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  1. Academic MOUs

MOU 225-17-017

Replaces MOU 225-11-0003


MEMORANDUM OF UNDERSTANDING BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE FOOD AND DRUG ADMINISTRATION AND
GEORGETOWN UNIVERSITY MEDICAL CENTER


This Memorandum of Understanding (MOU) Is made and entered into as of the 6th day of June, 2017, by and between the United States Food and Drug Administration ("FDA"), and Georgetown University, on behalf of its Georgetown University Medical Center ("GUMC"). FDA and GUMC are referred to individually as a "Party" and collectively as the "Parties."

I. Purpose

FDA and GUMC share interests In promoting scientific progress through the exchange of scientific capital in the diverse disciplines that directly and Indirectly affect human and animal health and medicine. Both Institutions foresee benefits from the mutual exchange of training and research expertise in regulatory science, pharmacology, patient-centered research, and translational science. This 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.

11. Background

FDA Is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21U.S.C. §§ 301, et seq.). 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, 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 communicate with stakeholders about complex scientific and public health Issues. Increased development of research, education, and outreach partnerships with GUMC, Including Its Program for Regulatory Science & Medicine, will greatly contribute to FDA's mission.

GUMC Is an Internationally recognized academic medical center with a three-part mission of research, teaching and patient care (patient care ls carried out through Georgetown's partnership with MedStar Health, Inc.). Its mission Is carried out with a strong emphasis on community outreach and a dedication to the concept of curae personalis, or "care of the whole person.”

FDA and GUMC endorse scientific training for faculty, students and staff to foster a well-grounded foundation In interdisciplinary fields In which academia and government share mutual Interest. On February 24, 2011, FDA and GUMC signed an MOU to set forth a framework for an alliance between FDA and GUMC. This MOU expired In February of 2016.

Ill. Substance of Agreement

This MOU replaces the MOU signed on February 24, 2011, and forms the basis for further development of scientific collaborations, outreach and educational Initiatives, and Intellectual partnerships between FDA and GUMC. The types of Initiatives expected to develop from this MOU include:
1. Advancing student education and training as well as matriculation Into the health and biomedical science professions;
2. Opportunities for FDA staff to serve as adjunct faculty or on advisory boards, and to serve as
mentors for students, postdoctoral fellows, and other trainees at GUMC;
3. Opportunities to convene joint meetings for education, research, and scientific exchange;
4. Research collaborations;
s. Cooperative International Initiatives; and
6. Access to unique facilities and equipment for scientific endeavors.

Under this MOU, FDA and GUMC 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, topics of mutual interest, and develop separate, written agreements for each collaboration that will outline the sharing of resources (if any) for that collaboration and the terms to govern that collaboration. Where applicable, these agreements shall Incorporate by reference this MOU. FDA may enter into a contract, grant or cooperative research and development agreement (CRADA) with GUMC to the extent authorized by law and available appropriations. 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 GUMC and FDA.

IV. General Provisions

1. Rights to any Inventions or other Intellectual property resulting from a collaboration between the Parties will be determined by the separate written agreements governing the collaboration, and will comply with current U.S. Government patent laws and any other applicable statutes and regulations. No Party, by virtue of their participation in activities under the MOU, will be required to disclose or license Intellectual property to the other Party. Neither Party shall use the name, logos, trademarks, service marks, trade names, seals, Insignia, symbols or decorative designs of the other Party or any derivatives thereof without prior written permission of the other Party.
2. Proprietary, trade secret and/or other nonpublic Information will not be disclosed under this MOU unless such disclosure Is permitted by law and the Parties have executed appropriate Confidential Disclosure Agreement covering such Information.
3. 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. GUMC Individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
4. FDA may provide an opportunity for GUMC students, post-doctoral trainees, or faculty to apply to a joint fellowship program at FDA to advance student and faculty education. One such mechanism may be through the Oak Ridge Institute for Science and Education (ORISE) fellowship program. If prospective fellows or faculty enters the program through the ORISE fellowship mechanism, FDA and the GUMC will adhere to the respective Agency Centers ORISE fellowship rules and regulations. Fellows or faculty members entering the program must agree to the ORISE terms of the appointment, which will be outlined in an offer of appointment letter.
5. It Is recognized that from time to time FDA and GUMC may be sharing in expenses and may require compensation of either Party by the other. As collaborations are developed, details of how costs are to be shared will be agreed to in advance under separate agreements and in compliance with all applicable federal requirements.

V. Resource Obligations

This MOU represents the broad outline of the FDA and GUMC'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, nor does It affect or supersede any existing or future agreements or arrangements between the Parties, nor does it affect the ability of the Parties to enter other agreements or arrangements related to this MOU.

VI. Liaison Officers

A. For the Georgetown University Medical Center:
Individual's name: Erin WIiheim, MPH Organization: Georgetown University
Executive Director, Program for Regulatory Science & Medicine 2115 Wisconsin Ave NW, Suite 603
Washington, D.C. 200S7
(202) 687-7190

B. For the Food and Drug Administration:
Khaled Bouri, Ph.D. Interdisciplinary Scientist
Office of Regulatory Science and Innovation, Office of the Chief Scientist 10903 New Hampshire Avenue,
Silver Spring, MD 20993
301-796-8476

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 weeks and notify the other Party through the designated administrative liaison.

VII. Term, Termination.  and Modification

This MOU will be effective when accepted by both parties. This MOU will continue in effect for 5 years from the Effective Date, and may be modified or terminated by mutual written consent by the Parties, or may be terminated by either Party upon a 90-day advance written notice to the other. In the event of termination, any collaboration that commenced before the date of termination may be completed upon the agreement of both Parties, provided that the terms of this MOU and any relevant separate agreements shall continue to govern such collaboration. This MOU may be assigned or otherwise transferred.

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 GUMC operate.


APPROVED AND ACCEPTED FOR GEORGETOWN UNIVERSITY MEDICAL CENTER

Edward M. Healton, M.D., M.P.H.
Executive Vice President and Executive Director

Date: 6-9-2017

APPROVED AND ACCEPTED FOR FOOD AND DRUG ADMINISTRATION:

Luciana Borio, M.D.
Chief Scientist, Acting

Date: 6-8-2017