ex10-74.htm


     

    
      

      

    

    


    LICENSE
      AND SUPPLY AGREEMENT

    


    


    THIS
      AGREEMENT is made on September 27, 2007, between

    


    Columbia
      Laboratories, Inc. (“Columbia”), a company incorporated under the laws of the
      state of Delaware, with offices at 354 Eisenhower Parkway, Livingston,


    New Jersey 07039;
      and

    


    Ascend
      Therapeutics, Inc.(“Ascend”), a company
      incorporated under the laws of the state of Virginia, with offices at 607
      Herndon Parkway, Suite 210, Herndon, Virginia 20170.

    


                   
      RECITALS:

    


    Whereas,
      Columbia possesses certain proprietary bioadhesive drug delivery technology
      as
      well as proprietary know-how and confidential information used or useful in
      the


    manufacture
      and use of bioadhesive drug products and is the owner or has licensed or has
      control of and is beneficially entitled to a number of patents that have been
      granted 

    or
      are
      pending in relation to the development and production of such products;
      and

    


    Whereas,
      Columbia possesses, or controls and directs, the requisite expertise, personnel
      and facilities for the formulation, development and supply of Product (as
      defined 

    below)
      utilizing the Columbia Technology (as defined below); and

    


    Whereas,
      Ascend wishes to have Columbia supply Product to Ascend for commercial sale,
      and
      for clinical studies required to obtain regulatory approvals necessary for
      

    Indications
      (as defined below); and

    


    Whereas,
      Columbia and Ascend both desire to enter into an agreement to give effect to
      the
      arrangements described herein,

    


    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:

    


    
      	
               

            	
              SECTION
                1 - DEFINITIONS

            


    

    


    
      	
              1.1

            	
              In
                this Agreement, unless the context otherwise
                requires:

            


    

    


     “Affiliate”
      means any corporation or entity controlling, controlled by, or under common
      control with Columbia or Ascend, as the case may be.  For the purposes
      of this Agreement, “control” (including "controlling", "controlled by" and
      "under common control with") of any Party, corporation or other business entity
      shall mean the direct or indirect beneficial ownership of more than fifty
      percent (50%) of the voting stock of, or more than a fifty percent (50%)
      interest in the income of, such corporation or other business entity, or such
      other direct or indirect interest or relationship as in fact constitutes actual
      control.

    


    
      
        
                

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    “Adverse
      Drug Experience” means any “adverse drug experience” as defined or contemplated
      by 21 C.F.R. 314.80 or 312.32, associated with the Product.

    


    “Adverse
      Drug Experience Report” means any oral, written or electronic report of any
      Adverse Drug Experience transmitted to any Party.

    


    “Ascend”
      means Ascend Therapeutics, Inc., and any of its Affiliates.

    


    “Columbia”
      means Columbia Laboratories, Inc., and any of its Affiliates.

    


     “Columbia
      Know-How” means all knowledge, information, trade secrets, data (including all
      clinical data) and expertise associated with Columbia's bioadhesive drug
      delivery technology that is not generally known to the public, owned or licensed
      by Columbia or to be developed or licensed by Columbia
      before or during the Term, whether or not covered by any patent, copyright,
      design, trademark or other industrial or intellectual property
      rights.

    


    “Columbia
      Patents” means any and all patents and patent applications as set forth in
      Exhibit A, and all rights therein, and including all extensions, continuations,
      continuations-in-part, divisionals, patents-of-additions, re-examinations,
      re-issues, supplementary protection certificates and foreign counterparts
      thereto owned by Columbia, or licensed to Columbia and associated with
      Columbia's bioadhesive drug delivery technology.

    


    “Columbia
      Technology” means the Columbia Know-How and Columbia Patents.

    


    "Commercially
      Reasonable" means with respect to a Party, and with respect to a Product,
      efforts and resources that are comparable to those generally used by a company
      in the pharmaceutical industry in the exercise of its reasonable business
      judgment relating to other prescription pharmaceutical products owned or
      licensed by it or to which it has exclusive rights, which have market potential
      and are at a stage of development or product life similar to the Product, taking
      into account measures of relative safety and efficacy, Product profile, the
      competitiveness of the marketplace, the proprietary position of the Product,
      the
      regulatory structure involved, the relative profitability of the Product, and
      other relevant factors, including without limitation comparative technical,
      legal, scientific, and/or medical factors.

    


    “Contract
      Year” means a period beginning on the Effective Date and each anniversary of the
      Effective Date and continuing up to the subsequent anniversary of the Effective
      Date.

    


    “Current
      Good Manufacturing Practice” or “cGMP” means manufacture in accordance with 21
      CFR Parts 210 and 211; as they may be amended from time to time.

    


    “DDMAC”
      means the FDA’s Division of Drug Marketing, Advertising and
      Communications.

    


    
      
        
                

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    “Effective
      Date” means January 1, 2008.

    


    “FDA”
      means the United States Food and Drug Administration.

    


    "Finished
      Package Form" means six (6) Product applicators individually wrapped in foil
      with required leaflet printed in one color and inserted into an appropriate
      box
      with customary trade dress printed in up to four colors.  The boxes
      will be placed into appropriate outer cartons (of twelve (12) boxes) which
      will
      be printed in one color with required labeling and UPC codes.

    


    “Indication”
      means any gynecological indication that the Product now has or may have in
      the
      future, including without limitation amenorrhea and endometrial protection,
      provided, however, that Indication shall not include uses relating to fertility,
      pregnancy, or preterm birth.

    


    “Joint
      Steering Committee” has the meaning set forth in Section 4.

    


    “Minimum
      Purchase Obligations” means Ascend’s obligations to purchase Product set forth
      on Exhibit B hereto for each period specified therein.

    


    “NDA”
      means a New Drug Application as such term is defined in 21 CFR Part
      314.

    


    “Net
      Selling Price” means, in the case of Product sold by Ascend or a sub-licensee,
      that sum determined by deducting from the aggregate gross sales proceeds billed
      for Product by Ascend or a sub-licensee, as the case may be, all as determined
      in accordance with generally accepted accounting principles on a basis
      consistent with Ascend’s audited financial statements, a maximum aggregate
      deduction of [***] to cover the following:

    


    
      	
               

            	
              (a)

            	
              customs
                duties, sales or use taxes, or other taxes (excluding income or
                corporation tax), directly related to the sale of Product which are
                paid
                by Ascend or its sub-licensees, as the case may
                be;

            


    

    


    
      	
               

            	
              (b)

            	
              a
                discount from the gross sales proceeds to cover such normal costs
                as are
                incurred by Ascend  or its sub-licensees, as the case may be, in
                respect of transport, shipping, and insurance, to the extent specifically
                referenced in the invoice and included in the invoice
                price;

            


    

    


    
      	
               

            	
              (c)

            	
              customary
                trade, quantity and cash discounts, chargebacks, deductions, and
                rebates
                directly related to the sale of Product and actually allowed and
                taken;

            


    

    


    
      	
               

            	
              (d)

            	
              amounts
                repaid or credited by reasons of rejections or return of goods, or
                because
                of retroactive price reductions specifically identifiable to the
                Product;
                and

            


    

    


    
      
        
                

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              (e) 
                 

            	
              amounts
                payable resulting from governmental (or agency thereof) mandated
                rebate
                programs and other third-party rebates to the extent actually
                allowed.

            


    

    


    Provided,
      however, that in the event Ascend shall sell Product together with other
      products of Ascend to third parties (by the method commonly known in the
      pharmaceutical industry as "bundling") and the price attributable to Product
      is
      less than the average price of "arms length" sales to similar customers for
      the
      reporting period in which sales occur (such bundled sales to be excluded from
      the calculation of the average price of "arms length" sales), gross sales
      proceeds for any such sales shall be the average price of "arms length" sales
      by
      Ascend or a sublicensee to similar customers during the reporting period in
      which such sales occur.

    


    "Party"
      or “Parties” means Ascend or Columbia, or both, as the case may be.

    


    “PDMA”
      means the Prescription Drug Marketing Act, as amended, and the rules and
      regulations promulgated thereunder.

    


    “Phase
      IV
      Clinical Study” means any post-marketing human clinical trial to confirm with
      statistical significance the safety and efficacy of the Product, whether
      initiated by a Party or at the request of the FDA, to delineate additional
      information about a drug’s risks, benefits, and optimal use, including, without
      limitation, safety surveillance studies, pharmacoeconomic studies,
      pharmacoepidemiology studies, studies relating to different dosing or schedules
      of administration, studies of the use of the drug in other patient populations
      or other stages of a disease or condition or for indications including (but
      not
      limited to) for the treatment of hyperplasia or hormone replacement therapy,
      or
      studies of the use of the drug over a longer period of time.

    


    “Phase
      IV
      Clinical Study Costs” shall mean all direct and indirect expenses and other
      costs incurred by or on behalf of a Party in connection with a Phase IV Clinical
      Study, including, without limitation, the costs of clinical studies, the
      preparation, collation and/or validation of data from such clinical studies
      and
      the preparation of medical writing and publishing.  Without limitation
      of the foregoing, Phase IV Clinical Study Costs shall
      include:  (a) all reasonable out-of-pocket costs incurred by a
      Party or its Affiliates, including payments made to Third Parties, with respect
      to any of the foregoing; (b) the direct and indirect costs of scientific,
      medical or technical personnel (including personnel expense, reasonable travel
      expenses and infrastructure costs but not including the costs of managerial,
      financial or legal personnel) engaged in such efforts; (c) the costs of
      clinical supply and related disposal; (d) the costs of preparing and
      submitting applications for FDA approvals; and (e) the acquisition costs of
      the Product.

    


    
      	
               

            	
               “Product”
                means the 4% w/w progesterone gel (45 mg) in single use, one piece,
                disposable vaginal applicators containing 1.45 g of gel and delivering
                1.125 g of gel, utilizing the Columbia Technology, and approved by
                the FDA
                under NDA 20-701.

            


    

    


    
      
        
                

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    “Product
      Complaint” means any report concerning the quality, purity, quantity, weight,
      pharmacologic activity, labeling or appearance of the Product.

    


    “Serious
      Adverse Drug Experience” means any Adverse Drug Experience that is fatal or
      life-threatening, requires hospitalization or prolongation of existing
      hospitalization, results in persistent or significant disability or incapacity,
      is a congenital anomaly/birth defect, or is of comparable medical significance
      or any other event which would constitute a “serious” Adverse Drug Experience
      pursuant to the terms of 21 C.F.R. 314.80 or 312.32.

    


    “Serious
      Adverse Drug Experience Report” means any Adverse Drug Experience Report that
      involves a Serious Adverse Drug Experience.

     

    “Trademark”
      means Prochieve® 4% and any other mark selected by the Parties for use with the
      Product.

    


     “Territory”
      means the United States, its territories and possessions.

    


    SECTION
      2 – LICENSE

    


    2.1           License

    


    
      	
            	 2.1.1	
              Columbia
                hereby grants to Ascend an exclusive license (even as to Columbia)
                in the
                Territory under the Columbia Technology to the extent it relates
                exclusively to the Product, and not to any other product or active
                component, to import, market, promote, use, distribute, offer to
                sell, and
                sell the Product in the Territory, but for the avoidance of doubt
                no
                rights are granted hereunder for Ascend to manufacture the
                Product.

            


    

    


    
      	
               

            	 2.1.2	
              Columbia
                hereby grants to Ascend a non-exclusive license under Columbia Technology
                that is not associated exclusively with the Product but that, in
                the
                absence of the license provided in this Section 2.1.2, would
                necessarily be infringed by Ascend's practice of the license granted
                in
                Section 2.1.1.  This non-exclusive license shall apply only to
                the extent necessary for Ascend to exercise its rights and discharge
                its
                obligations under this Agreement with respect to the
                Product.

            


    

    


    
      	
               

            	 2.1.3	
              Ascend
                shall have the right to grant sublicenses under the rights and licenses
                granted to it in this Article 2, provided that, any such sublicense
                shall be approved by Columbia, said approval not being unreasonably
                withheld, conditioned or delayed, and shall obligate the sublicensee
                to
                comply with all relevant terms of this Agreement and Ascend remains
                liable
                to Columbia for all material acts and omissions of any such
                sublicensee.

            


    

     

    
      	
               

            	 2.1.4	
              Except
                as specifically set forth in this Agreement, neither Party shall
                acquire
                any license or other intellectual property interest, by implication
                or
                otherwise, in any

            


    

    


    
      
        
                

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               information
                disclosed to it under this Agreement or under any patents or patent
                applications owned or controlled by the other Party or its
                Affiliates.

            


    

     

    


    
      	
              2.2

            	 	
              Except
                as otherwise expressly provided herein, nothing in this Agreement
                shall,
                during or after the Term hereof, grant Ascend any of Columbia’s rights in
                or related to the Product, including, but not limited to, Columbia’s
                rights in or to trademarks, copyrights, the Product’s NDA, Drug Master
                Files, patent or other intellectual property rights, preclinical
                or
                clinical data, manufacturing rights relating to the Product, or any
                supply
                of the Product or the active ingredient thereof.  For the
                avoidance of doubt, no rights are granted to Ascend hereunder with
                respect
                to the Product or the manufacture, use, promotion, marketing or sale
                thereof outside the Territory.

            


    

    


    
      	
              SECTION
                3 - INTELLECTUAL PROPERTY

            	
            


    

    


    
      	
              3.1

            	
              Ownership
                of Intellectual
                Property

            


    

    


    
      	
               

            	 3.1.1	
              Columbia
                shall remain the sole owner of all Columbia
                Technology.

            


    

    


    
      	
               

            	 3.1.2	
              Columbia
                shall be entitled to use the Columbia Technology in connection with
                Columbia’s commercial arrangements otherwise than in relation to the
                Product in the Territory, and in connection with the Product following
                termination of this Agreement.

            


    

    


    
      	
              3.2

            	
              Each
                Party shall promptly notify the other if it becomes aware of any
                claim or
                threatened or likely claim that the Product or the development,
                manufacture, importation, marketing, use or sale thereof infringes
                a
                patent or other intellectual property right of any third
                party.  In the event of such an infringement claim or potential
                claim, the Parties shall discuss in good faith the actions, if any,
                to be
                taken; provided that in no event shall either Party be obligated
                to
                continue manufacture, importing, marketing, sale and distribution
                of the
                Product if it reasonably believes that such action would constitute
                infringement of a third party's intellectual property
                rights.

            


    

    


    
      	
              3.3

            	
              Enforcement

            


    

    


    
      	
               

            	
              3.3.1    

            	
              Ascend
                and Columbia shall promptly inform the other in writing of any alleged
                infringement of which it shall become aware by a third party of any
                patents within the Columbia Technology and Ascend shall provide Columbia
                with any available evidence of
                infringement.

            


    

    


    
      	
               

            	
              3.3.2    
                

            	
              Columbia,
                at its option, shall be entitled to institute or have instituted
                any
                administrative, judicial or other proceeding ("Enforcement Proceedings")
                to prevent or stop any infringement or unauthorized use of the Columbia
                Technology at its own expense and for its own benefit. Ascend agrees
                to
                provide all reasonable co-operation and assistance to Columbia in
                relation
                to any such Enforcement Proceedings and agrees to be named as a party
                in
                any Enforcement

            


    

    


    
      
        
                

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    Proceedings,
      as necessary, that may be instituted hereunder.  Columbia shall
      reimburse Ascend its reasonable costs and expense for such
      cooperation.

    


    
      	
               

            	
              3.3.3    
                

            	
              In
                the event that Columbia does not institute or have instituted Enforcement
                Proceedings relating to Columbia Patents, then Ascend may enforce
                such
                rights at its own expense.  Columbia shall cooperate with Ascend
                and provide all reasonable assistance in relation to any such Enforcement
                Proceedings and agrees to be named as a party in any
                Enforcement Proceedings, as necessary, instituted by Ascend
                hereunder.  Ascend  shall seek written approval from
                Columbia, which may not be unreasonably withheld or delayed, prior
                to
                taking action and shall keep Columbia informed of the action and
                may not
                enter into any settlement agreement without Columbia’s consent, which may
                not be unreasonably withheld or delayed.  Any reasonable fees
                and costs borne by Columbia shall be reimbursed by Ascend.  In
                the event that Ascend decides to enforce the Columbia Patents in
                accordance with this paragraph, any recovery remaining after the
                deduction
                of reasonable expenses (including attorneys' fees and expenses) incurred
                in relation to such Enforcement Proceedings shall be
                shared equally between the Parties.

            


    

    


    
      	
              3.4

            	
              Defense

            


    

    


    
      	
               

            	
              3.4.1    
                

            	
              In
                the event that a claim or proceeding is threatened or brought against
                a
                Party by a third party alleging that the manufacture, sale, use or
                offer
                for sale of Product infringes the patent or other intellectual property
                rights of that or any other third party in the Territory (“IP Claim”),
                that Party shall promptly advise the other Party of such IP Claim
                and the
                Parties shall meet to discuss the manner in which such IP Claim should
                be
                defended.

            


    

    


    
      	
               

            	
              3.4.2    
                

            	
              Neither
                Party shall acknowledge to the third party or to any other person
                the
                validity of any IP Claim of such a third party, and shall not compromise
                or settle any IP Claim relating thereto without the prior written
                consent
                of the other Party, such consent not to be unreasonably withheld
                or
                delayed.  Ascend shall be responsible for the conduct of the
                proceedings in defending any IP Claim, with counsel acceptable to
                Columbia.  Ascend shall keep Columbia advised of all material
                developments in said proceedings.

            


    

    


    
      	
              3.4.3    
                

            	
              Ascend
                shall indemnify Columbia and its Affiliates against any and all actions,
                losses, claims, demands, damages, costs and liabilities (including
                reasonable attorneys’ fees) due to any IP Claim, except to the extent that
                (i) use of the Columbia Technology as contemplated by this Agreement
                necessarily infringes third party patent rights or (ii) the Product
                necessarily infringes third party intellectual property rights by
                reason
                of the Columbia Technology.

            


    

    


    
      	
              3.4.4    

            	
              In
                accordance with their obligations pursuant to this Agreement, the
                Parties
                shall take such action as is reasonable, such as to cease selling
                the
                Product, or to re-engineer or modify the Product so as to avoid infringing
                the patent rights of a

            


    

    


    
      
        
                

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    third
      party, or entering into a license agreement with such third party after due
      consideration of each of the Party’s interests in the matter.

    


    
      	
              3.4.5    
                

            	
              Neither
                Party shall have any liability to the other Party whatsoever or howsoever
                arising for any losses incurred as a result of Ascend having to cease
                selling the Product as a result of an IP
                Claim, except that if such an IP
                Claim arises due to (i) use of the Columbia Technology as contemplated
                by
                this Agreement necessarily infringes third party patent rights or
                (ii) the
                Product necessarily infringes third party intellectual property rights
                by
                reason of the Columbia Technology, Columbia shall repay to Ascend
                the
                purchase price of any Product purchased and in Ascend’s then current
                inventory that can no longer be sold, including reasonable, documented,
                direct, out-of-pocket costs incurred for transportation and/or destruction
                of said Product. Columbia shall have no liability to Ascend for any
                enhanced or punitive damages awarded as a result of any willful patent
                infringement, unless such damages are the direct result of Columbia’s
                breach of this Agreement.

            


    

    


    
      	
              3.5

            	
              Trademarks

            


    

     

    


     

    
      	
              3.5.1    
                

            	
              Should
                the Parties agree to use a trademark other than Prochieve® 4% for the
                Product, Columbia shall register the trademark in its name with respect
                to
                the Product.

            


    

     

    
      	
              3.5.2    
                

            	
              Columbia
                hereby grants to Ascend a non-assignable, non-sublicensable,
                non-exclusive, royalty-free right and license to use the Trademark
                in the
                Territory solely in connection with Ascend’s promotion of the Product in
                accordance with this Agreement. Such license shall expire immediately
                upon
                the expiration or termination of this Agreement. Ascend recognizes
                Columbia’s title to the Trademark, and shall not at any time, during or
                after the Term, do or knowingly suffer to be done any act or thing
                which
                will in any way impair the rights of Columbia in or to the
                Trademark.  Ascend acknowledges and agrees that it shall not
                acquire and shall not claim any title to the Trademark adverse to
                Columbia
                by virtue of the rights granted under this Agreement or through Ascend’s
                use of the Trademark, it being the intention of the parties that
                all
                goodwill and improved reputation generated by Ascend and use of the
                Trademark shall inure to the benefit of
                Columbia.

            


    

     

    


    
      
        
                

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              SECTION
                4 - JOINT STEERING COMMITTEE

            	
               

            


    

    


    
      	
              4.1

            	
              The
                Parties recognize that cooperation will be required from each Party
                to
                successfully commercialize the Product, and for this purpose, the
                Parties
                will establish a Joint Steering
                Committee.

            


    

    


    
      	
              4.2

            	
              The
                Joint Steering Committee shall consist of a chief representative
                from each
                Party together with such additional personnel, consultants or
                sub-contractors, from each Party who are appropriately skilled and
                knowledgeable in relation to the Product. A Party may change any
                of its
                representatives at any time if a new person (with appropriate expertise
                to
                replace the outgoing member) is appointed by giving written notice
                to the
                other Party.  The total number of members may be changed by
                unanimous vote of the Joint Steering Committee from time to time
                as
                appropriate; provided, that the Joint Steering Committee shall in
                all
                cases be comprised of an equal number of members from each of Columbia
                and
                Ascend.  One representative from Ascend shall serve as Chairman
                of the Joint Steering Committee.  The members appointed to the
                Joint Steering Committee by each Party shall be vested with appropriate
                decision-making authority and power by such
                Party.

            


    

    


    
      	
              4.3

            	
              Unless
                otherwise agreed by the Parties, the Joint Steering Committee shall
                meet
                at least once each calendar quarter.  The first meeting of the
                Joint Steering Committee shall be held in December 2007.  The
                Joint Steering Committee may meet in person or by means of such telephone,
                video or other communication facilities as permit all members of
                the Joint
                Steering Committee to communicate with each other simultaneously
                and
                instantaneously, provided, however, that the Joint Steering Committee
                shall meet at least once per year in person and such meetings shall
                be
                held at the offices of Columbia, or as otherwise agreed by the
                Parties.  Meetings shall be co-chaired by the chief
                representatives of the Parties.  Subject to Section 4.4,
                decisions shall be made unanimously, each Party having one (1) vote
                regardless of the number of representatives present or voting; provided,
                that no such vote shall be valid unless each party is represented
                by at
                least one member either by written proxy or actual presence at the
                meeting
                at which the vote is taken. At and between meetings of the Joint
                Steering
                Committee, each Party shall keep the other fully and regularly informed
                as
                to its progress with its respective
                obligations.

            


    

    


    
      	
              4.4

            	
              In
                the event of a dispute within the Joint Steering Committee that cannot
                be
                resolved by consensus, such dispute shall be referred to the Presidents
                of
                Ascend and Columbia who shall discuss the matter and attempt to reach
                an
                amicable solution.  The provisions of this Section 4.4 shall be
                without prejudice to the Parties’ other rights and
                remedies.

            


    

    


    
      	
              4.5

            	
              The
                Joint Steering Committee shall not have the authority to amend, modify
                or
                waive any of the terms or conditions of this
                Agreement.

            


    

    


    
      	
              4.6

            	
              The
                responsibilities of the Joint Steering Committee shall be exercised
                consistent with this Agreement and shall include, but shall not be
                limited
                to:

            


    

    


    
      	
              4.6.1   
                

            	
              reviewing
                and approving the marketing plan prior to the beginning of
                each

            


    

    


    
      
        
                

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              calendar
                year, including matters relating to managed markets, distribution
                and
                trade pipeline;

            


    

    
      	
              4.6.2 
                   

            	
              monitoring
                and reviewing compliance with the marketing plan and, in connection
                therewith, reviewing and approving any material change
                thereto;

            


    

    
      	
              4.6.3    
                

            	
              reviewing,
                coordinating and directing all development activities for the Product,
                including matters concerning Product labeling and Phase IV Clinical
                Study;

            


    

    
      	
              4.6.4    
                

            	
              reviewing
                and approving protocols to be used in any Phase IV Clinical Study
                with
                respect to the Product;

            


    

    
      	
              4.6.5  
                  

            	
              reviewing
                and discussing manufacturing and regulatory status updates provided
                by
                Columbia to the Joint Steering
                Committee;

            


    

    
      	
              4.6.6 
                   

            	
              reviewing
                pricing for the Product, including the timing of any pricing changes;
                provided that any price increase is subject to Columbia approval
                in its
                sole discretion and in no event shall the wholesale acquisition cost
                for
                the Product be less than $38.89 per Finished Dosage Form without
                the prior
                written consent of Columbia in its sole discretion;
                and

            


    

    
      	
              4.6.7  
                  

            	
              such
                other functions as may be mutually agreed upon by the parties from
                time to
                time.

            


    

    


    
      	
              4.7  

            	
              For
                the avoidance of doubt, any decisions of the Joint Steering Committee
                with
                respect to matters that require FDA approval or otherwise relate
                to
                regulatory compliance of the Product shall require Columbia’s prior
                written consent.

            


    

    


    
      	
              4.8  

            	
              The
                Joint Steering Committee shall have responsibility for and shall
                make all
                decisions with respect to any recall, market withdrawal or any other
                corrective action related to the Product.  In the interest of
                clarity, the power of the Joint Steering Committee with respect to
                the
                foregoing is limited to (i) the ability to sanction, but not to mandate
                a
                recall by Ascend, and (ii) vetoing a suggestion by either
                Party.  At Ascend’s request and expense, Columbia shall provide
                assistance to Ascend in conducting such recall, market withdrawal
                or other
                corrective action. Columbia shall be under no liability whatsoever
                to
                compensate Ascend or make any other payment to Ascend for any decision
                to
                recall, initiate a market withdrawal or take any other corrective
                action
                with respect to the Product, except in the case of a recall or market
                withdrawal caused solely by the negligence or willful malfeasance
                of
                Columbia, its Affiliates or subcontractors, or by the breach by Columbia
                of its representations and warranties in this Agreement, in which
                case
                Columbia shall replace Product returned and reimburse
                Ascend for
                its reasonable, documented, direct, out-of-pocket costs in
                connection with such recall, market withdrawal or other corrective
                action
                provided that Ascend shall not be in material breach of its obligations
                hereunder and
                Columbia’s liability to reimburse Ascend hereunder shall not exceed
                [***].

            


    

    


    
      	
              SECTION
                5 - ASCEND OBLIGATIONS

            	
               

            


    

    


    
      	
              5.1  

            	
              Ascend
                shall, at its sole expense, warehouse and distribute the Product,
                and may
                at its sole discretion negotiate and enter into accounts with managed
                market entities and institutional customers (e.g., pharmacy benefit
                managers, health plans, long term care pharmacy providers, employers,
                the
                United States Government and state and local governments, including
                Medicare), and otherwise ensure that the Product is
                freely

            


    

    


    
      
        
                

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    distributed
      in all trade channels and not subject to unusual restraints or conditions to
      access as compared to similar products. 

    


    
      	
              5.2  

            	
              Ascend
                shall be responsible for:

            


    

    


    
      	
              5.2.1  

            	
              all
                direct and indirect costs incurred by Ascend for its sales force
                in
                connection with marketing and selling the Product including (without
                limitation) sales representative training, sample accountability,
                sales
                force automation and sales operations
                support;

            


    

    
      	
              5.2.2  

            	
              having
                a marketing presence in at least two national-level meetings per
                year;
                and

            


    

    
      	
              5.2.3  

            	
              exploring
                the possibility of re-branding the Product for gynecological indications
                and exploring regulatory options for expanding gynecological indications
                for the Product.

            


    

    


    
      	
              5.3

            	
              Ascend
                shall, at its sole expense, use Commercially Reasonable efforts to
                promote
                the Product and endeavor to persuade health care professionals to
                prescribe, and patients to use, the Product.  All statements,
                core selling messages and materials to be utilized by Ascend to promote
                the Product shall be subject to the prior approval of Columbia in
                accordance with Section 5.8 below.  Ascend will cause its
                sales force and Ascend employees and agents acting on Ascend’s behalf to
                comply with this Agreement and all applicable legal requirements
                in
                connection with the promotion of the Product, including,
                without limitation, the FDA’s regulations and guidelines concerning the
                advertising of prescription drug products, DDMAC’s promotional guidelines,
                the American Medical Association’s Guidelines on Gifts to Physicians, the
                Pharmaceutical Research and Manufacturers of America Guidelines for
                Marketing Practices, the Prescription Drug Marketing Act of 1987,
                as
                amended, and the rules and regulations promulgated thereunder, and
                the
                Accreditation Council for Continuing Medical Education Standards
                for
                Commercial Support of Continuing Medical Education, which may be
                applicable to the activities (including, without limitation, the
                warehousing, handling and distribution of Samples) to be performed
                by
                Ascend hereunder.  It is understood, and Ascend agrees, that it
                will be accountable for the acts or omissions of the sales force
                and its
                employees and agents to the extent such acts or omissions fail to
                comply
                with Ascend’s obligations under this
                Agreement.

            


    

    


    
      	
              5.4  

            	
              Ascend
                will not make any false or misleading representations to health care
                professionals, customers or others regarding Columbia or the Product
                and
                will not make any representations, warranties or guarantees with
                respect
                to the specifications, features or capabilities of the Product that
                are
                not consistent with the applicable current FDA approved labeling,
                package
                insert or other documentation accompanying or describing the Product,
                including Columbia’s limited warranty and disclaimers.  Ascend
                shall not make any negative statements about any other Columbia products
                in an effort to promote the
                Product.

            


    

    


    
      	
              5.5

            	
              To
                the extent requested by Ascend, Columbia shall deliver to Ascend
                all
                training materials for the Product in its possession on the date
                hereof
                less a reasonable amount

            


    

     

    


    
      
        
                

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    thereof
      for archival purposes.  Ascend shall, at its own expense, develop
      training materials for its sales representatives in other media or forms
      provided that such materials shall be subject to Columbia’s review as
      promotional materials as provided in Section 5.8.  Ascend shall,
      at its own expense, train its sales representatives using such training
      materials, the other promotional materials and such programs as Ascend shall
      deem appropriate that are in compliance with Ascend’s obligations hereunder and
      all other legal requirements.  Such programs shall include training
      with respect to reporting Adverse Drug Experiences and Product Complaints.
      None
      of Ascend, the sales force and Ascend’s employees and agents shall offer, pay,
      solicit or receive any remuneration to or from healthcare professionals in
      order
      to induce referrals of or purchase of the Product.  The sales force
      shall have no direct contact with, nor shall the sales force be involved with
      the delivery of Product to patients, other than delivery of Samples directly
      to
      healthcare professionals authorized to prescribe the Product.  The
      sales force shall be trained in connection with compliance with
      Sec. 1128B(b) of the Social Security Act and the AMA Guidelines on Gifts to
      Physicians from Industry prior to engaging in promotion of the
      Product.

     

    
      	
              5.6

            	
              Columbia
                will have no obligation to train Ascend’s sales force.  Ascend
                may request Columbia’s assistance in the initial training and additional
                training on new developments in connection with the
                Product.  Any such request shall be made with reasonable notice
                to Columbia and shall be at Ascend’s expense for Columbia’s out-of-pocket
                costs.

            


    

    


    
      	
              5.7

            	
              Ascend
                shall at its sole expense, create, develop, produce or otherwise
                obtain,
                and utilize promotional, marketing, educational and training materials
                that are necessary to support fully the promotional effort for the
                Product.  Such promotional materials may include, by way of
                example, detailing aids; leave behind items; journal advertising;
                educational programs; formulary binders; appropriate reprints and
                reprint
                carriers; product monographs; patient support kits; materials to
                support
                the handling of physician requests; convention exhibit materials;
                direct
                mail; market research survey and analysis; training materials; and
                scripts
                for telemarketing and
                teleconferences.

            


    

    


    
      	
              5.8

            	
              Prior
                to the use thereof, Ascend shall provide to Columbia for review prototypes
                of all promotional materials created by Ascend.  Columbia shall
                notify Ascend of any objections it has to such prototype and the
                basis
                therefor within thirty (30) days following its receipt
                thereof.  Ascend shall modify such promotional materials to the
                extent necessary to resolve any objections made by Columbia to such
                promotional materials on the grounds that such promotional materials
                are
                inconsistent with any legal requirements or this Agreement and shall
                in
                good faith consider and address any of Columbia’s other
                objections.  If such promotional materials are approved by
                Columbia in accordance with this Section 5.8, Ascend shall provide
                Columbia with the requisite number of copies of the final form thereof
                in
                a timely manner so as to allow Columbia to satisfy its obligation
                to file
                such materials with DDMAC.

            


    

    


    
      
        
                

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              5.9

            	
              To
                the extent requested by Ascend, Columbia shall deliver to Ascend
                all
                promotional materials created by Columbia in its inventory on the
                date
                hereof less a reasonable amount thereof for archival
                purposes.  Columbia shall have no obligation to create
                additional copies of any existing promotional materials or to otherwise
                incur any expense in connection with providing such existing promotional
                materials to Ascend.  Ascend agrees to reimburse Columbia for
                any direct costs incurred by Columbia in connection with fulfilling
                any
                request made by Ascend under this Section 5.9.  Any
                existing promotional materials supplied to Ascend under this
                Section 5.9 shall be delivered to a single location specified by
                Ascend in writing prior to such delivery.  Columbia hereby
                grants to Ascend the non-exclusive right, during the Term, to use
                any
                existing promotional materials supplied to Ascend pursuant to this
                Section 5.9 in the performance of its obligations under this
                Agreement.

            


    

    


    
      	
              5.10

            	
              On
                or prior to (a) December 1, 2007, and (b) October 1 of the preceding
                calendar year with respect to each calendar year during the Term,
                Ascend
                shall develop a marketing plan for the calendar year (as applicable),
                and
                submit the marketing plan to the Joint Steering Committee for review
                and
                approval.  The marketing plan shall set forth the manner in
                which the Product is to be promoted during the period to which the
                marketing plan relates.

            


    

    


    
      	
              5.11

            	
              The
                Parties acknowledge that each may receive requests for medical information
                concerning the Product from health care professionals and consumers
                regarding the Product.  Until the date six (6) months after the
                date hereof or such earlier date as Ascend may specify to Columbia
                in
                writing, the Parties shall coordinate all professional services activities
                through Columbia, who shall be the responsible party for responding
                to all
                such requests until such time.  Commencing on the date six (6)
                months after the date hereof or such earlier date as Ascend may specify
                to
                Columbia in writing, Ascend shall be responsible for promptly responding
                to such requests, which response shall be in compliance with all
                applicable legal requirements.  Each Party shall promptly
                provide the other Party with (i) copies of all written materials and
                (ii) written summaries of all oral advice, provided by such Party in
                response to such inquiries. 

            


    

    


    
      	
              5.12

            	
              Ascend
                shall promptly notify Columbia of any such actions taken by Ascend
                that
                are reasonably likely to result in a material adverse effect on the
                marketability of the Product in the
                Territory.

            


    

    


    
      	
              SECTION
                6 - REGULATORY AFFAIRS

            	
               

            


    

    


    
      	
              6.1

            	
              Columbia
                shall be responsible at its expense for maintaining the NDA for the
                Product with the FDA, provided, however, that any Phase IV Clinical
                Study
                will be at Ascend’s sole cost and expense and Ascend will provide to
                Columbia any information in Ascend’s possession that Columbia requires to
                meet its reporting obligations to FDA.  Ascend agrees that the
                NDA and any other submissions to FDA with respect to the Product
                shall be
                in the name of, and shall be owned by, Columbia or its designee.
                Notwithstanding anything to the contrary in this Agreement, should
                Columbia determine, in its sole

            


    

    


    
      
        
                

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              discretion,
                that certain information otherwise required to be disclosed to Ascend
                and/or to FDA contains trade secrets or proprietary information,
                then
                Columbia may disclose such information directly to FDA and not to
                Ascend,
                and Ascend hereby agrees not to seek to obtain such information from
                FDA,
                or through any other means.

            


    

    


    
      	
              6.2

            	
              Each
                Party shall notify the other Party as soon as possible of any notification
                received by the Party from FDA or any other regulatory authority
                to
                conduct an inspection of its manufacturing or other facilities used
                in the
                development, manufacturing, packaging, storage, or handling of the
                Product.  Copies of all material correspondence with the FDA or
                other regulatory authority related specifically to the development,
                manufacturing, packaging, storage, or handling of the Product will
                be
                provided by each Party to the other
                Party.

            


    

    


    
      	
              6.3

            	
              To
                the extent Ascend seeks to amend the labeling or support additional
                advertising claims for the Product, it may design, conduct and control
                such additional Phase IV Clinical Study at its sole expense necessary
                to
                obtain FDA approval, provided, that Ascend shall give Columbia prior
                written notice of its intention to do so. Product and placebo necessary
                for the conduct of such Phase IV Clinical Studies shall be supplied
                in
                bulk by Columbia at Columbia’s fully absorbed cost. Columbia shall own and
                have unrestricted rights to the clinical data generated as a result
                of
                each Phase IV Clinical Study to be filed in connection with Columbia's
                regulatory submissions both within and outside the
                Territory.

            


    

     

    
      	
              6.4

            	
              Unless
                otherwise required by law, Columbia will retain exclusive authority
                over
                and responsibility for complying with all regulatory requirements
                and
                maintaining all contacts with FDA with respect to the Product, including,
                but not limited to, maintaining and updating of the NDA, , the reporting
                of any Adverse Drug Reactions to the FDA, the compliance of promotional
                materials with FDA rules and regulations, and the filing of promotional
                materials with DDMAC, provided however that the submission of applications
                to FDA for new indications will be at Ascend’s cost. Ascend shall not,
                without the consent of Columbia or unless so required by law, correspond
                or communicate with the FDA or with any other governmental authority,
                whether within the Territory or otherwise, concerning the Product,
                or
                otherwise take any action concerning the NDA for the Product or any
                application.  Furthermore, Ascend shall, immediately upon
                receipt of any communication from the FDA or from any other governmental
                authority relating to the Product, forward a copy of the same to
                Columbia
                and respond to all inquiries by Columbia relating thereto.  If
                Ascend is required by law to communicate with the FDA or with any
                other
                governmental authority relating to the Product, then Ascend shall
                so
                advise Columbia immediately and provide Columbia in advance with
                a copy of
                any proposed written communication, or a written summary of any proposed
                oral communication with the FDA or any other governmental
                authority.  Ascend shall comply with any and all reasonable
                direction of Columbia concerning any meeting or written or oral
                communication with the FDA or any other governmental authority relating
                to
                the Product unless otherwise required by
                law.

            


    

    


    
      
        
                

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              6.5

            	
              Ascend
                shall refer any oral or written Product Complaint which it receives
                concerning the Product to Columbia within four (4) days of its receipt
                thereof; provided, that all complaints concerning suspected or actual
                Product tampering, contamination or mix-up shall be delivered within
                twenty-four (24) hours of its receipt thereof.  Ascend shall not
                take any other action in respect of any such Product Complaint without
                the
                consent of Columbia unless otherwise required by law.  All
                Product Complaints shall be directed to:  Manager, Quality
                Assurance, by facsimile at (973)
                994 - 3001.

            


    

     

    
      	
              6.6

            	
              Each
                Party shall notify the other: (i) of all Serious Adverse Drug
                Experience Reports within forty-eight (48) hours of the time such
                Serious
                Adverse Drug Experience Report becomes known to such Party (including
                its
                employees); and (ii) of all Adverse Drug Experience Reports within
                five (5) days of the time such Adverse Drug Experience Report becomes
                known to such Party (including its employees). Except as may otherwise
                be
                required by law, (i) Ascend shall not disclose any information
                concerning Adverse Drug Experience Reports or Serious Adverse Drug
                Experience Reports to any person or governmental authority without
                the
                prior consent of Columbia; and (ii) Columbia shall have the sole
                discretion to determine whether any Product Complaint, Adverse Drug
                Experience Report or Serious Adverse Drug Experience Report must
                be
                reported to the FDA or any other governmental authority. All follow-up
                investigations concerning Adverse Drug Experience Reports and Serious
                Adverse Drug Experience Reports shall be conducted by Columbia; provided
                that Ascend shall have the right to participate in such investigations
                upon its request.  Ascend shall provide all reasonable
                cooperation with any such follow-up investigation as may be requested
                by
                Columbia from time to time.

            


    

     

    


    SECTION
      7 – MANUFACTURING AND
      SUPPLY, FORECASTS; PURCHASE ORDERS; MINIMUM PURCHASE
      OBLIGATIONS

    


    
      	
              7.1

            	
              Ascend
                Forecasts

            


    

    


    On
      or
      before November 15, 2007, and on or before the fifteenth (15th) day of
      each
      calendar month during the Term, Ascend shall submit to Columbia a written
      forecast of Ascend’s requirements, by month, for the following twelve (12)
      months (the “Rolling Forecast”). The initial forecast shall contain a forecast
      for [***]. The first six (6) months of each Rolling Forecast for Product in
      Finished Package Form 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 Ascend.  As such, Ascend
      shall be bound to purchase from Columbia one hundred percent (100%) of those
      quantities of the Product set forth in each Binding Forecast and not to purchase
      any amounts forecasted beyond the Binding Forecast.  Columbia shall
      use Commercially Reasonable efforts to comply with Purchase Orders (as
      hereinafter defined) for Product furnished pursuant to Section 7.2, including
      Purchase Orders for Products in excess of [***]forecasted amounts; provided,
      however, that such inability to supply amounts in excess of [***]shall not
      constitute a breach of this Agreement by Columbia.  Columbia shall
      notify Ascend in writing of any prospective

    


    
      
        
                

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    problems
      of which it is aware that might prevent it from meeting Ascend’s forecasted
      order quantities or estimated delivery dates.

    


    7.2           Binding
      Purchase Orders

    


    With
      each
      Binding Forecast referenced in Section 7.1 hereof, Ascend shall furnish to
      Columbia a binding purchase order (each, a “Purchase Order”) for the quantity of
      the Product which Ascend shall purchase and Columbia shall deliver. Columbia
      shall acknowledge receipt of such Purchase Order and confirm that the Purchase
      Order can be supplied.  Each such Purchase Order shall designate the
      quantity of the Product, taking into consideration the fact that only full
      batch
      quantities may be ordered (except in the first calendar year of the Term when
      [***]may be ordered), production yields may vary, and full batch quantities
      may
      consist of more or less than the specified number of units.

    


    7.3           Excess
      Quantities; Changes in Purchase Requirements

    


    Columbia
      shall use Commercially Reasonable efforts to accommodate any Ascend request
      for
      any Product in excess of the quantities described in any previously-submitted
      Purchase Order, or for delivery of any of the Product sooner than as otherwise
      provided in such Purchase Order; provided, that, for quantities in excess of
      [***], Ascend shall bear any and all additional costs or expenses (including
      but
      not limited to additional costs or expenses associated with production,
      transportation or insurance related to shipping the Product) as a result of
      Columbia’s compliance with such request.  Should business conditions
      necessitate reduction or delay in Purchase Order requirements above the Minimum
      Purchase Obligations, then Columbia shall use Commercially Reasonable efforts
      to
      implement such requested changes; provided, that Ascend shall bear any and
      all
      additional costs or expenses (including but not limited to carrying costs or
      expenses associated with raw materials, schedule changes or finished goods
      inventory) as a result of Columbia’s compliance with such request.

    


    7.4           Minimum
      Purchase Obligations

    


    Ascend
      agrees to and shall comply with the Minimum Purchase Obligations during the
      Term
      set forth on Exhibit B hereto.

    


    7.5           Manufacturing
      Activities

     

    The
      Product to be manufactured by or for Columbia shall be manufactured to meet
      applicable specifications for the Product in accordance with the NDA, cGMP’s and
      in compliance with all other applicable legal requirements

     

    7.6           Delivery

    


    
      
        
                

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    Columbia
      shall deliver all Product EXW
      (as such term is defined and used in Incoterms2000, ICC Official Rules for
      Interpretation of Trade Terms) Columbia’s 

                   
      manufacturing facility.

    


    
      	
              7.7  

            	
              Inspection;
                Rejection

            


    

    


    Ascend
      may inspect the Product upon receipt to verify its conformity to the relevant
      Purchase Order as of the time the Product was delivered to Ascend.  If
      Ascend determines that a shipment of the Product does not conform to the
      Purchase Order as of the time it was delivered to Ascend, then Ascend shall
      notify Columbia in writing of all non-conformities that existed at the time
      of
      the delivery of the Product to Ascend.  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 Product.  Such
      notice shall specify the reasons for rejection.  If Ascend does not so
      reject the Product within thirty (30) days after delivery, Ascend shall be
      deemed to have accepted the Product.  After Ascend accepts the
      Product, or is deemed to have accepted the Product, it shall have no recourse
      against Columbia except as set forth in Sections 3.4.5, 4.8, and this Section
      7.  After notice of rejection is received by Columbia, Ascend shall
      cooperate with Columbia in determining whether such rejection is
      justified.  Columbia shall notify Ascend as soon as reasonably
      possible, but not later than thirty (30) days after receipt of the notice from
      Ascend, whether it accepts Ascend’s basis for rejection.  If Columbia
      accepts Ascend’s determination that the Product is non-conforming, then Ascend
      shall be entitled to the remedies set forth in Section 7.8 hereof.  If
      Columbia does not accept Ascend’s determination that the Product is
      non-conforming, and Ascend does not accept Columbia’s conclusion, then Columbia
      and Ascend 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 Ascend, then Ascend shall purchase the Product at the agreed upon
      price.  If the third party rules that the Product does not conform to
      the Purchase Order at the time the Product was delivered to Ascend, then Ascend
      shall be entitled to the remedies set forth in Section 7.8 hereof.

    


    
      	
              7.8

            	
              Any
                Product delivered to Ascend by Columbia which is finally rejected
                in
                accordance with Section 7.7, or which is otherwise not in compliance
                with
                the warranties set forth in Section 7.5, shall be replaced at Columbia’s
                expense as soon as is Commercially
                Reasonable.

            


    

    


    7.9           Samples

     

    
      	
              7.9.1  

            	
              On
                or before
                December 15, 2007, Columbia will provide and Ascend will accept
                delivery of Samples which will be comprised of [***].

            


    

    


    
      	
              7.9.2  

            	
              Columbia
                shall provide or cause to be provided to Ascend, from time to time
                as
                reasonably requested by Ascend, and in such quantities as are mutually
                agreed by

            


    

    


    
      
        
                

                     [***]
              A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY
              WITH THE SECURITIES AND EXCHANGE
              COMMISSION.      
      

                    

                        
        
      
    

          
          

        

        
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            the
      parties to be
      reasonably necessary for Ascend to fulfill its promotion obligations under
      this
      Agreement, with samples of the Product (“Samples”) labeled as
      

            “Sample”or “Not
      for Sale” or in similar
      fashion and to be distributed by Ascend solely in connection with the
      performance of its sales force.  Columbia shall ship such


            Samples
      to a central
      warehouse designated by Ascend, and the risk of loss and responsibility for
      handling and warehousing of the Samples shall pass to Ascend upon 

            delivery
      to a carrier
      designated by Ascend.  Ascend shall be responsible for distributing
      the Samples to its sales representatives in a timely manner.  Columbia
      shall 

            invoice
Ascend
      for each shipment of Samples at its fully absorbed cost payable within 30 days
      of the invoice date.  

    


    
      	
              7.9.3  

            	
              Ascend
                shall be solely responsible for securing the return of and reconciling
                Sample inventories from discontinued sales representatives. Upon
                its
                receipt of Samples, Ascend shall be solely responsible for accountability
                and compliance with the PDMA, and other applicable legal requirements
                relating to such Samples or the distribution of same and shall be
                responsible for adherence by its sales representatives to such legal
                requirements.  Columbia shall have the right to audit the
                records and/or reports for the Samples, as required to be kept by
                Ascend
                under the PDMA, during normal business hours, at convenient times
                and upon
                no less than five (5) calendar days’ prior
                notice.

            


    

    


    7.10           Product Returns

     

          Each
      Party shall be responsible
      for all costs associated with the return of Product shipped by that Party
      before, during, or after the Term and whether received by Ascend or


          Columbia,
      provided such return is
      made in accordance with the Party’s published return policy. Each Party shall
      reimburse the other Party within 30 days of an invoice for 

          reasonable,
      documented costs
      incurred by a Party for the return of Product shipped by the other
      Party.

     

    SECTION
      8 – PRICE AND PAYMENT

    


    
      	
              8.1  

            	
              The
                purchase price to be paid by Ascend for the Product in Finished Package
                Form shall be thirty-five percent (35%) of the average Net Selling
                Price
                of the Product per unit in Finished Package Form in the calendar
                year
                multiplied by the number of units of Finished Package Form delivered
                to
                Ascend by Columbia.

            


    

     

    
      	
              8.2

            	
              Ascend's
                initial invoice price for the Product purchased from Columbia shall
                be
                [***]of the estimated purchase price pursuant to Section 8.1 and
                shall be
                paid thirty (30) days after the later of (A) receipt by Ascend of
                an
                invoice for such Product, or (B) the shipment by Columbia of the
                corresponding Product. Ascend's payments to Columbia shall be in
                U.S.
                dollars via wire
                transfer of immediately available funds to such bank account as Columbia
                shall designate in writing prior to the date of such payment. In
                the

            


    

     

    


    
      
        
                

                     [***]
              A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY
              WITH THE SECURITIES AND EXCHANGE
              COMMISSION.      
      

                    

                        
        
      
    

          
          

        

        
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              event
                that any payment due under this Agreement is not made when due, the
                amount
                due shall accrue interest beginning on the tenth (10th) day following
                the
                date on which such payment was due, calculated at the annual rate
                equal to
                the higher of one percent (1.0%) per month or two percent (2%) above
                the
                thirty (30)-day LIBOR for U.S. dollars reported in the Wall Street
                Journal for the due date, calculated from the due date until paid in
                full. Such payment when made shall be accompanied by all interest
                so
                accrued.

            


    

     

    
      	
              8.3

            	
              Forty-five
                (45) days after the end of each calendar year any necessary adjustments
                to
                such purchase price to reflect the actual thirty-five percent (35%)
                of the
                average Net Selling Price of the Product per unit in Finished Package
                Form
                sold in the calendar year multiplied by the number of units of Finished
                Package Form delivered to Ascend by Columbia in the calendar year
                shall be
                made in a report from Ascend to Columbia. Overpayments by Ascend
                will be
                credited against the next purchase of Product. Underpayments by Ascend
                shall be paid to Columbia with the
                report.

            


    

     

    
      	
              8.4

            	
              Each
                Party shall keep full and accurate books, records and invoices with
                respect to the its Net Selling Price for no less than three (3) years
                after the end of the calendar year during which such sales occurred
                during
                the Term of this Agreement and for two (2) years
                thereafter.  Upon reasonable written notice and not more than
                twice in any twelve (12) month period, each Party shall permit an
                independent auditor reasonably acceptable to the other Party, to
                have
                access during normal business hours to sales and payment records
                directly
                related to sales of the Product in the Territory solely for the purpose
                of
                determining whether there has been an overpayment or underpayment
                by a
                Party pursuant to this Agreement for any period ending not more than
                twenty-four (24) months prior to the date of such request; provided,
                however, that the books and records for any particular period shall
                be
                subject to only one audit.  Any report rendered by the
                independent auditor in connection therewith shall only disclose whether
                there has been an overpayment or underpayment and the amount of such
                overpayment or underpayment (as the case may be).  The fees and
                expenses relating to the services of the independent auditor shall
                be
                borne by the Party requesting the audit; provided, however, that
                the other
                Party shall reimburse the Party requesting the audit for the reasonable
                fees and expenses of such auditor in the event the audit reveals
                an
                underpayment for the relevant period of more than five percent
                (5%).

            


    

    


    
      	
              8.5

            	
              In
                the event that Ascend determines to accept a bona fide offer from
                a third
                party, or a third party accepts a bona fide offer of Ascend, for
                the
                Product (i) on or before [***], Ascend agrees to pay Columbia [***],
                or
                (ii) after [***], but on or before [***], Ascend agrees to pay Columbia
                [***].  For the sake of clarity, this provision shall apply only
                when the sole asset being transferred is the Product and shall not
                apply,
                for example, in the event that the Product is transferred to a third
                party
                due to a merger, acquisition or other form of business
                combination.

            


    

    


    
      	
              SECTION
                9 - TERM AND TERMINATION

            	
               

            


    

    


    
      	
              9.1

            	
              This
                Agreement shall be deemed to have come into force on the date first
                written above and, subject to the rights of termination outlined
                in this
                Section 9 will expire on the five (5) year anniversary of the Effective
                Date (the "Term").

            


    

    


    
      
        
                

                     [***]
              A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY
              WITH THE SECURITIES AND EXCHANGE
              COMMISSION.      
      

                    

                        
        
      
    

          
          

        

        
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              9.2

            	
              In
                addition to the rights of termination provided for elsewhere in this
                Agreement, either Party will be entitled to terminate this Agreement
                by
                written notice to the other Party
                if:

            


    

    


    
      	
              9.2.1  
                

            	
              that
                other Party commits any breach of any of the provisions of this Agreement,
                and in the case of a breach capable of remedy, fails to remedy the
                same
                within sixty (60) days after receipt of a written notice of the breach
                and
                requiring it to be remedied or within ten (10) days in the case of
                a
                failure to make a monetary payment;
                or

            


    

    


    
      	
              9.2.2  
                

            	
              if
                that other Party shall make a general assignment for the benefit
                of
                creditors, or files or has filed against it a petition for
                bankruptcy, reorganization or an arrangement for the benefit of creditors,
                or for the appointment of a receiver, trustee or creditor representative
                for the property or assets of such Party under any federal or state
                insolvency law, which, if filed against such Party, has not been
                dismissed
                or discharged within sixty (60)
                days.

            


    

    


    
      	
              9.3

            	
              For
                the purposes of Section 9.2.1, a breach will be considered capable
                of
                remedy if the Party in breach can comply with the provision in question
                in
                all respects other than as to the time of performance (provided that
                time
                of performance is not of the
                essence).

            


    

    


    
      	
              9.4

            	
              Ascend
                may terminate this Agreement upon not less than sixty (60) days prior
                written notice to Columbia if:

            


    

     

                   9.4.1 A
      generic form of the Product enters the market or

    
      	
              9.4.2  
                

            	
              A
                product recall or market withdrawal occurs that is material to the
                reputation or ongoing supply of the product and not the result of
                the
                negligence or misconduct of Ascend.

            


    

    


    
      	
              9.5  

            	
              Ascend
                may terminate this Agreement without cause for any reason upon not
                less
                than one hundred eighty (180) days prior written notice to Columbia;
                provided, however, that: Ascend shall not be due any Sunset
                Fee.

            


    

    


    
      	
              9.6  

            	
              Columbia
                may terminate this Agreement upon written notice to Ascend in the
                event
                that (i) the number of units of Product dispensed to patients for
uses
                relating
                to fertility, pregnancy, and preterm birth in any calendar quarter,
                as determined by data from the IMS Health National Drug and Therapeutic
                Index, equals or exceeds [***]of
                Product dispensed for all uses in such calendar quarter, (ii) Columbia
                notifies Ascend in writing of Columbia’s intent to terminate this
                Agreement under this Section 9.6, and (iii) the number of units of
                Product
                dispensed to patients for uses
                relating
                to fertility, pregnancy, and preterm birth equals or exceeds [***]of  Product
                dispensed to patients for all
                uses
                during the three full calendar month period immediately following
                receipt of such notice (the "Cure Period"); provided, however, that
                Columbia may immediately terminate this Agreement at any time after
                the
                Cure Period upon written notice to Ascend in the event that the number
                of
                units of Product dispensed to patients for uses
                relating
                to fertility, pregnancy, and preterm birth in any three-month
                period after the Cure Period (and not


            


    

     

    


    
      
        
                

                     [***]
              A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY
              WITH THE SECURITIES AND EXCHANGE
              COMMISSION.      
      

                    

                        
        
      
    

          
          

        

        
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    including
      any month during the Cure Period) equals or exceeds [***]of
      Product dispensed to patients for all uses in
      such
      three-month period.

     

    
      	
              9.7  

            	
              Ascend
                may terminate this Agreement upon written notice to Columbia in the
                event
                that (i) the number of units of Crinone and Prochieve 8% dispensed
                to
                patients for uses
                relating
                to the Indication in any calendar quarter, as determined by data
                from the IMS Health National Drug and Therapeutic Index, equals or
                exceeds
                [***]of
                Product dispensed for all uses in such calendar quarter, (ii) Ascend
                notifies Columbia in writing of Ascend’s intent to terminate this
                Agreement under this Section 9.7, and (iii) the number of units of
                Crinone
                and Prochieve 8% dispensed to patients for uses
                relating
                to the Indication equals or exceeds [***]of  Product
                dispensed to patients for all
                uses
                during the Cure Period; provided, however, that Ascend may
                immediately terminate this Agreement at any time after the Cure Period
                upon written notice to Columbia in the event that the number of units
                of
                Crinone and Prochieve 8% dispensed to patients for uses
                relating
                to the Indication in any three-month period after the Cure Period
                (and not including any month during the Cure Period) equals or exceeds
                [***]of
                Product dispensed to patients for all uses
                in such three-month period.

            


    

     

    


    
      	
              SECTION
                10 - CONSEQUENCES OF TERMINATION

            	
               

            


    

    


    
      	
              10.1

            	
              Upon
                exercise of those rights of termination specified in Section 9 or
                elsewhere in this Agreement, this Agreement shall, subject to the
                provisions of this Agreement which survive the termination of this
                Agreement, terminate and be of no further legal force or
                effect.

            


    

    


    
      	
              10.2

            	
              Termination
                of this Agreement by Columbia or by Ascend shall be without prejudice
                to
                Columbia’s right to receive payment of all obligations owed to, and costs
                incurred by, Columbia during the period prior to the effective date
                of the
                termination.  Ascend shall be liable to Columbia for any
                uncancellable obligations and expenses incurred by Columbia prior
                to such
                termination in connection with the Product and all costs incurred
                by
                Columbia in terminating such work.

            


    

    


    
      	
              10.3

            	
              Upon
                termination of the Agreement by either Party, the following shall
                be the
                consequences:

            


    

    


    
      	
              10.3.1  
                

            	
              all
                confidentiality provisions set out herein shall remain in full force
                and
                effect for a period of 10 years from the date of
                termination of this Agreement;

            


    

    


    
      	
              10.3.2 
                 

            	
              all
                responsibilities and warranties shall insofar as appropriate remain
                in
                full force and effect, including without limitation the provisions
                of
                Sections 3 (Intellectual Property) and 11 (Warranty and Indemnity),
                which
                shall survive any termination of this
                Agreement;

            


    

    


    
      	
              10.3.3 
                 

            	
              the
                rights of inspection and audit shall continue in force for the period
                referred to in the relevant provisions of this
                Agreement;

            


    

    


    
      
        
                

                     [***]
              A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY
              WITH THE SECURITIES AND EXCHANGE
              COMMISSION.      
      

                    

                        
        
      
    

          
          

        

        
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              10.3.4  

            	
              Columbia
                shall be entitled to research, develop and commercialize the Product
                for
                its own benefit in the Territory in accordance with the provisions
                of
                Section 10.4; and

            


    

    


    
      	
              10.3.5  
                

            	
              Ascend
                shall deliver to Columbia all training and promotional materials
                created
                by Ascend in its inventory on the termination date less a reasonable
                amount thereof for archival
                purposes.

            


    

    


    
      	
              10.4  

            	
              Following
                (i) the Term (or any extension thereof), (ii) the early termination
                of
                this Agreement without cause by Columbia, or (iii) the early termination
                of this Agreement without cause by Ascend which termination is on
                or after
                January 1, 2010, Columbia shall pay to Ascend a “Sunset Fee” consisting of
                [***]of
                Columbia’s “Net Sales” (determined by multiplying Columbia’s
                average Net
                Selling Price during the period by the number of units sold by Columbia
                during the period) over [***]
                in the first full year after termination, and [***]of
                Columbia’s Net Sales over [***]
                in the second full year after
                termination.

            


    

    


    
      	
              10.5

            	
              Upon
                the termination of this Agreement for any reason, each Party shall
                return
                the other Party’s Confidential Information to such other Party or at the
                other Party’s option, destroy all originals and copies of the other
                Party’s Confidential Information; provided, that each Party may retain
                a
                copy of the other Party’s Confidential Information in its legal department
                for archival purposes.

            


    

     

    
      	
               

            	
              10.6

            	
              If
                this Agreement is terminated by Columbia for cause pursuant to Section
                9,
                Ascend shall discontinue use of the Product and shall arrange, at
                Ascend’s
                sole cost and expense, for the lawful disposal of all unsold
                Product.  In the event of any other termination or expiration of
                this Agreement, Ascend shall be entitled to retain, use and sell
                any
                remaining supplies of Product then in its possession or control,
                provided
                that any such use or sale shall be subject to the terms and restrictions
                of this Agreement and Columbia shall not take any action to impair
                such
                use or sale by Ascend;

            


    

    


    
      	
              10.7

            	
              If
                Columbia should require for any reason whatsoever a license from
                Ascend in
                order to research, develop and commercialize the Product after the Term or
                earlier termination of this Agreement, Ascend hereby grants to Columbia
                a
                non-exclusive, fully paid, royalty free license, with the right to
                sublicense, for the purposes of making, having made, packaging, importing,
                using, offering for sale, selling and having sold the
                Product.

            


    

    


    SECTION
      11 - WARRANTY AND INDEMNITY

    


    11.1           Each
      Party represents and warrants to the other Party that

    


    
      	
              11.1.1  
                

            	
              it is
                a corporation duly organized, validly existing and in good standing
                under
                the laws of the state of its incorporation, and it has all necessary
                corporate power and corporate authority to own its properties and
                to
                conduct its business, as currently
                conducted;

            


    

    


    
      
        
                

                     [***]
              A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY
              WITH THE SECURITIES AND EXCHANGE
              COMMISSION.      
      

                    

                        
        
      
    

          
          

        

        
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              11.1.2  

            	
              the
                execution and delivery of this Agreement and the consummation of
                the
                transactions contemplated hereby are within its corporate power,
                have been
                duly authorized by all necessary corporate proceedings, and this
                Agreement
                has been duly executed and delivered by
                it;

            


    

    


    
      	
              11.1.3  

            	
              the
                execution and delivery of this Agreement and the consummation of
                the
                transactions contemplated hereby do not: conflict with or result
                in a
                breach of any provision of its organizational documents; result in a
                material breach of any material agreement to which it is
                party; require it to obtain any material approval or
                consent  from any governmental authority or third party other
                than those consents and approvals which have been obtained prior
                to the
                date hereof; or violate any legal requirement applicable to it in any
                material respect;

            


    

    


    
      	
              11.1.4  

            	
              this
                Agreement
                constitutes a valid and binding obligation, enforceable against it
                in
                accordance with its terms, subject to bankruptcy, reorganization,
                insolvency and other similar laws affecting the enforcement of creditors’
                rights in general and to general principles of equity (regardless
                of
                whether considered in a proceeding in equity or an action at law);
                and

            


    

    


    
      	
              11.1.5  

            	
              in
                performing a Phase IV Clinical Study, it will exercise all due skill
                and
                care in conducting such activities; and it will comply with the provisions
                of this Agreement, all FDA and other approvals, all applicable state
                and
                local regulatory approvals and all applicable laws, ordinances and
                regulations.

            


    

    


    
      	
              11.2  

            	
              Columbia
                warrants and represents to Ascend
                that:

            


    

    


    
      	
              11.2.1 
                  

            	
              to
                the knowledge of Columbia as of the date hereof, (i) the manufacture,
                use,
                importation, promotion and sale of the Product in the Territory in
                accordance with this Agreement will not infringe any patents, trademarks
                or other intellectual property rights of any third party, (ii) none
                of the
                Patents are invalid, (iii) the Patents are in full force and are
                not
                subject to any pending, or to the knowledge of Columbia as of the
                date
                hereof, threatened re-examination, opposition, interference or litigation
                proceedings in the Territory;

            


    

    


    
      	
               

            	
              11.2.2   
                

            	
              to
                the knowledge of
                Columbia as of the date hereof there is approximately one month of
                inventory of the Product in the
                trade;

            


    

    


    
      	
               

            	
              11.2.3 
                  

            	
              Columbia
                has not and will not during the Term acquire another product that
                competes
                directly with the Product, provided that, for the avoidance of doubt,
                the
                8% w/w progesterone gel (90 mg) in single use, one piece, disposable
                vaginal applicators containing 1.45 g of gel and delivering 1.125
                g of
                gel, utilizing the Columbia Technology, and approved by the FDA under
                NDA
                20-701, and any comparable product in a progressive hydration vaginal
                tablet, are not competitive
                products;

            


    

    


    
      
        
                

                     [***]
              A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY
              WITH THE SECURITIES AND EXCHANGE
              COMMISSION.      
      

                    

                        
        
      
    

          
          

        

        
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              11.2.4   
                

            	
              Columbia
                has not and during the Term will not enter into any contracts with
                government entities concerning the Product that require reimbursements
                under Medicaid, Medicare or other government payer
                programs;

            


    

    


    
      	
               

            	
              11.2.5   
                

            	
              as
                of the date
                hereof there are no pending or threatened Claims or IP Claims
                related to the Product; and

            


    

    


    
      	
               

            	
              11.2.6   
                

            	
              as
                of the date
                hereof the Product is safe and effective for use as it is currently
                labeled and sold.

            


    

    


    
      	
              11.3  

            	
              Indemnification
                by Columbia

            


    

    


    Columbia
      agrees that in addition to any and all other rights and remedies of Ascend,
      whether at law or in equity, Columbia shall defend, indemnify and hold Ascend
      and its Affiliates and their respective officers, directors, employees,
      independent contractors, agents, and assigns harmless from and against any
      and
      all actions claims, demands, proceedings, suits, losses, damages, costs and
      expenses (including reasonable attorneys’ fees) of whatsoever kind or nature
      (including but not limiting the generality of the foregoing, in respect of
      death, injury, loss or damage to any person or property) (collectively,
“Claims”) arising in any way out of or connected with: (i) any breach or alleged
      breach by Columbia of any representation, warranty or covenant contained in
      this
      Agreement; (ii) any negligence or willful misconduct by Columbia, its Affiliates
      or subcontractors; or (iii) any product liability Claim, unless such Claim
      arises from modifications of, or claims for, the Product by Ascend.

    


    
      	
              11.4  

            	
              Indemnification
                by Ascend

            


    

    


    Ascend
      agrees that in addition to any and all other rights and remedies of Columbia,
      whether at law or in equity, Ascend shall defend, indemnify and hold Columbia
      and its Affiliate, its officers, directors, employees, independent contractors,
      agents and assigns harmless from and against any and all Claims arising out
      of
      or connected with:  (i) any breach or alleged breach by Ascend of any
      representations, warranty or covenant contained in this Agreement; (ii) any
      negligence or willful misconduct by Ascend, its Affiliates or subcontractors;
      or
      (iii) any product liability Claim based on modifications of, or claims for,
      the
      Product by Ascend.

    


    
      	
              11.5  

            	
              Cooperation  The
                Parties agree that:

            


    

    


    
      	
              11.5.1   
                

            	
              the
                indemnifying Party shall have the right in its sole discretion to
                conduct
                all proceedings and negotiations connected with such Claims; provided,
                however, that the indemnifying Party shall not settle any Claim without
                the consent of the indemnified Party, which consent shall not be
                unreasonably withheld or delayed; and provided, further, that if
                the
                indemnifying Party fails to defend a Claim, the indemnified Party
                shall
                have the right to undertake the defense of any such
                Claim

            


    

    


    
      
        
                

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              at
                the expense and for the account of the indemnifying Party and the
                indemnifying Party shall pay all such expenses within thirty (30)
                days of
                the receipt of any invoice with respect
                thereto;

            


    

    


    
      	
              11.5.2
                   

            	
              the
                indemnified Party shall promptly notify the indemnifying Party of
                all such
                Claims and shall not make any admissions regarding them unless legally
                required to do so;

            


    

    


    
      	
              11.5.3   
                

            	
              the
                indemnified Party shall, at the indemnifying Party’s expense, provide the
                indemnifying Party with reasonable assistance in connection with
                such
                claims;

            


    

    


    
      	
              11.5.4   
                

            	
              the
                indemnifying Party shall keep the indemnified
                Party informed as to the status of any Claim, and
                not less than every sixty (60) days shall provide the indemnified
                Party with a written status report on the
                Claim.

            


    

    


    
      	
              11.6

            	
              THE
                WARRANTIES CONTAINED IN THIS SECTION 11 ARE IN LIEU OF ALL OTHER
                REPRESENTATIONS AND WARRANTIES.  COLUMBIA DISCLAIMS ALL OTHER
                WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ALL
                WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT, EXCEPT AS OTHERWISE
                PROVIDED HEREIN, OR FITNESS FOR A PARTICULAR PURPOSE.  EXCEPT AS
                EXPRESSLY STATED IN SECTION 7 AND THIS SECTION 11, COLUMBIA SHALL
                NOT BE
                LIABLE IN CONTRACT, TORT OR OTHERWISE FOR ANY LOSS, DAMAGE, EXPENSE
                OR
                INJURY, ARISING OUT OF OR IN CONNECTION WITH A PRODUCT OR ANY DEFECT
                IN A
                PRODUCT OR FROM ANY OTHER CAUSE.

            


    

    


    
      	
              11.7

            	
              NOTWITHSTANDING
                ANYTHING TO THE CONTRARY IN THIS AGREEMENT, COLUMBIA AND
                ASCEND  SHALL NOT BE LIABLE TO THE OTHER BY REASON OF ANY
                CONDITION OR TERM OR DUTY OF COMMON LAW, OR UNDER THE EXPRESS TERMS,
                REPRESENTATIONS OR WARRANTIES OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL,
                SPECIAL OR INCIDENTAL OR PUNITIVE LOSS OR DAMAGE (WHETHER FOR LOSS
                OF
                CURRENT OR FUTURE PROFITS, LOSS OF ENTERPRISE VALUE OR OTHERWISE)
                AND
                WHETHER OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR
                EMPLOYEES OR AGENTS OR OTHERWISE.  EXCEPT AS OTHERWISE EXPRESSLY
                STATED IN THIS AGREEMENT, WITH RESPECT TO ANY CLAIM OF DAMAGES,
                COMPENSATION OR MONETARY RECOVERY OR OTHER RELIEF ASSERTED OR WHICH
                CAN BE
                ASSERTED BY ASCEND , IN NO EVENT SHALL ASCEND  MAKE ANY CLAIM,
                BE PERMITTED TO RECOVER, SEEK TO OBTAIN OR OBTAIN, ENCOURAGE OR ASSIST
                OR
                PERMIT ANY THIRD PARTY TO OBTAIN, ANY AWARD OF DAMAGES, FINDING OF
                LIABILITY OR ANY EQUIVALENT THERETO, REGARDLESS OF THE FORM OF SUCH
                ACTION, WHETHER IN CONTRACT OR TORT, OR AT LAW OR EQUITY AND WHETHER
                PERMITTED UPON FRAUD, MISREPRESENTATION OR OTHERWISE, AGAINST COLUMBIA,
                ITS SHAREHOLDERS, AFFILIATES, SUBSIDIARIES, AGENTS,
                EMPLOYEES,

            


    

    


    
      
        
                

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              DIRECTORS,
                OFFICERS AND/OR ANY PERSON OR ENTITY ACTING IN CONCERT OR UNDER THE
                DIRECTION OF COLUMBIA, IN AN AMOUNT WHICH WOULD RESULT IN A PAYMENT
                TO
                ASCEND  OR ANY OTHER PERSON OR ENTITY WHICH EXCEEDS THE TOTAL
                AMOUNTS ACTUALLY PAID TO COLUMBIA BY ASCEND  UNDER SECTION 8 OF
                THIS AGREEMENT DURING THE TWELVE (12) MONTHS IMMEDIATELY PRECEDING
                THE
                DATE SUCH CLAIM OF LIABILITY IS MADE.  ASCEND AGREES TO ENTER
                INTO SUCH STIPULATIONS OF FACT OR LAW AS MAY BE REQUIRED TO GIVE
                EFFECT TO
                THIS PROVISION.

            


    

    


    
      	
              11.8

            	
              Insurance:

            


    

    


    
      	
              11.8.1  
                

            	
              At
                all times while this Agreement is in effect, each Party shall procure
                and
                maintain, at its own expense and for its own benefit, the following
                insurance in amounts no less than that specified for each
                type:

            


    

    


    
      	
              11.8.1.1   
                

            	
              commercial
                general liability insurance with combined limits of
                [***]per occurrence, [***]per accident
                for bodily injury, including death, and property damage, which policy
                shall include coverage for all hired, owned and not-owned automobiles
                and
                trucks;

            


    

     

    
      	
              11.8.1.2   
                

            	
              worker’s
                compensation and disability insurance in the amount required by the
                law of
                the state in which such party’s employees are located and employer’s
                liability insurance with limits of [***]per
                occurrence;

            


    

     

    
      	
              11.8.1.3   
                

            	
              automobile
                liability insurance covering automobiles and trucks used by or on
                behalf
                of such party with combined single limit of [***]per
                occurrence and [***]per accident for bodily injury,
                including death, and property damage, which policy shall include
                coverage
                for all hired, owned and not-owned automobiles and trucks;
                and

            


    

     

    
      	
              11.8.1.4   
                

            	
              product
                liability insurance with limits of not less than [***]per
                occurrence and in the aggregate.

            


    

     

    
      	
               

            	 	
              11.8.2  
                

            	
              Upon
                request, no more often than on an annual basis, a Party shall furnish
                the
                other Party with a certificate(s) from the insurance carrier(s) (having
                a
                minimum AM Best rating of A) showing the coverages set forth above
                and
                naming the other Party an additional insured.  This insurance
                may be cancelled or altered only after thirty (30) days written notice
                is
                given to the other Party.

            


    

    


    SECTION
      12 - MISCELLANEOUS PROVISIONS

    


    12.1           Confidentiality

    


    
      	
              12.1.1   
                

            	
              Any
                information, whether written or oral, pertaining to the Product or
                the
                commercialization thereof that has been or will be communicated or
                delivered by Columbia to Ascend, or by Ascend to Columbia, including,
                without limitation,

            


    

    


    
      
        
                

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              trade
                secrets, business methods, and cost, supplier, manufacturing and
                customer
                information, shall be treated by Ascend and Columbia, respectively,
                as
                Confidential Information, and shall not be disclosed or revealed
                to any
                third party whatsoever or used in any manner except as expressly
                provided
                for herein; provided, however, that such Confidential Information
                shall
                not be subject to the restrictions and prohibitions set forth herein
                to
                the extent that such Confidential
                Information:

            


    

    


    
      	
              12.1.1.1    
                

            	
              is
                available to the public in public literature or otherwise, or after
                disclosure by one Party to the other becomes publicknowledge through
                no
                fault of the Party receiving such Confidential
                Information; or

            


    

    


    
      	
              12.1.1.2   
                

            	
              was
                known to the Party receiving such Confidential Information prior
                to the
                receipt of such Confidential Information by such Party, whether received
                before or after the date of this Agreement;
                or

            


    

    


    
      	
              12.1.1.3   
                

            	
              is
                obtained by the Party  receiving such Confidential Information
                from a third party not subject to a requirement of confidentiality
                with
                respect to such Confidential Information;
                or

            


    

    


    
      	
              12.1.1.4   
                

            	
              is
                required to be disclosed pursuant to: (i) any order of a court having
                jurisdiction and power to order such information to be released or
                made
                public; or (ii) any lawful action of a governmental or regulatory
                agency
                provided that each Party  shall notify the other in writing of
                any disclosure of information required hereunder prior to such
                disclosure.

            


    

    


    
      	
              12.1.2 
                 

            	
              Each
                Party  shall take in relation to the Confidential Information of
                the other Party  all such precautions as it normally takes with
                its own Confidential Information to prevent any improper disclosure
                of
                such Confidential Information to any third party; provided, however,
                that
                such Confidential Information may be disclosed within the limits
                required
                to obtain any authorization from the FDA or any governmental or regulatory
                agency or, with the prior written consent of the other Party, which
                shall
                not be unreasonably withheld or delayed, or as may otherwise be required
                in connection with the purposes of this
                Agreement.

            


    

    


    
      	
              12.1.3   
                

            	
              Each
                of the Parties agrees that it will not use, directly or indirectly,
                any
                know-how of the other Party (including Columbia Know-How), or other
                Confidential Information disclosed to it by the other Party or obtained
                by
                it from the other Party  pursuant to this Agreement, other than
                as expressly provided herein.

            


    

    


    
      	
              12.1.4   
                

            	
              Neither
                Party will publicize the existence of this Agreement in any way without
                the prior written consent of the other Party subject to the disclosure
                requirements of applicable laws and regulations.  In the event
                that either Party wishes to make an announcement concerning the Agreement,
                that Party will seek the consent of the other Party.  The terms
                of any such announcement shall be agreed in good
                faith.  Columbia and Ascend shall also co-operate in good faith
                with respect to

            


    

    


    
      
        
                

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              any
                stock exchange filings, public announcements, or filings with the
                United
                States Securities and Exchange Commission that may be necessary following
                execution of this Agreement.

            


    

    


    
      	
              12.2  

            	
              Alternative
                Dispute Resolution

            


    

    


     

    
      	
              12.2.1  
                 

            	
              The
                Parties will try to settle their differences amicably between
                themselves.  If any claim, dispute, or controversy of whatever
                nature arising out of or relating to this Agreement, including the
                performance or alleged non-performance of a Party of its obligations
                under
                this Agreement arises between the Parties (each a “Dispute”), a Party may
                notify the other Party in writing of such Dispute.  If the
                Parties are unable to resolve the Dispute within 20 days of receipt
                of the
                written notice by the other Party, such Dispute will be referred
                to the
                Chief Executive Officers of each of the Parties who will use their
                good
                faith efforts to resolve the Dispute within 30 days after such
                referral.

            


    

     

    
      	
              12.2.2    
                

            	
              If
                a Dispute is not resolved as provided in the preceding Section 12.2.1,
                whether before or after termination of this Agreement, the Parties
                hereby
                agree to resolve such Dispute by final and binding arbitration
                administered under the rules of arbitration of the American Arbitration
                Association (AAA) (the “Rules”) by one arbitrator appointed in accordance
                with the Rules, provided that upon request of either Party, three
                arbitrators will be appointed, thus forming a panel.  If the
                Parties are unable to mutually select such panel within 30 days after
                initiating such selection procedure, the panel will be selected in
                accordance with the Rules as applicable to a panel of three
                arbitrators.  The decision and award rendered by the panel will
                contain findings of fact and conclusions of law and be final and
                binding.  In any such arbitration, the arbitrators will not have
                the right to modify the terms and conditions of this
                Agreement.  As a result, the rights and obligations of the
                Parties will be determined in accordance with the terms and conditions
                of
                this Agreement and any decision or award will be only in accordance
                with
                the terms and conditions of this Agreement.  The Parties will
                exert reasonable efforts to have the decision and award rendered
                within
                six (6) months after the first to occur of (i) notice of breach of
                this
                Agreement, which breach is a subject of the arbitration, and (ii)
                a notice
                invoking this arbitration provision.  Judgment upon the award
                may be entered in any court having jurisdiction thereof.  Any
                arbitration pursuant to this section will be held in Wilmington,
                Delaware,
                or such other place as may be mutually agreed upon in writing by
                the
                Parties.  With respect to any Disputes arising in connection
                with an alleged breach of a Party’s rights and obligations with respect to
                confidential Know-How or Confidential Information received from the
                other
                Party, the arbitrator will apply the discovery provisions of the
                Federal
                Rules of Civil Procedure.  This means that depositions may be
                taken and full discovery may be obtained in any arbitration commenced
                under this Section with respect to such
                Disputes.

            


    

     

    
      	
              12.2.3    
                

            	
              Notwithstanding
                the provisions of this Section, either Party will have the right
                to

            


    

    


    
      
        
                

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    seek
      temporary or permanent injunctive relief in any court of competent jurisdiction
      as may be available to such Party under the laws and rules applicable in such
      jurisdiction.

    


    
      	
              12.3 

            	
              Assignments/Sub-contracting

            


    

    


    This
      Agreement may not be assigned by either Party without the prior written consent
      of the other Party, which consent shall not be unreasonably withheld or delayed,
      except that a Party may without such consent assign this Agreement in whole
      or
      in part and delegate its duties hereunder to an Affiliate or a successor to
      all
      or substantially all of its business or assets whether by sale, merger,
      consolidation, acquisition, transfer, operation of law or otherwise; provided,
      that such assignment shall not relieve the assignor of any liability or
      obligation hereunder. Columbia shall also have the right to subcontract all
      or
      any portion of its obligations under this Agreement to a third party with the
      prior written consent of Ascend, which shall not be unreasonably withheld or
      delayed. Ascend hereby consents to those subcontractors of Columbia retained
      as
      of the date hereof.

    


    
      	
              12.4

            	
              Severability

            


    

    


    If
      any
      provision in this Agreement is agreed by the Parties to be, or is deemed to
      be,
      or becomes invalid, illegal, void or unenforceable under any law that is
      applicable hereto:

    


    
      	
              12.4.1   
                

            	
              such
                provision will be deemed amended to conform to applicable laws so
                as to be
                valid and enforceable or, if it cannot be so amended without materially
                altering the intention of the Parties, it will be deleted, with effect
                from the date of such agreement or such earlier date as the Parties
                may
                agree; and

            


    

    


    
      	
              12.4.2   
                

            	
              the
                validity, legality and enforceability of the remaining provisions
                of this
                Agreement shall not be impaired or affected in any
                way.

            


    

    


    
      	
              12.5

            	
              Force
                Majeure

            


    

    


    Neither
      Party  shall be liable to the other for delay or failure in the
      performance of the obligations on its part contained in this Agreement if and
      to
      the extent that such failure or delay is due to circumstances beyond its control
      which it could not have avoided by the exercise of reasonable diligence
      including but not limited to: act of God, war or insurrection; civil commotion;
      destruction of essential facilities or materials by earthquake, fire, flood
      or
      storm; labor disturbance (whether or not any such labor disturbance is within
      the power of the affected Party  to settle); epidemic; or other
      similar event; provided, however, that the Party  so affected shall
      notify the other Party  promptly should such circumstances arise,
      giving an indication of the likely extent and duration thereof, and shall use
      all Commercially Reasonable efforts to avoid, remove or alleviate such causes
      of
      non-performance and shall resume performance of its obligations hereunder with
      the utmost dispatch whenever such causes are removed. In the event of force
      majeure lasting more than six (6) months, the Parties agree to meet and discuss
      how this Agreement can be justly and fairly implemented under the circumstances
      and if the

    


    
      
        
                

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    Parties
      are unable to agree upon how the Agreement can be implemented then either Party
      may terminate the Agreement upon thirty (30) days written notice.

    


    
      	
              12.6

            	
              Relationship
                of the Parties

            


    

    


    Nothing
      contained in this Agreement shall be deemed to create any association,
      partnership, joint venture, or other relationship of principal and agent, master
      and servant, or employer and employee between the Parties to this Agreement
      or
      Affiliates thereof, or to provide either Party with the right, power or
      authority, whether express or implied, to create any such duty or obligation
      on
      behalf of the other Party.

    


    12.7         No
      Third-Party Rights

     

    This
      Agreement is intended for the exclusive benefit of the Parties hereto and their
      respective successors and permitted assigns. Nothing contained in the Agreement
      shall be construed as granting any rights or benefits in or to any third party,
      and no person shall assert any rights as third-party beneficiary
      hereunder.

     

    12.8          Entire
      Agreement

     

    This
      Agreement (including all schedules and exhibits attached hereto, which are
      incorporated herein by this reference) sets forth the entire agreement between
      the parties hereto pertaining to the subject matter hereof and all negotiations,
      preliminary agreements, memoranda or letters of proposal or intent, discussions
      and understandings of the parties hereto in connection with the subject matter
      hereof, including the Confidentiality Agreement May 22, 2007, are superseded
      hereby.  All discussions between the Parties have been merged into
      this Agreement and neither Party shall be bound by any definition, condition,
      understanding, representation, warranty, covenant or provision other than as
      expressly stated in or contemplated by this Agreement or as subsequently shall
      be set forth in writing and executed by a duly authorized representative of
      the
      party to be bound thereby.  The foregoing shall not relieve any party
      from liability resulting from the breach of the Confidentiality Agreement prior
      to the date hereof.

    


    12.9          Interpretation

     

    In
      this
      Agreement the singular includes the plural and vice versa, the masculine
      includes the feminine and vice versa, and references to natural persons include
      corporate bodies, partnerships and vice versa. Any reference to a Section or
      Exhibit, unless otherwise specifically provided, shall be respectively to a
      Section or Exhibit of this Agreement. The headings of this Agreement are for
      ease of reference only and shall not affect its construction
      or interpretation. The language used in this Agreement is deemed to be the
      language chosen by the Parties to express their mutual intent, and no rules
      of
      strict construction will be applied against any Party.

    


    


    
      
        
                

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              12.10

            	
              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.

    


    
      	
              12.11

            	
              Amendments

            


    

    


    No
      amendment, modification or addition hereto shall be effective or binding on
      either Party unless set forth in writing and executed by a duly authorized
      representative of each Party.

    


    
      	
              12.12

            	
              Waiver

            


    

    


    No
      waiver
      of any right under this Agreement shall be deemed effective unless contained
      in
      a written document signed by the Party charged with such waiver, and no waiver
      of any breach or failure to perform shall be deemed to be a waiver of any future
      breach or failure to perform or of any other right arising under this
      Agreement.

    


    
      	
              12.13

            	
              No
                Effect on Other
                Agreements

            


    

    


    No
      provision of this Agreement shall be construed so as to negate, modify or affect
      in any way the provisions of any other agreement between the Parties unless
      specifically referred to, and solely to the extent provided, in any such other
      agreement.

    


    
      	
              12.14

            	
              Governing
                Law and Jurisdiction

            


    

    


    This
      Agreement is construed under and ruled by the laws of the State of Delaware,
      without regard to that state’s rules on conflicts of law.

    


    The
      Parties agree that the United Nations Convention on Contracts for the
      International Sale of Goods shall not apply to the interpretation and
      construction of this Agreement

    


    
      	
              12.15

            	
              Counterparts

            


    

    


    This
      Agreement may be executed in one or more counterparts, each of which shall
      be
      deemed to be an original document, but all such separate counterparts shall
      constitute only one and the same instrument.

    


    
      	
              12.16

            	
              Notice

            


    

    


    All
      notices required or permitted hereunder shall be given in writing and sent
      by
      facsimile transmission, or mailed postage prepaid by certified or registered
      mail (return

     

    


    
      
        
                

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    receipt
      requested), or sent by a nationally recognized express courier service, or
      hand-delivered at the following address:

     

    Columbia
      at

    


    Columbia
      Laboratories, Inc.

    354
      Eisenhower Parkway

    Livingston,
      New Jersey 07039

    Attention:          President

    With
      copy
      to:   General Counsel

    


    Telephone:        973-994-3999

    Fax:                     973-994-3001

    


    Ascend
      at

    


    Ascend
      Therapeutics, Inc.,

    607
      Herndon Parkway

    Suite
      210

    Herndon,
      Virginia 20170.

    Attention:         
      President

    With
      copy
      to:   General Counsel

    


    Telephone:        703-471-4744

    Fax:                     703-478-0959

    


    or
      to
      such other address(es) and telecopier numbers as may from time to time be
      notified by either Party to the other hereunder.

    


    Any
      notice sent by overnight courier shall be deemed to have been delivered within
      2
      working days and any notice sent by telex or telecopy shall be deemed to have
      been delivered within 24 hours.  Notice of change of address shall be
      effective upon receipt.

    


    


    
      
        
                

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    IN
      WITNESS of which the Parties have executed this Agreement.

    


    ASCEND
      THERAPEUTICS, INC.

    


    By:           /S/
      Jay A
      Bua                                                      

    


    Name:                      Jay
      A
      Bua                                                      

    


    Title:                       
      President                                           

    


    


    COLUMBIA
      LABORATORIES, INC.

    


    By:           /S/
      Robert S
      Mills                                                      

    


    Name:                      Robert
      S
      Mills                                                      

    


    Title:                       
      President &
CEO                                                      

    


    
      
        
                

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    Exhibits
      A & B Intentionally Omitted

    


    


    


    
      
        
                

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