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September 21, 2015 Elizabeth .I. Fischmann Acting Designated Agency Ethics Of?cial Acting Associate General Counsel US. Department of Health and Human Services 200 Independence Avenue, SW, Rm 710E Washington, DC. 20201 Dear Ms. Fischmann: The purpose of this letter is to describe the steps that I will take to avoid any actual or apparent con?icts of interest in the event that I am con?rmed for the position of Commissioner, Food and Drug Administration (FDA), US. Department of Health and Human Services (HHS). As required by 18 U.S.C. 208(a), I will not participate personally and substantially in any particular matter in which I know that I have a ?nancial interest directly and predictably affected by the matter, or in which I know that a person whose interests are imputed to me has a ?nancial interest directly and predictably affected by the matter, unless I ?rst obtain a written waiver, pursuant to 18 U.S.C. 208(b)(1), or qualify for a regulatory exemption, pursuant to 18 U.S.C. 208(b)(2). I understand that the interests of the following persons are imputed to me: any spouse or minor child of mine; any general partner of a partnership in which I am a limited or general partner; any organization in which I serve as of?cer, director, trustee, general partner or employee; and any person or organization with which I am negotiating or have an arrangement concerning prospective employment. Effective February 22, 2015, I commenced an unpaid leave of absence from my tenured professorial position at Duke University School of Medicine, operating under the auspices of Duke University Medical Center (Duke). On that same date, I also resigned from all other positions, board memberships and advisory committees associated with my tenured position. Upon con?rmation, I will continue my unpaid leave of absence, and I will not participate personally and substantially in any particular matter that to my knowledge has a direct and predictable effect on the ?nancial interests of Duke University or Duke University Medical Center, unless I ?rst obtain a written waiver, pursuant to 18 U.S.C. 208(b)(1), or qualify for the exemption at 5 C.F.R. 2640.203 or another regulatory exemption, pursuant to 18 U.S.C. 208(b)(2). On February 22, 2015, I resigned from my position as a physician with Private Diagnostic Clinic, PLLC. For a period of one year after the date of my resignation, I will not participate personally and substantially in any particular matter involving speci?c parties in which I know Private Diagnostic Clinic is a party or represents a party, unless I am ?rst authorized to participate pursuant to 5 C.F.R. Also, on January 26, 2015, I resigned from my board position on the Board of Directors for Portola Pharmaceuticals, Inc. For a period of one year after the date of my resignation, I will

Ms. Elizabeth Fischmann Page 2 not participate personally and substantially in any particular matter involving speci?c parties in which I know Portola Pharmaceuticals, Inc. is a party or represents a party, unless I am authorized to participate pursuant to 5 C.F.R. On February 22, 2015, I of?cially terminated my position as a principal member of Faculty Connection LLC. For a period of one year after my resignation, I also will not participate personally and substantially in any particular matter involving speci?c parties in which I know Faculty Connection LLC is a party or represents a party, unless I am ?rst authorized to participate pursuant to 5 C.F.R. In addition, I will not participate personally and substantially in any particular matter involving speci?c parties in which I know a former client of mine is a party or represents a party for a period of one year after I last provided service to that client, unless I am ?rst authorized to participate, pursuant to 5 C.F.R. 263 This recusal will apply to the following clients that I provided services to while with Faculty Connection LLC: Client Date ofLast Service Amgen Inc. 11/28/14 AstraZeneca PLC 12/12/1 4 Daichi Sankyo Inc. 10/07/14 Medscape, LLC 1 2/04/14 Merck Co., Inc. 02/22/15 Novartis AG 10/25/14 Sano? SA (includes Sgno?-Avem?is) 1 1/28/14 On February 22, 2015, I resigned from my position of Chairman of the Board of the Clinical Research Forum Foundation. For a period of one year after the date of my resignation, I will not participate personally and substantially in any particular matter involving speci?c parties in which I know the Clinical Research Forum Foundation is a party or represents'a party, unless I am authorized to participate pursuant to 5 C.F.R. On February 22, 2015, I resigned from my position of Editor-in?Chief for the American Heart Journal, published by Elsevier B.V. For a period of one year after the date of my resignation, I will not participate personally and substantially in any particular matter involving speci?c parties in which I know the American Heart Journal (AHJ), or Elsevier B.V., is a party or represents a party, unless I am authorized to participate pursuant to 5 C.F.R. 2635.5 02(d). On February 22, 2015, I resigned from my position as President of the not-for?pro?t David H. Murdock Research Institute, the ?agship institute of North Carolina Research Campus. For a period of one year after the date of my resignation, I will not participate personally and substantially in any particular matter involving speci?c parties in which I know the David H. Murdock Research Institute, or North Carolina Research Campus, is a party or represents a party, unless I am authorized to participate pursuant to 5 C.F.R. 263 5 .5 02(d).

Ms. Elizabeth Fischmann Page 3 On February 22, 2015, I resigned from my Co-Chair position with the Clinical Trials Transformation Initiative. For a period of one year after the date of my resignation, I will not participate personally and substantially in any particular matter involving speci?c parties in which I know the Clinical Trials Transformation Initiative is a party or represents a party, unless I am authorized to participate pursuant to 5 C.F.R. In order to avoid potential con?icts of interest during my appointment as Commissioner, 1, my spouse, or any minor children of mine will not acquire any direct ?nancial interest in entities listed on the FDA prohibited holdings list or in entities involved, directly or through subsidiaries, in the following industries: (1) research, development, manufacture, distribution, or sale of pharmaceutical, biotechnology, or medical devices, equipment, preparations, treatment, or products; (2) veterinary products; (3) healthcare management or delivery; (4) health, disability, or workers compensation insurance or related services; (5) food and/or beverage production, processing or distribution; (6) communications media; (7) computer hardware, computer software, and related internet technologies; (8) wireless communications; (9) social sciences and economic research organizations; (10) energy or utilities; (11) commercial airlines, railroads, shiplines, and cargo carriers; or (12) sector mutual funds that concentrate their portfolios on one country other than the United States. In addition, we will not acquire any interests in sector mutual funds that concentrate in any of these sectors. 1 have been advised that this ethics agreement will be posted publicly, consistent with 5 U.S.C. 552, on the website of the U.S. Of?ce of Government Ethics with ethics agreements of other Presidential nominees who ?le public ?nancial disclosure reports. Finally, I understand that as an appointee I am required to sign the Ethics Pledge (Exec. Order No. 13490) and that I will be bound by the requirements and restrictions therein in addition to the commitments I have made in this ethics agreement. Sincerely, Robert M. Califf