EX-10.1



 Exhibit 10.1 

AMENDMENT 

TO MANUFACTURING AND SUPPLY AGREEMENT 

THIS AMENDMENT (this “Amendment”) to the Manufacture and Supply Agreement dated as of December 8, 2009
(the “Agreement”) is entered into as of the 31st 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)


  
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 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]