Exhibit 10.69
AMENDMENT N° 1 TO THE AMENDED AND RESTATED LICENSE AND
SUPPLY AGREEMENT
THIS AMENDMENT N° 1 TO THE AMENDED AND RESTATED LICENSE AND SUPPLY AGREEMENT
(the “Amendment”) effective as of the Closing Date, is made and entered into by
and between Columbia Laboratories (Bermuda) Limited, a corporation organized and
existing under the laws of Bermuda (“Licensor”) and Ares Trading S.A., a
corporation organized and existing under the laws of Switzerland (“Licensee”).
Licensor and Licensee may be referred to herein as a “Party” or, collectively,
as “Parties.”
RECITALS:
WHEREAS, the Parties entered into an Amended and Restated License and Supply
Agreement on June 4, 2002 (the “License and Supply Agreement”), amending and
restating the License and Supply Agreement entered into between the Parties on
May 20, 1999;
WHEREAS, the Parties wish to enter into this Amendment as a result of the
Parties, Serono Inc. (which is an Affiliate of Licensee), and Columbia
Laboratories, Inc. entering into an agreement pursuant to which Licensee’s U.S.
rights under the License and Supply Agreement are terminated (the “U.S.
Agreement”);
WHEREAS the Parties shall enter into this Amendment simultaneously with the
execution of the U.S. Agreement;
WHEREAS, capitalized terms used and not otherwise defined in this Amendment are
used as defined in the License and Supply Agreement and/or the U.S. Agreement.
If a capitalized term is defined in both the License and Supply Agreement and
the U.S. Agreement, then for the purposes of this Amendment, the definition in
the License and Supply Agreement shall apply.
NOW, THEREFORE, in consideration of the various promises and undertakings set
forth herein, the Parties agree to amend the License and Supply Agreement as
follows:

  1.   Section 1 (f) is deleted and not replaced.     2.   The following phrase
of Section 1 (h) is deleted and not replaced:         “(i) the United States or
(ii)”     3.   The following wording is inserted to the first sentence of
Section 1 (s), between the phrases “or sublicensees” and “from or on account
of”:         “(for the sake of clarity, the definition of Net Sales hereunder
shall not include any sales of Product by the Licensor)”     4.   The last two
sentences of Section 1 (s) are deleted and not replaced.     5.   Section 1 (z)
(bb) is amended to read as follows:

“Territory” shall mean all countries and territories of the world except for the
United States and for Sub-Saharan Africa. “Sub-Saharan Africa” shall mean the
following countries: the Republic of South Africa, Lesotho, Botswana, Zimbabwe,
Namibia,

 

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Mozambique, Zaire, Kenya, Malawi, Mauritius, Seychelles, Madagascar, Zambia and
Swaziland.”

  6.   Section 2 (g) is amended to read as follows:

“Licensor shall make reasonable efforts to obtain from its licensee in
Sub-Saharan Africa any right such licensee may have to market, use, sell, make
or have made the Product and to use the Trademarks. Upon Licensor obtaining such
rights, “Territory” under this Agreement shall be automatically redefined to
mean “all the countries in the world, excluding the United States”. Any
incidental out-of-pocket costs incurred by Licensor in obtaining such rights
shall be for the account of Licensee, when prior approved by Licensee.”

  7.   Section 2 (h) is deleted and not replaced.     8.   Sections 3 (a),
(b) and (c ) are deleted and not replaced.     9.   The last sentence of the
first paragraph of Section 4 (m) (which, for the avoidance of doubt, begins with
“Licensor may manufacture..” and ends with “..shearing cycles.” is deleted and
not replaced.     10.   The last paragraph Section 4 (m) (which is the last
sentence of Section 4 (m)) is amended by deleting the phrase “under the
Marketing Agreement”.     11.   Section 4 (s) is amended in its entirety to read
as follows:

“Each Party shall be responsible for receiving and responding to complaints and
requests for information from patients and others regarding the Product sold by
it and each Party shall provide reasonable assistance to the other Party in
responding to such complaints and requests for information and shall be
responsible for investigating and resolving any complaints. Within thirty
(30) days following the end of each calendar month during the term of the
Agreement, each Party shall provide the other Party with a written report
detailing complaints regarding the Product received during such month, provided
that each Party shall notify the other Party of any serious adverse events
within two (2) days following notice to either Party of such serious adverse
event. During the term of this Agreement, each Party shall make available to the
other Party information about the Product as may be necessary to carry out the
provisions and purposes of this Agreement and the U.S. Agreement, including
without limitation general medical information relating to the Product’s
storage, use and safety. Each Party shall provide prompt written notice to the
other Party, including relevant references, of any information which the Party
giving notice believes in its reasonable judgment is material for medical
information services. Material information shall include, but not be limited to,
published or unpublished reports or other clinical or laboratory data received
by either Party about Product safety, contraindications, treatment programs in
the indications specified by the approved Product insert, stability, storage and
shipping, pharmacology, and other information that either Party believes in its
reasonable judgment is relevant to safe and effective Product use. The Party
giving notice shall provide reasonable follow-up information and prompt written
replies to verbal or written questions from the other Party pertinent to medical
information services about the Product. On a periodic basis as agreed by both
Parties, but no less than annually, each Party shall provide the other Party a
written summary of information about the Product, which in the reasonable
judgment of the Party providing the information, is material for the medical
services information of the other Party.”

  12.   The penultimate sentence of Section 4 (t) is amended to read as follows:

 

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“If the Product defect causing the corrective action shall be found to result
solely from one of the Party’s , its Affiliates’ or sublicensees’ marketing, use
or sale of the Product, then the costs and expenses of such corrective action
shall be paid by such Party.”

  13.   A new sentence is added following the end of the Section 4 (t) to read
as follows:

“The Licensor shall be responsible for the costs of any corrective action
(i) outside of the Territory and (b) within the Territory, if found to result
solely from the manufacture and supply of the Product hereunder.”

  14.   The first paragraph of Section 5 (a) is amended to read as follows:

“The Purchase Price to be paid by the Licensee for the Product in Finished
Packaged Form shall be the Base Price of thirty percent (30%) of Net Sales,
whichever is greater, unless otherwise agreed as contemplated in paragraph 4
(q).”

  15.   The second paragraph of Section 5 (a) (which, for the avoidance of
doubt, begins with “Whether the Net Sales were made..” and ends with “..from the
reference of the dispute or difference.”) is deleted in its entirety and not
replaced.     16.   Section 5 (f) is deleted and not replaced.     17.   The
last sentence of Section 13 is amended to read as follows:

“In the event that the Licensee shall continue to market the Product under the
terms of this Agreement for twenty-five (25) years from the Effective Date in
the European Union and Canada, Licensee shall thereafter own the Trademarks and
related goodwill in the Territory.”

  18.   The address of Ares Trading S.A. referred to in Section 17 is Ares
Trading SA, c/o Zone Industrielle de l’Ouriettaz, 1267 Coinsins, Switzerland. A
copy of each notice to Licensee shall be sent to General Counsel, Serono
International SA, 9 chemin des Mines, 1202 Geneva, Switzerland. The address of
Columbia Laboratories (Bermuda) Ltd., referred to in Section 17 is Canon’s
Court, 22 Victoria Street, PO Box HM 1179, Hamilton HM 12, Bermuda. A copy of
each notice to Licensor shall be sent to General Counsel, Columbia Laboratories,
Inc., 354 Eisenhower Parkway, Livingston, New Jersey 07039, USA.     19.  
Effectiveness. This Amendment shall enter into effect as of the Closing Date (as
such term is defined in the U.S. Agreement).     20.   Counterparts; Fax;
Signatures. This Amendment may be executed in any two (2) counterparts,
including by facsimile, each of which, when executed, shall be deemed to be an
original and both of which together shall constitute the one and same document.
    21.   Full Force and Effect. Except as set forth in this Amendment and in
the U.S. Agreement, the License and Supply Agreement shall remain in full force
and effect.

 

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IN WITNESS WHEREOF, the Parties have caused this Amendment to be executed and
delivered by their respective duly authorized officers.
ARES TRADING S.A.

         
By:
  /S/ Francois Naef
 
   
 
  Name: Francois Naef    
 
  Title: Senior Executive Vice President    
 
       
By:
  /S/ Franck Latrille    
 
       
 
  Name: Franck Latrille    
 
  Title: Senior Executive Vice President    

COLUMBIA LABORATORIES (Bermuda), Ltd.

         
By:
  /S/ Robert S Mills
 
   
Name:
  Robert S Mills    
Title:
  President    

SIGNATURE PAGE TO AMENDMENT NO. 1