MEMORANDUM OF UNDERSTANDING
By and Between the
UNITED STATES FOOD AND DRUG ADMINISTRATION,
THE IV2 ALLIANCE, INC.
THIS MEMORANDUM OF UNDERSTANDING (“MOU”) establishes the framework on how the Food and Drug Administration (“FDA”) and The IV2 Alliance, Inc. (“IV2”) intend to collaborate and involve a consortium of various stakeholders including academic, research and clinical stakeholders, advocacy groups, members of industry, international partners, and others who may collaborate at various intervals in projects of shared interest to: (1) advance regulatory science; and (2) foster biomedical and biotechnology innovations, including innovations in (a) personalized medicine, (b) health information technology, (c) data mining analytics, (d) post-market safety surveillance, (e) comparative safety and efficacy analyses, and (f) international harmonization to support FDA’s mission. FDA and IV2 are each referred to individually as a “Party” and collectively as the “Parties.”
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 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 will contribute to FDA’s mission.
The IV2 Alliance, Inc. is a Maryland non-profit corporation. IV2’s purpose is to promote collaboration within the scientific, research and provider communities to achieve advances in the field of healthcare and wellness. IV2 is planned as a consortium of preeminent academic, research and clinical stakeholders, advocacy groups, members of industry, international partners, and others, with a mission to collaborate with the FDA as part of efforts to innovate new products, policies, and procedures that will protect, promote, and advance global public health.
III. SUBSTANCE OF THE AGREEMENT
FDA and IV2 share a common interest in a unique collaborative applied science epicenter in White Oak, Maryland. The purpose of this MOU is to establish the framework for a collaboration among FDA and IV2 (including IV2’s planned consortium of academic, research and clinical stakeholders, advocacy groups, members of industry, international partners, and others) to: (1) advance Regulatory Science; and (2) foster biomedical innovations, including innovations in (a) personalized medicine, (b) health information technology, (c) data mining analytics, (d) post-market safety surveillance, (e) comparative safety and efficacy analyses, and (f) international harmonization to support FDA’s primary mission to protect, promote, and advance public health.
IV2 will collaborate with FDA as a part of a planned consortium of preeminent academic, research and clinical stakeholders, advocacy groups, members of industry, international partners, and others as part of efforts to innovate new products, policies, and procedures that will protect, promote, and advance global public health.
All activities undertaken pursuant to this MOU shall be subject to the availability of resources of the Parties, and specifically subject to federal appropriations to fund the FDA. For any specific initiative undertaken pursuant to this MOU, the Parties shall mutually agree upon the priorities, targeted outcomes, and financial commitments (if any) of the Parties, which shall be set forth in separate written agreements (“Supplemental Agreements”) that shall govern those specific initiatives and shall incorporate by reference this MOU. These Supplemental Agreements may include cooperative research and development agreements (“CRADAs”) between the FDA and IV2 to the extent authorized by law. The terms and conditions of any of the Supplemental Agreements will be in accordance with applicable federal laws and regulations, and shall be negotiated and executed by appropriate representatives of FDA and IV2.
IV. ROLES AND RESPONSIBILITIES
Consistent with all applicable statutes, regulations and policies, FDA and IV2 will work together to develop concepts for collaborations to: (1) advance regulatory science; and (2) foster biomedical and biotechnology innovations, including innovations in (a) personalized medicine, (b) health information technology, (c) data mining analytics, (d) post-market safety surveillance, (e) comparative safety and efficacy analyses, and (f) international harmonization to support FDA’s mission. These collaborative efforts will be developed under separate agreements that specify policies, terms, and responsibilities of FDA and IV2. Projects resulting from this collaboration may involve working with other stakeholders, including stakeholders outside of the Federal government.
V. GENERAL PROVISIONS
Information Sharing Guidelines: The Parties may enter into separate Confidential Non-Disclosure Agreements (“NDAs”) pertaining to certain data and information shared pursuant to this MOU. Any sharing of non-public information, including confidential commercial and trade secret information, will be in accordance with applicable statutes, FDA regulations, and policies. (See, e.g., 21 U.S.C. 331(j), 21 U.S.C. 360(j), 18 U.S.C. 1905, 21 C.F.R. 20.61 and 20.63.) Furthermore, FDA will not share any confidential commercial information and trade secrets with IV2, unless a waiver is obtained by the owner of such information.
Intellectual Property: The term “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 pursuant to this MOU. The term “Intellectual Property” refers to patents, patent applications, know-how, trade secrets, trademarks, service marks, copyrights, and computer programs either used or developed under the activities of Supplemental Agreements pursuant to this MOU. Inventions made under a Federal research and development grant or contract shall be subject to the Bayh-Dole Act. No party, by virtue of their participation in activities under this MOU shall be required to disclose or license Intellectual Property to the other Party. No Party shall use the name, logos, trademarks, service marks, trade names, seals, insignia, symbols, or decorative designs of any other Party (or any derivatives thereof) without the prior written permission of the Party owning those trademark and other rights to the name, logo, and the like.
Conflict of Interest: Individual participants under this MOU, who are not United States Government employees will be expected to abide by the conflict of interest rules and policies as specified by FDA, and as may be set out in any of the Supplemental Agreements governing those activities. This may require individual participants to disclose their financial holdings and those of their spouse and minor children with entities that are substantially regulated by FDA, and may limit the individual participants’ ability to accept gifts or have employment with entities that are regulated by FDA. The Parties will be advised of any potential conflict so that conflicting assignments can be avoided consistent with HHS/FDA requirements. If, at any time prior to or during the performance of activities under this 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 in this MOU, so that the necessary and appropriate action(s) can be undertaken. A determination will be made promptly by FDA as to whether or not a conflict of interest exists and, if so, as to how to resolve or mitigate the conflict. The Parties to this MOU will take all reasonable action to avoid activities or relationships that would cause a reasonable person to question the impartiality of their actions.
Security: Each Party shall inform the Parties of their security policies and procedures regarding access to and use of facilities, and the Parties will comply with those policies and procedures. Each Party may restrict or limit access to its property and facilities, at any time, for any reason. IV2 participants in activities under this MOU on FDA’s property acknowledge and agree that they will comply with all federal statutes and regulations.
VI. RESOURCE OBLIGATIONS
This MOU represents the broad outline of FDA’s and IV2’s intent to collaborate in the areas of mutual interest. This MOU does not create any binding, enforceable obligations against any Party, unless and until a mutually acceptable Supplemental Agreement is executed by the Parties. All activities that may be undertaken pursuant to 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 into other agreements or arrangements related to this MOU.
VII. INTENT OF THE PARTIES
Nothing in this MOU intends to create a legally binding obligation between the Parties or the obligation of appropriated funds. Any activities under this MOU that contemplate future funding by the Parties will be carried out under a separate agreement under which the obligation of funds is appropriate and properly effectuated.
The activities to be engaged in by IV2 under this MOU agreement shall be collaborative in nature and IV2 will not seek payment from FDA for such activities.
The Parties understand and agree to abide by restrictions relating to lobbying and publicity and propaganda activities. The Parties will not use federal funds for “grass roots” lobbying efforts that expressly encourage citizens to contact Congress or State or local government officials to support or oppose any law, legislation, or policy, either before or after the introduction of any bill, measure, resolution, or policy. This prohibition does not preclude direct communication between FDA and Congress or State or local government officials through proper official channels for the efficient conduct of public business or through normal and recognized executive-legislative relationships.
VIII. LIAISON OFFICERS
Liaison Officers’ contact information:
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Attn: Dr. Margaret Hamburg, Commissioner
or Walter Harris, Deputy Commissioner for Operations
The IV2 Alliance, Inc.
11900 Tech Road
Silver Spring, MD 20904
Attn: Jonathan M. Genn, President
Each Party may designate new liaisons at any time by notifying the other Parties’ liaisons in writing. If, at any time, an individual designated as a liaison under this MOU becomes unavailable or unable to fulfill those functions, then the relevant Party shall name a successor liaison within two weeks following any request to name a successor, and shall notify the other Parties of the newly named successor liaison.
IX. TERM, TERMINATION, AND MODIFICATION
This MOU shall become effective upon acceptance of the Parties and will continue for an initial term of (2) years, with 3 option years. Each option year will automatically renew, unless either Party elects to terminate this MOU by 120 days’ advance written notice prior to the end of the initial term or any additional term. This MOU may be modified at any time by mutual agreement of the Parties.
X. STATUTES, REGULATIONS, RULES, AND POLICIES
This MOU and all associated agreements shall be subject to the applicable statutes, regulations, rules, and policies under which FDA and IV2 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
United States Food and Drug Administration
Dr. Margaret Hamburg, Commissioner
May 1, 2013
Approved and Accepted for
The IV2 Alliance, Inc.
Jonathan M. Genn, President
May 1, 2013