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MOU 225-16-005

MEMORANDUM OF UNDERSTANDING
BETWEEN THE FOOD AND DRUG ADMINISTRATION
AND UNIVERSITY OF ROCHESTER

I.  Purpose
 
This memorandum of Understanding (“MOU”) is entered into by and between the Food and Drug Administration (“FDA”), a federal agency of the U.S. government, and the University of Rochester (“UR”), a private, co-educational, nonsectarian nonprofit research university, (each, a “Party,” and together, the “Parties”). The Parties agree to collaborate under the following terms.
 
II. Background
 
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 among other things, directs its activities toward promoting and protecting the public health by ensuring 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. 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 makes efforts to 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 UR will greatly contribute to FDA's mission.
 
The University of Rochester is one of the country’s top-tier research universities, with Schools of Arts, Sciences and Engineering, Music, Medicine and Dentistry, Nursing, Business and Education. The University of Rochester Medical Center (URMC), one of the nation’s top academic medical centers, forms the centerpiece of UR’s biomedical research and teaching, patient care, and community outreach missions. Facilitating collaborative research, experiential training, and professional development opportunities with a range of external partners in a priority for the UR. Developing these partnerships with the FDA will directly support the research and educational goals of the Ur, particularly in enhancing regulatory science and translational research.
 
III. Substance of the Memorandum of Understanding
 
The FDA and UR share interests in promoting scientific progress through exchange of scientific capital in diverse fields of science that affect human health and medicine. Both Parties foresee benefits from scientific training for students, academicians, and FDA staff to foster a well-grounded foundation in interdisciplinary science on which scientific learning can grow. Under this MOU, FDA and UR will seek opportunities to participate together in collaborative research and training as permitted under appropriate statutory authority. This MOU promotes the Parties’ shared interests, anticipating collaborations pursued through a variety of programs, including without limitations.
     
a) Collaborative research;
b) Cooperative international initiatives
c) Various science-based academic initiatives;
d) Promotion of student education and matriculation into the health and biomedical sciences professions;
e) Opportunities for FDA staff to serve as UR adjunct faculty or on advisory boards;
f)  Opportunities to convene joint meetings for education and research;
g) Shared access to unique facilities and equipment for scientific endeavors;
h) Fellowships, and
I)  Student internships.
 
Before any specific collaboration is initiated or implemented, the parties (via the Liaison Officers) shall identify priorities, specific topics of mutual interest, and development 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 some or all of the terms of this MOU. The Supplemental Agreements may include contracts, grants, or cooperative research and development agreements (“CRADA”) between FDA and UR to the extent authorized by law and available appropriations. The terms and conditions of any Supplemental Agreements will be in accordance with an applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within the UR and FDA.
 
IV. General Provisions
 
a) 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. 
 
b) Non-Public Information
 
Both Parties recognize that information to which they have access that contains any of the following types of information must be protected from unauthorized disclosure: (1) confidential commercial information, such as the information that would be protected from public disclosure under Exemption 4 of the Freedom of Information Act (FOIA); (2) personal privacy information, such as the information that would be protected from public disclosure under Exemption 6 or 7(c) of FOIA; or (3) information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., Trade Secrets Act (18 U.S.C. Section 1905), the Privacy Act (5 U.S.C. section 552a), the Freedom of Information Act (5 U.S.C. Section 552), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Health Insurance Potability Act and Accountability Act (HIPPA), Pub. L. 104-191), and the Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. 1232g; 34 CFR Part 99).   
 
c) Confidentiality Disclose Agreements
Proprietary and nonpublic information will not be disclosed in the pursuit of initiatives anticipated under this MOU, unless such disclosure is governed by separate confidentiality disclosure agreements or to the extent, such disclosure is permitted by law.
 
d) Security
 
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. UR individuals participating in the activities anticipated under this MOU on FDA property will comply with all applicable federal statutes and regulations.
 
e) Conflict of interest
 
Individual participants in activities anticipated under this agreement who are not U.S. Government employees will be expected to abide by conflict of interest rules and policies as specified by FDA when participating in, or as a condition to participating in, such activities. This may require individual participants to disclose their financial holdings and those of their spouse ad minor children, and may limit their ability to accept gifts and have employment with entities that are substantially regulated by FDA. Individual participants will be advised by FDA in advance of any potential conflict so conflicting assignments can be avoided consistent with the Department of Health and Human Services and FDA requirements. If at any time prior to or during the performance of activities anticipated under this MOU, the Parties or a program participant believes that a potential or actual conflict of exists, the parties or participant must notify the appropriate authorities within their respective institutions and contact the designated FDA official listed on this MOU so the necessary action/s can be undertaken. A determination will be made by FDA on whether a conflict of interests exists and, if so, how to resolve or mitigate it. Parties to this MOU will act to avoid activities or relationships that would cause a reasonable person to question the impartiality of their actions.
 
V. Resource obligations
 
This MOU represents the broad outline of the FDA and UR’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 with other third parties. This MOU and all associated agreements will be subject to the applicable statutes, regulations, rules, and policies under which FDA and UR operate.
 
VI. Liaison Officers
 
The individual to whom all inquiries to FDA should be addressed is:
 
Eileen Parish, M.D.
Senior Advisor for Professional Development
Office of Scientific and Professional Development
Office of the Chief Scientist
Office of the Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
White Oak Building 32, Room 2302
Silver Spring, MD 20993
301-796-8552
 
The individual to whom all inquri8eis to UR should be addressed is:
 
Scott Steele, Ph.D.
Director, Government and Academic Research Alliances
Associate Professor, Public health Sciences
University of Rochester Medical Center
265 Crittenden Blvd
Office 1.208 Box # CU 420708
Rochester, NY 14642-0708
Office: 585-275-0708
 
Each party may designate new liaison 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 MOU become unavailable to fulfill their functions, the Parties will name a new liaison within two weeks and notify the other Party through the designated administrative liaison.
 
VII. Marks and Use of Name
 
Neither party shall use the registered marks of the other Party without the prior written consent of the other party in each instance. UR shall control the use of the names the University of Rochester, including associated trademarks and service marks. FDA shall have the right to use these names and marks for performing its obligations set forth in subsequent agreements anticipated under this MOU, but only with UR’s prior written consent in each instance. Ur agrees to abide by FDAs logo policy. In the event of a dispute with respect to this section, such as dispute shall be governed by U.S. law.
 
VIII. Headings
 
The article and Section headings in this MOU are inserted for convenience only and shall not be construed to limit or modify the scope of any provision of this MOU.
 
IX. Non-binding MOU
 
This MOU does not constitute and will not give to any legally binding obligation on the part of either Party to collaborate or cooperate on any of the items stated in Article III or any other part of this MOU. The parties agreed that any binding terms and conditions regarding such collaboration or cooperation including, but not limited to financial terms, will be set forth in a separate written agreement which will only be binding on either Party after it has been executed by authorized representatives of the Parties. Where applicable, these agreements may incorporate by reference some of all of this MOU. FDA may enter into a contract, grant, or cooperative agreement with UR to the extent authorize 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 FDA and UR.
 
X. Term, Termination, and Modification
 
This MOU becomes effective upon execution by both Parties and will continue in effect for five (5) years. It may be renewed in writing executed by both Parties. It may be modified at any time only in writing executed by both Parties. Either Party upon 60-day advance written notice to the other may terminate it, for any reason.
 
XI. Statutes, Regulations, Rules, and Policies
 
This MOU and any subsequent, binding agreements anticipated in this MOU will be subject to the applicable statutes, regulations, rules, and policies under which FDA and UR operate.
 
The undersigned individuals represent and warrant that they are duly authorized by their respective institutions to execute this MOU.
 
Food and Drug Administration
 
Luciana Borio, M.D.
Acting Chief Scientist
U.S. Food and Drug Administration
 
December 14, 2015
 
The University of Rochester
 
Mark B. Taubman, M.D.
Dean, School of Medicine and Dentistry
CEO, University of Rochester Medical Center
 
December 11, 2015