FINANCIAL DISCLOSURE - ACC



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EXHIBIT C

FINANCIAL DISCLOSUR FORM

[Principal, Co-, Sub- Investigator(s)]

[ STUDY ]

Institution: _________________

PI / Co-I/Sub-I: ________________

Name (please print) __________________, M.D. Date completed: _______________

Please note that a disclosure must be completed by the Principal Investigator and each Co-Investigator and each Sub-Investigator involved in the treatment or evaluation of research subjects in the Study.

This Financial Disclosure Form is completed in relation to the study entitled: ________________ (“Study”) being sponsored by [______] (“Sponsor”) and being conducted by [PI/Co-I/ Sub-I] at ____________________ (“Institution”).

1. During the course of the Study and for one year after its conclusion, do you, your spouse, immediate family members and/or dependent children collectively expect to receive (directly or indirectly) from Sponsor cash or non-cash compensation or remuneration (see below for examples) in excess of $25,000? YES_____ NO_____

If yes, please describe in detail in the table below. Include all consulting, core laboratory, advisory, honoraria, preceptorship and research grant payments you expect to receive (either directly or indirectly through an affiliated entity) and the value of all equipment or materials provided to you or an affiliated entity at or below market cost. DO NOT INCLUDE PAYMENTS EXPECTED TO BE RECEIVED BY YOU, INSTITUTION OR ANY AFFILIATED ENTITY PURSUANT TO THE CLINICAL Study AGREEMENT FOR THE ABOVE CAPTIONED STUDY TO WHICH THIS EXHIBIT IS INCORPORATED OR FOR THE COSTS OF CONDUCTING ANY OTHER CLINICAL STUDY.

|Recipient |Type of Compensation (e.g., |Amount or Value of |Reason/Basis for Compensation |

|(you, your spouse, immediate family|cash, goods, etc.) |Compensation |(e.g., honoraria for three |

|member dependent child, or | | |presentations) |

|affiliated entity) | | | |

| | | | |

| | | | |

| | | | |

| | | | |

2. During the course of the Study and for one year after its conclusion, do you expect the Institution to receive from Sponsor collectively cash or non-cash compensation in excess of $25,000 in support of your, your spouse’s, immediate family member’ or your dependent children’s own activities? YES_____ NO_____

If yes, please describe in detail in the table below. Include all cash and non-cash grants (including equipment and materials grants) made to Institution in support of your own research or your department’s research or that of your spouse’s, immediate family members’ and/or your dependent children. DO NOT INCLUDE PAYMENTS EXPECTED TO BE RECEIVED BY INSTITUTION PURSUANT TO THE CLINICAL Study AGREEMENT FOR THE ABOVE CAPTIONED STUDY TO WHICH THIS EXHIBIT IS INCORPORATED.

|Person whose Activities are being |Type of Compensation |Amount or Value of |Activities Supported |

|Supported |(e.g., cash, equipment, |Compensation | |

|(you, your spouse, or dependent child) |etc.) | | |

| | | | |

| | | | |

| | | | |

| | | | |

3. Do you, your spouse, immediate family members and/or dependent children expect to have any proprietary interest (directly or indirectly) in the [Device] (as defined in the Clinical Trial Agreement) being tested (i.e., copyright, trademark or patent or other intellectual property rights relating to the [Device], rights to royalties, licensing fees, or other fees, profits or revenue from sales of the [Device], etc.)?

YES_____ NO_____

If yes, please describe in detail in the space provided below.

4. Do you, your spouse, immediate family members and/or dependent children have a financial arrangement(s) with the Sponsor or its affiliates in which the value of the compensation for conducting the Study could be influenced by the outcome of the Study?

YES_____ NO_____

5. Do you, your spouse, immediate family members and/or your dependent children (either directly or through a trust and/or any entities controlled by any of the foregoing persons) have or expect to receive from Sponsor during the course of the Study and for one year after its conclusion any Significant Equity Interest in the Sponsor ? “Significant Equity Interest” means any (1) ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices (generally, interests in a non-publicly traded corporation); or (2) equity interest in a publicly traded corporation that exceeds $50,000.

YES_____ NO_____

For all questions answered “yes” above, please describe below any steps taken to minimize the potential for bias resulting from any of the disclosed arrangements, interests, or payments:

This information is being requested pursuant to regulations of the Food and Drug Administration relating to Financial Disclosure by Clinical Investigators. As an investigator in this Study, you are required by law to fully and accurately provide this information and to update it, to the extent your responses to any of these questions changes. It is your responsibility to keep this information current during the time of the Study and for one year after Sponsor completes the Study or terminates the Study, whichever occurs sooner. Please be thorough, complete and accurate in your responses. If you have any questions concerning the information requested above, please contact the Sponsor representative.

By your signature below, you represent that all of the above information is true, complete and correct, and you agree to promptly update or amend, by written notice to Sponsor, the information contained in this Exhibit [C] as may be necessary to ensure that such information is true, complete and correct at all times during the term of this Agreement and for one (1) year after the completion or termination of the Clinical Study as required by 21 C.F.R. Part 54.

_______________________________

Signature

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