SEC Company Response from AVADEL PHARMACEUTICALS PLC (AVDL) (CIK 0001012477) — Nov 4, 2005
AVADEL PHARMACEUTICALS PLC (AVDL) (CIK 0001012477)
Date: Nov. 4, 2005 · CIK: 0001012477 · Accession: 0000950133-05-004941
AI Filing Summary & Sentiment
File numbers found in text: 000-28508
Show Raw Text
CORRESP
1
filename1.htm
corresp
HOGAN & HARTSON
L.L.P.
November 4, 2005
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
Re:
Flamel Technologies S.A.
Form 20-F for the fiscal year ended December 31, 2004
filed June 15, 2005
Commission File No. 000-28508
Dear Mr. Rosenberg:
We have reviewed the comments of
the Staff, as provided to us by telephone on
October 14, 2005, with respect to the above-referenced filing. Enclosed herewith are the Staff’s
comments followed by our responses on behalf of Flamel Technologies S.A. (the “Company”).
Form 20-F – December 31, 2004
Consolidated Financial Statements, page F-1
3. License, Research and Consulting Agreements, page F-13
Comment:
Referring to your response to comment 1, for those agreements where a partner directly funds
the research and development, please disclose the amounts funded by them and all other costs
directly attributable to those projects. For instance, for those internal services that are
not included in those costs, consider the need to disclose those amounts with an explanation as
to why they were not allocated to the externally funded contracts.
WASHINGTON, DC
BALTIMORE BEIJING BERLIN BOULDER BRUSSELS BUDAPEST CARACAS COLORADO SPRINGS DENVER GENEVA HONG KONG LONDON
LOS ANGELES MIAMI MOSCOW MUNICH NEW YORK NORTHERN VIRGINIA PARIS SHANGHAI TOKYO WARSAW
Response:
The partnership agreements for research and development efforts are such that the Company has
no “obligation to perform contractual services” for the counter-party and no obligation to
repay funds received no matter the future economic benefit arising from the outcome of the
results. The cash received from partners relates to rights to access Flamel’s proprietary
technologies. Agreements are established in such a way that the Company performs these
services on a “best efforts” basis with no guarantee as to either the technological or
commercial success.
Research efforts conducted by the Company are associated with platforms across which
collaborative arrangements are supported. As such, the costs of the research and development
efforts far exceed the research and development funding received from partners. Due to the
Company’s ability to share resources and knowledge across multiple research platforms, the cost
allocation to partner-funded agreements would be based on estimated data of human resource time
incurred, which the Company does not track in such a way that would enable the accurate
identification of actual costs incurred.
Based on the foregoing, the Company believes that given the nature of the arrangements,
the extent of its research platforms and the inability to identify accurately costs incurred on
partnered projects, additional disclosure of research and development costs is not necessary
for the investor to understand the effects on the financial statements.
SB Pharma Puerto Rico Inc. (GSK), page F-13
Comment:
Because the Supply Agreement with GSK appears to require a repayment of all advances if the
agreement were to be breached, please tell us how you have met the condition described in
paragraph 16 of FAS 140 de-recognizing the advances as liabilities. Further, clarify for us
what equipment the company will receive title to and the terms of the agreement, i.e. the
equipment already received on the books or the equipment owned by GSK.
Response:
The Company’s requirement to repay all advances is subject to the occurrence of circumstances
in the future. Consequently, the requirement to repay is a contingent liability subject to the
provisions of FAS 5. Given the Company’s ability to perform under supply arrangements and
based on its historical experience, the contingency is not considered probable. In light of
this, the Company believes that the nature of the advances does not meet the definition of a
liability and does not fall within the scope of FAS 140.
The Company has immediate title to all facility related assets and, upon cessation of the
regular supply agreement, the Company will receive title to all installed equipment used to
manufacture the product that, during the course of the Supply Agreement, vests with GSK.
The Company acknowledges that: the Company is responsible for the adequacy and accuracy of the
disclosure in its filings; staff comments or changes to disclosure in response to staff comments do
not foreclose the Securities and Exchange Commission (the “Commission”) from taking any action with
respect to the filing; and the Company may not assert staff comments as a defense in any proceeding
initiated by the Commission or any person under Federal securities laws of the United States.
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.
Very truly yours,
/s/ Amy Bowerman
Freed
Amy Bowerman Freed
cc:
Ms. Keira Ino, Securities and Exchange Commission
Mr. Jim Atkinson, Securities and Exchange Commission
Mr. Stephen Willard, Flamel Technologies S.A.