MEMORANDUM OF UNDERSTANDING
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVI CES
THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF TRANSLATIONAL SCIENCES
OFFICE OF CLINICAL PHARMACOLOGY
THOMAS JEFFERSON UNIVERSITY BY AND THROUGH ITS JEFFERSON MEDICAL COLLEGE, DEPARTMENT OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS
The United States Food and Drug Administration (FDA) and Thomas Jefferson University, by and through its Jefferson Medical College, Department of Pharmacology and Experimental Therapeutics (“TJU”) share interests in promoting scientific progress through exchange of scientific capital in Clinical Pharmacology Training and Research Program. Both institutions foresee benefits from the mutual exchange of training and research expertise in clinical pharmacology and translational sciences. 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, 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 also communicate with stakeholders about complex scientific and public health issues. Increased development of research, education and outreach partnerships within the Thomas Jefferson University will greatly contribute to FDA’s mission.
Thomas Jefferson University through its Jefferson Medical College’s Department of Pharmacology and Experimental Therapeutics (TJU DPET) is a unique academic, research-based clinical pharmacology program including basic research of molecular mechanisms underlying normal and abnormal physiology to define novel therapeutic targets, translational research to adapt observations from the laboratory to patients and clinical research to examine the behavior of novel therapeutics in humans. The program trains medical and pharmacy practitioners and pharmaceutical scientists at all levels of instruction and experience (professional, graduate, post-graduate, and continuing studies). Through this training and research program, FDA will gain knowledge of top notch bench science, and through mutual exchange of new knowledge and collaboration, we can effectively translate research findings to the bedside in order to benefit the public health.
III. Substance of Agreement
This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and TJU. The types of initiatives expected to develop from this MOU include:
1. Advancing student education and matriculation into the health and biomedical science professions. One of the mechanisms to enroll students/post-doctoral trainees/residents from TJU into the joint fellowship program at the FDA is through the 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, the Office of Clinical Pharmacology and TJU will adhere to the CDER ORISE Fellowship rules and regulations. 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.
2. Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;
3. Opportunities to convene joint meetings for education and research;
4. Research collaborations;
5. Cooperative international initiatives; and
6. Accessing unique facilities and equipment for scientific endeavors.
Under this MOU, joint efforts will be undertaken to obtain grants and other 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 for collaboration and sharing of resources. Where applicable, these agreements shall incorporate by reference this MOU. FDA may enter into a contract, grant or cooperative agreement with TJU to the extent authorized by law and available appropriations. The terms and conditions of any such awards will be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within TJU and FDA.
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 used 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. Accordingly, all TJU employees who work on any project under the MOU shall be required to sign an agreement that effects a present assignment of their future inventions to TJU. 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 TJU 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. 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 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 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. TJU individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
5. It is recognized that from time to time FDA and institutions within TJU will be sharing in expenses and may require compensation of either Party by the other. As research projects are developed, details of how costs are to be shared will be agreed to in advance under other contractual mechanisms as appropriate and in compliance with all applicable federal requirements.
V. Resource Obligations
This MOU represents the broad outline of the FDA and TJU’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 into 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 TJU operate.
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 21 | Room 4509
Silver Spring, MD 20993
Tel: 301-796-2106 | Fax: 301-796-9907
The individual to whom all inquiries to TJU should be addressed is:
Scott A. Waldman, M.D., Ph.D.
Department of Pharmacology & Experimental Therapeutics
Thomas Jefferson University
Jefferson Medical College
Philadelphia, Pennsylvania 19107
Phone: (215) 955-6086
Fax: (215) 955-5681
Each Party may designate new liaisons at any time by notifying the other Party's liaison officers in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill their 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 at any time by mutual written agreement of both Parties. It may be terminated, for any reason, 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 TJU operate.
APPROVED AND ACCEPTED FOR THE THOMAS JEFFERSON UNIVERSITY by and through its Jefferson Medical College Signed by: APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION Signed by:
Mark L. Tykocinski, MD
Sr. Vice President, TJU and
Dean, Jefferson Medical College
Date: December 9, 2011
Janet Woodcock, MD
Director, CDER, FDA
Date: December 2, 2011
APPROVED AND ACCEPTED FOR THE THOMAS JEFFERSON UNIVERSITY by and through its Jefferson Medical College
APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION
This is an amendment to the Memorandum of Understanding (MOU) 225-12-0004 dated December 9, 2011, to change the termination date from December 10, 2016 to December 9, 2021.
This amendment is permissible under VII. Term, Termination, and Modification. All other terms, condition, and content of the MOU Number 225-12-0004, executed on December 9, 2011, remain unchanged.