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MOU 225-11-0013


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
CHDI FOUNDATION, INC.

I. Purpose
 

The United States Food and Drug Administration (FDA) and CHDI Foundation, Inc. (CHDI) share interests in promoting scientific progress through exchange of scientific capital in Clinical Pharmacology Training and Research. Both institutions foresee benefits from the mutual exchange of training and research expertise in clinical pharmacology and translational science. This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote these shared interests, which can be pursued through information sharing in collaborative research to develop disease progression models for Huntington’s disease.
 

II. Authority:
 

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301 et seq.).
 

III. Background


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 and cosmetics. To accomplish its mission, FDA must stay abreast of the latest developments in research and also communicate with stakeholders about complex scientific and public health issues. An outreach partnership with CHDI to increase research development will greatly contribute to FDA’s mission.
CHDI is a private, not-for-profit research organization that:

  • Works with an international network of scientists to discover drugs that slow the progression of Huntington’s disease.
  • Seeks to accelerate scientific progress by serving as a collaborative enabler.
  • Encourages and supports cooperation and collaboration among HD researchers of exploratory biology through the identification and validation of therapeutic targets, and from drug discovery and development to clinical studies and trials.
     

III. Substance of Agreement
 

This MOU forms the basis for development of scientific research collaborations and outreach expected to develop from this MOU including:

 

  1. Research collaborations to provide opportunities for post-doctoral trainees or residents sponsored by CHDI through the joint fellowship program through the CDER Oak Ridge Institute for Science and Education (ORISE) fellowship program. Fellows entering the program must agree to adhere to the term of appointment which will be outlined in an offer of appointment letter.
  2. Access to data and updates from selected HD observational studies and clinical trials.
  3. Face to face meetings and teleconferences between FDA, CHDI and the larger HD research community.
  4. Access to unique facilities and equipment for scientific endeavors.
     

IV. General Provisions
 

  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.  Accordingly, all employees who work for the recipient of a grant or for a contractor on any project under this MOU shall be required to sign an agreement that effects a present assignment of their future inventions to the grant recipient or contractor.  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. 
  2. Supplemental Agreements – 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 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 parties within CHDI and FDA.
  3. Confidentiality – Access to any confidential, non-public information shall be governed by separate Confidential Disclosure Agreements in which the Parties will agree and certify in writing that they shall not further release, publish or disclose such information, except as required by law, and that they shall protect such information in accordance with the provisions of 21 U.S.C 33(j), 21 U.S.C. 360k(c), 18 U.S.C. 1905, and other pertinent laws and regulations governing the confidentiality of such information.  No proprietary data, trade secrets or patient confidential information shall be disclosed among the Parties unless the Parties have executed a Confidential Disclosure Agreement covering such data and the disclosure is permitted by applicable law.  Such Confidential Disclosure Agreements may be part of, or be executed pursuant to, Supplemental Agreements covering specific collaborations.
  4. 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.  CHDI individuals participating in activities under this MOU on FDA’s property will comply with all applicable federal statutes and regulations.
  5. Conflict of Interest – 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.  This may require 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.  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.
     

V. Resource Obligations
 

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

FDA’s Center for Drug Evaluation and Research (CDER) is the lead center for this MOU. The individual to whom all inquiries to FDA should be addressed is:
 

Vikram Sinka

Food and Drug Administration
Center for Drug Evaluation and Research
Division of Pharmacometrics
Office of Clinical Pharmacology
10903 New Hampshire Avenue
Silver Spring, MD 20993
301-402-3166

The individual to whom all inquiries to CHDI should be addressed is:
Robi Blumenstein
President
CHDI Management, Inc. (Advisor)
CHDI Foundation, Inc.
350 Seventh Avenue, Suite 601
New York, NY 10001
212-239-9300
robi.blumenstein@chdifoundation.org
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 Party will name a new liaison within 2 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 three (3) 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 CHDI operate.
Signatures are on the next page.

 

APPROVED AND ACCEPTED FOR CHDI FOUNDATION, INC. 

Signed By: Robi Blumenstein

President, CHDI Management Inc., Authorized Representative of CHDI Foundation, Inc. 

Date:August 26, 2011
 

APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION

Signed By: Janet Woodcock,

MD Director, CDER, FDA


Date: August 23, 2011
 


 

FIRST AMENDMENT TO MEMORANDUM OF UNDERSTANDING
 
FIRST AMENDMENT TO MEMORANDUM OF UNDERSTANDING (this “Amendment”), dated as of December 10, 2013, by and between the Food and Drug Administration, an agency of the United States Government (the “FDA”), and CHDI Foundation, Inc., a New Jersey corporation (the “Foundation”).
The FDA and the Foundation entered into that certain Memorandum of Understanding (MOU Number 225-11-0013); dated as of August 26, 2011 (such agreement as amended shall hereinafter to as the “MOU”).
 
The MOU had an initial term of three years and the parties desire to extend the term by an additional three years to provide for continuity in promoting scientific progress through exchange of scientific capital in Clinical Pharmacology Training and Research.
Capitalized terms used herein but not otherwise defined shall have the meanings ascribed thereto in the MOU.
 
The parties hereto desire to amend, modify, and supplement the MOU as provided herein. In consideration of the mutual representations, warranties and covenants contained herein and other good and valuable consideration, the receipt, and sufficiency of which are hereby acknowledged, the arties hereby agree as follows:
 

1.  Amendments, Modifications and Supplements to the MOU.

 
a.       Article IV of the MOU is hereby amended by deleting the name and related contact for the individual list to receive inquiries for FDA and replacing it with the following text:
 
          “Yaning Wang, Ph.D.
          Associate Director for Science
          Division of Pharmacometrics
          Office of Clinical Pharmacology
          Office of Translational Science
          Center for Drug Evaluation and Research
          U.S. Food and Drug Administration
          301-796-1624
          Yaning.wnag@fda.hhs.gov
 
b.      Article VII of the MOU is hereby amended by deleting the first sentence of such Article VII in its entirety and replacing it with the following text:
 
          “This MOU become effective upon acceptance by both Parties and will continue in effect for six (6) years.”
 
  1. Single MOU: Inconsistent Terms. This Amendment is hereby annexed to and forms a part of the MOU. In the event of any inconsistency between the provisions of this Amendment and those contained in the MOU to which this Amendment is annexed, the provisions of this Amendment shall govern and be binding.
 
  1. Ratification of the MOU. The MOU is hereby ratified by the parties, and the terms and provisions of the MOU as amended, modified, and supplemented by this Amendment shall remain in full force and effect.
 
In witness of the foregoing, the Parties have executed this Amendment as the date first written above.
Authorized Representative for FDA:
 
Janet Woodcock, M.D.
Director, CDER, FDA
 
December 19, 2013
 
Authorized Representative for Foundation:
CHDI Foundation, Inc.
Robi Blumenstein
President, CDHI Management
 
December 19, 2013