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  1. FDA Memoranda of Understanding

MOU 225-19-003

MOU 225-19-003

MEMORANDUM OF UNDERSTANDING
BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE FOOD AND DRUG ADMINISTRATION
MASSACHUSETTS INSTITUTE OF TECHNOLOGY
ON BEHALF OF THE MIT MEDIA LAB

I. Purpose

The United States Food and Drug Administration (FDA), and Massachusetts Institute of Technology (MIT), on behalf of the MIT Media Lab, are mutually interested in facilitating scientific progress through collaborative, interdisciplinary research, educational and training initiatives.  Both institutions contemplate benefits from the mutual exchange of training and research expertise through joint participation in education and training programs involving the FDA Information Exchange and Data Transformation (INFORMED) Program, and the Health 0.0 initiative at the MIT Media Lab.  This Memorandum of Understanding (MOU) establishes a framework for such collaborative educational, research and training opportunities.  FDA and MIT may be referred to individually as a “Party” and collectively as “Parties” herein.

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 et seq). In fulfilling its responsibilities under the FD&C 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, medical devices and radiological products and the safety and security of foods, dietary and cosmetics, 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 also communicate with stakeholders about complex scientific and public health issues. Increased development of research and educational partnerships with MIT will greatly contribute to FDA’s mission.

The MIT Media Lab  conducts interdisciplinary, innovative, pioneering research and unique, unconventional educational programs that enable transformative, futuristic advances with myriad applications worldwide.

III.  Substance of Agreement:

This MOU forms the basis for development of academic, intellectually stimulating, scientific collaborations, outreach and educational initiatives between FDA and MIT Media Lab. The types of activities anticipated to develop from this MOU include the following.  Any such activities undertaken pursuant to this MOU are subject to the availability of personnel, resources, and funds, and the execution of separate written agreements as described below, that will govern such activities.

A. Advancing regulatory science research through collaborative activities with the Information Exchange and Data Transformation (INFORMED) program.
a. Opportunities to explore collaborative research with FDA faculty and staff.  
b. Frequent communication with FDA faculty and staff via face-to-face meetings, conference calls or teleconferences.
c. Communication of this collaborative effort through web pages, press releases, teleconferences, joint conferences, and symposia.

B. Opportunities to convene joint meetings for education and research; and

 

C. Research collaborations.

Pursuant to this MOU, joint efforts will be undertaken to develop collaborative research and training programs 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 a separate, written agreement for each collaboration that will describe the research objectives, resources required, including required financial compensation/reimbursement, personnel and other support,  each Party’s respective obligations and activities, and the terms and conditions that will govern the collaboration, in compliance with all applicable federal requirements. Where applicable, these agreements shall incorporate by reference this MOU.  FDA may enter into a contract, grant or cooperative agreement with MIT 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 MIT and FDA.

IV. General Provisions:

A. Rights to any inventions resulting from collaborative research will be determined by the separate written research agreement(s) governing the effort, based on current U.S. Government law, including the Bayh-Dole Act, and any other applicable statutes and regulations.

B. FDA and MIT may enter into a Research Collaboration Agreement (RCA) or a Cooperative Research and Development Agreement (CRADA) specific to a particular collaborative project. The terms of such RCA or CRADA will address intellectual property rights.

C. Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is permitted by law and is governed by an appropriate confidentiality and non-disclosure agreement, to be separately negotiated and executed by the Parties. FDA will not disclose any personally identifiable information to MIT.

D. Each Party will inform the other Party of its security policies and procedures regarding access to and use of its respective facilities, as applicable. 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.  MIT individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations. FDA employees and/or agents participating in activities under this MOU at MIT facilities will comply with all relevant MIT policies and procedures.

E. The Parties will cooperate and comply with each Party's respective policies and procedures regarding access to and use of the Party’s names, trademarks and logos. 

V. Resource Obligations:

This MOU represents the broad outline of the Parties’ intentions to collaborate in areas of mutual interest.  It does not create binding, enforceable obligations against either Party. All activities that may be undertaken by and pursuant to 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 between 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 MIT operate respectively.

VI. Liaison Officers:

FDA’s Office of the Commissioner is the lead for this MOU.

The individual to whom all inquiries to FDA should be addressed is:
Sean Khozin, MD, MPH
Director, Information Exchange and Data Transformation
Food and Drug Administration
Sean.Khozin@fda.hhs.gov

MIT Administrative Contact:
Nancy Sahagian
Senior Contract Administrator
MIT Office of Sponsored Programs
77 Massachusetts Ave, NE18-901
Cambridge, MA  02139
nsahag@mit.edu  |  617-715-4295


MIT Technical Contacts:
Joichi (Joi) Ito,  MIT Media Lab,  joi@media.mit.edu;  617.715.4366
Pratik Shah, MIT Media Lab, pratiks@mit.edu;  617.324.3859

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 MOU 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 MOU becomes effective upon the last signature date by the Parties and will continue in effect for five (5) years.  It may be renewed and/or modified by mutual written agreement signed by each Party’s authorized representative. 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 and MIT operate.

IN WITNESS WHEREOF, the Parties, by their undersigned representatives, have caused this MOU to be executed. This MOU may be executed in counterparts and each counterpart shall be deemed an original.

Approved and Accepted for Food and Drug Administration
/s/
Sean Khozin, MD, MPH
Director, Information Exchange and Data Transformation
Date  1-30-19

Approved and Accepted for Massachusetts Institute of Technology
/s/
Michael P. Corcoran
Assistant Director
Office of Sponsored Programs
Date  1-30-19