corresp
February 28, 2011
Ms. Cecilia D. Blye
Office of Global Security Risk
U.S. Securities and Exchange Commission
Washington, DC 20549-7010
USA
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Re: |
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Medtronic, Inc.
Form 10-K for the Fiscal Year Ended April 30, 2010
Filed June 29, 2010
File No. 1-07707 |
Dear Ms. Blye:
Please find below Medtronic, Inc.s responses to your comments as noted in your letter to
Medtronic, Inc. (Medtronic or the Company) dated January 19, 2011. We refer to our telephone
conversations with Pradip Bhaumik, Special Counsel, pursuant to which Medtronic requested and
received an extension to submit responses on or before February 28, 2011.
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It appears from your website that your subsidiary, Medtronic Mediterranean SAL, operates in
Iran, Sudan, and Syria, and that your products are available in two clinics in Iran. We note
October 2009 public information indicating that you operate in Latin America, a region that
can be understood to include Cuba. We note also your reference to donations to Cuba, in your
letter to us dated September 14, 2006. As you know, Cuba, Iran, Sudan, and Syria are
identified by the State Department as state sponsors of terrorism, and are subject to U.S.
economic sanctions and assets or export controls. Please describe to us your past, current,
and anticipated contacts with the referenced countries, whether through subsidiaries,
distributors, or other direct or indirect arrangements, since your letter to us dated
September 14, 2006. Your response should describe any goods, services, technology,
information, or support that you have provided into Cuba, Iran, Sudan, and Syria, directly or
indirectly, and any agreements, commercial arrangements, or other contacts you have had with
the governments of the referenced countries or entities controlled by them. |
Medtronic Response to Comment 1:
A description of Medtronics operations involving Iran, Sudan, Syria and Cuba is provided below.
February 28, 2011
Page 2
As background, the foreign-incorporated subsidiaries of the Company that have engaged in business
dealings pertinent to your Offices inquiry regarding Iran, Sudan and Syria are (1) Medtronic
Trading NL B.V. (Medtronic Trading) a wholly-owned, indirect subsidiary of Medtronic incorporated
in The Netherlands1 and (2) Medtronic Mediterranean SAL (Medtronic Mediterranean), a
subsidiary of Medtronic incorporated in Lebanon, which operates a small office in Beirut to provide
support services to Medtronic Trading. Medtronic Tradings European Operation Center (EOC) is
the major distribution and inventory management center for most of the Companys sales in Europe,
the Middle East, and Africa. Since January 1, 2003, the EOC has been located in Heerlen, The
Netherlands.
Please note that the Company and its foreign affiliates supply any humanitarian products to parties
in U.S.-sanctioned markets in full compliance with applicable U.S. and local laws. For several
years, the Company has had in place an Export Management Program that helps ensure the Companys
compliance with sanctions constraints administered and enforced by the U.S. Treasury Departments
Office of Foreign Assets Control (OFAC), and the U.S. Commerce Departments Bureau of Industry
and Security (BIS).
Operations in Iran
Medtronic Trading sells a broad range of medical devices and surgical tools, namely products from
Medtronics Cardiac Rhythm Disease Management (CRDM), Spinal, CardioVascular, Physio-Control,
Neuromodulation, Surgical Technologies, and Diabetes businesses to three distributors of those
products in Iran. We understand the distributors then sell our products to hospitals in Iran.
Medtronic Trading also sells medical devices and surgical tools from certain of these businesses to
the purchasing body for the Iranian Ministry of Health and one other direct purchaser in Iran for
use in hospitals in that country. Sales to the three distributors, the Iranian Ministry of Health
and the other purchaser in Iran in Medtronics fiscal year ended April 30, 2010 were approximately
$28.43 million.
Our marketing and support activities and dealings with the government in Iran are described below
under Marketing and Support Activities in Iran, Sudan and Syria.
Operations in Sudan
Medtronic Trading sells a limited number of medical devices and surgical tools, namely products
from its CRDM, CardioVascular, Diabetes, and Surgical Technologies businesses to two distributors
in Sudan. We understand the distributors then sell our devices to Sudanese hospitals. Sales to
such distributors in Medtronics fiscal year ended April 30, 2010 were approximately $670,000.
Our marketing and support activities and dealings with the government in Sudan are described below
under Marketing and Support Activities in Iran, Sudan and Syria.
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1 |
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Medtronic Trading NL B.V., a wholly-owned
subsidiary of Medtronic B.V. (a wholly-owned subsidiary of Medtronic,
incorporated in The Netherlands), was established in late October 2005 as a
result of an internal corporate reorganization. Prior to late October 2005,
Medtronic B.V. was the party that engaged in certain limited business dealings
pertinent to your Offices inquiry. |
February 28, 2011
Page 3
Operations in Syria
Medtronic Trading sells medical devices, namely products from its CRDM, CardioVascular, Cardiac
Surgery, Neuromodulation, Spinal, Diabetes, and Surgical Technologies businesses, to four
distributors in Syria. We understand these distributors then sell our products to hospitals in
Syria. Sales to such distributors in Medtronics fiscal year ended April 30, 2010 were
approximately $950,000.
Our marketing and support activities and dealings with the government in Syria are described below
under Marketing and Support Activities in Iran, Sudan and Syria.
Marketing and Support Activities in Iran, Sudan and Syria
Medtronics marketing and support activities involving Iran, Sudan and Syria are coordinated
through Medtronic Mediterranean. The activities include limited contact by local, non-U.S.
employees of that office with distributors in those countries related to processing of orders
received at that office. Sales of Medtronic products to the distributors in Iran, Syria and Sudan
are concluded and shipped through EOC. To our knowledge and except as mentioned above, we have no
dealings with the governments of those countries, or with entities controlled by or affiliated with
those governments.
Operations, Marketing and Support Activities in Cuba
Medtronic is not aware of any revenue from sales into Cuba by the Company or its representatives.
On January 8, 2010, Medtronic obtained license number D428269, from BIS (the D428269 License)
authorizing the sale of Medtronic implantable cardiac devices and other products described in the
D428269 License to MediCuba, the government-owned distributor of medical products in Cuba. The
D428269 License is valid through January 31, 2012, but as of the date of this response letter,
Medtronic has not effectuated any sales under the D428269 License. Medtronic anticipates the future
supply of the approved products to MediCuba pursuant to the D428269 License.
One employee from Medtronic and another from Medtronic Puerto Rico Operations Co., Medtronics
wholly-owned subsidiary that operates in Latin America, traveled to Cuba in October 2009, as
permitted under a license issued to Medtronic by OFAC.
To our
knowledge and except as mentioned above, Medtronic has no dealings with the government of Cuba, or with entities
controlled by or affiliated with the government of Cuba.
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Please discuss the materiality of your operations in, and other contacts with, Cuba, Iran,
Sudan, and Syria, described in response to the foregoing comment, and whether they constitute
a material investment risk for your security holders. You should address materiality in
quantitative terms, including the approximate dollar amounts of any revenues, assets, and
liabilities associated with each of the referenced countries for the last three fiscal years
and the subsequent interim period. Also, address materiality in terms
of qualitative factors |
February 28, 2011
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that a reasonable investor would deem important in making an investment decision,
including the potential impact of corporate activities upon a companys reputation and share
value. As you know, various state and municipal governments, universities, and other investors
have proposed or adopted divestment or similar initiatives regarding investment in companies
that do business with U.S.-designated state sponsors of terrorism. Your materiality analysis
should address the potential impact of the investor sentiment evidenced by such actions directed
toward companies that have operations associated with Cuba, Iran, Sudan, or Syria. |
Medtronic Response to Comment 2:
Based on an assessment of both quantitative and qualitative factors, Medtronic believes that our
operations in Iran, Sudan, Syria and/or Cuba are not material to Medtronic and do not constitute a
material investment risk to our security holders. In assessing materiality of such operations, we
considered materiality based on quantitative factors as well as qualitative factors that a
reasonable investor would deem important in making an investment decision in Medtronic securities,
including the potential impact on Medtronics reputation and share value.
We refer the Staff to our response to comment No. 1 for a description of the Companys sales in
each named country in fiscal year 2010. In aggregate, Medtronics total sales in Iran, Sudan,
Syria and Cuba were approximately $30.05 million, which is approximately 0.20% of Medtronics total
sales in fiscal year 2010 of $15.8 billion. Therefore, Medtronic respectfully advises the Staff
that our operations or contacts in those countries, individually or in the aggregate, are
quantitatively immaterial to our security holders, our business, or our financial condition and
results of operations.
In addition, qualitative factors do not render our operations in Syria, Iran, Sudan and Cuba
material. As stated above, we understand that our limited humanitarian business in these markets
is conducted in full compliance with applicable U.S. and local laws. We believe the various
products we sell in these countries are strictly used for medical purposes and do not have an
alternative use. In light of the humanitarian nature of our products and the patient community
that benefits from our products, we do not believe that these operations have materially affected
our reputation or share value or that they constitute a material investment risk to our security
holders.
Medtronic is aware of the legislation and guidelines referred to by the Staff that have been
adopted by certain states and organizations permitting or requiring divestment from, or reporting
of interests in, companies that do business with certain U.S.-designated state sponsors of
terrorism. We do not believe that such legislation has, to date, had a material impact on
Medtronics reputation or share value. Medtronic will continue to monitor the status of this
legislation, as well as legislation proposed, but not yet enacted by such governments or
organizations, and whether it may have any material impact on Medtronic and our security holders.
February 28, 2011
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Pursuant to your request, the Company acknowledges that:
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the Company is responsible for the adequacy and accuracy of the disclosure in the
filing; |
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Staff comments or changes to disclosure in response to Staff comments do not foreclose
the Commission from taking any action with respect to the filing; and |
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the Company may not assert Staff comments as a defense in any proceeding initiated by
the Commission or any person under the federal securities laws of the United States. |
If you have any questions regarding these matters, please contact me at (763) 505-2758.
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Sincerely, |
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/s/ Keyna P. Skeffington |
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Keyna P. Skeffington |
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Vice President, Deputy
General Counsel and Assistant Secretary |
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Medtronic, Inc. |
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MS LC300 |
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World Headquarters |
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710 Medtronic Parkway NE |
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Minneapolis, MN 55432-5604 |
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Phone: (763) 505-2758 |
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Fax: (763) 514-4879 |
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Email:
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keyna.skeffington@medtronic.com |
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Amanda Rivitz, Assistant Director, Division of Corporate Finance |
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Pradip Bhaumik, Special Counsel |
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