MOU 225-18-007

MEMORANDUM OF UNDERSTANDING
BETWEEN U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE FOOD AND DRUG ADMINISTRATION
OFFICE OF WOMEN’S HEALTH
AND KAROLINSKA INSTITUTE
AND STOCKHOLMS LÄNS LANDSTING/HÄLSO- OCH SJUKVÅRDSFÖRVALTNINGEN (STOCKHOLM COUNTY COUNCIL/ HEALTHCARE
ADMINISTRATION)

 

I. Preamble

 

The Food and Drug Administration (FDA) Office of Women’s Health (FDA OWH), Karolinska Institutet (KI) and the Stockholms Läns Landsting/Hälso-Och Sjukvårdsförvaltningen (SLL/HSF) (Stockholm County Council/ Healthcare Administration) share common priorities and interests in promoting awareness and understanding of gender medicine and the science of sex-based differences. Each organization intends to facilitate these goals through the mutually beneficial exchange of information of significance to/for women’s health through the collective development of information content. The collaboration is intended to focus on sharing examples of best practices and international perspectives. The expansion of research and development, education, and outreach activities with the KI and SLL HSF can greatly contribute to FDA OWH’s mission to protect and advance women’s health.

 

II. Purpose

 

This Memorandum of Understanding (MOU) sets out a framework for potential future collaboration on women’s health initiatives between the Department of Health and Human Services, FDA OWH, the KI, and SLL HSF (collectively referred to as “the Participants”). 
  

III. Collaborative Activities

 

The goal of this collaboration is to advance and share, at the international level, key information, and resources on the science of sex-based differences. The types of initiatives anticipated to develop as a result from this MOU include:

 

1.        Mutually-developed information content that may be used by all Participants and that will feature best practices in women’s health research, as well as sex and gender research findings;

 

2.        Presentations, speaking engagements, face-to face meetings, webinars, teleconferences and participation at various national and international forums to promote the activities of this collaboration; and

 

3.        Sharing of information such as research findings, data, and content about various public health and safety topics.

 

Under this MOU, the Participants intend to seek opportunities to participate in collaborative research, education, and intellectual partnerships 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, as appropriate, develop separate, written arrangements for collaboration.

 

IV. General Provisions

 

1.        Rights to any inventions resulting from collaborative research will be determined by the

separate written research arrangements governing the effort, based on current U.S. Government patent law and any other applicable statutes and regulations.

 

2.        Institutions within KI, SLL HSF, and FDA OWH may decide to enter into Cooperative Research and Development Agreements (CRADAs) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.

 

3.        Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure agreements or to the extent permitted by law.

 

4.        The Participants intend that information FDA OWH provides to KI and SLL HSF be publicly available material. FDA OWH may reuse the content for all FDA purposes and may share these materials with other collaborators or requestors.

 

5.        KI and SLL HSF may, at their own discretion, provide FDA OWH access to proprietary information, which may be governed by a separate Confidentiality Disclosure Agreement.

 

6.        FDA OWH, KI and SLL HSF intend to provide to each other inbound and outbound links to and from the mutually developed information content, unless that content is exempt from disclosure under the Freedom of Information Act, 5 U.S.C §552, or other applicable Federal statutes or regulations.

 

7.        The Participants do not intend to use the other Participants’ trademarks and logos without permission. Any internet webpages developed in connection with this MOU should be free of advertisements or links that might imply FDA’s or SSL HSF’s approval or support of such groups and/or products.

 

V. Resource Obligations: 

 

This MOU represents the broad outline of the Participants’ intention to collaborate in areas of mutual interest. It does not create binding, enforceable rights or obligations. 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 into other agreements or arrangements related to this MOU. 

 

VI. Limitations on Liability

         

In no event will any Participant be liable to another Participant under any theory of liability or for any costs of cover or for indirect, special, incidental, or consequential damages arising out of activities undertaken under this MOU.

 

VII. Liaison Officers:

 

Liaison Officers are the primary points of contact for activities associated with this MOU. The Liaison Officers for matters within the scope of this MOU as of the effective date are:

 

A.     U.S. Food and Drug Administration:

 

Pamela E. Scott, PhD
Deputy Director
Office of Women's Health
Office of the FDA Commissioner
10903 New Hampshire Ave, Silver Spring, MD 20993

United States

Email: pamela.scott@fda.hhs.gov

Office Telephone: 301-796-9440

 

Karolinska Institutet:

 

Karin Schenck-Gustafsson MD, Ph.D, FESC

Professor of Cardiology, Chief Consultant, Department of Cardiology, Karolinska University Hospital

Founder and Chair, Centre for Gender Medicine, Karolinska Institutet

Thorax, N3:06

SE 17176 Stockholm

Sweden

Email: Karin.Schenck-Gustafsson@ki.se

Office Telephone: +46 8 51774686,

+468 51772245, +468 51771619

 

Stockholms Läns Landsting/Hälso- och Sjukvårdsförvaltningen (Stockholm County Council/ Healthcare Administration):

 

Anikó Vég, PhD
Head of Unit
Department of e-Health and Strategic IT
Healthcare Administration
Stockholm County Council
Box 17533
118 91 Stockholm
Sweden
Email: aniko.veg@sll.se
Office Telephone: +46 8 123 135 91
 

 

Each Participant may designate new liaisons by notifying the other Participants’ liaisons in writing. If an individual designated as a liaison under this MOU becomes unavailable to fulfill those functions, the Participant affected intends to name a new liaison within two (2) weeks and notify the other Participants through the designated liaisons.

 

VIII. Duration, Modification, and Termination

 

Participants intend this MOU to take effect upon the date of the last Participant’s signature and to continue for three (3) years. The Participants may modify this MOU by mutual written decision, specifying the date the modifications are to take effect. This MOU may be terminated by any Participant upon sixty (60) calendar days’ written notice to the other Participants. The termination of this MOU should not affect the completion of ongoing projects and programs conducted under this MOU unless the Participants declare otherwise in writing.

 

 

IX. 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 OWH and the institutions within the Karolinska Institutet and Stockholm County Council/Healthcare Administration operate.

 

APPROVED AND ACCEPTED FOR THE:

 

U.S. FOOD AND DRUG ADMINISTRATION 

Marsha Henderson

Assistant Commissioner

for Women's Health 

February 1, 2018

 

KAROLINSKA INSTITUTET 

February 14, 2018

 

STOCKHOLMS LÄNS LANDSTING/HÄLSO- OCH SJUKVÅRDSFÖRVALTNINGEN 

(STOCKHOLM COUNTY COUNCIL/ HEALTHCARE ADMINISTRATION) 

February 23, 2018