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MOU 225-11-0003

 

MEMORANDUM OF UNDERSTANDING
BETWEEN GEORGETOWN UNIVERSITY ON BEHALF OF
GEORGETOWN UNIVERSITY MEDICAL CENTER
AND THE
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
 
This Memorandum of Understanding (“MOU”) is made and entered into as of the 24th day of February 24, 2011, by and between the United States Food and Drug Administration (“FDA”), and Georgetown University, on behalf of its Georgetown University Medical Center (“GUMC”).   Each FDA and GUMC is referred to individually as a “Party” and collectively as the “Parties.”
 
RECITALS
 
A.  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 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. FDA’s centers and offices are more fully described in Attachment A.
 
B.  GUMC is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (patient care is carried out through Georgetown’s collaboration 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.”
 
C.  FDA and GUMC share interests in scientific progress in the diverse disciplines that directly and indirectly affect human and animal health and medicine.  The Parties 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.
 
D. FDA and GUMC desire to enter into this MOU to set forth a framework for an alliance between FDA and GUMC. The MOU is intended to leverage the Parties’ combined strengths, resources, and proximity for stimulating innovation in regulatory science, ethics, education, and training within the scope of FDA mission and the broad academic charge of GUMC. The activities described will be aligned with the mutual interests of the two Parties to modernize the product development and regulatory sciences to more efficiently bring products to market, while reducing uncertainties about post-marketing product performance.
 
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 742 and 903 of the Federal Food, Drug, and Cosmetic Act (21 USC 379l and 903). 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 scientific and intellectual collaborations, outreach and educational initiatives between FDA and GUMC.  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.  Identification and convening of a steering committee to guide a process for scientific and intellectual collaborations, outreach, and education initiatives. 
2.  Personnel exchanges between university faculty and staff and FDA’s scientists and staff as permitted by the Intergovernmental Personnel Act; 
3.  Educational opportunities for qualified students (graduate and undergraduate), staff members, and faculty members in the Parties’ laboratories, classrooms, clinical settings and offices; 
4.  Opportunities for FDA personnel to serve as adjunct faculty, advisory board members, and dissertation advisors at GUMC; 
5.  Joint meetings for education and research; 
6.  Research collaborations; 
7.  Cooperative international activities including outreach; 
8.  Sharing of unique facilities and equipment for increased results and cost efficiencies for scientific endeavors; and 
9.  Development of regular workshops where faculty from GUMC and FDA’s scientists and staff share information about on going 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, 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 and GUMC 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 GUMC and FDA.
 
C. Contributions of FDA. FDA’s contributions to the Parties’ collaborations will be detailed in the Supplemental Agreements 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.  Laboratory and/or office space in support of activities under this agreement.
2.  Access to facilities and equipment, including necessary training and guidance, in so far 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 GUMC institutions.
4.  Willingness to participate in courses and seminars within GUMC, based on availability of resources.
5.  Continuing and frequent communication with faculty and staff.
6.  Openness and welcome to faculty, staff, and students wishing to visit FDA’s laboratories.
7.  Promulgation and communication of identified collaborative efforts through appropriate means.
 
D. Contributions of GUMC. GUMC’s contributions to the Parties’ collaborations will be detailed in the Supplemental Agreements for each collaboration. Such contributions may, subject to the availability of funds and as GUMC deems appropriate, include the following:
 
1.  Laboratory and/or office space in support of activities under this agreement at identified institutions, subject to any limitations imposed by Georgetown University’s tax-exempt bonds.
2.  Access to facilities and equipment, including necessary training and guidance, in so far 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 FDA’s scientists and staff.
4.  Continuing and frequent communication with FDA’s scientists and staff.
5.  Openness and welcome to FDA’s scientists and staff wishing to visit relevant GUMC programs and laboratories.
6.  Promulgation and communication of identified collaborative efforts through appropriate means.
7.  Appropriate faculty/affiliate appointments for appropriate FDA professional staff, provided that appointment of such candidates will advance specific programmatic objectives of the parties as appropriate, and provided that such appointments comply with university policies on appointment of faculty/affiliates.
 
II.    COVENANTS.
 
A.  Confidentiality. Access to any confidential, non-public information shall be govered 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(j), 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 the 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.  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 InterestIndividual participants in activities under this MOU who are not U.S. Government employees will be expected to 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 HHS/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.  GUMC individuals participating in activities under this MOU on FDA’s property will comply with all applicable federal statutes and regulations.
 
III.    CONTACTS
 
Liaison Officers:
 
Howard J. Federoff, M.D., Ph.D.
Executive Vice President and Executive Dean for Health Sciences
Georgetown University Medical Center
4000 Reservoir Road, N.W.
120 Building D
Washington, D.C. 20007
202-687-4600
hjf@georgetown.edu
 
Leslie D. Wheelock, M.S., R.N.
Director, Office of Scientific Professional Development
Office of the Chief Scientist, Office of the Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
White Oak Building 32, Room 4274
Silver Spring, M.D. 20993
301-796-8450
Leslie.wheelock@fda.hhs.gov
 
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.

IV.    PERIOD OF AGREEMENT; TERMINATION

 
A.  This MOU becomes effective upon acceptance by both parties and will continue in effect for five (5) years. It may be modified upon mutual agreement of the Parties. 
B.  Either Party may terminate the MOU upon sixty (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 agreement of both Parties, provided that the terms of this MOU and any relevant Separate Agreement shall continue to govern such collaboration.
 
V.      REGULATIONS
 
This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and GUMC 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 Medical Center
Signed by: Howard J. Federoff, M.D., Ph.D.
Executive Vice President and Executive Dean
 
Date: February 24, 2011
Approved and Accepted
for the Food and Drug Administration
Jesse L. Goodman, M.D., M.P.H.
Chief Scientist and Deputy Commissioner
for Science and Public Health
 
Date: February 24, 2011

APPENDIX A
 
FDA Centers/Offices
 
The U.S. Food and Drug Administration (FDA) is comprised of six product-oriented centers and a nationwide field force. FDA is a scientific regulatory agency responsible for the safety of the nation’s domestically produced and imported foods, cosmetics, drugs, biologics, medical devices, and radiological products. It is one of the oldest federal agencies whose primary function is consumer protection. The agency touches and directly influences the lives of everyone in the United States FDA is recognized internationally as the leading food and drug regulatory agency in the world. Many foreign nations seek and receive FDA’s help in improving and monitoring the safety of their products FDA is part of the Executive Branch of the United States Government within the Department of Health and Human Services (DHHS) and the Public Health Service (PHS).
 
FDA Centers/Offices include:
 
Office of the Commissioner (OC) – is committed to providing the overall scientific and regulatory policies for the entire agency, including special FDA initiatives. OC includes the Immediate Office, the Office of Women’s Health, Office of Minority Health, Office of the Chief of Staff, Office of Policy, Planning and Budget, Office of Legislation, Office of Administration, Office of International Programs, Office of Equal Opportunity and Diversity Management, Office of the Chief Counsel, Office of the Counselor to the Commissioner, Office of Special Medical Programs, Office of External Affairs, Office of Regulatory Affairs, Office of Foods, and the Office of the Chief Scientist.
 
Center for Biologics Evaluation and Research (CBER) - CBER is committed to advancing the public health through innovative regulations that ensure the safety, effectiveness and timely delivery to patients of biological products. CBER protects and enhances public health through regulating of biological and related products including blood, vaccines, tissue, allergenic and biological therapeutics.
 
Center for Drug Evaluation and Research (CDER) - CDER is committed to promoting and protecting public health by assuring that safe and effective drugs are available to Americans. Opportunities exist for faculty and students in pharmaceutical science, biochemistry, chemistry, biotechnology, bioengineering and chemical engineering, as well as many other scientific and engineering disciplines to engage with research and regulatory scientists in flexibly structured programs within the Center.
 
Center for Devices and Radiological Health (CDRH) - CDRH assures that new medical devices are safe and effective before they are marketed. The Center also monitors devices throughout the product life cycle, including a nationwide post market surveillance system, and assures that radiation-emitting devices meet radiation safety standards.
 
Center for Food Safety and Applied Nutrition (CFSAN) – CFSAN, with the Agency’s field staff, is responsible for promoting and protecting the public’s health by ensuring the nation’s food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled.
 
Center for Veterinary Medicine (CVM) - CVM is a consumer protection organization that fosters public and animal health by approving safe and effective products for animals and by enforcing other applicable provisions of the Federal Food, Drug, and Cosmetic Act and other authorities.
 
Center for Tobacco (CTP) - CTP is responsible for planning, managing, directing and coordinating major tobacco program objectives to support the Family Smoking Prevention and Tobacco Control Act. This law gives FDA authority over tobacco products by adding a new chapter to the Federal Food, Drug, and Cosmetic Act for tobacco products and reinstating the 1996 final rule. Some of the Agency’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions. The law gives FDA the authority to regulate tobacco products and manufacturers - not growers.
 
National Center for Toxicological Research (NCTR) - NCTR conducts peer-reviewed scientific research that supports and anticipates FDA’s current and future regulatory needs. This involves fundamental and applied research specifically designed to define biological mechanisms of action underlying the toxicity of products regulated by FDA. This research is aimed at understanding critical biological events in expressing toxicity and at developing methods to improve assessment of human exposure, susceptibility and risk.
 
Office of Regulatory Affairs (OM) - The FDA’s Office of Regulatory Affairs is the lead office for all FDA Field activities as well as providing FDA leadership on imports, inspections, and enforcement policy.  ORA supports the five FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States.  ORA develops FDA-wide policy on compliance and enforcement and executes FDA’s Import Strategy and Food Protection Plans. 
 
ORA staffs are dispersed throughout the United States.  Over 85 percent of ORA’s staff works in 5 Regional Offices, 20 District Offices, 13 Laboratories, and more than 150 Resident Posts and Border Stations.  ORA Headquarters is comprised of the Office of Resource Management; Office of Regional Operations; and, the Office of Enforcement located in Rockville, Maryland and the Office of Criminal Investigations located throughout the United States. FDA maintains offices and staff in Washington, D.C., the U.S. Virgin Islands, Puerto Rico, and in all States except Wyoming. 
 
Besides executing its mission through its Federal workforce, ORA also works with its State, Local, Tribal, and Territories counterparts to further FDA’s mission.  ORA funds grants and cooperative agreements to perform State inspections and provide technical assistance to the States in such areas as milk, food, and shellfish safety.