MEMORANDUM OF UNDERSTANDING
BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF TRANSLATIONAL SCIENCES
OFFICE OF CLINICAL PHARMACOLOGY
AND
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA SAN FRANCISCO (UCSF) CAMPUS
SCHOOL OF PHARMACY

I. Purpose

The United States Food and Drug Administration (FDA) and the University of California San Francisco (UCSF), School of Pharmacy (the Parties) share interests in promoting scientific progress through exchange of scientific capital in Clinical Pharmacology Training and Research Program. Both institutions foresee benefits from the mutual exchange of training and research expertise in clinical pharmacology and translational science. This Memorandum of Understanding (MOU) 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). In fulfilling its responsibilities under the Act, FDA among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products and the safety and security of foods and cosmetics. 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 the UCSF will contribute to FDA's mission.

UCSF's School of Pharmacy is consistently ranked among the top pharmacy schools in the country and houses the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI). Through its education, research, and service program, the School of Pharmacy conducts research and prepares regulatory scientists with the knowledge needed to improve drug development and drug regulatory systems. UCSF is one of the world's leading biomedical research institutions, producing a steady stream of scientific knowledge and clinical achievements. The creation of new knowledge and making such knowledge available in the world of health care (through education and technology transfer) are at the core of the UCSF's mission.

Through this training and research program, FDA and UCSF will have the opportunity to develop and access - innovative basic science research, and through the exchange of knowledge and collaboration, research findings can be translated to the bedside to benefit the public health.

III. Substance of Agreement

This MOU forms the basis for development of scientific collaborations, outreach and
educational initiatives and intellectual partnerships between FDA and UCSF. The types of initiatives expected to develop from this MOU include:

1. Advancing student education and matriculation into the health and biomedical science professions. One of the mechanisms to enroll students/post-doctoral trainees/residents from UCSF into the joint fellowship program at the FDA is through the CDER Oak Ridge Institute for Science and Education (ORISE) fellowship program. Faculty sabbatical may be covered under ORISE if applicable. If prospective fellows or faculty members enter the program through the ORISE fellowship program mechanism, the Office of Clinical Pharmacology and UCSF will adhere to the CDER ORISE Fellowship rules and regulations. Fellows and/or faculty members selected for the ORISE program must agree to adhere to the term of appointment which will be outlined in an offer of appointment letter.
2. Graduate students in the UCSF School of Pharmacy may participate in the FDA’s Student Volunteer Service Program, where they would work together with an FDA scientist. FDA scientists who mentor students or participate in UCSF activities may be considered for adjunct faculty appointments at UCSF.
3. Opportunities for FDA staff to mentor students, give lectures, or provide on curricula;
4. Opportunities to convene joint meetings for outreach, education and research;
5. Research collaborations;
6. Cooperative international initiatives; and
7. Access to unique facilities and equipment for scientific endeavors.

IV. 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.

2. Institutions within UCSF 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. The Parties will not, as a part of the activities covered by this MOU, share any non-public information, including (1) confidential commercial information, such as the information that would be protected from public disclosure pursuant to Exemption 4 of the Freedom of Information Act (FOIA); (2) personal privacy information, such as the information that would be protected from public disclosure pursuant to Exemption 6 or 7 (c) of the FOIA; or (3) information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., Trade Secrets Act (18 USC 1905)), the Privacy Act (5 USC 552a), other Freedom of Information Act exemptions not mentioned above (5USC 552(v)), the Federal Food, Drug, and Cosmetic Act (21 USC 301 et seq.), and the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191). Access to non-public information shall be governed by separate Confidentiality Disclosure Agreements.
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. UCSF 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 UCSF will 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.

V. Resource Obligations

This MOU represents the broad outline of the FDA and UCSF'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.

VI. 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:

• Padmaja Mummaneni, Ph.D.
  US Food and Drug Administration
  10903 New Hampshire Avenue
  FDA White Oak campus, Bldg. 51 Room 2516
  Silver Spring, MD 20993
  Tel: 301-796-2027
  Email: padmaja. mummaneni@fda.hhs.gov

The individual to whom all inquiries to UCSF should be addressed is:

• Lawrence Lin, Ph.D.
  University of California, San Francisco
  School of Pharmacy
  1550 4th Street, Room 578, Box 2911
  San Francisco, CA 94143
  Tel: 415-476-5216
  Email: Lawrence.Lin@ucsf.edu

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 functions, the Parties will name a new liaison within two (2) weeks and notify the other Party through the designated administrative liaison.

VII. Term, Termination, and Modification:

This agreement becomes effective upon acceptance by both Parties and will continue in effect for five (5) years. This agreement may be renewed or modified by mutual written agreement of both Parties and may be terminated by either Party upon sixty (60)-day advance written notice to the other Party.

VIII. 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, UCSF, and the institutions within UCSF operate.

Approved and Accepted for the Regents of the
University of California, San Francisco Campus
Office of Sponsored Research – Contracts and Grants Division

/s/
Jeff Warner
Award Team Manager
Date: 03/05/2024

Approved and Accepted for the US Food and Drug Administration

/s/
Signed by: Patrizia Cavazzoni, M.D.
Director, CDER, FDA
Date: 03/11/2024