Unassociated Document


    Exhibit
      10.7

     

    Portions
      herein identified by [***] have been omitted
      pursuant to a request for confidential treatment and have been filed separately
      with the 

    Commission
      pursuant to Rule 406 of the Securities Act
      of 1933, as amended.

     

    LICENSE
      AGREEMENT

    


    


    This
      AGREEMENT is made by and between BTG INTERNATIONAL LTD., a British corporation
      with its principal place of business at 10 Fleet Place, Limeburner Lane, London,
      EC4M 7SB, England (“BTG”); and COUGAR BIOTECHNOLOGY INC., a Delaware Corporation
      with its principal place of business in Los Angeles, California, USA
      (“Licensee”).

    


    The
      background of this agreement is as follows:

    


    
      	
              1.

            	
              BTG
                is the assignee of, and has the right to grant licenses under, certain
                patents and patent applications in various countries.
                

            


    

    


    
      	
              2.

            	
              BTG
                has access to certain technical information, data and knowhow relating
                to
                the inventions which are the subject matter of the patents and patent
                applications, and has the right to license and transfer such technical
                information, data and knowhow.

            


    

    


    
      	
              3.

            	
              Licensee
                wants to obtain a license under the patent rights, and wants to obtain
                access to and a license under the technical information and knowhow,
                to
                make, have made, use and sell Licensed
                Products.

            


    

    


    


    NOW
      THEREFORE, in consideration of the mutual covenants and agreements herein
      contained, BTG and Licensee agree as follows:

    


    


    
      	
              I.

            	
              DEFINITIONS.
                As
                used in this Agreement, the following terms have the meanings
                assigned:

            


    

    


    
      	 	
              1.1

            	
              "Affiliate"
                means any organization, firm, or entity (i) with respect to which
                the
                parties have or will have during the term of this Agreement ownership
                interest of more than fifty percent (50%) or (ii) which directly
                or
                indirectly, through one or more intermediates, controls, is controlled
                by,
                or is in common control with the
                party.

            


    

    


    
      	 	
              1.2

            	
              “Applicable
                Laws” means all laws, ordinances, rules and regulations of any kind
                whatsoever of any governmental or regulatory authority (international,
                foreign, federal, state or local), including, without limitation,
                all
                laws, ordinances, rules and regulations promulgated by the United
                States
                Food and Drug Administration
                (“FDA”).

            


    

    


    
      	 	
              1.3

            	
              “Distributor”
                means any entity with whom Licensee, its Affiliates or Sublicensees
                establish a business arrangement for the commercial marketing of
                Licensed
                Product.

            


    

     

     

    
      
        
        

      

      
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              1.4

            	
              “Effective
                Date” means the day on which this Agreement is executed on behalf of both
                parties.

            


    

    


    
      	 	
              1.5

            	
              “Fair
                Market Value” means the cash consideration that Licensee or its
                Affiliates, Sublicensees or Distributors would realize from an
                unaffiliated, unrelated buyer in an arm's length sale of an identical
                item
                sold in the same quantity and at the same time and place of the
                transaction.

            


    

    


    
      	 	
              1.6

            	
              “Field
                of Use” shall mean any therapeutic use that is intended to prevent, treat,
                ameliorate or cure a human disease, pathology or
                condition.

            


    

    


    
      	 	
              1.7

            	
              “Force
                Majeure” means any extraordinary,
                unexpected and unavoidable event such as acts of God, floods, fires,
                riots, war, labor disturbances, failures of sources of supply, or
                any such
                event caused by the reason of any law, order, proclamation, regulation,
                ordinance, demand or requirement of any relevant government or any
                authority or representative thereof, or by reason of any other cause,
                provided that the party claiming relief on account of such other
                cause can
                demonstrate that it was extraordinary, unexpected and unavoidable
                by the
                exercise of reasonable care.

            


    

    


    
      	 	
              1.8

            	
              “Initiation”
                means, with respect to the Pivotal Clinical Trial, the administration
                of
                the first dose of a Licensed Product to the first enrolled subject
                of the
                Pivotal Clinical Trial.

            


    

     

    
      	 	
              1.9

            	
              “Licensed
                Knowhow” means all trade secrets, inventions, confidential or proprietary
                information and data: (i) that is disclosed to Licensee by or at
                the
                direction of BTG or BTG’s assignor; (ii) that is owned by or licensed to
                BTG or BTG’s assignor at the time of such disclosure; and (iii) that
                relates to the inventions that are the subject matter of the Licensed
                Patents. Licensed Knowhow includes, without limitation, technical
                data, knowhow, chemical compounds, biological material, reports,
                manufacturing processes, formulations, modes of delivery and methods
                of
                use, pre-clinical and clinical data, documentation relating to regulatory
                submissions and marketing authorizations (including any Investigational
                New Drug Applications, New Drug Applications and equivalent documents),
                and post-registration clinical trial information and data relating
                to the
                Licensed Products.
                

            


    

    


    
      	 	
              1.10

            	
              "Licensed
                Patents" means: (i) the patents and patent applications (and any
                patents
                issuing therefrom) listed on Schedule 1.10 and all foreign counterpart
                patents and patent applications; (ii) all continuation, divisional,
                extension, reissue patents and reexamination certificates granted
                thereon,
                including Supplementary Protection Certificates; and (iii) patents
                and
                patent applications (and any patents issuing therefrom) that may
                hereafter
                be filed by BTG relating or pertaining to any Licensed Knowhow, together
                with all continuations, divisional, extension, reissue patents and
                reexamination certificates granted thereon, including Supplementary
                Protection Certificates.

            


    

     

     

    
      
        
        

      

      
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              1.11

            	
              ”Licensed
                Product” means any product made, sold, or otherwise disposed of by or on
                behalf of Licensee which: (i) falls within the scope of, or utilizes
                any
                method or process that falls within the scope of, the Licensed Patents;
                or
                (ii) incorporates, or is itself, the invention which is the subject
                of the
                Licensed Patents; or (iii) embodies or uses, or the design, manufacture,
                production or sale of which embodies or uses, any of the Licensed
                Knowhow.

            


    

    


    
      	 	
              1.12

            	
              “Licensee
                Technology” means all inventions, ideas, conceptions or
                reductions-to-practice, patentable or not, information, works and
                data
                that are generated, identified, discovered, created, made or controlled
                by
                Licensee, its employees or a third party on behalf of Licensee, relating
                to the Licensed Product or its production, including,
                without limitation, technical data, knowhow, chemical compounds,
                biological material, reports, manufacturing processes, formulations,
                modes
                of delivery and methods of use, pre-clinical and clinical data,
                documentation relating to regulatory submissions and marketing
                authorizations (including any Investigational New Drug Applications,
                New
                Drug Applications and equivalent documents), and post-registration
                clinical trial information and data relating to the Licensed
                Products.

            


    

    


    
      	 	
              1.13

            	
              “Licensed
                Territory” shall mean the world.

            


    

    


    
      	 	
              1.14

            	
              “Net
                Sales” shall mean the amounts received by Licensee or an Affiliate or
                Sublicensee or Distributor of the Licensee from the sale of Licensed
                Products to a third party purchaser, less the following deductions,
                to the
                extent that such amounts are included in the gross amounts received:
                (i)
                freight, packaging and insurance costs incurred in transporting the
                Licensed Product to customers; (ii) quantity, cash and other trade
                discounts actually allowed and taken (other than advertising allowances;
                and fees or commissions to Licensee’s employees); (iii) customs duties,
                surcharges, sales and other taxes (but excluding income taxes) and
                other
                governmental charges incurred in connection with the sale, transfer,
                use,
                exportation or importation of Licensed Products; and (iv) amounts
                repaid
                or credited by reason of returns, recalls, rejections or retroactive
                price
                reductions.

            


    

    


    For
      purposes of this Section 1.14, sales of Licensed Products shall be deemed to
      be
      made when the revenue for such sales is recognized by Licensee in accordance
      with Licensee’s standard accounting practices consistently applied. However, if
      Licensee subsequently takes a bad debt charge against any receivable resulting
      from the sale of Licensed Products, Licensee shall be entitled to credit
      one-half of the amount of the royalty paid under Section 5.1 attributable to
      such sale against future payments owed by Licensee to BTG hereunder, until
      and
      unless the amount of the bad debt charge is subsequently recovered.

    


    In
      the
      case of any sale, lease, hire or other disposition to any third party which
      is
      not an arm’s length transactions, Licensed Products shall be valued at the Fair
      Market Value for purposes of calculating Net Sales.

     

    
      
        
        

      

      
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              1.14.1

            	
              Transfer
                of a Licensed Product to an Affiliate, Sublicensee or Distributor
                for sale
                by the Affiliate, Sublicensee or Distributor shall not be considered
                a
                sale; in the case of such a transfer the Net Sales shall be based
                on the
                gross billing price of the Licensed Products by the Affiliate, Sublicensee
                or Distributor to its ultimate arms-length customer.
                

            


    

    


    
      	 	
              1.14.2

            	
              In
                addition to a bona fide sale to a bona fide customer, every commercial
                use
                or disposition of any Licensed Product shall be considered a sale
                of such
                Licensed Product at the price then payable in an arm's length transaction,
                except for the following uses or dispositions: (i) in assuring product
                testing or control; (ii) for reasonable, limited promotional distribution
                to physicians; (iii) for distribution to researchers for the sole
                purpose
                of industry research by or on behalf of Licensee or any of its Affiliates,
                Sublicensees or Distributors; (iv) in obtaining Regulatory Approvals;
                or
                (v) required to be provided to a regulatory agency or a court of
                law.
                

            


    

    


    
      	 	
              1.15

            	
              “Pivotal
                Clinical Trial” means a human clinical trial (whether denominated “Phase
                II”, “Phase III”, or otherwise) conducted to establish efficacy of
                Licensed Product and to meet the requirements to file a New Drug
                Application for Licensed Product with health regulatory authorities
                in the
                particular indication tested. 

            


    

    


    
      	 	
              1.16

            	
              “Qualified
                Licensee Equity” means stock, warrants or other equity interests in
                Licensee (or, if this Agreement is assigned by Licensee under Article
                XIV
                hereof, in any assignee), provided: (i) that such stock, warrants
                or other
                equity interests are registered under applicable securities laws
                and
                regulations; and (ii) that such stock, warrants or other equity interests
                are actively traded on a recognized market on the day in which it
                is
                issued to BTG.

            


    

    


    
      	 	
              1.17

            	
              “Regulatory
                Approval” means: (i) in the United States, approval of a New Drug
                Application and satisfaction of any related applicable FDA registration
                and notification requirements, and (ii) in any country other than
                the
                United States, approval by any governmental or regulatory body comparable
                to the FDA that is necessary to make and sell Licensed Products
                commercially in such country.

            


    

    


    
      	 	
              1.18

            	
              “Reporting
                Period” means a three (3) month period ending March 31, June 30, September
                30, and December 31 of each calendar
                year.

            


    

    


    
      	 	
              1.19

            	
              “Non-Royalty
                Consideration” means all amounts, and all consideration (including but not
                limited to equity, stock options, stock warrants and the like) received
                by
                Licensee from its Sublicensees in consideration of any grant of rights
                with respect to Licensed Patents, Licensed Knowhow or Licensed Products,
                including but not limited to payments or other consideration for
                options
                for licenses, exercise of such options, grant of licenses, paid up
                licenses, initial license fees, milestone payments, license maintenance
                payments, and all other payments or other consideration made to Licensee
                for such grant other than the
                following:

            


    

     

     

    
      
        
        

      

      
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              1.19.1

            	
              payments
                received from the sale of debt or equity securities of the Company,
                so
                long as such payments received from the sale of debt or equity securities
                do not constitute more than [***] percent [***] of the total
                Non-Royalty Consideration received by Licensee in any one transaction,
                and
                to the extent that such payments exceed [***] percent [***] of
                the total Non-Royalty Consideration in any one transaction, all amounts
                in
                excess of [***] percent [***] percent shall be deemed to be
                Non-Royalty Consideration for purposes of Section 4.4 hereof; and
                

            


    

    


    
      	 	
              1.19.2

            	
              payments
                received by the Licensee that are specifically designated in any
                agreement
                with a third party to be dedicated to the research and development
                of the
                Licensed Products or dedicated to establish a marketing and sales
                force
                for sales of Licensed Products; provided, however, that the amount
                of such
                payments: (i) reasonably correlates with the amounts which Licensee
                can
                reasonably be expected to expend for such purposes; and (ii) is consistent
                with the amounts of such payments which are customarily made in comparable
                transactions in the pharmaceutical industry.


            


    

    


    If
      Licensee receives any payments from an Affiliate or Sublicensee based upon
      the
      milestone events described in Section 4.2, and if the amount of those payments
      exceeds the sums set forth in Section 4.2, then the excess amount of such
      payments will be deemed Non-Royalty Consideration hereunder. 

    


    
      	 	
              1.20

            	
              “Sublicensee”
                means any entity to whom Licensee grants a sublicense pursuant to
                Article
                III of this Agreement

            


    

    


    


    
      	
              II.

            	
              LICENSE
                GRANT.

            


    

    


    
      	 	
              2.1

            	
              BTG
                hereby grants to Licensee and Licensee hereby accepts for the term
                of this
                Agreement the non-transferable, exclusive, royalty-bearing license
                under
                Licensed Patents in the Field of Use to make, have made, use, lease,
                sell
                and otherwise dispose of Licensed Products in the Licensed
                Territory.

            


    

     

     

    
      
        
        

      

      
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              2.2

            	
              BTG
                hereby grants to Licensee and Licensee hereby accepts for the term
                of this
                Agreement the non-transferable, exclusive, royalty-bearing license
                to use
                the Licensed Knowhow the
                Field of Use to
                make, have made, use, lease, sell and otherwise dispose of Licensed
                Products in
                the Licensed Territory.

            


    

    


    
      	 	
              2.3

            	
              BTG
                agrees not to assert any claim of infringement of any of the Licensed
                Patents against customers, mediate and immediate, of Licensee or
                its
                Affiliates, Sublicensees or Distributors with respect to any Licensed
                Products obtained directly or indirectly from Licensee or its Affiliates,
                Sublicensees or Distributors.

            


    

    


    
      	 	
              2.4

            	
              For
                so long as the licenses granted in this Article II remain exclusive,
                BTG
                will not grant any other person a license under the Licensed Patents
                and/or Licensed Knowhow to make, have made, use, lease, sell or otherwise
                dispose of Licensed Products, and will not itself make, have made,
                use,
                lease, sell or otherwise dispose of Licensed
                Products.

            


    

    


    
      	 	
              2.5

            	
              Nothing
                contained in this Agreement shall be construed as a license, express
                or
                implied, under any patents owned by or licensed to BTG other than
                the
                Licensed Patents, or under any information owned by or licensed to
                BTG
                other than the Licensed Knowhow. 

            


    

    


    


    
      	
              III.

            	
              SUBLICENSING.

            


    

    


    
      	 	
              3.1

            	
              Licensee
                may grant sublicenses under the rights granted to it in Article II,
                provided that such sublicenses shall be at least as favorable to
                BTG as
                this Agreement, and provided that each Sublicensee is bound under
                a
                written agreement with Licensee containing terms and conditions consistent
                with and no less restrictive than those applicable to Licensee hereunder.
                Licensee will include a copy of this Agreement as an exhibit to all
                sublicenses. Without limitation, all sublicenses shall include the
                following:

            


    

    


    
      	 	
              3.1.1

            	
              A
                provision specifying that the sublicense is personal to the Sublicensee,
                and may not be further sublicensed or
                assigned.

            


    

    


    
      	 	
              3.1.2

            	
              A
                provision allowing direct access by BTG or its representatives to
                inspect
                and audit the books and records of the Sublicensee for purposes of
                verifying royalties payable
                thereunder.

            


    

    


    
      	 	
              3.1.3

            	
              Provisions
                permitting termination of the sublicense in accordance with Section
                3.2
                below and other provisions for termination equivalent to those contained
                in this Agreement.

            


    

    


    
      	 	
              3.1.4

            	
              A
                provision for conversion to a license directly between the Sublicensee
                and
                BTG upon termination of this Agreement as provided in Section
                12.4.1.

            


    

     

     

    
      
        
        

      

      
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    Licensee
      will notify BTG of the proposed terms of any sublicenses in advance, and will
      permit BTG to comment upon the legal and commercial reasonableness of the
      proposed terms.

    


    
      	 	
              3.2

            	
              The
                Licensee shall be responsible for the observance and performance
                by every
                Sublicensee of the terms and conditions of the sublicense, and shall
                be
                directly liable to BTG for any breach, non-observance or non-performance
                by any Sublicensee which results in a breach by the Licensee under
                this
                Agreement.

            


    

    


    
      	 	
              3.3

            	
              Following
                the grant of sublicense, Licensee shall:


            


    

     

    
      	 	
              3.3.1

            	
              Forward
                a copy of the sublicense agreement within thirty (30) days of
                execution.

            


    

    


    
      	 	
              3.3.2

            	
              Notify
                BTG in the case of any breach by the Sublicensee, and if requested
                by BTG,
                promptly serve notice upon the Sublicensee specifying the breach,
                and
                terminating the sublicense in accordance with its terms if the breach
                is
                not timely cured.

            


    

    


    


    
      	
              IV.

            	
              LICENSE
                FEES, MILESTONES AND NON-ROYALTY
                CONSIDERATION.

            


    

    


    
      	 	
              4.1

            	
              Licensee
                shall pay to BTG the sum of Five
                Hundred Thousand (500,000) Pounds as an Initial License Fee, which
                amount shall not be refunded to Licensee because of any condition
                precedent or condition subsequent. The Initial License Fee will be
                paid by
                wire transfer of immediately available funds within two (2) business
                days
                of the execution of this Agreement.

            


    

    


    
      	 	
              4.2

            	
              Licensee
                shall pay to BTG the following non-refundable, non-creditable Development
                Milestone License Fees, payable within thirty (30) days following
                the
                milestone event date, whether such milestones are achieved by Licensee
                or
                by any Licensee Affiliate or
                Sublicensee:

            


    

    


    
      	 	
              4.2.1

            	
              Upon
                Initiation of the Pivotal Clinical Trial: [***], up to [***] of which
                may
                be paid in the form of Qualified Licensee
                Equity.

            


    

    


    
      	 	
              4.2.2

            	
              Upon
                submission of a New Drug Application or similar application for Regulatory
                Approval: [***].

            


    

    


    
      	 	
              4.2.3

            	
              Upon
                Regulatory Approval in the United States:
                [***].

            


    

     

     

    
      
        
        

      

      
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              4.2.4

            	
              Upon
                the earlier to occur of: (i) Regulatory Approval in any country in
                the
                European Union; or (ii) one year following first commercial sale
                of
                Licensed Products anywhere in the world:
                [***].

            


    

    


    
      	 	
              4.2.5

            	
              Upon
                Regulatory Approval in Japan:
                [***].

            


    

    


    
      	 	
              4.3

            	
              Until
                the first commercial sale of a Licensed Product, Licensee shall pay
                to BTG
                a non-refundable, non-creditable License Maintenance Fee of [***],
                payable
                upon the one-year anniversary date of the Effective Date of this
                Agreement, and upon each successive one-year anniversary date thereafter
                until Regulatory Approval. The amount of such License Maintenance
                Fee
                payments may be credited against any milestone payments described
                in
                Section 4.2 made during the calendar year in which such License
                Maintenance Fee is paid, but may not be credited against milestone
                payments made during any preceding or subsequent calendar year, or
                against
                any royalty payments due hereunder.

            


    

    


    
      	 	
              4.4

            	
              Licensee
                shall pay to BTG a portion of all Non-Royalty Consideration as
                follows:

            


    

    


    
      	 	
              4.4.1

            	
              If
                Licensee sublicenses rights to the Licensed Product prior to Initiation
                of
                the Pivotal Clinical Trial, Licensee will pay BTG [***] percent
                of all Non-Royalty Consideration, until such time as Licensee has
                recouped
                an amount equal to all out-of-pocket development costs and expenditures
                (but not including any overhead or other internal cost allocations)
                directly incurred and paid by Licensee prior to the date of such
                sublicense in developing Licensed Products pursuant to the Development
                Plan described in Section 7.2, and thereafter, Licensee will pay
                BTG [***] percent of all Non-Royalty
                Consideration.

            


    

    


    
      	 	
              4.4.2

            	
              If
                Licensee sublicenses rights to the Licensed Product after Initiation
                of
                the Pivotal Clinical Trial, Licensee will pay BTG [***] percent of
                all Non-Royalty Consideration.

            


    

    


    
      	 	
              4.4.3

            	
              Licensee
                will pay BTG the portion of all royalties received from Sublicensees
                as
                provided in Section 5.3.

            


    

    


    
      	 	
              4.5

            	
              If
                Licensee sublicenses rights to the Licensed Products under Article
                III,
                Licensee will pay BTG the following sublicense milestone fees based
                on the
                Sublicensee’s total cumulative sales of Licensed
                Products:

            


    

     

     

    
      
        
        

      

      
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              4.5.1

            	
              When
                the Sublicensee has sold a cumulative total of [***] in Net Sales,
                [***].

            


    

    


    
      	 	
              4.5.2

            	
              When
                the Sublicensee has sold a cumulative total of [***] in Net Sales,
                [***].

            


    

    


    
      	 	
              4.5.3

            	
              When
                the Sublicensee has sold a cumulative total of [***] in Net Sales,
                [***].

            


    

    


    
      	 	
              4.5.4

            	
              When
                the Sublicensee has sold a cumulative total of [***] in Net Sales,
                [***].

            


    

    


    BTG
      agrees that up to [***] percent of any of the payments described in this
      Section 4.5 may be made in the form of Qualified Licensee Equity. 

    


    
      	 	
              4.6

            	
              Within
                ten (10) days after receipt, Licensee shall forward to BTG copies
                of
                regulatory correspondence relevant to the (i) Initiation and Completion
                event milestones and (ii) the marketing application submission and
                approval milestones specified in this Article IV and, further, copies
                of
                correspondence from a regulatory agency that grants approval for
                marketing
                or other commercial use of a Licensed Product in any country. Such
                correspondence shall be subject to the confidentiality and limited
                use
                obligations of Article VII.

            


    

    


    


    
      	
              V.

            	
              ROYALTIES
                AND MINIMUM ROYALTIES.

            


    

    


    
      	 	
              5.1

            	
              In
                consideration of the license granted in Article II, Licensee shall
                pay BTG
                a royalty calculated upon the Net Sales of all Licensed Products
                sold by
                Licensee and its Affiliates and Distributors as
                follows:

            


    

    


    
      	 	
              5.1.1

            	
              For
                the first [***] in net sales made by Licensee and its Affiliates
                and
                Distributors in each calendar year, [***]  percent of the Net
                Sales.

            


    

    


    
      	 	
              5.1.2

            	
              For
                the next [***] in net sales made by Licensee and its Affiliates and
                Distributors in each calendar year, [***]  percent of the Net
                Sales.

            


    

    


    
      	 	
              5.1.3

            	
              For
                all net sales in excess of [***] made by Licensee and its Affiliates
                and
                Distributors in each calendar year, [***] percent of the Net
                Sales.

            


    

     

     

    
      
        
        

      

      
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              5.2

            	
              Beginning
                in the fourth full calendar year after Regulatory Approval, BTG will
                have
                the right to terminate the exclusive grant of rights herein contained
                if
                in any such year the royalties payable to BTG hereunder are less
                than
                [***], subject to the following:

            


    

    


    
      	 	
              5.2.1

            	
              In
                the fourth full calendar year after Regulatory Approval, so long
                as actual
                earned royalties payable hereunder are at least [***], Licensee will
                have
                the right to retain its exclusivity hereunder by paying BTG the difference
                between [***] and the amount of earned royalties. Beginning in the
                fifth
                full calendar year after Regulatory Approval, the [***] in minimum
                royalties must be from actual earned
                royalties.

            


    

    


    
      	 	
              5.2.2

            	
              The
                provisions of this Section 5.2 shall not apply if, and only to the
                extent
                that, Licensee is prevented from making or selling Licensed Products
                due
                to Force Majeure; provided that, to the extent feasible, Licensee
                takes
                reasonable steps to overcome or mitigate the effects of the Force
                Majeure
                event, and thereafter commences
                and continues diligent performance whenever the Force Majeure is
                removed.
                

            


    

    


    
      	 	
              5.2.3

            	
              If
                BTG exercises its right to terminate the exclusive grant of rights
                herein
                contained under this Section 5.2, Licensee will thereafter have and
                retain
                the non-exclusive right and license to make, have made, use, lease,
                sell
                and otherwise dispose of Licensed Products, including the rights
                to
                sublicense or assign its rights, upon all of the terms and conditions
                herein contained. The provisions of Section 12.4, and in particular
                Section 12.4.2, shall not apply to any termination of Licensee’s exclusive
                rights under this Section 5.2.

            


    

     

    
      	 	
              5.3

            	
              Licensee
                shall pay BTG [***] percent of all royalties that it receives from
                its Sublicensees; however, in no event will Licensee pay BTG an amount
                that is less than [***] percent of the Net Sales received by its
                Sublicensees or their Affiliates or Distributors for their sales
                or other
                dispositions of Licensed Products.

            


    

    


    
      	 	
              5.4

            	
              Licensee
                will provide BTG with good faith annual forecasts of the projected
                amount
                of its sales of Licensed Products. Such forecasts shall be for BTG’s
                planning purposes only. Licensee does not warrant the accuracy of
                such
                sales forecasts, and will not be liable to BTG in any way for any
                inaccuracy, or for any act or omission of BTG in reliance upon such
                forecasts. 

            


    

     

     

    
      
        
        

      

      
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              VI.

            	
              ROYALTY
                PAYMENTS, REPORTS, AND OTHER ACCOUNTING
                MATTERS.

            


    

    


    
      	 	
              6.1

            	
              Within
                thirty (30) days after each Reporting Period, Licensee will submit
                to BTG
                a report summarizing (i) the total Net Sales for sales or other
                dispositions by Licensee during such Reporting Period separately
                enumerated by country, (ii) the computation of any royalty payable
                during
                that Reporting Period, and (iii) the amount of royalty due for such
                Reporting Period. Licensee will pay the amount of any royalty due
                simultaneously with submission of its report.


            


    

     

    
      	 	
              6.2

            	
              All
                sums payable to BTG pursuant to this Agreement will be paid in United
                States Dollars. If royalties accrue in a currency other than United
                States
                Dollars, those royalties will be converted to United States Dollars
                at the
                exchange rate listed in the Wall Street Journal on the last day of
                the
                Reporting Period during which the royalties accrued. Licensee’s reports,
                as required by Section 6.1, will contain a statement setting forth
                any
                such computation of the number of United States Dollars remitted.
                All
                royalties that remain unpaid for more than thirty (30) days after
                their
                due date will bear interest from the due date until paid at a
                rate [***] percent greater than the prime interest rate published in
                the New York edition of the Wall Street
                Journal.

            


    

    


    
      	 	
              6.3

            	
              All
                sums payable to BTG under this Agreement are exclusive of any sales
                tax or
                equivalent, which will be payable by Licensee. In addition, all such
                sums
                will be paid in full without deduction of taxes, charges and other
                duties
                (including any withholding or other income taxes) that may be imposed;
                provided, that where Licensee is required by law to make such deduction
                or
                withholding, Licensee will be entitled to deduct such amounts and,
                if BTG
                so requests, will provide BTG with evidence of payment of such amount.
                

            


    

    


    
      	 	
              6.4

            	
              Licensee
                and its Affiliates, Sublicensees and Distributors will keep records
                that
                are adequate to establish the accuracy of the reports and the computation
                of royalties due under this Agreement for a period of five (5) calendar
                years including the five (5) years following termination or expiration
                of
                the licenses granted under Article II. Licensee will permit these
                records
                to be inspected and audited, at BTG’s expense, to verify the correctness
                of such reports and computations. Such inspections and audits will
                be
                during reasonable business hours and on reasonable notice to Licensee.
                If
                royalties are found to have been understated by an amount in excess
                of
                [***], Licensee shall reimburse BTG for its costs and expenses incurred
                in
                having the inspection and audit
                conducted.

            


    

    


    
      	 	
              6.5

            	
              Royalties
                shall be due upon all Licensed Products manufactured during the term
                of
                this Agreement that remain unsold at its expiration or termination,
                and
                shall be calculated and paid when sold in accordance with Section
                6.1.

            


    

    


    
      	 	
              6.6

            	
              Nothing
                in this Agreement will be construed as requiring Licensee to pay
                royalties
                under any expired patent, or any applicable claim or claims of a
                Licensed
                Patent that are declared invalid or not infringed or unenforceable
                by a
                court of competent jurisdiction from whose decision no appeal is
                or can be
                taken.

            


    

     

     

    
      
        
        

      

      
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              VII.

            	
              DILIGENCE;
                DEVELOPMENT AND COMMERCIALIZATION OF THE LICENSED
                PRODUCTS.

            


    

    


    
      	 	
              7.1

            	
              Promptly
                following BTG’s receipt of the Initial License Fee forth in Section 3.1,
                BTG will provide Licensee with any Licensed Knowhow that has not
                already
                been provided to Licensee prior to the Effective Date hereof.
                

            


    

    


    
      	 	
              7.2

            	
              Licensee
                has provided BTG with its plan for development, Regulatory Approval,
                manufacture, commercial exploitation and marketing of the Licensed
                Products (the “Development Plan”), a copy of which is attached as Schedule
                7.2. 

            


    

    


    
      	 	
              7.3

            	
              Licensee
                shall use all commercially reasonable efforts to diligently develop
                Licensed Products and seek Regulatory Approval in accordance with
                the
                Development Plan.
                Licensee
                shall diligently commence and conduct development of the Licensed
                Products, and will diligently undertake all actions required to obtain
                Regulatory Approval. Once Regulatory Approval has been obtained,
                Licensee
                will diligently commercialize the Licensed Products in all countries
                in
                which Regulatory Approval has been obtained; will use its best
                efforts to promote the distribution and sale of Licensed Products;
                and
                will seek to maximize demand for Licensed Products. Licensee will
                make
                available all necessary manufacturing, marketing and sales resources
                and
                facilities necessary to meet market demand for Licensed
                Products.

            


    

    


    
      	 	
              7.4

            	
              As
                of the Effective Date, Licensee shall be responsible, financially
                and
                otherwise, for all development of the Licensed Products conducted
                by or
                for Licensee and for seeking Regulatory Approval. BTG may provide
                Licensee
                with certain existing information and clinical data that is included
                as
                part of the Licensed Knowhow which Licensee may use in connection
                with
                Regulatory Approval; provided, that BTG will have no responsibility
                or
                liability for any actions or omissions in connection with Licensee’s use
                of such information and clinical data. Licensee or its Affiliates
                or
                Sublicensees shall hold legal title to all applications for marketing
                authorizations submitted by Licensee, and shall assume full responsibility
                for the clinical protocols developed in support of such applications
                for
                marketing authorization. 

            


    

    


    
      	 	
              7.5

            	
              At
                least once every six (6) months, Licensee will provide BTG with a
                summary
                midyear report on the status of development of the Licensed Products,
                and
                the efforts undertaken by Licensee and all Sublicensees to seek Regulatory
                Approval. Each such report shall include with respect to the applicable
                six (6) month period a description of the research and development
                and
                regulatory activities conducted both in the United States and outside
                the
                United States with respect to the Licensed Products. BTG and Licensee
                will
                meet or confer every six (6) months with respect to Licensee’s activities
                described in this Section 7.5.

            


    

     

     

    
      
        
        

      

      
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              VIII.

            	
              INTELLECTUAL
                PROPERTY.

            


    

    


    
      	 	
              8.1

            	
              BTG
                will, at
                its own expense, apply for, prosecute, seek prompt issuance of, and
                maintain the Licensed Patents. BTG will have the discretion to prosecute
                and maintain the Licensed Patents in the manner that BTG deems legally
                and
                commercially justified, including the right to cancel, amend or abandon
                any Licensed Patent, and to determine the countries in which the
                Licensed
                Patents will be prosecuted or maintained. Notwithstanding the foregoing,
                BTG and Licensee will confer at least once every six (6) months to
                discuss
                reasonable and commercially appropriate actions to prosecute and
                maintain
                the Licensed Patents, and BTG will consider in good faith any comments
                or
                suggestions that Licensee may offer with the view towards strengthening
                the scope, claims and geographic coverage of the Licensed
                Patents.

            


    

    


    
      	 	
              8.2

            	
              Licensee
                will cooperate with BTG, at BTG’s expense, in the filing, prosecution and
                maintenance of the Licensed Patents. In addition, Licensee
                shall cooperate fully with BTG in pursuing and securing available
                extensions or restoration of patent term for the Licensed Patents,
                including Supplementary Protection Certificates. Any patent extension
                or
                restoration of patent term or other supplemental product protection
                which
                is secured by BTG shall be deemed within the Licensed
                Patents.

            


    

    


    
      	 	
              8.3

            	
              Licensee
                and BTG will promptly notify the other of any infringement or suspected
                infringement that may come to its attention of any intellectual property
                rights relating to the Licensed Product, including, without limitation,
                the Licensed Patents and Licensed Knowhow. If a third party infringes
                any
                Licensed Patent or Licensed Knowhow, BTG will have the first right
                (but
                not the obligation), at its own expense, to pursue any and all injunctive
                relief and any or all compensatory and other remedies and relief
                against
                such third party, and Licensee will have the right to participate
                in such
                action at its own expense. If BTG determines not to pursue a claim
                with
                respect to such infringement within one hundred eighty (180) days
                after
                receipt of written notice from Licensee requesting BTG to do so,
                then
                Licensee will have the right (but not the obligation), to do so at
                its own
                expense, and BTG shall have the right to participate in such action
                at its
                own expense.

            


    

    


    
      	 	
              8.4

            	
              If
                a party elects to pursue a claim of infringement against a third
                party,
                the other party will use all reasonable efforts to assist and cooperate
                with the party pursuing such claim, including joining in any action
                or
                providing a power of attorney if necessary. Each party will bear
                its own
                costs and expenses relating to such pursuit. Any damages or other
                amounts
                collected will be distributed, first, to the party that pursued the
                claim
                to cover its costs and expenses and second, to the other party to
                cover
                its costs and expenses, if any, relating to the pursuit of such claim.
                Any
                damages or costs recovered in connection with any action filed by
                Licensee
                hereunder which exceed the parties’ out-of-pocket costs and expenses of
                litigation, shall be deemed to be Net Sales from sales of Licensed
                Products in the fiscal quarter in which received by Licensee, and
                Royalties shall be payable by Licensee to BTG thereon in accordance
                with
                the terms of this Agreement. If the action is filed and pursued by
                BTG,
                then all damages or costs recovered which exceed the parties’
                out-of-pocket costs and expenses of litigation shall be retained
                by BTG.
                No
                settlement, consent judgment or other final disposition of an action
                for
                infringement or validity may be entered into as to any Licensed Patent
                or
                Licensed Knowhow without BTG's prior written
                consent.

            


    

     

     

    
      
        
        

      

      
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              8.5

            	
              If
                a third party institutes a patent infringement, trade secret
                misappropriation or similar proceeding against Licensee during the
                term of
                this Agreement, alleging that the manufacture, marketing, sale, use
                or
                importation of the Licensed Product infringes one or more patent
                or other
                intellectual property rights held by such third party, then Licensee
                will
                have the sole right (but not the obligation), at its sole expense,
                to
                assume direction and control of the defense of such claim. Licensee
                will
                not have the right to settle or otherwise dispose of any such claim
                without the consent of BTG, which consent will not be unreasonably
                withheld.

            


    

    


    
      	 	
              8.6

            	
              Licensee
                will legibly mark all Licensed Products (or, if marking Licensed
                Products
                themselves is infeasible, will mark all associated packaging and
                product
                literature) with an appropriate patent notice in accordance with
                laws that
                govern marking of patented
                products.

            


    

    


    


    
      	
              IX.

            	
              CONFIDENTIALITY.

            


    

    


    
      	 	
              9.1

            	
              BTG
                and Licensee agree that all Licensed Knowhow and the Licensee Technology,
                and all other information of either party pertaining to the subject
                matter
                of this Agreement which either party designates as confidential in
                accordance with Section 9.5 (collectively, “Confidential Information”)
                will be transmitted and received in confidence. In addition, “Confidential
                Information” shall also include all information and data provided to
                Licensee prior to the Effective Date of this Agreement under the
                terms of
                the Confidential Disclosure Agreement between the parties dated August
                20,
                2003. Each party agrees to use the same degree of care to prevent
                disclosure of the Confidential Information as it uses to protect
                and
                safeguard its own highly valuable proprietary information, but in
                any
                event, not less than a reasonable degree of care. Licensee agrees
                to use
                the Licensed Knowhow solely and exclusively pursuant to the licenses
                granted to Licensee in Article II of this Agreement, and BTG agrees
                to use
                the Licensee Technology Knowhow solely and exclusively pursuant to
                the
                licenses granted to BTG in Section 12.4 of this
                Agreement.

            


    

     

     

    
      
        
        

      

      
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              9.2

            	
              Except
                for disclosure to each party’s Sublicensees under Article III and Section
                12.4.3, neither party will disclose any Confidential Information
                to any
                third party without the disclosing party’s written consent. Each party
                will obtain from its employees and Sublicensees written undertakings
                to
                maintain in confidence the Confidential Information, and will obtain
                similar written undertakings to maintain in confidence the Confidential
                Information from consultants, contractors, suppliers, or other third
                parties who receive, or are granted access to, the Confidential
                Information with the disclosing party’s consent.
                

            


    

    


    
      	 	
              9.3

            	
              Upon
                termination of this Agreement for any reason, except as provided
                herein,
                each party agrees that it will make no further use of the Confidential
                Information, will keep the Confidential Information in confidence,
                and
                will immediately deliver to the disclosing party all written or tangible
                Confidential Information and all copies thereof.
                

            


    

    


    
      	 	
              9.4

            	
              The
                obligations of confidentiality set forth in this Article IX will
                not apply
                to any Confidential Information that: (i) is already known to the
                receiving party at the time of disclosure; (ii) is publicly available
                or
                becomes publicly available without a breach of this Agreement by
                the
                receiving party; (iii) is rightfully received by the receiving party
                from
                a third party without duty of confidentiality; (iv) is independently
                developed by the receiving party; or (v) is required to be disclosed
                as a
                result of a final order of a court of competent
                jurisdiction.

            


    

    


    
      	 	
              9.5

            	
              To
                be subject to the obligations of this Article IX, all Confidential
                Information in written or tangible form must be marked with an appropriate
                designation, such
                as "CONFIDENTIAL" or “PROPRIETARY". All Confidential Information that is
                orally or visually disclosed will be subject to the obligations of
                this
                Article IX only if it is identified as confidential or proprietary
                at the
                time the disclosure is made and is subsequently described in a written
                document that is marked with the appropriate designation and delivered
                to
                the receiving party within thirty (30) days after the date of oral
                or
                visual disclosure. Notwithstanding the foregoing, any report or disclosure
                made or provided to BTG by Licensee pursuant to the terms of this
                Agreement shall be treated as Confidential Information regardless
                of
                whether it is disclosed verbally or in writing and whether it has
                been
                marked as "CONFIDENTIAL" or “PROPRIETARY".


            


    

    


    
      	 	
              9.6

            	
              Nothing
                contained in this Agreement will be construed to obligate either
                party to
                disclose to the other party information obtained from a non-Affiliate
                third party under obligations restricting disclosure
                thereof.

            


    

     

     

    
      
        
        

      

      
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              9.7

            	
              BTG
                and Licensee will jointly agree upon the terms of a press release
                communicating the existence of this Agreement and the parties’
                relationship hereunder, which will be issued on or shortly after
                the
                Effective Date. Licensee will also acknowledge BTG as the source
                of the
                Licensed Patents and Licensed Knowhow in all future public communications
                relating to the Licensed Product, provided, that Licensee will provide
                BTG
                with an advance copy of all press releases and other public communications
                relating to the Licensed Products in which BTG is
                named.

            


    

    


    


    
      	
              X.

            	
              REPRESENTATIONS,
                WARRANTIES AND
                DISCLAIMERS.

            


    

    


    
      	 	
              10.1

            	
              BTG
                represents and warrants that, as of the Effective Date of this
                Agreement:

            


    

    


    
      	 	
              10.1.1

            	
              It
                has the legal power to extend the rights granted to License under
                this
                Agreement.

            


    

    


    
      	 	
              10.1.2

            	
              No
                license or covenant not to sue has been granted to any third party
                to
                make, have made, use, have used, develop, have developed, improve,
                have
                improved, import, have imported, export, have exported, lease, have
                leased, sell, and/or have sold any product under the Licensed
                Patents.

            


    

    


    
      	 	
              10.1.3

            	
              Neither
                BTG nor its Affiliates has made any claim against a third party alleging
                any infringement, misappropriation or violation of any of the Licensed
                Patents.

            


    

    


    
      	 	
              10.1.4

            	
              There
                have been no claims or judicial proceedings commenced by or against
                BTG
                concerning any of the Licensed Patents or the Licensed Knowhow, and
                BTG
                has received no notice alleging or threatening any such claims or
                judicial
                proceedings.

            


    

    


    
      	 	
              10.1.5

            	
              BTG
                has granted no lien or encumbrance involving the Licensed Patents
                or
                Licensed Knowhow, and BTG will not encumber the Licensed Patents
                after the
                Effective Date of this Agreement. 

            


    

    


    
      	 	
              10.2

            	
              Each
                party represents and warrants that it has the full corporate power
                and
                authority to enter into and perform this Agreement. This Agreement
                has
                been duly authorized and duly executed and delivered by both parties,
                and
                it is valid, binding and enforceable against both parties in accordance
                with its terms. 

            


    

    


    
      	 	
              10.3

            	
              Except
                as set forth in this Article X, neither party makes or extends any
                other
                representations or warranties, and BTG makes no representation or
                warranties, express, implied or statutory, with respect to the Licensed
                Patents or Licensed Knowhow that is not expressly set forth in this
                Article. Except as provided herein, all Licensed Patents and Licensed
                Knowhow are made available to Licensee on an "as is" basis, and all
                Licensee Technology is made available to BTG on an “as is” basis. BTG does
                not warrant that the Licensed Patents are valid or enforceable; that
                the
                Licensed Patents or Licensed Knowhow have utility, are error free,
                or that
                they will meet Licensee's requirements; or that their exploitation
                does
                not or will not infringe any existing or future patent of another
                person,
                or that any of the Licensed Patents are valid. ANY IMPLIED WARRANTIES
                OF
                MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NONINFRINGEMENT
                OF
                THIRD PARTY PATENTS, ARE EXPRESSLY DISCLAIMED AND EXCLUDED. The entire
                risk as to the results obtained by practicing under the Licensed
                Patents
                and utilizing the Licensed Knowhow, or performance of the Licensed
                Products, is assumed by Licensee.

            


    

     

     

    
      
        
        

      

      
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              10.4

            	
              BTG
                and Licensee specifically agree that in no event shall either party
                be
                liable for indirect, incidental, special or consequential damages
                of any
                kind, including without limitation economic damage or lost profits,
                even
                if the party has been advised or is aware of the possibility of such
                damages.

            


    

     

     

    
      	
              XI.

            	
              LIABILTIY
                AND INDEMNIFICATION.

            


    

    


    
      	 	
              11.1

            	
              Licensee
                will defend, indemnify and hold harmless BTG, and its assignor, and
                their
                respective officers, directors, employees, agents and consultants,
                from
                and against all claims, demands, actions, liabilities and damages,
                and any
                costs and expenses which they incur in defending any action (including
                attorneys’ fees and expenses), in connection with the clinical testing,
                manufacture, use, sale, offer for sale, importation, lease or other
                transfer or disposal of any products (including Licensed Products)
                by
                Licensee and its Sublicensees other than with respect to claims arising
                out of the gross negligence or willful misconduct of BTG. The scope
                of
                such obligation to defend, indemnify and hold harmless includes,
                without
                limitation, any damage, loss or liability arising from injury or
                death of
                any person or damage to any property, and any fines or other penalties
                imposed by any governmental body arising from or related in any way
                to the
                import, export, manufacture, use, sale, offer for sale, lease or
                other
                transfer or disposal of products (including Licensed Products) or
                the
                waste stream resulting from the manufacture or handling
                thereof.

            


    

    


    
      	 	
              11.2

            	
              Insurance.
                Without limiting Licensee's indemnity obligations under the preceding
                paragraph, Licensee shall, prior to any clinical trial or sale of
                any
                Licensed Product, cause to be in force, an “occurrence based type”
                liability insurance policy which:

            


    

    


    
      	 	
              11.2.1

            	
              Insures
                BTG for all claims, damages, and actions mentioned in this Section
                of this
                Agreement;

            


    

    


    
      	 	
              11.2.2

            	
              Includes
                a contractual endorsement providing coverage for all liability which
                may
                be incurred by Indemnitees in connection with this Agreement for
                which
                Licensee has an indemnification obligation hereunder;
                

            


    

    


    
      	 	
              11.2.3

            	
              Requires
                the insurance carrier to provide BTG with no less than thirty (30)
                days'
                written notice of any change in the terms or coverage of the policy
                or its
                cancellation; and

            


    

    


    
      	 	
              11.2.4

            	
              Provides
                BTG product liability coverage in an amount no less than [***] per
                occurrence for bodily injury and [***] per occurrence
                for property damage, subject to a reasonable aggregate
                amount.

            


    

    


    
      	 	
              11.3

            	
              If
                Licensee is unable to obtain “occurrence based type” liability insurance,
                Licensee shall procure “claims made type” liability coverage to be
                effective prior to any clinical trial or sale of any Licensed Patent,
                and
                throughout the term of this Agreement and “tail coverage”, extending at
                least ten (10) years after termination of this Agreement. Licensee
                shall
                notify BTG prior to its first clinical trial or first commercial
                sale of
                any Licensed Product, of all insurance coverage available to Licensee
                to
                meet Licensee‘s obligations under Article 11 of this Agreement and other
                assets available to Licensee which may be used by Licensee should
                the
                insurance coverage available to Licensee not be sufficient to meet
                Licensee obligations hereunder.

            


    

     

     

    
      
        
        

      

      
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              XII.

            	
              TERM
                AND TERMINATION.

            


    

    


    
      	 	
              12.1

            	
              Unless
                terminated as provided in this Article XII, the term of this Agreement
                shall commence upon its Effective Date and shall remain in force
                until the
                date of expiration of the last to expire of any patent of the Licensed
                Patents. Upon expiration of the term of the Agreement as provided
                in this
                Section 12.1, Licensee’s rights to Licensed Knowhow will thereupon become
                perpetual, irrevocable and fully paid-up, and Licensee may thereafter
                use
                the Licensed Knowhow to make, have made, use, lease, sell and otherwise
                dispose of any products in any country of the world without any further
                royalty payment to BTG.

            


    

    


    
      	 	
              12.2

            	
              Either
                party may terminate this Agreement if the other party is in material
                default of any of its obligations and such default remains uncured
                for at
                least sixty (60) days after written notice of the default is given
                to the
                defaulting party by the non-defaulting party. In addition, if either
                party
                files a petition in bankruptcy or insolvency or is adjudged bankrupt
                or
                insolvent, or makes an assignment for the benefit of creditors or
                otherwise acknowledges insolvency, the other party may terminate
                this
                Agreement by providing ten (10) days prior written
                notice.

            


    

    


    
      	 	
              12.3

            	
              BTG
                may terminate this Agreement and the licenses herein granted upon
                thirty
                (30) days' written notice to the Licensee, or may terminate the licenses
                herein granted with respect to any geographic territory without
                terminating it as to other geographic territories, if any of the
                following
                events occurs:

            


    

    


    
      	 	
              12.3.1

            	
              if
                Licensee at any time ceases to develop Licensed Products for a continuous
                period of six (6) months unless such failure is as a result of Force
                Majeure; provided
                that, to the extent feasible, Licensee takes reasonable steps to
                overcome
                or mitigate the effects of the Force Majeure event, and thereafter
                commences
                and continues with diligent performance whenever the Force Majeure
                event
                is removed;

            


    

    


    
      	 	
              12.3.2

            	
              if
                Licensee fails to achieve the following development milestones within
                six
                (6) months after the timeframes specified in this Section 12.3.2,
                unless
                such failure is as a result of Force Majeure; provided
                that, to the extent feasible, Licensee takes reasonable steps to
                overcome
                or mitigate the effects of the Force Majeure event, and thereafter
                commences
                and continues with diligent performance whenever the Force Majeure
                event
                is removed: (i) Optimization of manufacturing process and preparation
                of
                GMP batches of API within [***] months following the Effective Date;
                and (ii) Submission of an IND within [***] months after completion of
                item (i) above; provided, however, that if the Licensee using all
                commercially reasonable efforts, is unable to meet the aforementioned
                timelines, BTG shall negotiate in good faith, a reasonable extension.
                

            


    

    


    
      	 	
              12.3.3

            	
              if
                Licensee fails to commence selling Licensed Products in any geographic
                territory within [***] months following Regulatory Approval in that
                territory, or if Licensee thereafter ceases to sell Licensed Products
                in a
                geographic territory for a continuous period of [***] months after
                the Licensed Products are first made available in the market in that
                territory, BTG may terminate the licenses herein granted with respect
                to
                that geographic territory or territories;
                or

            


    

    


    
      	 	
              12.3.4

            	
              if
                control of Licensee is acquired by any entity, or entity or person(s)
                not
                having control of Licensee at the Effective Date and such change
                in
                control materially adversely affects the development and marketing
                of
                Licensed Product as contemplated under this Agreement or materially
                adversely affects BTG's rights or legal interests under this Agreement
                or
                the economic benefits to BTG under this Agreement. For the purposes
                hereof, "control" shall mean the power to direct or cause the direction
                of
                the management and policies of an entity, whether through the ownership
                of
                voting securities, by contract or otherwise.


            


    

     

     

    
      
        
        

      

      
        18
          of 22

        
          

        

      

      
        
        

      

    

     

    
      	 	
              12.4

            	
              If
                BTG terminates this Agreement under Section 12.2 or 12.3 prior to
                the
                expiration of the Agreement term, then the following will take effect
                upon
                the effective date of such
                termination:

            


    

    


    
      	 	
              12.4.1

            	
              All
                rights under the Licensed Patents and the Licensed Knowhow granted
                by BTG
                to Licensee pursuant to Article II will terminate, and all rights
                granted
                therein will immediately revert to BTG with no further notice or
                action
                required on BTG’s behalf. In that event, any sublicense granted by
                Licensee shall be automatically assigned by Licensee to BTG without
                any
                action of either Party such that the sublicense becomes a direct
                license
                between BTG and the applicable Sublicensee.


            


    

    


    
      	 	
              12.4.2

            	
              Licensee
                automatically grants to BTG a non-exclusive, world-wide, royalty-free
                license, with the right to sublicense, under Licensee Technology
                to make,
                have made, use, offer to sell, sell and import Licensed Products.
                In
                addition to the license granted under this Section 12.4.2, Licensee
                will
                also promptly provide BTG with reasonable access to all Licensee
                Technology, and will provide BTG with copies of all Licensee Technology
                that exists in tangible form, including but not limited to, any
                pre-clinical and clinical trial results and regulatory files related
                to
                the Licensed Product. If BTG so requests, Licensee will provide reasonable
                assistance of appropriate Licensee personnel to discuss the Licensee
                Technology. BTG will reimburse License for all reasonable out-of-pocket
                expenses that its personnel incur in providing such assistance.
                

            


    

    


    
      	 	
              12.4.3

            	
              Licensee
                shall immediately transfer possession and ownership to BTG (and shall
                cause all contractors used by Licensee to transfer possession and
                ownership) of all Regulatory Approvals, together with pre-clinical
                and
                clinical data and information, all clinical trial databases, all
                data
                generated in support of applications for marketing authorization,
                and all
                other information and documents relating to Regulatory Approval,
                and all
                correspondence between Licensee and any contractor of Licensee and
                any
                regulatory agency, that were created and/or developed by Licensee
                in
                connection with obtaining or seeking to obtain Regulatory Approval.
                

            


    

    


    
      	 	
              12.5

            	
              The
                provisions of Sections 10.3, 10.4, 12.4 and Articles V, IX and XI
                will
                survive any termination or expiration of this
                Agreement.

            


    

     

     

    
      
        
        

      

      
        19
          of 22

        
          

        

      

      
        
        

      

    

     

    
      	
              XIII.

            	
              NOTICES
                AND OTHER COMMUNICATIONS.

            


    

    


    
      	 	
              13.1

            	
              Any
                notice or other communication required or permitted to be made or
                given to
                either party shall be sent to the other party by overnight courier
                service
                (Federal Express or the like), addressed to the party at its address
                set
                forth below, or to such other address as the party may designate
                by
                written notice given to the other
                party.

            


    

    


    In
      the
      case of BTG:

    BTG
      International, Inc.

    Five
      Tower Bridge

    300
      Barr
      Harbor Drive

    West
      Conshohocken, PA. 19428

    Attn:
      General Counsel

    


    In
      the
      case of Licensee:

    Cougar
      Biotechnology, Inc.

    10940
      Wilshire Blvd., Suite 600

    Los
      Angeles, California 90024 USA

    Attention:
      President

    


    


    
      	
              XIV.

            	
              ASSIGNMENTS.

            


    

    


    
      	 	
              14.1

            	
              This
                Agreement and the rights and duties apper-taining hereto may not
                be
                assigned by either party without first obtaining the written consent
                of
                the other which consent shall not be unreasonably withheld. Any such
                purported assignment, without the written con-sent of the other party,
                shall be null and of no effect. Notwith-standing the foregoing, BTG
                may
                assign this Agreement and its right to receive payments hereunder,
                and
                Licensee may assign this A-greement without such consent to a purchaser,
                merging or consolidating corpo-ra-tion, or acquirer of substantially
                all
                of the Company's assets or business and/or pursuant to any
                reorgani-za-tion quali-fying under section 368 of the Internal Revenue
                Code of 1986 as amended, as may be in effect at such
                time.

            


    

    


    


    
      	
              XV.

            	
              MISCELLANEOUS.

            


    

    


    
      	 	
              15.1

            	
              Licensee
                shall obtain the prior written approval of BTG prior to making use
                of the
                name of any BTG employee or the name BTG for any commercial purpose,
                except as required to comply with law, regulation or court
                order.

            


    

    


    
      	 	
              15.2

            	
              Each
                of the parties will from time to time at the other’s reasonable request
                and expense, and without further consideration, execute and deliver
                such
                other documents and take such further action as the other party may
                reasonably require to more effectively evidence, perfect, or complete
                any
                matter provided for herein.

            


    

     

     

    
      
        
        

      

      
        20
          of 22

        
          

        

      

      
        
        

      

    

     

    
      	 	
              15.3

            	
              Any
                consent by any party to, or waiver of, a breach by the other party,
                whether express or implied, will not constitute a consent to, or
                waiver
                of, any other different or subsequent
                breach.

            


    

    


    
      	 	
              15.4

            	
              If
                any provision of this Agreement is held by a court of competent
                jurisdiction to be invalid, void or unenforceable, it shall be severed
                from this Agreement and the remaining provisions shall remain in
                full
                force without being impaired or invalidated in any
                way.

            


    

    


    
      	 	
              15.5

            	
              The
                parties are independent contractors. Neither party has any express
                or
                implied right or authority to assume or create any obligations on
                behalf
                of the other or to bind the other to any contract, agreement or
                undertaking with any third party.

            


    

    


    
      	 	
              15.6

            	
              No
                amendment or modification of this Agreement shall be valid or binding
                upon
                the parties unless made in writing and signed by or on behalf of
                the party
                against which enforcement is
                sought.

            


    

    


    
      	 	
              15.7

            	
              This
                Agreement shall be construed, and the legal relationships between
                the
                parties hereto shall be determined, in accordance with the laws of
                the
                State of Delaware, United States of America, without giving effect
                to its
                conflicts of laws provisions.

            


    

    


    
      	 	
              15.8

            	
              This
                Agreement embodies the entire understanding of the parties and shall
                supersede all previous communications, representations, or understandings,
                either oral or written, between the parties relating to the subject
                matter
                hereof. 

            


    

    


    


    


    


    


    


    


    [The
      remainder of this page is intentionally left blank]

     

    
      
        
        

      

      
        21
          of 22

        
          

        

      

      
        
        

      

    

     

    IN
      WITNESS WHEREOF, the parties intending to be legally bound, have caused this
      Agreement to be duly executed in duplicate original on the dates set forth
      below, the later of which is the Effective Date.

     

    
      
        	
                BTG
                  INTERNATIONAL LTD.

              	
                COUGAR
                  BIOTECHNOLOGY, INC. 

              
	 	 
	 	 
	 	 
	
                By:
                  _____________________________

              	
                By:
                  _______________________________

              
	 	 
	
                Title:
                  ___________________________

              	
                Title:
                  ______________________________

              
	 	 
	
                Date:
                  ___________________________

              	
                Date:
                  ______________________________

              
	 	 
	 	 
	 	 
	
                By:
                  ____________________________

              	 
	 	 
	
                Title:
                  ___________________________

              	 
	 	 
	
                Date:
                  ___________________________

              	 


      



     

    
      
        
        

      

      
        22
          of 22

        
          

        

      

      
        
        

      

    

     

    

      Schedule
        1.10

      License
        Patents


      
        	
                136420

              
	
                PYRIDYL-STEROID
                  SYNTHESIS

              


      

       

      
        	
                Country

              	 	
                Filing
                  number

              	 	
                Filing
                  date

              	 	
                Publication
                  number 

              	 	
                Publication
                  date 

              	 	
                Grant
                  number 

              	 	
                Grant
                  date 

              	 	
                Observation
                  

              
	
                AUSTRIA

              	 	
                E176481

              	 	
                22/SEP/1994

              	 	
                0721461

              	 	
                17/JUL/1996

              	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                REMARKS
                  : NB. 5618807 [REF. 135279 US2] COVERING THE SYNTHESIS OF THE COMPOUNDS,
                  CORRESPONDING TO CASE 136420 WORLD-WIDE

              
	
                AUSTRIA

              	 	
                E176481

              	 	
                22/SEP/1994

              	 	
                0721461

              	 	
                17/JUL/1996

              	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                AUSTRALIA

              	 	
                94/76618

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                676088

              	 	
                17/JUN/1997

              	 	
                REMARKS
                  : NB. 5618807 [REF. 135279 US2] COVERING THE SYNTHESIS OF THE COMPOUNDS,
                  CORRESPONDING TO CASE 136420 WORLD-WIDE

              
	
                AUSTRALIA

              	 	
                94/76618

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                676088

              	 	
                17/JUN/1997

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                BELGIUM

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	
                0721461

              	 	
                17/JUL/1996

              	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                REMARKS
                  : NB. 5618807 [REF. 135279 US2] COVERING THE SYNTHESIS OF THE COMPOUNDS,
                  CORRESPONDING TO CASE 136420 WORLD-WIDE

              
	
                BELGIUM

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	
                0721461

              	 	
                17/JUL/1996

              	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                CANADA

              	 	
                2170286

              	 	
                22/SEP/1994

              	 	 	 	 	 	 	 	 	 	
                REMARKS
                  : NB. 5618807 [REF. 135279 US2] COVERING THE SYNTHESIS OF THE COMPOUNDS,
                  CORRESPONDING TO CASE 136420 WORLD-WIDE

              
	
                CANADA

              	 	
                2170286

              	 	
                22/SEP/1994

              	 	 	 	 	 	 	 	 	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                SWITZERLAND

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                REMARKS
                  : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                  corresponding to case 136420 world-wide

              
	
                SWITZERLAND

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                GERMANY

              	 	
                69416419.4

              	 	
                22/SEP/1994

              	 	
                0721461

              	 	
                17/JUL/1996

              	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                REMARKS
                  : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                  corresponding to case 136420 world-wide

              
	
                GERMANY

              	 	
                69416419.4

              	 	
                22/SEP/1994

              	 	
                0721461

              	 	
                17/JUL/1996

              	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                DENMARK

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                REMARKS
                  : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                  corresponding to case 136420 world-wide

              
	
                DENMARK

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                EPC

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	
                0721461

              	 	
                17/JUL/1996

              	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                REMARKS
                  : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                  corresponding to case 136420 world-wide

              
	
                EPC

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	
                0721461

              	 	
                17/JUL/1996

              	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                SPAIN

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                REMARKS
                  : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                  corresponding to case 136420 world-wide

              
	
                SPAIN

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                FRANCE

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	
                0721461

              	 	
                17/JUL/1996

              	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                REMARKS
                  : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                  corresponding to case 136420 world-wide

              
	
                FRANCE

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	
                0721461

              	 	
                17/JUL/1996

              	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                UNITED
                  KINGDOM

              	 	
                9320132.5

              	 	
                30/SEP/1993

              	 	 	 	 	 	 	 	 	 	
                REMARKS
                  : COMBINE UK-2. NB. 5618807 [ref. 135279 US2] covering the synthesis
                  of
                  the compounds, corresponding to case 136420 world-wide

              
	
                UNITED
                  KINGDOM

              	 	
                9320132.5

              	 	
                30/SEP/1993

              	 	 	 	 	 	 	 	 	 	
                10207

              
	
                UNITED
                  KINGDOM

              	 	
                9320132.5

              	 	
                30/SEP/1993

              	 	 	 	 	 	 	 	 	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                UNITED
                  KINGDOM

              	 	
                9414192.6

              	 	
                14/JUL/1994

              	 	 	 	 	 	 	 	 	 	
                REMARKS
                  : TO BE COMBINED WITH UK-1 DUE 30-SEP-1994. NB. 5618807 [ref. 135279
                  US2]
                  covering the synthesis of the compounds, corresponding to case
                  136420
                  world-wide

              
	
                UNITED
                  KINGDOM

              	 	
                9414192.6

              	 	
                14/JUL/1994

              	 	 	 	 	 	 	 	 	 	
                10207

              
	
                UNITED
                  KINGDOM

              	 	
                9419139.2

              	 	
                22/SEP/1994

              	 	
                2282377

              	 	
                05/APR/1995

              	 	
                2282377

              	 	
                03/SEP/1997

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	
                UNITED
                  KINGDOM

              	 	
                9419139.2

              	 	
                22/SEP/1994

              	 	
                2282377

              	 	
                05/APR/1995

              	 	
                2282377

              	 	
                03/SEP/1997

              	 	
                10207

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                UNITED
                  KINGDOM

              	 	
                9419139.2

              	 	
                22/SEP/1994

              	 	
                2282377

              	 	
                05/APR/1995

              	 	
                2282377

              	 	
                03/SEP/1997

              	 	
                REMARKS
                  : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                  corresponding to case 136420 world-wide

              
	
                UNITED
                  KINGDOM

              	 	
                9414192.6

              	 	
                14/JUL/1994

              	 	 	 	 	 	 	 	 	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                GREECE

              	 	
                990400688

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                REMARKS
                  : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                  corresponding to case 136420 world-wide

              
	
                GREECE

              	 	
                990400688

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                HONG
                  KONG

              	 	
                98101634.3

              	 	
                03/MAR/1998

              	 	 	 	 	 	
                HK1002634

              	 	
                04/SEP/1998

              	 	
                REMARKS
                  : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                  corresponding to case 136420 world-wide

              
	
                HONG
                  KONG

              	 	
                98101634.3

              	 	
                03/MAR/1998

              	 	 	 	 	 	
                HK1002634

              	 	
                04/SEP/1998

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                IRELAND

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                REMARKS
                  : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                  corresponding to case 136420 world-wide

              
	
                IRELAND

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                ITALY

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                REMARKS
                  : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                  corresponding to case 136420 world-wide

              
	
                ITALY

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                JAPAN

              	 	
                95/510163

              	 	
                22/SEP/1994

              	 	
                97/502994

              	 	
                25/MAR/1997

              	 	 	 	 	 	
                REMARKS
                  : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                  corresponding to case 136420 world-wide

              
	
                JAPAN

              	 	
                95/510163

              	 	
                22/SEP/1994

              	 	
                97/502994

              	 	
                25/MAR/1997

              	 	 	 	 	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                LUXEMBOURG

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                REMARKS
                  : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                  corresponding to case 136420 world-wide

              
	
                LUXEMBOURG

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                MONACO

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                REMARKS
                  : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                  corresponding to case 136420 world-wide

              
	
                MONACO

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                MEXICO

              	 	
                9407545

              	 	
                29/SEP/1994

              	 	 	 	 	 	
                195256

              	 	
                09/FEB/2000

              	 	
                REMARKS
                  : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                  corresponding to case 136420 world-wide

              
	
                MEXICO

              	 	
                9407545

              	 	
                29/SEP/1994

              	 	 	 	 	 	
                195256

              	 	
                09/FEB/2000

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                NETHERLANDS

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	
                0721461

              	 	
                17/JUL/1996

              	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                REMARKS
                  : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                  corresponding to case 136420 world-wide

              
	
                NETHERLANDS

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	
                0721461

              	 	
                17/JUL/1996

              	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                NEW
                  ZEALAND

              	 	
                273367

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                273367

              	 	
                18/NOV/1997

              	 	
                REMARKS
                  : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                  corresponding to case 136420 world-wide

              
	
                NEW
                  ZEALAND

              	 	
                273367

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                273367

              	 	
                18/NOV/1997

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                PORTUGAL

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                REMARKS
                  : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                  corresponding to case 136420 world-wide

              
	
                PORTUGAL

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	 	 	 	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                SWEDEN

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	
                0721461

              	 	
                17/JUL/1996

              	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                REMARKS
                  : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                  corresponding to case 136420 world-wide

              
	
                SWEDEN

              	 	
                94927003.7

              	 	
                22/SEP/1994

              	 	
                0721461

              	 	
                17/JUL/1996

              	 	
                0721461

              	 	
                03/FEB/1999

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                SINGAPORE

              	 	
                9609266-3

              	 	
                06/APR/1996

              	 	
                0049321

              	 	
                18/MAY/1998

              	 	
                49321

              	 	
                31/DEC/2001

              	 	
                REMARKS
                  : TRANSITIONAL APPLICATION BASED ON UK-3 (9419139.2). NB. 5618807
                  [ref.
                  135279 US2] covering the synthesis of the compounds, corresponding
                  to case
                  136420 world-wide

              
	
                SINGAPORE

              	 	
                9609266-3

              	 	
                06/APR/1996

              	 	
                0049321

              	 	
                18/MAY/1998

              	 	
                49321

              	 	
                31/DEC/2001

              	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                PCT

              	 	
                PCT/GB94/02054

              	 	
                22/SEP/1994

              	 	
                WO95/09178

              	 	
                06/APR/1995

              	 	 	 	 	 	
                REMARKS
                  : NB. 5618807 [REF. 135279 US2] COVERING THE SYNTHESIS OF THE COMPOUNDS,
                  CORRESPONDING TO CASE 136420 WORLD-WIDE

              
	
                PCT

              	 	
                PCT/GB94/02054

              	 	
                22/SEP/1994

              	 	
                WO95/09178

              	 	
                06/APR/1995

              	 	 	 	 	 	
                SYNTHESIS
                  OF 17-(3-PYRIDYL) STEROIDS

              
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 


      

    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    

      Schedule
        1.10

      License
        Patents

    

     

    
      	
              Country

            	 	
              Filing
                number

            	 	
              Filing
                date

            	 	
              Publication
                number 

            	 	
              Publication
                date 

            	 	
              Grant
                number 

            	 	
              Grant
                date 

            	 	
              Observation
                

            


    

    
      	
              HONG
                KONG

            	 	
              98101634.3

            	 	
              03/MAR/1998

            	 	 	 	 	 	
              HK1002634

            	 	
              04/SEP/1998

            	 	
              REMARKS
                : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                corresponding to case 136420 world-wide

            
	
              HONG
                KONG

            	 	
              98101634.3

            	 	
              03/MAR/1998

            	 	 	 	 	 	
              HK1002634

            	 	
              04/SEP/1998

            	 	
              SYNTHESIS
                OF 17-(3-PYRIDYL) STEROIDS

            
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
              IRELAND

            	 	
              94927003.7

            	 	
              22/SEP/1994

            	 	 	 	 	 	
              0721461

            	 	
              03/FEB/1999

            	 	
              REMARKS
                : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                corresponding to case 136420 world-wide

            
	
              IRELAND

            	 	
              94927003.7

            	 	
              22/SEP/1994

            	 	 	 	 	 	
              0721461

            	 	
              03/FEB/1999

            	 	
              SYNTHESIS
                OF 17-(3-PYRIDYL) STEROIDS

            
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
              ITALY

            	 	
              94927003.7

            	 	
              22/SEP/1994

            	 	 	 	 	 	
              0721461

            	 	
              03/FEB/1999

            	 	
              REMARKS
                : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                corresponding to case 136420 world-wide

            
	
              ITALY

            	 	
              94927003.7

            	 	
              22/SEP/1994

            	 	 	 	 	 	
              0721461

            	 	
              03/FEB/1999

            	 	
              SYNTHESIS
                OF 17-(3-PYRIDYL) STEROIDS

            
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
              JAPAN

            	 	
              95/510163

            	 	
              22/SEP/1994

            	 	
              97/502994

            	 	
              25/MAR/1997

            	 	 	 	 	 	
              REMARKS
                : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                corresponding to case 136420 world-wide

            
	
              JAPAN

            	 	
              95/510163

            	 	
              22/SEP/1994

            	 	
              97/502994

            	 	
              25/MAR/1997

            	 	 	 	 	 	
              SYNTHESIS
                OF 17-(3-PYRIDYL) STEROIDS

            
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
              LUXEMBOURG

            	 	
              94927003.7

            	 	
              22/SEP/1994

            	 	 	 	 	 	
              0721461

            	 	
              03/FEB/1999

            	 	
              REMARKS
                : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                corresponding to case 136420 world-wide

            
	
              LUXEMBOURG

            	 	
              94927003.7

            	 	
              22/SEP/1994

            	 	 	 	 	 	
              0721461

            	 	
              03/FEB/1999

            	 	
              SYNTHESIS
                OF 17-(3-PYRIDYL) STEROIDS

            
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
              MONACO

            	 	
              94927003.7

            	 	
              22/SEP/1994

            	 	 	 	 	 	
              0721461

            	 	
              03/FEB/1999

            	 	
              REMARKS
                : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                corresponding to case 136420 world-wide

            
	
              MONACO

            	 	
              94927003.7

            	 	
              22/SEP/1994

            	 	 	 	 	 	
              0721461

            	 	
              03/FEB/1999

            	 	
              SYNTHESIS
                OF 17-(3-PYRIDYL) STEROIDS

            
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
              MEXICO

            	 	
              9407545

            	 	
              29/SEP/1994

            	 	 	 	 	 	
              195256

            	 	
              09/FEB/2000

            	 	
              REMARKS
                : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                corresponding to case 136420 world-wide

            
	
              MEXICO

            	 	
              9407545

            	 	
              29/SEP/1994

            	 	 	 	 	 	
              195256

            	 	
              09/FEB/2000

            	 	
              SYNTHESIS
                OF 17-(3-PYRIDYL) STEROIDS

            
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
              NETHERLANDS

            	 	
              94927003.7

            	 	
              22/SEP/1994

            	 	
              0721461

            	 	
              17/JUL/1996

            	 	
              0721461

            	 	
              03/FEB/1999

            	 	
              REMARKS
                : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                corresponding to case 136420 world-wide

            
	
              NETHERLANDS

            	 	
              94927003.7

            	 	
              22/SEP/1994

            	 	
              0721461

            	 	
              17/JUL/1996

            	 	
              0721461

            	 	
              03/FEB/1999

            	 	
              SYNTHESIS
                OF 17-(3-PYRIDYL) STEROIDS

            
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
              NEW
                ZEALAND

            	 	
              273367

            	 	
              22/SEP/1994

            	 	 	 	 	 	
              273367

            	 	
              18/NOV/1997

            	 	
              REMARKS
                : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                corresponding to case 136420 world-wide

            
	
              NEW
                ZEALAND

            	 	
              273367

            	 	
              22/SEP/1994

            	 	 	 	 	 	
              273367

            	 	
              18/NOV/1997

            	 	
              SYNTHESIS
                OF 17-(3-PYRIDYL) STEROIDS

            
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
              PORTUGAL

            	 	
              94927003.7

            	 	
              22/SEP/1994

            	 	 	 	 	 	
              0721461

            	 	
              03/FEB/1999

            	 	
              REMARKS
                : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                corresponding to case 136420 world-wide

            
	
              PORTUGAL

            	 	
              94927003.7

            	 	
              22/SEP/1994

            	 	 	 	 	 	
              0721461

            	 	
              03/FEB/1999

            	 	
              SYNTHESIS
                OF 17-(3-PYRIDYL) STEROIDS

            
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
              SWEDEN

            	 	
              94927003.7

            	 	
              22/SEP/1994

            	 	
              0721461

            	 	
              17/JUL/1996

            	 	
              0721461

            	 	
              03/FEB/1999

            	 	
              REMARKS
                : NB. 5618807 [ref. 135279 US2] covering the synthesis of the compounds,
                corresponding to case 136420 world-wide

            
	
              SWEDEN

            	 	
              94927003.7

            	 	
              22/SEP/1994

            	 	
              0721461

            	 	
              17/JUL/1996

            	 	
              0721461

            	 	
              03/FEB/1999

            	 	
              SYNTHESIS
                OF 17-(3-PYRIDYL) STEROIDS

            
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
              SINGAPORE

            	 	
              9609266-3

            	 	
              06/APR/1996

            	 	
              0049321

            	 	
              18/MAY/1998

            	 	
              49321

            	 	
              31/DEC/2001

            	 	
              REMARKS
                : TRANSITIONAL APPLICATION BASED ON UK-3 (9419139.2). NB. 5618807
                [ref.
                135279 US2] covering the synthesis of the compounds, corresponding
                to case
                136420 world-wide

            
	
              SINGAPORE

            	 	
              9609266-3

            	 	
              06/APR/1996

            	 	
              0049321

            	 	
              18/MAY/1998

            	 	
              49321

            	 	
              31/DEC/2001

            	 	
              SYNTHESIS
                OF 17-(3-PYRIDYL) STEROIDS

            
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
              PCT

            	 	
              PCT/GB94/02054

            	 	
              22/SEP/1994

            	 	
              WO95/09178

            	 	
              06/APR/1995

            	 	 	 	 	 	
              REMARKS
                : NB. 5618807 [REF. 135279 US2] COVERING THE SYNTHESIS OF THE COMPOUNDS,
                CORRESPONDING TO CASE 136420 WORLD-WIDE

            
	
              PCT

            	 	
              PCT/GB94/02054

            	 	
              22/SEP/1994

            	 	
              WO95/09178

            	 	
              06/APR/1995

            	 	 	 	 	 	
              SYNTHESIS
                OF 17-(3-PYRIDYL) STEROIDS

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      SCHEDULE
        7.2

      DEVELOPMENT
        PLAN

       

      Preliminary
        Clinical Development Plan for Abiraterone Acetate

       

      Key
        Steps
        (and timeline) 

       

      Overall
        Objective 

       

      Cougar’s
        goal is to perform clinical trials of abiraterone acetate that will support
        its
        indication as a second line therapy for patients with metastatic prostate
        cancer
        that has progressed following treatment with hormonal therapy that includes
        an
        LHRH agonist/antagonist and antiandrogen therapy. Cougar’s strategy involves
        obtaining approval of abiraterone initially in the United States, followed
        by
        Europe and other countries. Plan to commence on Effective Date of License
        Agreement.

       

      1.
        Preclinical- optimize manufacturing process, prepare GMP batches of API.
        Time
        required 6 months. Critical Path

       

      2.
        Perform
        toxicology and stability studies. Time required: 12months. Critical
        Path

       

      3.
        Enable
        advisory functions:

       

      a)
        Create
        a clinical advisory team - consisting of experts in hormone refractory prostate
        cancer (HRPC), Endocrinologist, FDA consultant and a statistician, to design
        a
        strategy for approval of Abiraterone as a second line therapy for metastatic
        patients who progress after failure of hormonal therapy ( LHRH Agonists and
        Antiandrogens). Time required: 4 months. Parallel to tasks 1 + 2 

       

      b)
        Assign
        an expert principle investigator who will gather the US historical experience
        with Ketoconazole/Hydrocortisone combination, in addition to the available
        reports. Time required: 3 months.
        Parallel
        to tasks 1 + 2 

       

      c)
        Schedule meeting with Southwest Oncology Group (SWOG) in order to discuss:
        i)
        possible collaboration and ii) access to their ongoing clinical trial data
        of
        Ketoconazole/ Hydrocortisone Vs Chemotherapy in HRPC. Time required: 3 months.
        Parallel to
        tasks 1
        +
        2 

       

      4.
        Prepare Phase I clinical trial protocol- Approximately 18 patients, dose
        escalation trial design (3 per dosage level) in HRPC patients who are
        progressing on combined hormonal therapy. Primary endpoints: safety. Secondary
        endpoints: efficacy as measured by PSA declines >50% and >75%, changes in
        endocrinological markers (testosterone, LH, FSH, cortisol, ACTH). Time required:
        4 months. Parallel to tasks 1
        +
        2 

       

      5.
        Draft
        and submit IND to FDA. Meet with institutional review boards (IRBs) at centers
        that are potential clinical sites for Phase I trial. Time required: 3-6 months.
        Critical Path after task 2.

       

      6.
        Initiate Phase I trial at 3-4 academic sites. Enroll and treat patients.
        Time
        required: 12-15 months. Critical path after task 5.

       

      7a.
        Review Phase I trial results after trial completion. Critical Path after
        task 6.
        Time required 3-6 months

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      b.
        Submit
        data to appropriate medical conference (e.g. ASCO). Prepare manuscript based
        on
        data and submit to appropriate medical journal (e.g. JCO, J Urology). Time
        required: 3-6 months. Parallel to tasks 7a and 8.

       

      8.
        Meet
        with FDA to discuss potential options for further development including:
        1) [ *
        * *] and 2) [ * * *]. Discuss how FDA views our package of the US experience
        with ketoconazole and hydrocortisone combination and discuss how much value
        in
        the historical experience will be accepted. Time required: 3 months. 
        Critical
        Path after task 7a.

       

      If
        development is pursued via a traditional approval
        track

       

      9a.
        Design clinical trial protocol for Phase II study based on discussion with
        FDA
        and our statistician. Assume approximately [ * * * ] patient trial in patients
        with progressive HRPC after treatment with [ * * * ]. Patients should be
        off [ *
        * * ] therapy for at least 2 months (to avoid paradoxical effect of [ * *
        * ]
        withdrawal). Since 90% of such HRPC patients progress within 3-6 months,
        primary
        endpoint of study should be [ * * * ]. Secondary end points of trial should
        be
        PSA declines and quality of life assessment (using to Dr Litwin’s instrument
        published in JAMA). Time required: 6-9 months. Critical path after task 8.
        

       

      9b.
        Ensure capability and capacity for clinical trial supplies (CTS) is prepared.
        Do
        this in parallel with Phase I study task 6.

       

      10.
        Initiate Phase II trial at [ * * * ] academic centers. Enroll and treat
        patients. If interim analysis is built into trial design, perform interim
        analysis of data. Seek a second FDA discussion regarding interim results
        and the
        need for and potential design of a phase III study (or an extended Phase
        II
        design). Time required [ * * * ]. 
        Critical
        Path after task 9a.

       

      11a.
        Review Phase II trial results after trial completion. Time required 3-6 months.
        Critical path after task 10

       

      11b
        Submit data to appropriate medical conference (e.g. ASCO). Prepare manuscript
        based on data and submit to appropriate medical journal (e.g. JCO, J Urology).
        Time required: 3 months in parallel with tasks 11a and 12.

       

      12a.
        Design Phase III randomized study of [ * * * ]. Assume approximately [ *
        * * ]
        patient trial in patients with progressive HRPC after treatment with [ *
        * * ].
        Patients should be off [ * * * ] therapy for at least 2 months (to avoid
        paradoxical effect of [ * * * ] withdrawal). Primary endpoint of study should
        be
        survival. Secondary end points of trial should be time to progression and
        pain
        with clinical and radiographic documentations, PSA declines and quality of
        life
        assessment (using to Dr Litwin’s instrument published in JAMA). Time required:
        6-9 months. Critical path after task 11a.

       

      12b.
        Ensure capability and capacity for CTS is prepared. Do this in parallel with
        Phase II study task 10.

       

      13.
        Initiate Phase III trial at [ * * * ] academic centers. Enroll and treat
        patients. If interim analysis is built into trial design, perform interim
        analysis of data. Time required [ * * * ] months. Critical Path after task
        12a
 

       

      14a.
        Review + analyse Phase III trial results after trial completion. Critical
        path
        after completion of task 13. Time required 6-9 months.

       

      14b
        Compile and submit NDA. Critical path after task 14a . Time required 6-9
        months.


       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      14c
        Submit data to appropriate medical conference (e.g. ASCO). Prepare manuscript
        based on data and submit to appropriate medical journal (e.g. JCO, J Urology).
        In parallel with tasks 14a and b. Time required: 6 months.

       

       

      If
        development is pursued via accelerated approval track

       

      9a.
        Design Phase II/III randomized trial of [ * * * ]. Assume approximately [
        * * *
        ] patient trial in patients with progressive HRPC after treatment with [
        * * *
        ]. Patients should be off [ * * * ] therapy for at least 2 months (to avoid
        paradoxical effect of [ * * * ] withdrawal). Since 90% of such HRPC patients
        progress within 3-6 months, primary endpoint of study should be [ * * * ].
        Secondary end points of trial should be PSA declines and quality of life
        assessment (using to Dr Litwin’s instrument published in JAMA). Time required
        6-9 months. Critical path after task 8. 

       

      9b.
        Ensure capability and capacity for clinical trial supplies (CTS) is prepared.
        Do
        this in parallel with Phase I/II study (task 6). For optimal progress, CTS
        will
        have to be identical to planned marketed product (must avoid latter entering
        critical path). 

       

      10.
        Initiate Phase II/III trial at [ * * * ] academic centers. Enroll and treat
        patients. If interim analysis is built into trial design, perform interim
        analysis of data. Time required [ * * * ] months. 
        Critical
        Path after task 9a.

       

      11a.
        Review Phase II/III trial results after trial completion. Critical Path after
        completion of task 10. Time required 3-6 months.

       

      11b
        Compile NDA - Time required to submit NDA 6-9 months. Critical path after
        task
        11a.

       

      11c.Submit
        data to appropriate medical conference (e.g. ASCO). Prepare manuscript based
        on
        data and submit to appropriate medical journal (e.g. JCO, J Urology). Not
        on
        critical path, in parallel with tasks 11a and 11b. Additional time required:
        6
        months.