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MOU 225-07-6001
MEMORANDUM OF UNDERSTANDING
BETWEEN
THE FOOD AND DRUG ADMINISTRATION
AND
THE LELAND STANDFORD JUNIOR UNIVERSITY (California)
I. Purpose:
The United States Food and Drug Administration (FDA) and Stanford University (the Parties) share interests in promoting scientific progress through exchange of scientific capital in diverse fields of science that affect human and animal health and medicine. Both institutions foresee benefits from scientific training for academicians and students to foster a well-grounded foundation in interdisciplinary science on which scientific learning can grow. 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 research, public outreach, extension activities, cooperative international initiatives, disciplinary training, and exchange of scientists and staff, including sabbaticals, postdoctoral fellowships, and student internships.
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 also 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 is recognized as one of the leading universities in the world. Multidisciplinary research and teaching are at the heart of Stanford’s initiatives on human health, the environment and sustainability, international affairs and the arts. The synthesis of teaching and research is fundamental to Stanford. Stanford is noted for multidisciplinary research within its schools and departments, as well as its independent laboratories, scientific centers and institutes.
III. Substance of Agreement:
This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and Stanford. The types of initiatives expected to develop from this MOU include:
Advancing student education and matriculation into the health and biomedical science professions;
Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;
Opportunities to convene joint meetings for education and research;
Research collaborations;
Cooperative international initiatives; and
Access to unique facilities and equipment for scientific endeavors.
Under this MOU, joint efforts will be undertaken to obtain grants and other extramural funds 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 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 shall be negotiated and executed by appropriate representatives of institutions within Stanford University and FDA.
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 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/or nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure agreements or to the extent such disclosure is permitted by law.
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 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 Stanford’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.
VI. Liaison Officers:
FDA’s Center for Devices and Radiological Health (CDRH) is the lead center for this MOU. The individual to whom all inquiries to FDA should be addressed is:
Nancy J. Pluhowski, MPA
Director, External Expertise and Partnerships
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
301-796-6660
301-847-8510 FAX
Nancy.pluhowski@fda.hhs.gov
The individual to whom all inquiries to Stanford University should be addressed is:
Paul Yock. M.D.
Professor of Bioengineering and Medicine
Stanford University School of Medicine
Stanford, California 94305
650-736-1160
650-724-8696 FAX
yock@stanford.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 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, Stanford University, and the institutions within Stanford University operate.
APPROVED AND ACCEPTED FOR STANFORD UNIVERSITY
Signed by:Harry Greenberg, M.D.
Senior Associate Dean for Research
Stanford University School of Medicine Director
Date: 1/12/2012
APPROVED AND ACCEPTED FOR FOOD AND DRUG ADMINISTRATION
Signed by:Jeffrey Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health
Date: 1/12/2012
http://www.fda.gov/AboutFDA/Partnership ... 318255.htm
