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  1. Confidentiality Commitments

FDA - WHO/TFI, Mutual Confidentiality Commitment

MUTUAL CONFIDENTIALITY ARRANGEMENT AND COMMITMENT NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY AND BETWEEN THE UNITED STATES FOOD AND DRUG ADMINISTRATION AND THE WORLD HEALTH ORGANIZATION THROUGH ITS TOBACCO FREE INITIATIVE

Whereas, as part and in the course of the discussions between the United States Food and Drug Administration (FDA) and the World Health Organization through its Tobacco Free Initiative (WHO/TFI), aimed at coordinating and facilitating the activities of the FDA and the WHO/TFI with respect to the regulation of tobacco products, each party may (as “the Disclosing Party”) disclose to the other party (as "the Receiving Party") certain information relating to its aforesaid activities that it considers non-public, confidential or proprietary to it or parties collaborating with it.

Whereas the aforesaid information may include otherwise non-public information such as, confidential product and/or commercial information; trade secret information; personal privacy information; law enforcement information, and/or internal, pre-decisional information,

Whereas the Disclosing Party will advise the Receiving Party of the otherwise non-public, proprietary or confidential nature of the information it intends to disclose at the time of disclosure,

Whereas, the Disclosing Party will mark the information in question as confidential, or, in the case of oral disclosure, will confirm the non-public, proprietary or confidential nature of the information to the Receiving Party in writing within fifteen calendar days after oral disclosure,

Whereas, any information of the type described in the previous statement and designated by FDA or WHO/TFI, as the case may be, as otherwise non-public, proprietary or confidential as aforesaid is hereinafter referred to as "Information",

Whereas FDA and WHO/TFI are willing to disclose Information to each other for the sole purpose of undertaking discussions aimed at facilitating FDA’s regulation of tobacco products and WHO/TFI’s global tobacco-related activities (hereinafter referred to as “the Purpose”).

Whereas FDA and WHO/TFI each affirm that they have the authority to protect Information from public disclosure.

Therefore, FDA and WHO/TFI each agree that in accepting Information as Receiving Party from the other as Disclosing Party, they shall abide by the following:

The Information disclosed by the Disclosing Party shall be treated by the Receiving Party as strictly confidential. The Receiving Party shall use such Information only for the Purpose and shall make no other use thereof unless and until a further agreement is executed with the Disclosing Party and/or, where appropriate, the owner of the Information in question permits such other use(s) thereof. In connection with the foregoing, the Receiving Party shall restrict access to Information received from the Disclosing Party hereunder strictly to those persons within its organization (i.e., FDA or WHO/TFI, as the case may be) who have a need to know for the Purpose and are bound by similar obligations of confidentiality and restrictions on use as contained in this Arrangement. For the avoidance of doubt and for purposes of this Arrangement, “persons within its organization” shall include: contractors; FDA Commissioned State officials, Special Government Employees; and WHO Administrative and Legal Officials, Governing Body Officials, Experts, and Temporary Advisers.

  1. The Receiving Party will not publicly disclose Information from the Disclosing Party without the written authorization of the owner of such Information, the written authorization from the individual who is the subject of the personal privacy Information, or a written statement from the Disclosing Party that the Information is no longer subject to the obligations contained herein.
     
  2. Nothing in this Arrangement shall prevent the Disclosing Party from disclosing its own Information to any third party.
     
  3. Nothing in this Arrangement shall be construed as a grant to the Receiving Party of any rights to the Information
     
  4. The obligations of confidentiality and restrictions on use referred to above shall not apply to any part of the Information which the Receiving Party is clearly able to, and does, demonstrate to the Disclosing Party:
     
    1. was lawfully in its possession and known to it (without any obligation of confidentiality) prior to disclosure by the Disclosing Party (as evidenced by written records or other competent proof); or
       
    2. was in the public domain or the subject of public knowledge at the time of disclosure by the Disclosing Party; or
       
    3. becomes part of the public domain or the subject of public knowledge through no fault of the Receiving Party; or
       
    4. becomes available to the Receiving Party from a third party not in breach of a legal obligation of confidentiality; or
       
    5. was subsequently and independently developed by or on behalf of the Receiving Party without access to the Information of the Disclosing Party.
       
  5. In addition, the Receiving Party shall be permitted to disclose Information received hereunder as may be strictly required by order of competent legislative or judicial authorities to which is it directly subject, provided that the Receiving Party shall:
     
    1. immediately notify the Disclosing Party in writing of any effort made to obtain Information of the Disclosing Party by such order, and provide adequate opportunity to the Disclosing Party to object to, or restrict, such disclosure or request confidential treatment thereof; and
       
    2. take all reasonable measures in an effort to ensure that the Information in question will be disclosed to such competent legislative or judicial authorities in a manner that protects such Information from public disclosure.
       
  6. Upon completion of the Purpose, each Party shall, upon written request from the other Party, promptly return to the other Party, or destroy, all of the Information received from the other Party, except that each Party may retain one copy of the Information in its confidential files for archival purposes only.
     
  7. Any notice to be given under this Arrangement shall be deemed to be sufficiently given for all purposes if successfully transmitted by facsimile and confirmed by mail, or if sent by registered mail or recorded delivery post (postage prepaid) addressed to the Party to be notified at the following address:

    WHO/TFI:
    The Tobacco Free Initiative
    Attn: Douglas W. Bettcher, Ph.D.
    20, avenue Appia
    1211 Geneva 27
    Switzerland
    Te1. +41.22.791.4253
    Fax. +41.22.791.4832

    FDA:
    Associate Commissioner for International Programs
    Office of International Programs
    United States Food and Drug Administration
    10903 New Hampshire Avenue
    Silver Spring, MD 20993
    United States of America
    Tel. +1 301-796-4600
    Fax. +1 301-595-7937
     
  8. This Arrangement constitutes the entire understanding of the Parties hereto with respect to the subject matter hereof and shall not be modified except by mutual agreement in writing.
     
  9. The Receiving Party will promptly inform the Disclosing Party of any circumstances or changes that would affect its ability to honor the commitments in this Arrangement.
     
  10. Nothing in or relating to this Arrangement shall imply an obligation on the part of WHO to submit to any national legislation or jurisdiction, or be deemed a waiver of any of the privileges and immunities of WHO under any national or international law, convention or agreement.
     
  11. In the unlikely event that any difference shall arise in the interpretation or application of this Arrangement, the matter shall be submitted to the Commissioner of Food and Drugs of the U.S. Food and Drug Administration and the Director, Office of the Director General of the World Health Organization, who will settle the question personally and jointly or through their duly authorized representatives.

Signed on behalf of FDA:

____________/s/______________
Murray M. Lumpkin, M.D., M.Sc.
Deputy Commissioner
International Programs

Food and Drug Administration
10903 New Hampshire Avenue
Building 31
Silver Spring, MD 20993
UNITED STATES OF AMERICA

Telephone: +1.301.796.8400
Facsimile: +1 (301.595.7937

Date: April 04, 2011

Signed on behalf of WHO/TFI:

___________/s/____________
Douglas W. Bettcher, Ph.D.
Director
Tobacco Free Initiative

World Health Organization
Tobacco Free Initiative
20, avenue Appia
CH-1211 Geneva 27
SWITZERLAND

Telephone: +41.22.791.4253M
Facsimile: +41.22.791.4832


Date: April 12, 2011

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