ex101.htm


    Exhibit
      10.1


     

    Confidential
      treatment has been requested for portions of this exhibit. The copy filed
      herewith omits the information subject to the confidentiality request. Omissions
      are designated as [***]. A complete version of this exhibit has been filed
      separately with the Securities and Exchange Commission.

     

     

    


     

     

    DEVELOPMENT
      AND LICENSE AGREEMENT

     

     

    


     

     

    between

     

     

    


     

     

    M
      & P Patent AG, c/o Fundationsanstalt, Heiligkreuz 6, 9490 Vaduz,
      Liechtenstein

     

     

    (the
      "Licensor")

     

     

    


     

     

    and

     

     

    


     

     

    Urigen
      Pharmaceuticals, Inc., 875 Mahler Road, Suite 235, Burlingame, CA
      94010, USA

     

     

    (the
      "Licensee")

     

     

    (each
      a
      "Party" and collectively the
      "Parties")

     

     

    


     

     

    concerning

     

     

    


     

     

    rights
      pertaining to Licensor's product NASOBOL®

     

     

    
      
        
        

      

      
        1

        
          

        

      

      
        
        

      

    

     

     

    INDEX

     

    
      
        	
                1.

              	
                DEFINITIONS

              	
                2

              
	 	 	 
	
                2.

              	
                LICENSE

              	
                2

              
	 	 	 
	
                3.

              	
                DEVELOPMENT

              	
                2

              
	 	 	 
	
                4.

              	
                COMMERCIALIZATION

              	
                2

              
	 	 	 
	
                5.

              	
                PAYMENTS
                  AND ROYALTIES

              	
                2

              
	 	 	 
	
                6.

              	
                REPORTS
                  AND RECORDS

              	
                2

              
	 	 	 
	
                7.

              	
                PATENT
                  AND TRADEMARK REGISTRATION AND MAINTENANCE

              	
                2

              
	 	 	 
	
                8.

              	
                INFRINGEMENT,
                  VALIDITY CHALLENGES AND THIRD PARTY RIGHTS

              	
                2

              
	 	 	 
	
                9.

              	
                INDEMNIFICATION

              	
                2

              
	 	 	 
	
                10.

              	
                WARRANTIES,
                  LIABILITY AND DISCLAIMER

              	
                2

              
	 	 	 
	
                11.

              	
                TERM
                  AND TERMINATION

              	
                2

              
	 	 	 
	
                12.

              	
                MISCELLANEOUS

              	
                2

              
	 	 	 
	
                13.

              	
                GOVERNING
                  LAW AND DISPUTE RESOLUTION

              	
                2

              


      

    

     

     

     

     

    
      
        
        

      

      
        2

        
          

        

      

      
        
        

      

    

     

     

     

     

    PREAMBLE

     

    Licensor
      is established as a company limited by shares in accordance with the laws of
      Liechtenstein.

     

    Licensor
      holds patents, trade marks and other intellectual property rights pertaining
      to
      an intranasal testosterone product (including the device for its administration)
      in development for the treatment of male hypogonadism.

     

    Licensee
      is a stock corporation established in accordance with the laws of Delaware
      and
      listed on the OTCBB under the stock symbol URGP. Licensee has an authorized
      capital stock of two hundred million (200,000,000) shares of which one hundred
      ninety million (190,000,000) shares of a nominal value of zero point zero zero
      one United States Dollars (USD 0.001) each are common shares and ten
      million (10,000,000) shares of a nominal value of zero point zero zero one
      United States Dollars (USD 0.001) each are preferred shares. As of the date
      hereof, Licensee has sixty eight million two hundred eighty-nine thousand five
      hundred thirty-five (68,289,535) common shares and two hundred ten (210)
      preferred shares series B issued and outstanding.

     

    Licensee
      specializes in the design and implementation of medicinal products for patients
      with urological ailments.

     

    Licensee
      desires to obtain from Licensor, and Licensor is willing to grant Licensee,
      the
      right to develop the Product in cooperation with Licensor and to commercialize
      it on an exclusive basis.

     

    Therefore,
      the Parties have come to the following agreement:

     

    
      	
              1.  

            	
              DEFINITIONS

            


    

     

    Terms
      used in this Agreement, unless otherwise specified, shall have the following
      meanings:

     

     

    
      	
               

            	
              Affiliate

            	
              Any
                corporation or other legal entity controlling, controlled by or under
                common control with the respective legal entity, whereby the term
                "control" shall mean direct or indirect ownership of at least fifty
                percent (50%) of the voting securities having the right to elect
                directors.

            


    

     

    
      	
               

            	
              Agreement

            	
              This
                agreement together with the
                Annexes.

            


    

     

    
      	
               

            	
              Annex

            	
              Any
                annex to this Agreement.

            


    

     

    
      	
               

            	
              Claims

            	
              The
                Claims according to
                Section 9.1.

            


    

     

     

    
      
        
        

      

      
        3

        
          

        

      

      
        
        

      

    

     

     

    
      	
               

            	
              Commercial
                Sale

            	
              Any
                Transfer of the Product by Licensee, an Affiliate or Distributor
                to a
                Third Party following regulatory approval of said Product in the
                country
                where such Transfer took place.

            


    

     

    
      	
            	
              Commercially Reasonable
                Efforts

            	
              Those
                efforts employed by the Parties, equivalent to that level of attention
                and
                care that they devote to their other businesses and products of similar
                commercial potential and at a similar stage of progress of
                development.

            


    

     

    
      	
               

            	
              Confidential
                Information

            	
              With
                respect to a Party, all information (and all tangible and intangible
                embodiments thereof), which is owned or controlled by such Party,
                is
                disclosed by such Party to the other Party pursuant to this Agreement
                and
                which a reasonable party would consider as confidential. Notwithstanding
                the foregoing, Confidential Information of a Party shall not include
                information which, and only to the extent, the receiving Party can
                establish by written documentation (i) has been generally known prior
                to
                disclosure of such information by the disclosing Party to the receiving
                Party, (ii) has become generally known, without the fault of the
                receiving
                Party, subsequent to disclosure of such information by the disclosing
                Party to the receiving Party, (iii) has been received by the receiving
                Party at any time from a source, other than the disclosing Party,
                rightfully having possession of and the right to disclose such information
                free of confidentiality obligations, (iv) has been otherwise known
                by the
                receiving Party free of confidentiality obligations prior to disclosure
                of
                such information by the disclosing Party to the receiving Party,
                (v) is
                independently developed without reference to the Confidential Information
                of the disclosing Party or (vi) is required to be disclosed by the
                receiving Party by applicable law or court
                order.

            


    

     

    
      	
               

            	
              Development
                Plan

            	
              The
                Development Plan attached hereto as
                Annex 1.

            


    

     

     

     

    
      
        
        

      

      
        4

        
          

        

      

      
        
        

      

    

     

     

    
      	
               

            	
              Distributor(s)

            	
              Any
                Third Party who buys Products from Licensee or its Affiliates for
                Transfer, including Exclusive and Non-Exclusive
                Distributor(s).

            


    

     

    
      	
               

            	
              Effective
                Date

            	
              The
                date when both Parties have signed this
                Agreement.

            


    

     

    
      	
               

            	
              Exclusive
                Distributor(s)

            	
              Any
                Distributor who has been granted any exclusivity (e.g. sole-exclusive,
                semi-exclusive or co-exclusive) to sell the Product with respect
                to one or
                several countries in the License
                Territory.

            


    

     

    
      	
               

            	
              FDA

            	
              The
                United States Food and Drug
                Administration.

            


    

     

    
      	
               

            	
              FDA
                Approval

            	
              The
                formal and final approval of the NDA by
                FDA.

            


    

     

    
      	
               

            	
              Gross
                Sales

            	
              Gross
                amount invoiced by:

            


    

     

    
      	
              (i)  

            	
              Licensee
                or its Affiliates for Transfer of Product(s), including Transfer
                to
                Non-Exclusive Distributors, but excluding Transfer to Exclusive
                Distributors; and

            


    

     

    
      	
              (ii)  

            	
              the
                Exclusive Distributors or their Affiliates for Transfer of
                Product(s).

            


    

     

    In
      the
      case of a transfer of the Product between Licensee or an Exclusive Distributor,
      respectively, and any of its Affiliate(s), Gross Sales shall be based on the
      further Transfer of such Product by such transferee.

     

    
      	
               

            	
              Holopack

            	
              HOLOPACK
                Verpackungstechnik GmbH, Bahnhofstrasse 20, D-73453
                Abtsgmünd-Untergröningen.

            


    

     

    
      	
               

            	
              Improvements

            	
              Any
                and all developments, inventions or discoveries of the Product in
                the
                License Field made by Licensor or its Affiliates, at any time during
                the
                term of this Agreement and shall include, but not be limited to,
                developments intended to enhance the safety and/or efficacy of the
                Product.

            


    

     

     

    
      
        
        

      

      
        5

        
          

        

      

      
        
        

      

    

     

     

    
      	
               

            	
              IND

            	
              The
                investigational new drug application, as defined in the United States
                Federal Food, Drug and Cosmetic Act, filed by Licensor for the Product
                with the FDA (ref. no. 70,512), and any amendments or supplement
                thereto.

            


    

     

    
      	
               

            	
              Initial
                Milestone Payment

            	
              The
                Initial Milestone Payment according to
                Section 5.1(ii).

            


    

     

    
      	
            	
              Joint
                Development Steering Committee

            	
               The
                Joint Development Steering Committee according to
                Section 3.5.

            


    

     

    
      	
               

            	
              Joint
                Marketing Committee

            	
              The
                Joint Marketing Committee according to
                Section 4.3.

            


    

     

    
      	
               

            	
              Joint
                Patent

            	
              A
                Joint Patent according to
                Section 7.6.

            


    

     

    
      	
               

            	
              Know-How

            	
              Preclinical
                data which are in Licensor's possession or control and required for
                Licensee to conduct the clinical trials and other development activities
                as provided by the Development
                Plan.

            


    

     

    
      	
               

            	
              Licensee
                Indemnitee

            	
              A
                Licensee Indemnitee according to Section
                9.2.

            


    

     

    
      	
               

            	
              License
                Field

            	
              Nasal
                delivery of testosterone to males (excluding
                females).

            


    

     

    
      	
               

            	
              License
                Territory

            	
              World-wide.

            


    

     

    
      	
               

            	
              Licensor
                Indemnitee

            	
              A
                Licensor Indemnitee according to Section
                9.1.

            


    

     

    
      	
               

            	
              Marketing
                Authorization(s)

            	
              With
                respect to a country within the License Territory, the regulatory
                and
                other authorizations required to market and sell the Product in such
                country.

            


    

     

    
      	
               

            	
              NDA

            	
              A
                new drug application, as defined in the United States Federal Food,
                Drug
                and Cosmetic Act, which covers the Product for the treatment of
                hypogonadism.

            


    

     

    
      	
               

            	
              Net
                Sales

            	
              Gross
                Sales of the Product less applicable Sales Returns and Allowances.
                Net
                Sales and its components shall be determined in accordance with US
                GAAP,
                consistently applied.

            


    

     

     

    
      
        
        

      

      
        6

        
          

        

      

      
        
        

      

    

     

     

    
      	
               

            	
              Non-Exclusive
                Distributor(s)

            	
              Any
                Distributor who is not an Exclusive
                Distributor.

            


    

     

    
      	
               

            	
              Party

            	
              Each
                party to this Agreement.

            


    

     

    
      	
               

            	
              Patent
                Right(s)

            	
              Any
                right in or deriving from the patents and patent applications or
                the
                equivalent of such patents or applications including but not limited
                to
                any division, continuation, continuation-in-part (CIP), including
                any
                foreign patent application or letters patent or the equivalent thereof,
                issuing thereon or reissue, re-examination or extension thereof,
                which
                claim the priority of or claim substantially the same subject matter
                as
                disclosed in the patents and patent applications listed in Annex
                2.

            


    

     

    
      	
               

            	
              Product(s)

            	
              Licensor's
                intranasal testosterone product, referred to as NASOBOL®
                and
                identified by Licensor's product ref. no. 291007, composed of (i)
                Licensor's proprietary device 3319F-B03B60 specified in Annex 3
                filled with (ii) Licensor's proprietary testosterone-preparation
                ref. no.
                291007 specified in Annex 4, and any Improvements thereto. For the
                sake of clarity, the term "Product" always means the combination
                product
                of Licensor's device and Licensor's testosterone preparation and
                not each
                of these components separately.

            


    

     

    
      	
               

            	
              Reporting
                Period

            	
              Each
                three (3) month period ending March 31, June 30,
                September 30 and December 31 in each calendar
                year.

            


    

     

    
      	
               

            	
              Reports

            	
              The
                Reports according to
                Section 6.3.

            


    

     

    
      	
               

            	
              Revenue-Independent
                Fees

            	
              Any
                payments from a Distributor to Licensee which are (i) attributable
                to the
                Product or any right granted in connection with the Product and (ii)
                not
                identified as Gross Sales; provided that such payments have actually
                been
                received by Licensee.

            


    

     

     

    
      
        
        

      

      
        7

        
          

        

      

      
        
        

      

    

     

     

    
      	
               

            	
              Royalties

            	
              The
                Royalties according to
                Section 5.2.

            


    

     

    
      	
               

            	
              Royalty
                Ceiling

            	
              The
                Royalty Ceiling according to
                Section 5.4.

            


    

     

    
      	
               

            	
              Royalty
                Period

            	
              With
                respect to (i) the first Royalty Period, the period beginning on the
                date of the first Marketing Authorization and ending at the end of
                the
                Reporting Period in effect twelve (12) months thereafter and
                (ii) each subsequent Royalty Period, the twelve (12) month period
                beginning on the day following the end of the first Royalty Period
                and
                each succeeding twelve (12) month period
                thereafter.

            


    

     

    
      	
               

            	
              Sales
                Returns and Allowances

            	
              Sum
                of (a) and (b), where (a) is a provision, determined by Licensee
                or an
                Exclusive Distributor, respectively, under US GAAP for Transfer of
                the
                Product in the License Territory for (i) trade, cash and quantity
                discounts on the Product (other than price discounts granted at the
                time
                of invoicing and which are already included in the determination
                of Gross
                Sales), (ii) credits or allowances given or made for rejection or
                return
                of previously sold Products or for rebates or retroactive price reductions
                (including rebates and chargebacks based upon statutory or governmental
                regulations), (iii) taxes, duties or other governmental charges levied
                on
                or measured by the billing amount for the Product, as adjusted for
                rebates
                and refunds (excluding income and franchise taxes), (iv) charges
                for
                freight and insurance directly related to the distribution of the
                Product,
                to the extent included in Gross Sales, and (v) credits for allowances
                given or made for wastage replacement, promotional samples, indigent
                patient and any other sales programs for the Product to the extent
                the
                sale of the Product was included in Gross Sales and the credit is
                applied
                against such Gross Sales and (b) is a periodic adjustment of the
                provision
                determined in (a) to reflect amounts actually incurred by Licensee
                or an
                Exclusive Distributor, respectively, in the License Territory for
                items
                (i), (ii), (iii), (iv) and (v) in clause (a) in a calendar
                year.

            


    

     

     

    
      
        
        

      

      
        8

        
          

        

      

      
        
        

      

    

     

    
      	
               

            	
              Section

            	
              Any
                section of this Agreement.

            


    

     

    
      	
               

            	
              Sublicensee(s)

            	
              Holopack
                and/or any other contract manufacturer determined in accordance with
                the
                terms and conditions of this Agreement which is granted a sublicense
                by
                Licensee to manufacture the Product for Licensee in accordance with
                the
                terms and conditions of this
                Agreement.

            


    

     

    
      	
               

            	
              Third
                Party

            	
              Any
                entity other than Licensor, Licensee, or their
                Affiliates.

            


    

     

    
      	
               

            	
              Trademark(s)

            	
              Licensor's
                trademark NASOBOL®
                or any other
                trademark that is both (a) determined by the Joint Marketing Committee
                and
                (b) registered and owned by
                Licensor.

            


    

     

    
      	
               

            	
              Transfer

            	
              Any
                sale, for value in the form of cash or otherwise, of the Product
                to a
                Third Party.

            


    

     

    
      	
               

            	
              USA

            	
              The
                United States of America.

            


    

     

    
      	
               

            	
              US
                GAAP

            	
              United
                States Generally Accepted Accounting Principles, consistently
                applied.

            


    

     

    
      	
               

            	
              Valid
                Claim

            	
              A
                claim of an unexpired, issued patent included in the Patent Rights
                that
                has not been held to be invalid by a final judgment of a court of
                competent jurisdiction or decision of a governmental agency from
                which no
                appeal can be taken.

            


    

     

    
      	
              2.  

            	
              LICENSE

            


    

     

    
      	
              2.1  

            	
              Grant
                of License

            


    

     

    
      	
              (i)  

            	
              Subject
                to the terms and conditions set forth by this Agreement, Licensor
                hereby
                grants to Licensee in the License Field in the License Territory
                an
                exclusive and royalty-bearing license to any and all of the Patent
                Rights,
                Know-How and Trademarks to:

            


    

     

    
      	
              (a)  

            	
              develop
                the Product in accordance with the Development
                Plan;

            


    

     

     

    
      
        
        

      

      
        9

        
          

        

      

      
        
        

      

    

     

     

    
      	
              (b)  

            	
              manufacture
                and have manufactured the Product by Sublicensee(s);
                and

            


    

     

    
      	
              (c)  

            	
              commercialize
                and sell the Product.

            


    

     

    
      	
              (ii)  

            	
              Unless
                stated otherwise by this Agreement, the exclusivity granted by Licensor
                to
                Licensee in Section 2.1(i) shall be effective also with regard to
                Licensor and its Affiliates.

            


    

     

    
      	
              (iii)  

            	
              The
                license grant pursuant to Section 2.1(i) shall include the grant of
                said license to any Affiliate of Licensee, provided that such Affiliate
                shall assume the same obligations as those of Licensee and be subject
                to
                the same terms and conditions hereunder and further provided that
                Licensee, jointly with said Affiliate, shall be responsible to Licensor
                for the proper performance by said Affiliate of any and all terms
                and
                conditions and obligations set forth by this
                Agreement.

            


    

     

    
      	
              (iv)  

            	
              The
                license grant pursuant to Section 2.1(i) shall include Licensee's
                right to sell the Products to Distributors; provided, however, that
                so
                long as the Royalty Ceiling is not achieved in accordance with
                Section 5.4 or 11.5 (a) any Exclusive Distributors are
                determined by the Joint Marketing Committee and (b) the agreement
                between Licensee and the respective Distributor is (aa) made in
                writing, (bb) is concluded at arms-length conditions,
                (cc) requires the Distributor to sell the Product under the
                Trademark(s), (dd) requires the Distributor to deliver to Licensee
                commercial sales reports with respect to the Product at the end of
                each
                Reporting Period, (ee) is consistent with the terms of this Agreement
                and (ff) incorporates terms and conditions sufficient to enable
                Licensee to comply with this Agreement. Licensee may not delegate
                to any
                Distributor its responsibility to file and maintain the applications
                for
                Marketing Authorizations pursuant to the terms and conditions of
                this
                Agreement unless (a) the Joint Marketing Committee approves such
                delegation and (b) Licensee procures by written agreement that such
                delegee holds any Marketing Authorization only on a trust basis,
                i.e., in
                the name and on behalf of Licensee. Licensee shall, promptly upon
                execution thereof, submit to Licensor a copy of any agreement entered
                into
                with any Distributor. Upon termination of this Agreement for any
                reason,
                any agreements with any Distributor shall be addressed in accordance
                with
                Section 11.7.

            


    

     

    
      	
              (v)  

            	
              So
                long as the Royalty Ceiling is not achieved in accordance with
                Section 5.4 or 11.5, the license grant pursuant to
                Section 2.1(i) shall exclude Licensee's right to make any
                modifications or alterations of the Product without the prior approval
                of
                the Joint Development Steering
                Committee.

            


    

     

    
      	
              (vi)  

            	
              Subject
                to this Section 2 and so long as the Royalty Ceiling is not achieved
                in accordance with Section 5.4 or 11.5, the license grant pursuant to
                Section 2.1(i) shall exclude Licensee's right to grant sublicenses of
                the rights under
                Section 2.1(i).

            


    

     

     

    
      	
              2.2  

            	
              Sublicenses.
                The Parties agree that the Product shall be manufactured by Holopack
                and/or any other Sublicense(s) determined by the Joint Marketing
                Committee. Licensee shall use Commercially Reasonable Efforts to
                enter
                into respective agreement(s) with such Sublicensee(s) and Licensor
                shall
                use Commercially Reasonable Efforts to support Licensee in entering
                into
                such agreement(s).

            


    

     

     

     

    
      
        
        

      

      
        10

        
          

        

      

      
        
        

      

    

     

     

    
      	
              3.  

            	
              DEVELOPMENT

            


    

     

    
      	
              3.1  

            	
              Development
                Plan. The Product shall be developed in accordance with the
                Development Plan attached hereto as Annex
                1.

            


    

     

    
      	
              3.2  

            	
              Licensor's
                Responsibilities. Licensor shall have the following
                responsibilities in connection with the development of the
                Product:

            


    

     

    
      	
              (i)  

            	
              make
                Commercially Reasonable Efforts to assist and support Licensee in
                conducting the development work under the Development
                Plan;

            


    

     

    
      	
              (ii)  

            	
              make
                accessible to Licensee within thirty (30) days after payment of the
                Initial Milestone Payment the Know-How in a form reasonably usable
                by
                Licensee;

            


    

     

    
      	
              (iii)  

            	
              authorize
                Licensee, including without limitation by providing the required
                declarations and powers of attorney, as the case may be, to use the
                IND to
                conduct the development work under the Development Plan;
                and

            


    

     

    
      	
              (iv)  

            	
              transfer
                the IND to Licensee upon receipt of the Initial Payment and (a) Urigen
                issues a purchase order for the validation study, phase II PK study
                and
                the safety study listed in Annex 1 or (b) pays the costs incurred
                by the
                Licensor in with accordance Section
                3.6(ii)..

            


    

     

    
      	
              3.3  

            	
              Licensee's
                Responsibilities. Licensee shall have the following
                responsibilities in connection with the development of the
                Product:

            


    

     

    
      	
              (i)  

            	
              make
                Commercially Reasonable Efforts to perform the development work provided
                by the Development Plan, including, without limitation, to conduct
                all
                clinical trials required for the filing of the
                NDA;

            


    

     

     

    
      	
              (ii)  

            	
              make
                Commercially Reasonable Efforts to get any and all information and
                data
                relating to the Product which are required to get Marketing Authorizations
                others than the FDA Approval;

            


    

     

     

    
      	
              (iii)  

            	
              keep
                Licensor informed about the activities under the Development Plan
                and make
                Licensee accessible any and all results derived from the work under
                the
                Development Plan;

            


    

     

     

    
      	
              (iv)  

            	
              copy
                Licensor on all correspondence with regulatory authorities and invite
                the
                Licensor members of the Joint Development Steering Committee to attend
                the
                meetings with such regulatory authorities;
                and

            


    

     

     

    
      	
              (v)  

            	
              subject
                to the approval of the Joint Development Steering Committee pursuant
                to
                Section 3.5(iii)(f), refrain from using (a) the Product, (b) the
                Know-How and (c) any Product-related data generated under this Agreement
                for any activity other than the activities foreseen by the Development
                Plan.

            


    

     

     

    
      
        
        

      

      
        11

        
          

        

      

      
        
        

      

    

     

     

    
      	
              3.4  

            	
              Development
                Work Prior to Initial Milestone Payment. Notwithstanding anything
                to the contrary in this Section 3, Licensor shall have final decision
                authority on and be responsible for any development work in relation
                to
                the Product conducted in accordance with the Development Plan and
                performed prior to the payment of the Initial Milestone Payment.
                With
                respect to costs incurred by Licensor in connection with such development
                work, Section 3.6(ii) applies.

            


    

     

    
      	
              3.5  

            	
              Joint
                Development Steering Committee. Licensor and Licensee shall
                establish a joint committee to coordinate and oversee the execution
                of the
                Development Plan.

            


    

     

    
      	
              (i)  

            	
              Members.
                The Joint Development Steering Committee shall consist of four (4)
                members, two (2) members from each Party. Licensee shall designate
                one (1)
                of its members as chairperson of the Joint Development Steering
                Committee.

            


    

     

    
      	
              (ii)  

            	
              Responsibilities
                of the Chairperson. The chairperson of the Joint Development
                Steering Committee shall:

            


    

     

    
      	
              (a)  

            	
              call
                meetings of the Joint Development Steering
                Committee;

            


    

     

    
      	
              (b)  

            	
              establish
                the agenda for each meeting of the Joint Development Steering Committee;
                and

            


    

     

    
      	
              (c)  

            	
              inform
                the members on progress made on the development of the Product upon
                request of any member and at each meeting of the Joint Development
                Steering Committee.

            


    

     

    
      	
              (iii)  

            	
              Responsibilities.
                The Joint Development Steering Committee
                shall:

            


    

     

    
      	
              (a)  

            	
              review
                and oversee the development of the Product as provided by the Development
                Plan;

            


    

     

    
      	
              (b)  

            	
              plan,
                schedule, review and evaluate the clinical trials as provided by
                the
                Development Plan;

            


    

     

    
      	
              (c)  

            	
              decide
                on any amendment or alteration of the Development
                Plan;

            


    

     

    
      	
              (d)  

            	
              approve
                any extension of the period for the filing of the
                NDA;

            


    

     

    
      	
              (e)  

            	
              decide
                on any modifications or alterations of the
                Product;

            


    

     

    
      	
              (f)  

            	
              approve
                uses of the Product, the Know-How and the Product-related data generated
                in connection with the development of the Product in accordance with
                the
                Development Plan for any activity other than the activities foreseen
                by
                the Development Plan; and

            


    

     

    
      	
              (g)  

            	
              decide
                on any other subject matter within the scope of the Development
                Plan.

            


    

     

     

    
      
        
        

      

      
        12

        
          

        

      

      
        
        

      

    

     

     

    
      	
              (iv)  

            	
              Meetings.
                The Joint Development Steering Committee shall meet on an as needed
                basis
                on such dates and at such times as the Parties shall agree; provided,
                however, that Licensor shall have the right to request up to two
                such
                meetings in every calendar year. The meetings shall alternate between
                the
                offices of the Parties unless the Parties otherwise
                agree.

            


    

     

    
      	
              (v)  

            	
              Decisions.
                All decisions of the Joint Development Steering Committee on matters
                pursuant to Section 3.5(iii) shall be made unanimously by the members
                (or their designees) present at any meeting. Such decisions shall
                require
                at least one (1) member of each Party being present at such meeting.
                However, with respect to development matters in dispute between the
                Parties which are (a) not referred to in Section 3.5(iii) and
                (b) outside the scope of the Development Plan, Licensee shall have
                final decision authority after due consultation with
                Licensor.

            


    

     

    
      	
              (vi)  

            	
              Expenses.
                Licensee shall be responsible for all travel (business class or
                equivalent) and related costs and expenses for all members, designees
                and
                invitees to attend meetings of, and otherwise participate on, the
                Joint
                Development Steering Committee.

            


    

     

    
      	
              3.6  

            	
              Costs

            


    

     

    
      	
              (i)  

            	
              Costs.
                Licensee shall fund the work to be performed pursuant to the Development
                Plan as provided thereby and bear all costs in connection with the
                execution of the Development Plan.

            


    

     

    
      	
              (ii)  

            	
              Costs
                Incurred Prior to Initial Milestone Payment. Costs incurred by
                Licensor in connection with the execution of the Development Plan
                prior to
                the payment of the Initial Milestone Payment shall be reimbursed
                by
                Licensee at the time of the payment of the Initial Milestone Payment
                together [***]
                to
                compensate for Licensor's risk.

            


    

     

    
      	
              4.  

            	
              COMMERCIALIZATION

            


    

     

    
      	
              4.1  

            	
              Licensor's
                Responsibilities

            


    

     

    
      	
              (i)  

            	
              Upon
                payment of the Initial Milestone Payment, subject to strict
                confidentiality pursuant to the terms set forth herein, Licensee
                may use
                all equipment listed in Annex 5 hereto free of charge at the
                premises of Holopack. For the avoidance of doubt, Licensee is responsible
                to procure the equipment required for scaling-up the manufacture
                of the
                Product. Licensee's aforementioned right may not impede the development
                and/or production by Licensor of products other than the
                Product.

            


    

    ______________

     

    
      
        	
                 

              	
                [***]CERTAIN
                  INFORMATION ON
                  THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES
                  AND
                  EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
                  WITH
                  RESPECT TO SUCH OMITTED
                  PORTIONS.

              


      

       

    

    
      
        
        

      

      
        13

        
          

        

      

      
        
        

      

    

     

    
      	
              (ii)  

            	
              Licensor
                has no obligation to fulfill production contracts for
                Licensee.

            


    

     

    
      	
              4.2  

            	
              Licensee's
                Responsibilities. Licensee shall have the following
                responsibilities in connection with the commercialization of the
                Product:

            


    

     

    
      	
              (i)  

            	
              file
                the NDA [***];
                however, in the event the FDA requires, instead of the PK study provided
                by the Development Plan, a clinical end point study (i.e., a study
                including primary parameters on efficacy), such period is automatically
                extended [***] and,
                thereafter, such period may only be extended by the Joint Development
                Steering Committee pursuant to Section 3.5(iii)(d), whereby it is
                understood that the grant of such extension is subject to the Joint
                Development Steering Committee's unanimous
                decision;

            


    

     

    
      	
              (ii)  

            	
              file
                and maintain with the European Medicines Agency (EMEA) within
                [***]
                after the filing date of the NDA the application for European Marketing
                Authorization;

            


    

     

    
      	
              (iii)  

            	
              file
                and maintain within [***]
                after the filing date of the NDA all applications for Marketing
                Authorizations in such other countries where Licensee wishes to exercise
                the license rights granted under this
                Agreement;

            


    

     

    
      	
              (iv)  

            	
              manufacture
                and, as the case may be, have manufactured the Product in accordance
                with
                the terms and conditions of this
                Agreement;

            


    

     

    
      	
              (v)  

            	
              sell
                the Product under one or several
                Trademark(s);

            


    

     

    
      	
              (vi)  

            	
              make
                Commercially Reasonable Efforts to perform the required marketing
                activities (such as quarterly plans of action, continuing medical
                education programs, direct-to consumer advertising and public relations
                campaigns in relation to the Product);
                and

            


    

     

    
      	
              (vii)  

            	
              subject
                to the approval of the Joint Marketing Committee pursuant to
                Section 4.3(iii)(e), refrain from using (a) the Product, (b) the
                Know-How, (c) any Product-related data generated in connection with
                the
                development of the Product in accordance with the Development Plan
                and (d)
                any Product-related data generated in connection with the
                commercialization of the Product for any other activity than the
                commercialization of the Product in accordance with the terms and
                conditions of this Agreement.

            


    

    ________________________

    
        
         

      

      
        
          	
                   

                	
                  [***]CERTAIN
                    INFORMATION ON
                    THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES
                    AND
                    EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
                    WITH
                    RESPECT TO SUCH OMITTED
                    PORTIONS.

                


        

      

       

       

    

     

    
      
        
        

      

      
        14

        
          

        

      

      
        
        

      

    

     

    
      	
              4.3  

            	
              Joint
                Marketing Committee. Licensor and Licensee shall establish a
                joint committee to approve, coordinate and oversee the commercialization
                of the Product (the "Joint Marketing
                Committee").

            


    

     

    
      	
              (i)  

            	
              Members.
                The Joint Marketing Committee shall consist of four (4) members,
                two (2)
                members from each Party. Licensee shall designate one (1) of its
                members
                as the chairperson of the Joint Marketing
                Committee.

            


    

     

    
      	
              (ii)  

            	
              Responsibilities
                of the Chairperson. The chairperson of the Joint Marketing
                Committee shall:

            


    

     

    
      	
              (a)  

            	
              call
                meetings of the Joint Marketing
                Committee;

            


    

     

    
      	
              (b)  

            	
              establish
                the agenda for each meeting of the Joint Marketing Committee;
                and

            


    

     

    
      	
              (c)  

            	
              inform
                the members on progress made on the commercialization of the Product
                upon
                request of any member and at each meeting of the Joint Marketing
                Committee.

            


    

     

    
      	
              (iii)  

            	
              Responsibilities.
                The Joint Marketing Committee
                shall:

            


    

     

    
      	
              (a)  

            	
              determine
                the Trademark(s) under which the Product shall be
                sold;

            


    

     

    
      	
              (b)  

            	
              determine
                the Exclusive Distributor(s) pursuant to Section 
                2.1(iv);

            


    

     

    
      	
              (c)  

            	
              approve
                the delegation of Licensee's responsibility to file and maintain
                an
                application for Marketing Authorization to a Distributor pursuant
                to
                Section 2.1(iv);

            


    

     

    
      	
              (d)  

            	
              determine
                the Sublicensee(s) pursuant to Section 2.2;
                and

            


    

     

    
      	
              (e)  

            	
              approve
                uses of the Product, the Know-How, the Product-related data generated
                in
                connection with the development of the Product in accordance with
                the
                Development Plan and the Product-related data generated in connection
                with
                the commercialization of the Product for any activity other than
                the
                commercialization of the Product in accordance with the terms and
                conditions of this Agreement.

            


    

     

    
      	
              (iv)  

            	
              Meetings.
                The Joint Marketing Committee shall meet on an as needed basis on
                such
                dates and at such times as the Parties shall agree; provided, however,
                that Licensor shall have the right to request up to two such meetings
                in
                every calendar year. The meetings shall alternate between the offices
                of
                the Parties unless the Parties otherwise
                agree.

            


    

     

    
      	
              (v)  

            	
              Decisions.
                All decisions of the Joint Marketing Committee, including without
                limitation on matters pursuant to Section 4.3(iii), shall be made
                unanimously by the members (or their designees) present at any meeting.
                Such decisions shall require at least one (1) member of each Party
                being
                present at such meeting. However, with respect to marketing matters
                not
                addressed in Section 4.3(iii) which are in dispute between the
                Parties, Licensee shall have final decision authority after due
                consultation with Licensor.

            


    

     

     

    
      
        
        

      

      
        15

        
          

        

      

      
        
        

      

    

     

    
      	
              (vi)  

            	
              Expenses.
                Licensee shall be responsible for all travel (business class or
                equivalent) and related costs and expenses for all members, designees
                and
                invitees to attend meetings of, and otherwise participate on, the
                Joint
                Marketing Committee.

            


    

     

    
      	
              4.4  

            	
              Marketing
                Authorizations. Subject to Section 11.6(iii), all Marketing
                Authorizations (and applications therefore and rights thereto) for
                the
                Product shall be applied for in the name of, and shall be owned
                exclusively, by Licensee.

            


    

     

    
      	
              4.5  

            	
              Costs.
                Licensee shall bear all costs in connection with the commercialization
                of
                the Product.

            


    

     

    
      	
              5.  

            	
              PAYMENTS
                AND ROYALTIES

            


    

     

    
      	
              5.1  

            	
              Milestone
                Payments. Licensee shall pay Licensor the following
                non-refundable milestone payments to be paid or transferred, respectively,
                only once irrespective of the number of times a milestone has been
                achieved:

            


    

     

    
      	
              (i)  

            	
              [***]of
                restricted common shares of Licensee upon the execution of this Agreement,
                to be transferred within ten (10) working days after the Effective
                Date
                and to be freely disposable by Licensor in accordance with the Securities
                Act of 1933 and Securities and Exchange Commission rules and
                regulations;

            


    

     

    
      	
              (ii)  

            	
              [***];

            


    

     

    
      	
              (iii)  

            	
              [***];
                and

            


    

     

    
      	
              (iv)  

            	
              [***].

            


    

     

    
      	
              5.2  

            	
              Royalty.
                Licensee shall pay Licensor within sixty (60) days after the end
                of each
                Royalty Period the following royalties on the Net Sales of all Products
                which are manufactured or Transferred in any country in the License
                Territory during the respective Royalty Period based on cumulated
                Net
                Sales in such Royalty Period (the
                "Royalties"):

            


    

    _________________

    
      
        	
                 

              	
                [***]CERTAIN
                  INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
                  WITH THE
                  SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS
                  BEEN
                  REQUESTED WITH RESPECT TO SUCH OMITTED
                  PORTIONS.

              


      

       

    

     

     

    
      
        
        

      

      
        16

        
          

        

      

      
        
        

      

    

     

    
      	
              (i)  

            	
              zero
                percent (0%) on the cumulated Net Sales from zero United States Dollars
                (USD 0) to thirty million United States Dollars
                (USD 30,000,000);

            


    

     

    
      	
              (ii)  

            	
              five
                percent (5%) on the cumulated Net Sales from thirty million one United
                States Dollars (USD 30,000,001) to sixty million United States
                Dollars (USD 60,000,000);

            


    

     

    
      	
              (iii)  

            	
              twelve
                percent (12%) on the cumulated Net Sales from sixty million one United
                States Dollars (USD 60,000,001) to one hundred million United States
                Dollars (USD 100,000,000);

            


    

     

    
      	
              (iv)  

            	
              sixteen
                percent (16%) on the cumulated Net Sales from one hundred million
                one
                United States Dollars (USD 100,000,001) to two hundred million United
                States Dollars
                (USD 200,000,000);

            


    

     

    
      	
              (v)  

            	
              twenty
                percent (20%) on the cumulated Net Sales from two hundred million
                one
                United States Dollars (USD 200,000,001) to three hundred million
                United States Dollars (USD 300,000,000);
                and

            


    

     

    
      	
              (vi)  

            	
              twenty-five
                percent (25%) on the cumulated Net Sales above three hundred million
                United States Dollars
                (USD 300,000,00).

            


    

     

    
      	
              5.3  

            	
              Participation
                in Revenue-Independent Fees. In addition to the payments pursuant
                to Section 5.2, Licensee shall pay Licensor within thirty (30) days
                after the end of each Reporting Period twenty-five percent (25%)
                of all
                Revenue-Independent Fees in the respective Reporting
                Period.

            


    

     

    
      	
              5.4  

            	
              Royalty
                Ceiling. Licensee's obligation to pay Royalties shall cease if
                the cumulative Royalties, excluding (i) the milestone payments pursuant
                to
                Section 5.1 and (ii) the participation in Revenue-Independent Fees
                pursuant to Section 5.3 have reached one hundred fifty million United
                States Dollars (USD 150,000,000; the "Royalty
                Ceiling"). Upon achievement of the Royalty Ceiling, the exclusive
                licenses granted to Licensee under Section 2 shall be automatically
                and without further notice deemed fully paid-up, freely assignable
                and
                sublicensable and shall irrevocably be granted until the date on
                which all
                Valid Claims included in the Patent Rights have expired in all countries
                of the License Territory.

            


    

     

    
      	
              5.5  

            	
              Form
                of Payment. All payments due to Licensor under this Agreement
                shall be payable in United States Dollars and shall be transferred
                by wire
                to:

            


    

     

    
      	 	Bank:	 Centrum
              Bank, FL 9490 Vaduz	 	 
	 	Account: 	 072
              1100 A 000 U	 	 
	 	IBAN: 	 LI
              610880-8072-1100-A-000-U	 	 
	 	Address
              of holder: 	 M
              et P Patent AG, FL 9490 Vaduz	 	 


    

                                                                                             

                                            

    
      	
              5.6  

            	
              Overdue
                Payments. The payments due under this Agreement shall, if
                overdue, bear interest beginning on the first day following the Royalty
                Period to which such payment was incurred and until payment thereof
                at a
                per annum rate equal to five percent (5%). Any such overdue payments
                when
                made shall be accompanied by all interest so
                accrued.

            


    

     

     

    
      
        
        

      

      
        17

        
          

        

      

      
        
        

      

    

     

     

    
      	
              5.7  

            	
              Taxes
                and Withholding. Licensor shall pay any and all taxes levied on
                account of all payments it receives under this Agreement. If laws
                or
                regulations require that taxes be withheld, Licensee will (i) deduct
                those
                taxes from the remittable payment (ii) timely pay the taxes to the
                proper
                taxing authority and (iii) send proof of payment to Licensor within
                thirty
                (30) days of receipt of confirmation of payment from the relevant
                taxing authority. Licensee agrees to make all lawful and reasonable
                efforts to minimize such taxes to Licensor. If Licensee is so required
                then Licensor and Licensee shall co-operate in all respects and take
                all
                reasonable steps to lawfully avoid payment of any such withholding
                taxes.
                Licensor shall provide Licensee prior to any payments under this
                Agreement, with all necessary forms or documentation required to
                claim the
                exemption from such withholding
                taxes.

            


    

     

    
      	
              5.8  

            	
              Foreign
                Exchange. The currency for all accounting to be made under this
                Agreement shall be United States Dollars. Except as the Parties otherwise
                mutually agree, the Reports shall be translated into United States
                Dollars
                using the currency exchange rates quoted by Bloomberg, a service
                of
                Bloomberg L.P., or in the event Bloomberg is not available, then
                The Wall
                Street Journal, on the last business day of the applicable calendar
                month
                or calendar quarter, as applicable. Payments shall be made in United
                States Dollars, using the currency exchange rates quoted by Bloomberg,
                a
                service of Bloomberg L.P., or in the event Bloomberg is not available,
                then The Wall Street Journal for the average monthly rate of
                exchange.

            


    

     

    
      	
              6.  

            	
              REPORTS
                AND RECORDS

            


    

     

    
      	
              6.1  

            	
              Progress
                Reports. At the end of each Reporting Period, Licensee shall
                report in writing to Licensor on progress made on research and
                development, status of applications for regulatory approvals,
                manufacturing and sublicensing.

            


    

     

    
      	
              6.2  

            	
              Milestone
                Achievement Notification. Licensee shall report to Licensor the
                dates on which it achieves the milestones set forth in Sections 5.1(iii)
                and 5.1(iv) within ten (10) days of each such
                occurrence.

            


    

     

    
      	
              6.3  

            	
              Commercial
                Sales and Revenue-Independent Fees Reports. Licensee shall
                deliver reports to Licensor within ten (10) days after the end of
                each
                Reporting Period (the "Reports"). Each report shall
                contain:

            


    

     

    
      	
              (i)  

            	
              Net
                Sales for the applicable Reporting Period in each
                territory;

            


    

     

    
      	
              (ii)  

            	
              amount
                of all Revenue-Independent Fees for the applicable Reporting
                Period;

            


    

     

    
      	
              (iii)  

            	
              total
                Royalties payable on Net Sales in United States Dollars;
                and

            


    

     

    
      	
              (iv)  

            	
              total
                participation of Licensor in the Revenue-Independent Fees in United
                States
                Dollars.

            


    

     

     

    
      
        
        

      

      
        18

        
          

        

      

      
        
        

      

    

    If
      no
      amounts are due to Licensor for any Reporting Period, the report shall so
      state.

     

    
      	
              6.4  

            	
              Records
                Retention; Audit

            


    

     

    
      	
              (i)  

            	
              Records.
                Commencing as of the date of the first Commercial Sale, Licensee
                shall
                keep at Licensee's headquarters for at least three (3) years from
                the end
                of the Royalty Period to which they pertain complete and accurate
                records
                of sales of the Product by Licensee, its Affiliates and the Exclusive
                Distributor(s), in sufficient detail to allow the accuracy of the
                Royalties to be confirmed.

            


    

     

    
      	
              (ii)  

            	
              Audit.
                Subject to the other terms of this Section 6.4(ii), at the request of
                Licensor, upon at least ten (10) business days' prior written notice,
                and
                at its sole expense (except as otherwise provided herein), Licensee
                shall
                permit an independent certified public accountant reasonably selected
                by
                Licensor and reasonably acceptable to Licensee to inspect the relevant
                records required to be maintained by Licensee under Section 6.4(i) at
                the headquarter of the Licensee during regular business hours. At
                Licensor's request, the accountant shall be entitled to audit the
                then-preceding three (3) years of Licensee's records for purposes
                of
                verifying Licensee's calculations of the Royalties, provided that
                no year
                shall be audited more than once. At Licensee's request, the accountant
                shall enter into a confidentiality agreement with both Parties limiting
                the disclosure and use of such information by such accountant to
                authorized representatives of the Parties and the purposes of this
                Section 6.4. Results of any such audit and at a Party's request the
                working papers for such audit shall be made available to both Parties
                and
                such results shall be binding on both Parties. If any such audit
                reveals a
                deficiency in the calculation of Royalties resulting from any underpayment
                by Licensee, Licensee shall promptly pay Licensor the amount remaining
                to
                be paid (plus interest thereon at the rate provided in Section 5.6),
                and if such underpayment is by five percent (5%) or more, Licensee
                shall
                pay the costs and expenses of the audit. If such audit reveals
                overpayments by Licensee in any year, such amounts shall promptly
                be
                refunded by Licensor to Licensee (plus interest thereon at the rate
                provided in Section 5.6).

            


    

     

    
      	
              7.  

            	
              PATENT
                AND TRADEMARK REGISTRATION AND MAINTENANCE; OWNERSHIP AND
                INVENTIONS

            


    

     

    
      	
              7.1  

            	
              Responsibility.
                Licensor shall have the sole responsibility to register and maintain
                the
                registrations of the Patent Rights and
                Trademarks.

            


    

     

    
      	
              7.2  

            	
              Information.
                Licensor shall keep Licensee reasonably informed of all filings and
                payments in connection with the registrations and maintenance of
                the
                Patent Rights and Trademarks.

            


    

     

    
      	
              7.3  

            	
              Costs.
                Licensor shall bear all costs in connection with the registration
                and
                maintenance of the Patent Rights and
                Trademarks.

            


    

     

    
      	
              7.4  

            	
              Ownership.
                Each Party shall remain the sole owner or licensee, as applicable,
                of all
                technology, discoveries, patent applications, patents, trade secrets
                and
                inventions owned or controlled by such Party on the Effective Date
                and
                shall have no rights in or to technology, discoveries, patent
                applications, patents, know-how and inventions owned by the other
                Party
                except as specifically provided by this
                Agreement.

            


    

     

     

    
      
        
        

      

      
        19

        
          

        

      

      
        
        

      

    

     

     

    
      	
              7.5  

            	
              Product-Related
                Inventions. The entire right and title in all technology relating
                to the Product and arising out of work performed by the Parties in
                the
                course of conducting activities pursuant to this Agreement conceived
                by
                employees or others acting on behalf of Licensor, Licensee or their
                Affiliates shall be owned solely by Licensor, subject to Licensee's
                exclusive rights hereunder. Licensee hereby assigns to Licensor without
                further compensation all of Licensee's right with respect to such
                Product-related inventions. To ensure Licensor's ownership of such
                Product-related inventions, Licensee shall promptly disclose each
                such
                Product-related invention to Licensor and, without disclosing the
                same to
                others, communicate to Licensor all available information relating
                to such
                Product-related inventions.

            


    

     

    
      	
              7.6  

            	
              Other
                Inventions. Subject to Section 7.5, the entire right and
                title in all technology out of work performed by the Parties in the
                course
                of conducting activities pursuant to this Agreement (i) conceived
                by
                employees or others acting solely on behalf of Licensor or its Affiliates
                shall be owned solely by Licensor, subject to Licensee's exclusive
                rights
                hereunder (ii) conceived by employees or others acting solely on
                behalf of
                Licensee or its Affiliates shall be owned solely by Licensee, and
                (iii)
                conceived by employees or others acting jointly on behalf of Licensor
                and
                Licensee, or their respective Affiliates, shall be owned solely by
                Licensor, subject to Licensee's exclusive rights hereunder. The Joint
                Development Steering Committee will determine the Party responsible
                for
                prosecuting patent applications relating to jointly owned technology.
                The
                preparation, filing and prosecution of patent application(s) relating
                to
                any jointly owned technology, and the maintenance and prosecution
                of any
                patent(s) resulting there from (a "Joint Patent"), shall
                be performed by counsel mutually acceptable to the Parties and costs
                for
                such preparation, filing, prosecution and maintenance shall be borne
                equally by the Parties. In the event either Party becomes aware of
                any
                actual or threatened infringement in the License Territory of any
                claim of
                a Joint Patent, that Party shall promptly notify the other and shall
                promptly discuss how to proceed in connection with such actual or
                threatened infringement. In the event that only one Party wishes
                to
                participate in such proceeding, it shall have the right to proceed
                alone,
                at its expense, and may retain any recovery; provided, at the request
                and
                expense of the participating Party, the other Party agrees to cooperate
                and join in any proceedings in the event that a Third Party asserts
                that
                the co-owner of such Joint Patent is necessary or indispensable to
                such
                proceedings. Subject to Licensee's exclusive rights hereunder, each
                Party
                shall have the right to practice any jointly owned technology as
                provided
                under applicable law, and with respect thereto, neither Party shall
                have a
                duty to account for revenues or profits earned in respect of the
                uses and
                exploitation of such inventions jointly owned by such Party to the
                other
                joint owner(s).

            


    

     

     

    
      
        
        

      

      
        20

        
          

        

      

      
        
        

      

    

     

    
      	
              8.  

            	
              INFRINGEMENT,
                VALIDITY CHALLENGES AND THIRD PARTY
                RIGHTS

            


    

     

    
      	
              8.1  

            	
              Infringement

            


    

     

    
      	
              (i)  

            	
              Notice
                of Infringement. Each Party shall promptly report in writing to
                the other Party during the term of this Agreement any known or suspected
                infringement of any Patent Right or Trademark in the License Field
                and
                License Territory of which such Party becomes aware, and shall provide
                the
                other Party with all available evidence supporting such infringement
                or
                suspected infringement.

            


    

     

    
      	
              (ii)  

            	
              Infringement
                Action by Licensor. Licensor shall have the sole right (but not
                the obligation), at its own costs and expense, to bring an infringement
                action or file any other appropriate action or claim directly related
                to
                infringement of a Patent Right or Trademark against any Third Party.
                If
                Licensor elects not to bring a suit against an alleged infringer,
                it shall
                inform Licensee and Licensee shall be entitled by Licensor to bring
                such
                infringement action by way of authority at Licensee's costs and expense.
                Licensor shall have the right to participate in and be represented
                in any
                suit under this Section 8.1(ii) by its own counsel at its own costs
                and expense.

            


    

     

    
      	
              (iii)  

            	
              Mutual
                Information. The Parties shall keep each other reasonably
                informed of all material developments in connection with any proceedings
                under this Section 8.1.

            


    

     

    
      	
              8.2  

            	
              Validity
                Challenges

            


    

     

    
      	
              (i)  

            	
              Defense
                by Licensor. Licensor shall, at its own costs and expense, use
                its reasonable efforts to defend the Patent Rights and Trademarks
                against
                validity challenges of Third
                Parties.

            


    

     

    
      	
              (ii)  

            	
              Defense
                by Licensee. In the event Licensor decides not to defend the
                Patent Rights or Trademarks as provided in Section 8.2(i), it shall
                inform Licensee thereof and Licensee shall be entitled by Licensor
                to
                conduct such litigation by way of authority at Licensee's costs and
                expense. Licensor shall have the right to participate in and be
                represented in any proceedings under this Section 8.2(ii) by its own
                counsel at its own costs and
                expense.

            


    

     

    
      	
              (iii)  

            	
              Mutual
                Information. The Parties shall keep each other reasonably
                informed of all material developments in connection with any proceedings
                under this Section 8.2.

            


    

     

    
      	
              8.3  

            	
              Third
                Party Rights

            


    

     

    
      	
              (i)  

            	
              Notice
                of Infringement Allegation. If Licensee is alleged by a Third
                Party to infringe patent rights or trademarks of such Third Party
                based on
                the exploitation of the Patent Rights or Trademarks, Licensee shall
                promptly inform in writing Licensor about such
                allegation.

            


    

     

     

    
      
        
        

      

      
        21

        
          

        

      

      
        
        

      

    

     

    
      	
              (ii)  

            	
              Defense
                by Licensee. Licensee shall make Commercially Reasonable Efforts
                to defend against any assertions pursuant to Section 8.3(i) at its
                own costs and expense. Licensee shall keep Licensor reasonably informed
                of
                all material developments in connection with any suit under this
                Section 8.3(ii). Licensor shall have the right to participate in and
                be represented in any suit under this Section 8.3(ii) by its own
                counsel at its own costs and
                expense.

            


    

     

    
      	
              8.4  

            	
              Conduct
                of Action; Costs. If required under applicable law in order for
                either Party to initiate or maintain a suit under this Section 8, the
                non-initiating Party shall join as a party to the suit, at the initiating
                Party's expense. The non-initiating Party shall offer reasonable
                assistance to the initiating Party in connection therewith at no
                charge to
                the non-initiating Party except for reimbursement of reasonable
                out-of-pocket expenses incurred in rendering such
                assistance.

            


    

     

    
      	
              8.5  

            	
              Recovery.
                Any award paid by a Third Party as the result of such proceedings
                (whether
                by way of settlement or otherwise) shall first be applied to reimbursement
                of the unreimbursed legal fees and expenses incurred by either Party
                and
                then the remainder shall be divided between the Parties as
                follows:

            


    

     

    
      	
              (i)  

            	
              if
                the amount is based on lost profits, (a) Licensee shall receive an
                amount
                equal to the damages the court determines Licensee has suffered as
                a
                result of the infringement less the amount of any Royalties and other
                payments that would have been due to Licensor on Net Sales lost by
                Licensee and any other lost opportunities as a result of the infringement
                and (b) Licensor shall receive an amount equal to the Royalties and
                other
                payments it would have received if such Net Sales had been made and
                such
                other opportunities captured by Licensee;
                and

            


    

     

    
      	
              (ii)  

            	
              awards
                other than those based on lost profits shall inure to the benefit
                of the
                initiating Party.

            


    

     

    
      	
              8.6  

            	
              Losses.
                The non-initiating Party shall not be liable for any losses incurred
                as
                the result of an action for infringement brought against the initiating
                Party as a result of the initiating Party's exercise of any right
                granted
                under this Agreement.

            


    

     

    
      	
              9.  

            	
              INDEMNIFICATION

            


    

     

     

    
      	
              9.1  

            	
              Indemnification
                by Licensee. Subject to Licensee’s indemnification rights under
                Section 9.2, Licensee shall indemnify, defend and hold harmless
                Licensor and its Affiliates and their respective trustees, directors,
                officers, medical and professional staff, employees and agents and
                their
                respective successors, heirs and assigns (each an
                "LicensorIndemnitee") from and against
                any liability, damage, loss or expense (including reasonable attorney's
                fees and expenses of litigation) incurred by or imposed upon the
                Licensor
                Indemnitees or any one of them in connection with any claims, suits,
                actions, demands, proceedings, causes of action or judgments arising
                out
                of (i) any theory of product liability (including, but not limited
                to,
                actions in the form of tort, warranty or strict liability; collectively
                the "Claims") concerning any Product developed, designed,
                tested preclinically or clinically, made, used or sold pursuant to
                any
                right or license granted under this Agreement or (ii) any breach
                of
                Licensee’s representations, warranties, covenants or other obligations
                hereunder or failure to comply with applicable law, except to the
                extent
                that the Claim results from gross negligent act or willful misconduct
                by
                an Licensor Indemnitee.

            


    

     

     

    
      
        
        

      

      
        22

        
          

        

      

      
        
        

      

    

     

     

    
      	
              9.2  

            	
              Indemnification
                by Licensor. Subject to Licensor's indemnification rights under
                Section 9.1, Licensor shall indemnify, defend and hold harmless
                Licensee and its Affiliates and their respective directors, officers,
                employees and agents and their respective successors, heirs and assigns
                (each a "Licensee Indemnitee") from and against any
                liability, damage, loss or expense (including reasonable attorney's
                fees
                and expenses of litigation) incurred by or imposed upon the Licensee
                Indemnitees or any one of them in connection with any Claims arising
                out
                of any breach of Licensor's representations and warranties pursuant
                to
                Sections 10.1, 10.3 and 10.4, except to the extent that the Claim
                results from gross negligent act or willful misconduct by a Licensee
                Indemnitee.

            


    

     

    
      	
              9.3  

            	
              Procedure.
                As applicable, each indemnifying Party agrees, at its own expense,
                to
                provide attorneys reasonably acceptable to the indemnified Party
                to defend
                against any Claim brought or filed against any Licensor or Licensee
                Indemnitee (as the case may be) with respect to the subject of indemnity
                contained herein, whether or not such Claims are rightfully brought.
                With
                respect to any Claim for indemnification under this Section 9, the
                Licensor or Licensee Indemnitees (as the case may be)
                shall:

            


    

     

    
      	
              (i)  

            	
              promptly
                notify the indemnifying Party in writing of any Claim in respect
                of which
                the Licensor or Licensee Indemnitees (as the case may be) intend
                to seek
                such indemnification hereunder;

            


    

     

    
      	
              (ii)  

            	
              provide
                the indemnifying Party sole control of the defense or settlement
                thereof;
                and

            


    

     

    
      	
              (iii)  

            	
              provide
                the indemnifying Party, at the indemnifying Party's request and expense,
                with reasonable assistance and full information with respect
                thereto.

            


    

     

    
      	
              10.  

            	
              WARRANTIES,
                LIABILITY AND DISCLAIMER

            


    

     

    
      	
              10.1  

            	
              General.
                As of the Effective Date, each Party represents to the other Party
                that:

            


    

     

    
      	
              (i)  

            	
              such
                Party is duly organized and validly existing under the laws of the
                state
                of its incorporation and has full corporate power and authority to
                enter
                into this Agreement and to carry out the provisions
                hereof;

            


    

     

    
      	
              (ii)  

            	
              such
                Party is duly authorized to execute and deliver this Agreement and
                to
                perform its obligations hereunder;

            


    

     

    
      	
              (iii)  

            	
              this
                Agreement is a legal and valid obligation binding upon it and is
                enforceable in accordance with its terms. To the best knowledge of
                such
                Party, the execution, delivery and performance of this Agreement
                by such
                Party does not conflict with any agreement, instrument or understanding,
                oral or written, to which it is a party or by which it may be bound,
                nor
                violate any law or regulation of any court, governmental body or
                administrative or other agency having authority over it;
                and

            


    

     

     

    
      
        
        

      

      
        23

        
          

        

      

      
        
        

      

    

     

    
      	
              (iv)  

            	
              there
                are no actions, suits or proceedings pending or, to its knowledge,
                threatened against it or its Affiliates that affect its ability to
                carry
                out its obligations under this
                Agreement.

            


    

     

    
      	
              10.2  

            	
              Restricted
                Shares in Licensee. Licensee represents to Licensor that the
                shares to be transferred to Licensor by Licensee pursuant to
                Section 5.1(i) are subject to the U.S. Federal Securities Act of
                1933. Licensor understands that such shares are characterized as
                "restricted securities" under U.S. federal securities laws inasmuch
                as
                they are being acquired from the Licensor in a transaction not involving
                a
                public offering and that under such laws and applicable regulations
                such
                securities may be resold without registration under the U.S. Federal
                Securities Act of 1933only in certain limited circumstances. Licensor
                agrees to resell such shares only in accordance with the provisions
                of
                Regulation S, pursuant to registration under the U.S. Federal Securities
                Act of 1933, or pursuant to an available exemption from registration,
                and
                agrees not to engage in hedging transactions with regard to such
                securities unless in compliance with the U.S. Federal Securities
                Act of
                1933. Licensor understands that the shares have not been registered
                under
                the Securities Act and will not sell, offer to sell, assign, pledge,
                hypothecate or otherwise transfer any of the Shares unless (i) pursuant
                to
                an effective registration statement under the U.S. Federal Securities
                Act
                of 1933, as amended, (ii) such holder provides Licensee with an opinion
                of
                counsel, in form and substance reasonably acceptable to Licensee,
                to the
                effect that a sale, assignment or transfer of the Shares may be made
                without registration under the U.S. Federal Securities Act of 1933
                and the
                transferee agrees to be bound by the terms and conditions of this
                Agreement, (iii) such holder provides Licensee with reasonable assurances
                (in the form of seller and broker representation letters) that the
                Shares
                can be sold pursuant to Rule 144 promulgated under the U.S. Federal
                Securities Act of 1933, (iv) pursuant to Rule 144(k) promulgated
                under the U.S. Federal Securities Act of 1933 following the applicable
                holding period, or (v) in accordance with the provisions of
                Regulation S. Licensor further understands that, except as provided
                below,
                certificates evidencing the shares may bear the following or any
                similar
                legend: "The
                securities represented hereby may not be transferred unless (i) such
                securities have been registered for sale pursuant to the U.S. Federal
                Securities Act of 1933, as amended, (ii) such securities may be sold
                pursuant to Rule 144(k), (iii) such securities may be sold pursuant
                to
                Regulation S, or (iv) the Company has received an opinion of counsel
                reasonably satisfactory to it that such transfer may lawfully be
                made
                without registration under the U.S. Federal Securities Act of 1933
                or
                qualification under applicable state securities laws. Hedging transactions
                involving the securities represented hereby may not be conducted
                unless in
                compliance with the U.S. Federal Securities Act of
                1933."

            


    

     

    
      	
              10.3  

            	
              Licensor's
                Patent Rights, Trademarks and IND. As of the Effective Date,
                Licensor represents to Licensee that to the best of Licensor's
                knowledge:

            


    

     

     

     

    
      
        
        

      

      
        24

        
          

        

      

      
        
        

      

    

     

    
      	
              (i)  

            	
              Licensor
                is the sole owner of all right, title and interest in and to the
                Patent
                Rights and the Trademarks and that, within the License Field, no
                such
                rights are licensed from a Third
                Party;

            


    

     

    
      	
              (ii)  

            	
              Licensor,
                within the License Field, has not at any time disposed of any Patent
                Rights or Trademarks whether by selling, assignment, license grant
                or
                otherwise and that it has the right to grant the exclusive licenses
                granted to Licensor in this Agreement. Licensor further has not granted
                any license under the Patent Rights or the Trademarks to any Third
                Party
                that would conflict with the licenses granted to Licensee hereunder
                and is
                under no obligation to grant any such
                license;

            


    

     

    
      	
              (iii)  

            	
              no
                patent or patent application included in the Patent Rights is the
                subject
                of any pending reexamination, reissue, interference, opposition,
                cancellation or other protest proceedings or legal disputes. No Trademark
                is the subject of any opposition or cancellation proceedings or other
                protest proceedings or legal
                disputes;

            


    

     

    
      	
              (iv)  

            	
              Licensor
                is the sole owner of the IND, free and clear of all liens, claims
                and
                encumbrances;

            


    

     

    
      	
              (v)  

            	
              no
                outstanding notice, citation, summons or order has been issued, no
                outstanding complaint has been filed, no outstanding penalty has
                been
                assessed and no investigation or review is pending or threatened
                by any
                government authority or other person with respect to any alleged
                violation
                by Licensor related to the Product;
                and

            


    

     

    
      	
              (vi)  

            	
              Licensor
                has paid all user fees and all other fees and payments due as of
                the
                Effective Date necessary in connection with the filing of the
                IND.

            


    

     

    
      	
              10.4  

            	
              No
                Third-Party Infringement. Licensor represents and warrants that
                to its knowledge there are no restrictions or limitations on the
                Licensor's Patent Rights and Trademarks and that there has been,
                by the
                Effective Date, no conflict with, or infringement or threatened or
                likely
                infringement directed to Licensor of any of the Licensor's Patent
                Rights,
                Know-How or Trademarks. Licensor makes no representation or warranty
                that
                the manufacture, use, importation or sale of the Product by Licensee
                or
                its Affiliates, Distributors or Sublicensees or their customers will
                not
                constitute an infringement of the intellectual property rights of
                others.
                Licensor makes no representations, extends no warranties of any kind,
                either express of implied, including but not limited to the implied
                warranties of merchantability or fitness for a particular purpose,
                and
                assumes no responsibility whatever with respect to design, development,
                manufacture, use, sale, importation or other disposition of the Product
                by
                Licensee, its Affiliates, Distributors or Sublicensees to their respective
                customers.

            


    

     

    
      	
              10.5  

            	
              Liability
                Limitation. Notwithstanding anything herein to the contrary, in
                no event shall either Party be liable to the other Party for lost
                profits
                or indirect, incidental, special, consequential or punitive damages
                resulting from this Agreement. For the avoidance of doubt, Licensor
                does
                not assume any liability under this Agreement as to the fitness of
                the
                Product for a particular use or the marketability of the
                Product.

            


    

     

     

    
      
        
        

      

      
        25

        
          

        

      

      
        
        

      

    

     

    
      	
              11.  

            	
              TERM
                AND TERMINATION

            


    

     

    
      	
              11.1  

            	
              Term.
                This Agreement shall enter into force on the Effective Date and shall
                remain in effect, on a country by country basis, until the date on
                which
                all Valid Claims included in the Patent Rights of such country have
                expired, unless this Agreement is terminated earlier in accordance
                with
                this Section 11.

            


    

     

    
      	
              11.2  

            	
              Ordinary
                Termination. Licensee may terminate this Agreement by giving nine
                (9) months' advance notice to
                Licensor.

            


    

     

    
      	
              11.3  

            	
              Termination
                with Immediate Effect. This Agreement may be terminated with
                immediate effect:

            


    

     

    
      	
              (i)  

            	
              by
                Licensor if Licensee fails to perform the Initial Milestone Payment
                when
                due;

            


    

     

    
      	
              (ii)  

            	
              by
                Licensor if Licensee fails to file the NDA pursuant to
                Section 4.2(i);

            


    

     

    
      	
              (iii)  

            	
              by
                Licensor, if the Net Sales of all Products do not reach or
                [***]in
                the second Royalty Period; provided, however, that Licensor refunds
                to
                Licensee the clinical development costs of the Product up to
                [***]
                which Licensee can show by written evidence (a) have been incurred
                by
                Licensee and (b) are directly attributable to the development of
                the
                Product; in the event the FDA requires a clinical end point study
                as
                provided in Section 4.2(i), such [***];

            


    

     

    
      	
              (iv)  

            	
              by
                Licensor if the Net Sales of all Products do not reach or exceed
                [***]in
                the fourth Royalty Period; provided, however, that Licensor refunds
                to
                Licensee the clinical development costs of the Product up to a maximum
                of
                [***]
                which Licensee can show by written evidence (a) have been incurred
                by
                Licensee and (b) are directly attributable to the development of
                the
                Product; in the event the FDA requires a clinical end point study
                as
                provided in Section 4.2(i), such maximum shall be [***];

            


    

     

    
      	
              (v)  

            	
              by
                Licensor if Licensee develops, manufactures or commercializes a product
                which Licensor reasonably considers to substitute the Product in
                any
                country of the License Territory where a Valid Claim
                exists;

            


    

     

     

    
      
        
        

      

      
        26

        
          

        

      

      
        
        

      

    

     

     

    
      	
              (vi)  

            	
              by
                Licensor if Licensee directly or indirectly challenges the validity
                of any
                Patent Right or Trademark;

            


    

     

    
      	
              (vii)  

            	
              subject
                to Licensor's right to immediate termination according to
                Sections 11.3(i) and 11.3(ii), by the non-defaulting Party if the
                other Party defaults in the performance of any of its material obligations
                under this Agreement to an extent that renders continuation of this
                Agreement unacceptable for the non-defaulting Party and if such default
                has not been cured within ninety (90) days after notification of
                the
                defaulting Party; "material obligation" shall include, without limitation,
                Licensee's obligations pursuant to Sections 4.2(ii), 5.1(iii) and
                5.1(iv); and

            


    

     

    
      	
              (viii)  

            	
              by
                Licensor in the event of bankruptcy, receivership, insolvency or
                assignment for the benefit of creditors of
                Licensee.

            


    

     

    
      	
              11.4  

            	
              Partial
                Termination. This Agreement automatically terminates in those
                countries of the License Territory where Licensee has not filed Marketing
                Authorizations within [***]
                after the filing date of the NDA pursuant to Section 4.2(iii). In
                respect
                of the countries concerned by such partial termination, the provisions
                set
                forth in Section 11.6 shall apply
                correspondingly.

            


    

     

    
      	
              11.5  

            	
              Change
                of Licensee's Ownership. If Licensee is acquired by a share or
                asset deal by a Third Party before the Royalty Ceiling has been reached,
                Licensee has the option to (i) pay, at the same time Licensee's
                acquisition is executed, to Licensor the difference between the Royalty
                Ceiling and the cumulative Royalties effectively paid up to that
                time,
                whereupon no further Royalties shall be due, or (ii) terminate this
                Agreement with immediate effect after the execution of Licensee's
                acquisition without any duty of Licensor to compensate for Licensee's
                clinical development costs of the
                Product.

            


    

     

    
      	
              11.6  

            	
              Effects
                of Termination. Upon termination of this
                Agreement in accordance with Section 11.2, 11.3, 11.4 or
                11.5(ii):

            


    

     

    
      	
              (i)  

            	
              Licensee
                shall immediately cease all (a) use of the rights and licenses granted
                under this Agreement and (b) Transfer of the
                Product;

            


    

     

    
      	
              (ii)  

            	
              each
                Party shall immediately return the Confidential Information of the
                other
                Party;

            


    

     

    
      	
              (iii)  

            	
              all
                Marketing Authorizations including, without limitation, any related
                application documents held by Licensee shall immediately be transferred
                to
                Licensor, whereby such transfer shall be arranged for by Licensee
                in due
                time in order that such transfer can be effected by the date the
                termination becomes effective;

            


    

    ____________________

     

    
      
        	
                 

              	
                [***]CERTAIN
                  INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
                  WITH THE
                  SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS
                  BEEN
                  REQUESTED WITH RESPECT TO SUCH OMITTED
                  PORTIONS.

              


      

       

    

     

    
      
        
        

      

      
        27

        
          

        

      

      
        
        

      

    

     

     

    
      	
              (iv)  

            	
              ownership
                of all trademarks and other intellectual property attributable to
                the
                Product and held by Licensee shall immediately be transferred to
                Licensor;

            


    

     

    
      	
              (v)  

            	
              all
                Royalties and other payments accrued or due to Licensor as of the
                termination date shall become immediately payable;
                and

            


    

     

    
      	
              (vi)  

            	
              Licensor
                has the option to acquire Licensee's remaining inventory of the Product
                at
                Licensee's cost price. If Licensor does not exercise such option
                within
                fourteen (14) days after termination of this Agreement, Licensee
                is
                granted a period of six (6) months from the date of termination of
                this
                Agreement during which it may sell its remaining inventory of the
                Product;
                provided, however, that it (a) sells such inventory in a manner
                substantially similar to the manner in which it was selling the Product
                prior to the termination of this Agreement and (b) pays to Licensor
                any
                Royalties accruing on sales of such Product in accordance with Section
                5
                hereof.

            


    

     

    
      	
              11.7  

            	
              Effects
                of Termination on Sublicenses and Distributors. Any sublicenses
                granted by Licensee under this Agreement as well as any agreements
                with
                any Distributors shall provide for termination or assignment to Licensor
                of Licensee's interest therein at the option of Licensor upon termination
                of this Agreement.

            


    

     

    
      	
              11.8  

            	
              Survival.
                Expiration or termination of this Agreement for any reason shall
                neither
                release either Party from any liability which at such time has already
                accrued or which thereafter accrues from a breach or default prior
                to such
                expiration or termination, nor affect in any way the survival of
                any other
                right, duty or obligation of either Party which is expressly stated
                elsewhere in this Agreement to survive such termination.
                Sections 7.5, 7.6, 9, 11.6, 11.7, 12.7 and 13 shall survive
                expiration or termination of this
                Agreement.

            


    

     

    
      	
              12.  

            	
              MISCELLANEOUS

            


    

     

    
      	
              12.1  

            	
              Notices.
                All notices or other communications between the Parties in connection
                with
                this Agreement shall be made in writing and sent by registered mail
                or a
                recognized courier service to the addresses listed on the first page
                of
                this Agreement or such other address as the addressee shall have
                specified
                in a notice actually received by the
                addressor.

            


    

     

     

    
      
        
        

      

      
        28

        
          

        

      

      
        
        

      

    

     

     

    
      	
              12.2  

            	
              Costs,
                Expenses and Taxes. Except as otherwise provided in this
                Agreement, all costs, expenses and taxes incurred in connection with
                this
                Agreement and the transactions contemplated hereby shall be paid
                by the
                Party incurring such costs, expenses and
                taxes.

            


    

     

    
      	
              12.3  

            	
              Entire
                Agreement. This Agreement constitutes the entire agreement
                between the Parties with respect to the subject matter of this Agreement
                and supersedes all other prior written and oral agreements of the
                Parties
                relating thereto.

            


    

     

    
      	
              12.4  

            	
              Amendment;
                Waiver. No provision of this Agreement may be modified, amended
                or waived except by an instrument in writing signed by the Parties.
                No
                failure of a Party to exercise a contractual right or to insist on
                strict
                compliance with this Agreement, and no practice at variance with
                the terms
                of this Agreement shall constitute a waiver of the right to demand
                strict
                compliance and shall not impair the rights with respect to any subsequent
                breach of this Agreement.

            


    

     

    
      	
              12.5  

            	
              Severability.
                If any provision of this Agreement is found invalid or unenforceable,
                the
                remainder of this Agreement remains in full force and effect. The
                invalid
                or unenforceable provision shall be replaced by such valid and enforceable
                provision attaining as nearly as possible the same economic
                effect.

            


    

     

    
      	
              12.6  

            	
              Assignment.
                So long as the Royalty Ceiling is not achieved in accordance with
                Section 5.4 or 11.5, Licensee may not transfer or assign its rights
                and obligations under this Agreement without the prior written consent
                of
                Licensor. Licensor shall not be restricted to assign or transfer
                the
                Patent Rights, the Trademarks, this Agreement or any of its rights
                and
                obligations under this Agreement. The rights and obligations of the
                Parties under this Agreement shall be binding upon and inure to the
                benefit of the successors and permitted assigns of the Parties. Any
                assignment not in accordance with this Agreement shall be
                void.

            


    

     

    
      	
              12.7  

            	
              Confidentiality.
                The Parties shall keep the Confidential Information and the contents
                of
                this Agreement strictly confidential. All public announcements or
                press
                releases issued in connection with the transactions contemplated
                by this
                Agreement shall only be published after the Parties have agreed on
                the
                contents of such public announcements or press
                releases.

            


    

     

    
      	
              12.8  

            	
              Execution.
                This Agreement may be executed in two or more counterparts, all of
                which
                when taken together shall be considered one and the same
                instrument.

            


    

     

    
      	
              12.9  

            	
              Force
                Majeure. Neither Party shall be held liable or responsible to the
                other Party nor be deemed to have defaulted under or breached this
                Agreement for failure or delay in fulfilling or performing any term
                of
                this Agreement when such failure or delay is caused by or results
                from
                causes beyond the control of the affected Party, such as fire, floods,
                embargoes, war, acts of war (whether war be declared or not),
                insurrections, riots, civil commotions, strikes, lockouts or other
                labor
                disturbances or acts of God.

            


    

     

    
      	
              12.10  

            	
              Independent
                Contractors. It is expressly agreed that Licensor and Licensee
                shall be independent contractors and that the relationship between
                the two
                Parties shall not constitute a partnership or agency of any kind.
                Neither
                Licensor nor Licensee shall have the authority to make any statements,
                representations or commitments of any kind, or to take any action,
                which
                shall be binding on the other Party, without the prior written consent
                of
                the other Party.

            


    

     

     

    
      
        
        

      

      
        29

        
          

        

      

      
        
        

      

    

     

     

    
      	
              13.  

            	
              GOVERNING
                LAW AND DISPUTE RESOLUTION

            


    

     

    
      	
              13.1  

            	
              Governing
                Law. This Agreement shall be governed by, and construed in
                accordance with, the laws of Switzerland, without giving effect to
                any
                conflict of law provisions thereof.

            


    

     

    
      	
              13.2  

            	
              Dispute
                Resolution. Any dispute arising out of or in relation to this
                Agreement shall be finally settled under the Rules of Arbitration
                of the
                International Chamber of Commerce. The place of arbitration shall
                be in
                Paris, France, and the arbitration proceedings shall be held in English.
                The arbitration tribunal shall consist of three (3) arbitrators.
                Each
                Party shall nominate in the request for arbitration and the answer
                thereto
                one (1) arbitrator and the two (2) arbitrators so named will then
                jointly
                appoint the third arbitrator as the chairman of the arbitration tribunal.
                If a Party fails to nominate its arbitrator or if the Parties cannot
                agree
                on the person to be named as chairman within sixty (60) days, the
                International Chamber of Commerce in Paris, France, shall make the
                necessary appointment of arbitrator or
                chairman.

            


    

     

     

    


     

     

    [signature
      page follows]

     

     

    


    
      
        
        

      

      
        30

        
          

        

      

      
        
        

      

    

     

     

    
      	 Place
              / date   	 	Place
              / date	 
	 	 	 	 
	November
              20, 2007	 	November
              20, 2007	 
	 	 	 	 
	 M
              & P Patent AG 	 	 Urigen
              Pharmaceuticals, Inc.	 
	 	 	 	 
	/s/
              Udo Mattern	 	/s/ 
              Terry Nida 	 
	Chairman
              and CEO 	 	COO	 
	 	 	 	 


    

                                                                                 

     

     

    
      
        
        

      

      
        31

        
          

        

      

      
        
        

      

    

    


     

     

    Annexes

     

    Annex
      1                      Development
      Plan

     

    Annex
      2                      Patent
      Rights

     

    Annex
      3                      Specification
      of the device 3319F-B03B60

     

    Annex
      4                      Specification
      of the testosterone-preparation ref. no. 291007

     

    Annex
      5                      Licensor's
      equipment

     

     

     

    K:\mandate\118184\license
      agreement\071115 license agreement urigen.doc

     

    
 

    
      
        
        

      

      
        32

        
          

        

      

      
        
        

      

    

     

     

    Annex
      1 - Development Plan

     

     

    [***]

     

     

    Annex
      2 - Patent Rights

     

    
      

        

      

       

        
        
          	
                   

                	
                  [***]CERTAIN
                    INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
                    WITH THE
                    SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS
                    BEEN
                    REQUESTED WITH RESPECT TO SUCH OMITTED
                    PORTIONS.

                


        

      

       

       

      
        
          
          

        

        
          33

          
            

          

        

        
          
          

        

      

       

       

    

    [***]Annex
      3 -
      Specification of the device 3319F-B03B60

     

     

    [***]

     

     

    


     

    

      

    

      
      
         

      

    

    Annex
      4 - Specification of the testosterone-preparation ref. no.
      291007

     

     

    [***]

     

     

    


     

     

    Annex
      5 - Licensor's equipment

     

     

    


     

    
      	
              Amount

            	
              Description

            	
              Specification

            
	
              6
                (six)

            	
              Tank
                for transport and storage of bulk mixture

            	
              250
                litre, stainless steel,

              no.
                GST 250

            
	
              1
                (one)

            	
              Tool
                for BFS filling and packaging

            	
              3
                x
                10 moulds,

              design
                no. 3319F-B03B60

            


    

     

    


     

    

      

    

      
      
        	
                 

              	
                [***]CERTAIN
                  INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
                  WITH THE
                  SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS
                  BEEN
                  REQUESTED WITH RESPECT TO SUCH OMITTED
                  PORTIONS.

              


      

       

      


      34