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  1. FDA Memoranda of Understanding

MOU 225-16-030

MEMORANDUM OF UNDERSTANDING U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES THE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH OFFICE OF TRANSLATIONAL SCIENCES OFFICE OF CLINICAL PHARMACOLOGY
AND
THE BOARD OF TRUSTEES OF THE UNIVERSITY OF ALABAMA FOR THE UNIVERSITY OF ALABAMA AT BIRMINGHAM ON BEHALF OF
THE SCHOOL OF MEDICINE DEPARTMENT OF NEUROLOGY

I. Purpose

The United States Food and Drug Administration (FDA) and The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham (UAB) on behalf of the School of Medicine, Department of Neurology (the Parties), share interests in promoting scientific progress through exchange of scientific capital in clinical pharmacology training and research programs. Both institutions foresee benefits from the mutual exchange of training and research expertise in clinical pharmacology and translational science. This Memorandum of Understanding (MOU) and the collaborative framework it provides will facilitate existing and new mutually agreed upon programs and activities and establishes the terms for collaboration to promote these shared interests, which can be pursued through a variety of programs including collaborative education and research.

II. Background

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.5.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 communicate with stakeholders about complex scientific and public health issues. Increased development of research, education, and outreach partnerships within the UAB will greatly contribute to FDA's mission.

The University of Alabama at Birmingham (UAB} School of Medicine is dedicated to excellence in the education of physicians and scientist s in all of the discipline s of medicine and biomedical investigation for careers in practice, teaching, and research. Central to this educational mission are the provision of outstanding medical care and services and the enhancement of new knowledge through clinical and
basic biomedical research. It also provides primary, secondary, and tertiary health care through the
University Hospital and clinics of the UAB Health System.

Ill. Substance of Agreement:

This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and UAB. The types of activities expected to be pursued under this MOU may include, but are not limited to the following:

1. Opportunities to apply for fellowship programs at the FDA to advance UAB student and faculty education and matriculation into the health and biomedical sciences. The CDER Oak Ridge Institute for Science and Education (ORISE) fellowship program is one of the mechanisms that can be used to bring students/post-doctoral candidates/faculty from UAB to FDA.
a. Faculty sabbatical may be covered under ORISE if applicable. If prospective fellows or faculty members enter through the ORISE fellowship program, the FDA and UAB will adhere to the CDER ORISE Fellowship requirements as well as any agency-wide ORISE requirements.
b. Fellows or faculty members entering the program must agree to adhere to the ORISE terms of appointment which will be outlined in an ORISE offer of appointment letter;

2. Personnel exchanges between university faculty, staff, and FDA's scientists and staff as permitted by the Intergovernmental Personnel Act;

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

4. Research collaborations; and

5. Access to unique facilities and equipment for scientific endeavors.

Under this MOU, FDA and UAB 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 into a contract, grant, or cooperative agreement with UAB 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 UAB and FDA.

Ill. General Provisions:

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

2. Institutions within UAB 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. Proprietary and non-public information will not be disclosed under this MOU, unless such disclosure is permitted by law. Any access to non-public information shall be governed by appropriate confidentiality agreements in which the Parties 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. 3310), 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. UAB 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 UAB 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.

6. As research projects are developed, details will be agreed to in advance under other agreements as appropriate and in compliance with all applicable federal requirements.

IV. Resource Obligations:

This MOU represents the broad outline of the FDA and UAB's intent to collaborate in areas of mutual interest. Afl activities that may be undertaken by this MOU are subject to the availability of personnel, resources, and funds. This MOU does not create binding, enforceable obligations against any Party. 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.

V. 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:

A. For the Party(s}: University of Alabama at Birmingham (UAB) Technical Matters;
Individual's name: Nita A Limdi, PharmD, PhD, MSPH Organization: University of Alabama at Birmingham (UAB) Title: Professor/Project Director
Address: 1720 211d Ave South, Suite AB 1170/ Birmingham, AL 35294-0111 Telephone Number: 205-934-4385
Email: nlimdi@uab.edu

Administrative Matters:
Individual's name: Melinda T. Cotten
Organization: University of Alabama at Birmingham (UAB) Title: Assistant Vice President, Sponsored Programs
Address: 1720 2ndAve South, Suite AB 1170
Telephone Number: 205-934-5266
Email: osp@uab.edu

B. For the Food and Drug Administration:
Individual' s name: Padmaja Mummaneni, PhD
Organization: Center for Drug Evaluation and Research, Office of Translational Sciences Title: Contract Officer Representative (COR)
Address: 10903 New Hampshire Avenue White Oak Building 51,
Silver Spring, MO 20993-0002
Telephone Number: 301-796-2027
Email: Padmaja.Mummaneni@fda.hhs.gov

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 agreement 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.

VI. Term, Termination, and Modification:

This agreement, when accepted by all Parties, will have an effective period of performance from the date of the latest signature and continuing for a period of five years and may be modified or terminated by mutual written consent of the parties or may be terminated by either Partner(s) upon a 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, UAB and the institutions within UAB operate.

APPROVED AND ACCEPTED FOR
University of Alabama at Birmingham (UAB)
By Melinda T. Cotton
Assistant Vice President, Sponsored Programs
Date: 11/23/16

PROJECT DIRECTOR APPROVAL
By Nita A. Limdi, PharmD, PhD, MSPH
Professor/Project Director
Date: 11/28/2016

APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION
By Janet Woodcock
Director, CDER
Date: 12/06/2016