corresp
HOGAN & HARTSON L.L.P.
February 7, 2006
VIA EDGAR AND FAX
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
Division of Corporate Finance
Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549
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Re:
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Flamel Technologies S.A. |
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Form 20-F for the fiscal year ended December 31, 2004 |
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filed June 15, 2005 |
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Commission File No. 000-28508 |
Dear Mr. Rosenberg:
We have reviewed a comment of the staff, as provided to us by telephone on January 17, 2006, with
respect to the above-referenced filing. Enclosed herewith is the staffs comment followed by our
response on behalf of Flamel Technologies S.A. (the Company).
Form 20-F December 31, 2004
Consolidated Financial Statements, page F-1
SB Pharma Puerto Rico Inc. (GSK), page F-13
Comment:
Please provide revised supplemental disclosure that better indicates what your obligations and
responsibilities in this agreement are. Include what happens in the event of a breach, the
total amount to be repaid, what constitutes a breach and whether it can be corrected. Focus
this disclosure on the economics of what happens and not the debits and credits that it took to
get there.
Mr. Jim B. Rosenberg
February 7, 2006
Page 2
Response:
The Company proposes to include the following disclosure regarding the agreement between the
Company and GlaxoSmithKline in the Companys Form 20-F for the fiscal year ended December 31, 2005:
In December 2004, Flamel and GlaxoSmithKline (GSK) entered into a supply agreement whereby
Flamel agreed to supply GSK with commercial supplies of product. The provisions of the
agreement include payments to Flamel of $20,717,000 to support the costs and capital
expenditure relative to the creation of a manufacturing area for the production of
commercial supply of the product. The capital expenditure consists of both buildings and
fixtures, and production equipment. For the duration of the supply agreement, title to the
building and fixtures vests with Flamel and title to production equipment vests with GSK.
If the Company breaches the supply agreement through gross negligence, GSK can chose to
terminate the supply agreement. The likely occurrence of this event is deemed remote given
the Companys ability to perform under supply arrangements based on its historical
experience. In the event of a breach and a decision to terminate the agreement, all
payments received become repayable to GSK and Flamel is to receive immediate title to all
production equipment.
Upon cessation of the supply agreement in the normal course, GSK will pass title to all
production equipment to Flamel without cost of any kind.
The Company considers that an amendment to the disclosure in connection with this agreement in
its Form 20-F for fiscal year ended December 31, 2004 would not be meaningful for investors
since all material elements pertaining to the agreement were disclosed in the Companys 2004
Form 20-F.
If you have any questions concerning this letter or if you would like additional information,
please do not hesitate to call me at (212) 918-8270.
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Very truly yours, |
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/s/ Amy Bowerman
Freed
Amy Bowerman Freed |
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cc:
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Ms. Keira Ino, Securities and Exchange Commission |
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Mr. Jim Atkinson, Securities and Exchange Commission |
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Mr. Stephen Willard, Flamel Technologies S.A. |