SECTION 1: PURPOSE & SCOPE.

• 1.1. ExesaLibero Pharma, Inc (ExesaLibero) seeks to ensure that all ExesaLibero Employees and Officials, including Investigators and Staff, are responsible for sustaining the highest ethical standards through values of integrity, honesty, and fairness in their research, service, and business practices.
• 1.2. This policy is to comply with 42 CFR 50.604 as required by Federal Regulations. As such, any violations of these policies will be reported the U.S. Public Health Service (NIH).

SECTION 2: CONFLICT OF INTEREST DEFINED; and CORRECTIVE ACTIONS FOR VIOLATIONS OF THIS RULE.

2.1 Conflict of Interest Defined.

• 2.1.1 A Conflict of Interest occurs when there is a divergence between a ExesaLibero Employee’s private, personal relationships or interests and their professional obligations to the ExesaLibero such that a reasonable observer might question whether the individual’s professional actions or decisions are determined by or substantially altered by considerations of personal benefit, gain, or advantage.
• 2.1.2 Whether a Conflict of Interest or the appearance of a Conflict of Interest exists depends on the situation, not on the character or actions of the individual. The determination of the existence of a Conflict of Interest or the appearance of a Conflict of Interest is done objectively on a case-by-case basis. Because the appearance of a Conflict of Interest can be as damaging or detrimental as an actual Conflict of Interest, for the purposes of this Rule, apparent Conflicts of Interest are treated the same as actual Conflicts of Interest. As a result, any appearance of a Conflict of Interest must also be disclosed and reviewed in accordance with this Rule by the Signing Official.

2.2 Corrective Actions for Violations of this Rule.

• 2.2.1 Any ExesaLibero Employee who fails to abide by the requirements within this Rule shall be subject to appropriate disciplinary action, including warning, suspension, termination, or other disciplinary action as may be appropriate.
• 2.2.3 Furthermore, although conduct may not violate this Rule, it may still be prohibited by the ExesaLibero under a different rule, policy, or standard of behavior. Accordingly, in such cases, the ExesaLibero reserves the ability to take any necessary action.

SECTION 3: CONFLICT OF INTEREST IN RESEARCH.

• 3.1 A Conflict of Interest in Research may exist where a Significant Financial Interest for Research could directly affect or reasonably appear to affect the design, conduct, or reporting of research or other activity sponsored by an outside entity.
• 3.2 Disclosure Requirements. All Investigators of any ExesaLibero research project must disclose any Significant Financial Interests for Research to the ExesaLibero. All Investigators must submit a Conflict of Interest in Research Disclosure at least annually.
  • 3.2.1 All Investigators must submit a Conflict of Interest in Research Disclosure regardless of whether or not he or she has a Significant Financial Interest for Research to report.
  • 3.2.2 All Investigators must submit and certify the disclosure as accurate and complete.
  • 3.2.3. All Investigators must update their disclosure within thirty (30) days of the development of a new Significant Financial Interest for Research.
  • 3.2.4 If an Investigator has not previously submitted an annual Conflict of Interest in Research Disclosure, the Investigator must submit a Conflict of Interest in Research Disclosure prior to submitting a research proposal seeking external funds or otherwise participating in any research activity regardless of the source offunding.
• 3.3 Review of Conflict of Interest in Research.
  • 3.3.1 Conflict of Interest in Research Disclosures submitted by Investigators shall be reviewed by ExesaLibero Signing Official. He shall determine if an Investigator has a Conflict of Interest in Research or the appearance of a Conflict of Interest in Research. If a Conflict is identified, he may determine that the Conflict can be managed through an appropriate Management Plan. If he determines that the Conflict cannot be managed, then it shall recommend steps to resolve the Conflict.

SECTION 4: OTHER CONFLICTS OF INTEREST.

• 4.1 To the extent a ExesaLibero Employee develops a real or perceived Conflict of Interest that is not expressly covered by this Rule, the ExesaLibero Employee must disclose this Conflict to their immediate supervisor within thirty (30) days of the development of the Conflict.
• 4.2 The ExesaLibero Employee’s supervisor shall report the disclosed Conflict of Interest to Human Resources (for Staff) or the President’s Office (for Investigators) to develop with the supervisor an appropriate Management Plan.
• 4.3 ExesaLibero Employees are required to fully comply with all disclosure requirements of third parties for any activity that requires a disclosure of a Conflict of Interest. Such disclosures may be required when engaging in various activities, including but not limited to seeking research grants, participating in speaking engagements, or contributing to a publication.

SECTION 5: RECORD KEEPING

• 5.1 As required by 42 CFR 50.604 of the Federal Regulations, all Conflict of Interest records will be retained for a period of three years.

SECTION 6: DEFINITIONS.

• 6.1 “Conflict of Interest in Research Disclosure” means a form developed to disclose the potential Conflicts of Interest in Research held by ExesaLibero Investigators developed by the Office of the President of ExesaLibero.
• 6.2 “Employee” means any Investigator and Staff.
• 6.3 “Family Member” means spouse, a person with whom the individual is living with as a partner, any dependent child, dependent grandchild, or dependent parent.
• 6.4 “Institutional Conflict of Interest Disclosure” means a form developed to disclose the potential institutional conflicts of interest of ExesaLibero Officials. The disclosure form for all employees is available as a downloadable file on this website.
• 6.5 “Investigator” means the project director or principal investigator/program director, coinvestigator, collaborator, senior/key personnel, and any other person, regardless of title or position, who is responsible for the design, conduct, reporting, or proposing of research or other activity that is sponsored by an extramural agency or enterprise. Postdoctoral scholars and fellows may be considered Investigators if designated as such by the President on a case-by-case basis.
• 6.6 “Management Plan” means an agreed plan to take action to address a Conflict of Interest, which may include eliminating the conflict, to ensure, to the extent possible, that the Employee’s actions do not violate ExesaLibero Policies, this Rule, or any other relevant laws, regulations, policies, or procedures.
• 6.7 “President” means the ExesaLibero President or their designee. The Signing Official for ExesaLibero is the ExesaLibero President or their designee.
• 6.8 “Significant Financial Interest for Research” means a financial interest consisting of one or more of the following interests of an Investigator or Family Member of the Investigator that reasonably appears related to the Investigator’s institutional responsibilities:
• 6.8.1.1 With regard to any publicly traded entity, the value of any remuneration received from the entity in the 12 months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, that when aggregated exceeds Five Thousand Dollars ($5,000.00).
• 6.8.2 With regard to any non-publicly traded entity, the value of any remuneration received from the entity during the 12 months preceding the disclosure, that when aggregated exceeds Five Thousand Dollars ($5,000.00), or when the Investigator or Family Member holds any equity interest in the entity.
• 6.8.3 Any intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
• 6.8.4 The term Significant Financial Interest for Research does not include the following types of financial interests: salary, royalties, or other remuneration paid by the ExesaLibero to the Investigator or family member if the Investigator is currently employed or otherwise appointed by the ExesaLibero; income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency; or income from service on advisory committees or review panels for a Federal, state, or local government agency.
• 6.9 “Staff” means all employees, not previously defined as an Investigator.
• 6.10 “ExesaLibero Official” means ExesaLibero President and Vice Presidents.