MEMORANDUM OF UNDERSTANDING BETWEEN
OFFICE OF THE CHIEF SCIENTIST, OFFICE OF THE COMMISSIONER, FOOD AND DRUG ADMINISTRATION,
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
AND
THE UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES REGARDING 4-DIMENSIONAL BIOPRINTING, BIOFABRICATION AND BIOMANUFACTURING PROGRAM, DEFENSE HEALTH PROGRAM, DEPARTMENT OF DEFENSE

I.    Purpose

This Memorandum of Understanding (MOU) between the Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration (FDA) and the Uniformed Services University of the Health Sciences (USU) regarding the 4-Dimensional Bioprinting, Biofabrication and Biomanufacturing Program, Defense Health Program, Department of Defense (4D Bio 3) (each a Party and collectively the Parties) provides a framework for research coordination and collaborative efforts between these two organizations. Both parties seek to increase our scientific knowledge and understanding of innovative new technologies that will advance the public health of all stakeholders.

II.    Background

FDA is authorized to enforce the Food, Drug and Cosmetic Act (the Act) as amended (21 U.S.C.
§ 301, et seq.). In fulfilling its responsibilities under the Act, FDA promotes and protects the public health by ensuring the safety, efficacy, and security of drugs, biological products, veterinary products, and medical devices, as well as 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 must stay abreast of the latest developments in innovative research and technologies and communicate with stakeholders about complex scientific and public health issues. Increased development of research, training and outreach partnerships with 4D Bio 3 will contribute greatly to FDA's Mission.
4D Bio 3 is funded by the Defense Health Program with the purpose of promoting the development and application of advanced bioprinting, biofabrication and biomanufacturing technologies research pursuant to the Department of Defense priorities and ultimately for translation to clinical medical defense care and training solutions. Translation of new innovative technologies into clinical practice through partnership with FDA will contribute greatly to 4D Bio 3's mission.

III.    Authority

FDA has authority to enter into this MOU pursuant to section 1003 of the Act (21 USC§ 393) and 301(a) of the Public Health Services Act (42 USC§ 241(a).

IV.    Substance of Agreement

This MOU forms the basis for the development of scientific collaborations, outreach and educational initiatives, and intellectual partnerships between FDA and USU regarding 4D Bio 3 endeavors. The types of initiatives expected to develop from this MOU include, but are not necessarily limited to, the following:

l.   Opportunities to convene joint meetings for education and research;
2.  Research collaboration;
3.  Cooperative international initiatives; and
4.  Access to unique facilities, expertise, patient populations and equipment for scientific endeavors.

Under this MOU, FDA and USU intend to 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 intend to identify priorities and topics of mutual interest and develop separate, written arrangements for collaboration and resource-sharing. The Parties intend that, when applicable, these arrangements incorporate by reference this MOU.

V.    General Provisions

The Parties intend that:

1.    Rights to any inventions resulting from collaborative research will be determined by the separate written research arrangements governing the effort, based on current U.S. Government law patent regulations and any other applicable statutes and regulations.

2.    USU and FDA may decide to enter into Cooperative Research and Development Agreements (CRADAs), grants, contracts, etc., for specific collaborative projects. The terms of such CRADAs, grants, contracts, etc., wil1 address Intellectual Property rights.

3.    Proprietary and/or nonpublic information may not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality and disclosure arrangements and to the extent that such disclosure is permitted by U.S. federal law.

4.    Each Patty 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. The Parties intend that individuals participating in activities under this MOU on government property comply with applicable U.S. federal law.

5.    This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which the patties operate, and nothing in the MOU shall be construed as changing the current requirements under the statutes and regulations administered and enforced by any Party. Further, nothing contained in this MOU constitutes a mandate or a requirement imposed on any Party that is additional to the mandates or requirements imposed on them, individually or collectively, by Federal statutes and regulations.

VI.    Resource Obligations

This MOU represents the broad outline of the intent of FDA and USU to collaborate in areas of mutual interest related to 4D Bio 3. It does not create binding, enforceable obligations against any Party. This MOU does not document nor provide for the exchange of funds or manpower between the Parties nor does it make any commitment of funds or resources. All activities that may be undertaken under 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 Partis to enter other agreements or arrangements related to this MOU.

VII.    Points of Contact

Science liaison for USU 4D Bio 3
Dr. Vincent Ho Director, 4D Bio 3
Chair and Professor, Department of Radiological Sciences Uniformed Services University of the Health Sciences

Science liaison for FDA:

Suzanne Fitzpatrick, PhD, DABT, ERT
Senior Advisor for Toxicology
FDA's Center for Food Safety and Applied Nutrition

All correspondence to be sent and notices to be given pursuant to this MOU will be addressed, if to the USU, to:

Agreements Manager
Financial & Manpower Directorate
Uniformed Services University of Health Sciences 4301 Jones Bridge Road
Bethesda, MD 20814
301.319.4525

Each Party may designate new points of contact by notifying the other Party in writing.

VIII.    Effective Date, Term, Termination, and Modification of MOU:

This MOU takes effect beginning on the day after the last Party signs. This MOU expires on 19 AUGUST 2024, unless terminated sooner. This MOU may be terminated in writing at will by either Party. This MOU may only be modified by the written agreement of the Patties, duly signed by their authorized representatives. This MOU will be reviewed annually on or around the anniversary of its effective date.

APPROVED:

Approved and Accepted for Uniformed Services University of the Health Sciences

/s/
RICHARD W. THOMAS, MD, DDS, FACS
President
Date: 11/15/2019

Approved and Accepted for the
Food and Drug Administration

/s/
RADM Denise M. Hinton
Chief Scientist
Date: 11/20/2019