MEMORANDUM OF UNDERSTANDING BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH AND
UNIVERSITY of UTAH

I. Purpose

The United States Food and Drug Administration (FDA) and University of Utah (the Parties) share interests in promoting scientific progress through exchange of scientific capital in an effort to enhance the assessment of safety and efficacy of FDA-regulated products. Both institutions foresee benefits from the mutual exchange of training and research expertise through joint participation in research, education and training involving the University of Utah. This Memorandum of Understanding (MOU) establishes terms for collaboration to promote these shared interests, which may 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 FD&C Act). In fulfilling its responsibilities under the FD&C 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, 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 also communicate with stakeholders about complex scientific and public health issues. Increased development of research, education and outreach partnerships with University of Utah will contribute to FDA's mission.

University of Utah is a public research and educational organization whose mission is to continually improve individual and community health and quality of life through excellence in patient care, educating scientists, healthcare professionals for the future, and engaging in research to advance knowledge and well-being.

Ill. Substance of Agreement:

This MOU forms the basis for development of certain scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and University of Utah. The types of initiatives expected to develop from t his MOU include:
A. Advancing education and training though research collaboration with students, post-doctoral trainees, and resident faculty from University of Utah at the FDA through the Center for Drug Evaluation;
B. Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;
C. Opportunities to convene joint meetings for education and research; and
D. Research collaborations.

Under this MOU, joint efforts will be undertaken to support 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 University of Utah 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 shall be negotiated and executed by appropriate representatives of institutions within University of Utah and FDA.

IV. General Provisions:

A. 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.

B. Institutions within University of Utah 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.

C. Proprietary and/or nonpublic information will not be disclosed between the parties to this MOU, unless such disclosure is permitted by law and is made subject to mutually acceptable confidentiality disclosure agreements.

D. Personnel of either Party accessing the premises of the other party comply with such 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. Access to FDA property by University of Utah individuals participating in activities under this
MOU is conditioned on such personnel complying with all applicable federal statutes and regulations.

E. It is recognized that from time to time FDA and institutions within University of Utah 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 University of Utah's intent to collaborate in areas of mutual interest.  It does not create binding, enforceable obligations against any Party. All activities that may be undertaken by this MOU are subject to the availability of personnel, resources, and funds. 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. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations and statutes under which FDA and University of Utah operate.

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:

Individual's name: Padmaja Mummaneni, PhD
Organization: Center for Drug Evaluation and Rese arch, Office of Translational Sciences Title: Consumer Safety Officer, Regulatory Health Project Manager, Contract Officer Representative (COR)
Address: 10903 New Hampshire Avenue, FDA White Oak Building 51, Room 2164 Silver Spring, MD 20993-0002
Telephone Number: 301-796-2027
Email: Padmaja [email protected]

The individual to whom all inquiries to University of Utah should be addressed is: Andrew S. Weyrich, Ph.D., Vice President for Research
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 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. It may be renewed by mutual written agreement of both Parties. It may be modified at any time by mutual written agreement of both Parties. It may be terminated by either Party upon 60-day advance written notice to the other.

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, University of Utah and the institutions within University of Utah operate.
 
ACCEPTED AND APPROVED FOR THE FOOD AND DRUG ADMINISTRATION

Signed by:

/S/
Janet Woodcock, M.D.
Director, Center for Drug Evaluation and Research
U.S. Food and Drug Administration

Date: 10/18/17

ACCEPTED AND APPROVED FOR THE UNIVERSITY OF UTAH

Signed by:

/S/
Andrew S. Weyrich, Ph.D.
Vice President for Research
Professor for Internal Medicine
H.A. & Edna Benning Presidential Endowed Chair
University of Utah
201 Presidents Circle, Room 210
Salt Lake City, Utah 84112-9011
801-581-7236

Date: 10/05/2017