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U.S. Department of Health and Human Services

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225-12-00027

 

MEMORANDUM OF UNDERSTANDING
BETWEEN
JOSLIN DIABETES CENTER
AND
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVI CES
U.S. FOOD AND DRUG ADMINISTRATION
 
I.          Purpose
 
The United States Food and Drug Administration (FDA) and Joslin Diabetes Center, affiliated with Harvard Medical School, share interests in promoting scientific progress through exchange of scientific capital in public health, epidemiology and research. This Memorandum of Understanding (MOU) forms the basis for the initial relations between FDA and Joslin Diabetes Center for sabbaticals, research and scientific education.
 
II.        Background
 
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended (21 U.S.C. 301). In fulfilling its responsibilities under the FD&C 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, and medical devices and the safety and security of foods, dietary supplements, cosmetics, and radiological products, as well as advancing the public health through regulation of 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 within will contribute to FDA’s mission.
Joslin Diabetes Center is a preeminent institution on the front lines of the world epidemic of diabetes – leading the battle to conquer diabetes in all of its forms through cutting-edge research and innovative approaches to clinical care and education.  Joslin’s mission is to improve the lives of people with diabetes and its complications through innovative care, education, and research that will lead to prevention and cure of the disease. Joslin's research team is a comprehensive and dynamic research program dedicated exclusively to diabetes anywhere in the world.  The principal areas of research focus include:
 
·         Clinical, Behavioral & Outcomes Research
·         Genetics & Epidemiology
·         Immunobiology
·         Integrative Physiology & Metabolism
·         Islet Cell & Regenerative Biology
·         Pathophysiology & Molecular Pharmacology
·         Vascular Cell Biology
 
Principal areas of education include courses and training programs for medical students, graduate students in other disciplines, medical residents, and post-doctoral fellows.
 
III.       Substance of Agreement:
 
This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and the Joslin Diabetes Center.   The 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 in 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, Office of Minority Health and the Joslin Diabetes Center will adhere to the FDA 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 Joslin faculty training in the regulatory science pathways;
c.       Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;
d.      Opportunities to convene joint meetings for education and research;
e.       Research collaborations;
f.       Access to unique facilities and equipment for scientific endeavors.
 
Under this MOU, FDA and Joslin 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 collaboration and sharing of resources. Where applicable, these agreements shall incorporate by reference this MOU.  FDA may enter a contract, grant or cooperative agreement with the Joslin Diabetes Center 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, and shall be negotiated and executed by appropriate representatives of institutions within the Joslin Diabetes Center and FDA.
 
IV.       General Provisions:
 
1.      Rights to any inventions resulting from collaborative research will be determined by the separate written research agreements governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations.
2.      Institutions within the Joslin Diabetes Center and FDA may decide to enter Cooperative Research and Development Agreements (CRADAs) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
3.      Proprietary and nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure agreements or to the extent such disclosure is permitted by 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.  Any Joslin Diabetes Center individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
5.      Intellectual Property Guidelines: "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. Accordingly, all Joslin Diabetes Center 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 Joslin Diabetes Center. 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.  It is recognized that occasionally FDA and the Joslin Diabetes Center share 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 compliant with all applicable federal requirements.
 
V.        Resource Obligations: 
 
This MOU represents the broad outline of how FDA and Joslin Diabetes Center 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. 
 
VI.       Liaison Officers:
 
            A.        Sharon Harpel
                        Vice President for Research Administration
                        Joslin Diabetes Center One Joslin Place Boston, MA 02215
                        617-732-2543
                        671-732-2542 (fax)
                        Sharon.Harpel@Joslin.Harvard.edu
:
 
FDA’s Office of Minority Health is the lead for this MOU. The individual to whom all the inquiries to the FDA should be addressed is:
 
B.        US Food and Drug Administration: 
 
           Jonca Bull, MD
           Director, Office of Minority Health
           Office of the Chief Scientists
           10903 New Hampshire Avenue
           Silver Spring, MD 20993
           301-796-8000
           jonca.bull@fda.hhs.gov
 
Each Party may designate new liaisons by notifying the other Party's liaison in writing. If an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Party affected will name a new liaison within two (2) weeks and notify the other Party through the designated 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 sixty (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 Joslin Diabetes Center operate.
 
APPROVED AND ACCEPTED FOR
JOSLIN DIABETES CENTER
 
Sharon Harpel
Vice President for Research Administration
 
September 1, 2012
 
 
APPROVED AND ACCEPTED FOR
FOOD AND DRUG ADMINISTRATION
 
 
Jesse Goodman, M.D., MPH
Chief Scientist, US FDA
 
August 28, 2012