MEMORANDUM OF UNDERSTANDING
U.S. DEPARTMENT OF HEALTH AND HUMA SERVI CES
THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF TRANSLATIONAL SCIENCES
OFFICE OF CLINICAL PHARMACOLOGY
THE HAMNER INSTITUTES FOR HEALTH SCIENCES
HAMNER - UNC INSTITUTE FOR DRUG SAFETY SCIENCES
The United States Food and Drug Administration (FDA) and the Hamner Institutes for Health Sciences' (HAMNER) including The Hamner-UNC Institute for Drug Safety Sciences (the Parties) share interests in promoting scientific progress through exchange of scientific capital in a Drug Hepatotoxicity Prediction 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.
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 the HAMNER will greatly contribute to FDA's mission.
The Hamner-UNC Institute for Drug Safety Sciences is providing strong national and international leadership in the understanding of mechanisms of drug hepatotoxicity. Through its research programs, the Institute for Drug Safety Sciences focuses on the preparation of physician-scientists to make fundamental and applied discovery and application of new science to define mechanisms of human drug hepatotoxicity. Specifically, the Institute for Drug Safety Sciences is making key contributions to the knowledge in this important area of drug safety. These contributions have direct contributions to the development of regulatory safety science. The Hamner-UNC Institute for Drug Safety Sciences is one of the world's leading research institutions for the study of mechanisms of drug toxicity, producing a steady stream of scientific discoveries and clinical advancements. 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 HAMNER mission. Through this research program, FDA will gain collaboration and benefit from the development of predictive models for drug hepatotoxicity research and in addition this will create training opportunities for regulatory safety scientists. Through mutual exchange of new knowledge and collaboration, we can effectively translate research findings to the advance of drug safety science in order to benefit the public health.
III. Substance of Agreement
This MOU forms the basis for development of scientific collaborations and intellectual partnerships between FDA and the HAMNER. The types of initiatives expected to develop from this MOU include:
I. Working to further develop the DILI-sim systems model for the study of mechanisms of drug-induced hepatotoxicity;
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, 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 to this MOU. The terms and conditions of any such agreements will be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within HAMNER 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 the HAMNER 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. The HAMNER individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
5. 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.
V. Resource Obligations
This MOU represents the broad outline of the FDA and HAMNER'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 Drug Evaluation and Research (CDER) is the lead center for this MOU. The individual to whom all inquiries to FDA should be addressed is:
• Ryan Chatman, Project Specialist
Food and Drug Administration
10903 New Hampshire Avenue
White Oak 51 1Room 2281
Silver Spring, MD 20993
Tel: 301-796-21061 Fax: 301-796-9907
The individual to whom all inquiries to the HAMNER or Hamner - UNC Institute for Drug Safety Sciences should be addressed is:
• Geoffrey Bock, Associate Manager, Research Program
Development and Support
The Hamner Institutes for Health Sciences
Six Davis Drive
Research Triangle Park, NC 27709
Tel: 919-558-13451 Fax: 919-558-1400
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. Terms, 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 and the HAMNER operate.
Approved and Accepted
for The Hamner Institutes for Health Sciences
Signed by: William F. Greenlee, PhD
Date: December 6, 2011
Approved and Accepted
for the Food and Drug Administration
Signed by: Janet Woodcock, MD
Date: December 2, 2011
Approved and Accepted
for the Hamner—UNC Institute for Drug Safety Sciences (IDSS)
Signed by: Paul Watkins, MD
Date: December 6, 2011