RAMONA OPTICS, INC.
PHS-FINANCIAL CONFLICT OF INTEREST (FCOI) POLICY
Persons covered by this Policy
This policy applies to all employees, including all full-time, part-time, temporary, and contract
employees, of RAMONA OPTICS, INC. who are planning to participate in, or are participating in,
Public Health Service (“PHS”) funded research by means of a grant or cooperative agreement.
Preamble
1. The primary goal of this policy is to promote objectivity in research by establishing standards
that provide a reasonable expectation that the design, conduct, and reporting of researchfunded under Public Health Service (PHS) grants or cooperative agreements will be free frombias resulting from Investigator financial conflicts of interest and to prevent an employee'sactivities from adversely influencing RAMONA OPTICS, INC.’s operations.
2. It is recognized that research related conflicts of interest can arise from legitimate andappropriate activities including economic development, public-private interactions, andemployee’s and their family’s personal business relationships.
3. This policy is implemented in accordance with 42 CFR Part 50 Subpart F - "Responsibility ofApplicants for Promoting Objectivity in Research for which Public Health Service Funding isSought" and 45 CFR Part 94 “Responsible Prospective Contractors" as well as all other relevant
policies of federal funding and oversight agencies.
A. Statement of general policy
1. The design, conduct, and reporting of Research funded under Public Health Service (PHS)
grants or cooperative agreements should be free from bias resulting from Investigator financial
conflicts of interest.
2. To provide a reasonable expectation of achieving the goal of this policy, Investigators shallcomplete appropriate training as required under this policy; Investigators shall disclose
perceived and real conflicts of interest annually and provide new or updated disclosures in atimely manner; RAMONA OPTICS, INC. shall provide for the elimination or management ofFinancial Conflicts of Interest; and RAMONA OPTICS, INC. shall make disclosures to both thePHS and to the public as required under this policy.
3. Nothing in this policy shall be construed to permit, even with disclosure, any activity that isprohibited by law.
4. For matters subject to this policy, to the extent of any conflict between this policy andprovisions of the general RAMONA OPTICS, INC. Conflict of Interest Policy, this policy
shall control.

5. Nothing in this policy shall be construed to limit or abridge the authority of RAMONAOPTICS, INC. management to take such action as they deem appropriate regardless of any
action or inaction by an employee of RAMONA OPTICS, INC.
B. Definitions
Institution refers to RAMONA OPTICS, INC.
Investigator means the project director or principal Investigator (PD/PI) and any other person,
regardless of title or position, who is responsible for the design, conduct, or reporting ofresearch funded by the PHS, or proposed for such funding, which may include, for example,
collaborators or consultants.
Institutional responsibilities means an Investigator’s professional responsibilities on behalf of
the Institution, and as defined by the Institution, including, but not limited to, activities such as
research, research consultation, teaching, professional practice, institutional committee
memberships, and service on panels such as Institutional Review Boards or Data and Safety
Monitoring Boards.
Financial interest means anything of monetary value, whether or not the value is readilyascertainable.
Financial Conflict of Interest (FCOI) means a significant financial interest that could directly
and significantly affect the design, conduct, or reporting of the NIH-funded research.
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 thedesign, conduct, and reporting of research will be free from bias.
Senior/Key Personnel means the Project Director/Principal Investigator (PD/PI) and any otherperson identified as senior/key personnel by the Institution in the grant application, progress
report, or any other report submitted to the NIH by the Institution under the regulation.
Significant Financial Interest (SFI) is defined by the regulation as:(1) A financial interest consisting of one or more of the following interests of the Investigator(and those of the Investigator’s spouse and dependent children) that reasonably appears to berelated to the Investigator’s institutional responsibilities:(i) With regard to any 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 andthe value of any equity interest in the 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 (e.g., consulting fees, honoraria, paid authorship);equity interest includes any stock, stock option, or other ownership interest, as determinedthrough reference to public prices or other reasonable measures of fair market value;(ii) With regard to any non-publicly traded entity, a significant financial interest exists if the valueof any remuneration received from the entity in the twelve months preceding the disclosure,when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse ordependent children) holds any equity interest (e.g., stock, stock option, or other ownershipinterest); or(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income
related to such rights and interests.
(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e.,that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that theexact monetary value may not be readily available), related to their institutional responsibilities;
provided, however, that this disclosure requirement does not apply to travel that is reimbursedor sponsored by a federal, state, or local government agency, an Institution of higher education
as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research
institute that is affiliated with an Institution of higher education. The Institution’s FCOI policy will
specify the details of this disclosure, which will include, at a minimum, the purpose of the trip,
the identity of the sponsor/organizer, the destination, and the duration. In accordance with theInstitution’s FCOI policy, the institutional official(s) will determine if further information is needed,including a determination or disclosure of monetary value, in order to determine whether thetravel constitutes an FCOI with the PHS-funded research.
(3) The term significant financial interest does not include the following types of financial
interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if theInvestigator is currently employed or otherwise appointed by the Institution, including intellectual
property rights assigned to the Institution and agreements to share in royalties related to suchrights; any ownership interest in the Institution held by the Investigator, if the Institution is acommercial or for-profit organization; income from investment vehicles, such as mutual funds 5and retirement accounts, as long as the Investigator does not directly control the investmentdecisions made in these vehicles; income from seminars, lectures, or teaching engagements
sponsored by a federal, state, or local government agency, an Institution of higher education as
defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research
institute that is affiliated with an Institution of higher education; or income from service on
advisory committees or review panels for a federal, state, or local government agency, anInstitution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a
medical center, or a research institute that is affiliated with an Institution of higher education.
C. Policy Implementation
1. Training Required: Investigators shall complete FCOI training provided by the Institution onor before their becoming subject to this policy and then every two (2) years thereafter.
Currently, RAMONA OPTICS, INC. uses the NIH web-based training which can be accessedat: (http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm). Investigators must save andprint the FCOI Certificate as proof of completion. Immediate training will be required if theInstitution revises this policy in a manner that affects the Investigator, when an Investigator is
new to the Institution, or as a result of a finding of noncompliance with this policy or amanagement plan, or other related misconduct.
2. Disclosure Requirement:(a) An Investigator shall disclose any situation in which the Investigator has, or may have, a realor potential Significant Financial Interest as defined and provided for herein. Research should
not be undertaken where a Significant Financial Interest is present until a determination andapproval has been made pursuant to this policy.
(b) Investigators shall keep their supervisors informed of the Investigator's Significant Financial
Interest. If a supervisor becomes aware of a conflict of interest that an employee has notdisclosed, the supervisor shall discuss the situation with the employee, require that a written
disclosure be made as provided in this policy, and inform RAMONA OPTICS, INC.to anticipate
the receipt of a new Disclosure.
3. Disclosure Frequency:(a) Disclosure must be made annually to RAMONA OPTICS, INC. If no Significant Financial
Interest is present a Disclosure must still be submitted that states “none”. The date such annualDisclosure is due shall be set by the RAMONA OPTICS, INC. and disseminated campus wide.
(b) In addition to the annual Disclosure, a new or updated Disclosure must be completed in atimely manner whenever a new or potential Significant Financial Interest arises or when asignificant change occurs concerning an existing Disclosure.
(c) In any event, Disclosure must be made within thirty (30) days of discovery or acquiring a new
Significant Financial Interest.
(d) Newly hired Investigators should make a Disclosure as part of their new hire employmentprocess.
4. Review and Management:(a) The Institution shall appoint and authorize a committee of appropriate composition and skills
to review the Disclosure and determine if it is a FCOI. This committee shall be known as theResearch Conflict of Interest Committee ("Committee") and serve at the pleasure of theInstitution.
(b) If a determination is made that a FCOI exists the Committee shall seek input from theInvestigator and recommend to the Institution a suitable action plan (“Management Plan”) toeliminate or manage the FCOI consistent with the objectives of this policy. The Management
Plan shall provide for its periodic review and updating at least annually. In the event that there isno reasonable way to manage a FCOI then the Investigator may be prohibited from participatingin the related Research until such a time as the FCOI is eliminated.
(c) Examples of conditions or restrictions that might be imposed to manage a financial conflict ofinterest include, but are not limited to:(i) Public disclosure of financial conflicts of interest (e.g., when presenting or publishing theresearch);(ii) For research projects involving human subjects research, disclosure of financial conflicts ofinterest directly to participants;(iii) 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 ofinterest;(iv) Modification of the research plan;

(v) Change of personnel or personnel responsibilities, or disqualification of personnel fromparticipation in all or a portion of the research;(vi) Reduction or elimination of the financial interest (e.g. sale of an equity interest);or(vii) Severance of relationships that create financial conflicts.
(d) The Institution shall review the proposed Management Plan and can approve, modify andapprove, or return to the Committee for additional work. Final review and determination must becompleted prior to the expenditure of any PHS funds for the applicable Research.
F. Violations and Sanctions
1. Sanctions: Violations of Institution policies, including the failure to avoid a prohibited activity
or disclose a conflict of interest in a timely manner, will be dealt with in accordance withapplicable policies and procedures that may include disciplinary actions up to and including
termination of employment.
2. Retrospective Review:(a) The Institution shall complete retrospective reviews of determinations of noncompliancewith this policy within 120 days of the determination.
(b) The retrospective reviews shall be documented; such documentation shall include, but notnecessarily be limited to, all of the following key elements: 1. Project number; 2. Project title; 3.
PD/PI or contact PD/PI if a multiple PD/PI model is used; 4. Name of the Investigator with theFCOI; 5. Name of the entity with which the Investigator has a financial conflict of interest; 6.
Reason(s) for the retrospective review; 7. Detailed methodology used for the retrospectivereview (e.g., methodology of the review process, composition of the review panel, documentsreviewed); 8. Findings of the review; and 9. Conclusions of the review.
(c) Based on the results of the retrospective review, if appropriate, the Institution shall update
the previously submitted FCOI report, specifying the actions that will be taken to manage thefinancial conflict of interest going forward.
(d) If bias is found, the Institution is required to notify the PHS Awarding Component promptly
and submit a mitigation report to the PHS Awarding Component. 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 the Institution's plan of action oractions 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 orfuture harm; analysis of whether the research project is salvageable). Thereafter, the Institution
will submit FCOI reports annually. Depending on the nature of the financial conflict of interest,
the Institution may determine that additional interim measures are necessary with regard to theInvestigator's participation in the PHS-funded research project between the date that thefinancial conflict of interest or the Investigator's noncompliance is determined and thecompletion of the Institution’s retrospective review.

3. Clinical Research: In any case in which the HHS determines that a PHS-funded project ofclinical research whose purpose is to evaluate the safety or effectiveness of a drug, medicaldevice, or treatment has been designed, conducted, or reported by an Investigator with a FCOI
that was not managed or reported by the Institution as required by this policy, RAMONAOPTICS, INC. shall require the Investigator involved to disclose the FCOI in each publicpresentation of the results of the research and to request an addendum to previously
published presentations.
G. Institutional Reporting
1. The Institution shall provide annual and revised reports of FCOI to PHS/National Institutes ofHealth (NIH) per the applicable regulations.
2. The Institution shall notify PHS/NIH of bias found in the design, conduct, or reporting ofPHS/NIH funded Research including whether Investigator failure to comply with this FCOI policyor management plan appears to have caused such bias.
3. FCOI records shall be maintained for at least three (3) years from the submission of the final
expenditure reports for the pertinent PHS/NIH funding or longer as required by other policy orregulation.
4. FCOI Informational requests by the public should be made to the Institution. The Institution
shall respond to requests for FCOI information within five (5) business days as provided forunder applicable regulations.
5. The Institution shall make the FCOI policy publicly available by posting it on the Institution’s
public website as required by the NIH Grants Policy Statement, Section 4.1.10.
H. Sub recipients
Institution shall require sub-recipient compliance with pertinent FCOI requirements as mandatedby PHS regulation.