UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported)

February 5, 2014

 

 

COLUMBIA LABORATORIES, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-10352   59-2758596

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

4 Liberty Square, Boston, Massachusetts 02109

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code

(617) 639-1500

Not Applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CRF 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 


Item 1.01 Entry into a Material Definitive Agreement.

On February 5, 2014, Columbia Laboratories (Bermuda) Ltd. (“Columbia Bermuda”), a wholly owned subsidiary of Columbia Laboratories, Inc., entered into an amendment (the “Amendment”) to the Manufacture and Supply Agreement, dated as of December 8, 2009, by and between Columbia Bermuda and Fleet Laboratories Limited (as amended, the “Agreement”), pursuant to which Fleet has agreed to manufacture and supply to Columbia Bermuda, and Columbia Bermuda has agreed to purchase, certain products. The Amendment is effective as of December 31, 2013.

The Amendment extends the term of the Agreement and provides for an expiration date of December 31, 2020 (the “Initial Term”); provided, however, that the Initial Term will be automatically extended for additional periods of two years (each a “Renewal Term”) unless either party to the Agreement gives to the other party, not less than six months prior to the expiration of the Initial Term or any Renewal Term, written notice of its intention not to extend the Agreement; and provided further, that upon termination of the Agreement, Fleet agrees to perform its obligations under the Agreement for the earlier of one year or Columbia Bermuda’s engagement and qualification of an alternative manufacturer of the Product.

The Amendment also provides that, commencing as of the effective date of the Amendment, and until such time as Columbia Bermuda provides Fleet with notice as described in the Amendment, Fleet will not be obligated to comply with U.S. Food and Drug Administration (FDA) regulatory standards and obligations, in general, unless otherwise specifically required by applicable law; provided, however, that compliance with all other applicable regulatory standards including those of the Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency will remain in effect throughout the period of tolling of the FDA obligations.

The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of such agreement, which is attached hereto as Exhibit 10.1 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

No.

  

Description

10.1    Amendment to Manufacturing and Supply Agreement, effective as of December 31, 2013, by and between Columbia Laboratories (Bermuda) Ltd., and Fleet Laboratories Limited.


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    COLUMBIA LABORATORIES, INC.
Date: February 6, 2014     By:   /s/ Jonathan B. Lloyd Jones
       

Jonathan B. Lloyd Jones

Vice President & Chief Financial Officer

Exhibit 10.1

AMENDMENT

T O M ANUFACTURING AND S UPPLY A GREEMENT

THIS AMENDMENT (this “ Amendment ”) to the Manufacture and Supply Agreement dated as of December 8, 2009 (the “ Agreement ”) is entered into as of the 31 st day of December, 2013 (the “ Amendment Effective Date ”), by and between Columbia Laboratories, (Bermuda) Ltd. , a limited company existing and organized under the laws of Bermuda, having a place of business at Canon’s Court, 22 Victoria Street, Hamilton HM 12, Bermuda (“ Columbia ”), and Fleet Laboratories Limited , a limited private company existing and organized under the laws of England, having a place of business at 94 Rickmansworth Road, Watford Herts, WD18 7JJ, United Kingdom (“ Fleet ”).

WHEREAS, Columbia and Fleet entered into the Agreement pursuant to which Fleet has agreed to manufacture and supply to Columbia, and Columbia has agreed to purchase, certain Products; and

WHEREAS, Columbia and Fleet have determined that it is in their respective best interests to amend the Agreement to: (i) extend the Term; (ii) provide for an expiration date of the Agreement; and (iii) modify certain quality matters.

NOW, THEREFORE, in consideration of the foregoing and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Columbia and Fleet agree as follows:

1. Capitalized terms used but not defined in this Amendment shall have the meanings ascribed to such terms in the Agreement

2. Section 12.1 of the Agreement, entitled Term, is hereby revised to provide in its entirety as follows:

12.1 Term . Unless terminated earlier pursuant to Section 12.2 below, the initial term of this Agreement shall expire on December 31, 2020 (“Initial Term”) and shall be automatically extended for additional periods of two (2) years (each a “Renewal Term”) and together with the Initial Term, the “Term”, unless either party gives to the other party, not less than six (6) months prior to expiration of the Initial Term or any Renewal Term, written notice of its intention not to extend this Agreement; provided, however, that upon termination of this Agreement Fleet agrees to perform its obligations under this Agreement for the earlier of one year or Columbia’s engagement and qualification of an alternative manufacturer of the Product.


3. Commencing as of the Amendment Effective Date and continuing until such time as Columbia provides Fleet with not less than 60 days prior written notice of its intent to require Fleet to reinstate such compliance, the parties agree that Fleet shall not be obligated to comply with FDA regulatory standards and obligations, in general, unless otherwise specifically required by applicable law. For the avoidance of doubt, compliance with all other applicable regulatory standards including those of MHRA and the European Medicines Agency shall remain in effect through-out the period of tolling of the FDA obligations.

4. Section 13.1 of the Agreement, entitled Notices, is hereby amended to provide new contact information for Columbia Laboratories, Inc. as follows:

With Copy to:

Columbia Laboratories, Inc.

4 Liberty Square

Fourth Floor

Boston, MA 02109

Tel: (617) 639-1500

Fax: (617) 482-0618

Attention: General Counsel

5. All other terms and conditions of the Agreement remain in full force and effect. Except as expressly provided in this Amendment, the Agreement shall remain unmodified and is hereby ratified and affirmed. The execution, delivery, and effectiveness of this Amendment shall not, except as expressly provided herein, operate as a waiver of any right, power, or remedy of Columbia or Fleet under the Agreement.

6. This Amendment, together with the Agreement, sets forth the entire agreement and understanding between the parties as to the subject matter hereof and thereof and merges all prior discussions and negotiations between them, and neither of the parties shall be bound by any conditions, definitions, warranties, understandings or representations with respect to such subject matter other than as expressly provided herein and therein or as duly set forth on or subsequent to the date hereof in writing and signed by a proper and duly authorized officer or representative of the party to be bound thereby.

7. This Amendment may be signed in counterparts, each and every one of which shall be deemed an original, notwithstanding variations in format or file designation which may result from the electronic transmission, storage and printing of copies of this Amendment from separate computers or printers. Executed signatures pages to this Amendment may be delivered by facsimile or a portable document format (PDF) copy (including copy(ies) sent by e-mail) and all such shall be deemed as if actual signature pages had been delivered.

*-*-*-*

(Signature Page Follows)

 

2


IN WITNESS WHEREOF, the parties have duly executed this Amendment as of the Amendment Effective Date.

 

COLUMBIA LABORATORIES (BERMUDA), LTD.
By:   /s/ Frank Condella

Name:

Title:

 

Frank Condella

President and CEO

 

FLEET, LABORATORIES LIMITED
By:   /s/ Hanna Coonagh

Name:

Title:

 

Hanna Coonagh

Managing Director Fleet

 

[Signature Page to Amendment]