U.S. DEPARTMENT OF HEALTH ANO HUMAN SERVICES THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH OFFICE OF TRANSLATIONAL SCIENCES OFFICE OF CLINICAL PHARMACOLOGY
AND
THE BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIVERSITY SCHOOL OF MEDICINE
DEPARTMENT OF BIOENGINEERING

I. Purpose

The United States Food and Drug Administration (FDA) and The Board of Trustees of the Leland Stanford Junior University on behalf of the Schools of Engineering & Medicine and Department of Bioengineering (Stanford University) (collectively, the Parties) share interests in promoting scientific progress through exchange of scientific capital in clinical pharmacology training and research programs. Both institutions foresee benefits from the mutual exchange of training and research expertise in clinical pharmacology and translational science. This Memorandum of Understanding (MOU) and the collaborative framework it provides will facilitate existing and new mutually agreed upon programs and activities and establishes the terms for collaboration to promote these shared interests, which can be pursued through a variety of programs including collaborative education and research.

II. Background

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301, et seq.). In fulfilling its responsibilities under the Act, FDA, among other things, directs it s activities toward promoting and protecting the public health by ensuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products and the safety and security of foods, dietary supplements, and cosmetics. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. To accomplish its mission, FDA must stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues. Increased development of research, education, and outreach partnerships within Stanford University will greatly contribute to FDA's mission.

Stanford University School of Medicine and the Department of Bioengineering have created interdisciplinary explorations and collaborations that have produced many of the innovations that sparked a biomedical revolution. Stanford University School of Medicine is dedicated to excellence in the education of scientists and physicians in all of the disciplines of sciences, medicine and biomedical investigation for careers in practice, teaching, and research. The central mission for the Department of Bioengineering is to create a fusion of engineering and life sciences that promotes scientific discovery and the invention of new technologies and therapies through research and education.

Ill. Substance of Agreement:

This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and Stanford University. The types of activities expected to be pursued under this MOU may include, but are not limited to the following:

1. Opportunities to apply for fellowship programs at the FDA to advance Stanford University student and faculty education and matriculation into the health and biomedical sciences. The CDER Oak Ridge Institute for Science and Education (ORISE) fellowship program is one of the mechanisms that can be used to bring students/post ­ doctoral candidates/faculty from Stanford University to FDA.
a. Fellows or faculty members entering the program must agree to adhere to the ORlSE terms of appointment which will be outlined in an ORISE offer of appointment letter;
b. Faculty sabbatical may be covered under ORISE if applicable. A separate agreement will be put in place that the appropriate parties will sign if applicable.

2. Personnel exchanges between university faculty, staff, and FDA's scientists and staff as permitted by the Intergovernmental Personnel Act;

3. Opportunities to convene joint meetings for education and research;

4. Research collaborations; and

5. Access to unique facilities and equipment for scientific endeavors.

Under this MOU, FDA and Stanford University will seek opportunities to participate together in collaborative research and training as permitted under appropriate statutory authority. Before any specific collaboration is initiated or implemented, the Parties shall identify priorities, topics of mutual interest, and develop separate, written agreements for collaboration and sharing of resources. Where applicable, these agreements shall incorporate by reference this MOU. FDA may enter into a contract, grant, or cooperative agreement with Stanford University to the extent authorized by law and available appropriations. The terms and conditions of any such awards will be in accordance with applicable federal law and regulations and with Stanford policies and regulations, and shall be negotiated and executed by appropriate representatives of institutions within Stanford University and FDA.

Ill. General Provisions:

1. Rights to any inventions resulting from collaborative research will be determined by the separate written research agreements governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations and applicable Stanford policies and regulations.

2. Institutions within Stanford University and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.

3. Proprietary and non-public information will not be disclosed under this MOU, unless such disclosure is permitted by law. Any access to non-public information shall be governed by appropriate confidentiality disclosure agreements in which the Parties agree and certify in writing that they shall not further release, publish or disclose such information and that they shall protect such information in accordance with the provisions of 21 U.S.C. 33l(j), 21U.S.C. 360j(c), 18 U.S.C. 1905, and other pertinent laws and regulations governing the confidentiality of such information. No proprietary data, trade secrets, or patient confidential information shall be disclosed among the Parties.

4. Each Party will comply with the other Party's security procedures and policies regarding access to and use of facilities. Either Party may restrict or limit access to its property and facilities at any time and for any reason. Stanford University individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.

5. It is recognized that from time to time FDA and institutions within Stanford University may be sharing in expenses and may require compensation of either Party by the other. As research projects are developed, details of how costs are to be shared will be agreed to in advance under other contractual mechanisms as appropriate and in compliance with all applicable federal requirements and all Stanford policies as might apply.

6. As research projects are developed, details will be agreed to in advance under other agreements as appropriate and in compliance with all applicable federal requirements.

IV. Resource Obligations:

This MOU represents the broad outline of the FDA and Stanford University's intent to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to the availability of personnel, resources, and funds. This MOU does not create binding, enforceable obligations against any Party. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU.

V. Liaison Officers:

FDA's Center for Drug Evaluation and Research (CDER) is the lead center for this MOU. The individual to whom all inquiries to FDA should be addressed is:

A. For the Party(s): Stanford University Technical Matters:

Individual's name: Russ B. Altman, MD, PhD Organization: Stanford University
Title: Professor
Address: Department of Bioengineering, Shriram Center, 443 Via Ortega, Altman Lab, MC: 4245 , Stanford, California 94305-4145
Telephone Number: (650) 725-3394 Email: Russ .Altman@stan ford.edu

Administrative Matters: Individual's name: Mark Cullen, MD Organization: Stanford University
Title: Senior Associate Dean, Research and Professor of Medicine
Address: Office of Dean, LKSC 321, 291 Campus Drive, Stanford, California 94305-5101 Telephone Number: 650-724-6966
Email: [email protected]

B. For the Food and Drug Administration:
Individual's name: Padmaja Mummaneni, PhD
Organization: Center for Drug Evaluation and Research, Office of Translational Sciences Title: Contract Officer Representative (COR)
Address: 10903 New Hampshire Avenue White Oak Building 51, Room 2164 Silver Spring, MD 20993-0002
Telephone Number: 301-796-2027
Email : Padma [email protected]

Each Party may designate new liaisons at any time by notifying the other Party's administrative liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those function s, the Parties will name a new liaison within 2 weeks and notify the other Party through the designated administrative liaison.

VI. Term, Termination, and Modification:

This agreement, when accepted by all Parties, will have an effective period of performance from the date of the latest signature and continuing for a period of five years and may be modified or terminated by mutual written consent of the parties or may be terminated by either Partner(s) upon a 60-day advance written notice to the other.

VII. Statutes, Regulations, Rules, and Policies

This MOU and all associated agreements will be subject to the applicable statutes, regulations, rules, and policies under which FDA, Stanford University and the institutions within Stanford University operate.

APPROVED AND ACCEPTED FOR Stanford University
/S/
By Marcia Cohen
Senior Associate Dean, Finance and Administration
Date: 10/6/17

PROJECT DIRECTOR APPROVAL
/S/
By Russ B. Altman, MD, PhD
Professor/Project Director
Date: 10/6/2017

APPROVED AND ACCEPTED FOR FOOD AND DRUG ADMINISTRATION
/S/
By Janet Woodcock, M.D., Director
Center for Drug Evaluation and Research
Date: 10/6/2017