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U.S. Department of Health and Human Services

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MOU 225-12-0006


I.                    Purpose
The United States Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) and LifeScience Alley have a shared interest in promoting regulatory science for medical devices. Both FDA and LifeScience Alley are referred to individually as a “Party” and collectively as the “Parties.” 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, and disciplinary training.
II.                  Background
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (“the Act”) as amended (21 U.S.C. 301). In fulfilling its responsibilities under the Act, CDRH is responsible for protecting and promoting public health by assuring the safety and effectiveness of medical devices and the safety of radiation-emitting products. 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. 
LifeScience Alley is a life sciences based nonprofit trade association, organized and operated exclusively for exempt purposes as set forth in section 501(c)(6) of the Internal Revenue Code, whose mission is to support advancement in research and technological innovation.
FDA and LifeScience Alley share interests in developing regulatory science for medical devices and in enhancing the understanding of the safety, effectiveness, quality, and performance of medical devices.
III.                Substance of the Agreement
This MOU forms the basis for development of scientific and intellectual collaborations, outreach and educational initiatives between FDA and LifeScience Alley. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. The types of activities expected to develop from this MOU include, but are not necessarily limited to the following:
1.      Identification and convening of a steering committee that includes industry leaders and University of Minnesota experts to guide a process for scientific and intellectual collaborations, outreach, and education initiatives. 
2.      Joint workshops and meetings for education and research; 
3.      Research collaborations in regulatory science; and
4.      Sharing of unique facilities and equipment for increased results and cost efficiencies for scientific endeavors.
Before any specific collaboration is initiated or implemented, the Parties shall identify priorities, topics of mutual interest, and develop separate, written agreements (“Supplemental Agreements”) for each collaboration that will outline each Party’s financial commitments (if any) to the collaboration and the terms to govern the collaboration. Where applicable, these agreements shall incorporate by reference the terms of this MOU.  The Supplemental Agreements may include contracts, grants or cooperative research and development agreements (“CRADAs”) between FDA and LifeScience Alley to the extent authorized by law and available appropriations.  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 LifeScience Alley and FDA.
IV.               General Provisions
  1. Data Sharing Guidelines: The Parties may enter into separate Confidential Disclosure Agreements (CDAs) pertaining to certain data and information shared pursuant to this MOU. In accordance with applicable disclosure statutes and FDA regulations, FDA will not share any confidential commercial information, trade secrets, or personal privacy information with LifeScience Alley, unless waiver is obtained from the owner of such information. See 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, 21 CFR 20.61 and 20.63.
  1. Intellectual Property.  “Invention” refers to any subject matter or discovery patentable under Title 35 of the United States Code and conceived or first reduced to practice under the activities of Supplemental Agreements to the MOU.  “Intellectual Property” refers to patents, patent applications, know-how, trade secrets, copyrights and computer programs either used or developed under the activities of Supplemental Agreements to the MOU.  Ownership of and rights to Inventions or Intellectual Property developed under a Supplemental Agreement will be addressed in the Supplemental Agreement.  Inventions made under a Federal research and development grant or contract will be subject to the Bayh-Dole Act.  No Party, by virtue of their participation in activities under the MOU, will be required to disclose or license intellectual property to the other Party. Neither Party shall use the name, logos, trademarks, service marks, trade names, seals, insignia, symbols or decorative designs of the other Party or any derivatives thereof without the prior written permission of the other Party. 
  1. Conflict of InterestIndividual participants in activities under this MOU who are not U.S. Government employees will be expected to abide by conflict of interest rules and policies as specified by FDA, and as set out in any Supplemental Agreement covering those activities. This may require individual participants to disclose their financial holdings and those of their spouse and minor children, and may limit their ability to accept gifts and have employment with entities that are substantially regulated by FDA. The Parties will be advised of any potential conflict so that conflicting assignments can be avoided consistent with the HHS/FDA requirements. If at any time prior to or during the performance of the activities under the MOU, the Parties believe that a potential or actual conflict exists, the Parties must notify the appropriate authorities within their respective institutions and contact the designated FDA officials listed on the MOU so that the necessary action/s can be undertaken. A determination will be made by FDA as to whether a conflict of interest exists and, if so, as to how to resolve or mitigate it. The Parties to the MOU will make every effort to avoid activities or relationships that would cause a reasonable person to question the impartiality of their actions.
  1. Security. Each Party will inform the other Party of its security policies and procedures regarding access to and use of facilities and the other Party will comply with those policies.  Either Party may restrict or limit access to its property and facilities, at any time, for any reason.  LifeScience Alley individuals participating in activities under this MOU on FDA’s property will comply with all applicable federal statutes and regulations.
V.                 Resource Obligations
This MOU represents the broad outline of the FDA and LifeScience Alley’s intent to collaborate in areas of mutual interest. It does not create binding, enforceable obligations against any Party. All activities that may be undertaken by 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 Parties to enter other agreements or arrangements related to this MOU. 
VI.               Liaison Officers
Liaison Officers:
For CDRH: 
Michelle McMurry-Heath, M.D., Ph.D.
Associate Director for Science
10903 New Hampshire Avenue
White Oak Building 66, Room 5428
Silver Spring, MD 20993
For LifeScience Alley:
Shaye Mandle
Vice President, Government & Affiliate Relations
1550 Utica Ave S #775
St. Louis Park, MN 55416
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 two weeks and notify the other Party through the designated administrative liaison.
VII.             Term, Termination, and Modification
This agreement becomes effective upon acceptance by both Parties and will continue in effect for five (5) years. It may be renewed by mutual written agreement of both Parties. It may be modified at any time by mutual written agreement of both Parties. It may be terminated by either Party upon 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 and LifeScience Alley operate.
IN WITNESS WHEREOF, the Parties, by their undersigned representatives, have caused this MOU to be executed. This MOU may be executed in counterparts and each counterpart shall be deemed an original.
Approved and Accepted
for LifeScience Alley
Signed by: Dale Wahlstrom
President & CEO
Date: December 7, 2011
Approved and Accepted
for the Food and Drug Administration
Signed by: Jeffrey Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health
Date: December 7, 2011