ATTESTATION AND DISCLOSURE FORM (2012 Cycle) Information provided pursuant to this requirement is considered confidential Student / Employee ID: 1802277 Department or Division: Health Affairs Last Name: Dunn Campus Telephone: 852-6201 First Name: David E-mail address: dldunn01@louisville.edu Covered Individual’s Direct Supervisor (Appropriate Authority) President James Ramsey The intent of this questionnaire is to help you identify external interests and activities you have that might affect or be affected by the roles you perform at the University of Louisville or under the auspices of the University of Louisville (Institution). This annual report is being conducted to comply with federal regulations (DHHS, PHS, and NSF Regulations, 21 CFR Parts 54, 312, 314, 320, 330, 601, 807, 812, 814, and 860, and OMB Circular A-110), state statutes (KRS 45A.340, 164.367, 164.390, 164.821) and University of Louisville Policies (Addressing Potential Individual Conflict of Interest Policy and Procedures and Addressing Potential Institutional Conflict of Interest Policy and Procedures). The main goals of these regulations, statutes and policies are to assure that a Covered Individual’s external interests and activities do not compromise the integrity of academic, business, clinical and research missions of the Institution and to maintain the public trust through disclosure and management of real or perceived conflicts of interest. These regulations, statutes and policies may not prohibit external relationships that might benefit employees, but they do require that they are fully reported to the Institution, reviewed and managed as appropriate. The following statements apply to you as an employee or affiliated researcher at the University of Louisville. The term “I” includes you, as a Covered Individual, and your immediate family members1. The term “sponsor” includes any entity (other than University of Louisville or one of its affiliated organizations, e.g., University of Louisville Research Foundation, University of Louisville Foundation, University of Louisville Athletic Association) that supports university activities. Note that private practice plans/PSCs and their affiliated foundations are not considered affiliated organizations for these purposes. “Support” means providing anything of value (e.g., funds, supplies, equipment, staff, etc.), regardless of whether restricted or unrestricted. The term “vendor” means an individual or entity that provides goods and / or services to the University of Louisville under contract (written or verbal). Covered Individuals are responsible for knowing, understanding, and complying with this procedure as it relates to their role, position, employment or enrollment at the Institution. Breaches of this procedure include, but are not limited to, failing to submit an ADF, intentionally submitting an incomplete, erroneous or misleading ADF, failing to provide additional information as required by the Appropriate Authority, or failing to follow an approved plan for managing, reducing or eliminating a potential conflict. A violation of this procedure, failure to complete this questionnaire or violation of federal regulations, state statutes or University of Louisville policies may result in sanctions, corrective measures and appropriate disciplinary actions, up to and including termination as determined by existing Institution policies. If you are at all unsure whether your particular situation constitutes an external interest, it is advisable to err on the side of reporting. Based on your responses, you may be contacted to provide additional explanation or information. If you require assistance, please contact the Conflict of Interest Office at COIOFF@louisville.edu or 852-1371 / 852-7612. Research specific questions should be directed to the Office of Research Integrity at ori@louisville.edu or 852-2454. 1 Immediate family member shall mean the Covered Individual’s biological, foster or adoptive parent, a stepparent, spouse, qualifying adult, a biological, adoptive or foster child, a step child, a legal ward or a person whom the covered individual has (or had during the person's youth) daily responsibility and financial support, mother, father, brother, sister, son, daughter, mother-in-law, father-in-law, brother-in-law, sister-in-law, son-in-law, daughter-in-law, grandparents, and grandchildren of both the covered individual and spouse and / or qualifying adult. A qualifying adult must be over 18 years of age, and, if a blood relative (or relative by adoption or marriage) must be of the same or younger generation of the Covered Individual (as used in KRS 391.010), and, must be residing in the covered individual's household and have done so for a period of at least 12 months, and, must be financially interdependent (for example, have joint checking account or joint mortgage) for 12 months or longer, and, must be unmarried. Part A: Code of Conduct Full Text of the Code of Conduct located at: http://louisville.edu/compliance/Code Standards of Conduct • Act Ethically and with Integrity • Ethically Conduct Teaching and Research • Be Fair and Respectful to Others • Avoid Conflicts of Interest and Commitment • Manage Responsibly • Carefully Manage Public, Private, and • Protect and Preserve University Resources Confidential Information • Promote a Culture of Compliance • Promote Health and Safety in the Workplace • Preserve Academic Freedom and Meet Academic Responsibilities I confirm that I have read the University of Louisville Code of Conduct (“Code”), understand it, and I agree to abide by the Standards of Conduct outlined in the Code so long as I remain a Covered Individual with the University of Louisville. Yes No Part B: Disclosure Form 1. Type of Disclosure Annual Amendment/Revision 2. Provide Name, title and department of all immediate family members employed by the University of Louisville Immediate Family Member Title Department Kelli M.B. Dunn, M.D. Professor Surgery Relationship to Covered Individual Spouse Part B.1: Business The following disclosure questions are to be answered by ALL Covered Individuals and are a condition of your Term of Appointment. When you answer each question, consider the following time interval: the previous 12 months and the anticipation of the coming 12 months (a two year window). 1. Do you and/or your immediate family members have a relationship with an Entity that is engaged in a business relationship with the University of Louisville or any of its Associated Organizations (University of Louisville Foundation, University of Louisville Research Foundation, University of Louisville Athletic Association)? Yes No 2. Do you or your Immediate Family Members collectively receive anything of value totaling more than $25 per year (“gift”) from a single Entity that is engaged in a business relationship with the University of Louisville, or any of its Associated Organizations (ULF, ULRF, ULAA)? (Examples of gifts would include - free meals, lodging, travel, discounted conference / registration fees, free or discounted tickets to entertainment events, software, gift cards / certificates, or other tangible items. Discounts received through the employee benefits programs do not need to be reported here.) Yes No 3. Do you or your Immediate Family Members employ Covered Individuals or students in an Entity that is engaged in a business relationship with the University of Louisville, or any of its Associated Organizations (ULF, ULRF, ULAA)? Yes No Jump to Part C.1 Business Part B.2: Academics This section must be completed by all Covered Individuals involved in the academic operations of the University of Louisville. Involved in academic operations includes: teaching a course, serving as an advisor to students or a student organization, serving as a Faculty Mentor/Thesis/Dissertation Advisor /Committee Member or Instructor (includes an enrollment, award, scholarship or graduation committees). When you answer each question, consider the following time interval: the previous 12 months and the anticipation of the coming 12 months (a two year window). 1. Do you or your Immediate Family Members have a relationship with an Entity that is engaged in an academic relationship with the University of Louisville, or any of its Associated Organizations (ULF, ULRF, ULAA)? Yes No 2. Do you or your Immediate Family Members collectively receive anything of value totaling more than $25 per year (“gift) from an Entity that is engaged in an academic relationship with the University of Louisville, or any of its Associated Organizations (ULF, ULRF, ULAA)? (Examples of gifts would include - free meals, lodging, travel, discounted conference / registration fees, free or discounted tickets to entertainment events, software, gift cards / certificates, free textbooks, or other tangible items. Receipt of examination copies of textbooks do not need to be reported here.) Yes No 3. Do you require or recommend your own, your supervisor’s or your Immediate Family Members' textbooks or other teaching aids? (This includes course pack, lab manual, materials, software or equipment to be used with University of Louisville instructional programs - “academic resource”.) Yes No 4. Do you or your Immediate Family Members serve as Faculty Mentor, Thesis or Dissertation Advisor, Committee Member or Instructor for a student that you also employ? Yes No 5. Do you or an Immediate Family Member serve as Faculty Mentor, Thesis or Dissertation Advisor, Committee Member or Instructor for a student that has an interest in an Entity in which you or your Immediate Family Members also hold a relationship? Yes No 6. Do you serve as Faculty Mentor, Thesis or Dissertation Advisor, Committee Member or Instructor for an Immediate Family Member? Yes No 7. Do you serve as Faculty Mentor, Thesis or Dissertation Advisor, Committee Member or Instructor for a student with whom you have an external personal or professional relationship? Yes No Jump to Part C.2 Academics Part B.3: Clinical This section must be completed by all Covered Individuals involved in the clinical operations of the University of Louisville. Clinical operations include: work, clinical practice, clinical research and education of University of Louisville clinical students, residents and fellows in all hospital and office settings owned, operated by, or rented by or otherwise under the control of entities using the UofL Health Care name. When you answer each question, consider the following time interval: the previous 12 months and the anticipation of the coming 12 months (a two year window). 1. Do you or your Immediate Family Members have a relationship with an Entity that is engaged in a clinical relationship with the University of Louisville, or any of its Associated Organizations (ULF, ULRF, ULAA)? (This includes providing or having the potential to provide support or advice, consulting, reviews, or assistance in evaluating the selection that is intended to result in the use or acquisition of products or services that impact the clinical operations of UofL Health Care or to which you make clinical referrals.) Yes No 2. Do you or your Immediate Family Members collectively receive anything of value totaling more than $25 per year (“gift”) from an Entity that is engaged in a clinical relationship with the University of Louisville or any of its Associated Organizations (ULF, ULRF, ULAA)? (Examples of gifts would include - free meals, lodging or travel, discounted conference / registration fees, free or discounted tickets to entertainment events, software, gift cards / certificates, or other tangible items.) Yes No 3. Do you or your Immediate Family Members employ Covered Individuals or students in an Entity that is engaged in a clinical relationship with the University of Louisville or any of its Associated Organizations (ULF, ULRF, ULAA) Yes No Jump to Part C.3 Clinical Part B.4: Research and Scholarly Activity This section must be completed by all Covered Individuals involved in research or scholarly activity, which being listed as an investigator, sub-investigator or study personnel, on a protocol that is submitted to the IRB, IACUC and / or IBC; being listed on a Food and Drug Administration (FDA) 1572 form; collecting and / or presenting original data, in any form; development of original materials; presentation of original materials in a public forum outside the University of Louisville, listed as study/project personnel on a sponsored project or award / contract, included on the budget of a sponsored program budget, have a biographical sketch included in a sponsored program proposal, contract solicitation. When you answer each question, consider the previous 12 months and the anticipation of the coming 12 months (a two year window). 1. Do you or your Immediate Family Members have a relationship with an Entity that supports the research or scholarly activity of yourself or of someone under your supervision or that is a competitor to an Entity that supports the research or scholarly activity of yourself or of someone under your supervision? (Examples would include ownership, stock options, officer or board positions, honoraria for lectures / workshops, teaching engagements, seminars or service on advisory boards.) Yes No 2. Do you or your Immediate Family Members collectively receive anything of value totaling more than $25 per year (“gift”) from a single Entity that is engaged in a research or scholarly activity relationship with the University of Louisville, or any of its Associated Organizations (ULF, ULRF, ULAA)? (Examples of gifts would include - free meals, lodging, travel, discounted conference / registration fees, free or discounted tickets to entertainment events, software, gift cards / certificates, or other tangible items. Discounts received through the employee benefits programs do not need to be reported here.) Yes No 3. Do you or your Immediate Family Members hold a proprietary interest (pending patent, issued patent, trademark, trade secret, copyright, invention, licensing agreement)related to the research or scholarly activity of yourself or of someone under your supervision? (Note: If the interest exists, but no funds have yet been received, the answer would still be ‘yes.’) Yes No 4. Do you or your Immediate Family Members receive direct payments or entitlements to direct payments in connection with the research or scholarly activity of yourself or of someone under your supervision? (Direct payments do not include payments for sponsored research agreements made to the University of Louisville Research Foundation.) Yes No 5. Do students, interns, residents, fellows, graduate students, or other trainees under your supervision or mentorship participate in University of Louisville research or scholarly activities in which you or your Immediate Family Members have an external interest? Yes No 6. Do you or your Immediate Family Members employ Covered Individuals or students in an Entity that is engaged in a research or scholarly activity relationship with the University of Louisville, or any of its Associated Organizations (ULF, ULRF, ULAA)? Yes No 7. Do you serve on an internal or external body with jurisdiction to award or distribute government funds (e.g. committees of NIH, FDA, or other governmental agencies, private professional or regulatory body) where participation would reasonably appear to be influenced by the presence or existence of an external interest or relationship? Yes No 8. Do you or your Immediate Family Members receive sponsored or reimbursed travel directly from an Entity that supports your research? Yes No Jump to Part C.4 Research and Scholarly Activity Part B.5 Institutional This section must be completed by ALL Institutional Officials. "Institutional Official" means persons holding administrator positions, including those holding these positions in a temporary capacity. This term includes, but is not limited to individuals serving as: Deans, Associate Deans, and Assistant Deans; Institute and Center Directors; General Counsel; University Compliance Officers; Director of Audit Services; Provost, Vice Provosts, Associate Vice Provosts, and Assistant Vice Provosts; President, Executive Vice Presidents, Senior Vice Presidents, Vice Presidents, Associate Vice Presidents, and Assistant Vice Presidents; and chairs of the Institutional Review Board, Institutional Biosafety Committee, Institutional Animal Care and Use Committee, Conflict Review Board and other similar committees that might be created in the future. When you answer each question, consider the following time interval: the previous 12 months and the anticipation of the coming 12 months (a two year window). 1. Do you have Institutional responsibility to make University of Louisville resource decisions (facilities, funds, personnel) for academic, business, clinical, research or scholarly activity relationships that also involve an Entity in which you or your Immediate Family Members hold a relationship? Yes No 2. Do Covered Individuals under your direct supervision engage in academic, business, clinical, research or scholarly activities with an Entity in which you or your Immediate Family Members hold a controlling interest or hold a relationship? Yes No Jump to Part C.5 Institutional Part B.6 Other 1. Do you have any external interests or activities that have not been covered in the above sections? Yes No If Yes, please provide a description of the external interest, activity or relationship below PART C: DISCLOSURE OF EXTERNAL INTERESTS Part C.1 Business (Questions to be answered for each entity in which you or an immediate family member has a relationship) C.1.1. What relationships do you and/or your immediate family members have with the Entity that is engaged in business transactions with U of L or one of its affiliated organizations? Name of Entity#1 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) No No Approximate Value Previous 12 months Expected in next 12 months Yes Philanthropic Donation Consulting Ownership Employment Training / Service Grant(non-research) Equipment Gift Equipment Loan Other (describe) Transaction Yes Royalty Payment No Yes Time Period Previous 12 months UL Affiliation (UL, ULF, ULRF, ULAA) UofL Upcoming 12 months Provision of Goods Provision of Services Provision of Funds Receipt of Goods Receipt of Services Receipt of Funds Other (describe) Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? Does the entity propose to rent or sell goods or to provide services to the Institution? If yes, are the goods and / or services available commercially, from other sources? No Yes Individual holding relationship CI or IFM DLD Name of Entity#2 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) No No Yes Approximate Value Previous 12 months Expected in next 12 months Yes UL Affiliation (UL, ULF, ULRF, ULAA) Philanthropic Donation Consulting Ownership Employment Training / Service Grant(non-research) Equipment Gift Equipment Loan Other (describe) Transaction No Yes Time Period Previous 12 months Upcoming 12 months Provision of Goods Provision of Services Provision of Funds Receipt of Goods Receipt of Services Receipt of Funds Other (describe) Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? Does the entity propose to rent or sell goods or to provide services to the Institution? If yes, are the goods and / or services available commercially, from other sources? No Yes Individual holding relationship CI or IFM Name of Entity#3 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) No No Yes Approximate Value Previous 12 months Expected in next 12 months Yes UL Affiliation (UL, ULF, ULRF, ULAA) Philanthropic Donation Consulting Ownership Employment Training / Service Grant(non-research) Equipment Gift Equipment Loan Other (describe) Transaction No Yes Time Period Previous 12 months Upcoming 12 months Provision of Goods Provision of Services Provision of Funds Receipt of Goods Receipt of Services Receipt of Funds Other (describe) Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? Does the entity propose to rent or sell goods or to provide services to the Institution? If yes, are the goods and / or services available commercially, from other sources? No Yes Individual holding relationship CI or IFM Name of Entity#4 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) No No Yes Approximate Value Previous 12 months Expected in next 12 months Yes UL Affiliation (UL, ULF, ULRF, ULAA) Philanthropic Donation Consulting Ownership Employment Training / Service Grant(non-research) Equipment Gift Equipment Loan Other (describe) Transaction No Yes Time Period Previous 12 months Upcoming 12 months Provision of Goods Provision of Services Provision of Funds Receipt of Goods Receipt of Services Receipt of Funds Other (describe) Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? Does the entity propose to rent or sell goods or to provide services to the Institution? If yes, are the goods and / or services available commercially, from other sources? No Yes Individual holding relationship CI or IFM C.1.2. What gifts have you and/or your immediate family members received from an Entity that is engaged in business transactions with U of L of one of its affiliated organizations? Gifts (check all that apply) No Yes Approximate Value Previous 12 months Expected in next 12 months Entity providing Gift Individual holding relationship CI or IFM Meals Travel or Lodging Meeting / Conference Registrations Tickets to Entertainment Events Software Gift Cards / Certificates Other (describe) C.1.3. In what capacity do you or your immediate family members employ faculty, staff, students or trainees in an Entity that is engaged in business transactions with the U of L or one of its affiliated organizations? Employment Relationships (check all that apply) Employee – full time Employee – part time Employee - contract Advisor Consultant Other (describe): No Yes List all such Covered Individuals and students employed Individual holding relationship CI or IFM Employing Entity C.2.1. What relationships do you and/or your immediate family members have with the external entity that is engaged in academic transactions with U of L or one of its affiliated organizations? ( Questions to be answered for each entity in which you or an immediate family member has a relationship) Name of Entity#1 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) Approximate Value Previous 12 months Expected in next 12 months UL Affiliation (UL, ULF, ULRF, ULAA) Philanthropic Donation Consulting Ownership Employment Training / Service Grant(non-research) Equipment Gift Equipment Loan Other (describe) Transaction Time Period Previous 12 months Upcoming 12 months Provision of Goods Provision of Services Provision of Funds Receipt of Goods Receipt of Services Receipt of Funds Other (describe) Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? Does the entity propose to rent or sell goods or to provide services to the Institution? If yes, are the goods and / or services available commercially, from other sources? No Yes Individual holding relationship CI or IFM Name of Entity#2 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) Approximate Value Previous 12 months Expected in next 12 months UL Affiliation (UL, ULF, ULRF, ULAA) Philanthropic Donation Consulting Ownership Employment Training / Service Grant(non-research) Equipment Gift Equipment Loan Other (describe) Transaction Time Period Previous 12 months Upcoming 12 months Provision of Goods Provision of Services Provision of Funds Receipt of Goods Receipt of Services Receipt of Funds Other (describe) Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? Does the entity propose to rent or sell goods or to provide services to the Institution? If yes, are the goods and / or services available commercially, from other sources? No Yes Individual holding relationship CI or IFM Name of Entity#3 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) Approximate Value Previous 12 months Expected in next 12 months UL Affiliation (UL, ULF, ULRF, ULAA) Philanthropic Donation Consulting Ownership Employment Training / Service Grant(non-research) Equipment Gift Equipment Loan Other (describe) Transaction Time Period Previous 12 months Upcoming 12 months Provision of Goods Provision of Services Provision of Funds Receipt of Goods Receipt of Services Receipt of Funds Other (describe) Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? Does the entity propose to rent or sell goods or to provide services to the Institution? If yes, are the goods and / or services available commercially, from other sources? No Yes Individual holding relationship CI or IFM Name of Entity#4 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) Approximate Value Previous 12 months Expected in next 12 months UL Affiliation (UL, ULF, ULRF, ULAA) Philanthropic Donation Consulting Ownership Employment Training / Service Grant(non-research) Equipment Gift Equipment Loan Other (describe) Transaction Time Period Previous 12 months Upcoming 12 months Provision of Goods Provision of Services Provision of Funds Receipt of Goods Receipt of Services Receipt of Funds Other (describe) Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? Does the entity propose to rent or sell goods or to provide services to the Institution? If yes, are the goods and / or services available commercially, from other sources? No Yes Individual holding relationship CI or IFM C.2.2. What gifts have you and/or your immediate family members received from an external entity that is engaged in academic transactions with U of L or one of its affiliated organizations? Gifts (check all that apply) Approximate Value Previous 12 months Expected in next 12 months Entity providing Gift Individual receiving gift Meals Travel or Lodging Meeting / Conference Registrations Tickets to Entertainment Events Software Gift Cards / Certificates Other (describe) C.2.3. What materials developed by yourself, your supervisor, or a member of your immediate family are required in courses taught by you at the U of L? (Questions to be answered for each course using materials developed by yourself or a member of immediate family member) Name of Course #1 Title of materials: Author (Self, Family Member, Supervisor): Are students required to purchase the materials? If yes, are they available on reserve at the library or departmental office? Are the required materials self-published? If not self-published, is there a royalty agreement in place? Is the course required for graduation? No Yes No Yes Name of Course #2 Title of materials: Author (Self, Family Member, Supervisor): Are students required to purchase the materials? If yes, are they available on reserve at the library or departmental office? Are the required materials self-published? If not self-published, is there a royalty agreement in place? Is the course required for graduation? Name of Course #3 Title of materials: Author (Self, Family Member, Supervisor): Are students required to purchase the materials? If yes, are they available on reserve at the library or departmental office? Are the required materials self-published? If not self-published, is there a royalty agreement in place? Is the course required for graduation? No Yes C.2.4. For each student that you and/or your immediate family members employ in an Entity, provide the following information: List all such U of L faculty, staff, students and trainees within this category Individual holding relationship CI or IFM Employment Relationships (check all that apply) Employee – full time Employee – part time Employee - contract Advisor Consultant Other (describe): University Relationship (Committee Member includes any enroll, scholarship or graduation committees) Advisor Instructor Committee Member Mentor Advisor Instructor Committee Member Mentor Advisor Instructor Committee Member Mentor Advisor Instructor Committee Member Mentor Advisor Instructor Committee Member Mentor Advisor Instructor Committee Member Mentor C.2.5. What students do you serve as a Faculty Mentor/Thesis/Dissertation Advisor/Committee Member or Instructor in which the student has a controlling interest in an Entity that you and/or your immediate family members hold a relationship? List all such Advisees/Mentees Name of Entity Consultant Consultant Consultant Consultant Consultant Consultant Relationship You hold with External Entity Advisory Board Contract Employee Advisory Board Contract Employee Advisory Board Contract Employee Advisory Board Contract Employee Advisory Board Contract Employee Advisory Board Contract Employee Board of Directors Board of Directors Board of Directors Board of Directors Board of Directors Board of Directors C.2.6. What members of your immediate family do you serve as a Faculty Mentor/Thesis/Dissertation Advisor/Committee Member or Instructor? Mentor Mentor Mentor Thesis/ Dissertation Advisor Thesis/ Dissertation Advisor Thesis/ Dissertation Advisor Committee Member Committee Member Committee Member Instructor Instructor Instructor Mentor Mentor Mentor Thesis/ Dissertation Advisor Thesis/ Dissertation Advisor Thesis/ Dissertation Advisor Committee Member Committee Member Committee Member Instructor Instructor Instructor C.2.7. What students do you serve as a Faculty Mentor/Thesis/Dissertation Advisor/Committee Member or Instructor as well as maintain an external professional or personal relationship? Mentor Mentor Mentor Mentor Mentor Mentor Thesis/ Dissertation Advisor Thesis/ Dissertation Advisor Thesis/ Dissertation Advisor Thesis/ Dissertation Advisor Thesis/ Dissertation Advisor Thesis/ Dissertation Advisor Committee Member Committee Member Committee Member Committee Member Committee Member Committee Member Instructor Instructor Instructor Instructor Instructor Instructor Part C.3 Clinical C.3.1. What relationships do you and/or your immediate family members have with the external entity that is engaged in clinical transactions with U of L Healthcare? ( Questions to be answered for each entity in which you or an immediate family member has a relationship) Name of Entity#1 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) Approximate Value Previous 12 months Expected in next 12 months Individual holding relationship CI or IFM Philanthropic Donation Consulting Ownership Employment Training / Service Grant(non-research) Equipment Gift Equipment Loan Other (describe): Transaction Provision of Goods Provision of Services Provision of Funds Provision of Referrals Receipt of Goods Receipt of Services Receipt of Funds Receipt of Referrals Other (describe): Previous 12 months Upcoming 12 months Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? Does the entity propose to rent or sell goods or to provide services to the U of L Healthcare? If yes, are the goods and / or services available commercially from other sources? No Yes Name of Entity#2 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) Approximate Value Previous 12 months Expected in next 12 months Individual holding relationship CI or IFM Philanthropic Donation Consulting Ownership Employment Training / Service Grant(non-research) Equipment Gift Equipment Loan Other (describe): Transaction Provision of Goods Provision of Services Provision of Funds Provision of Referrals Receipt of Goods Receipt of Services Receipt of Funds Receipt of Referrals Other (describe): Previous 12 months Upcoming 12 months Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? Does the entity propose to rent or sell goods or to provide services to the U of L Healthcare? If yes, are the goods and / or services available commercially from other sources? No Yes Name of Entity#3 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) Approximate Value Previous 12 months Expected in next 12 months Individual holding relationship CI or IFM Philanthropic Donation Consulting Ownership Employment Training / Service Grant(non-research) Equipment Gift Equipment Loan Other (describe): Transaction Provision of Goods Provision of Services Provision of Funds Provision of Referrals Receipt of Goods Receipt of Services Receipt of Funds Receipt of Referrals Other (describe): Previous 12 months Upcoming 12 months Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? Does the entity propose to rent or sell goods or to provide services to the U of L Healthcare? If yes, are the goods and / or services available commercially from other sources? No Yes Name of Entity#4 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) Approximate Value Previous 12 months Expected in next 12 months Individual holding relationship CI or IFM Philanthropic Donation Consulting Ownership Employment Training / Service Grant(non-research) Equipment Gift Equipment Loan Other (describe): Transaction Provision of Goods Provision of Services Provision of Funds Provision of Referrals Receipt of Goods Receipt of Services Receipt of Funds Receipt of Referrals Other (describe): Previous 12 months Upcoming 12 months Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? Does the entity propose to rent or sell goods or to provide services to the U of L Healthcare? If yes, are the goods and / or services available commercially from other sources? No Yes Name of Entity#5 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) Approximate Value Previous 12 months Expected in next 12 months Individual holding relationship CI or IFM Philanthropic Donation Consulting Ownership Employment Training / Service Grant(non-research) Equipment Gift Equipment Loan Other (describe): Transaction Provision of Goods Provision of Services Provision of Funds Provision of Referrals Receipt of Goods Receipt of Services Receipt of Funds Receipt of Referrals Other (describe): Previous 12 months Upcoming 12 months Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? Does the entity propose to rent or sell goods or to provide services to the U of L Healthcare? If yes, are the goods and / or services available commercially from other sources? No Yes C.3.2. What gifts have you and/or your immediate family members received from an external entity that is engaged in clinical transactions with U of L Healthcare? Gifts (check all that apply) Approximate Value Previous 12 months Expected in next 12 months Entity providing Gift Individual receiving gift Meals Travel or Lodging Meeting / Conference Registrations Tickets to Entertainment Events Software Gift Cards / Certificates Other (describe) C.3.3. In what capacity do you and/or your immediate family members employ faculty, staff, students or trainees in an external entity that is engaged in clinical transactions with the U of L Healthcare? Employment Relationships (check all that apply) Employee – full time Employee – part time Employee - contract Advisor Consultant Other (describe): List all such U of L faculty, staff, students and trainees employed Individual holding relationship CI or IFM Part C.4 Research and Scholarly Activity C.4.1. What relationships do you and/or your immediate family members have with the external entity that is engaged in research or scholarly activity transactions with U of L of one of its affiliated organizations? ( Questions to be answered for each entity in which you or an immediate family member has a relationship) Name of Entity#1 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) Approximate Value Previous 12 months Expected in next 12 months UL Affiliation (UL, ULF, ULRF, ULAA) Philanthropic Donation Consulting Ownership Employment (includes Chief Scientific Officer) Stock or Stock Options or other ownership interests Executive Position (President, VP,etc) Board of Directors Training / Service Grant Advisory Board Honorarium Entitlement to Deferred Compensation Payment for lectures or papers Royalties for inventions Sponsored Research Payment for product evaluation Research Supplies Gift Research Equipment Gift Research Equipment Loan Other (describe): Activity (Check all that apply) Animal Research Applied Research Time Period Previous 12 Upcoming months 12 months If yes, provide applicable IRB, IACUC, IBC and / or Award # Individual holding relationship CI or IFM Bench Work Clinical Trial Human Subjects, Not Clinical Trial Preclinical Pilot Study Feasibility Study Marketing Study CME Educational Activity Non-CME Activity Speaker’s Bureau Data Safety Monitoring Board Other (describe): Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? No Yes Please Explain: Is the entity contributing gift funds that are under your control or of direct benefit to your research or scholarly activity to U of L or one of its affiliated organizations? Does the entity manufacture or commercialize any device, vaccine, procedure, drug or any other product associated with the research? Please Explain: If yes, are the goods and / or services available commercially from other sources? Does the entity participate in deciding the direction of the research? Is it reasonable to anticipate that the entity will or could be directly and significantly affected by the design, conduct or reporting of the research activity? Please Explain: Will any of the research be conducted in the entity’s facilities? Please indicate how many hours per week will be spent in the entity’s facilities Please Explain: Will entity employees or consultants use any U of L facilities to conduct their portion of the research? Will any of the entity’s personnel work on the research? Name of Entity#2 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) Approximate Value Previous 12 months Expected in next 12 months UL Affiliation (UL, ULF, ULRF, ULAA) Philanthropic Donation Consulting Ownership Employment (includes Chief Scientific Officer) Stock or Stock Options or other ownership interests Executive Position (President, VP,etc) Board of Directors Training / Service Grant Advisory Board Honorarium Entitlement to Deferred Compensation Payment for lectures or papers Royalties for inventions Sponsored Research Payment for product evaluation Research Supplies Gift Research Equipment Gift Research Equipment Loan Other (describe): Activity (Check all that apply) Animal Research Applied Research Bench Work Clinical Trial Human Subjects, Not Clinical Trial Preclinical Pilot Study Feasibility Study Time Period Previous 12 Upcoming months 12 months If yes, provide applicable IRB, IACUC, IBC and / or Award # Individual holding relationship CI or IFM Marketing Study CME Educational Activity Non-CME Activity Speaker’s Bureau Data Safety Monitoring Board Other (describe): Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? No Yes Please Explain: Is the entity contributing gift funds that are under your control or of direct benefit to your research or scholarly activity to U of L or one of its affiliated organizations? Does the entity manufacture or commercialize any device, vaccine, procedure, drug or any other product associated with the research? Please Explain: If yes, are the goods and / or services available commercially from other sources? Does the entity participate in deciding the direction of the research? Is it reasonable to anticipate that the entity will or could be directly and significantly affected by the design, conduct or reporting of the research activity? Please Explain: Will any of the research be conducted in the entity’s facilities? Please indicate how many hours per week will be spent in the entity’s facilities Please Explain: Will entity employees or consultants use any U of L facilities to conduct their portion of the research? Will any of the entity’s personnel work on the research? Name of Entity#3 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) Approximate Value Previous 12 months Expected in next 12 months UL Affiliation (UL, ULF, ULRF, ULAA) Philanthropic Donation Consulting Ownership Employment (includes Chief Scientific Officer) Stock or Stock Options or other ownership interests Executive Position (President, VP,etc) Board of Directors Training / Service Grant Advisory Board Honorarium Entitlement to Deferred Compensation Payment for lectures or papers Royalties for inventions Sponsored Research Payment for product evaluation Research Supplies Gift Research Equipment Gift Research Equipment Loan Other (describe): Activity (Check all that apply) Animal Research Applied Research Bench Work Clinical Trial Human Subjects, Not Clinical Trial Preclinical Pilot Study Feasibility Study Time Period Previous 12 Upcoming months 12 months If yes, provide applicable IRB, IACUC, IBC and / or Award # Individual holding relationship CI or IFM Marketing Study CME Educational Activity Non-CME Activity Speaker’s Bureau Data Safety Monitoring Board Other (describe): Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? No Yes Please Explain: Is the entity contributing gift funds that are under your control or of direct benefit to your research or scholarly activity to U of L or one of its affiliated organizations? Does the entity manufacture or commercialize any device, vaccine, procedure, drug or any other product associated with the research? Please Explain: If yes, are the goods and / or services available commercially from other sources? Does the entity participate in deciding the direction of the research? Is it reasonable to anticipate that the entity will or could be directly and significantly affected by the design, conduct or reporting of the research activity? Please Explain: Will any of the research be conducted in the entity’s facilities? Please indicate how many hours per week will be spent in the entity’s facilities Please Explain: Will entity employees or consultants use any U of L facilities to conduct their portion of the research? Will any of the entity’s personnel work on the research? Name of Entity#4 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) Approximate Value Previous 12 months Expected in next 12 months UL Affiliation (UL, ULF, ULRF, ULAA) Philanthropic Donation Consulting Ownership Employment (includes Chief Scientific Officer) Stock or Stock Options or other ownership interests Executive Position (President, VP,etc) Board of Directors Training / Service Grant Advisory Board Honorarium Entitlement to Deferred Compensation Payment for lectures or papers Royalties for inventions Sponsored Research Payment for product evaluation Research Supplies Gift Research Equipment Gift Research Equipment Loan Other (describe): Activity (Check all that apply) Animal Research Applied Research Bench Work Clinical Trial Human Subjects, Not Clinical Trial Preclinical Pilot Study Feasibility Study Time Period Previous 12 Upcoming months 12 months If yes, provide applicable IRB, IACUC, IBC and / or Award # Individual holding relationship CI or IFM Marketing Study CME Educational Activity Non-CME Activity Speaker’s Bureau Data Safety Monitoring Board Other (describe): Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? No Yes Please Explain: Is the entity contributing gift funds that are under your control or of direct benefit to your research or scholarly activity to U of L or one of its affiliated organizations? Does the entity manufacture or commercialize any device, vaccine, procedure, drug or any other product associated with the research? Please Explain: If yes, are the goods and / or services available commercially from other sources? Does the entity participate in deciding the direction of the research? Is it reasonable to anticipate that the entity will or could be directly and significantly affected by the design, conduct or reporting of the research activity? Please Explain: Will any of the research be conducted in the entity’s facilities? Please indicate how many hours per week will be spent in the entity’s facilities Please Explain: Will entity employees or consultants use any U of L facilities to conduct their portion of the research? Will any of the entity’s personnel work on the research? C.4.2. What gifts have you and/or your immediate family members received from an external entity that is engaged in research transactions with U of L or one of its affiliated organizations? Gifts (check all that apply) Approximate Value Previous 12 months Expected in next 12 months Entity providing Gift Individual receiving gift Meals Travel or Lodging Meeting / Conference Registrations Tickets to Entertainment Events Software Gift Cards / Certificates Other (describe) C.4.3. What proprietary interests do you and/or your immediate family members hold with the Entity that is engaged in research transactions with U of L of one of its affiliated organizations? ( Questions to be answered for each entity in which you or an immediate family member has a relationship) Name of Entity#1 Proprietary Interest (check all that apply) Previous 12 months Expected in next 12 months If yes, provide applicable IRB, IACUC, IBC and / or Award # Individual holding relationship CI or IFM Pending / Provisional Patent Issued Patent Licensing Agreement / Option Material Transfer Agreement Trademark / Copyright Trade Secret Invention Other (describe) Is an entity in which you or an immediate family member hold a relationship currently have rights or negotiating rights? No Yes Entity holds a license from U of L If yes, is the entity providing any proprietary data, materials or equipment, as part of a licensing or sponsored research agreement? Are there any other U of L employees listed as inventors that also hold equity in the entity? Please explain: Entity is negotiating a license Entity holds a license, but U of L assigned the invention to me Entity holds a license, but the application, patent, license or copyright did not arise from my employment at U of L Name of Entity#2 Proprietary Interest (check all that apply) Previous 12 months Expected in next 12 months If yes, provide applicable IRB, IACUC, IBC and / or Award # Individual holding relationship CI or IFM Pending / Provisional Patent Issued Patent Licensing Agreement / Option Material Transfer Agreement Trademark / Copyright Trade Secret Invention Other (describe) Is an entity in which you or an immediate family member hold a relationship currently have rights or negotiating rights? No Yes Entity holds a license from U of L If yes, is the entity providing any proprietary data, materials or equipment, as part of a licensing or sponsored research agreement? Are there any other U of L employees listed as inventors that also hold equity in the entity? Please explain: Entity is negotiating a license Entity holds a license, but U of L assigned the invention to me Entity holds a license, but the application, patent, license or copyright did not arise from my employment at U of L Name of Entity#3 Proprietary Interest (check all that apply) Previous 12 months Expected in next 12 months If yes, provide applicable IRB, IACUC, IBC and / or Award # Individual holding relationship CI or IFM Pending / Provisional Patent Issued Patent Licensing Agreement / Option Material Transfer Agreement Trademark / Copyright Trade Secret Invention Other (describe) Is an entity in which you or an immediate family member hold a relationship currently have rights or negotiating rights? No Yes Entity holds a license from U of L If yes, is the entity providing any proprietary data, materials or equipment, as part of a licensing or sponsored research agreement? Are there any other U of L employees listed as inventors that also hold equity in the entity? Please explain: Entity is negotiating a license Entity holds a license, but U of L assigned the invention to me Entity holds a license, but the application, patent, license or copyright did not arise from my employment at U of L Name of Entity#4 Proprietary Interest (check all that apply) Previous 12 months Expected in next 12 months If yes, provide applicable IRB, IACUC, IBC and / or Award # Individual holding relationship CI or IFM Pending / Provisional Patent Issued Patent Licensing Agreement / Option Material Transfer Agreement Trademark / Copyright Trade Secret Invention Other (describe) Is an entity in which you or an immediate family member hold a relationship currently have rights or negotiating rights? No Yes Entity holds a license from U of L If yes, is the entity providing any proprietary data, materials or equipment, as part of a licensing or sponsored research agreement? Are there any other U of L employees listed as inventors that also hold equity in the entity? Please explain: Entity is negotiating a license Entity holds a license, but U of L assigned the invention to me Entity holds a license, but the application, patent, license or copyright did not arise from my employment at U of L C.4.4. What direct payments are you and/or your immediate family members receiving in relation to your research? Direct Payments (check all that apply) Milestone Payments Incentive Payments Recruitment Bonuses Reimbursement for services above reasonable costs Other (describe) Approximate Value Previous 12 months Expected in next 12 months If yes, provide applicable IRB, IACUC, IBC and / or Award # C.4.5. What research projects in which you and/or your immediate family members have an external interest involve students, interns, residents, fellows, graduate students, or other trainees under your supervision or mentorship? (Questions to be answered for each project sponsored by an entity in which you or an immediate family member has a relationship) Project#1 Provide applicable IRB, IACUC, IBC and / or Award # What is the nature of the relationship with the individual Student Resident Fellow Trainee Intern Other: Trainee Intern Other: Trainee Intern Other: Student, Resident, Fellow, Trainee, Intern, Other (please specify) What entity is supporting the project? List an unbiased third party who can serve as a co-mentor for these individuals Are there any constraints or restrictions imposed on the reporting or publication of the student / trainee work? Project#2 What is the nature of the relationship with the individual No Yes Please Explain Provide applicable IRB, IACUC, IBC and / or Award # Student Resident Fellow Student, Resident, Fellow, Trainee, Intern, Other (please specify) What entity is supporting the project? List an unbiased third party who can serve as a co-mentor for these individuals Are there any constraints or restrictions imposed on the reporting or publication of the student / trainee work? Project#3 What is the nature of the relationship with the individual No Yes Please Explain Provide applicable IRB, IACUC, IBC and / or Award # Student Resident Student, Resident, Fellow, Trainee, Intern, Other (please specify) What entity is supporting the project? List an unbiased third party who can serve as a co-mentor for these individuals Are there any constraints or restrictions imposed on the No Yes Please Explain Fellow reporting or publication of the student / trainee work? Project#4 What is the nature of the relationship with the individual Provide applicable IRB, IACUC, IBC and / or Award # Student Resident Fellow Trainee Intern Other: Trainee Intern Other: Student, Resident, Fellow, Trainee, Intern, Other (please specify) What entity is supporting the project? List an unbiased third party who can serve as a co-mentor for these individuals Are there any constraints or restrictions imposed on the reporting or publication of the student / trainee work? Project#5 What is the nature of the relationship with the individual No Yes Please Explain Provide applicable IRB, IACUC, IBC and / or Award # Student Resident Student, Resident, Fellow, Trainee, Intern, Other (please specify) What entity is supporting the project? List an unbiased third party who can serve as a co-mentor for these individuals Are there any constraints or restrictions imposed on the reporting or publication of the student / trainee work? No Yes Please Explain Fellow C.4.6. In what capacity do you and/or your immediate family members employ faculty, staff, students or trainees in an external entity that is engaged in research transactions with the U of L or one of its affiliated organizations? Employment Relationships (check all that apply) Employee – full time Employee – part time Employee - contract Advisor Consultant Other (describe): List all such U of L faculty, staff, students and trainees employed Individual holding relationship CI or IFM C.4.7. For what external or internal bodies do you and/or your immediate family members serve that has jurisdiction to award or distribute government funds (e.g. committees of NIH, FDA, or other governmental agencies, private professional or regulatory body) where participation would reasonably appear to be influenced by the presence or existence of an external interest or relationship? List all such internal and external bodies within this category Individual holding relationship CI or IFM C.4.8. From which Entity do you and/or your immediate family members receive sponsored or directly reimbursed travel expenses? Name of Entity#1 Type of Entity Public Private For Profit Not for Profit Purpose of Trip (check all that apply) Duration Destination Individual traveling Duration Destination Individual traveling Investigator Meeting Training Consulting Lecture Advisory Board Data Safety Monitoring Board Speakers’ Bureau Presentation Other (describe): Name of Entity#2 Type of Entity Public Private For Profit Not for Profit Purpose of Trip (check all that apply) Investigator Meeting Training Consulting Lecture Advisory Board Data Safety Monitoring Board Speakers’ Bureau Presentation Other (describe): Name of Entity#3 Type of Entity Public Private For Profit Not for Profit Purpose of Trip (check all that apply) Duration Destination Individual traveling Duration Destination Individual traveling Investigator Meeting Training Consulting Lecture Advisory Board Data Safety Monitoring Board Speakers’ Bureau Presentation Other (describe): Name of Entity#4 Type of Entity Public Private For Profit Not for Profit Purpose of Trip (check all that apply) Investigator Meeting Training Consulting Lecture Advisory Board Data Safety Monitoring Board Speakers’ Bureau Presentation Other (describe): Name of Entity#5 Type of Entity Public Private For Profit Not for Profit Purpose of Trip (check all that apply) Investigator Meeting Training Consulting Lecture Advisory Board Data Safety Monitoring Board Speakers’ Bureau Presentation Other (describe): Duration Destination Individual traveling C.5.1. What relationship do you and/or your immediate family members hold with the external entity that engages in business, academic, clinical or research transactions with the U of L or one of its affiliated organizations? ( Questions to be answered for each entity in which you or an immediate family member has a relationship) Name of Entity#1 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) Approximate Value Previous 12 months Expected in next 12 months Philanthropic Donation Consulting Ownership Employment Stock or Stock Option Executive Position (President, VP,etc) Board of Directors Advisory Board Honorarium Entitlement to Deferred Compensation Equipment Gift Equipment Loan Other (describe): Co-editor Activity (Check all that apply) UL Affiliation (UL, ULF, ULRF, ULAA) UofL CI-DLD Time Period Previous 12 Upcoming months 12 months Conduct Research Assigning Research or Research resources Purchasing Accounts Receivable Contracting Personnel Facilities Use Vendor Selection and / or Approval Clinical Care Academic Services Other (describe): Co-editor No Individual holding relationship CI or IFM Yes Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? Please Explain: Does the entity serve as a vendor, research sponsor or maintain another relationship to the University of Louisville? What is the nature of the entity? Business Civil Social Professional Religious Do you hold proprietary rights in the entity? Does the entity participate in deciding the direction of the administrative decisions at the University of Louisville? Is it reasonable to anticipate that the entity will or could be directly and significantly affected by administrative decisions at the University of Louisville? Name of Entity#2 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) Approximate Value Previous 12 months Expected in next 12 months Philanthropic Donation Consulting Ownership Employment Stock or Stock Option Executive Position (President, VP,etc) Board of Directors Advisory Board Honorarium Entitlement to Deferred Compensation Equipment Gift Equipment Loan Other (describe): Activity (Check all that apply) Time Period Please Explain: Bookstore could decide not to carry and sellSchartz's Textbook of Surgery of which I am a chapter author and coeditor. UL Affiliation (UL, ULF, ULRF, ULAA) Individual holding relationship CI or IFM Previous 12 months Upcoming 12 months Conduct Research Assigning Research or Research resources Purchasing Accounts Receivable Contracting Personnel Facilities Use Vendor Selection and / or Approval Clinical Care Academic Services Other (describe): Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? No Yes Please Explain: Does the entity serve as a vendor, research sponsor or maintain another relationship to the University of Louisville? What is the nature of the entity? Business Civil Social Professional Religious Do you hold proprietary rights in the entity? Does the entity participate in deciding the direction of the administrative decisions at the University of Louisville? Is it reasonable to anticipate that the entity will or could be directly and significantly affected by administrative decisions at the University of Louisville? Name of Entity#3 Type of Entity Public Private For Profit Not for Profit Relationships (check all that apply) Philanthropic Donation Consulting Ownership Employment Approximate Value Previous 12 months Expected in next 12 months Please Explain: . UL Affiliation (UL, ULF, ULRF, ULAA) Individual holding relationship CI or IFM Stock or Stock Option Executive Position (President, VP,etc) Board of Directors Advisory Board Honorarium Entitlement to Deferred Compensation Equipment Gift Equipment Loan Other (describe): Activity (Check all that apply) Time Period Previous 12 Upcoming months 12 months Conduct Research Assigning Research or Research resources Purchasing Accounts Receivable Contracting Personnel Facilities Use Vendor Selection and / or Approval Clinical Care Academic Services Other (describe): Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? No Yes Please Explain: Does the entity serve as a vendor, research sponsor or maintain another relationship to the University of Louisville? What is the nature of the entity? Business Civil Social Do you hold proprietary rights in the entity? Does the entity participate in deciding the direction of the administrative decisions at the University of Louisville? Is it reasonable to anticipate that the entity will or could be directly and significantly affected by administrative decisions at the University of Louisville? Name of Entity#4 Type of Entity Public Please Explain: Professional Religious Private For Profit Not for Profit Relationships (check all that apply) Approximate Value Previous 12 months Expected in next 12 months UL Affiliation (UL, ULF, ULRF, ULAA) Individual holding relationship CI or IFM Philanthropic Donation Consulting Ownership Employment Stock or Stock Option Executive Position (President, VP,etc) Board of Directors Advisory Board Honorarium Entitlement to Deferred Compensation Equipment Gift Equipment Loan Other (describe): Activity (Check all that apply) Time Period Previous 12 Upcoming months 12 months Conduct Research Assigning Research or Research resources Purchasing Accounts Receivable Contracting Personnel Facilities Use Vendor Selection and / or Approval Clinical Care Academic Services Other (describe): Is the entity providing or receiving goods, services or funds in an area that you supervise, select or evaluate services, select goods or make referrals? No Yes Please Explain: Does the entity serve as a vendor, research sponsor or maintain another relationship to the University of Louisville? What is the nature of the entity? Business Civil Social Professional Religious Do you hold proprietary rights in the entity? Does the entity participate in deciding the direction of the administrative decisions at the University of Louisville? Is it reasonable to anticipate that the entity will or could be directly and significantly affected by administrative decisions at the University of Louisville? Please Explain: C.5.2. In what capacity do individuals under your direct supervision engage in business, academic, clinical or research transactions with an external entity in which you and/or your immediate family members hold a relationship or controlling interest? List all such direct reports Russell W. Bessette, M.D. Individual holding relationship CI or IFM David L. Dunn, M.D., Ph.D. ADDITIONAL INFORMATION Based upon the responses, the Conflict of Interest Office may follow up with you for additional information to ensure compliance with federal regulations and I or U of L policies. ACKNOWLEDGMENT I hereby acknowledge that I have read and understand the ADDRESSING POTENTIAL INDIVIDUAL CONFLICT OF INTEREST POLICY AND PROCEDURES AND ADDRESSING POTENTIAL INSTITUTIONAL CONFLICT OF INTEREST POLICY AND PROCEDURES and that the aforementioned facts and situations indicate all External Interests and Activities with regard to my role(s) at the University of Louisville. If I have none, I have so indicated in the spaces provided. I acknowledge that I have a continuing obligation to file an updated form within 30 days, if changes arise that may either give rise to a new External Interest or Activity or the elimination of an External Interest or Activity previously disclosed. s;gnedth;s_6th_~,. Employee Signature~a<""'=> Employee Printed Name _ _David L. Dunn, MD., Ph.D._ _ _ _ _ _ _ _ _ _ _ _ __