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MOU 225-14-8001

Memorandum of Understanding Between
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 University of Cologne,
Represented By the Chancellor, In Tum Represented By the Chief
Executive Director of the University Hospital of Cologne, Kerpener Str. 62, 50937
Cologne, Germany With the Implementing Division: Department of Pharmacology
Prof. Dr. Uwe Fuhr

I.              Purpose
The United States Food and Drug Administration  (FDA) and the University Hospital of Cologne and its Department of Pharmacology  (University Hospital of Cologne)-(the Participants),  share interests in promoting scientific progress through knowledge exchange of scientific capital in pharmacology and translational research with regard to characterization of drug transporters. This Memorandum of Understanding (MOU) establishes the framework 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.S.C. §301 et seq.). In fulfilling its responsibilities  under the Act, FDA, among other things, promotes and protects 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 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 developmentsin research and also communicate with stakeholders about complex scientific and public health issues. Increased development of research, education and outreach partnerships with the University Hospital of Cologne will greatly contribute to FDA's mission.

The University Hospital of Cologne is part of the University of Cologne. The University of Cologne is a non-profit, public research and teaching institution established in 1388, covering almost all scientific disciplines. The University Hospital of Cologne has several research groups, of which two focus on clinical pharmacology and basic transporter research, respectively, with the aim of promoting the understanding of the role of drug transporters in drug safety, drug effects and drug-drug interactions. The University Hospital of Cologne is engaged in a series of research programs to expand knowledge of biological systems and their application to medicine and global energy and climate issues. FDA and the University Hospital of Cologne have a mutual interest in collaborating and effectively translating research findings to the bedside to benefit the public health.
III.            Substance of Agreement
This MOU forms the basis for the development of scientific collaborations, outreach and educational initiatives, and intellectual partnerships between FDA and the University Hospital of Cologne. The types of initiatives expected to develop from this MOU include:
I.  Advancing student education and matriculation into the health and biomedical science professions. One of the mechanisms to enroll students/post-doctoral trainees/residents from the University of Cologne in the joint fellowship program at the FDA is through the Center for
Drug Evaluation and Research's(CDER) Oak Ridge Institute for Science and Education (ORISE) fellowship program. Faculty sabbaticals may also be covered under ORISE. If prospective fellows or faculty members enter the program through the ORISE mechanism, the Office of Clinical Pharmacology and the University of Cologne intend to adhere to the CDER ORISE fellowship rules and regulations. Fellows or faculty members entering the program should be prepared to adhere to the term of appointment, which will be outlined in an offer of appointment letter.
2.  Opportunities to convene joint meetings for education and research;
3.  Research collaborations;
4.  Cooperative international initiatives; and
5.  Access to unique facilities and equipment for scientific endeavors.
Under this MOU, FDA and the University Hospital of Cologne 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 Participants intend to identify priorities and topics of mutual interest and develop separate, written arrangements for collaboration and resource sharing. The Participants intend that, when applicable, these arrangements incorporate by reference this MOU.

IV.           General Provisions:
The Participants intend that:
I.                     Rights to any inventions resulting from collaborative research be determined by the separate written research arrangements governing the effort, based on current U.S. and German patent regulations and any other applicable statutes and regulations
2.                    The University of Cologne, Medical Faculty and the University Hospital of Cologne and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) for specific collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
3.                     Proprietary and/or nonpublic information not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure arrangements, or except to the extent that such disclosure is permitted by U.S. federal law.
4.                     Each Participant will comply with the other Participant's security procedures and policies regarding access to and use of facilities. Either Participant may restrict or limit access to its property and facilities at any time and for any reason. The Participants intend that individuals participating in activities under this MOU on FDA property comply with applicable U.S. federal law.
5.                     It is recognized that from time to time FDA and institutions within the Universityof Cologne and the University Hospital of Cologne may share expenses and may request compensation to one Participant by the other. The Participants intend that, as research projects are developed, details of how costs are to be shared shall be agreed to in advance under appropriate contractual mechanisms and in compliance with all applicable U.S. federal requirements.
V.            Resource Obligations:
This MOU represents the broad outline of the intent of FDA and the University Hospital of Cologne to collaborate in areas of mutual interest. It does not create binding, enforceable obligations against any Participant. 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 Participants and does not affect the ability of the Participants to enter other agreements or arrangements related to this MOU.

VI.           Liaison Officers:
A.  For the University Hospital of Cologne
Legal Matters: Jutta Landvogt, External Funding Administration University Hospital of Cologne, Kerpener Str. 62, 50937 K6ln, Germany Tel: +49 221 478-5204
Fax: +49 221 478-87752
Scientific Matters: Prof. Dr. Uwe Fuhr, Dept. of Pharmacology, University
Hospital of Cologne, Gleueler Str. 24, 50931 K6ln, Germany. Tel: +49 221-5230
Fax: +49 221-7011 uwe.fuhr@uk-koeln.de
B.  For the U.S. Food and Drug Administration: Nisha Bruce, Contract Liaison Specialist
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Tel: 301-796-2600; Fax: 301-796-9907
Each Participant may designate new liaisons at any time by notifying the other Participant'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 Participant previously represented by that individual intends to name a new liaison within two weeks and notify the other Participant through the designated administrative liaison.
VII.         Term, Termination, and Modification:
This MOU, when accepted by both Participants, will be effective for three years starting on the date of the last signature. It may be modified or terminated by mutual written consent of the Participants or may be terminated by either Participant upon 60 days' written notice to the other.
VIII.        Statutes, Regulations, Rules, and Policies
This MOU and all associated arrangements will be subject to the applicable statutes, regulations, rules, and policies under which FDA and the institutions within the University Hospital of Cologne operate.




By Jutta Landvogt

In Vertretung R. Peter

Head of External Funding Administration

June 30, 2014




By Janet Woodcock, M.D.

Director, Center for Drug Evaluation and Research

June 9, 2014


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