MEMORANDUM OF UNDERSTANDING
U.S. DEPARTMENT OF HEALTHAND HUMAN SERVI CES
THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF MEDICAL POLICY
THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK
The Food and Drug Administration (FDA) and the Trustees of Columbia University in the City of New York (Columbia) share interests in promoting scientific progress through exchange of scientific capital in promoting postmarket safety surveillance research. Both institutions foresee benefits from the mutual exchange of training and research expertise that will enhance FDA's existing postmarket safety system and future expansion of drug safety surveillance and monitoring systems. This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote these shared interests, which can be pursued through various programs including collaborative education and research.
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act). 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, and for regulating tobacco products. 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 Columbia will contribute to FDA’s mission.
Columbia University is one of the world's most important centers of research and at the same time is a distinctive and distinguished site of learning for undergraduates and graduate students in many scholarly and professional fields. Columbia University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.
III. Substance of Agreement:
This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and Columbia. The types of initiatives expected to develop from this MOU include:
a. Advancing student education and matriculation into the health, biomedical and applied science professions. One of the mechanisms to enroll students, post-doctoral trainees and residents from Columbia into the joint fellowship program at the FDA is through the Center for Drug Evaluation and Research (CDER) Oak Ridge Institute for Science and Education (ORISE) fellowship program. Faculty sabbatical may be covered under ORISE if applicable. If prospective fellows or faculty members enter the program through the ORISE Fellowship program mechanism, CDER and Columbia will adhere to the CDER ORISE Fellowship rules. Fellows or faculty members entering the program must agree to adhere to the term of appointment which will be outlined in an offer of appointment letter.
b. Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;
c. Opportunities to convene joint meetings for education and research;
d. Research collaborations;
e. Cooperative international initiatives, and
f. Accessing unique facilities and equipment for scientific endeavors.
Under this MOU, joint efforts will be undertaken to obtain extramural funds 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 of collaboration and sharing of resources. Where applicable, these agreements shall incorporate by reference this MOU. FDA may enter additional agreements with Columbia to the extent authorized by law and available appropriations. The terms and conditions of any such awards will comply with applicable federal law and regulations.
IV. General Provisions:
1. "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 the MOU. "Intellectual Property" refers to patents, patent applications, know-how, trade secrets, copyrights and computer programs either use or developed under the activities of the MOU. Rights to Inventions or Intellectual Property developed under the MOU will be addressed in separate project-specific development and implementation agreements among the Parties. Inventorship will be governed by U.S. law. In the case of sole inventorship, ownership will be governed by the policies of the employer of the Invention. In the case of joint Inventorship, ownership of Inventions will be jointly owned. Inventions made under a Federal 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.
2. Institutions within the Columbia and FDA may decide to enter Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
3. Access to non-public information shall be governed by separate Confidentiality Disclosure Agreements in which the Parties will agree and certify in writing that they shall not further release, publish or disclose such information and that they shall protect such information in accordance with the provisions of 21 U.S.C. 331(j), 21 D.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 permitted by applicable 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. Columbia individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
V. Resource Obligations:
This MOU represents the broad outline of how FDA and Columbia intend 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 available 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. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and Columbia operate.
IV. VI. Liaison Officers:
A. Columbia University:
Senior Project Officer'
Sponsored Projects Administration
615 West 131st Street
Room 254, Mail Code 8725
New York, NY 10027-7922
Tel: (212) 854-0371
Fax: (212) 854-2738
B. Food and Drug Administration:
Senior Project Management Officer
10903 New Hampshire Ave
Bldg. 51 Room 2212
Silver Spring, MD 20993
Tel: (301) 796-0381
Fax: (301) 847-3529
Each Party may designate new liaisons by notifying the other Party's administrative liaison in writing. If 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. Term, 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 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, Columbia and the institutions within the Columbia operate.
Approved and Accepted
for The Trustees of Columbia University in the City of New York
Signed by: Juliana Powell
Assistant Director, Morningside
Sponsored Projects Administration
Date: October 19, 2011
Approved and Accepted
for the Food and Drug Administration
Signed by: Janet Woodcock, M.D.
Director, CDER, FDA
Date: August 24, 2011