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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) July 1, 2010
COLUMBIA LABORATORIES, INC.
 
(Exact name of registrant as specified in its charter)
Commission File No. 1-10352
     
Delaware   59-2758596
     
(State of Incorporation)   (I.R.S. Employer
    Identification No.)
     
354 Eisenhower Parkway    
Livingston, New Jersey   07039
     
(Address of principal   Zip Code
executive offices)    
Registrant’s telephone number, including area code: (973) 994-3999
     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):
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


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Item 1.01 Entry into a Material Definitive Agreement
Item 2.01 Completion of Acquisition or Disposition of Assets
Item 3.02 Unregistered Sales of Equity Securities
Item 3.03 Material Modification to Rights of Security Holders
Item 5.01 Changes in Control of Registrant
Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year
Item 5.07 Submission of Matters to a Vote of Security Holders
Item 8.01 Other Events
Item 9.01 Financial Statements and Exhibits
SIGNATURE
Exhibit Index
EX-3.1
EX-4.1
EX-10.1
EX-10.2
EX-10.3
EX-99.1
EX-99.2
EX-99.3


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Item 1.01 Entry into a Material Definitive Agreement.
Descriptions of the Supply Agreement, License Agreement and Investor’s Rights Agreement are set forth under Item 2.01 of this Current Report on Form 8-K and are incorporated by reference into this item.
Item 2.01 Completion of Acquisition or Disposition of Assets.
Watson Transactions
On July 2, 2010, Columbia Laboratories, Inc. (the “Company”) completed the previously announced sale to Coventry Acquisition, Inc. (the “Buyer”), a subsidiary of Watson Pharmaceuticals, Inc. (“Watson”), pursuant to the terms of that certain Purchase and Collaboration Agreement, dated as of March 3, 2010 (the “Purchase Agreement”), among the Company, the Buyer and Watson of (i) substantially all of its assets primarily relating to the research, development, regulatory approval, manufacture, distribution, marketing, sale and promotion of pharmaceutical products containing progesterone as an active ingredient, including CRINONE 8% progesterone gel, PROCHIEVE 4% progesterone gel and PROCHIEVE 8% progesterone gel, each sold by the Company in the United States (collectively, the “Progesterone Products”), including certain intellectual property, promotional materials, contracts, product data and regulatory approvals and regulatory filings (the “Purchased Assets”), and (ii) 11,200,000 shares (the “Acquisition Shares”) of the Company’s common stock, $.01 par value per share (the “Common Stock”). The Company has retained certain assets and rights relating to its progesterone business, including all rights necessary to perform its obligations under its agreement with an affiliate of Merck Serono S.A. (“Merck Serono”). The transactions pursuant to the Purchase Agreement and the ancillary agreements thereto are referred to herein as the “Watson Transactions.”
In consideration for the sale of the Purchased Assets and the Acquisition Shares, the Company has received $47 million in cash and the Buyer has assumed certain liabilities associated with the Purchased Assets. The Buyer has reported that the source of the funds used to effect the Watson Transactions was working capital. In addition, pursuant to the terms of the Purchase Agreement, the Buyer agreed to pay the Company up to $45.5 million in cash upon the achievement of several contingent milestones as follows: (i) upon the delivery of results from the Company’s Phase III PREGNANT Study designed to evaluate the ability of PROCHIEVE 8% to reduce the risk of preterm birth in women with a short cervix of between 1.0 and 2.0 centimeters (the “PTB Indication”) as measured by transvaginal ultrasound at mid-pregnancy (the “PREGNANT Study”) and (A) if the results of the PREGNANT Study reflect the achievement of a primary endpoint, reduction in preterm birth, p-value that is less than or equal to 0.05 and greater than 0.01, $6 million or (B) if the results of the PREGNANT Study reflect the achievement of a primary endpoint, reduction in preterm birth, p-value that is less than or equal to 0.01, $8 million; provided, however, in each case, the results reflect the achievement of a secondary endpoint, infant outcomes composite score, p-value that is less than or equal to 0.05; (ii) upon acceptance by the United States Food and Drug Administration of a new drug application (or a supplemental new drug application) to market PROCHIEVE 8% for the PTB Indication, $5 million; (iii) upon the first commercial sale of PROCHIEVE 8% in the United States for the PTB Indication, $30 million; (iv) upon filing and acceptance by the applicable regulatory authority of an application for the authorization to market a Progesterone Product for the PTB Indication in a

 


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country or jurisdiction outside the United States, $0.5 million; and (v) upon a grant by any applicable regulatory authority of an approval to market a Progesterone Product for the PTB Indication in a country or jurisdiction outside of the United States, $2 million.
Pursuant to the Purchase Agreement, after the closing thereunder, the Buyer has also agreed to make certain royalty payments to the Company in each year during the relevant royalty period based on the sales of certain Progesterone Products (each a “Royalty Product”), at the rates of (A) 10% of the portion of annual United States net sales which are less than or equal to $150,000,000, (B) 15% of the portion of annual United States net sales which are greater than $150,000,000 and less than or equal to $250,000,000, (C) 20% of the portion of annual United States net sales which are greater than $250,000,000 and (D) 10% of annual net sales outside of the United States in a country where the Buyer or its affiliates are commercializing any Royalty Product; provided, however that (x) if generic entry by a third party with respect to any Royalty Product occurs in any country such that quarterly net sales of such Royalty Product in such country are reduced by 50% and such reduction is directly attributable to the marketing or sale in such country of such generic equivalent, the royalty rate shall be reduced by 50% in such country (a “Generic Entry”), (y) if the Buyer or any of its affiliates grants any licenses, sublicenses, distribution or marketing rights or otherwise collaborates with a third party to commercialize any Royalty Product in a country outside of the United States, in lieu of royalties payable in respect of net sales, the Company will be entitled to 20% of gross profits associated with such commercialization in such country, and (z) in the event that a Generic Entry by the Buyer or its affiliates with respect to any Royalty Product in a country occurs in the circumstances permitted by the Purchase Agreement, in lieu of royalties payable in respect of net sales for such generic product, the Company will be entitled to 20% of gross profits associated with the commercialization of such generic product in such country.
Pursuant to the Purchase Agreement, the Company and the Buyer have also agreed to collaborate with respect to the development of Progesterone Products. In connection therewith, the parties agreed to establish a joint development committee to oversee and supervise all development activities. The Company will be responsible for completion of the PREGNANT Study and such other activities as determined by the joint development committee. The Company will be responsible for the costs of conducting the PREGNANT Study and the preparation, filing and approval process of the related new drug application (or supplemental new drug application) up to a maximum amount of $7 million from January 1, 2010. All other development costs incurred in connection with the development collaboration will be paid by the Buyer.
The parties, pursuant to the Purchase Agreement, have entered into various ancillary agreements described below, including an Investor’s Rights Agreement, a Supply Agreement pursuant to which the Company will supply the Progesterone Products to the Buyer for sale in the United States at a price equal to 110% of the cost of goods sold and a License Agreement relating to the grant of certain intellectual property licenses.
As part of the Purchase Agreement, the Company has agreed not to manufacture, develop or commercialize products containing progesterone or any other products for the PTB Indication, subject to certain exceptions, until the second anniversary of the date on which the Company and the Buyer terminate their relationship with respect to the joint development of the Progesterone Products. The joint development collaboration is terminable by either party beginning July 2, 2015.

 


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The Company has granted to the Buyer certain registration rights with respect to the resale of the Acquisition Shares and the right to designate one member to the Board until the Buyer no longer owns at least 10% of the Company’s outstanding Common Stock, pursuant to the terms of the Investor’s Rights Agreement, dated July 2, 2010, between the Buyer and the Company (the “Investor’s Rights Agreement”). The Buyer, under the Investor’s Rights Agreement, has agreed to certain limitations on its ability to transfer the Acquisition Shares.
The Acquisition Shares are being offered and sold to the Buyer under the Purchase Agreement in reliance on exemptions from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), pursuant to Section 4(2) under the Securities Act and Rule 506 promulgated thereunder, based on the nature of the Buyer and certain representations made by the Buyer to the Company.
Termination of the PharmaBio Agreement
On July 2, 2010, the Company terminated the Investment and Royalty Agreement, dated March 5, 2003, between the Company and PharmaBio Development Inc., as amended and supplemented from time to time (the “PharmaBio Agreement”). Termination of the PharmaBio Agreement was in accordance with the terms of a previously reported amendment to the PharmaBio Agreement, dated March 3, 2010, permitting the Company to make certain payments required thereunder on an accelerated and discounted basis on the date the Company consummates a sale such as the sale of the Company’s assets in connection with the Watson Transactions.
Forgiveness of the Amounts owed under Watson Note
On July 2, 2010, the $15,000,000, plus accrued interest, owed by the Company to Watson pursuant to the terms of that certain forgivable Term Loan Promissory Note, dated June 1, 2010, bearing interest at the rate of 4% per annum (the “Watson Note”) was forgiven in accordance with the terms of the Watson Note. Watson provided a pay-off letter to the Company to this effect.
Investor’s Rights Agreement
In connection with the Watson Transactions, the Company entered into the Investor’s Rights Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference. Pursuant to the Investor’s Rights Agreement, the Buyer has the right to nominate one director (the “Designee”) to the Company’s board of directors, and the Company will use its commercially reasonable efforts to expand its board of directors and appoint such designee as a director prior to July 9, 2010 (the “Designation Right”) . The Company has also agreed to use its commercially reasonable efforts to facilitate the re-election of the Buyer’s board designee until such time as the Buyer ceases to hold at least 10% of the outstanding shares of Common Stock. The Buyer has selected Fred Wilkinson, Executive Vice President — Global Brands of Watson as its Designee. The Buyer is subject to a six month “lock-up” commencing on July 2, 2010 (the “Initial Lock-Up Period”), during which it is not permitted to sell the Acquisition Shares, subject to certain limited exceptions. Following the Initial Lock-Up Period (and until 18 months after July 2, 2010), subject to certain exceptions, the Buyer agreed that it will not, during any fiscal quarter, transfer more than 2 million shares of Common

 


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Stock. The transfer restrictions will expire at the time that the Buyer no longer holds 10% of the outstanding shares of Common Stock. In order to provide the Buyer with liquidity with respect to its holdings in the Company following the Initial Lock-Up Period, the Company agreed to use its commercially reasonable efforts to file a shelf registration statement with the Securities and Exchange Commission not later than 90 days prior to the end of the Initial Lock-Up Period and to keep such shelf registration statement effective until the earliest of the fourth anniversary of July 2, 2010, the date on which all of the Acquisition Shares have been transferred by the Buyer or the date upon which the Acquisition Shares may be sold by Buyer under Rule 144 (without limitation as to volume or compliance with certain specified provisions of Rule 144). Pursuant to the Investor’s Rights Agreement, the Company also agreed to certain indemnification and contribution provisions, including with respect to liabilities arising under the Securities Act.
The foregoing is a summary of the terms of the Investor’s Rights Agreement, and does not purport to be complete and is subject to, and qualified in its entirety by reference to, the full text of the Investor’s Rights Agreement.
Supply Agreement
In connection with the Watson Transactions, the Company entered into the Supply Agreement, dated as of July 2, 2010, by and between the Company and the Buyer (the “Supply Agreement”), which is filed as Exhibit 10.2 to this Current Report on Form 8-K and is incorporated herein by reference. Pursuant to the Supply Agreement, the Company is the exclusive supplier of the Progesterone Products to the Buyer for sale in the United States at a price equal to 110% of the cost of goods sold. The initial purchase order under the Supply Agreement, of finished goods inventory held on hand by the Company on July 2, 2010, was made by the Buyer at the time of the execution of the Supply Agreement for a batch price set forth in the Supply Agreement, calculated based on an agreed upon cost of goods formula, which includes a monthly adjustment to reflect the current foreign currency exchange rates. The initial purchase order will be delivered to the Buyer within 30 days after July 2, 2010 and each purchase order made pursuant to the Supply Agreement thereafter will be for a delivery date no earlier than 90 days following the Company’s receipt of such purchase order. The Supply Agreement, unless earlier terminated in accordance with its terms, shall remain in force through May 19, 2015, and shall renew automatically for two-year terms thereafter, unless either party gives written notice of its intention not to renew at least 180 days prior to expiration of the then applicable term. The Supply Agreement is terminable by the Buyer upon 180 days’ notice, upon the expiration or termination of the Joint Development Period (as defined in the Purchase Agreement) and by either party at any time pursuant to standard termination provisions, including the insolvency or uncured default of the other party.
The foregoing is a summary of the terms of the Supply Agreement, and does not purport to be complete and is subject to, and qualified in its entirety by reference to, the full text of the Supply Agreement.
License Agreement
In connection with the Watson Transactions, the Company entered into the License Agreement, dated as of July 2, 2010, by and among the Company, the Buyer and Columbia Laboratories (Bermuda) Ltd. (the “License Agreement”), which is filed as Exhibit 10.3 to this Current Report

 


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on Form 8-K and is incorporated herein by reference. Pursuant to the License Agreement, the parties granted each other certain licenses to use certain intellectual property.
The Company granted to the Buyer, subject to the Purchase Agreement and agreements with Dimera Incorporated and Merck Serono an exclusive, irrevocable, perpetual, royalty-free and fully paid-up license, with the right to grant sublicenses, under the Excluded Asset Technology and Seller Next Generation Delivery System Technology (each as defined in the License Agreement), in each case for the purposes of developing, manufacturing, having manufactured, using, importing, exporting, marketing, selling, offering to sell or otherwise commercializing pharmaceutical products containing progesterone as an active pharmaceutical ingredient (“Licensed Products”) in any and all fields.
     The Buyer granted to the Company:
    a non-exclusive, non-transferable, royalty-free and fully paid-up license to the patents and know-how included among the Purchased Assets and the know-how arising from the development activities pursuant to the Purchase Agreement for the purpose of supplying the Licensed Products to the Buyer under the terms and conditions of the Supply Agreement;
 
    a non-exclusive, non-transferable, royalty-free and fully paid-up license to the patents and know-how included among the Purchased Assets, the know-how arising from the development activities and the patents and know-how controlled by the Buyer but identified for the Company’s use in writing, for the purposes of conducting the Company’s development activities under the Purchase Agreement;
 
    an exclusive, irrevocable, perpetual, royalty-free and fully paid-up license, with the right to grant sublicenses to the patents and know-how included among the Purchased Assets and certain know-how arising from the development activities pursuant to the Purchase Agreement for the purposes of the Company’s compliance with its agreements with Dimera Incorporated and Merck Serono; and
 
    a non-exclusive, irrevocable, perpetual, royalty-free and fully paid-up license, with the right to grant sublicenses to develop, manufacture, have manufactured, use, import, export, market, sell, offer to sell or otherwise commercialize the Seller Next Generation Delivery System (as defined in the License Agreement) to the extent that it incorporates or delivers any product other than the Licensed Products in any and all fields.
The License Agreement may be terminated upon mutual written agreement of the parties. If one party enters bankruptcy, the other party is entitled to a complete duplicate of, or access to, any intellectual property licensed under the License Agreement.
The foregoing is a summary of the terms of the License Agreement, and does not purport to be complete and is subject to, and qualified in its entirety by reference to, the full text of the License Agreement.

 


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Item 3.02 Unregistered Sales of Equity Securities
On July 2, 2010, the Company completed the purchase of approximately $40 million of the Company’s Convertible Subordinated Notes, due December 31, 2011, bearing interest at the rate of 8% per annum (the “Notes”), pursuant to the terms of the Note Purchase and Amendment Agreements, dated March 3, 2010 (the “Note Purchase Agreements”), entered into with the holders (the “Holders”) of the Notes (who are each accredited investors (as such term is defined in Rule 501 under the Securities Act)). In exchange for the Notes, on July 2, 2010, the Company paid the aggregate purchase price of (i) $26 million in cash, (ii) warrants (the “Warrants”) to purchase 7,750,000 shares of Common Stock (the “Warrant Shares”) and (iii) 7,407,407 shares of Common Stock (the “NPA Shares” and, collectively with the Warrants and the Warrant Shares, the “Securities”).
The Warrants will be exercisable, subject to certain limitations specified therein, during the period commencing 180 days after their issuance, and ending on July 2, 2015, unless earlier exercised or terminated as provided in the Warrants. The Warrants will be exercisable for an aggregate of 7,407,407 Warrant Shares. The exercise price per share, subject to adjustment in certain circumstances, is $1.35. A Form of Warrant is attached hereto as Exhibit 4.1.
Under the terms of the Note Purchase Agreements, the Company has granted Holders who are Affiliates (as such term is defined in Rule 405 of the Securities Act) certain registration rights with respect to the resale of the NPA Shares and the Warrant Shares.
Under the Note Purchase Agreements, until 45 days after the Company’s public announcement of the results of the PREGNANT Study, if the Company issues any shares of Common Stock (or Common Stock equivalents) for a price that is less than $2.00 per share, the Company must offer the Holders, subject to certain exceptions, the right to exchange their Warrants for cash payments of up to an aggregate of $3,999,996.
The NPA Shares and Warrants are being offered and sold to the Holders in reliance on exemptions from the registration requirements of the Securities Act pursuant to Section 4(2) under the Securities Act and Rule 506 promulgated thereunder, based on the nature of the Holders and certain representations made by them to the Company.
Neither the Acquisition Shares nor the Securities have been registered under the Securities Act (or the laws of any state or other jurisdiction) and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements thereof. This Form 8-K does not constitute an offer for the sale of any securities of the Company or a solicitation of any offer to buy any securities of the Company.
In addition to the matters discussed above, a description of the sale of the Acquisition Shares is set forth under Item 2.01 of this Current Report on Form 8-K and is incorporated by reference into this item.
Item 3.03 Material Modification to Rights of Security Holders
On July 1, 2010, the Company’s stockholders approved the Certificate of Amendment of Restated Certificate of Incorporation of the Company to increase the number of shares of the Company’s authorized Common Stock from 100,000,000 to 150,000,000 (the “Charter

 


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Amendment”), as described below under Item 5.07 of this Current Report. On July 1, 2010, the Company filed the Certificate of Amendment of Restated Certificate of Incorporation with the Secretary of State of Delaware. A copy of the Certificate of Amendment of Restated Certificate of Incorporation of the Company is attached hereto as Exhibit 3.1.
Item 5.01 Changes in Control of Registrant
Descriptions of the Watson Transactions and the Designation Right are set forth under Item 2.01 of this Current Report on Form 8-K and are incorporated by reference into this item.
Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.
A description of the Charter Amendment is set forth under Item 3.03 of this Current Report on Form 8-K and is incorporated by reference into this item.
Item 5.07 Submission of Matters to a Vote of Security Holders.
On July 1, 2010, the Company held a special meeting of its stockholders (the “Special Meeting”). At the Special Meeting, the Company’s stockholders voted on the following three proposals: (i) to approve the Asset Sale pursuant to the Purchase Agreement, (ii) to approve the Charter Amendment, and (iii) to adjourn the Special Meeting to a later date, if necessary or appropriate, to allow for the solicitation of additional proxies in favor of the proposal(s) to approve the Asset Sale and/or Charter Amendment if there are insufficient votes to approve the Asset Sale and/or Charter Amendment, as applicable (the “Adjournment Proposal”). A total of 38,475,536 shares of Common Stock, 0 shares of Series B Preferred Stock and 59,000 shares of Series E Preferred Stock, voting together as a single class, were voted in person or by proxy (with the holders of shares of Common Stock entitled to one vote per share, the holders of shares of Series B Preferred Stock entitled to 20 votes per share and the holders of shares of Series E Preferred Stock entitled to 50 votes per share, collectively, the “Voting Power”). The votes cast represented 60.5% of the total Voting Power entitled to be voted.
Proposal 1: To approve the Asset Sale pursuant to the Purchase Agreement:
             
Votes For   Votes Against   Abstentions   Broker Non-Votes
39,935,773   1,419,610   70,153   0
Proposal 2: To approve the Charter Amendment:
             
Votes For   Votes Against   Abstentions   Broker Non-Votes
40,530,682   820,626   74,228   0
Proposal 3: To approve the Adjournment Proposal:
             
Votes For   Votes Against   Abstentions   Broker Non-Votes
39,501,907   1,843,518   80,111   0
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995:
This communication contains forward-looking statements, which statements are indicated by the words “may,” “will,” “plans,” “believes,” “expects,” “anticipates,” “potential,” and similar

 


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expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to, the following: the successful marketing of CRINONE ® and STRIANT ® in the United States; the successful marketing of CRINONE by Merck Serono outside the United States; the timely and successful completion of the ongoing Phase III PREGNANT (PROCHIEVE ® Extending Gestation A New Therapy) Study of PROCHIEVE 8% to reduce the risk of preterm birth in women with a short cervix at mid-pregnancy; successful development of a next-generation vaginal progesterone product; success in obtaining acceptance and approval of new products and new indications for current products by the United States Food and Drug Administration and international regulatory agencies; the impact of competitive products and pricing; the Company’s ability to obtain financing in order to fund its operations and repay its debt as it becomes due; the timely and successful negotiation of partnerships or other transactions; the strength of the United States dollar relative to international currencies, particularly the euro; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in the Company’s reports filed with the Securities and Exchange Commission. All forward-looking statements contained herein are neither promises nor guarantees. The Company does not undertake any responsibility to revise or update any forward-looking statements contained herein.
Item 8.01 Other Events.
The Company issued a press release entitled “Columbia Laboratories Stockholders Approve Sale of Progesterone Assets to Watson Pharmaceuticals” on July 1, 2010, and a press release entitled “Columbia Laboratories Completes Sale of Progesterone Assets to Watson Pharmaceuticals” on July 6, 2010. Copies of the press releases are filed as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(b) Pro Forma Financial Information.

 


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Exhibit No.   Description
3.1
  Certificate of Amendment to Restated Certificate of Incorporation of Columbia Laboratories, Inc., filed with the Secretary of State of Delaware July 1, 2010
 
   
4.1
  Form of Warrant to Purchase Common Stock
 
   
10.1
  Investor’s Rights Agreement
 
   
10.2
  Supply Agreement
 
   
10.3
  License Agreement
 
   
99.1
  Press Release, dated July 1, 2010
 
   
99.2
  Press Release, dated July 6, 2010
 
   
99.3
  Unaudited Pro Forma Financial Statements of Columbia Laboratories, Inc.

 


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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.
Dated: July 2, 2010
         
  COLUMBIA LABORATORIES, INC.
 
 
  By:   /s/ Lawrence A. Gyenes    
    Lawrence A. Gyenes   
    Senior Vice President, Chief Financial Officer & Treasurer   
 

 


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Exhibit Index
     
Exhibit No.   Description
3.1
  Certificate of Amendment to Restated Certificate of Incorporation of Columbia Laboratories, Inc., filed with the Secretary of State of Delaware July 1, 2010
 
   
4.1
  Form of Warrant to Purchase Common Stock
 
   
10.1
  Investor’s Rights Agreement
 
   
10.2
  Supply Agreement
 
   
10.3
  License Agreement
 
   
99.1
  Press Release, dated July 1, 2010
 
   
99.2
  Press Release, dated July 6, 2010
 
   
99.3
  Unaudited Pro Forma Financial Statements of Columbia Laboratories, Inc.

 

Exhibit 3.1
CERTIFICATE OF AMENDMENT
OF
RESTATED CERTIFICATE OF INCORPORATION
OF
COLUMBIA LABORATORIES, INC.
     Columbia Laboratories, Inc., a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “Corporation”), DOES HEREBY CERTIFY:
     FIRST: The first paragraph of Article FOURTH of the Restated Certificate of Incorporation, as previously amended, of the Corporation is hereby deleted in its entirety and replaced with the following:
“The total number of shares of capital stock which the Corporation is authorized to issue is one hundred fifty-one million (151,000,000) shares, of which one hundred fifty million (150,000,000) shares shall be denominated common stock, $.01 par value per share (“Common Stock”), and one million (1,000,000) shares shall be denominated preferred stock, $.01 par value per share (“Preferred Stock”).”
     SECOND: The aforesaid amendment was duly adopted in accordance with the applicable provisions of Section 242 of the General Corporation Law of the State of Delaware.
     IN WITNESS WHEREOF, Columbia Laboratories, Inc. has caused this Certificate to be signed by Frank C. Condella, Jr., its Chief Executive Officer, this 1 st day of July, 2010.
         
  COLUMBIA LABORATORIES, INC.
 
 
  By:   /s/ Frank C. Condella, Jr.    
    Frank C. Condella, Jr.   
    Chief Executive Officer   

 

         
Exhibit 4.1
COLUMBIA LABORATORIES, INC.
WARRANT TO PURCHASE COMMON STOCK
No. W-               July 2, 2010
Void After July 2, 2015
THIS CERTIFIES THAT, for value received,                                           , with its principal office at                                                                , or its permitted assigns (the “ Holder ”), is entitled to subscribe for and purchase at the Exercise Price (defined below) from Columbia Laboratories, Inc., a Delaware corporation, with its principal office at 354 Eisenhower Parkway, Livingston, New Jersey 07039 (the “ Company ”), up to                                  shares of common stock of the Company, $0.01 par value per share (the “ Common Stock ”), subject to adjustment as provided herein. This Warrant is one of a series of substantially similar Warrants being issued as of the date hereof (the “ Issuance Date ”) pursuant to the terms of those certain Note Purchase and Amendment Agreements (the “ NPA Warrants ”), dated on or after March 3, 2010, each by and among the Company and certain other persons or entities (each a “ Purchaser ” and together, the “ Purchasers ”), including the original Holder of this Warrant (the “ Note Purchase Agreements ” and including the Note Purchase and Amendment Agreement, dated as of March 3, 2010, between the Company and the original Holder, the “ Note Purchase Agreement ”). Capitalized terms not otherwise defined herein shall have the respective meanings ascribed to such terms in the Note Purchase Agreement.
      1. DEFINITIONS . As used herein, the following terms shall have the following respective meanings:
          (a) “ Business Day ” means any day other than Saturday, Sunday or other day on which commercial banks in The City of New York are authorized or required by law to remain closed.
          (b) “ Closing Bid Price ” and “ Closing Sale Price ” means, for any security as of any date, the last closing bid price and last closing trade price, respectively, for such security on the Principal Market, as reported by Bloomberg, or, if the Principal Market begins to operate on an extended hours basis and does not designate the closing bid price or the closing trade price, as the case may be, then the last bid price or last trade price, respectively, of such security prior to 4:00:00 p.m., New York time, as reported by Bloomberg, or, if the Principal Market is not the principal securities exchange or trading market for such security, the last closing bid price or last trade price, respectively, of such security on the principal securities exchange or trading market where such security is listed or traded as reported by Bloomberg, or if the foregoing do not apply, the last closing bid price or last trade price, respectively, of such security in the over-the-counter market on the electronic bulletin board for such security as reported by Bloomberg, or, if no closing bid price or last trade price, respectively, is reported for such security by Bloomberg, the average of the bid prices, or the ask prices, respectively, of any market makers for such security as reported in the “pink sheets” by Pink Sheets LLC (formerly the National Quotation Bureau, Inc.). If the Closing Bid Price or the Closing Sale Price cannot be calculated for a security on a particular date on any of the foregoing bases, the Closing Bid Price or the Closing

 


 

Sale Price, as the case may be, of such security on such date shall be the fair market value as mutually determined by the Company and the Holder. All such determinations to be appropriately adjusted for any stock dividend, stock split, stock combination or other similar transaction during the applicable calculation period.
          (c) “ Exercise Period ” shall mean the period commencing 180 days after the date hereof and ending at 5:00 p.m., New York time, on July 2, 2015, unless sooner exercised or terminated as provided below.
          (d) “ Exercise Price ” shall mean $1.35, subject to adjustment pursuant to Section 5 below.
          (e) “ Exercise Shares ” shall mean the shares of the Common Stock issued upon exercise of this Warrant, subject to adjustment pursuant to the terms herein, including but not limited to adjustment pursuant to Section 5 below.
          (f) “ Principal Market ” means the principal securities exchange or securities market on which the Common Stock is then traded.
          (g) “ Trading Day ” means any day on which the Common Stock is traded on the Principal Market; provided that “Trading Day” shall not include any day on which the Common Stock is scheduled to trade on such exchange or market for less than 4.5 hours or any day that the Common Stock is suspended from trading during the final hour of trading on such exchange or market (or if such exchange or market does not designate in advance the closing time of trading on such exchange or market, then during the hour ending at 4:00:00 p.m., New York Time).
2. EXERCISE OF WARRANT .
           2.1 Method of Exercise . Subject to the terms and conditions hereof (including, without limitation, the limitations set forth in Section 2.5), this Warrant may be exercised by the Holder at any time during the Exercise Period, in whole or in part, by (i) delivery of a written notice, in the form attached hereto as Exhibit A (the “ Exercise Notice ”), of the Holder’s election to exercise this Warrant to the Company and (ii) (A) payment to the Company of an amount equal to the applicable Exercise Price multiplied by the number of shares of Common Stock as to which this Warrant is being exercised (the “ Aggregate Exercise Price ”) in cash or by wire transfer of immediately available funds or (B) by notifying the Company that this Warrant is being exercised pursuant to a Cashless Exercise (as defined in Section 2.3). The Holder shall not be required to deliver the original Warrant in order to effect an exercise hereunder. Execution and delivery of the Exercise Notice with respect to less than all of the Common Stock shall have the same effect as cancellation of the original Warrant and issuance of a new Warrant evidencing the right to purchase the remaining number of Exercise Shares. On or before the first Business Day following the date on which the Company has received each of the Exercise Notice and the Aggregate Exercise Price (or notice of a Cashless Exercise) (the “ Exercise Delivery Documents ”), the Company shall transmit by facsimile an acknowledgment of confirmation of receipt of the Exercise Delivery Documents to the Holder and the Company’s transfer agent (the “ Transfer Agent ”). On or before the third Business Day following the date

 


 

on which the Company has received all of the Exercise Delivery Documents (the “ Share Delivery Date ”), the Company shall (X) provided that the Transfer Agent is participating in The Depository Trust Company (“ DTC ”) Fast Automated Securities Transfer Program, upon the request of the Holder, credit such aggregate number of Exercise Shares to which the Holder is entitled pursuant to such exercise to the Holder’s or its designee’s balance account with DTC through its Deposit Withdrawal Agent Commission system, or (Y) if the Transfer Agent is not participating in the DTC Fast Automated Securities Transfer Program, issue and dispatch by overnight courier to the address as specified in the Exercise Notice, a certificate, registered in the Company’s share register in the name of the Holder or its designee, for the number of Exercise Shares to which the Holder is entitled pursuant to such exercise which certificates shall not bear any restrictive legends unless required pursuant to the Note Purchase Agreement or the Company places (or cauces to be placed) a restrictive legend thereon in accordance with Section 4.3(b) hereof. Upon delivery of the Exercise Delivery Documents, the Holder shall be deemed for all corporate purposes to have become the holder of record of the Exercise Shares with respect to which this Warrant has been exercised, irrespective of the date such Exercise Shares are credited to the Holder’s DTC account or the date of delivery of the certificates evidencing such Exercise Shares as the case may be. If this Warrant is submitted in connection with any exercise pursuant to this Section 2.1 and the number of Exercise Shares represented by this Warrant submitted for exercise is greater than the number of Exercise Shares being acquired upon an exercise, then the Company shall as soon as practicable and in no event later than three Business Days after any exercise and at its own expense, issue a new Warrant (in accordance with Section 2.4) representing the right to purchase the number of Exercise Shares purchasable immediately prior to such exercise under this Warrant, less the number of Exercise Shares with respect to which this Warrant is exercised. No fractional shares of Common Stock are to be issued upon the exercise of this Warrant. Fractional shares shall be treated as provided in Section 6. The Company shall pay any and all taxes which may be payable with respect to the issuance and delivery of Exercise Shares upon exercise of this Warrant.
           2.2 Company’s Failure to Timely Deliver Securities . If within three Trading Days after the Company’s receipt of the facsimile copy of a Exercise Notice the Company shall fail to issue and deliver a certificate to the Holder and register such Exercise Shares on the Company’s share register or credit the Holder’s balance account with DTC for the number of Exercise Shares to which the Holder is entitled upon such Holder’s exercise hereunder or if the Company fails to deliver to the Holder the certificate or certificates representing the applicable Exercise Shares (or credit the Holder’s balance account at DTC with the applicable Exercise Shares) within three Trading Days after its obligation to do so under clause (ii) below and if on or after such Trading Day the Holder purchases (in an open market transaction or otherwise) shares of Common Stock to deliver in satisfaction of a sale by the Holder of Exercise Shares issuable upon such exercise that the Holder anticipated receiving from the Company (a “ Buy-In ”), then the Company shall, within three Business Days after the Holder’s request and in the Holder’s discretion, either (i) pay cash to the Holder in an amount equal to the Holder’s total purchase price (including brokerage commissions, if any) for the shares of Common Stock so purchased (the “ Buy-In Price ”), at which point the Company’s obligation to deliver such certificate (and to issue such Exercise Shares) or credit such Holder’s balance account with DTC shall terminate, or (ii) promptly honor its obligation to deliver to the Holder a certificate or certificates representing such Exercise Shares or credit such Holder’s balance account with DTC and pay cash to the Holder in an amount equal to the excess (if any) of the Buy-In Price over the

 


 

product of (A) such number of Exercise Shares, times (B) the Closing Bid Price on the date of exercise.
           2.3 Cashless Exercise . Notwithstanding any provisions herein to the contrary, if, at any time during the Exercise Period, the Current Market Price (as defined below) of one share of Common Stock is greater than the Exercise Price (at the date of calculation as set forth below), in lieu of exercising this Warrant by payment of cash, the Holder may exercise this Warrant by a cashless exercise by surrender of this Warrant at the principal office of the Company together with the properly endorsed Notice of Exercise and the Company shall issue to the Holder a number of Exercise Shares computed using the following formula:
             
 
  X =   Y (B-A)
 
   
 
      B    
 
           
Where:   X =   the number of Exercise Shares to be issued to the Holder.
 
           
    Y =   the number of Exercise Shares purchasable upon exercise of all of the Warrant or, if only a portion of the Warrant is being exercised, the   portion of the Warrant being exercised.
 
           
     A = the Exercise Price.
 
           
     B = the Current Market Price of one share of Common Stock.
     “ Current Market Price ” means on any particular date:
          (a) if the Common Stock is traded on the Nasdaq Capital Market, the Nasdaq Global Market or the Nasdaq Global Select Market (or their successors), the average of the closing prices of the Common Stock of the Company on such market over the five trading days ending immediately prior to the applicable date of valuation;
          (b) if the Common Stock is traded on any registered national stock exchange but is not traded on the Nasdaq Capital Market, the Nasdaq Global Market or the Nasdaq Global Select Market (or their successors), the average of the closing prices of the Common Stock of the Company on such exchange over the five trading days ending immediately prior to the applicable date of valuation;
          (c) if the Common Stock is traded over-the-counter, but not on the Nasdaq Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market or a registered national stock exchange, the average of the closing bid prices over the 30-day period ending immediately prior to the applicable date of valuation; and
          (d) if there is no active public market for the Common Stock, the value thereof, as determined in good faith by the Board of Directors of the Company upon due consideration of the proposed determination thereof by the Holder.
           2.4 Partial Exercise . If this Warrant is exercised in part only, the Company shall, upon surrender of this Warrant, execute and deliver, within 10 days of the date of exercise,

 


 

a new Warrant evidencing the rights of the Holder, or, subject to Section 8, such other person as shall be designated in the Notice of Exercise, to purchase the balance of the Exercise Shares purchasable hereunder. In no event shall this Warrant be exercised for a fractional Exercise Share, and the Company shall not distribute a Warrant exercisable for a fractional Exercise Share. Fractional shares shall be treated as provided in Section 6.
           2.5 Limitations on Exercise .
          (a) The Company shall not effect the exercise of this Warrant, and the Holder shall not have the right to exercise this Warrant, to the extent that after giving effect to such exercise, such Person (together with such Person’s affiliates) would beneficially own in excess of 9.99% of the shares of Common Stock outstanding immediately after giving effect to such exercise. For purposes of the foregoing sentence, the aggregate number of shares of Common Stock beneficially owned by such Person and its affiliates shall include the number of shares of Common Stock issuable upon exercise of this Warrant with respect to which the determination of such sentence is being made, but shall exclude shares of Common Stock which would be issuable upon (i) exercise of the remaining, unexercised portion of this Warrant beneficially owned by such Person and its affiliates and (ii) exercise or conversion of the unexercised or unconverted portion of any other securities of the Company beneficially owned by such Person and its affiliates (including, without limitation, any convertible notes or convertible preferred stock or warrants) subject to a limitation on conversion or exercise analogous to the limitation contained herein. Except as set forth in the preceding sentence, for purposes of this paragraph, beneficial ownership shall be calculated in accordance with Section 13(d) of the Securities Exchange Act of 1934, as amended. For purposes of this Warrant, in determining the number of outstanding shares of Common Stock, the Holder may rely on the number of outstanding shares of Common Stock as reflected in (1) the Company’s most recent Form 10-K, Form 10-Q, Current Report on Form 8-K or other public filing with the Securities and Exchange Commission, as the case may be, (2) a more recent public announcement by the Company or (3) any other notice by the Company or the Transfer Agent setting forth the number of shares of Common Stock outstanding. For any reason at any time, upon the written request of the Holder, the Company shall within one Business Day confirm in writing to the Holder the number of shares of Common Stock then outstanding. In any case, the number of outstanding shares of Common Stock shall be determined after giving effect to the conversion or exercise of securities of the Company, including the NPA Warrants, by the Holder and its affiliates since the date as of which such number of outstanding shares of Common Stock was reported.
          (b) The Company shall not be obligated to issue any shares of Common Stock upon exercise of this Warrant, if the issuance of such shares of Common Stock would exceed that number of shares of Common Stock which the Company may issue upon exercise, redemption or conversion, as applicable, of the NPA Warrants or otherwise without breaching the Company’s obligations under the rules or regulations of the applicable Principal Market (the number of shares which may be issued without violating such rules and regulations, the “ Exchange Cap ”), except that such limitation shall not apply in the event that the Company (A) obtains the approval of its stockholders as required by the applicable rules of the applicable Principal Market for issuances of shares of Common Stock in excess of such amount or (B) obtains a written opinion from outside counsel to the Company that such approval is not required, which opinion shall be reasonably satisfactory to the Holders. Unless and until such

 


 

approval or written opinion is obtained, no Holder shall be issued in the aggregate, upon exercise or conversion, as applicable, of any NPA Warrants, shares of Common Stock in an amount greater than the product of the Exchange Cap multiplied by a fraction, the numerator of which is the total number of shares of Common Stock underlying the NPA Warrants issued to such Holder pursuant to the Note Purchase Agreements on the Issuance Date and the denominator of which is the aggregate number of shares of Common Stock underlying the NPA Warrants issued to the Purchasers pursuant to the Note Purchase Agreements on the Issuance Date (with respect to each Purchaser, the “ Exchange Cap Allocation ”). In the event that any Holder shall sell or otherwise transfer any of such Holder’s NPA Warrants, the transferee shall be allocated a pro rata portion of such Holder’s Exchange Cap Allocation, and the restrictions of the prior sentence shall apply to such transferee with respect to the portion of the Exchange Cap Allocation allocated to such transferee. In the event that any Holder of NPA Warrants shall exercise all of such Holder’s NPA Warrants into a number of shares of Common Stock which, in the aggregate, is less than such Holder’s Exchange Cap Allocation, then the difference between such Holder’s Exchange Cap Allocation and the number of shares of Common Stock actually issued to such Holder shall be allocated to the respective Exchange Cap Allocations of the remaining holders of NPA Warrants on a pro rata basis in proportion to the shares of Common Stock underlying the NPA Warrants then held by each such holder. In the event that the Company is prohibited from issuing any Warrant Shares for which an Exercise Notice has been received as a result of the operation of this Section 2.5(b), the Company shall pay cash in exchange for cancellation of such Warrant Shares, at a price per Warrant Share equal to the difference between the Closing Sale Price and the Exercise Price as of the date of the attempted exercise.
           2.6 Insufficient Authorized Shares . If at any time while any of the Warrants remain outstanding the Company does not have a sufficient number of authorized and unreserved shares of Common Stock to satisfy its obligation to reserve for issuance upon exercise of the Warrants at least a number of shares of Common Stock equal to 100% of the number of shares of Common Stock as shall from time to time be necessary to effect the exercise of all of the Warrants then outstanding (the “ Required Reserve Amount ”) (such event an “ Authorized Share Failure ”), then the Company shall immediately take all action necessary to increase the Company’s authorized shares of Common Stock to an amount sufficient to allow the Company to reserve the Required Reserve Amount for the Warrants then outstanding. Without limiting the generality of the foregoing sentence, as soon as practicable after the date of the occurrence of an Authorized Share Failure, but in no event later than 90 days after the occurrence of such Authorized Share Failure, the Company shall hold a meeting of its stockholders for the approval of an increase in the number of authorized shares of Common Stock. In connection with such meeting, the Company shall provide each stockholder with a proxy statement and shall use its best efforts to solicit its stockholders’ approval of such increase in authorized shares of Common Stock and to cause its board of directors to recommend to the stockholders that they approve such proposal.
      3. COVENANTS OF THE COMPANY .
           3.1 Covenants as to Exercise Shares . The Company covenants and agrees that all Exercise Shares that may be issued upon the exercise of the rights represented by this Warrant will, upon issuance, be validly issued and outstanding, fully paid and nonassessable, and free from all taxes, liens and charges with respect to the issuance thereof. The Company further

 


 

covenants and agrees that the Company will at all times during the Exercise Period have authorized and reserved, free from preemptive rights, a sufficient number of shares of its Common Stock to provide for the exercise of the rights represented by this Warrant. If at any time during the Exercise Period the number of authorized but unissued shares of Common Stock shall not be sufficient to permit exercise of this Warrant, the Company will take such corporate action as may, in the opinion of its counsel, be necessary to increase its authorized but unissued shares of Common Stock (or other securities as provided herein) to such number of shares as shall be sufficient for such purposes.
           3.2 Notices of Record Date . In the event of any taking by the Company of a record of the holders of any class of securities for the purpose of determining the holders thereof who are entitled to receive any dividend (other than a cash dividend which is the same as cash dividends paid in previous quarters) or other distribution, the Company shall mail to the Holder, at least ten days prior to the date specified herein, a notice specifying the date on which any such record is to be taken for the purpose of such dividend or distribution.
      4. REPRESENTATIONS OF HOLDER .
           4.1 Acquisition of Warrant for Personal Account . The Holder represents and warrants that it is acquiring the Warrant and the Exercise Shares solely for its account for investment and not with a present view toward the public sale or distribution of said Warrant or Exercise Shares or any part thereof and has no present intention of selling or distributing said Warrant or Exercise Shares or any arrangement or understanding with any other persons regarding the sale or distribution of said Warrant or, except in accordance with the provisions of Article V of the Note Purchase Agreement, if applicable, the Exercise Shares, and except as would not result in a violation of the Securities Act of 1933, as amended. The Holder will not, directly or indirectly, offer, sell, pledge, transfer or otherwise dispose of (or solicit any offers to buy, purchase or otherwise acquire or take a pledge of) the Warrant except in accordance with the Securities Act of 1933, as amended, and will not, directly or indirectly, offer, sell, pledge, transfer or otherwise dispose of (or solicit any offers to buy, purchase or otherwise acquire or take a pledge of) the Exercise Shares except in accordance with the provisions of Article V of the Note Purchase Agreement, if applicable, or pursuant to and in accordance with the Securities Act of 1933, as amended.
           4.2 Securities Are Not Registered .
          (a) The Holder understands that the offer and sale of the Warrant or the Exercise Shares have not been registered under the Securities Act of 1933, as amended, on the basis that no distribution or public offering of the securities of the Company is to be effected and/or pursuant to specific exemptions from the registration provisions of the Securities Act of 1933, as amended, which exemptions depend upon, among other things, the bona fide nature of the Holder’s investment intent as expressed herein. The Holder realizes that the basis for such exemptions may not be present if, notwithstanding its representations, the Holder has a present intention of acquiring the Warrants and/or the Exercise Shares for a fixed or determinable period in the future, selling (in connection with a distribution or otherwise), granting any participation in, or otherwise distributing the Warrants and/or the Exercise Shares. The Holder represents and warrants that it has no such present intention.

 


 

          (b) The Holder recognizes that the Warrant and the Exercise Shares must be held indefinitely unless they are subsequently registered under the Securities Act of 1933, as amended, or an exemption from such registration is available. The Holder recognizes that the Company has no obligation to register the Warrant or, except as provided in the Note Purchase Agreement, if applicable, the Exercise Shares, or to comply with any exemption from such registration.
           4.3 Disposition of Warrant and Exercise Shares .
          (a) The Holder further agrees not to make any disposition of all or any part of the Warrant or Exercise Shares in any event unless and until:
          (i) There is then in effect a registration statement under the Securities Act of 1933, as amended, covering such proposed disposition and such disposition is made in accordance with said registration statement;
          (ii) Solely with respect to the Warrant, the Holder shall have furnished to the Company the Certificate, after which the Holder may dispose of such Warrant in accordance with the provisions of Rule 144 under the Securities Act of 1933, as amended;
          (iii) Solely with respect to the Exercise Shares that the Holder acquires pursuant to the “cashless exercise” provisions of Section 2.3 hereof, and only if the Holder shall have furnished to the Company the Certificate at the time of such “cashless exercise”, the Holder may dispose of such Exercise Shares in accordance with the provisions of Rule 144 under the Securities Act of 1933, as amended; or
          (iv) If reasonably requested by the Company, the Holder shall have furnished the Company with an opinion of counsel, reasonably satisfactory to the Company, for the Holder to the effect that such disposition will not require registration of such Warrant or Exercise Shares under the Securities Act of 1933, as amended, or any applicable state securities laws; provided, that no opinion shall be required for any disposition made or to be made in accordance with the provisions of Rule 144 under the Securities Act of 1933, as amended.
          (b) The Holder understands and agrees that all certificates evidencing the Exercise Shares to be issued to the Holder may bear a legend in substantially the following form (except such legend will not be placed on Exercise Shares acquired under the Warrant pursuant to a “cashless exercise” pursuant to Section 2.3 if immediately prior to such “cashless exercise” the Holder provides the Certificate to the Company):
THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR THE SECURITIES LAWS OF ANY STATE OF THE UNITED STATES. THE SECURITIES MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED, HYPOTHECATED, TRANSFERRED OR ASSIGNED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT FOR THE SECURITIES UNDER APPLICABLE SECURITIES LAWS, OR UNLESS OFFERED, SOLD, PLEDGED,

 


 

HYPOTHECATED OR TRANSFERRED PURSUANT TO AN AVAILABLE EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THOSE LAWS. COLUMBIA LABORATORIES, INC. SHALL BE ENTITLED TO REQUIRE AN OPINION OF COUNSEL SATISFACTORY TO COLUMBIA LABORATORIES, INC. THAT SUCH REGISTRATION IS NOT REQUIRED TO THE EXTENT THAT AN OPINION IS REQUIRED PURSUANT TO THE AGREEMENT UNDER WHICH THE SECURITIES WERE ISSUED.
      5. ADJUSTMENTS . In the event of changes in the outstanding Common Stock of the Company by reason of any stock split, stock dividend, recapitalization, reclassification, combination or exchange of shares, reorganization, liquidation, dissolution, consolidation or merger effected by the Company, the number and class of shares available under the Warrant in the aggregate and the Exercise Price shall be correspondingly adjusted to give the Holder of the Warrant, on exercise for the same aggregate Exercise Price, the total number, class and kind of shares or other property, including cash, as the Holder would have owned had the Warrant been exercised prior to the event and had the Holder continued to hold such shares until after the event requiring adjustment. The form of this Warrant need not be changed because of any adjustment in the Exercise Price and/or number, class and kind of shares subject to this Warrant. The Company shall promptly provide a certificate from its Chief Financial Officer notifying the Holder in writing of any adjustment in the Exercise Price and/or the total number, class and kind of shares issuable upon exercise of this Warrant, which certificate shall specify the Exercise Price and number, class and kind of shares under this Warrant after giving effect to such adjustment. For the avoidance of doubt, if necessary to effectuate the provisions of this paragraph 5, any successor to the Company or surviving entity in a reorganization, consolidation or merger effected by the Company shall deliver to the Holder confirmation (or a new warrant to the effect) that such successor or surviving entity shall have all of the obligations of the Company under this Warrant with the same effect as if such successor or surviving entity had been named as the Company herein, and that there shall be issued upon exercise of this Warrant (or a new warrant) at any time after the consummation of such reorganization, consolidation or merger, in lieu of the shares of Common Stock issuable upon the exercise of this Warrant prior to such transaction, the total number, class and kind of shares or other property, including cash, as the Holder would have owned had the Warrant been exercised prior to such transaction and had the Holder continued to hold such shares until after such transaction.
      6. FRACTIONAL SHARES . No fractional shares shall be issued upon the exercise of this Warrant as a consequence of any adjustment pursuant hereto. All Exercise Shares (including fractions) issuable upon exercise of this Warrant may be aggregated for purposes of determining whether the exercise would result in the issuance of any fractional share. If, after aggregation, the exercise would result in the issuance of a fractional share, the Company shall, in lieu of issuance of any fractional share, pay the Holder otherwise entitled to such fraction a sum in cash equal to the product resulting from multiplying the fair market value of the Common Stock on the date of exercise of this Warrant by such fraction.
      7. NO STOCKHOLDER RIGHTS . This Warrant in and of itself shall not entitle the Holder to any voting rights or other rights as a stockholder of the Company.

 


 

      8. TRANSFER OF WARRANT . Subject to applicable laws and compliance with Section 4.3, this Warrant and all rights hereunder are transferable, by the Holder in person or by duly authorized attorney, upon delivery of this Warrant and the form of assignment attached hereto to any transferee designated by Holder.
           8.1 Upon such surrender and, if required, such payment, the Company shall execute and deliver a new Warrant or Warrants in the name of the assignee or assignees and in the denomination or denominations specified in such instrument of assignment, and shall issue to the assignor a new Warrant evidencing the portion of this Warrant not so assigned, and this Warrant shall promptly be cancelled. A Warrant, if properly assigned, may be exercised by a new holder for the purchase of shares of Common Stock without having a new Warrant issued.
           8.2 If, at the time of the surrender of this Warrant in connection with any transfer of this Warrant, (i) the transfer of this Warrant shall not be registered pursuant to an effective registration statement under the Securities Act of 1933, as amended, and under applicable state securities or blue sky laws, and (ii) the Holder has not furnished to the Company the Certificate at such time, the Company may require, as a condition of allowing such transfer (A) that the Holder or transferee of this Warrant, as the case may be, furnish to the Company a written opinion of counsel (which opinion shall be in form, substance and scope customary for opinions of counsel in comparable transactions) to the effect that such transfer may be made without registration under the Securities Act of 1933, as amended, and under applicable state securities or blue sky laws, and (B) that the holder or transferee execute and deliver to the Company an investment letter in form and substance acceptable to the Company; provided , in any case, that the transferee shall be an “accredited investor” as defined in Rule 501(a)(1), (a)(2), (a)(3), (a)(7), or (a)(8) promulgated under the Securities Act of 1933, as amended, or a “qualified institutional buyer” as defined in Rule 144A(a) under the Securities Act of 1933, as amended.
      9. LOST, STOLEN, MUTILATED OR DESTROYED WARRANT . If this Warrant is lost, stolen, mutilated or destroyed, the Company may, on such terms as to indemnity or otherwise as it may reasonably impose (which shall, in the case of a mutilated Warrant, include the surrender thereof), issue a new Warrant of like denomination and tenor as the Warrant so lost, stolen, mutilated or destroyed. Any such new Warrant shall constitute an original contractual obligation of the Company, whether or not the allegedly lost, stolen, mutilated or destroyed Warrant shall be at any time enforceable by anyone.
      10. MODIFICATIONS AND WAIVER . This Warrant and any provision hereof may be changed, waived, discharged or terminated only by an instrument in writing signed by the Company and (i) Purchasers holding Warrants representing at least a majority of the number of Exercise Shares then issuable upon exercise of any then unexercised Warrants issued pursuant to the Note Purchase Agreements, provided , however , that such modification, amendment or waiver is made with respect to all unexercised Warrants issued pursuant to the Note Purchase Agreements and does not adversely affect the Holder without adversely affecting all holders of Warrants in a similar manner; or (ii) the Holder.
      11. NOTICES, ETC . All notices required or permitted hereunder shall be in writing and shall be deemed effectively given: (a) upon personal delivery to the party to be notified, (b) when sent by confirmed email, telex or facsimile if sent during normal business hours of the

 


 

recipient, if not, then on the next business day, (c) five days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one business day after deposit with a nationally recognized overnight courier, specifying next day delivery, with written verification of receipt. All communications shall be sent to the Company at the address listed on the signature page and to the Holders at the addresses on the Company records, or at such other address as the Company or Holder may designate by ten days’ advance written notice to the other party hereto.
      12. ACCEPTANCE . Receipt of this Warrant by the Holder shall constitute acceptance of and agreement to all of the terms and conditions contained herein.
      13. GOVERNING LAW . This Warrant and all rights, obligations and liabilities hereunder shall be governed by the laws of the State of New York without regard to the principles of conflict of laws.
      14. DESCRIPTIVE HEADINGS . The descriptive headings of the several paragraphs of this Warrant are inserted for convenience only and do not constitute a part of this Warrant. The language in this Warrant shall be construed as to its fair meaning without regard to which party drafted this Warrant.
      15. SEVERABILITY . The invalidity or unenforceability of any provision of this Warrant in any jurisdiction shall not affect the validity or enforceability of such provision in any other jurisdiction, or affect any other provision of this Warrant, which shall remain in full force and effect.
      16. ENTIRE AGREEMENT . This Warrant constitutes the entire agreement between the parties pertaining to the subject matter contained in it and supersedes all prior and contemporaneous agreements, representations, and undertakings of the parties, whether oral or written, with respect to such subject matter.
      17. REMEDIES, OTHER OBLIGATIONS, BREACHES AND INJUNCTIVE RELIEF . The remedies provided in this Warrant shall be cumulative and in addition to all other remedies available under this Warrant and the Note Purchase Agreements, at law or in equity (including a decree of specific performance and/or other injunctive relief), and nothing herein shall limit the right of the Holder right to pursue actual damages for any failure by the Company to comply with the terms of this Warrant. The Company acknowledges that a breach by it of its obligations hereunder will cause irreparable harm to the Holder and that the remedy at law for any such breach may be inadequate. The Company therefore agrees that, in the event of any such breach or threatened breach, the holder of this Warrant shall be entitled, in addition to all other available remedies, to an injunction restraining any breach, without the necessity of showing economic loss and without any bond or other security being required.
[SIGNATURE PAGE FOLLOWS]

 


 

      IN WITNESS WHEREOF , the Company has caused this Warrant to be executed by its duly authorized officer as of July 2, 2010.
         
  COLUMBIA LABORATORIES, INC.
 
 
  By:      
    Name:   Frank C. Condella, Jr.   
    Title:   Chief Executive Officer  
    Address:   354 Eisenhower Parkway, Livingston, New Jersey 07039    
    Attention: General Counsel  
    Facsimile:   973.994.3001   
 

 

Exhibit 10.1
INVESTOR’S RIGHTS AGREEMENT
Dated July 2, 2010

 


 

TABLE OF CONTENTS
       
    Page
SECTION 1 DEFINITIONS
  1
1.1 Certain Definitions
  1
 
   
SECTION 2 REGISTRATION RIGHTS
  4
2.1 Shelf-Registration
  4
2.2 Expenses
  4
2.3 Registration Procedures
  4
2.4 Indemnification
  7
2.5 Registration Covenants
  9
2.6 Rule 144 Reporting
  11
 
   
SECTION 3 BOARD OF DIRECTORS
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3.1 Investor Designee
  11
3.2 Designation
  11
3.3 Change in Designee
  11
3.4 Information
  11
3.5 Termination of Rights
  12
3.6 No Compensation
  12
3.7 Confidentiality Agreement
  12
 
   
SECTION 4 LOCK-UP AGREEMENT
  12
4.1 Lock-Up Agreement
  12
4.2 Stop-Transfer Instructions
  14
4.3 Termination of Lock-Up Agreement
  14
 
   
SECTION 5 MISCELLANEOUS
  14
5.1 Amendment
  14
5.2 Notices
  14
5.3 Information
  14
5.4 Successors and Assigns
  15
5.5 Entire Agreement
  15
5.6 Delays or Omissions
  15
5.7 Severability
  15
5.8 Titles and Subtitles
  15
5.9 Counterparts
  16
5.10 Further Assurances
  16
5.11 Injunctive Relief
  16
5.12 Governing Law
  16
5.13 Arbitration
  16
5.14 Recapitalization, Exchanges, Etc
  17
5.15 Conflict
  17

 


 

INVESTOR’S RIGHTS AGREEMENT
     This Investor’s Rights Agreement (this “ Agreement ”) is dated as of July 2, 2010, and is between Columbia Laboratories, Inc., a Delaware corporation (the “ Company ”), and Coventry Acquisition, Inc., a Delaware corporation (the “ Investor ”). All capitalized terms used and not defined herein shall have such meanings as set forth in the Purchase and Collaboration Agreement, dated as of March 3, 2010, by and between the Company and the Investor (the “ Purchase and Collaboration Agreement ”).
RECITALS
      WHEREAS , the Investor and the Company are parties to the Purchase and Collaboration Agreement pursuant to which Investor, among other things, acquired from the Company 11,200,000 shares of Common Stock (the “ Shares ”); and
      WHEREAS , the Company and the Investor are entering into this Agreement pursuant to the Purchase and Collaboration Agreement.
      NOW, THEREFORE , in consideration of the foregoing and for other good and valuable consideration, the sufficiency of which is acknowledged, the parties hereto agree as follows:
ARTICLE I.
DEFINITIONS
      1.1 Certain Definitions . As used in this Agreement, the following terms shall have the meanings set forth below:
(a) “ AAA ” shall have the meaning set forth in Section 5.13(a).
(b) “ Affiliate ” shall mean, with respect to any Person (as defined below), any other Person controlling, controlled by or under direct or indirect common control with such Person (for the purposes of this definition “ control, ” when used with respect to any specified Person, shall mean the power to direct the management and policies of such Person, directly or indirectly, whether through ownership of voting securities, by contract or otherwise; and the terms “ controlling ” and “ controlled ” shall have meanings correlative to the foregoing).
(c) “ Agreement ” shall have the meaning set forth in the Preamble.
(d) “ Arbitrator ” shall have the meaning set forth in Section 5.13(b).
(e) “ Board ” shall mean the Company’s board of directors.
(f) “ Business Day ” shall mean a day Monday through Friday on which banks are generally open for business in New York City.
(g) “ Bylaws ” shall mean the Company’s Amended and Restated Bylaws, as amended from time to time.

 


 

(h) “ Certificate ” shall mean the Company’s Restated Certificate of Incorporation as filed with the Secretary of State of the State of Delaware and as amended from time to time.
(i) “ Commission ” shall mean the Securities and Exchange Commission or any other federal agency at the time administering the Securities Act.
(j) “ Common Stock ” shall mean the Company’s common stock, $0.01 par value per share.
(k) “ Company ” shall have the meaning set forth in the Preamble.
(l) “ DGCL ” shall mean the General Corporation Law of the State of Delaware.
(m) “ Dispute ” shall have the meaning set forth in Section 5.13(a).
(n) “ Enforcing Court ” shall have the meaning set forth in Section 5.13(e).
(o) “ Exchange Act ” shall mean the Securities Exchange Act of 1934, as amended, or any similar successor federal statute and the rules and regulations thereunder, all as the same shall be in effect from time to time.
(p) “ Filing Date ” shall have the meaning set forth in Section 2.1(a).
(q) “ Financial Statements ” shall mean the financial statements of the Company filed with the Commission in connection with the registration contemplated under this Agreement.
(r) “ Indemnified Party ” shall have the meaning set forth in Section 2.4(c).
(s) “ Indemnifying Party ” shall have the meaning set forth in Section 2.4(c).
(t) “ Initial Lock-Up Period ” shall have the meaning set forth in Section 4.1(a).
(u) “ Investor ” shall have the meaning set forth in the Preamble.
(v) “ Investor Designee ” shall have the meaning set forth in Section 3.1.
(w) “ Nasdaq Stock Market ” shall have the meaning set forth in Section 2.3(i).
(x) “ Person ” shall mean any person, individual, corporation, limited liability company, partnership, trust or other nongovernmental entity or any governmental agency, court, authority or other body (whether foreign, federal, state, local or otherwise).
(y) “ Purchase and Collaboration Agreement ” shall have the meaning set forth in the Preamble.
(z) The terms “ register, ” “ registered ” and “ registration ” refer to the registration effected by preparing and filing a registration statement in compliance with the Securities Act and applicable rules and regulations thereunder, and the declaration or ordering of the effectiveness of such registration statement.

 


 

(aa) “ Registrable Securities ” shall mean (i) any Shares and (ii) any Common Stock issued as a dividend or other distribution with respect to or in exchange for or in replacement of the Shares referenced in (i) above, in each case until Transferred by the Investor to the extent permitted by this Agreement; provided , however , that Registrable Securities shall not include any securities described in clause (i) or (ii) above which have previously been registered or which have been sold to the public either pursuant to a Registration Statement or Rule 144, or which have been sold in a private transaction.
(bb) “ Registration Expenses ” shall mean all expenses incurred by the Company in complying with Section 2.1 hereof, including, without limitation, all registration, qualification and filing fees, printing expenses, escrow fees, fees and expenses of counsel for the Company, “blue sky” fees and expenses and the expense of any special audits incident to or required by any such registration (but, for the avoidance of doubt, excluding the fees of legal counsel for the Investor).
(cc) “ Registration Statement ” shall mean any registration statement of the Company filed with the Commission on the appropriate form pursuant to the Securities Act which covers any Registrable Securities pursuant to the provisions of this Agreement and all amendments and supplements to any such Registration Statement, including post-effective amendments, all exhibits thereto and all materials incorporated by reference therein.
(dd) “ Registration Period ” shall have the meaning set forth in Section 2.1(b).
(ee) “ Rule 144 ” shall mean Rule 144 as promulgated by the Commission under the Securities Act, as such Rule may be amended from time to time, or any similar successor rule that may be promulgated by the Commission.
(ff) “ Securities Act ” shall mean the Securities Act of 1933, as amended, or any similar successor federal statute and the rules and regulations thereunder, all as the same shall be in effect from time to time.
(gg) “ Selling Expenses ” shall mean all underwriting discounts and the selling commissions and stock transfer taxes applicable to the sale of Registrable Securities and the fees and disbursements of counsel for the Investor.
(hh)“ Shares shall have the meaning set forth in the Recitals.
(ii) “ Shelf Registration Statement ” shall have the meaning set forth in Section 2.1(a).
(jj) “ Subsidiary ” shall mean, when used with reference to an entity, any other entity of which (i) securities or other ownership interests having ordinary voting power to elect a majority of the board of directors or other Persons performing similar functions, or (ii) a majority of the outstanding securities of which, are owned directly or indirectly by such entity.
(kk)“ Transaction Delay Notice ” shall have the meaning set forth in Section 2.5(b).
(ll) “ Transaction Delay Period ” shall have the meaning set forth in Section 2.5(b).

 


 

(mm) “ Transfer ” and “ Transferred ” shall mean to directly or indirectly sell, transfer, exchange, assign, pledge, hypothecate, make any short sale of, loan, grant any option for the purchase of, or otherwise dispose of.
ARTICLE II.
REGISTRATION RIGHTS
      2.1 Shelf-Registration .
(a) The Company shall use commercially reasonable efforts to file not later than ninety (90) days before the end of the Initial Lock-Up Period (the “ Filing Date ”) a Registration Statement pursuant to Rule 415 under the Securities Act with the Commission covering the resale of the Registrable Securities on a delayed or continuous basis (the “ Shelf Registration Statement ”), and effect the registration, qualifications or compliances (including, without limitation, the execution of any required undertaking to file post-effective amendments, appropriate qualifications or exemptions under applicable “blue sky” or other state securities laws and appropriate compliance with applicable securities laws, requirements or regulations) of the Registrable Securities as promptly as possible after the filing thereof. The Shelf Registration Statement will be on Form S-3; provided , that if Form S-3 is not available for use by the Company on the Filing Date, then the Registration Statement will be on such form as is then available.
(b) Except for such times as the Company is permitted hereunder to suspend the use of the prospectus forming part of the Shelf Registration Statement pursuant to Section 2.5, use commercially reasonable efforts to keep such registration, and any qualification, exemption or compliance under state securities laws which the Company determines to obtain, continuously effective, and to keep such Shelf Registration Statement free of any untrue statement of a material fact or omission to state a material fact required to be stated therein or necessary to make the statements contained therein not misleading, in light of the circumstances in which they were made, until the earliest of the following: (i) the date of the fourth (4 th ) anniversary of the date on which the Shelf Registration Statement is initially declared effective by the Commission, (ii) the date all of the Registrable Securities have been Transferred by the Investor and (iii) the date all of the Registrable Securities then held by the Investor may be sold by the Investor under Rule 144 during any ninety (90) day period without complying with the provisions of clause (c) or (f) of Rule 144. The period of time during which the Company is required hereunder to keep the Shelf Registration Statement effective is referred to herein as the “ Registration Period .” The rights of the Investor under this Section 2 shall terminate on the last day of the Registration Period.
      2.2 Expenses . All Registration Expenses incurred in connection with any registration, qualification, exemption or compliance pursuant to Section 2, shall be borne by the Company. All Selling Expenses relating to the sale of Registrable Securities registered hereunder by or on behalf of the Investor shall be borne by the Investor.
      2.3 Registration Procedures . In the case of the registration, qualification, exemption or compliance effected by the Company pursuant to this Agreement, the Company shall:

 


 

(a) notify the Investor within three (3) Business Days:
(i) when the Shelf Registration Statement or any amendment thereto has been filed with the Commission and when the Shelf Registration Statement or any post-effective amendment thereto has become effective;
(ii) of any request by the Commission for amendments or supplements to the Shelf Registration Statement or the prospectus included therein, upon which the Company will use its commercially reasonable efforts to file the same with the Commission;
(iii) of the issuance by the Commission of any stop order suspending the effectiveness of the Shelf Registration Statement or the initiation of any proceedings for such purpose;
(iv) of the receipt by the Company of any notification with respect to the suspension of the qualification of the Registrable Securities included therein for sale in any jurisdiction or the initiation or threatening of any proceeding for such purpose, upon which the Company will use its commercially reasonable efforts promptly to obtain the withdrawal of such suspension or address any such proceedings, as applicable; and
(v) of the occurrence of any event that requires the making of any changes in the Shelf Registration Statement or the prospectus forming a part thereof so that, as of such date, the Shelf Registration Statement and the prospectus forming a part thereof, as applicable, do not contain an untrue statement of material fact, and do not omit to state a material fact required to be stated therein or necessary to make the statements therein (in the case of the prospectus, in the light of the circumstances under which they were made) not misleading ( provided , that, in no event shall such notice contain any material, non-public information);
(b) use commercially reasonable efforts to obtain the withdrawal of any order suspending the effectiveness of the Shelf Registration Statement as soon as reasonably practicable;
(c) promptly furnish the Investor, without charge, at least one copy of the Shelf Registration Statement and any post-effective amendment thereto, including Financial Statements and schedules, and, if explicitly requested, all exhibits in the form filed with the Commission;
(d) during the Registration Period, promptly deliver to the Investor, without charge, as many copies of the prospectus included in the Shelf Registration Statement and any amendment or supplement thereto as the Investor may reasonably request; and, subject to the limitations contained herein, the Company consents to the use, consistent with the provisions hereof, of the prospectus or any amendment or supplement thereto by the Investor in connection with the offering and sale of the Registrable Securities covered by the prospectus forming a part thereof or any amendment or supplement thereto;
(e) during the Registration Period, if the Investor so requests, deliver to the Investor, without charge, (i) one copy of the following documents: (A) its annual report to its stockholders, if any (which annual report shall contain financial statements audited in accordance with generally accepted accounting principles in the United States of America by an independent registered public accounting firm of recognized standing), (B) its annual report on Form 10-K (or similar form), (C) its definitive proxy statement with respect to its annual meeting of stockholders, (D)

 


 

each of its quarterly report(s) on Form 10-Q (or similar form), and (E) a copy of the full Shelf Registration Statement (the foregoing, in each case, excluding exhibits); and (ii) if explicitly requested, all exhibits excluded by the parenthetical to the immediately preceding clause (E);
(f) prior to any public offering of Registrable Securities pursuant to the Shelf Registration Statement, promptly take such actions as may be necessary to register or qualify or obtain an exemption for offer and sale under the securities or “blue sky” laws of such United States jurisdictions as the Investor reasonably requests in writing; provided , that the Company shall not for any such purpose be required to qualify generally to transact business as a foreign corporation in any jurisdiction where it is not so qualified or to consent to general service of process in any such jurisdiction, and do any and all other acts or things reasonably necessary or advisable to enable the offer and sale in such jurisdictions of the Registrable Securities covered by the Shelf Registration Statement;
(g) upon the occurrence of any event contemplated by Section 2.3(a)(v) above, except for such times as the Company is permitted hereunder to suspend the use of the prospectus forming part of the Shelf Registration Statement, pursuant to Section 2.5, the Company shall use commercially reasonable efforts to as soon as reasonably practicable prepare a post effective amendment to the Shelf Registration Statement or a supplement to the prospectus forming a part thereof, or file any other required document so that, as thereafter delivered to purchasers of the Registrable Securities included therein, such prospectus will not include any untrue statement of a material fact or omit to state any material fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading;
(h) otherwise use commercially reasonable efforts to comply in all material respects with all applicable rules and regulations of the Commission which could affect the sale of the Registrable Securities;
(i) use commercially reasonable efforts to cause the Registrable Securities included in the Shelf Registration Statement to be listed on the NASDAQ Global Market (“ NASDAQ Stock Market ”) or, if the Common Stock is not then listed on the NASDAQ Stock Market, on the principal national securities exchange on which the Common Stock is then listed, or if the Common Stock is not then listed on a national securities exchange, authorized for quotation on any automated quotation system on which the Common Stock is then quoted;
(j) during the Registration Period, furnish to the Investor, without charge, copies of any correspondence from the Commission or the staff of the Commission to the Company or its representatives relating to the Shelf Registration Statement or any document incorporated by reference therein within five (5) Business Days after the Company’s receipt thereof;
(k) use commercially reasonable efforts to take all other steps necessary to effect the registration of the Registrable Securities contemplated hereby and to enable the Investor to sell Registrable Securities under Rule 144; and
(l) if the Investor so requests in writing, permit a single counsel, designated by the Investor to review and provide reasonable comments to the Shelf Registration Statement and all

 


 

amendments and supplements thereto, within three (3) Business Days prior to the filing thereof with the Commission;
provided , that, in the case of clause (l) above, the Company shall not be required (A) to delay the filing of the Shelf Registration Statement or any amendment or supplement thereto to incorporate any comments to the Shelf Registration Statement or any amendment or supplement thereto by or on behalf of the Investor if such comments would require or result in a delay in the filing of the Shelf Registration Statement, amendment or supplement, as the case may be, and the Company reasonably believes (after consulting with legal counsel) that such comments are not necessary to incorporate into the Shelf Registration Statement or any amendment or supplement thereto in order to comply with the Securities Act or (B) to provide, and shall not provide, the Investor or its representatives with material, non-public information unless the Investor agrees to receive such information and enters into a written confidentiality agreement with the Company in a form reasonably acceptable to the Company.
      2.4 Indemnification .
(a) To the extent permitted by law, the Company shall (subject to Section 2.4(c) below) indemnify the Investor, each of its directors and officers, and each person who controls the Investor within the meaning of Section 15 of the Securities Act, with respect to any registration that has been effected pursuant to this Agreement, against all claims, losses, damages and liabilities (or action in respect thereof), including any of the foregoing incurred in settlement of any litigation, commenced or threatened (subject to Section 2.4(c) below), arising out of or based on any untrue statement (or alleged untrue statement) of a material fact contained in the Shelf Registration Statement, prospectus or any amendment or supplement thereof, or based on any omission (or alleged omission) to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading (in case of any prospectus, in light of the circumstances in which they were made), or any violation by the Company of any rule or regulation promulgated under the Securities Act applicable to the Company and relating to any action or inaction required of the Company in connection with any such registration, qualification or compliance, and will reimburse the Investor and each person controlling the Investor, for reasonable legal and other out-of-pocket expenses reasonably incurred in connection with investigating or defending any such claim, loss, damage, liability or action as incurred; provided that the Company will not be liable in any such case to the extent that any untrue statement or omission is made in reliance upon and in conformity with written information furnished to the Company by or on behalf of the Investor specifically for use in preparation of the Shelf Registration Statement, prospectus, amendment or supplement.
(b) The Investor will indemnify the Company, each of its directors and officers, and each person who controls the Company within the meaning of Section 15 of the Securities Act, against all claims, losses, damages and liabilities (or actions in respect thereof), including any of the foregoing incurred in settlement of any litigation, commenced or threatened (subject to Section 2.4(c) below), arising out of or based on any untrue statement (or alleged untrue statement) of a material fact contained in the Shelf Registration Statement, prospectus, or any amendment or supplement thereof, or based on any omission (or alleged omission) to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading (in case of any prospectus, in light of the circumstances in which they were

 


 

made), and will reimburse the Company, such directors and officers, and each person controlling the Company for reasonable legal and any other expenses reasonably incurred in connection with investigating or defending any such claim, loss, damage, liability or action as incurred, in each case to the extent, but only to the extent, that such untrue statement or omission or allegation thereof is made in reliance upon and in conformity with written information furnished to the Company by or on behalf of the Investor specifically for use in preparation of the Shelf Registration Statement, prospectus, amendment or supplement. Notwithstanding the foregoing, the Investor’s aggregate liability pursuant to this Section 2.4(b) and Section 2.4(d) shall be limited to the net amount received by the Investor from the sale of the Registrable Securities pursuant to the Shelf Registration Statement.
(c) Each party entitled to indemnification under this Section 2.4 (the “ Indemnified Party ”) shall give notice to the party required to provide indemnification (the “ Indemnifying Party ”) promptly after such Indemnified Party has actual knowledge of any claim, action or litigation as to which indemnity may be sought, and shall permit the Indemnifying Party (at its expense) to assume the defense of any such claim, action or litigation resulting therefrom; provided , that counsel for the Indemnifying Party, who shall conduct the defense of such claim, action or litigation, shall be approved by the Indemnified Party (whose approval shall not unreasonably be withheld), and the Indemnified Party may participate in such defense at such Indemnified Party’s expense (and after the assumption of the defense of any such claim, action or litigation by the Indemnifying Party, the Indemnified Party shall not be entitled to reimbursement or indemnification for its legal or other out-of-pocket expenses incurred in action with investigating or defending any such claim, action or litigation except for out-of-pocket costs (excluding legal or other professional fees or expenses) solely to the extent incurred by the Indemnified Party for it to comply with any order or legally binding determination of a court or other governmental authority or to provide assistance in the defense or investigation of such claim at the request or direction of the Indemnifying Party), and provided , further , that the failure of any Indemnified Party to give notice as provided herein shall not relieve the Indemnifying Party of its obligations under this Agreement, except to the extent such failure is materially prejudicial to the Indemnifying Party in defending such claim, action or litigation. The Indemnified Party shall not settle, compromise, or consent to the entry of any judgment with respect to any such claim, action or litigation without the prior written consent of the Indemnifying Party (which consent will not be unreasonably withheld) and the Indemnifying Party shall not be liable for any compromise, settlement or consent to the entry of any judgment with respect to any claim, action or litigation effected without its prior written consent. No Indemnifying Party, in its defense of any such claim, action or litigation, shall, except with the consent of each Indemnified Party, settle, compromise or consent to entry of any judgment which does not include as an unconditional term thereof the giving by the claimant or plaintiff to such Indemnified Party of a release from all liability in respect to such claim, action or litigation.
(d) If the indemnification provided for in this Section 2.4 is held by a court of competent jurisdiction to be unavailable to an Indemnified Party with respect to any loss, liability, claim, damage or expense referred to therein, then the Indemnifying Party, in lieu of indemnifying such Indemnified Party thereunder, shall contribute to the amount paid or payable by such Indemnified Party as a result of such loss, liability, claim, damage or expense in such proportion as is appropriate to reflect the relative fault of the Indemnifying Party on the one hand and of the Indemnified Party on the other in connection with the statements or omissions which resulted in

 


 

such loss, liability, claim, damage or expense as well as any other relevant equitable considerations. The relative fault of the Indemnifying Party and of the Indemnified Party shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission to state a material fact relates to information supplied by the Indemnifying Party or by the Indemnified Party and the parties’ relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission.
(e) The amount paid or payable by an Indemnified Party as a result of the losses, claims, damages, and liabilities referred to in this Section 2.4 shall include the reasonable legal or other expenses reasonably incurred by such Indemnified Party in connection with investigating or defending any such action or claim, subject to the provisions of Section 2.4(c). No Person guilty of fraudulent misrepresentation (within the meaning of the Securities Act) shall be entitled to contribution from any Person who was not guilty of such fraudulent misrepresentation.
(f) The obligations of the Company and the Investor under this Section 2.4 shall survive the completion of any offering of Registrable Securities under the Shelf Registration Statement.
      2.5 Registration Covenants .
(a) The Investor agrees that, upon receipt of any notice from the Company of the happening of any event:
(i) requiring the preparation of a supplement or amendment to a prospectus relating to Registrable Securities so that, as thereafter delivered to the Investor, such prospectus shall not contain an untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein not misleading, the Investor will forthwith discontinue offering or Transferring Registrable Securities pursuant to the Shelf Registration Statement and prospectus forming a part thereof contemplated by Section 2.1 until its receipt of copies of the supplemented or amended prospectus from the Company and, if so directed by the Company, the Investor shall deliver to the Company all copies, other than permanent file copies then in the Investor’s possession, of the prospectus covering such Registrable Securities current at the time of receipt of such notice;
(ii) contemplated by Section 2.3(a)(iii), the Investor shall forthwith discontinue offering or Transferring Registrable Securities pursuant to the Shelf Registration Statement and the prospectus forming a part thereof contemplated by Section 2.1 until its receipt of a notice from the Company stating that the stop order of the type referred to in Section 2.3(a)(iii) is no longer applicable or that the Commission will not issue any such stop order pursuant to the proceedings of the type referred to in Section 2.3(a)(iii); or
(iii) contemplated by Section 2.3(a)(iv), the Investor shall forthwith discontinue offering or Transferring Registrable Securities pursuant to the Shelf Registration Statement and the prospectus forming a part thereof contemplated by Section 2.1 until its receipt of a notice from the Company that any suspension of the type referred to in Section 2.3(a)(iv) is no longer applicable or that no Person will issue any such suspension pursuant to any proceedings (threatened or initiated) of the type referred to in Section 2.3(a)(iv).

 


 

(b) Notwithstanding anything in this Agreement to the contrary, if the Company delivers to the Investor a certificate, signed by an officer of the Company (the “ Transaction Delay Notice ”), stating that in the good faith judgment of the Board (i) continued use of the Shelf Registration Statement for purposes of effecting offers or sales of the Registrable Securities pursuant thereto would require, under the Securities Act or the Exchange Act, premature disclosure in the Shelf Registration Statement (or the prospectus that is a part thereof or any document that is or would be incorporated therein) of material, nonpublic information concerning the Company, its business or prospects or any proposed material transaction involving the Company, (ii) such premature disclosure would be materially adverse to the Company, its business or prospects or any such proposed material transaction or would make the successful consummation by the Company of any such material transaction significantly less likely and (iii) it is therefore desirable to suspend the use by the Investor of the Shelf Registration Statement (and the prospectus that is a part thereof) for purposes of effecting offers or sales of the Registrable Securities pursuant thereto, then the right of the Investor to use the Shelf Registration Statement (and the prospectus that is a part thereof) for purposes of effecting offers or sales of the Registrable Securities pursuant thereto shall be suspended. Notwithstanding the foregoing, the Company shall not under any circumstances be entitled to exercise its right to suspend the use of the Shelf Registration Statement on more than two (2) occasions during any twelve (12) month period, and each such suspension shall not be for more than thirty (30) days per such occasion (the “ Transaction Delay Period ”). The Investor hereby covenants and agrees that it will not sell any Registrable Securities pursuant to the Shelf Registration Statement during the periods the Shelf Registration Statement is withdrawn or the ability to sell thereunder is suspended as set forth in this Section 2.5(b). During the period the ability of the Investor to sell Registrable Securities under the Shelf Registration Statement is suspended pursuant to this Section 2.5(b) the Company shall not file a Registration Statement during the related Transaction Delay Period for the offer or sale of any securities for its own account or for the offer or sale of any securities for the account of any stockholder of the Company.
(c) As a condition to the inclusion of its Registrable Securities, the Investor shall furnish to the Company such information, including completing an investor questionnaire in the form provided by the Company, as shall be required in connection with any registration referred to in this Section 2.
(d) The Investor acknowledges and agrees that the Registrable Securities sold pursuant to the Shelf Registration Statement are not Transferable on the books of the Company unless the stock certificate submitted to the transfer agent evidencing such Registrable Securities is accompanied by a certificate reasonably satisfactory to the Company to the effect that (i) the Registrable Securities have been Transferred in accordance with the Shelf Registration Statement and (ii) the requirement of delivering a current prospectus has been satisfied.
(e) At the end of the Registration Period the Investor shall discontinue sales of Registrable Securities pursuant to the Shelf Registration Statement upon receipt of notice from the Company of its intention to remove from registration the Registrable Securities covered by the Shelf Registration Statement which remain unsold, and the Investor shall notify the Company of the number of Registrable Securities registered which remain unsold immediately upon receipt of such notice from the Company.

 


 

      2.6 Rule 144 Reporting . With a view to making available the benefits of certain rules and regulations of the Commission that may permit the sale of the Registrable Securities to the public without registration, the Company agrees to use its commercially reasonable efforts to:
(a) Make and keep adequate current public information with respect to the Company available in accordance with Rule 144; and
(b) File with the Commission in a timely manner all reports and other documents required of the Company under the Securities Act and the Exchange Act.
ARTICLE III.
BOARD OF DIRECTORS
      3.1 Investor Designee .
(a) Upon execution of this Agreement and in accordance with the terms of this Section 3, the Investor shall have the right to designate one Person for election to the Board as its nominee in its sole discretion (the “ Investor Designee ”). Within five (5) Business Days after the date hereof, the Company shall take all commercially reasonable actions to expand the Board in accordance with the Certificate, the Bylaws and the DGCL to create one vacancy on the Board and appoint the Investor Designee to fill such vacancy.
(b) Subject to Section 3.5, following the appointment of the Investor Designee pursuant to Section 3.1(a), for applicable subsequent elections of the members of the Board, the Company shall take all such actions as are commercially reasonable to facilitate the Investor Designee’s re-election to the Board.
(c) The Investor Designee must be eligible under applicable law and regulations of any national securities exchange on which Company securities are traded to serve on the Board; provided , however , that the Investor Designee shall not be required to be “independent” under the listing rules of any applicable national securities exchange, if any, on which Company securities are traded.
      3.2 Designation . The initial Investor Designee shall be Fred Wilkinson .
      3.3 Change in Designee . From time to time, subject to Section 3.5, the Investor may, in its sole discretion, notify the Company in writing of its intention to remove the Investor Designee that is serving on the Board and/or to select a new Investor Designee for election to the Board (whether to replace a prior Investor Designee or to fill a vacancy on the Board caused by the resignation or removal of a prior Investor Designee). Subject to Section 3.5, in the event of such an initiation of a removal or selection of an Investor Designee under this Section 3.3, the Company shall take such commercially reasonable actions as are necessary to facilitate such removal or election. Notwithstanding the foregoing sentence, the Company shall not be required to hold a special meeting of stockholders to replace an Investor Designee and in no event shall there be more than one Investor Designee on the Board.
      3.4 Information . The Investor shall at the request of the Company provide, and shall cause the Investor Designee to provide, all information regarding the Investor Designee that the

 


 

Company may reasonably request for inclusion in any proxy statement or other report that is required to contain such information that the Company is required to file with the Commission or any national securities exchange on which the Company’s securities are listed. The Investor represents, warrants and agrees that any such information supplied to the Company will not contain any untrue statement of a material fact, or omit to state any material fact required to be stated therein in order to make the statements therein, in light of the circumstances under which they were made, not misleading.
      3.5 Termination of Rights . The rights provided to the Investor under this Section 3 shall terminate at the first time when the Investor ceases to hold at least ten percent (10%) of the then outstanding Common Stock; provided , however , that an Investor Designee who is appointed or elected prior to the time when the Investor ceases to hold at least ten percent (10%) of the then outstanding Common Stock may continue as a director of the Company until the Company’s next meeting of stockholders held after the time when the Investor ceases to hold at least ten percent (10%) of the then outstanding Common Stock at which the stockholders are requested to take action with respect to the election of directors of the Company. For purposes of this Section 3.5, in determining, at any time, how many shares of Common Stock the Investor holds, only the Shares then held by the Investor should be considered and no other shares of Common Stock held by the Investor shall be considered.
      3.6 No Compensation . The Investor Designee shall not be entitled to receive compensation in any form from the Company in connection with such designation or in respect of his or her position as a member of the Board.
      3.7 Confidentiality Agreement . Notwithstanding anything contained herein to the contrary, no Investor Designee shall be entitled to become a member of the Board unless and until he or she executes a confidentiality agreement in a form agreed to by the Company, the Investor and the Investor Designee, each acting reasonably.
ARTICLE IV.
LOCK-UP AGREEMENT
      4.1 Lock-Up Agreement .
(a) Except as otherwise permitted in this Section 4.1, the Investor agrees not to Transfer the Shares or any legal or beneficial interest therein, without the prior written consent of the Company, from the date hereof until the date which is six (6) months after the date of this Agreement (the “ Initial Lock-Up Period ”); provided that the Investor shall have the right to participate in any buy-back of Common Stock by the Company, any tender offer or exchange offer for shares of Common Stock or in any extraordinary business combination or recapitalization transaction involving the Company that is approved by the stockholders of the Company by a vote required under applicable law.
(b) Notwithstanding Section 4.1(a), the Investor shall be permitted to Transfer any portion or all of the Shares at any time to any Affiliate under common control with the Investor; provided , that any transferee agrees in writing to be bound by the provisions of this Section 4 to the reasonable

 


 

satisfaction of the Company; provided , further that any such Transfer shall not relieve the Investor from its obligations hereunder.
(c) Following the Initial Lock-Up Period, subject to Sections 4.3 and 5.3, the Investor agrees that it will not, during any fiscal quarter of the Company, Transfer more than two million (2,000,000) of the Shares; provided , however , the restrictions in this Section 4.1(c) shall terminate eighteen (18) months following the date of this Agreement.
(d) In addition to the foregoing Transfer restrictions, the Investor shall not be entitled to transfer any Registrable Securities at any time if such Transfer would violate the Securities Act, or any state (or other jurisdiction) securities or “blue sky” laws applicable to the Company or the applicable Transfer of Registrable Securities.
(e) Each certificate representing the Registrable Securities shall bear the following legend:
THE SALE, ASSIGNMENT, TRANSFER OR OTHER DISPOSITION OF THE SECURITIES EVIDENCED BY THIS CERTIFICATE IS RESTRICTED BY THE TERMS OF AN INVESTOR’S RIGHTS AGREEMENT, DATED AS OF JULY 2, 2010, COPIES OF WHICH ARE ON FILE WITH THE ISSUER OF THIS CERTIFICATE. NO SALE, ASSIGNMENT, TRANSFER OR OTHER DISPOSITION SHALL BE EFFECTIVE UNLESS AND UNTIL THE TERMS AND CONDITIONS OF SUCH INVESTOR’S RIGHTS AGREEMENT HAVE BEEN COMPLIED WITH IN FULL.
THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR THE SECURITIES LAWS OF ANY STATE OF THE UNITED STATES. THE SECURITIES MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED, HYPOTHECATED, TRANSFERRED OR ASSIGNED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT FOR THE SECURITIES UNDER APPLICABLE SECURITIES LAWS, OR UNLESS OFFERED, SOLD, PLEDGED, HYPOTHECATED OR TRANSFERRED PURSUANT TO AN AVAILABLE EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THOSE LAWS. COLUMBIA LABORATORIES, INC. (THE “COMPANY”) SHALL BE ENTITLED TO REQUIRE AN OPINION OF COUNSEL SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED.
(f) In the event that the restrictive legend set forth in Section 4.1(e) has ceased to be applicable, the Company shall promptly provide the Investor or its permitted transferee, with new

 


 

certificates for such Registrable Securities not bearing the legend with respect to which the restriction has ceased and terminated.
      4.2 Stop-Transfer Instructions . In order to enforce Section 4.1, the Company may impose stop-transfer instructions with respect to any Company securities owned by the Investor.
      4.3 Termination of Lock-Up Agreement . This Section 4 shall terminate at the first time when the Investor, and its Affiliates (other than the Company), in the aggregate, cease to hold at least ten percent (10%) of the then outstanding Common Stock. For purposes of this Section 4.3, in determining, at any time, how many shares of Common Stock the Investor and its Affiliates hold, only the Shares then held by the Investor and its Affiliates shall be considered and no other shares of Common Stock held by the Investor and/or its Affiliates shall be considered.
ARTICLE V.
MISCELLANEOUS
      5.1 Amendment . Except as expressly provided herein, neither this Agreement nor any term hereof may be amended, waived, discharged or terminated other than by a written instrument referencing this Agreement and signed by the Company and the Investor.
      5.2 Notices . All notices and other communications required or permitted hereunder shall be in writing and shall be mailed by registered or certified mail, postage prepaid, sent by electronic mail or otherwise delivered by hand, messenger or courier service addressed:
(a) if to the Investor, to the address or electronic mail address of the Investor set forth beneath its name on the signature pages hereto, as may be updated in accordance with the provisions hereof, with a copy (which shall not constitute notice) to Latham & Watkins LLP, 650 Town Center Drive, 20th Floor, Costa Mesa, CA 92626-1925, Attention: R. Scott Shean; and
(b) if to the Company, to the address or electronic mail address of the Company set forth beneath its name on the signature pages hereto, as may be updated in accordance with the provisions hereof, with a copy (which shall not constitute notice) to Kaye Scholer LLP, 425 Park Avenue, New York, NY 10022, Attention: Adam H. Golden and Steven G. Canner.
     Each such notice or other communication shall for all purposes of this Agreement be treated as effective or having been given (i) if delivered by hand, messenger or courier service, when delivered (or if sent via a nationally-recognized overnight courier service, freight prepaid, specifying next-business-day delivery, two (2) Business Days after deposit with the courier), (ii) if sent via registered or certified mail, at the earlier of its receipt or five (5) days after the same has been deposited in a regularly-maintained receptacle for the deposit of the United States mail, addressed and mailed as aforesaid, or (iii) if sent via electronic mail, when directed to the relevant electronic mail address, if sent during normal business hours of the recipient, or if not sent during normal business hours of the recipient, then on the recipient’s next Business Day in either case confirmed in writing.
      5.3 Information . The Investor hereby acknowledges that it is aware (and the Investor agrees that any Person, including the Investor Designee, who otherwise receives from

 


 

the Investor confidential non-public information relating to the Company has been and will be advised) that the United States securities laws restrict any Person who possesses material, non-public information regarding the Company from purchasing or selling securities of the Company and from communicating such information to any other Person under circumstances in which it is reasonably foreseeable that such Person is likely to purchase or sell such securities.
      5.4 Successors and Assigns . Except as permitted by Section 4.1(b), this Agreement and the rights and obligations of the parties hereunder shall not be assignable or otherwise transferred, in whole or in part, by the Company or the Investor without the written consent of both parties hereto . Any attempted assignment or transfer of this Agreement shall be null and void.
      5.5 Entire Agreement . This Agreement and the exhibits hereto, the Purchase and Collaboration Agreement and the Other Agreements (as defined in the Purchase and Collaboration Agreement) constitute the full and entire understanding and agreement between the parties with regard to the subject hereof and thereof . No party hereto shall be liable or bound to any other party in any manner with regard to the subjects hereof or thereof by any warranties, representations or covenants except as specifically set forth herein or therein.
      5.6 Delays or Omissions . Except as expressly provided herein, no delay or omission to exercise any right, power or remedy accruing to any party to this Agreement upon any breach or default of any other party under this Agreement shall impair any such right, power or remedy of such non-defaulting party, nor shall it be construed to be a waiver of any such breach or default, or an acquiescence therein, or of or in any similar breach or default thereafter occurring, nor shall any waiver of any single breach or default be deemed a waiver of any other breach or default theretofore or thereafter occurring. Any waiver, permit, consent or approval of any kind or character on the part of any party of any breach or default under this Agreement, or any waiver on the part of any party of any provisions or conditions of this Agreement, must be in writing and shall be effective only to the extent specifically set forth in such writing. All remedies, either under this Agreement or by law or otherwise afforded to any party to this Agreement, shall be cumulative and not alternative.
      5.7 Severability . If any provision of this Agreement becomes or is declared by a court of competent jurisdiction to be illegal, unenforceable or void, portions of such provision, or such provision in its entirety, to the extent necessary, shall be severed from this Agreement, and such court will replace such illegal, void or unenforceable provision of this Agreement with a valid and enforceable provision that will achieve, to the extent possible, the same economic, business and other purposes of the illegal, void or unenforceable provision. The balance of this Agreement shall be enforceable in accordance with its terms.
      5.8 Titles and Subtitles . The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement . All references in this Agreement to sections, paragraphs and exhibits shall, unless otherwise provided, refer to sections and paragraphs hereof and exhibits attached hereto.

 


 

      5.9 Counterparts . This Agreement may be executed and delivered by PDF signature and in any number of counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
      5.10 Further Assurances . Each party hereto agrees to execute and deliver, by the proper exercise of its corporate, limited liability company, partnership or other powers, all such other and additional instruments and documents and do all such other acts and things as may be necessary to more fully effectuate this Agreement.
      5.11 Injunctive Relief . The Parties hereto agree that irreparable damage would occur in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached and that such damages would not be fully compensable by an award of money damages. It is accordingly agreed that the parties hereto shall be entitled to an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions of this Agreement without posting a bond or other undertaking, this being in addition to any other remedy to which they are entitled at law or in equity.
      5.12 Governing Law . This Agreement (including any claim or controversy arising out of or relating to this Agreement) shall be governed by and construed in accordance with the laws of the State of Delaware without regard to conflict of law principles that would result in the application of any law other than the laws of the State of Delaware.
      5.13 Arbitration .
          (a) All disputes, differences, controversies and claims of the parties hereto arising out of or relating to this Agreement (individually, a “ Dispute ” and, collectively, “ Disputes ”), except as otherwise provided under this Agreement, shall be resolved by final and binding arbitration administered by the American Arbitration Association (“ AAA ”) under its Commercial Arbitration Rules, subject to the provisions of this Section 5.13.
          (b) Following the delivery of a written demand for arbitration by either party hereto, each of the Company and Investor shall choose one (1) arbitrator within ten (10) Business Days after the date of such written demand and the two (2) chosen arbitrators shall mutually, within ten (10) Business Days after selection, select a third (3 rd ) arbitrator (each, an “ Arbitrator ” and together, the “ Arbitrators ”), each of whom shall be a retired judge selected from a roster of arbitrators provided by the AAA. If the third (3 rd ) Arbitrator is not selected within fifteen (15) Business Days after the delivery of the written demand for arbitration (or such other time period as the parties hereto may agree), the parties hereto shall promptly request that the commercial panel of the AAA select an independent Arbitrator meeting such criteria
          (c) The rules of arbitration shall be the Commercial Rules of the American Arbitration Association; provided , however , that notwithstanding any provisions of the Commercial Arbitration Rules to the contrary, unless otherwise mutually agreed to by the Company and the Investor, the sole discovery available to each party hereto shall be its right to conduct up to two (2) non-expert depositions of no more than three (3) hours of testimony each.

 


 

          (d) The Arbitrators shall render an award by majority decision within three (3) months after the date of appointment, unless the parties hereto agree to extend such time. The award shall be final and binding upon the parties hereto.
          (e) Any judicial proceeding arising out of or relating to this Agreement or the relationship of the parties hereto, including without limitation any proceeding to enforce this Section 5.13, to review or confirm the award in arbitration, shall be brought exclusively in the Delaware Chancery Court sitting in the county of New Castle, Delaware (the “ Enforcing Court ”). By execution and delivery of this Agreement, each party hereto accepts the jurisdiction of the Enforcing Court.
          (f) Each party hereto shall pay its own expenses in connection with the resolution of Disputes pursuant to this Section 5.13, including attorneys’ fees, unless determined otherwise by the Arbitrator.
          (g) The parties hereto agree that the existence, conduct and content of any arbitration pursuant to this Section 5.13 shall be kept confidential and no party hereto shall disclose to any Person any information about such arbitration, except in connection with such arbitration or as may be required by law or by any court, regulatory or governmental authority (or any exchange on which such party’s securities are listed) or for financial reporting purposes in such party’s financial statements.
          (h) Notwithstanding the foregoing, none of the provisions of this Agreement (including this Section 5.13) shall restrict the right of any party hereto to seek injunctive relief or other equitable remedies, to enjoin any breach or threatened breach of this Agreement or otherwise specifically enforce any provision of this Agreement.
      5.14 Recapitalization, Exchanges, Etc . The provisions of this Agreement shall apply to the full extent set forth herein with respect to (i) the Registrable Securities, (ii) any and all securities into which the shares of Common Stock are converted, exchanged or substituted in any recapitalization or other capital reorganization by the Company and (iii) any and all equity securities of the Company or any successor or assign of the Company (whether by merger, consolidation or otherwise) which may be issued in respect of, in conversion of, in exchange for, or in substitution of, the shares of Common Stock and shall be appropriately adjusted for any stock dividends, splits, reverse splits, combinations, recapitalizations and the like occurring after the date hereof. The Company shall cause any successor or assign (whether by merger, consolidation or otherwise) to assume this Agreement or enter into a new agreement with the Investor on terms substantially the same as this Agreement as a condition of any such transaction.
      5.15 Conflict . In the event of any conflict between the Company’s books and records and this Agreement or any notice delivered hereunder, the Company’s books and records will control absent fraud or error.
(signature page follows)

 


 

     IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement as of the date first written above.
         
  COLUMBIA LABORATORIES, INC.
 
 
  By:   /s/ Frank C. Condella, Jr.    
    Name:   Frank C. Condella, Jr.   
    Title:   Chief Executive Officer
 
    Address:   354 Eisenhower Parkway
Plaza 1, Second Floor
Livingston, New Jersey 07039 
 
 
  COVENTRY ACQUISITION, INC.
 
 
  By:   /s/ Paul M. Bisaro    
    Name:   Paul M. Bisaro   
    Title:   President and Chief Executive Officer
 
    Address:   311 Bonnie Circle
Corona, California 92880-2882 
 
 

 

Exhibit 10.2
SUPPLY AGREEMENT
     THIS SUPPLY AGREEMENT (this “ Agreement ”) is made as of July 2, 2010 (the “ Effective Date ”), by and between Columbia Laboratories, Inc. , a corporation existing and organized under the laws of the State of Delaware, having a place of business at 354 Eisenhower Parkway, Plaza 1, Second Floor, Livingston, NJ 07039 (“ Supplier ”), and Coventry Acquisition, Inc. , a corporation existing and organized under the laws of the State of Delaware , having a place of business at 311 Bonnie Circle, Corona, California 92880 (hereinafter “ Buyer ”). Capitalized terms used herein but not otherwise defined herein shall have the definitions ascribed to them in the Purchase and Collaboration Agreement (as hereinafter defined).
W I T N E S S E T H :
     WHEREAS, Buyer and Supplier have entered into that certain Purchase and Collaboration Agreement, dated as of March 3, 2010 (the “ Purchase and Collaboration Agreement ”), providing for the purchase by Buyer from Supplier of certain assets related to, and a collaboration with respect to the Development of, the Products (as hereinafter defined); and
     WHEREAS, in connection with the Purchase and Collaboration Agreement, Buyer and Supplier have agreed to enter into this Agreement pursuant to which Supplier will be the exclusive supplier of the Products for Buyer.
     NOW THEREFORE, in consideration of the premises, which are incorporated herein by reference, and other good and valuable consideration, the receipt and adequacy of which is hereby acknowledged, the parties hereto agree as follows:
1. SCOPE OF AGREEMENT
     1.1 Appointment of Supplier . Subject to the terms and conditions hereof, Buyer hereby appoints Supplier as its exclusive source and supplier of all of the requirements of Buyer, its Affiliates and Partners for the products identified on Exhibit 1.1 hereto in the United States in packaged, ready-for-sale form (the “ Products ”), and Supplier agrees to act as the exclusive source and supplier of the requirements of Buyer, its Affiliates and Partners for the Products. For purposes hereof “Partner” means any Third Party to whom Buyer or its Affiliates has sold, assigned, transferred, disposed of, licensed or conveyed any of the Purchased Assets or rights in any Products. Notwithstanding anything to the contrary, upon written notice from Buyer, provided to Supplier in accordance with Section 19 at least thirty (30) days prior to the date of any requested change, Buyer may designate any of Buyer’s Affiliates or Partners for the purpose of furnishing purchase orders and for receipt of shipments of Products from Supplier; provided that, at any time, there shall be only one such party and that any such designation shall not relieve Supplier of its obligations hereunder.
     1.2 Inventory on Hand . Buyer shall purchase the quantities of finished goods Products in inventory of Supplier or its Affiliates (“ Inventory ”) on the First Closing Date for the Purchase Price determined in accordance with Section 5.1, including any partial Batches (as defined in Section 2.3 below). Within thirty (30) days after the Effective Date, Supplier shall deliver the Inventory to Buyer in accordance with Section 3.1, subject to acceptance by Buyer in accordance with Section 3.2. Except as otherwise provided in this Agreement, the other terms and

 


 

conditions of this Agreement shall apply to such Product to the same extent as if it were ordered pursuant to a Purchase Order furnished pursuant to Section 2.3.
2. FORECASTS; PURCHASE ORDERS; MANUFACTURE
     2.1 Supplier Forecasts . Supplier’s forecasts for Product in place immediately prior to the First Closing Date shall govern for the first four (4) months after the First Closing Date. Supplier shall use Commercially Reasonable Efforts during such period to meet Buyer requirements for Product in excess of said pre-closing forecasts, but inability to supply such excess amounts of Product shall not constitute a breach of this Agreement by Supplier.
     2.2 Buyer Forecasts . At the First Closing, and on or before the fifteenth (15 th ) day of each calendar month during the Term (as hereinafter defined) Buyer shall and agrees to submit to Supplier a written forecast of Buyer’s, its Affiliates’ and Partners’ requirements, by calendar month, for the following twelve (12) calendar months for Product (the “ Rolling Forecast ”). The first Rolling Forecast shall include Supplier’s forecast for the first four (4) months after the First Closing and any additional amount of Product required by Buyer, its Affiliates and Partners in each of the first four (4) calendar months after the First Closing. The first four (4) calendar months of each Rolling Forecast for Products will be firm orders (the “ Binding Forecast ”). It is understood that such forecasts, updated monthly, that extend beyond the Binding Forecast, are intended to be good faith estimates only, and shall not be binding upon Buyer or Supplier. Buyer shall be bound to purchase from Supplier, and Supplier shall supply, one hundred percent (100%) of those quantities of the Products set forth in each Binding Forecast. Supplier shall comply with Purchase Orders for Products furnished pursuant to Section 2.3 and shall use Commercially Reasonable Efforts to supply amounts in excess of one hundred percent (100%) of the Binding Forecast amounts; provided, however, that inability to supply amounts in excess of one hundred percent (100%) shall not constitute a breach of this Agreement by Supplier. Supplier shall notify Buyer in writing of any prospective problems of which it is aware that might prevent it from meeting Buyer’s forecasted order quantities or estimated delivery dates.
     2.3 Binding Purchase Orders . At the First Closing and with each Binding Forecast referenced in Section 2.2 hereof, Buyer shall furnish to Supplier a binding purchase order (each, a “ Purchase Order ”) for the quantity of the Products which Buyer shall purchase and Supplier shall deliver in accordance with the most recent Binding Forecast and this Agreement. Supplier shall acknowledge receipt of such Purchase Order. Each such Purchase Order shall designate the quantity of the Products ordered, taking into consideration the fact that all Purchase Orders must be for one or more full batches (each a “ Batch ”). A Batch of 8% Product, as identified on Exhibit 1.1 , is approximately 610,000 individual applicators, provided however, that production yields may vary, and a yield of between 580,000 and 620,000 individual applicators will be considered an 8% Product Batch. A Batch of 4% Product, as identified on Exhibit 1.1 , is approximately 150,000 individual applicators, provided however, that production yields may vary, and a yield of between 140,000 and 160,000 individual applicators will be considered a 4% Product Batch. The initial Purchase Order(s) shall first be filled by utilizing Supplier’s inventory on hand (other than Inventory), including finished goods and in-transit and in-process inventory of Supplier, labeled with the name and NDC number of Supplier, until exhausted. Each Purchase Order shall specify a delivery date for the ordered Product no earlier than ninety (90) days following Supplier’s receipt of the Purchase Order.

 


 

     2.4 Buyer’s Ability to Require Supplier to Subcontract the Manufacture of Product .
          (a) In the event that (i) the parties reasonably determine that the demand for any Product is projected to exceed (as evidenced by the Rolling Forecasts provided by Buyer to Supplier) or (ii) the demand for any Product actually exceeds (as evidenced by Purchase Orders provided by Buyer to Supplier) Supplier’s capacity to supply Buyer with such Product, Buyer shall have the right to require Supplier to employ a manufacturer selected by Buyer and reasonably acceptable to Supplier (“ Subcontract Manufacturer ”), for the manufacture of such Product pursuant to the terms of this Agreement. Buyer shall exercise this right by (A) specifying to Supplier the amount of any such excess demand for such Product and the monthly period(s) in which such excess demand is expected to occur or has occurred and (B) notifying Supplier of the amounts of such excess demand for such Product which the Subcontract Manufacturer shall manufacture and supply to Supplier.
          (b) If Supplier is unable to manufacture or supply substantially all of any Product required to be supplied to Buyer under the terms of this Agreement for any reason whatsoever including, for example, and without limitation, an injunction against such manufacture issued by a government authority, Buyer shall have the right to require Supplier to employ a Subcontract Manufacturer, selected by Buyer and reasonably acceptable to Supplier, for the manufacture of such Product for the remaining Term pursuant to the terms of this Agreement. Buyer’s rights under this Section 2.4(b) shall be exercisable only if (i) Supplier’s inability to manufacture or supply such Product could reasonably be expected to result in the unavailability of such Product for commercial sale for at least thirty (30) days, (ii) Buyer provides reasonable evidence of the Subcontract Manufacturer’s ability to start manufacture of such Product more rapidly than Supplier could restart manufacture of such Product, and (iii) Supplier’s inability to manufacture or supply such Product did not result, wholly or in part, from a breach by Buyer of its representations, warranties or obligations under this Agreement.
          (c) If, more than four (4) times in any two (2) year period, Supplier fails to supply, in conforming form, all or substantially all of the amount of Products subject to an accepted Purchase Order submitted in accordance with this Agreement (excluding amounts in excess of one hundred percent (100%) of amounts covered by the applicable Binding Forecast) within thirty (30) days after the delivery date specified for such Products in the respective Purchase Orders in accordance with Section 2.3 (such failure, a “ Critical Supply Failure ”), such Critical Supply Failure shall constitute a material breach under Section 10.2(c), and Buyer shall have the right, at Buyer’s sole discretion, to (i) require Supplier to employ a Subcontract Manufacturer (selected by Buyer and reasonably acceptable to Supplier), for the manufacture of such Product for the remaining Term pursuant to the terms of this Agreement or (ii) terminate this Agreement pursuant to Section 10.2(c).
          (d) Supplier agrees that, notwithstanding anything to the contrary in this Agreement, Buyer, at any time after the Effective Date, may designate Buyer, or an Affiliate of Buyer or a Third Party, for the manufacture and supply of Product, provided that (i) Buyer will bear the cost and expense of establishing Buyer, or an Affiliate of Buyer or a Third Party, for the manufacture and supply of any Product and (ii) Buyer, or an Affiliate of Buyer or a Third Party, may only supply up to fifty percent (50%) of the amount of Product ordered in excess of three (3) Batches per calendar year.

 


 

     2.5 Provisions Applicable With Subcontract Manufacturer Supplier . If, at any time, Supplier subcontracts with a Subcontract Manufacturer pursuant to Sections 2.4(a) — (c), or subcontracts with an Affiliate or a Third Party other than pursuant to Sections 2.4(a) — (c), for the manufacture and supply of any Product, such Subcontract Manufacturer or such Affiliate or a Third Party shall be reasonably acceptable to Buyer. Supplier shall provide the Subcontract Manufacturer, the Affiliate or Third Party, as applicable, or cause the Subcontract Manufacturer, the Affiliate or Third Party to be provided, with all rights required for the manufacture of such Product and with all assistance reasonably requested by the Subcontract Manufacturer in setting up and overseeing its manufacturing facility, including know-how concerning the manufacture of such Product, and copies of all written or other tangible forms of recorded know-how reasonably related to the manufacture of such Product. Supplier shall obtain and enforce agreements from any such Subcontract Manufacturer, Affiliate or Third Party requiring the Subcontract Manufacturer, Affiliate or Third Party to keep all such information conveyed to such Subcontract Manufacturer, Affiliate or Third Party confidential and not to use any such rights, materials or information to manufacture Products other than for Products for sale to Supplier.
3. SHIPMENTS AND ACCEPTANCE
     3.1 Delivery . Supplier shall deliver all Products DDP (as such term is defined and used in Incoterms 2000, ICC Official Rules for Interpretation of Trade Terms) to Buyer’s warehouse in Gurnee, Illinois, United States, or any other single destination within the United States identified by Buyer at least thirty (30) days prior to the requested delivery date. Title and risk of loss will transfer from Supplier to Buyer upon delivery of Product to Buyer.
     3.2 Inspection; Rejection . Buyer may inspect the shipment of Product upon receipt to verify such shipment’s conformity to the relevant Purchase Order as of the time the Product was delivered to Buyer. If Buyer determines that any portion or all of any shipment of the Product did not conform to the Purchase Order as of the time it was delivered to Buyer (each non-conforming Product, a “ Defective Product ”), then Buyer shall be entitled to reject such portion or all of any shipment of Product that includes Defective Product. Buyer shall notify Supplier in writing if the shipment of Product includes Defective Product that existed at the time of the delivery of the Products to Buyer. Such notification shall be made as soon as reasonably practicable after discovery of the nonconformity, but not later than thirty (30) days after delivery of the Products. Such notice shall specify the reasons for rejection. If Buyer does not so reject the Products within thirty (30) days after delivery, Buyer shall be deemed to have accepted the Products. After Buyer accepts a Product, or is deemed to have accepted a Product, except with respect to Latent Defects (as defined herein below), Buyer shall have no recourse against Supplier except as set forth in Section 6 hereof. After notice of rejection is received by Supplier, Buyer shall cooperate with Supplier in determining whether such rejection is justified. Supplier shall notify Buyer as soon as reasonably possible, but not later than thirty (30) days after receipt of the notice from Buyer, whether it accepts Buyer’s basis for rejection. Notwithstanding anything to the contrary, if a portion or all of any shipment of Product has a latent defect that renders such Product a Defective Product prior to the expiry date of such Product and that (a) was not reasonably discoverable within the inspection period specified in this Section 3.2 and (b) was attributable to Supplier’s manufacture and/or supply and (iii) did not occur after receipt of such Product by Buyer as described in Section 3.2 (each such defect, a “ Latent Defect ”), Buyer shall promptly, and in no event more than twenty (20) days after the discovery or notification of

 


 

such Latent Defect, notify Supplier of such Latent Defect. If Supplier accepts Buyer’s determination that the Product is a Defective Product or that the Product contains a Latent Defect, then Buyer shall be entitled to the remedies set forth in Section 6.5 hereof. If Supplier does not accept Buyer’s determination that the Product is a Defective Product or that the Product contains a Latent Defect, and Buyer does not accept Supplier’s conclusion, then Supplier and Buyer shall jointly select an independent Third Party to determine whether it conforms to the Purchase Order. The parties agree that such Third Party’s determination shall be final. If the Third Party rules that the Product conformed to the Purchase Order as of the time the Product was delivered to Buyer or that the Product does not contain a Latent Defect, as applicable, then Buyer shall be deemed to have accepted the Product at the agreed upon price and Buyer shall bear the cost of such independent Third Party determination. If the Third Party rules that the Product does not conform to the Purchase Order at the time the Product was delivered to Buyer or that the Product contains a Latent Defect, then Buyer shall be entitled to the remedies set forth in Section 6.5 hereof and Supplier shall bear the cost of such independent Third Party determination.
4. RECORDS AND AUDIT RIGHTS, PUBLIC STATEMENTS; RECALLS
     4.1 Records; Audit Rights . Supplier shall maintain, and shall cause its Affiliates and contract manufacturers and other agents to maintain, all records necessary to comply with all applicable Laws relating to the manufacture, filling, packaging, testing, storage and shipment of Products. All such records shall be maintained for such period as may be required by applicable Laws; provided, however, that all records relating to the manufacture, stability and quality control of Products shall be retained until the parties agree to dispose of such records. Buyer and its authorized representatives shall have the right, at Buyer’s sole cost and expense, to audit, inspect, and observe the manufacture, storage, disposal, and transportation of Products once per contract year, during normal business hours upon thirty (30) days’ prior written notice; provided that Buyer may conduct additional audits if required to address serious manufacturing issues or complaints that necessitate reporting to a regulatory authority or for any for cause audits.
     4.2 Public Statements . Neither party shall use, or authorize others to use, the name, symbols, or marks of the other in any advertising or publicity material or make any form of representation or statement with regard to the services provided hereunder which would constitute an express or implied endorsement by such other of any commercial product or service without the other’s prior written approval.
     4.3 Recalls . Buyer, in Buyer’s sole discretion, shall determine whether any Product must be withdrawn or recalled from the market. To the extent legally required, Buyer shall notify all regulatory authorities of any such withdrawal or recall. All costs of withdrawals or recalls (including costs incurred by Supplier while assisting Buyer) shall be borne by Buyer, except in the case of recalls or withdrawals caused solely by the negligence or willful malfeasance of Supplier, its Affiliates or subcontractors or by the material breach by Supplier of its representations and warranties in this Agreement, in which case Supplier shall credit Buyer for the cost of the recalled or withdrawn Product and Buyer’s reasonable costs incurred with such withdrawals or recalls. Buyer shall give Supplier prompt written notice of any withdrawals or recalls that Buyer believes was caused or may have been caused by the negligence or willful

 


 

malfeasance of Supplier, its Affiliates or subcontractors or the material breach by Supplier of its representations and warranties in this Agreement.
5. PRICE AND PAYMENT
     5.1 Price .
          (a) The purchase price for Products supplied hereunder (the “ Purchase Price ”) shall be one hundred and ten percent (110%) of COGS calculated in accordance with this Section 5.1(a) and paid in accordance with Section 5.1(d). For purposes hereof “ COGS ” means internal and external costs incurred in manufacturing, acquiring, product testing activities for quality assurance and quality control, packaging, transporting, storing and/or cGMP compliance determined in accordance with United States generally accepted accounting principles, as consistently applied by Supplier in accordance with Supplier’s past practice and in the ordinary course of Supplier’s business, in each case to the extent related and allocable to the Product supplied to Buyer hereunder. Notwithstanding the foregoing, “COGS” shall (i) include payroll taxes and customs charges consistent in type and nature with those set forth on Exhibit 5.1(a) , and (ii) exclude any and all (A) costs attributable to general corporate activities, including, by way of example, executive management, investor relations, business development, legal affairs and finance, (B) Taxes other than as described in clause (i) above, and (C) the NDA maintenance fee and applicable FDA establishment fees. Exhibit 5.1(a) to this Agreement sets forth further detail on the calculation of COGS. For purposes hereof “cGMP” means current good manufacturing practices of the FDA and other appropriate agencies, as set forth in 21 C.F.R. Parts 210 and 211 and all applicable FDA rules, regulations, guides and guidances, as amended from time to time and in effect during the term of this Agreement.
          (b) Buyer shall reimburse Supplier the amount actually paid by Supplier in connection with applicable FDA establishment fees to the extent related and allocable to the Product supplied to Buyer hereunder; provided, that, with respect to the period from the Effective Date through September 30, 2010, Buyer’s liability for such establishment fees shall be an amount equal to $457,200 multiplied by a fraction, the numerator of which is (i) the number of days during such period, and the denominator of which is (ii) 365. Supplier shall provide Buyer with a detailed invoice of any amounts due and payable pursuant to this Section 5.1(b) and Buyer shall pay the amount of such invoice within thirty (30) days following receipt.
          (c) Supplier shall at all times use Commercially Reasonable Efforts to keep the cost of acquiring any Product from a contract manufacturer or Subcontract Manufacturer, if applicable, as low as possible.
          (d) For each Batch of Product supplied hereunder, Buyer shall pay Supplier the Purchase Price (the “Batch Price” ) calculated as set forth in this Section 5.1(d). For the period from the Effective Date through December 31, 2010, the Batch Price for 8% Product and the Batch Price for 4% Product shall equal the amount for such Product set forth on Exhibit 5.1(d) , subject to adjustment in accordance with Section 5.1(e) below. For each calendar year thereafter, Supplier shall notify Buyer of the Batch Price applicable to purchases of Product during such calendar year no later than December 31 st of the year immediately preceding such calendar year. Such Batch Price shall be Supplier’s good faith estimate of COGS for such

 


 

calendar year, determined based on Buyer’s Rolling Forecast, Supplier’s projected costs for such calendar year and foreign currency exchange rates in effect as of the last Business Day of November immediately preceding Supplier’s notice, subject to adjustment in accordance with Section 5.1(e); provided, however, that, except for adjustment in accordance with Section 5.1(e), the Batch Price in any calendar year shall not be greater than one hundred twenty percent (120%) of the Batch Price in the prior, just-ended calendar year.
          (e) The Batch Price shall be adjusted on a monthly basis to reflect foreign currency exchange rates in effect as published in the Wall Street Journal on the last Business Day of the month immediately preceding the applicable month.
          (f) On or after each shipment of the Product, Supplier shall provide Buyer with an invoice setting forth the Batch Price payable for such delivery pursuant to this Section 5. Each such invoice shall, to the extent applicable, identify the Purchase Order number, quantities of the Product, aggregate Batch Price of Product supplied pursuant to such Purchase Order and the total amount to be remitted to Supplier.
          (g) Buyer will pay amounts due pursuant to this Agreement within forty-five (45) days of the date of invoice.
          (h) Buyer will make all payments to Supplier, due pursuant to this Agreement, to Supplier’s accounts in the United States.
     5.2 Intentionally Omitted .
     5.3 Interest . If a party (or any successor thereto pursuant to the terms of this Agreement) fails to pay in full on or before the date due any payment that is required to be paid under this Agreement, such party (or any successor thereto pursuant to the terms of this Agreement) will also pay to the other Party, on demand, interest on any such amount beginning on such due date at an annual rate (calculated on the basis of a 360-day year) equal to the “base rate” as announced by JPMorgan N.A., or any successor thereto, in New York, New York in effect on such due date, plus three (3) percent to be assessed from the date payment of the amount in question first became due.
     5.4 Taxes .
          (a) Supplier and Buyer each shall cooperate with the other party, as reasonably requested by the other party, to minimize or eliminate Taxes to the extent legally permissible, including by making available to such other party any existing resale certificates, exemption certificates or other existing information relevant for such purpose.
          (b) If applicable Tax Law requires Buyer to withhold any Tax from a payment to Supplier, Buyer shall withhold such Tax and shall pay the amount withheld to the relevant Tax authority.
          (c) As soon as practicable after any payment of withheld Taxes by Buyer to a Tax authority, Buyer shall deliver to Supplier the original or a certified copy of a receipt issued

 


 

by such Tax authority evidencing such payment, a copy of the return reporting that payment or other evidence of such payment reasonably satisfactory to Supplier.
6. REPRESENTATIONS AND WARRANTIES
     6.1 Representations and Warranties of Supplier . Supplier represents and warrants to Buyer that:
          (a) the Products shall be manufactured and packaged in compliance with the provisions of the Federal Food, Drug, and Cosmetic Act located at 21 U.S.C. §§ 301 to 397 (2000), as it may be amended from time to time, and regulations promulgated thereunder (the “ Act ”), the laws or regulations imposed by other involved health regulatory authorities within the Territory, and cGMPs;
          (b) as of the time of delivery to Buyer (i) Product (other than Inventory) with an FDA approved shelf-life greater than or equal to thirty (30) months shall have minimum dating of not less than twenty-four (24) months shelf-life prior to expiration, (ii) Product (other than Inventory) with an FDA approved shelf-life less than thirty (30) months shall have minimum dating of not less than eighteen (18) months shelf-life prior to expiration and (iii) Inventory shall have minimum dating of not less than twelve (12) months shelf-life prior to expiration;
          (c) as of the time any Product is delivered to Buyer and during the shelf life of such Product, such Product shall conform to the specifications set forth in the NDA for such Product ( the “ Specifications ”); and
          (d) upon transfer of the risk of loss of a Product, as provided in Section 3.1, good and valid title to such Product sold hereunder will be conveyed by Supplier to Buyer free and clear of any Encumbrances created by Supplier.
     6.2 Representations and Warranties of Buyer . Buyer represents and warrants to Supplier that Buyer will not make any false claims in any packaging, labeling, advertising or promotional material regarding the Products.
     6.3 EXCEPT AS OTHERWISE PROVIDED IN THE PURCHASE AND COLLABORATION AGREEMENT, THE WARRANTIES SET FORTH IN SECTION 6.1 OF THIS AGREEMENT ARE THE EXCLUSIVE WARRANTIES GIVEN BY SUPPLIER TO BUYER WITH RESPECT TO THE SUPPLY OF PRODUCTS HEREUNDER, AND ARE GIVEN AND ACCEPTED IN LIEU OF ANY AND ALL OTHER WARRANTIES, GUARANTEES, CONDITIONS AND REPRESENTATIONS, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
     6.4 EXCEPT AS OTHERWISE PROVIDED IN THE PURCHASE AND COLLABORATION AGREEMENT, THE WARRANTIES SET FORTH IN SECTION 6.2 OF THIS AGREEMENT ARE THE EXCLUSIVE WARRANTIES GIVEN BY BUYER TO SUPPLIER WITH RESPECT TO THE PURCHASE OF PRODUCT HEREUNDER,

 


 

AND ARE GIVEN AND ACCEPTED IN LIEU OF ANY AND ALL OTHER WARRANTIES, GUARANTEES, CONDITIONS AND REPRESENTATIONS, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
     6.5 Remedy . Any Product delivered to Buyer by Supplier which is finally determined to be a Defective Product or contain a Latent Defect in accordance with Section 3.2, shall be replaced at Supplier’s expense, as Buyer’s sole and exclusive remedy.
7. INDEMNIFICATION
     Each party agrees that it shall indemnify the other party for and hold such other party harmless against any Losses incurred by such other party as a result of a breach of a representation, warranty, covenant, agreement or obligation of such party contained in this Agreement, in accordance with the terms and conditions contained in the Purchase and Collaboration Agreement.
8. INSURANCE
     8.1 Coverage . Each party shall maintain during the performance of this Agreement the following insurance or self-insurance in amounts no less than that specified for each type:
          (a) Commercial general liability insurance with combined limits of not less than $1,000,000 per occurrence, $1,000,000 per accident for bodily injury, including death, and property damage, a general aggregate limit of not less than $1,000,000 and products/completed operations aggregate of not less than $1,000,000 which coverage shall insure such party for product liability claims and its obligations under this Agreement;
          (b) Workers compensation insurance in the amounts required by the law of the state(s) in which such party’s workers are located and employer’s liability insurance with limits of not less than $500,000 per occurrence;
          (c) automobile liability insurance covering automobiles and trucks used by or on behalf of such party either on or away from the other parties’ premises with combined single limit of not less than $1,000,000 per occurrence and $1,000,000 per accident for bodily injury, including death, and property damage, which policy shall include coverage for all hired, owned and no-owned automobiles and trucks; and
          (d) Product Liability Insurance with limits not less than $10,000,000.
     8.2 Evidence . Each party shall provide the other with evidence of its insurance or self insurance. Each party shall provide to the other thirty (30) days prior, written notice of any cancellation or material change in its coverage. Each party agrees to deliver to the other concurrently with the execution of this Agreement and thereafter annually, a certificate from the insurance company(ies) evidencing that all the insurance required by this Agreement is in force, including a broad form vendors’ endorsement naming the other party as an additional insured.

 


 

9. CONFIDENTIALITY
     The terms of the Confidentiality Agreement shall apply to any information provided by Supplier to Buyer.
10. TERM AND TERMINATION
     10.1 Term . This Agreement shall come into effect on the Effective Date. Unless otherwise terminated as provided in Section 10.2 or Section 12.2 hereof, this Agreement shall remain in force through May 19, 2015 (for the purpose of this Section 10 the “ Initial Term ”). This Agreement shall renew automatically in two (2) year increments after the Initial Term (each, a “ Renewal Term ” and, collectively with the Initial Term, the “ Term ”) unless either party gives written notice to the other of its intention to not renew at least one hundred and eighty (180) days prior to expiration of the Initial Term or the then applicable Renewal Term.
     10.2 Termination .
          (a) Purchase and Collaboration Agreement . Buyer shall have a right to terminate this Agreement, upon one hundred and eighty (180) days prior written notice to Supplier, upon the expiration or termination of the Joint Development Period, as provided in the Purchase and Collaboration Agreement.
          (b) Insolvency . A party may immediately terminate this Agreement without written notice to the other party, if (i) the other party is the subject of voluntary or involuntary bankruptcy proceedings instituted on behalf of or against such it (except for involuntary bankruptcy proceedings which are dismissed within sixty (60) days); (ii) an administrative receiver, receiver and manager, interim receiver, custodian, sequestrator or similar officer is appointed in respect of the other party (collectively, the “ Receiver ”) and that party has not caused the underlying action or the Receiver to be dismissed within sixty (60) days after the Receiver’s appointment; (iii) the Board of Directors of the other party shall have passed a resolution to wind up that party, or such a resolution shall have been passed other than a resolution for the solvent reconstruction or reorganization of that party; (iv) a resolution shall have been passed by that party or that party’s directors to make an application for an administration order or to appoint an administrator; or (e) the other party makes a general assignment, composition or arrangement with or for the benefit of all or the majority of that party’s creditors, or makes, suspends or threatens to suspend making payments to all or the majority of that party’s creditors.
          (c) Default . In the event either party commits a material breach or defaults in the performance or observance of any of the material provisions of this Agreement, and such breach or default is not cured within one hundred and twenty (120) days (or within fifteen (15) days in the case of any payment default or obligation to pay royalties hereunder) after the receipt of notice thereof from the other party specifying such breach or default, the party not in breach or default shall be entitled (without prejudice to any of its other rights) to terminate this Agreement, without additional penalty, termination fee or cost, by giving notice to take effect immediately.

 


 

11. EFFECT OF EXPIRATION OR TERMINATION
     11.1 Mutual Obligations . Upon expiration or termination of this Agreement pursuant to Section 10 with effect as of the effective date of termination:
          (a) the party terminating this Agreement shall be released from all obligations and duties imposed or assumed hereunder except from those provided in Sections 4.1, 4.2, 6, 7, 8 and 9 and this Section 11 and Section 21; and
          (b) the other party shall lose the benefit of any rights granted in this Agreement, except for those accrued prior to the effective date of termination and those set forth in Sections 4.1, 4.2, 6, 7, 8 and 9 and this Section 11 and Section 21.
     11.2 Purchase Orders .
          (a) Where this Agreement is terminated by Buyer pursuant to Section 10.2(a) or by Supplier pursuant to Section 10.2(b) or 10.2(c), Supplier will be entitled, at its option, to fill or cancel any Purchase Orders that were submitted by Buyer prior to such termination. If Supplier elects to fill any such Purchase Orders, Supplier shall use commercially reasonable efforts to fill any such Purchase Orders. If Supplier elects not to fill any such Purchase Orders, Buyer shall reimburse Supplier for the costs (including, but not limited to, raw material costs) incurred in connection with Purchase Orders that Supplier had started to supply prior to the termination of this Agreement and that are canceled by Supplier pursuant to this Section 11.2(a).
          (b) Where this Agreement is terminated by Buyer pursuant to Section 10.2(b) or 10.2(c), Supplier will be entitled, at its option, to fill or cancel any Purchase Orders that were submitted by Buyer, its Affiliates or sublicensees prior to such termination; provided that if Supplier elects not to fill any such Purchase Orders, Supplier shall be liable for the costs (including, but not limited to, raw material costs) incurred in connection with Purchase Orders that Supplier had started to manufacture prior to the expiration or termination of this Agreement and that are canceled by Supplier pursuant to this Section 11.2(b).
     11.3 Financial Obligations . In the event that this Agreement is terminated pursuant to Section 10.2 by either party, Buyer shall make all payments accruing prior to the effective date of termination to Supplier in the manner specified herein. Supplier may proceed to enforce payment of all outstanding payments. Each party may proceed to collect any other monies owed to such party and to exercise any or all of the rights and remedies contained herein or otherwise available to such party by law or in equity, successively or concurrently at the option of such party.
     11.4 Transition upon Termination; HSR .
          (a) Upon expiration or termination of this Agreement for any reason pursuant to Sections 10 or 12.2, Supplier and its Affiliates shall provide to Buyer, its Affiliates or Third Party designee(s) such cooperation and assistance as may be reasonably required to facilitate Buyer, its Affiliates or Third Party designee(s) to bring about a smooth and orderly transition to one or more new manufacturers and suppliers of Product following such expiration or termination and continuing for such period of time following such termination as is reasonably necessary to fully

 


 

effectuate such transition. Buyer shall pay the reasonable internal and external costs incurred by Supplier in providing such cooperation and assistance.
          (b) Upon the expiration or termination of this Agreement, Buyer and Supplier will determine whether any transfer of rights under this Agreement to Buyer is subject to the premerger notification requirements of the HSR Act. If HSR Act filings are required, Buyer and Supplier will use commercially reasonable efforts to make such filings and cause the HSR Act waiting period to expire or terminate.
     11.5 No Release . Termination of this Agreement for any reason whatsoever shall neither be deemed a release, nor shall it relieve either party from any obligation under this Agreement which may have accrued prior thereto.
12. FORCE MAJEURE
     12.1 Suspension of Obligations . If by reason of “force majeure”, which shall mean for the purpose of this Agreement (a) acts of God, war, riots, civil unrest, acts of the public enemy, fires, earthquakes, severe weather or storms, or (b) to the extent beyond the reasonable control of the affected party, strikes, labor disputes, labor shortages, product transportation interruptions or shortages, accidents, unavailability of raw materials or supplies, or any act in consequence of compliance with any order of any government or governmental authority, and, in the case of either (a) or (b), the affected party is delayed or prevented from complying with its obligations under this Agreement, such affected party shall promptly give notice to the other party with an estimated date by which the contingency will be removed.
     12.2 Termination . To the extent that a party is or has been delayed or prevented by force majeure from complying with its obligations under this Agreement, the other party may suspend the performance of its obligations until the contingency is removed. If the party delayed or prevented from complying with its obligations under this Agreement cannot permanently remove the contingency, or if the contingency affecting such party results in a delay extending beyond three (3) months, the other party (upon notice) shall have a right to terminate this Agreement and Section 11, subject to Section 6.5(b), if applicable, shall apply, with the party delayed or prevented from complying with its obligations under this Agreement deemed to be the non-terminating party.
13. NOTICES
     All notices, requests, claims, demands and other communications hereunder shall be in writing and shall be deemed to have been duly given (a) when received if delivered personally, (b) when transmitted if telecopied (which is confirmed), (c) upon receipt, if sent by registered or certified mail (postage prepaid, return receipt requested) and (d) the day after it is sent, if sent for next-day delivery to a domestic address by overnight mail or courier, to the parties at the following addresses:

 


 

If to Supplier, to:
Columbia Laboratories, Inc.
354 Eisenhower Parkway
Plaza 1, Second Floor
Livingston, New Jersey 07039
Attention: General Counsel
Facsimile: 973.994.3001
with copies (which shall not constitute notice) sent concurrently to:
Kaye Scholer LLP
425 Park Avenue
New York, NY 10022
Attention: Adam H. Golden and Steven G. Canner
Facsimile: 212.836.8689
If to Buyer, to:
Coventry Acquisition, Inc.
311 Bonnie Circle
Corona, CA 92880
Attention: General Counsel
Facsimile: 951.493.5817
with copies (which shall not constitute notice) sent concurrently to:
Latham & Watkins LLP
650 Town Center Drive
20th Floor
Costa Mesa, CA 92626-1925
Attention: R. Scott Shean
Facsimile: 714.755.8290
provided, however, that if any party shall have designated a different address by notice to the others, then to the last address so designated.
14. ASSIGNMENT
     Neither party may assign its rights and obligations under this Agreement without the other party’s prior written consent, except that: either party may (a) assign its rights and obligations under this Agreement or any part hereof to one or more of its Affiliates without the consent of the other party; and (b) assign this Agreement in its entirety without the other party’s consent to an entity that acquires all or substantially all of the business or assets of the assigning party to which this Agreement relates, whether by merger, acquisition or otherwise; provided, however, that in the event of Supplier’s exercise of its right under clause (b), notwithstanding the Product quantity and minimum order requirements set forth in Section 2.4(d), Buyer, or an Affiliate of Buyer or a Third Party, may manufacture and supply any and all amounts of Product that Buyer, or an Affiliate of Buyer or a Third Party, may require, without further obligation to

 


 

Supplier under the terms of this Agreement; provided, further, that to the extent an assignment of rights or obligations by Supplier pursuant to this Section 14 increases the Taxes (including without limitation any withholding Taxes) of, or the amounts owed under Section 5.1(a) subsection (i) by, Buyer (or an Affiliate or Partner of Buyer that has been designated by Buyer pursuant to Section 1 as of the time of such assignment by Supplier), Supplier or the assignee shall indemnify Buyer (or such Affiliate or Partner of Buyer) for and hold it harmless against such increase. In the case of any permitted assignment, the assigning party shall remain responsible for the performance of this Agreement by the assignee. The assigning party shall provide the other party with prompt written notice of any such assignment. Any permitted assignee shall assume all obligations of its assignor under this Agreement, and no permitted assignment shall relieve the assignor of liability hereunder. Any attempted assignment in contravention of the foregoing shall be void. Subject to the terms of this Agreement, this Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and permitted assigns.
15. NO WAIVER
     The failure of either party to enforce any condition or part of this Agreement at any time shall not be construed as a waiver of that condition or part, nor shall it forfeit any rights to future enforcement thereof.
16. RELATIONSHIP OF THE PARTIES
     Nothing contained in this Agreement shall be deemed to constitute a partnership, joint venture, or legal entity of any type between Supplier and Buyer, or to constitute one as the agent of the other. Both parties shall act solely as independent contractors, and nothing in this Agreement shall be construed to give either party the power or authority to act for, bind, or commit the other party.
17. HEADINGS, INTERPRETATION
     The headings of sections of this Agreement are for convenience of reference only and shall not affect the meaning or interpretation of this Agreement in any way. Words denoting the singular shall include the plural and vice versa; words denoting any gender shall include all genders; and words denoting persons shall include bodies corporate, and vice versa.
18. SEVERABILITY
     If any term, provision, covenant or restriction of this Agreement is held by a court of competent jurisdiction or other Regulatory Authority to be invalid, void, unenforceable or against its regulatory policy such determination shall not affect the enforceability of any others or of the remainder of this Agreement.
19. ENTIRE AGREEMENT; AMENDMENT OR MODIFICATION
     This Agreement may not be amended, supplemented or otherwise modified except by an instrument in writing signed by both parties hereto. This Agreement, the Purchase and Collaboration Agreement, the Confidentiality Agreement and the Other Agreements contain the

 


 

entire agreement of the parties hereto with respect to the subject matter hereof, superseding all negotiations, prior discussions and preliminary agreements made prior to the date hereof. No provision of this Agreement may be amended or modified other than by a written document signed by authorized representatives of both parties.
20. FORMS
     The parties recognize that, during the Term, a Purchase Order, acknowledgement form or similar routine document (collectively “ Forms ”) may be used to implement or administer provisions of this Agreement. Therefore, the parties agree that the terms of this Agreement will prevail in the event of any conflict between this Agreement and the printed provision of such Forms, or typed provisions of Forms that add to, vary, modify or are at conflict with the provisions of this Agreement with respect to Product sold hereunder during the Term.
21. GOVERNING LAW
     This Agreement (including any claim or controversy arising out of or relating to this Agreement) shall be governed by and construed in accordance with the Laws of the State of Delaware without regard to conflict of law principles that would result in the application of any Law other than the Laws of the State of Delaware.
22. ARBITRATION
     22.1 All disputes, differences, controversies and claims of the parties arising out of or relating to this Agreement (individually, a “ Dispute ” and, collectively, “ Disputes ”), except as otherwise provided under this Agreement, shall be resolved by final and binding arbitration administered by the American Arbitration Association (“ AAA ”) under its Commercial Arbitration Rules, subject to the provisions of this Section 22.
     22.2 Following the delivery of a written demand for arbitration by either party, each of Buyer and Supplier shall choose one (1) arbitrator within ten (10) Business Days after the date of such written demand and the two chosen arbitrators shall mutually, within ten (10) Business Days after their selection, select a third (3 rd ) arbitrator (each, an “ Arbitrator ” and together, the “ Arbitrators ”), each of whom shall be a retired judge selected from a roster of arbitrators provided by the AAA. If the third (3 rd ) Arbitrator is not selected within fifteen (15) Business Days after delivery of the written demand for arbitration (or such other time period as the Parties may agree), the parties shall promptly request that the commercial panel of the AAA select an independent Arbitrator meeting such criteria.
     22.3 The rules of arbitration shall be the Commercial Rules of the American Arbitration Association; provided, however, that notwithstanding any provisions of the Commercial Arbitration Rules to the contrary, unless otherwise mutually agreed to by Buyer and Supplier, the sole discovery available to each party shall be its right to conduct up to two (2) non-expert depositions of no more than three (3) hours of testimony each.
     22.4 The Arbitrators shall render an award by majority decision within three (3) months after the date of appointment, unless the parties agree to extend such time. The award shall be final and binding upon the parties.

 


 

     22.5 Any judicial proceeding arising out of or relating to this Agreement or the relationship of the parties, including without limitation any proceeding to enforce this Section 22, to review or confirm the award in arbitration, shall be brought exclusively in the Delaware Chancery Court sitting in the county of New Castle, Delaware (the “ Enforcing Court ”). By execution and delivery of this Agreement, each party accepts the jurisdiction of the Enforcing Court.
     22.6 Each party shall pay its own expenses in connection with the resolution of Disputes pursuant to this Section 22, including attorneys’ fees, unless determined otherwise by the Arbitrator.
     22.7 The parties agree that the existence, conduct and content of any arbitration pursuant to this Section 22 shall be kept confidential and no party shall disclose to any Person any information about such arbitration, except as may be required by Law or by any Regulatory Authority (or any exchange on which such Party’s securities are listed) or for financial reporting purposes in such party’s financial statements.
     22.8 Notwithstanding the forgoing, none of the provisions of this Agreement (including the provision of this Section 22) shall restrict the right of any party to seek injunctive relief or other equitable remedies, to enjoin any breach or threatened breach of this Agreement or otherwise specifically enforce any provision of this Agreement.

 


 

     IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement as of the date and year first above mentioned.
         
  COLUMBIA LABORATORIES, INC.
 
 
  By:   /s/ Frank C. Condella, Jr.    
    Name:   Frank C. Condella, Jr.   
    Title:   Chief Executive Officer   
 
  COVENTRY ACQUISITION, INC.
 
 
  By:   /s/ Paul M. Bisaro    
    Name:   Paul M. Bisaro   
    Title:   President and Chief Executive Officer   
 

 

Exhibit 10.3
LICENSE AGREEMENT
          This LICENSE AGREEMENT (the “ Agreement ”), dated as of July 2, 2010 (the “ Effective Date ”), is entered into by and between Columbia Laboratories, Inc., a Delaware corporation, and Columbia Laboratories (Bermuda) Ltd., a Bermuda corporation (together, “ Seller ”), and Coventry Acquisition, Inc., a Delaware corporation (“ Buyer ”). Seller and Buyer are each referred to herein as a “ Party ”, and collectively, as the “ Parties .”
RECITALS
           WHEREAS , the Columbia Laboratories, Inc., Watson Pharmaceuticals, Inc., a Nevada corporation and Buyer have entered into a Purchase and Collaboration Agreement, dated as of March 3, 2010 (the “ PCA ”), for the sale by Seller, and the purchase by Buyer, of the First Closing Date Purchased Assets on the First Closing Date and the Second Closing Date Purchased Assets on the Second Closing Date (each as defined in the PCA);
           WHEREAS, pursuant to the PCA, the Parties will collaborate with respect to certain Development activities relating to the Products (as defined in the PCA); and
           WHEREAS , as a condition to the First Closing (as defined in the PCA) under the PCA, Buyer will grant to Seller certain licenses, and Seller will grant Buyer certain licenses, on the terms and conditions set forth herein.
           NOW , THEREFORE , in consideration of the foregoing and the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
ARTICLE I.
DEFINITIONS
          For the purposes of this Agreement, the following terms shall have the following meanings. All other capitalized terms used herein and not defined in this Agreement shall be as defined in the PCA.
          “ Ascend Agreement ” means the License and Supply Agreement, dated as of September 27, 2007, between Columbia Laboratories, Inc. and Ascend Therapeutics, Inc.
          “ Buyer Introduced Technology ” means all Patents and Know-How Controlled by Buyer from time to time during the Joint Development Period covering technology identified by Buyer in writing for use by Seller in Seller Development Activities.
          “ Buyer Technology ” means the Purchased Asset Technology and Collaboration Technology.

 


 

          “ Collaboration Invention ” shall have the meaning set forth in Section 3.2(a) hereof.
          “ Collaboration Invention Patent ” shall have the meaning set forth in Section 3.2(a) hereof.
          “ Collaboration Technology ” shall have the meaning set forth in Section 3.2(a) hereof.
          “ Dimera Agreement ” means the Reciprocal License Agreement, dated as of May 19, 2004, among Columbia Laboratories, Inc., Columbia Laboratories (Bermuda) Ltd. and Dimera Incorporated.
          “ Effective Date ” means the date set forth in the Preamble.
          “ Excluded Asset Patents ” shall have the meaning set forth in the definition of Excluded Asset Technology.
          “ Excluded Asset Technology ” means (a) the Patents (“ Excluded Asset Patents ”) and Know-How Controlled by Seller and/or its Affiliates as of the First Closing Date which relate primarily to the Products and are not included in the Purchased Assets, and (b) the Seller Next Generation Delivery System Patents.
          “ Non-US Asset Purchaser ” shall have the meaning set forth in Section 2.3(a) hereof.
          “ Non-US Rights to Intellectual Property ” shall have the meaning set forth in Section 2.3(a) hereof.
          “ Product Infringement ” shall have the meaning set forth in Section 3.4(a)(i) hereof.
          “ Purchased Asset Patents ” shall have the meaning set forth in the definition of Purchased Asset Technology.
          “ Purchased Asset Technology ” means the Patents (“ Purchased Asset Patents ”) and Know-How included in the Purchased Assets.
          “ Seller Next Generation Delivery System Invention ” shall have the meaning set forth in Section 3.2(b) hereof.
          “ Seller Next Generation Delivery System Patents ” means any Patent Controlled by Seller and/or its Affiliates containing at least one claim that, without a license thereunder, would be infringed by the manufacture, use, marketing, importing, exporting, sale, offer for sale or other Commercialization of any product utilizing a Seller Next Generation Delivery System.

 


 

          “ Seller Next Generation Delivery System Technology ” shall have the meaning set forth in Section 3.2(b) hereof.
          “ Territory ” means worldwide.
ARTICLE II.
CERTAIN LICENSES RELATING TO THE PRODUCTS
          2.1 Grant of Licenses .
          (a) Grant of Technology Licenses to Buyer . Subject to the terms and conditions of this Agreement, the PCA, the Ascend Agreement, the Merck-Serono Agreement, and the Dimera Agreement, Seller hereby grants to Buyer an exclusive (even as to Seller and its Affiliates), irrevocable, perpetual, royalty-free and fully paid-up (except as provided in the PCA) license, with the right to grant sublicenses subject to Section 2.2, under the Excluded Asset Technology and Seller Next Generation Delivery System Technology to Develop, manufacture, have manufactured, use, import, export, market, sell, offer to sell or otherwise Commercialize the Products in the Territory in any and all fields.
          (b) Grant of Technology Licenses to Seller . Subject to the terms and conditions of this Agreement and the PCA, including without limitation Section 8.11 of the PCA, Buyer hereby grants to Seller:
               (i) a non-exclusive, non-transferable (except pursuant to Section 6.8), royalty-free and fully paid-up license under the Buyer Technology to manufacture, have manufactured, import and export the Products for the purpose of supply of such Products to Buyer under the terms and conditions of the Supply Agreement;
               (ii) a non-exclusive, non-transferable (except pursuant to Section 6.8), royalty-free and fully paid-up license under the Buyer Technology, Collaboration Technology and Buyer Introduced Technology for the sole purpose of conducting the Seller Development Activities during the Joint Development Period;
               (iii) an exclusive (even as to Buyer and its Affiliates), irrevocable, perpetual, royalty-free and fully paid-up license, with the right to grant sublicenses subject to Section 2.2, under (A) the Purchased Asset Technology and Collaboration Technology (but solely to the extent such Collaboration Technology arises out of clinical trials conducted by or on behalf of Seller on the Product known as progesterone/COL-1620 vaginal gel containing progesterone in a concentration of either four percent (4%) or eight percent (8%)) to the extent required to permit Seller or its Affiliate to perform under and comply with the terms of the Merck-Serono Agreement and (B) the Purchased Asset Technology to the extent required to permit Seller or its Affiliate to perform under and comply with the terms of the Dimera Agreement; and
               (iv) a non-exclusive, irrevocable, perpetual, royalty-free and fully paid-up license, with the right to grant sublicenses subject to Section 2.2, under Collaboration Technology to Develop, manufacture, have manufactured, use, import, export, market, sell, offer

 


 

to sell or otherwise Commercialize the Seller Next Generation Delivery System to the extent that it incorporates or otherwise delivers any product other than Products in the Territory in any and all fields.
          2.2 Sublicenses . In the event that a Party shall have the right to grant sublicenses under licenses granted pursuant to Section 2.1 of this Agreement, each such Party shall ensure that its sublicensee shall be subject to a written agreement with terms and condition that are consistent with, and no less protective of, the other Party than the terms and conditions hereunder, provided that, it is acknowledged that the Seller shall have no obligation to amend the Merck-Serono Agreement or the Dimera Agreement notwithstanding that such agreements include licenses that constitute sublicenses hereunder.
          2.3 Non-U.S. Rights.
          (a) To the extent that rights licensed by Seller hereunder are to be used in connection with or in order to exploit the Non-United States Purchased Assets purchased by a wholly-owned Subsidiary of Parent pursuant to Section 11.1 of the PCA (such licensed rights, the “ Non-US Rights to Intellectual Property, ” and such wholly-owned Subsidiary, the “ Non-US Asset Purchaser ”), such Non-US Rights to Intellectual Property shall be licensed to the Non-US Asset Purchaser.
          (b) To the extent that rights licensed to Seller hereunder are rights to use the Non-United States Purchased Assets purchased by the Non-US Asset Purchaser, such rights shall be licensed to Columbia Laboratories (Bermuda) Ltd.
ARTICLE III.
DEVELOPMENT UNDER THE PCA
          3.1 Invention Disclosures . Each Party shall promptly disclose to the other Party any inventions and other Know-How, including any inventions or other Know-How related to the Products or any Next Generation Product, arising under the Parties’ activities conducted pursuant to the PCA during the Joint Development Period. Such disclosures shall be provided in writing and in sufficient detail for the other Party to understand the scope and nature of such inventions and other Know-How. Any such disclosure shall be treated as the Confidential Information (as defined in the PCA) of the disclosing Party, subject to the terms of this Article III.
          3.2 Ownership of Inventions . All inventions arising from the Parties’ activities pursuant to the PCA during the Joint Development Period, including any Patents covering such inventions, shall be owned as follows:
          (a) All inventions arising from the Parties’ activities under the PCA (each, a “ Collaboration Invention ”) and any Patent covering any such an invention (each, a “ Collaboration Invention Patent ”) and Know-How arising from the Parties’ activities under the PCA (Collaboration Invention Patents and such Know-How, collectively, “ Collaboration Technology ”) shall be owned by Buyer. Notwithstanding the previous sentence, Collaboration Invention and Collaboration Technology shall exclude any Seller Next Generation Delivery

 


 

System Inventions and Seller Next Generation Delivery System Technology. Seller and Affiliates of Seller shall assign, and hereby assign, to Buyer all right, title and interest in and to Collaboration Inventions, and all right, title and interest in, to and under Collaboration Technology, in each case, held by Seller and/or Affiliates of Seller. Seller shall, and shall cause its Affiliates to, cooperate with Buyer and take all reasonable actions and execute agreements, instruments and documents as may be reasonably required to perfect Buyer’s right, title and interest in and to Collaboration Inventions and Buyer’s right, title and interest in, to and under Collaboration Technology.
          (b) All inventions arising from the Parties’ activities under the PCA that relate solely to the Seller Next Generation Delivery System (each a “ Seller Next Generation Delivery System Invention ”) and any Patent covering such an invention (each such Patent to constitute a Seller Next Generation Delivery System Patent) and Know-How arising from the Parties’ activities under the PCA that relates solely to the Seller Next Generation Delivery System (Seller Next Generation Delivery System Patents and such Know-How, collectively, “ Seller Next Generation Delivery System Technology ”) shall be owned by Seller. Buyer and Affiliates of Buyer shall assign, and hereby assign, to Seller all right, title and interest in and to Seller Next Generation Delivery System Inventions, and all right, title and interest in, to and under Seller Next Generation Delivery System Technology, in each case, held by Buyer and/or Affiliates of Buyer. Buyer shall, and shall cause its Affiliates to, cooperate with Seller and take all reasonable actions and execute agreements, instruments and documents as may be reasonably required to perfect Seller’s right, title and interest in and to Seller Next Generation Delivery System Inventions and Seller’s right, title and interest in, to and under Seller Next Generation Delivery System Technology.
          (c) Determination of inventorship shall be made in accordance with United States patent laws.
          3.3 Patent Prosecution .
          (a) Purchased Asset Patents and Collaboration Invention Patents .
               (i) Subject to Sections 3.3(a)(ii) and 3.3(a)(iii), Buyer will have the responsibility for, and the obligation with respect to, filing, prosecuting and maintaining the Purchased Asset Patents and Collaboration Invention Patents, at Buyer’s sole cost and expense. Seller will fully cooperate with Buyer, at Buyer’s expense, in connection with the filing, prosecution and maintenance of such Purchased Asset Patents and such Collaboration Invention Patents, including by providing access to relevant Persons and executing all documentation reasonably requested by Buyer or its Affiliates.
               (ii) Buyer will consult with Seller and keep Seller reasonably informed of the status of the Purchased Asset Patents and Collaboration Invention Patents, and will provide Seller with all material filings and correspondences with the patent authorities with respect to such Purchased Asset Patents and such Collaboration Invention Patents for Seller’s review and comment; provided that Buyer shall have full and complete control over the filing, prosecution and maintenance of the Purchased Asset Patents and the Collaboration Invention Patents.

 


 

               (iii) Buyer will notify Seller of any decision not to file applications for, or to cease prosecution and/or maintenance of, or not to continue to pay the expenses of prosecution and/or maintenance of, any Purchased Asset Patent or Collaboration Invention Patent. Buyer will provide such notice at least sixty (60) days prior to any filing or payment due date, or any other due date that requires action, in connection with such Purchased Asset Patent or Collaboration Invention Patent. In such event, Buyer shall permit Seller, at Seller’s sole discretion and expense, to file or to continue prosecution or maintenance of such Purchased Asset Patent or such Collaboration Invention Patent, in each case, in Buyer’s name.
          (b) Excluded Asset Patents and Seller Next Generation Delivery System Patents . Seller will have the responsibility for, and the obligation with respect to, filing, prosecuting and maintaining the Excluded Asset Patents and Seller Next Generation Delivery System Patents at Seller’s sole cost and expense. Buyer will fully cooperate with Seller, at Seller’s expense, in connection with the filing, prosecution and maintenance of the Excluded Asset Patents and Seller Next Generation Delivery System Patents, including by providing access to relevant Persons and executing all documentation reasonably requested by Seller or its Affiliates. Seller shall have full and complete control over the filing, prosecution and maintenance of the Excluded Asset Patents and Seller Next Generation Delivery Patents; provided that, so long as Buyer is Developing and/or Commercializing a Product utilizing the Seller Next Generation Delivery System, Seller will:
               (i) consult with Buyer and keep Buyer reasonably informed of the status of the Seller Next Generation Delivery System Patents with respect to such Product, and will provide Buyer with all material filings and correspondences with the patent authorities with respect to such Seller Next Generation Delivery System Patents for Buyer’s review and comment; and
               (ii) notify Buyer of any decision not to file applications for, or to cease prosecution and/or maintenance of, or not to continue to pay the expenses of prosecution and/or maintenance of, any Seller Next Generation Delivery System Patents with respect to such Product. Seller will provide such notice at least sixty (60) days prior to any filing or payment due date, or any other due date that requires action, in connection with any such Seller Next Generation Delivery System Patent and Buyer, at Buyer’s sole discretion and expense, will have a right to file or to continue prosecution or maintenance of such Seller Next Generation Delivery System Patent in Seller’s name.
          3.4 Patent Infringement .
          (a) Purchased Asset Patents and Collaboration Invention Patents .
               (i) Each Party will notify the other of any infringement by a Third Party of any of the Purchased Asset Patents, Collaboration Invention Patents or Seller Next Generation Delivery System Patents that cover a Product of which such Party becomes aware, including any “patent certification” filed in the United States under 21 U.S.C. §355(b)(2) or 21 U.S.C. §355(j)(2) or similar provisions in other jurisdictions and of any declaratory judgment, opposition, or similar action alleging the invalidity, unenforceability or non-infringement of any

 


 

of the Purchased Asset Patents, Collaboration Invention Patents or Seller Next Generation Delivery System Patents that cover a Product (collectively “ Product Infringement ”).
               (ii) Buyer will have the sole right to bring and control any legal action in connection with Product Infringement at Buyer’s own expense as it reasonably determines appropriate, and Seller shall have the right, at Seller’s own expense, to be represented in any such action by counsel of its own choice.
               (iii) If Buyer fails to bring an action or proceeding with respect to, or to terminate, infringement of any Purchased Asset Patents, Collaboration Invention Patents or Seller Next Generation Delivery System Patents that cover a Product (A) within ninety (90) days following notice of alleged infringement or (B) prior to ten (10) days before the time limit, if any, set forth in the appropriate laws and regulations for the filing of such actions, whichever comes first, Seller shall have the right, upon prior consultation with Buyer, to bring and control any such action at Seller’s own expense and by counsel of its own choice.
               (iv) At the request of the Party prosecuting the Product Infringement action or proceeding, the other Party, at the prosecuting Party’s expense, shall provide reasonable assistance in connection therewith, including by executing reasonably appropriate documents, cooperating in discovery and joining as a party to the action if required.
               (v) In connection with any such proceeding, Buyer shall not enter into any settlement admitting the invalidity of, or otherwise impairing the Purchased Asset Patents, Collaboration Invention Patents or Seller Next Generation Delivery System Patents that cover a Product in any manner that would impair royalties payable pursuant to the PCA without the prior written consent of Seller, which will not be unreasonably withheld or delayed.
               (vi) Any recoveries resulting from an action relating to a claim of Product Infringement shall be first applied against payment of each Party’s costs and expenses in connection therewith. Any remainder will be considered Net Sales for purposes of Section 2.8(d) of the PCA.
          (b) Excluded Asset Patents and Seller Next Generation Delivery System Patents .
               (i) Each Party will notify the other of any infringement by a Third Party of any of the Excluded Asset Patents or Seller Next Generation Delivery System Patents (other than Seller Next Generation Delivery System Patents that cover a Product, which are included within Section 3.4(a)(i)) of which such Party becomes aware, including any “patent certification” filed in the United States under 21 U.S.C. §355(b)(2) or 21 U.S.C. §355(j)(2) or similar provisions in other jurisdictions and of any declaratory judgment, opposition, or similar action alleging the invalidity, unenforceability or non-infringement of any of such Excluded Asset Patent or Seller Next Generation Delivery System Patent (other than Seller Next Generation Delivery System Patents that cover a Product, which are included within Section 3.4(a)(i)).
               (ii) Seller will have the sole right to bring and control any legal action in connection with infringement of any Excluded Asset Patent or Seller Next Generation

 


 

Delivery System Patents (other than Seller Next Generation Delivery System Patents that cover a Product, which are included within Section 3.4(a)(ii)) at Seller’s own expense as it reasonably determines appropriate.
               (iii) If Seller fails to bring an action or proceeding with respect to, or to terminate, infringement of any Excluded Asset Patent or Seller Next Generation Delivery System Patents (other than Seller Next Generation Delivery System Patents that cover a Product, which are included within Section 3.4(a)(iii)) (A) within ninety (90) days following notice of alleged infringement or (B) prior to ten (10) days before the time limit, if any, set forth in the appropriate laws and regulations for the filing of such actions, whichever comes first, Buyer shall have the right, upon prior consultation with Seller, to bring and control any such action at its own expense and by counsel of its own choice.
               (iv) At the request of the Party prosecuting the infringement action or proceeding, the other Party shall provide reasonable assistance in connection therewith, including by executing reasonably appropriate documents, cooperating in discovery and joining as a party to the action if required.
               (v) In connection with any such proceeding, the Party prosecuting the infringement action or proceeding shall not enter into any settlement admitting the invalidity of, or otherwise impairing any Excluded Asset Patent or Seller Next Generation Delivery System Patent (other than Seller Next Generation Delivery System Patents that cover a Product, which are included within Section 3.4(a)(v)) utilized in a Product in any manner that would impair the other Party’s Development and/or Commercialization of such Product or a product utilizing the Seller Next Generation Delivery System without the prior written consent of the other Party, which will not be unreasonably withheld or delayed.
               (vi) Any recoveries resulting from an action relating to a claim of infringement of any Excluded Asset Patent or Seller Next Generation Delivery System Patent (other than Seller Next Generation Delivery System Patents that cover a Product, which are included within Section 3.4(a)(vi)) utilized in a Product shall be first applied against payment of each Party’s costs and expenses in connection therewith. Any remainder will be retained by Seller.
          3.5 Third Party Agreements . Each Party shall ensure that any agreement entered into with Third Parties engaged to perform Development activities pursuant to the PCA provides for ownership of inventions and other rights in favor of such Party consistent with this Agreement.
ARTICLE IV.
CONSIDERATION; NO IMPLIED LICENSES
          4.1 Consideration . The rights and obligations provided under this Agreement are being provided as a condition to the First Closing under the PCA. As such, no further consideration, financial or otherwise, will be due under this Agreement, except as expressly provided herein.

 


 

          4.2 No Implied Licenses . Any Intellectual Property rights of a Party not expressly granted to the other Party under the provisions of this Agreement shall be retained by such Party. Except as expressly provided in this Agreement, a Party does not grant to the other Party any right or license in any Intellectual Property right, whether by implication, estoppel or otherwise.
ARTICLE V.
TERM AND TERMINATION
          5.1 Term . The term of this Agreement shall commence on the Effective Date and shall continue until the Parties mutually agree in writing to terminate this Agreement.
          5.2 Bankruptcy . Any licenses granted under or pursuant to this Agreement by either Party to the other Party are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11, US Code (the “ Bankruptcy Code ”), licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code. The Parties agree that during the term of this Agreement, each Party, as a licensee of rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against a Party under the Bankruptcy Code, then the other Party (which is not a Party to such proceeding) will be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property licensed to such other Party under this Agreement and all embodiments of such intellectual property, and same, if not already in such other Party’s possession, will be promptly delivered by the Party to such other Party (a) upon any such commencement of a bankruptcy proceeding upon its written request therefor, unless the Party subject to such proceeding elects to continue, and thereafter continues, to perform all of its obligations under this Agreement, or (b) if not delivered under (a) above, following the rejection of this Agreement by or on behalf of the Party subject to such proceeding upon written request therefor by the non-subject Party.
ARTICLE VI.
MISCELLANEOUS
          6.1 Disclaimer of Warranty . EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THIS AGREEMENT OR THE PCA, NEITHER PARTY MAKES ANY REPRESENTATIONS NOR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE RELATED TO ANY AND ALL OF THE INTELLECTUAL PROPERTY LICENSED HEREUNDER, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER REPRESENTATIONS AND WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS, STATUTORY OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE.
          6.2 Governing Law . This Agreement (including any claim or controversy arising out of or relating to this Agreement) shall be governed by and construed in accordance

 


 

with the Laws of the State of Delaware without regard to conflict of law principles that would result in the application of any Law other than the Laws of the State of Delaware.
          6.3 Waiver . Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the party waiving such term or condition. The failure of any Party to enforce any condition or part of this Agreement at any time shall not be construed as a waiver of that condition or part, nor shall it forfeit any rights to future enforcement thereof.
          6.4 Notices . All notices, requests, claims, demands and other communications hereunder shall be in writing and shall be deemed to have been duly given (a) when received if delivered personally, (b) when transmitted if telecopied (which is confirmed), (c) upon receipt, if sent by registered or certified mail (postage prepaid, return receipt requested) and (d) the day after it is sent, if sent for next-day delivery to a domestic address by overnight mail or courier, to the Parties at the following addresses:
          If to Seller, to:
Columbia Laboratories, Inc.
354 Eisenhower Parkway
Plaza 1, Second Floor
Livingston, NJ 07039
Attention: General Counsel
Facsimile: 973.994.3001
          with copies (which shall not constitute notice) sent concurrently to:
Kaye Scholer LLP
425 Park Avenue
New York, NY 10022
Attention: Adam H. Golden and Steven G. Canner
Facsimile: 212.836.8689
          If to Buyer, to:
Coventry Acquisition, Inc.
311 Bonnie Circle
Corona, CA 92880
Attention: General Counsel
Facsimile: 951.493.5817

 


 

          with copies (which shall not constitute notice) sent concurrently to:
Latham & Watkins LLP
650 Town Center Drive, 20th Floor
Costa Mesa, CA 92626-1925
Attention: R. Scott Shean
Facsimile: 714.755.8290
provided, however, that if any Party shall have designated a different address by notice to the others, then to the last address so designated.
          6.5 (a) Relationship of the Parties . The Parties are independent contractors. Nothing herein is intended, or shall be deemed, to constitute a partnership, agency, joint venture or employment relationship between the Parties. Neither Party shall be responsible for the other Party’s acts or omissions; and neither Party shall have authority to speak for, represent or obligate the other Party in any way without prior written authority from the other Party. Subject to the terms of this Agreement, the activities and resources of each Party shall be managed by such Party, acting independently and in its individual capacity.
          (a) No Third Party Beneficiaries . This Agreement is solely for the benefit of the Parties hereto and their respective Affiliates and no provision of this Agreement shall be deemed to confer upon any third parties any remedy, claim, liability, reimbursement, claim of action or other right in excess of those existing without reference to this Agreement.
          6.6 Amendment; Entire Agreement . This Agreement may not be amended, supplemented or otherwise modified except by an instrument in writing signed by both Parties hereto. This Agreement, the PCA, the Other Agreements and the Confidentiality Agreement contain the entire agreement of the Parties hereto with respect to the Transactions, superseding all negotiations, prior discussions and preliminary agreements made prior to the Effective Date.
          6.7 Severability . If any term, provision, covenant or restriction of this Agreement is held by a court of competent jurisdiction or other Regulatory Authority to be invalid, void, unenforceable or against its regulatory policy such determination shall not affect the enforceability of any others or of the remainder of this Agreement.
          6.8 Assignment and Transfer .
          (a) Neither this Agreement nor any right or obligation hereunder may be assigned or otherwise transferred by either Party without the prior written consent of the other Party, except that either Party may, without consent of the other Party, assign or otherwise transfer this Agreement and its rights and obligations hereunder in whole or in part: (i) to any Affiliate; (ii) in connection with a merger, reorganization or a sale or transfer of all or substantially all of the assets to which this Agreement relates. Any attempted assignment or other transfer not in accordance with this Section 6.8 shall be void. Any permitted assignee shall assume in writing all assigned obligations of its assignor under this Agreement. The Party making any assignment or other transfer permitted under this Section 6.8 shall provide prompt written notice to the other Party of such assignment or transfer. The assignor shall remain jointly

 


 

and severally liable with any such assignee(s) with respect to all obligations and liabilities of the assignor hereunder.
          (b) Successors and Assigns . Except as otherwise provided herein, this Agreement shall be binding upon and inure to the benefit of the Parties hereto and their successors and permitted assigns.
          6.9 Arbitration .
          (a) All disputes, differences, controversies and claims of the Parties arising out of or relating to the Agreement (individually, a “ Dispute ” and, collectively, “ Disputes ”), except as otherwise provided under this Agreement, shall be resolved by final and binding arbitration administered by the American Arbitration Association (“ AAA ”) under its Commercial Arbitration Rules, subject to the provisions of this Section 6.9.
          (b) Following the delivery of a written demand for arbitration by either Party, each of Buyer and Seller shall choose one (1) arbitrator within ten (10) Business Days after the date of such written demand and the two chosen arbitrators shall mutually, within ten (10) Business Days after selection select a third (3rd) arbitrator (each, an “ Arbitrator ” and together, the “ Arbitrators ”), each of whom shall be a retired judge selected from a roster of arbitrators provided by the AAA. If the third (3rd) Arbitrator is not selected within fifteen (15) Business Days after delivery of the written demand for arbitration (or such other time period as the Parties may agree), the Parties shall promptly request that the commercial panel of the AAA select an independent Arbitrator meeting such criteria.
          (c) The rules of arbitration shall be the Commercial Rules of the American Arbitration Association; provided, however, that notwithstanding any provisions of the Commercial Arbitration Rules to the contrary, unless otherwise mutually agreed to by Buyer and Seller, the sole discovery available to each Party shall be its right to conduct up to two (2) non expert depositions of no more than three (3) hours of testimony each.
          (d) The Arbitrators shall render an award by majority decision within three (3) months after the date of appointment, unless the Parties agree to extend such time. The award shall be final and binding upon the Parties.
          (e) Any judicial proceeding arising out of or relating to this Agreement or the relationship of the Parties, including without limitation any proceeding to enforce this Section 6.9, to review or confirm the award in arbitration, shall be brought exclusively in the Delaware Chancery Court sitting in the county of New Castle, Delaware (the “ Enforcing Court ”). By execution and delivery of this Agreement, each Party accepts the jurisdiction of the Enforcing Court.
          (f) Each Party shall pay its own expenses in connection with the resolution of Disputes pursuant to this Section 6.9, including attorneys’ fees, unless determined otherwise by the Arbitrator.
          (g) The Parties agree that the existence, conduct and content of any arbitration pursuant to this Section 6.9 shall be kept confidential and no Party shall disclose to any Person

 


 

any information about such arbitration, except in connection with such arbitration or as may be required by Law or by any Regulatory Authority (or any exchange on which such Party’s securities are listed) or for financial reporting purposes in such Party’s financial statements.
          (h) Notwithstanding the foregoing, none of the provisions of this Section 6.9 shall restrict the right of any Party to seek injunctive relief or other equitable remedies, to enjoin any breach or threatened breach of this Agreement or otherwise specifically enforce any provision of this Agreement.
          6.10 Remedies .
          (a) Injunctive Relief . The Parties hereto agree that irreparable damage would occur in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached and that such damages would not be fully compensable by an award of money damages. It is accordingly agreed that the Parties hereto shall be entitled to an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions of this Agreement without posting a bond or other undertaking, this being in addition to any other remedy to which they are entitled at law or in equity. The parties agree that notwithstanding Section 6.9, any Action brought for an injunction, or for specific performance shall be heard and exclusively in the Delaware Chancery Court sitting in New Castle County and each Party waives any objection which it may now or hereafter have to the laying of venue of any such proceeding, and irrevocably submits to the jurisdiction of such courts in any such suit, action or proceeding.
          (b) Indemnification . Seller represents and warrants to Buyer that, other than the Non-US Rights to Intellectual Property, any Intellectual Property licensed by Seller to Buyer hereunder (including without limitation any Excluded Asset Technology and Seller Next Generation Delivery System Technology licensed by Seller to Buyer pursuant to Section 2.1(a)) is owned directly by Columbia Laboratories, Inc., and has not been assigned or otherwise transferred to any other Person. Seller shall indemnify, reimburse and defend Buyer and its Affiliates and each of their respective Representatives, successors and assigns from and against, and hold them harmless from, any Taxes (including without limitation any withholding Taxes) arising from any breach of the foregoing representation and warranty.
          6.11 Interpretation . Unless the context of this Agreement otherwise requires, (a) words of one gender include the other gender; and (b) words using the singular or plural number also include the plural or singular number, respectively. Reference to days are to calendar days unless specified otherwise. References to any statute, act, or regulation are to that statute, act, or regulation as amended, modified or supplemented from time to time in accordance with the terms hereof and thereof. The headings contained in this Agreement are for convenience of reference only and shall not be considered in interpreting this Agreement. The words “hereof”, “herein” and “hereunder” and words of like import used in this Agreement shall refer to this Agreement as a whole and not to any particular provision of this Agreement. Whenever the words “include”, “includes” or “including” are used in this Agreement, they shall be deemed to be followed by the words “without limitation”, whether or not they are in fact followed by those words or words of like import. The language in all parts of this Agreement shall be construed, in all cases, according to its fair meaning. The Parties acknowledge that each

 


 

Party and its counsel have reviewed and revised this Agreement and that any rule of construction to the effect that any ambiguities are to be resolved against the drafting Party shall not be employed in the interpretation of this Agreement.
          6.12 Counterparts . This Agreement may be executed in two or more counterparts (including by facsimile or by an electronic scan delivered by electronic mail), each of which shall be deemed to be an original, but all of which, taken together, shall constitute one and the same agreement and shall become effective when counterparts have been signed by each of the Parties hereto delivered to the other Parties, it being understood that all Parties need not sign the same counterpart.
          6.13 Further Actions . Each Party will duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, as may be reasonably necessary or as the other Party may reasonably request in connection with this Agreement in order to carry out more effectively the provisions and purposes hereof.
[ Remainder of Page Left Intentionally Blank ]

 


 

           IN WITNESS WHEREOF , the Parties hereto have caused this Agreement to be duly executed as of the date first above written.
         
 
COLUMBIA LABORATORIES, INC.
 
 
  By:   /s/ Frank C. Condella, Jr.    
    Name:   Frank C. Condella, Jr.   
    Title:   Chief Executive Officer   
 
  COLUMBIA LABORATORIES (BERMUDA) LTD.
 
 
  By:   /s/ Michael McGrane    
    Name:   Michael McGrane   
    Title:   Vice President   
 
  COVENTRY ACQUISITION, INC.
 
 
  By:   /s/ Paul M. Bisaro    
    Name:   Paul M. Bisaro   
    Title:   President and Chief Executive Officer   
 

 

Exhibit 99.1
(COLUMBIA LABORATORIES INC. LOGO)
NEWS
COLUMBIA LABORATORIES STOCKHOLDERS APPROVE SALE
OF PROGESTERONE ASSETS TO WATSON PHARMACEUTICALS
LIVINGSTON, NJ — July 1, 2010 — Columbia Laboratories, Inc. (Nasdaq: CBRX) announced that in a special meeting of stockholders held this morning, stockholders approved the sale of substantially all of Columbia’s progesterone related assets to Watson Pharmaceuticals, Inc. (NYSE: WPI) (the “Watson Transaction”). Stockholders also voted to increase the number of authorized shares of Columbia’s common stock, $0.01 par value per share, from 100,000,000 to 150,000,000 (the “Charter Amendment”).
“We are pleased that our stockholders have approved the sale of our progesterone assets to Watson and the share increase necessary to complete that transaction,” said Frank C. Condella, Jr., Columbia’s president and chief executive officer. “We look forward to closing this transaction in the next few days, and using some of the initial proceeds to immediately retire our debt. This is the first step in Columbia’s transformation to a focused development company, debt-free, with a clearer path to profitability.”
As previously announced, on March 3, 2010, Columbia entered into a definitive agreement to sell substantially all of its progesterone related assets, including its preterm birth patent applications, and 11.2 million shares of newly-issued common stock to Watson. Columbia will receive $47 million upfront from Watson, and Watson will forgive all principal and accrued interest on the $15 million subordinated term loan dated June 1, 2010. Columbia will also receive royalties of 10 to 20 percent of annual net sales of certain progesterone products, and is eligible for an additional amount of up to $45.5 million based on success milestones in the potential preterm birth indication. Watson will fund the development of a second-generation vaginal progesterone product as part of a comprehensive life-cycle management strategy.
Columbia will retain certain assets and rights to its progesterone business, including all rights necessary to perform its obligations under its agreement with Merck Serono S.A. Merck Serono holds marketing rights to and makes payments to Columbia related to CRINONE ® (progesterone gel) sales in all countries outside the United States.
The Watson Transaction is expected to close within three business days.
354 Eisenhower Parkway
Plaza I, Second Floor
Livingston, NJ 07039
TEL: (973) 994-3999
FAX: (973) 994-3001

 


 

About CRINONE/PROCHIEVE
CRINONE ® 8% (progesterone gel) is currently used for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with a progesterone deficiency. Patient preference for CRINONE 8% has been demonstrated in five clinical trials. This product is also available under the trade name PROCHIEVE ® . For more information, please visit www.crinoneusa.com .
The most common side effects of CRINONE 8%/ PROCHIEVE 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. CRINONE 8%/ PROCHIEVE 8% is contraindicated in patients with active thrombophlebitis or thromboembolic disorders or a history of hormone associated thrombophlebitis or thromboembolic disorders, missed abortion, undiagnosed vaginal bleeding, liver dysfunction or disease, and known or suspected malignancy of the breast or genital organs.
About Columbia Laboratories
Columbia Laboratories, Inc. is a specialty pharmaceutical company focused on developing products for the women’s healthcare and endocrinology markets that use its novel bioadhesive drug delivery technology.
Columbia is conducting a randomized, double-blind, placebo controlled Phase III clinical program, called the PREGNANT (PROCHIEVE ® Extending GestatioN A New Therapy) Study, to evaluate the safety and efficacy of PROCHIEVE 8% (progesterone gel) to reduce the risk of preterm birth in women with a cervical length between 1.0 and 2.0 centimeters as measured by transvaginal ultrasound at mid-pregnancy. The primary endpoint of this study is a reduction in the incidence of preterm birth at less than or equal to 32 weeks gestation vs. placebo. The Company expects study results around the end of the year.
Columbia’s press releases and other company information are available at Columbia’s website at www.columbialabs.com and its investor relations website at www.cbrxir.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are indicated by the words “may,” “will,” “plans,” “believes,” “expects,” “anticipates,” “potential,” and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to, the following: the successful marketing of CRINONE ® and STRIANT ® in the United States; the successful marketing of CRINONE by Merck Serono outside the United States; the timely and successful completion of the ongoing Phase III PREGNANT (PROCHIEVE ® Extending Gestation A New Therapy) Study of PROCHIEVE 8% to reduce the risk of preterm birth in women with a short cervix at mid-pregnancy; successful development of a next-generation vaginal progesterone product; success in obtaining acceptance and approval of new products and new indications for current products by the United States Food and Drug Administration and international regulatory agencies; the impact of competitive products and pricing; our ability to obtain financing in order to fund our operations and repay our debt as it becomes due; the timely and successful negotiation of partnerships or other transactions; the strength of the United States dollar relative to international currencies, particularly the euro; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia’s reports filed with the SEC. Completion of the sale of the assets under the Purchase and Collaboration Agreement with Watson Pharmaceuticals, Inc., and the other transactions disclosed in the Company’s press release dated March 4, 2010 and in the definitive proxy statement filed with the SEC on June 1, 2010, are

 


 

subject to various conditions to closing, and there can be no assurance those conditions will be satisfied or that such sale or other transactions will be completed on the terms described in the Purchase and Collaboration Agreement with Watson Pharmaceuticals, Inc., or other agreements related thereto or at all. All forward-looking statements contained herein are neither promises nor guarantees. Columbia does not undertake any responsibility to revise or update any forward-looking statements contained herein.
CRINONE ® , PROCHIEVE ® and STRIANT ® are registered trademarks of Columbia Laboratories, Inc.
Contact:
Lawrence A. Gyenes
Senior Vice President, Chief Financial Officer & Treasurer
Columbia Laboratories, Inc.
(973) 486-8860
Seth Lewis
Vice President, The Trout Group LLC
(646) 378-2952
###

 

Exhibit 99.2
(COLUMBIA LABORATORIES, INC LOGO)
NEWS
COLUMBIA LABORATORIES COMPLETES SALE OF
PROGESTERONE ASSETS TO WATSON PHARMACEUTICALS
COMPANY RETIRES ALL DEBT
LIVINGSTON, NJ — July 6, 2010 — Columbia Laboratories, Inc. (Nasdaq: CBRX) announced today that it has closed the sale of its progesterone related assets and 11.2 million shares of common stock to Watson Pharmaceuticals, Inc. (NYSE: WPI) (the “Watson Transaction”). Columbia’s business now consists of its royalty and manufacturing revenues, potential milestone payments, its collaboration with Watson on the development of next-generation progesterone products, and its novel bioadhesive drug delivery technologies and other products.
“We are very pleased to complete this transaction with Watson, and to emerge a debt free company with a significantly improved outlook,” said Frank C. Condella, Jr., Columbia’s president and chief executive officer. “In the near term, Columbia will focus on the smooth transfer of domestic commercial operations for CRINONE ® 8% (progesterone gel) to Watson, completing the PREGNANT Study of PROCHIEVE ® 8% (progesterone gel), and developing with Watson the next generation progesterone product.”
At the closing, Columbia received from Watson $47 million in cash. In addition, Watson forgave all principal and accrued interest on the $15 million subordinated term loan dated June 1, 2010. Columbia will receive royalties of 10 to 20 percent of annual net sales of certain progesterone products. The Company is also eligible for additional amounts of up to $45.5 million based on success milestones in the potential preterm birth indication. Watson will fund the development of second-generation vaginal progesterone products as part of a comprehensive life-cycle management strategy.
Columbia retains certain assets and rights to its progesterone business, including all rights necessary to perform its obligations under its agreement with Merck Serono S.A. Merck Serono holds marketing rights to and makes payments to Columbia related to CRINONE ® (progesterone gel) sales in all countries outside the United States.
354 Eisenhower Parkway
Plaza I, Second Floor
Livingston, NJ 07039
TEL: (973) 994-3999
FAX: (973) 994-3001

 


 

Columbia used approximately $16 million of the initial proceeds of the Watson Transaction to pre-pay the balance of the minimum royalty payments due in November 2010 to PharmaBio Development, and $26 million, together with stock and warrants, to pre-pay 100% of the $40 million in convertible notes due December 31, 2011. As a result, Columbia is now debt-free with over $25 million in cash and approximately 84 million common shares outstanding.
About Columbia Laboratories
Columbia Laboratories, Inc. is focused on developing products that utilize its novel bioadhesive drug delivery technologies to optimize drug delivery in a controlled, sustained manner. The Company’s strategy is to fund new development projects through proof of concept, then partner for later-stage clinical development and commercialization. CRINONE ® 8% (progesterone gel) is marketed by Watson Pharmaceuticals in the United States and by Merck Serono in foreign countries.
Columbia is conducting a randomized, double-blind, placebo controlled Phase III clinical program, called the PREGNANT (PROCHIEVE ® Extending GestatioN A New Therapy) Study, to evaluate the safety and efficacy of PROCHIEVE 8% (progesterone gel) to reduce the risk of preterm birth in women with a cervical length between 1.0 and 2.0 centimeters as measured by transvaginal ultrasound at mid-pregnancy. The primary endpoint of this study is a reduction in the incidence of preterm birth at less than or equal to 32 weeks gestation vs. placebo. The Company expects study results around the end of the year.
Columbia’s press releases and other company information are available at Columbia’s website at www.columbialabs.com and its investor relations website at www.cbrxir.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are indicated by the words “may,” “will,” “plans,” “believes,” “expects,” “anticipates,” “potential,” and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to, the following: the successful marketing of CRINONE ® by Watson Pharmaceuticals, Inc., in the United States; the successful marketing of CRINONE by Merck Serono outside the United States; the timely and successful completion of the ongoing Phase III PREGNANT (PROCHIEVE ® Extending Gestation A New Therapy) Study of PROCHIEVE 8% to reduce the risk of preterm birth in women with a short cervix at mid-pregnancy; successful development of a next-generation vaginal progesterone product; success in obtaining acceptance and approval of new products and new indications for current products by the United States Food and Drug Administration and international regulatory agencies; the impact of competitive products and pricing; the timely and successful negotiation of partnerships or other transactions; the strength of the United States dollar relative to international currencies, particularly the euro; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia’s reports filed with the SEC. Columbia does not undertake any responsibility to revise or update any forward-looking statements contained herein.
CRINONE ® and PROCHIEVE ® are trademarks of Watson Pharmaceuticals, Inc.
Contact:
Lawrence A. Gyenes
Senior Vice President, Chief Financial Officer & Treasurer

 


 

Columbia Laboratories, Inc.
(973) 486-8860
Seth Lewis
Vice President, The Trout Group LLC
(646) 378-2952
###

 

Exhibit 99.3
UNAUDITED PRO FORMA
FINANCIAL STATEMENTS
     The following Unaudited Pro Forma Financial Statements give effect to (i) the transactions (the “Watson Transactions”) contemplated under the Purchase and Collaboration Agreement (the “Purchase Agreement”), dated March 3, 2010, by and among Columbia Laboratories, Inc. (“Company”), Coventry Acquisition, Inc. (the “Buyer”) and Watson Pharmaceuticals, Inc. (“Watson”), (ii) the issuance and forgiveness by Watson of that certain $15 million term loan pursuant to a Term Loan Promissory Note, dated June 1, 2010 (the “Watson Note”), and (iii) the elimination of substantially all of the Company’s debt (the “Debt Retirement”) as a result of the satisfaction of the Company’s payment obligations owing to (a) PharmaBio Development, Inc. (“PharmaBio”) pursuant to the Investment and Royalty Agreement, dated March 5, 2003, between the Company and PharmaBio, as amended and supplemented from time to time (the “PharmaBio Agreement”), and (b) the holders of the $40 million in outstanding principal amount of the Company’s convertible subordinated notes due December 31, 2011 (the “Notes”), pursuant to certain Note Purchase and Amendment Agreements (“Note Purchase Agreements”) entered into with the holders of the Notes and are based upon the Company’s Unaudited Statements of Net Revenues and Direct Costs for U.S. Progesterone Products for the fiscal year ended December 31, 2009 and the quarter ended March 31, 2010 and the related notes included in the Company’s Definitive Proxy Statement on Schedule 14A, dated June 1, 2010 and from the Company’s financial statements for the fiscal year ended December 31, 2009 and the quarter ended March 31, 2010 and the related notes, each included in the Company’s filings on Form 10-K/A for the fiscal year ended December 31, 2009, or Form 10-Q for the quarter ended March 31, 2010, respectively, and certain estimates, adjustments and assumptions that the Company’s management believes to be reasonable. The Unaudited Pro Forma Consolidated Statements of Operations for the fiscal year ended December 31, 2009 and the quarter ended March 31, 2010 are presented as if the Watson Transactions and the Debt Retirement were completed as of January 1, 2009 and the Unaudited Pro Forma Consolidated Balance Sheet as of March 31, 2010 is presented as if the Watson Transactions, the issuance and forgiveness of the Watson Note, and the Debt Retirement were consummated at March 31, 2010.
     The Unaudited Pro Forma Financial Statements include adjustments to reflect the effects of the Watson Transactions and the issuance and forgiveness of the Watson Note. After the closing of the Watson Transactions, the Company is no longer directly involved in the commercialization of pharmaceutical products containing progesterone as an active ingredient, including CRINONE 8% progesterone gel, PROCHIEVE 4% progesterone gel and PROCHIEVE 8% progesterone gel, each sold by the Company in the United States (collectively, the “Progesterone Products”) and the Company is primarily involved in the supplying of Progesterone Products to the Buyer and Ares Trading S.A., an affiliate of Merck Serono S.A. (“Merck Serono”). The Unaudited Pro Forma Financial Statements also include adjustments in respect of the effects of the Debt Retirement. The Unaudited Pro Forma Financial Statements should be read in conjunction with the Company’s Annual Report on Form 10-K/A for the fiscal year ended December 31, 2009, the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2010 and the Company’s Definitive Proxy Statement on Schedule 14A, dated June 1, 2010.

 


 

     The Unaudited Pro Forma Financial Statements are based on the issuance of the $15 million Watson Note, the transactions that occurred at the closings under the Purchase Agreement and the Debt Retirement, including the sale by the Company of certain of its assets pursuant to the Purchase Agreement (the “Assets”), its receipt of a $47,000,000 cash payment from the Buyer at the closing of the transactions contemplated by the Purchase Agreement (“Upfront Payment”), the issuance by the Company of 11,200,000 shares (“Acquisition Shares”) of the Company’s common stock, $.01 par value per share (“Common Stock”), to the Buyer pursuant to the Purchase Agreement, the forgiveness of the $15,000,000 Watson Note, the payment by the Company to PharmaBio of $16,028,197 in cash (which represents the net present value of the Company’s payment obligations under the PharmaBio Agreement of $16,500,000 due in November 2010, discounted at a rate of 4.6% to March 31, 2010), and the payment by the Company of approximately $26,800,000 in cash (including accrued and unpaid interest), and the issuance by the Company of warrants to purchase 7,750,000 shares of Common Stock (the “Warrants”) and 7,407,407 shares of Common Stock under the Note Purchase Agreements. The issuance and forgiveness of the Watson Note has not been broken out separately in the Unaudited Pro Forma Financial Statements; instead the net effect of the issuance and forgiveness of the Watson Note, results in $15,000,000 of deferred revenue. The Unaudited Pro Forma Financial Statements do not give effect to the Company’s receipt of any portion of the up to $45,500,000 in contingent milestone payments that may be payable to it pursuant to the terms of the Purchase Agreement. In addition, the Unaudited Pro Forma Financial Statements do not give effect to any adjustments in respect of potential reductions in the Company’s Research and Development or General and Administrative expenses that may occur following the consummation of the Watson Transactions.
     Pro forma information is intended to provide investors with information about the continuing impact of a transaction by showing how a specific transaction might have affected historical financial statements, illustrating the scope of the change in the historical financial position and results of operations. The adjustments made to historical financial information give effect to events that are directly attributable to the Watson Transactions, the issuance and forgiveness of the Watson Note and the Debt Retirement, factually supportable, and expected to have a continuing impact. The Unaudited Pro Forma Financial Statements are prepared in accordance with Article 11 of Regulation S-X.
     The Unaudited Pro Forma Financial Statements set forth below are not fact and there can be no assurance that the Company’s actual results will not differ significantly from those set forth below or that the impact of the Watson Transactions, the issuance and forgiveness of the Watson Note and the Debt Retirement will not differ significantly from those presented below. Accordingly, the Unaudited Pro Forma Financial Statements are presented for illustrative purposes only and do not purport to represent, and are not necessarily indicative of, what the Company’s actual financial position and results of operations would have been had the Watson Transactions, the issuance and forgiveness of the Watson Note and the Debt Retirement occurred on the dates indicated, nor are they indicative of the Company’s future financial position or results of operations.

 


 

Unaudited Pro Forma Consolidated Statement of Operations
For the Quarter Ended March 31, 2010
                                 
    For the Quarter Ended March 31, 2010 A  
    Historical     Pro Forma Adjustments        
    Columbia     Sale of U.S.     Pro Forma        
    Laboratories,     Progesterone     Adjustments        
    Inc.     Products (-) B     (+)     Pro Forma  
NET REVENUES
  $ 7,172,899     $ 4,356,251     $ 798,484   C   $ 3,615,132  
 
COST OF REVENUES
    1,176,579       329,872       329,872   D     1,176,579  
 
                       
Gross profit
    5,996,320       4,026,379       468,612       2,438,553  
 
                       
 
OPERATING EXPENSES:
                               
Selling and distribution
    3,250,319       3,250,319              
General and administrative
    4,126,318             (1,525,000)   E     2,601,318  
Research and development
    2,341,818                   2,341,818  
Amortization of licensing right
    1,261,182       1,261,182              
 
                       
Total operating expenses
    10,979,637       4,511,501       (1,525,000 )     4,943,136  
 
                       
 
                               
Loss from operations
    (4,983,317 )     (485,122 )     1,993,612       (2,504,583 )
 
                       
 
                               
OTHER INCOME (EXPENSE):
                               
Interest income
    1,620                   1,620  
Interest expense
    (2,302,794 )           2,302,794   F      
Change in fair value of derivative
    (2,781,660 )           2,781,660   G      
Other, net
    (110,685 )                 (110,685 )
 
                       
 
    (5,193,519 )           5,084,454       (109,065 )
 
                       
 
                               
Net loss before income tax
    (10,176,836 )     (485,122 )     7,078,066       (2,613,648 )
State income tax benefits
    (2,200 )                 (2,200 )
 
                       
Net loss
  $ (10,179,036 )   $ (485,122 )     7,078,006       (2,615,848 )
 
                       
 
                               
LOSS PER COMMON SHARE — BASIC AND DILUTED
  $ (0.16 )                     (0.03 )
 
                           
 
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING — BASIC AND DILUTED
    65,388,921               18,607,407   X, Y      83,996,328   X, Y 
 
                         

 


 

Unaudited Pro Forma Consolidated Statement of Operations
For the Year Ended December 31, 2009
                                 
    For the Year Ended December 31, 2009 A  
            Pro Forma Adjustments        
    Historical     Sale of U.S.     Pro Forma        
    Columbia     Progesterone     Adjustments        
    Laboratories, Inc.     Products (-) B     (+)     Pro Forma  
NET REVENUES
  $ 32,196,381     $ 15,182,828     $ 2,746,712   C   $ 19,760,265  
 
                               
COST OF REVENUES
    9,194,538       1,116,754       1,116,754   D     9,194,538  
 
                       
Gross profit
    23,001,843       14,066,074       1,629,958       10,565,727  
 
                       
 
                               
OPERATING EXPENSES:
                               
Selling and distribution
    11,982,229       11,982,229              
General and administrative
    10,559,298                   10,559,298  
Research and development
    8,579,035                   8,579,035  
Amortization of licensing right
    5,044,728       5,044,728              
 
                       
Total operating expenses
    36,165,290       17,026,957             19,138,333  
 
                       
 
                               
Loss from operations
    (13,163,447 )     (2,960,883 )     1,629,958       (8,572,606 )
 
                       
 
                               
OTHER INCOME (EXPENSE):
                               
Interest income
    33,830                   33,830  
Interest expense
    (8,851,253 )           8,848,828   F     (2,425 )
Other, net
    (243,720 )                 (243,720 )
 
                       
 
    (9,061,143 )           8,848,828       (212,315 )
 
                       
 
                               
Net loss before income tax
    (22,224,590 )     (2,960,883 )     10,478,786       (8,784,921 )
State income tax benefits
    355,032                   355,032  
 
                       
Net loss
  $ (21,869,558 )   $ (2,960,883 )     10,478,786       (8,429,889 )
 
                       
 
                               
LOSS PER COMMON SHARE — BASIC AND DILUTED
  $ (0.39 )                     (0.11 )
 
                           
 
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING — BASIC AND DILUTED
    56,358,843               18,607,407   X, Y     74,966,250   X, Y
 
                         

 


 

Unaudited Pro Forma Consolidated Balance Sheet As of March 31, 2010
                                 
    As of March 31, 2010  
    Historical                      
    Columbia                      
    Laboratories,     Pro Forma                
    Inc.     Adjustments             Pro Forma  
CURRENT ASSETS
                               
Cash and cash equivalents of which $9,220,493 is interest bearing
  $ 11,284,243     $               $    
Upfront Payment from Watson
          47,000,000       H          
Payment for Notes
          (25,999,999 )     I          
Payment for Notes accrued interest
          (800,000 )     J          
Payment for PharmaBio
          (16,028,197 )     K          
Payment for Series C preferred stock
          (600,000 )     L          
Transaction costs
          (2,475,000 )     M          
Sale of finished goods inventory to Watson
          598,560       N          
Watson Note
          15,000,000       O          
 
                       
Cash and cash equivalents
    11,284,243       16,695,364               27,979,607  
Accounts receivable, net of allowances for doubtful accounts of $100,000
    3,297,668                     3,297,668  
Inventories
    3,088,990       (598,560 )     N       2,490,430  
Prepaid expenses and other current assets
    1,009,323                     1,009,323  
 
                         
Total current assets
    18,680,224       16,096,804               34,777,028  
 
                         
 
                               
PROPERTY AND EQUIPMENT
    637,812                     637,812  
 
                               
INTANGIBLE ASSETS — NET
    17,509,150       (17,509,150 )            
Deposits/long term investments
    483,328                     483,328  
Deferred charges
    950,696       (950,696 )     Q        
 
                         
OTHER ASSETS
    1,434,024       (950,696 )             483,328  
 
                         
 
                               
TOTAL ASSETS
  $ 38,261,210     $ (2,363,042 )           $ 35,898,168  
 
                         

 


 

Unaudited Pro Forma Consolidated Balance Sheet As of March 31, 2010
                                 
    As of March 31, 2010  
    Historical                      
    Columbia                      
    Laboratories,     Pro Forma                
    Inc.     Adjustments             Pro Forma  
CURRENT LIABILITIES:
                               
Current portion of financing agreements
  $ 58,563     $ (58,563 )     R     $  
Accounts payable
    2,805,472                     2,805,472  
Accrued expenses
    5,512,142       (800,000 )     J       4,712,142  
Derivative embedded within convertible notes, fair value
    2,781,660       (2,781,660 )     G        
 
                         
Total current liabilities
    11,157,837       (3,640,223 )             7,517,614  
NOTES PAYABLE
    33,749,209       (33,749,209 )     S        
DEFERRED REVENUE
    312,181       15,000,000       O       32,819,031  
 
            17,506,850       T          
 
                             
LONG-TERM PORTION OF FINANCING AGREEMENTS
    15,867,735       (15,867,735 )     U        
REDEEMABLE WARRANTS
          2,456,798       V       2,456,798  
 
                         
TOTAL LIABILITIES
    61,086,962       (18,293,519 )             42,793,443  
 
                         
 
                               
COMMITMENTS AND CONTINGENCIES
                               
Contingently redeemable series C preferred stock, 600 shares issued and outstanding in 2009 (liquidation preference of $600,000)
    600,000       (600,000 )     L        
 
                         
 
                               
STOCKHOLDERS’ EQUITY (DEFICIENCY):
                               
Preferred stock, $.01 par value; 1,000,000 shares authorized
                           
Series B convertible preferred stock, 130 shares issued and outstanding (liquidation preference of $13,000)
    1                     1  
Series E convertible preferred stock 59,000 shares issued and outstanding (liquidation preference of $5,900,000)
    590                     590  
Common Stock $.01 par value; 100,000,000 shares authorized; 65,761,986 shares issued (footnotes W, X and Y)
    657,619       186,074       X, Y       843,693  
Capital in excess of par value
    243,191,797       19,723,851       X, Y       264,916,425  
 
                               
 
            2,000,777     AA        
Less cost of 152,795 treasury shares
    (306,369 )                   (306,369 )
Accumulated deficit
    (267,158,299 )     (904,448 )     Z       (272,538,524 )
 
            (2,000,777 )   AA        
 
                               
 
            (2,475,000 )     M          
Accumulated other comprehensive income
    188,909                     188,909  
Stockholders’ equity (deficiency)
    (23,425,752 )     16,530,477               (6,895,275 )
 
                         
 
                               
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIENCY)
  $ 38,261,210     $ (2,363,042 )           $ 35,898,168  
 
                         

 


 

NOTES TO UNAUDITED PRO FORMA
FINANCIAL STATEMENTS
Description of Transaction and Basis of Presentation
     The historical information in the Unaudited Pro Forma Financial Statements is derived from the Company’s Unaudited Statements of Net Revenues and Direct Costs for U.S. Progesterone Products for the fiscal year ended December 31, 2009 and the quarter ended March 31, 2010 and the related notes included in the Company’s Definitive Proxy Statement on Schedule 14A, dated June 1, 2010 and from the Company’s financial statements for the fiscal year ended December 31, 2009 and the unaudited financial statements for the quarter ended March 31, 2010 and the related notes, each as included in the Company’s filings on Form 10-K/A for the fiscal year ended December 31, 2009, or Form 10-Q for the quarter ended March 31, 2010, respectively. The Unaudited Pro Forma Financial Statements as of and for the year ended at December 31, 2009 and the quarter ended March 31, 2010 are presented to illustrate the estimated effects of the Watson Transactions, the issuance and forgiveness of the Watson Note and the Debt Retirement on the Company had those transactions occurred on January 1, 2009 for purposes of the Unaudited Pro Forma Consolidated Statements of Operations and at March 31, 2010 for purposes of the Unaudited Pro Forma Consolidated Balance Sheet including but not limited to the following:
    The Company is, after the closing under the Purchase Agreement, no longer directly involved in the commercialization of Progesterone Products and is primarily in the business of supplying Progesterone Products to the Buyer and Merck Serono;
 
    The Debt Retirement, including the payment by the Company to PharmaBio of $16,028,197 in cash (which represents the net present value of the Company’s payment obligations under the PharmaBio Agreement of $16,500,000 due in November 2010, discounted at a rate of 4.6% to March 31, 2010), and payment by the Company of approximately $26,800,000 in cash (including accrued and unpaid interest), and the issuance by the Company of the Warrants to purchase 7,750,000 shares of Common Stock and the 7,407,407 shares of Common Stock issuable under the Note Purchase Agreements;
 
    The sale by the Company of the Assets, receipt of the $47,000,000 Upfront Payment from the Buyer and the issuance of the 11,200,000 Acquisition Shares to the Buyer pursuant to the Purchase Agreement;
 
    The issuance of the Watson Note pursuant to which Watson loaned the Company $15,000,000 and the forgiveness of such amount upon the closing of the Watson Transactions; and
 
    Each of the other Pro Forma Adjustments described in the notes below.

 


 

     The Unaudited Pro Forma Financial Statements do not give effect to the Company’s receipt of any portion of the up to $45,500,000 in contingent milestone payments that may be payable to the Company pursuant to the terms of the Purchase Agreement. In addition, the Unaudited Pro Forma Financial Statements do not give effect to any adjustments in respect of potential reductions in the Company’s research and development or general and administrative expenses that may occur following the consummation of the Watson Transactions.
Allocation of $47,000,000 Upfront Payment
         
Upfront Payment from the Buyer
  $ 47,000,000  
Acquisition Shares
    (11,984,000 )
Write-off of Net Book Value of Intangible Assets to be sold pursuant to the Purchase Agreement
    (17,509,150 )
 
     
Net Proceeds (Deferred Revenue)
  $ 17,506,850  
Pro Forma Adjustments
     Pro forma information is intended to reflect the impact of the Watson Transactions, the issuance and forgiveness of the Watson Note and the Debt Retirement on the Company’s historical financial position and results of operations through adjustments that are directly attributable to the Watson Transactions, the issuance and forgiveness of the Watson Note and the Debt Retirement, factually supportable and expected to have a continuing impact. These Unaudited Pro Forma Financial Statements reflect the adjustments that, in the opinion of the Company’s management, are necessary to present fairly the pro forma results of operations and financial position set forth above.
A.   The pro forma information is presented on the basis that the Watson Transactions, the issuance and forgiveness of the Watson Note and the Debt Retirement had occurred (x) as of January 1, 2009 for the Unaudited Pro Forma Consolidated Statements of Operations for the year ended as of December 31, 2009 and the quarter ended March 31, 2010, and (y) at March 31, 2010 for the Unaudited Pro Forma Consolidated Balance Sheet as of March 31, 2010, including that as of such dates the Company transferred the Assets to the Buyer, received the $47,000,000 cash Upfront Payment from the Buyer, received the $15,000,000 proceeds of the Watson Note and the Watson Note was forgiven, issued the 11,200,000 Acquisition Shares to the Buyer, paid to PharmaBio $16,028,197 in cash (which represents the net present value of the Company’s payment obligations under the PharmaBio Agreement (as amended by the PharmaBio Amendment) of $16,500,000 due in November 2010, discounted at a rate of 4.6% to March 31, 2010), paid approximately $26,800,000 in cash (including accrued and unpaid interest) and issued the Warrants to purchase 7,750,000 shares of Common Stock and the 7,407,407 shares of Common Stock under the Note Purchase Agreements, and that the Company will no longer be directly involved in the commercialization of the Progesterone Products and will be primarily be involved in the supplying of Progesterone Products to the Buyer and Merck Serono. The unaudited pro forma information does not give effect to the Company’s receipt of any portion of the up to $45,500,000 in contingent milestone payments that may be payable to the Company pursuant to the Purchase Agreement. In addition, the Unaudited Pro Forma Financial Statements do not give effect to any adjustments in respect of potential reductions in the Company’s research and development or general and administrative

 


 

expenses that may occur following the consummation of the Watson Transaction. These Unaudited Pro Forma Financial Statements reflect all adjustments that, in the opinion of the Company’s management, are necessary to present fairly the pro forma results of operations and financial position presented herein.
B.   Represents the unaudited net revenues and direct expenses for the U.S. Progesterone Products for the year ended December 31, 2009 and the quarter ended March 31, 2010.
C.   Represents the Net Sales (as defined below) that the Company would have made to the Buyer under the Supply Agreement entered into by the Company and the Buyer on July 2, 2010 (the “Supply Agreement”) and royalties that the Company would have received under the Purchase Agreement had all Progesterone Products sold by the Company in the U.S. during the fiscal year ended December 31, 2009 and the quarter ended March 31, 2010 been manufactured by the Company and sold to the Buyer under the Supply Agreement during 2009 and the first quarter of 2010, respectively (at the pricing set forth in the Supply Agreement), and then sold during 2009 and the first quarter of 2010, respectively, by the Buyer to its customers at the prices that the Company sold Progesterone Products to the Company’s customers during the relevant period.
    “Net Sales” means, with respect to sales of a Progesterone Product by the Buyer and its affiliates and/or licensees, sublicensees, distributors or other agents, the amount of gross sales (in dollars or other currencies) for such Progesterone Product, reduced by the sum of the following items relating to such sales that are actually given to or taken by, as applicable, the Buyer, and its affiliates and/or licensees, sublicensees, distributors or other agents, to the extent such deductions are accrued and recognized under and in accordance with United States generally accepted accounting principles (or other internationally recognized accounting standard in use by the Buyer):
    trade, quantity and cash discounts;
 
    adjustments for price adjustments, billing errors, rejected goods, returns, product recalls and damaged goods (excluding goods damaged while under the control of the Buyer or its affiliates or their respective licensees, sub-licensees, or distributors);
 
    credits, charge-backs, reimbursements, and similar payments provided to wholesalers and other distributors, buying groups, health care insurance carriers, pharmacy benefit management companies, health maintenance organizations, other institutions or health care organizations or other customers;
 
    rebates or other price reductions provided to any regulatory authority with respect to any state or federal Medicare, Medicaid or similar programs;
 
    any invoiced charge for freight, insurance, handling or other transportation costs directly related to delivery of the Progesterone Products;
 
    distributor fees per contract based solely as a percentage of gross sales; and

 


 

    taxes that are in the nature of tariffs, duties, excise, sales, use or value-added taxes;
    provided , however , that the foregoing deductions shall only be deducted once and only to the extent not otherwise deducted from gross sales.
D.   Represents cost of revenues that the Company would have incurred had all Progesterone Products sold by it in the United States during the fiscal year ended December 31, 2009 and the quarter ended March 31, 2010, respectively, been manufactured by the Company and sold to the Buyer under the Supply Agreement during 2009 and the first quarter of 2010, respectively.
E.   Represents the reversal of the costs directly related to the Watson Transactions and the Debt Retirement incurred during the quarter ended March 31, 2010.
F.   Represents interest expense on the Notes and obligations owing to PharmaBio under the PharmaBio Agreement as if the Debt Retirement had occurred on January 1, 2009.
G.   Represents the reversal of the non-cash charge for the embedded derivative related to the Notes which was booked during the first quarter of 2010 as it is a non-recurring charge directly related to the Watson Transaction and Debt Retirement that has no continuing impact.
H.   Represents the $47,000,000 Upfront Payment in cash that would be received by the Company from the Buyer under the Purchase Agreement.
I.   Represents the approximately $26,000,000 cash payment (excluding the payment relating to accrued and unpaid interest) that would be made by the Company to the Note holders at the closings under the Note Purchase Agreements.
J.   Represents the approximately $800,000 of accrued and unpaid interest on the Notes that would be paid by the Company at the closings under the Note Purchase Agreements.
K.   Represents the $16,028,197 in cash (which is the net present value of the Company’s payment obligations under the PharmaBio Agreement (as amended by the PharmaBio Amendment) of $16,500,000 due in November 2010, discounted at a rate of 4.6% to March 31, 2010).
L.   Assumes that all holders of the Company’s Series C Preferred Stock had exercised their rights, resulting from the sale of the Assets pursuant to the Purchase Agreement, to have their shares of Series C Preferred Stock redeemed by the Company as of March 31, 2010 and that the Company had redeemed such shares on such date.
M.   Reflects the remaining estimated transaction related costs and expenses unpaid at March 31, 2010, which include fees and expenses relating to legal services, accounting services, investment advisory fees, fairness opinion fees and proxy statement printing and distribution. Total transaction costs are estimated to be $4,000,000.

 


 

N.   Represents the finished goods inventory of Progesterone Products to be sold by the Company to the Buyer at the closing of the Watson Transactions pursuant to the Supply Agreement.
O.   Reflects the cash proceeds and the forgiveness of the $15,000,000 Watson Note.
P.   Reflects the write-off of net book value of intangible assets that would be sold by the Company pursuant to the Purchase Agreement.
Q.   Reflects the write-off of deferred charges related to financing costs for the Notes and obligations owing to PharmaBio under the PharmaBio Agreement.
R.   Represents payment of the current portion of the Company’s obligations owing to PharmaBio under the PharmaBio Agreement.
S.   Represents the settlement of the Notes which is $39,999,998, less the unamortized discount related to the relative fair market value of the warrants issued by the Company in connection with the sale of the Notes and the beneficial conversion feature.
T.   Reflects deferred revenue from the $47,000,000 Upfront Payment that would be received by the Company from the Buyer under the Purchase Agreement less the value of the 11,200,000 Acquisition Shares as determined by the closing price of the Common Stock on March 31, 2010, and the write off of the net book value of intangible assets described in Note P.
U.   Represents the payment of the unpaid portion of the $30 million minimum royalty obligation payable under the PharmaBio Agreement (without giving effect to the amendment to the PharmaBio Agreement on March 3, 2010), net of unamortized imputed interest and the value of certain warrants issued to PharmaBio.
V.   Represents the fair market of the Company’s contingent obligation as of March 31, 2010 under the Note Purchase Agreements to purchase the Warrants for an aggregate purchase price of $3,999,996 under certain circumstances.
W.   Assumes that, as of March 31, 2010, the Company had amended its Restated Certificate of Incorporation, as amended, to increase the number of the Company’s authorized shares of Common Stock from 100,000,000 to 150,000,000.
X.   Assumes that the Company had issued the 11,200,000 Acquisition Shares to the Buyer as of January 1, 2009 at a price of $1.07 per share (which was the closing price of the Company’s Common Stock on March 31, 2010).
Y.   Assumes that the Company had issued the 7,407,407 shares of Common Stock under the Note Purchase Agreements as of January 1, 2009 at a price of $1.07 (which was the closing price of the Company’s Common Stock on March 31, 2010).
Z.   Represents unamortized expense for options and restricted shares issued under the Company’s 1996 Long-Term Performance Plan or the Company’s 2008 Long-Term

 


 

    Incentive Plan that would vest and/or become exercisable upon consummation and as a result of the sale of the Assets pursuant to the Purchase Agreement.
 
AA.   Represents net loss on extinguishment of debt as of March 31, 2010, less the value of the embedded derivative related to the Notes.