MOU 225-23-002

MEMORANDUM OF UNDERSTANDING BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE FOOD AND DRUG ADMINISTRATION, CENTER FOR DRUG EVALUATION AND RESEARCH
AND
UNIVERSITY OF PENNSYLVANIA, PERELMAN SCHOOL OF MEDICINE

I. Purpose

The United States Food and Drug Administration (FDA) and the University of Pennsylvania (the Parties) have a shared interest in scientific progress in the diverse disciplines that directly and indirectly affect human and animal health and medicine. The Parties also endorse scientific training for faculty, students, and staff to foster a well-grounded foundation in interdisciplinary fields in which academia and government share mutual interest. This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote these shared interests, which can be pursued through a variety of programs including collaborative research, public outreach, extension activities, cooperative international initiatives, disciplinary training, and exchange of scientists and staff, including sabbaticals, postdoctoral fellowships, and student internships.

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, and medical devices and 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 research and communicate with stakeholders about complex scientific and public health issues. Increased development of research, education, and outreach partnerships with University of Pennsylvania, Perelman School of Medicine will greatly contribute to FDA’s mission. FDA’s Centers and Offices are described in Appendix A.

University of Pennsylvania, Perelman School of Medicine, an academic home for biostatisticians and non-clinician- epidemiologists, supports primary research in biostatistics and epidemiology, whose mission is to discover, teach and promote impactful ways to preserve health, manage chronic disease and treat acute illness, by capitalizing on synergies across three scientific disciplines of biostatistics, epidemiology and informatics. University of Pennsylvania, Perelman School of Medicine, also includes program in clinical pharmacoepidemiology (i.e., the use and effects of medications in populations) to focus on healthier people through advances across the full spectrum of population-health science.

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 Pennsylvania, Perelman School of Medicine. The types of activities expected to develop from this MOU include, but are not necessarily limited to, the following:

1. Develop a steering committee for the purpose of providing support for scientific and intellectual collaborations, outreach activities, and education initiatives.
2. Personnel exchanges between university faculty, staff, and FDA's scientists and staff as permitted by the Intergovernmental Personnel Act;
3. Opportunities to apply for a joint fellowship program at the FDA to advance student and faculty education. One mechanism to enroll students/post-doctoral trainees/residents from University of Pennsylvania into a joint fellowship program at FDA may be through the Oak Ridge Institute for Science and Education (ORISE) fellowship program. If prospective fellows or faculty enter the program through the ORISE fellowship mechanism, FDA and the University of Pennsylvania will adhere to the respective Agency Centers’ ORISE fellowship rules and regulations. Fellows or faculty members entering the program must agree to the ORISE terms of the appointment which will be outlined in an offer of appointment letter;
4. Educational opportunities for qualified students (graduate and undergraduate), staff members, and faculty members in the Parties' laboratories, classrooms, clinical settings and offices;
5. Opportunities for FDA personnel to serve as adjunct faculty and advisory board members. at University of Pennsylvania
6. Research collaborations;
7. Cooperative international activities including outreach;
8. To the extent permitted by federal statutes and regulation, sharing of unique facilities and equipment for increased results and cost efficiencies for scientific endeavors; and
9. Host joint meetings and workshops on research, education, and outreach activities of mutual interest to stimulate engagement and disseminate research findings.

A. FDA agrees to:

For programs agreed to in writing, and in advance by both parties, FDA may, as permitted by applicable statutes and regulations and subject to the availability of funds, and as it deems appropriate, offer University of Pennsylvania, Perelman School of Medicine the following:

1. Laboratory and/or office space in support of activities under this agreement.
2. To the extent permitted by federal statute and regulation, access to facilities and equipment, including necessary training and guidance, in so far as such use does not interfere with the primary mission of either party
3. Active participation in establishing collaborative research, education, extension and outreach efforts with faculty, students, and staff within University of Pennsylvania.
4. Willingness to participate in courses and seminars within University of Pennsylvania, based on availability of resources.
5. Continuing and frequent communication with faculty and staff.
6. Highlight and Communicate the collaborative efforts through appropriate means (e.g., publication coordinated and cleared through the parties’ respective media/ communications offices).

B. University of Pennsylvania, Perelman School of Medicine agrees to:

For programs agreed to in advance by both parties, University of Pennsylvania may offer FDA the following:

1. Laboratory and/or office space in support of activities under this agreement at identified institutions.
2. Access to facilities and equipment, including necessary training and guidance, in so far as such use does not interfere with the primary mission of either party.
3. Active participation in establishing collaborative research, education, extension, and outreach efforts with FDA scientists and staff.
4. Continuing and frequent communication with FDA scientists and staff.
5. Highlight and Communicate the collaborative efforts through appropriate means.
6. Adjunct, affiliate and research faculty appointments for appropriate FDA professional staff, if appointment of such candidates will advance specific programmatic objectives of the parties as appropriate, and if such appointments comply with university policies on appointment of faculty/affiliates and with relevant FDA regulations.

IV. General Provisions:

1. Rights to any inventions resulting from collaborative research will be determined by 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.
2. University of Pennsylvania and FDA may decide to enter supplemental agreements that may include contracts, grants, or cooperative research and development agreements ("CRADA”) between FDA and University of Pennsylvania to the extent authorized by law and available appropriations. The terms of such supplemental agreements will address intellectual Property rights. The terms and conditions of any Supplemental Agreements will be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within the University of Pennsylvania and FDA.
3. Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure agreements and to the extent such disclosure is permitted by 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. University of Pennsylvania 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 University of Pennsylvania 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.

V. Resource Obligations:

This MOU represents the broad outline of the FDA and University of Pennsylvania 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.

VI. CONTACTS:

A. For the University of Pennsylvania

Individual's name:
Emma A. Meagher, MD
Professor, Medicine and Pharmacology
Vice Dean, Perelman School of Medicine, University of Pennsylvania
Vice President, University of Pennsylvania Health System
Address: 3620 Hamilton Walk, Anatomy-Chemistry, Room 214/215, Philadelphia, PA 19104
Telephone Number: Office: 215-662-2174 Email: emma@upenn.edu

David Fajgenbaum,MD, MBA, MsC
Assistant Professor of Medicine, Translational Medicine & Human Genetics
Founding Director, Patient Impact, Orphan Disease Center
Co-Founder & Executive Director, Castleman Disease Collaborative Network (CDCN)
Organization: Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA
Address: 3620 Hamilton Walk, Anatomy-Chemistry, Room 214/215, Philadelphia, PA 19104 Telephone Number: Office: 215-614-0935, Fax: 877-991-9674
Email: davidfa@pennmedicine.upenn.edu

B. For the Food and Drug Administration:

Individual Name: Padmaja Mummaneni, Ph.D.
Title: Consumer Safety Officer, Regulatory Health Project Manager, Contract Officer Representative (COR)
Organization: Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Clinical Pharmacology
Address: 10903 New Hampshire Avenue White Oak Building 51, Room 2164 Silver Spring, MD 20993-0002
Telephone Number: 301-796-2027
Email: Padmaja.Mummaneni@fda.hhs.gov

Each Party may designate new contacts at any time by notifying the other Party's contact in writing. If, at any time, an individual designated as a contact under this agreement becomes unavailable to fulfill those functions, the Parties will name a new contact within 2 weeks and notify the other Party through the designated contact.

VII. Term, Termination, and Modification:

This agreement, when accepted by all partners, will have an effective period of performance from the date of the latest signature until five years (5) and may be modified or terminated by mutual written consent the partners 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, University of Pennsylvania, Perelman School of Medicine, and the institutions within University of Pennsylvania operate.

APPROVED AND ACCEPTED FOR THE University of Pennsylvania

/s/
Jonathan A. Epstein, MD
Senior Vice President and Chief Scientific Officer
University of Pennsylvania Health System
Perelman School of Medicine
Philadelphia, PA, United States
Date: 05/30/2023

APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION

/s/
Patrizia Cavazzoni, M.D
Director, CDER, U.S. FOOD AND DRUG ADMINISTRATION
Date: 05/30/2023

APPENDIX A

FDA Centers/Offices

The U.S. Food and Drug Administration (FDA) is comprised of six product-oriented centers and a nationwide field force. FDA is a scientific regulatory agency responsible for the safety of the nation’s domestically produced and imported foods, cosmetics, drugs, biologics, medical devices, and radiological products. It is one of the oldest federal agencies whose primary function is consumer protection. The agency touches and directly influences the lives of everyone in the United States. FDA is recognized internationally as the leading food and drug regulatory agency in the world. Many foreign nations seek and receive FDA's help in improving and monitoring the safety of their products. FDA is part of the Executive Branch of theUnited States Government within the Department of Health and Human Services (DHHS) and the Public Health Service (PHS).

FDA Centers and Offices include:

Office of the Commissioner (OC) - OC is committed to providing the overall scientific and regulatory policies for the entire agency, including special FDA initiatives. OC includes
the Immediate Office, the Office of Women's Health, Office of Minority Health,Office of the Chief of Staff, Office of Policy, Planning and Budget, Office of Legislation, Office of Administration, Office of International Programs, Office of Equal Opportunity and Diversity Management, Office of the Chief Counsel, Office of the Counselor to the Commissioner, Office of Special Medical Programs, Office of External Affairs, Office of Regulatory Affairs, Office of Foods,and the Office of the Chief Scientist.

Center for Biologics Evaluation and Research (CBER) - CBER is committed to advancing the public health through innovative regulations that ensure the safety, effectiveness, and timely delivery to patients of biological products. CBER protects and enhances public health through regulating biological and related products including blood, vaccines, tissue, allergenic and biological therapeutics.

Center for Drug Evaluation and Research (CDER) - CDER is committed to promoting and protecting public health by assuring that safe and effective drugs are available to Americans. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.

Center for Devices and Radiological Health (CDRH) - CDRH assures that new medical devices are safe and effective before they are marketed. The Center also monitors devices throughout the product life cycle, including a nationwide post market surveillance system, and assures that radiation-emitting devices meet radiation safety standards.

Center for Food Safety and Applied Nutrition CCFSAN)- CFSAN and the Agency's field staff, is responsible for promoting and protecting the public's health by ensuring the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled.

Center for Veterinary Medicine (CVM) - CVM is a consumer protection organization
that fosters public and animal health by approving safe and effective products for animals and by enforcing other applicable provisions of the Federal Food, Drug, and Cosmetic Act and other authorities.

Center for Tobacco (CTP) - CTP is responsible for planning, managing, directing, and coordinating major tobacco program objectives to support the Family Smoking Prevention and Tobacco Control Act. This law gives FDA authority over tobacco products by adding a new chapter to the Food, Drug and Cosmetic Act for tobacco products and reinstating the 1996 final rule. Some of the Agency’s responsibilities under the law includes setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions. The law gives FDA the authority to regulate tobacco products and manufacturers - not growers.

National Center for Toxicology Research (NCTR) - NCTR conducts peer-reviewed scientific research that supports and anticipates the FDA's current and future regulatory needs. This involves fundamental and applied research specifically designed to define biological mechanisms of action underlying the toxicity of products regulated by the FDA. This research is aimed at understanding critical biological events in expressing toxicity and at developing methods to improve assessment of human exposure, susceptibility, and risk.

Office of Regulatory Affairs (ORA) - ORA is the lead office for all Field activities of the Food and Drug Administration including inspection of food, feed, and medical product manufacturing, transport and storage facilities for compliance with exiting law; as well as enforcement activities. It includes the Office of Criminal Investigations.

APPENDIX B

University of Pennsylvania

University of Pennsylvania’s mission is to advance knowledge and improve health through research, patient care, and the education of trainees in an inclusive culture that embraces diversity, fosters innovation, stimulates critical thinking, supports lifelong learning, and sustains the legacy of excellence.

The Orphan Disease Center of the University of Pennsylvania exists to facilitate and fund research and develop transformative therapies for rare diseases with significant unmet need. One of the orphan disease center programs ‘Center for Cytokine Storm Treatment & Laboratory’ (CSTL) vision is to conduct groundbreaking research on Castleman disease and other cytokine storms to identify optimal treatments and provide world-class patient care. The CSTL pursues its mission through basic & translational research, clinical research, clinical trial and multi-disciplinary patient care.