About FDA

MOU 225-12-8000

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 Clinical Pharmacology
and The Systems Biology Institute

 

I. Purpose
 
The United States Food and Drug Administration (FDA) and the Systems Biology Institute (SBI) share interests in promoting scientific progress through knowledge exchange of scientific capital in pharmacology and translational Research. 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. 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 it 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 the SBI will greatly contribute to FDA’s mission.
 
SBI is a non-profit private research institution established in 2000 with the aim of promoting systems biology research and its application to medicine and global sustainability. SBI is engaged in a series of research programs to expand knowledge on biological systems and its application to medicine and global energy and climate issues. FDA and SBI have a mutual interest in collaborating on systems drug and therapy design.
 
III. Substance of Agreement
 
This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and SBI. The types of initiatives expected to develop from this MOU include:
 
  1. Advancing student education and matriculation into the health and biomedical science professions.
  2. Opportunities to convene joint meetings for education and research;
  3. Research Collaborations;
  4. Cooperative international initiatives; and
  5. Access to unique facilities and equipment for scientific endeavors.
Under this MOU, FDA and SBI 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 and 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 research agreement with SBI 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 the 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 SBI and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms such as 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 and use of facilities. Either Party may restrict or limit access to its property and facilities at any time and for any reason. 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 SBI may share 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 SBI’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 under 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
 

For the Systems Biology Institute:

 
Dr. Hiroaki Kitano, Director
Systems Biology Institute
Falcon Building 5-6-9 Shirokanedai
Minato, Tokyo 108-0071 Japan

For the U.S. Food and Drug Administration

 
Darrell Abernethy, M.D., Ph.D.
Food and Drug Administration
Associate Director for Drug Safety
White Oak 51 Room 3176
10903 New Hampshire Ave
Silver Spring, MD 20993
Phone: 30-1796-5008
 
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 Party previously represented by that individual will name a new liaison within two week and notify the other Party through the designated administrative liaison.
 
VII. Term, Termination, and Modification
 
This agreement, when accepted by all partners, will have an effective period of performance of three years starting on the date of the latest signature and may be modified or terminated by mutual written consent the partners may be terminated by either Partner(s) 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 and the institutions within SBI operative.
 
APPROVED AND ACCEPTED FOR                                               APPROVED AND ACCEPTED FOR THE
THE SYSTEMS BIOLOGY INSTITUTE                                          FOOD AND DRUG ADMINISTRATION
 
Hiroaki Kitano, Ph.D.                                                                   Janet Woodcock, MD
President SBI                                                                                 Director, CDER, FDA
 
June 11, 2012                                                                                May 29, 2012
 
AMENDMENT 1
 
This is first to the Memorandum of Understanding (MOU) 225-12-8000 between the Food and Drug Administration (FDA) and the Systems Biology Institute (SBI). The purpose of this amendment is to extend the termination date for an additional three years. This permissible under Section VII, Term, Termination, and Modification. Execution of this amendment provides continuity in the collaboration to promote scientific progress through knowledge, exchange of scientific capital in pharmacology and translational research. All other content and conditions stated in MOU 225-12-8000, dated June 11, 2012 will remain unchanged.
 
The System Biology Institute:
 
Dr. Hiroaki Kitano, Director
System Biology Institute
Falcon Building SF, 5-6-9
Minato, Tokyo 108-0071 Japan
 
U.S. Food and Drug Administration
 
Darrell Abernethy, M.D., Ph.D.
Food and Drug Administration
Associate Director for Drug Safety
White Oak 51, Room 3716
10903 New Hampshire Avenue
Silver Spring, MD 20993
301-796-5008
 
This amendment, when accepted by all parties, will have an effective period of performance for three years starting on the date of the latest signature and may be modified or terminated by written mutual consent of the Partners or may be terminated by either
Partner(s) upon a 60 day advance written notice to the other.
 
APPROVED AND ACCEPTED BY:
U.S. FOOD AND DRUG ADMINISTRATION 
Janet Woodcock, M.D. 
June 8, 2015
 
APPROVED AND ACCEPTED BY:
THE SYSTEMS BIOLOGY INSTITUTE 
Dr. Hiroaki Kitano
Administrator and Chief Operating Officer 
June 9, 2015

 

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