MEMORANDUM OF UNDERSTANDING
BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE FOOD AND DRUG ADMINISTRATION (FDA)
CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
OFFICE OF TRANSLATIONAL SCIENCES
AND
THE UNIVERSITY OF PITTSBURGH

This Memorandum of Understanding (“MOU”) is made and entered into by and between the United States Food and Drug Administration (hereafter referred to as “FDA”) and the University of Pittsburgh - Of the Commonwealth System of Higher Education, through its School of Pharmacy (hereafter “University of Pittsburgh”), Pittsburgh, Pennsylvania, collectively referred to as the “Parties.”

WHEREAS the Parties wish to explore and establish a cooperative relationship through their mutual interest in the areas of education and research, the parties agree as follows:

I. Purpose

This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote FDA and University of Pittsburgh’s shared interests, which can be pursued through a variety of programs including but not limited to:  (a) joint research projects in fields of mutual interest; (b) exchange of academic publications and reports; (c) sharing of experiences in innovative teaching methods and course design; (d) organization of joint symposia, workshops, and conferences; (e) opportunities for faculty development and exchange; (f) opportunities for student exchange; and (g) opportunities for exchange of visiting research scholars.

II. Background

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.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.

The ‘University Of Pittsburgh’ (PITT) is a state-related research university, founded as the Pittsburgh Academy in 1787, a member of the Association of American Universities (AAU), which comprises 62 preeminent doctorate-granting research institutions in North America. It’s affiliated PITT school of health sciences, medicine is a center addressing basic and applied biomedical research and has pioneered historically in major medical advances such as the Salk polio vaccine, multiple-organ transplantation and focusing to improve the health and well-being of individuals and populations through cutting-edge biomedical research, innovative educational programs in medicine and biomedical science, and leadership in academic medicine. The ‘PITT school of pharmacy’ vision within the school of health science is strive for excellence in discovery and advancement of science-based use of medicines and other interventions to enhance the vitality and quality of life and is committed to improving health through excellence, innovation, and leadership in education of pharmacists and pharmaceutical scientists, in research and scholarship, in care of patients, and in service to communities. 

III. Substance of Agreement

This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and University of Pittsburgh. The types of initiatives expected to develop from this MOU include:

A. Opportunities for students, post-doctoral trainees, and residents from the University of Pittsburgh to apply for the Center for Drug Evaluation and Research (CDER) ORISE fellowship program to advance student education and matriculation into the health and biomedical science professions.  Faculty sabbatical may be covered under ORISE if applicable. If prospective fellows or faculty members enter the program through the ORISE Fellowship program mechanism, CDER and University of Pittsburgh will adhere to the CDER ORISE Fellowship rules, which will be provided to University of Pittsburgh upon commencement of the program.  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 FDA staff to serve as adjunct faculty or on advisory boards;

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

D. Research collaborations.

Under this MOU, joint efforts will be undertaken to support 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 University of Pittsburgh 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 University of Pittsburgh and FDA.

IV. Term, Termination, and Modification:

This MOU shall remain in force for five years from the date of the last signature. Either Party may terminate this MOU by providing 90 days’ advance written notice to the other Party. The Parties may extend or renew this MOU by agreement, confirmed in a written amendment signed by each Party’s authorized signatory.

V. Additional Terms:

No amendment of the terms of this MOU will be effective unless made in writing and signed by each Party’s authorized signatory. Each Party represents that the individuals signing this MOU have the authority to sign on its behalf in the capacity indicated.

VI. General Provisions:

Prior to initiating any specific activity or program, the Parties will negotiate and enter into a definitive agreement, signed by each Party’s authorized signatory, describing the terms of the arrangement, including but not limited to, financial commitments, academic freedom commitments, immigration and compliance obligations and details of the exchange or collaborative relationship. This MOU is not intended to create any legally binding obligations on either institution but, rather, it is intended to facilitate discussions regarding general areas of cooperation.

A. 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.

B. Institutions within University of Pittsburgh 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.

C. Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is permitted by law and is governed by appropriate confidentiality disclosure agreements.

D. 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. University of Pittsburgh individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.

E. It is recognized that from time to time FDA and institutions within University of Pittsburgh may 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.

VII. Resource Obligations:

This MOU represents the broad outline of the FDA and University of Pittsburgh’s intent to collaborate in areas of mutual interest. All 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.

Liaison Officers:
A. For The University of Pittsburgh:
Individual's name: Jacqueline Detty
Organization: School of Pharmacy, University of Pittsburgh
Title: Executive Assistant
Address: 1104 Salk Hall | 3501 Terrace Street, Pittsburgh, PA 15261
Telephone Number: 412.624.2400
Email: [email protected]

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, Room 2164
Silver Spring, MD 20993-0002
Telephone Number: 301-796-2027 
Email:  [email protected]

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.

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, University of Pittsburgh, and the institutions within University of Pittsburgh operate.

APPROVED AND ACCEPTED FOR UNIVERSITY OF PITTSBURGH
Arthur S. Levine, MD
Senior Vice Chancellor for the Health Sciences
John and Gertrude Petersen Dean of Medicine

Date: 1/12/2018

Patricia Kroboth, PhD
Dean, School of Pharmacy
Dr. Gordon J. Vanscoy Professor, Pharmaceutical Sciences

Date: 1/12/2018 

APPROVED AND ACCEPTED FOR US FOOD AND DRUG ADMINISTRATION
Janet Woodcock, MD
Director of the FDA Center for Drug Evaluation and Research

Date: 1/18/2018