MEMORANDUM OF UNDERSTANDING
BETWEEN GEORGETOWN UNIVERSITY LAW CENTER
AND THE U.S. FOOD AND DRUG ADMINISTRATION
OFFICE OF INTERNATIONAL PROGRAMS
This Memorandum of Understanding ("MOU") is made and entered into as of October 19, 2011, by and between the United States Food and Drug Administration's (FDA) Office of International Programs ("FDA-OIP"), and Georgetown University, on behalf of its Georgetown University Law Center ("GULC"), O’Neill Institute for National and Global Health (“the O’Neill Institute”). FDA-OIP and the O'Neill Institute are each referred to individually as a “Party” and collectively as the “Parties.”
A. FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act ("the Act") as amended (21 U.S.C. 301 et seq.). In fulfilling its responsibilities under the Act, FDA directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, 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 communicate with stakeholders about complex scientific and public health issues
B. The O'Neill Institute is a premier center for health law, scholarship and policy. Housed at Georgetown University Law Center in Washington DC, the O'Neill Institute's mission is to provide innovative solutions for the leading health problems both domestically and globally. The Institute also draws upon the University's considerable intellectual resources, including the School of Medicine, School of Nursing and Health Studies, the Public Policy Institute, the School of Foreign Service, and the Kennedy Institute of Ethics.
C. FDA-OIP and the O'Neill Institute share interests in the progress of the diverse disciplines that directly and indirectly affect human and animal health and medicine. The Parties endorse appropriate training for faculty, students and staff to foster a well-grounded foundation in interdisciplinary fields in which academia and government share mutual interest
D. The Parties desire to enter into this MOU to establish a framework for an alliance between FDA-OIP and the O'Neill Institute. The MOU is intended to leverage the Parties' (and their parent organizations') combined strengths, resources, and proximity for stimulating innovation in the global aspects of regulatory law, ethics, education, and training within the scopes of FDA's
and O'Neill institute’s missions. The activities described will be aligned with the mutual interests of the two Parties.
E. This MOU will, as described more fully below, be implemented by Supplemental Agreements covering specific collaborations. FDA has statutory authority to enter into such agreements, including, inter alia, authority provided by sections 746 and 1003 of the Federal Food, Drug, and Cosmetic Act (21 USC 3791 and 393). The specific authority for each such collaboration will be
recited in the Supplemental Agreement covering that collaboration.
NOW, THEREFORE, in consideration of the mutual promises herein set forth, and of other good and valuable consideration, the Parties agree as follows, intending to be bound hereby:
I. COLLABORATIONS; SUPPLEMENTAL AGREEMENTS
A. Areas of Collaboration. This MOU forms the basis for development of intellectual collaborations, outreach, and educational initiatives between FDA-OIP and the O'Neill Institute. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. The types of activities expected to develop from this MOU include, but are not necessarily limited to the following:
1. Personnel exchanges between GULC and O'Neill Institute faculty and staff and FDA's scientists and staff as permitted by the Intergovernmental Personnel Act;
2. Educational opportunities for qualified law students, staff members, and faculty members in the Parties' classrooms, clinical settings, and offices, including potential externship placements and mentorship programs for qualified students;
3. Opportunities for FDA personnel to serve as adjunct faculty at GULC under the O'Neill Institute's LL.M. programs subject to the approval of the Office of Graduate Programs at GULC and GULC's policies and procedures;
4. Opportunities for FDA personnel to provide input into the development of the Global Health LL.M. food and drug regulatory curriculum stream;
5. Joint meetings for education and research in the U.S. or elsewhere;
6. Research collaborations;
7. Cooperative international activities including holding joint seminars and providing support for relevant visiting scholars or regulatory officials in the U.S. or elsewhere;
8. Capacity building in developing countries, including the development of a Global Health LL.M./Regulatory scholarship to fund students from developing counties with high relevance to the FDA, with the aim of improving global food and drug regulatory capacity internationally; and
9. Development of regular workshops where faculty from the O'Neill Institute, other GULC faculty and FDA's scientists and staff share information about ongoing research, education, extension, and outreach efforts of mutual interest.
B. Supplemental Agreements. Before any specific collaboration is initiated or implemented, the parties shall identify priorities and topics of mutual interest and develop separate, written agreements ("Supplemental Agreements") for each collaboration that will outline each Party's financial commitments (if any) to the collaboration and the terms to govern the collaboration. Where applicable， these agreements shall incorporate by reference the terms of this MOU. The Supplemental Agreements may include contracts, grants or cooperative research and development agreements ('‘CRADA") between FDA-OIP and the O'Neill Institute to the extent authorized by law and available appropriations. The terms and conditions of any Supplemental Agreements will be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within the O'Neill Institute and FDA-OIP.
C. Contributions of FDA. FDA's contributions to the Parties' collaborations will be detailed in the Supplemental Agreements to be negotiated by FDA-OIP on behalf of FDA with the O'Neill Institute for each collaboration. Such contributions may, as permitted by applicable statutes and regulations and subject to the availability of funds, and as FDA deems appropriate, include the following:
1. Office space in support of activities under this MOU or any Supplemental Agreements;
2. Access to facilities and equipment, including necessary training and guidance, insofar as such use does not interfere with the primary mission of either party;
3. Active participation in establishing collaborative research, education, extension and outreach efforts with faculty, students, and staff within the O'Neill institute programs;
4. Willingness to participate in courses and seminars within the O'Neill Institute's LL.M program, based on availability of resources;
5. Continuing and frequent communication with faculty and staff on opportunities for the O'Neill Institute to contribute to FDA's mission，
6. Openness and welcome to faculty, staff, and students wishing to visit FDA's offices and laboratories; and
7. Promulgation and communication of identified collaborative efforts through appropriate means.
D. Contributions of the O'Neill Institute. The O'Neill Institute's contributions to the Parties’collaborations will be detailed in a Supplemental Agreement for each collaboration to be negotiated with FDA-OIP. Such contributions may, subject to the availability of funds and as the O'Neill lnstitute deems appropriate, include the following:
1. Access to O'Neill Institute facilities at GULC, and coordination of access to other Georgetown University facilities, including necessary training and guidance, insofar as such use does not interfere with the primary mission of either party, and subject to availability and any limitations imposed by Georgetown University's tax exempt bonds;
2. Active participation in establishing collaborative research, education, extension and outreach efforts with FDA's scientists and staff;
3. Continuing and frequent communication with FDA's scientists and staff;
4. Openness and welcome to FDA's scientists and staff wishing to visit relevant the O'Neill Institute programs; and
5. Promulgation and communication of identified collaborative efforts through appropriate means.
A. Confidentiality. Access to any confidential , non-public information shall be governed by separate Confidential Disclosure Agreements in which the Parties will agree and certify in writing that they shall not further release, publish or disclose such information , except as required by law, and that they shall protect such information in accordance with the provisions of 21 U.S.C. 331 0), 21 U.S.C. 360j(c) ， 18 U.S.C. 1905, and other pertinent laws and regulations governing the confidentiality of such information. No proprietary data, trade secrets or patient confidential information shall be disclosed among the Parties unless the Parties have executed a Confidential Disclosure Agreement covering such data and such disclosure is permitted by applicable law. Such Confidential Disclosure Agreements may be part of, or be executed pursuant to, Supplemental Agreements covering specific collaborations.
B. Intellectual Property. "Invention" refers to any subject matter or discovery patentable under Title 35 of the United States Code and conceived or first reduced to practice under the activities of Supplemental Agreements to the MOU. "Intellectual Property" refers to patents, patent applications, know-how, trade secrets, copyrights and computer programs either used or developed under the activities of Supplemental Agreements to the MOU. Ownership of and rights to Inventions or Intellectual Property developed under a Supplemental Agreement will be addressed in the Supplemental Agreement. Inventions made under a Federal research and development grant or contract will be subject to the Bayh-Dole Act. Accordingly, all GULC employees who work on any project under this MOU shall be required to sign an agreement that effects a present assignment of their future inventions to GULC. 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 the prior written permission of the other Party
C. Conflict of Interest. Individual participants in activities under this MOU who are not U.S. Government employees will abide by conflict of interest rules and policies as specified by FDA, and as set out in any Supplemental Agreement covering those activities. This may require individual participants to disclose their financial holdings and those of their spouse and minor children , and may limit their ability to accept gifts and have employment with entities that are substantially regulated by FDA. The Parties will be advised of any potential conflict so that conflicting assignments can be avoided consistent with the FDA requirements. If at any time prior to or during the performance of the activities under the MOU, the Parties believe that a potential or actual conflict exists, the Parties must notify the appropriate authorities within their respective institutions and contact the designated FDA officials listed on the MOU so that the necessary action/s can be undertaken. A determination will be made by FDA as to whether a conflict of interest exists and, if so, as to how to resolve or mitigate it. The Parties to the MOU will make every effort to avoid activities or relationships that would cause a reasonable person to question the impartiality of their actions.
D. Security. Each Party will inform the other Party of its security policies and procedures regarding access to and use of facilities, and the other Party will comply with those policies. Either Party may restrict or limit access to its property and facilities, at any time, for any reason. The O'Neill Institute individuals participating in activities under this MOU on FDA's property will comply with all applicable federal statutes and regulations.
Lawrence O. Gostin
Linda D. and Timothy J. O'Neill Professor of Global Health Law
Faculty Director, O'Neill Institute for National and Global Health Law
Georgetown University Law Center
600 New Jersey Avenue, NW
Washington, DC 20001
Tel: +1 202-662-9373
Katherine C. Bond, SC.D.
Associate Director, Technical Cooperation and Capacity Building
Office of International Programs
Office of the Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
Tel: + 1 301-796-8318 (Office)
+ 1 301-332-7163 (Blackberry)
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 Party's liaison under this MOU becomes unavailable to fulfill those functions, the Party will name a new liaison within two weeks and notify the other Party through the designated administrative liaison.
IV. PERIOD OF AGREEMENT: TERMINATION
A. This MOU becomes effective upon acceptance by both parties and will continue in effect for five years. It may be modified upon mutual agreement of the Parties.
B. Either Party may terminate the MOU upon 60-Days written notice to the other Party.
C. In the event of termination, any collaboration that commenced before the date of termination may be completed upon the written agreement of both Parties, provided that the terms of this MOU and any relevant Separate Agreement shall continue to govern such collaboration.
This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and Georgetown University operate.
VI. MISCELLANEOUS TERMS
A. Neither this MOU nor any rights or obligations under this MOU may be assigned or otherwise transferred.
B. No failure by either Party at any time to insist on performance by the other Party or compliance by the other Party with any condition or provision of this MOU, or to pursue remedies relating to any breach of any provision of this MOU by the other Party, shall be deemed a waiver nor shall any such failure to act affect the right at a later time to enforce the same or to pursue related remedies.
C. This MOU does not supersede any other existing agreements or grants between the Parties.
D. If any provision of this MOU is held invalid or unenforceable, the other provisions of this MOU shall remain in full force and effect.
E. This MOU may be executed in counterparts, each of which shall be deemed an original, but taken together shall constitute one instrument
IN WITNESS WHEREOF, the parties hereto have executed this MOU as of the day and year first above written.
Approved and Accepted
for Georgetown University Law Center
Signed by: Lawrence Gostin
University Professor and Faculty Director
Date: October 19, 2011
Approved and Accepted
for the Food and Drug Administration
Signed by: Mary Lou Valdez
Associate Commissioner for International Programs
Date: October 19, 2011