f. maintain conscientious handling of Company funds and property
g. not disclose Company confidential information
h. disclose and have permission for outside employment or business activity
Definitions
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“Business Entity” means a sole proprietorship, partnership, joint venture, or any other form of enterprise, whether conducted for profit or not.
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“the Company” means Life Biosciences LLC and its wholly- and partially- owned subsidiaries.
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“Conflict of Interest Committee” means the committee responsible for reviewing Conflict of Interest issues relating to the Director. It will consist of the other members of the board of directors of the Company.
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“Director” means the CEO of Life Biosciences Inc., a wholly-owned operating company of Life Biosciences LLC.
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“Family Member” means a spouse, domestic partner, child, parent, sibling, or in-law.
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“Financial Conflict of Interest” means any situation in which an Interested Party has the opportunity or appears to have the opportunity to influence the Company’s decisions or use resources or confidential or proprietary information of the Company in ways that could lead to professional, personal or financial gain, or otherwise give improper advantage to the Interested Party or a Family Member or organizations in which he or she or Family Member hold official positions or Significant Financial Interests.
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“Financial Interest” means anything of monetary value, whether or not the value is readily ascertainable.
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“Interested Party” means all persons employed by the Company, directors of the Company, or persons with decision making authority to commit the resources of the Company or participate in the Company Research.
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“Research” means a systematic investigation which is designed to develop or contribute to generalizable knowledge in which an Interested Party or those under the control of such Interested Party a) obtains data; or b) generates data not previously known. Intervention includes both physical procedures by which data are gathered and manipulations of the environment that are performed for research purposes.
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“Personnel Action” means recruiting, hiring, sponsoring, appointing, terminating, promoting, demoting, setting compensation or other benefits, and allocating Company resources such as space and funding.
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“Public Health Service” means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS include, but are not limited to, the Administration for Children and Families, Administration on Aging, Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Federal Occupational Health, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, and Substance Abuse and Mental Health Services Administration.
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“Significant Financial Interest” means a Financial Interest consisting of one or more of the following interests of an Interested Party or his/her Family Member: A. With regard to any publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the Business Entity in the twelve months preceding the disclosure and the value of any equity interest in the Business Entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary for example, consulting fees and honoraria; equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value; B. With regard to any non-publicly traded Business Entity, a Significant Financial Interest exists if the value of any remuneration received from the Business Entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Interested Party or his/her Family Member holds any equity interest, for example, stock, stock option, partnership interest, or other ownership interest; or Intellectual property rights and interests. The term “Significant Financial Interest” does not include:
a. Salary, royalties or other remuneration from the Company;
b. Income from seminars, lectures or teaching engagements sponsored by a Federal, state, or local government agency, a U.S. institution of higher education, an academic teaching hospital, a medical Company, or a research institute that is affiliated with an institution of higher education;
c. Income from service on advisory committees or review panels for a Federal, state, or local government agency, a U.S. institution of higher education, an academic teaching hospital, a medical Company, or a research institute that is affiliated with an institution of higher education; or
d. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Interested Party or his/her spouse, domestic partner or dependent child does not directly control the investment decisions made in these vehicles.
e. Equity investments amounting to less than 0.001% of a publicly- traded company that is in an industry unrelated to the Company Research.
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“Transaction” is used in its broadest sense and includes, but is not limited to, loans, buying or selling goods or services, research, investigation, testing or patient care. The term does not include the purchase by an Interested Party or Family Member of goods or services offered by the Company in the normal course of business
Disclosure, Review and Monitoring Requirements
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Interested Parties will disclose Significant Financial Interests upon hiring or appointment to a position that is an Interested Party, at least annually thereafter, and within 30 days of discovering or acquiring a new Significant Financial Interest.
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The Director will insure that Interested Parties submit their Significant Financial Interests according to #1. above. The Director will promptly review any new financial disclosures and determine whether there exists a Financial Conflict of Interest for the Interested Party.
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The Conflict of Interest Committee will insure that the Director files his Significant Financial Interest statement and will promptly review such statement to determine whether there exists a Financial Conflict of Interest for the Director.
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The Director and/or the Conflict of Interest Committee will establish a management plan for dealing with a Financial Conflict of Interest of an Interested Party or the Director themselves to remove the conflict or manage the conflict in accordance with 42 CFR 50.605(a).
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The Director and/or the Conflict of Interest Committee will monitor any Interested Party on a management plan to insure compliance.
Reporting Requirements
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The Director will send initial and annual and revised Financial Conflict of Interest reports, including all reporting elements required by the relevant regulations, to the NIH for the Company and its subrecipients, if applicable. Reports will be sent prior to expenditure of NIH funds, within 60 days of identification for a new Interested Party assigned to an NIH project, within 60 days of the identification of a new Financial Conflict of Interest for existing Interested Parties, and at least annually.
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The Director will promptly notify NIH if bias is found with the design, conduct or reporting of NIH-funded Research along with a mitigation report in accordance to regulation 42 CFR 50.605(a)(3)(iii).
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The Director will promptly notify NIH if an Interested Party fails to comply with the Company Financial Conflict of Interest policy or a Financial Conflict of Interest management plan.
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The Director will maintain all Financial Conflict of Interest related records for at least 3 years from the date of the final expenditures report is submitted to NIH following completion of the grant activity for which the reports were solicited.
Enforcement Mechanisms and Remedies
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Reporting Violations
a. If an Interested Party becomes aware of any arrangement which constitutes a conflict for any other Interested Party that was not disclosed, that Interested Party will immediately disclose the matter to the Director.
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Sanctions
a. Violations of this policy by Interested Parties will be reported to the Director for appropriate action. If a violation of this policy has biased the design, conduct or reporting of any government funded research, the Director will determine what corrective action should be taken and will notify the awarding agency. The Director may, at his or her discretion, appoint an ad hoc committee to review the situation and determine the corrective action that should be taken. Intentional violations of this policy or may result in immediate suspension or dismissal in accordance with the Company’s established personnel policies.
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Disclosure
a. If it is determined that government funded Research has been conducted by an Interested Party with an unreported Significant Financial Interest, the Company will require the disclosure of that Significant Financial Interest in each public presentation of the results of the research.
Subrecipient Requirements
The Director will insure, via contractual agreement, that all subrecipient organizations that are involving in conducting the Company Research follow the subrecipient organization’s own policies consistent with the 42 CFR 50.605 regulation.
Public Accessibility
This Conflict of Interest Policy will be posted and maintained up to date on the Company’s Website: Lifebiosciences.com
Any Financial Conflict of Interest associated with government funded Research involving an Interested Party will be published on the Company’s website within 60 days of identification of such conflict and be maintained for at least three years.
Training Requirements and Affirmation
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The Director will insure that each new and existing Interested Party will read and sign this policy.
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The Director will insure that each new and existing Interested Party will be trained on the importance of and method of financial disclosure upon hire or appointment to a Company Research project. Such training will be repeated at least every four years and the Interested Party will again sign the then in-force Conflict of Interest policy relating to PHS grants.
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The Director will insure that training is repeated for any Interested Party not in compliance with the policy of the management plan for the Party.
Amendment
The Company reserves the rights to amend, amend and restate, terminate or waive this policy at its discretion, in each case in accordance with applicable law.