-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, OZqiG8/ogu0eIs6p6xhSilW7yU8uPkpSgZ7UKaQyEUnV23bsxJJPLAtrsSFK9q59 ndrk6TtDohgVfIezMjxgdA== 0000821995-07-000017.txt : 20080225 0000821995-07-000017.hdr.sgml : 20080225 20071214134115 ACCESSION NUMBER: 0000821995-07-000017 CONFORMED SUBMISSION TYPE: CORRESP PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20071214 FILER: COMPANY DATA: COMPANY CONFORMED NAME: COLUMBIA LABORATORIES INC CENTRAL INDEX KEY: 0000821995 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 592758596 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: CORRESP BUSINESS ADDRESS: STREET 1: 354 EISENHOWER PARKWAY CITY: LIVINGSTON STATE: NJ ZIP: 07039 BUSINESS PHONE: 9739943999 MAIL ADDRESS: STREET 1: 354 EISENHOWER PARKWAY CITY: LIVINGSTON STATE: NJ ZIP: 07039 CORRESP 1 filename1.htm corresp.htm
 


 

 
 
 
 
 
December 14, 2007
 
Mr. James B. Rosenberg
Senior Assistant Chief Accountant
United States Securities and Exchange Commission
Division of Corporation Finance
Washington, DC 20549
 
Re:           Columbia Laboratories, Inc.
                 Form 10-K for Fiscal Year Ended December 31, 2006
                 File No. 1-10352
 
Dear Mr. Rosenberg:
 
This replies to the Staff’s comment letter dated December 3, 2007, to Columbia Laboratories, Inc., (hereinafter “Columbia,” “Company,” “we,” “us,” or “our”) commenting on our From 10-K for the year ended December 31, 2006. I have restated the Staff’s observation below, followed by our response.
 
        Operations, page 5
 
                        1.  We note that you contract manufacturing activities to third parties in the United Kingdom, Switzerland and Italy, and the risk factor on page 23 says that you “are    
                                  dependent upon third-party developers and manufacturers, the loss of which could result in a loss of revenues.” If you are substantially dependent on any specific
                                  manufacturing agreements, please identify the manufacturer, the products that each manufactures, and discuss the material terms of those agreements. Also, file
                                  the agreements as exhibits to your Form 10-K. If you are not substantially dependent on any manufacturing agreements, provide us with an analysis supporting your
                                  determination.
 
We are dependent on three manufacturers for the products that we sell to marketing partners around the world and commercialize ourselves in the United States. We sell five vaginal gel products that are each manufactured by Fleet Laboratories Limited in the United Kingdom and filled into overwrapped single-use disposable applicators by Maropack, A.G., in Switzerland. Our single buccal product is manufactured for us by Mipharm S.p.A., in Italy. We will expand the discussion of these operations in our From 10-K for the year ending December 31, 2007, as presented below. In addition, we will file our agreements with Fleet Laboratories and Maropack as exhibits to our Form 10-K, for the year ending December 31, 2007. (Our agreement with Mipharm was previously filed as Exhibit 10.31 to our report on Form 10-Q for the quarter ended June 30, 2002.) While these additional disclosures will provide more clarity for investors going forward, we believe our prior disclosures about our dependence on contract manufacturing operations were adequate to inform investors about the possible impact on revenues of a loss of those operations.
 
Operations

Our sales and marketing organization operates solely in the United States, and is specifically focused on a select group of obstetricians,
gynecologists, reproductive endocrinologists, general endocrinologists, urologists and primary care physicians.  We have entered into
partnerships to commercialize our products outside of the United States and within certain markets in the United States, and seek to enter
into additional partnerships to commercialize our products in new countries and with additional audiences in the United States that we do not
currently address.
We are dependent on three manufacturers for the products that we sell to marketing partners around the world and commercialize
ourselves in the United States. We sell five vaginal gel products that are each manufactured in bulk by Fleet Laboratories Limited, Watford Herts,
United Kingdom (“Fleet”) and filled into overwrapped single-use disposable applicators by Maropack AG, Zell, Switzerland (“Maropack”).
Our single buccal product is manufactured for us by Mipharm S.p.A., Milan, Italy (“Mipharm”).
Our wholly owned subsidiary, Columbia Laboratories (Bermuda) Ltd., entered into an agreement dated July 12, 1996, with Fleet to
manufacture our progesterone vaginal gel products for delivery in bulk containers. Pursuant to the agreement Fleet built and operates a
dedicated suite for the manufacture of hormone products, which was partially funded by Columbia. Fleet may pass on increases in the cost of
materials on three months notice and increases in labor on the anniversaries of the agreement. The original term of the agreement was 10
years after which the agreement continues in effect and either party may terminate the agreement on twelve (12) months prior written notice.
Payments under the agreement are made in pounds sterling. Fleet also manufactures the Company’s non-progesterone vaginal gel products
for delivery in bulk containers pursuant to individual purchase orders.
Our then wholly owned subsidiary, Columbia Laboratories (Ireland) Ltd., entered into an agreement dated October 28, 1993 (which
agreement was later transferred to our wholly owned subsidiary, Columbia Laboratories (Bermuda) Ltd.), with Maropack to fill our bulk vaginal
gel products into overwrapped single-use disposable applicators. The original term of the agreement was one (1) year with automatic one (1)
year renewals. Either party may terminate the agreement on six (6) months prior written notice before the end of any renewal term. Prices are
renegotiated annually based on forecasted production volumes. Payments under the agreement are made in Swiss francs.
Our wholly owned subsidiary, Columbia Laboratories (Bermuda) Ltd., entered into an agreement dated May 7, 2002 with Mipharm to
manufacture at least eighty-five percent (85%) of our requirements for our Striant® testosterone buccal product for sale in the United States,
Europe and Latin America. Pursuant to the agreement Mipharm built and operates a dedicated suite for the manufacture of hormone products,
one-half of the cost of which was paid by us. The original term of the agreement is twelve (12) years with automatic three (3) year renewals.
Either party may terminate the agreement on twelve (12) months prior written notice before the end of any term. The price of the product may increase
based on increases in labor costs in Italy or raw materials, but no greater than the percentage increase of the European Consumer Price Index. Payments
under the agreement are made in Euros.
   



 



 
If you have further questions or the responses require further explanation, please do not hesitate to contact me at 973 486 8860.


Very truly yours,


/S/ James A. Meer
James A. Meer
Senior Vice President and Chief Financial Officer



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-----END PRIVACY-ENHANCED MESSAGE-----