Document:

Unassociated Document

    Exhibit
      10.10

    

    Portions
      of this exhibit marked [*] are omitted and are requested to be treated
      confidentially.

    

    

    

    NS-187
      LICENSE AGREEMENT

    

    

    

    BETWEEN

    

    NIPPON
      SHINYAKU CO., LTD.

    

    AND

    

    INNOVIVE
      PHARMACEUTICALS, INC.

    

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    

      
        	
                ARTICLE
                  1 DEFINITIONS

              	
                2

              
	 	 
	
                ARTICLE
                  2 GRANT OF LICENSE

              	
                10

              
	 	 
	
                ARTICLE
                  3 DISCLOSURE OF INFORMATION

              	
                12

              
	 	 
	
                ARTICLE
                  4 ADRs REPORTING

              	
                12

              
	 	 
	
                ARTICLE
                  5 UPFRONT, MILESTONE, SUBLICENSE PAYMENTS AND
                  ROYALTIES

              	
                13

              
	 	 
	
                ARTICLE
                  6 MINIMUM SALES REQUIREMENT

              	
                16

              
	 	 
	
                ARTICLE
                  7 REPORTS AND ACCOUNTING

              	
                17

              
	 	 
	
                ARTICLE
                  8 DEVELOPMENT PROGRAM

              	
                20

              
	 	 
	
                ARTICLE
                  9 SECRECY

              	
                22

              
	 	 
	
                ARTICLE
                  10 REPRESENTATIONS

              	
                24

              
	 	 
	
                ARTICLE
                  11 SALES PROMOTION

              	
                29

              
	 	 
	
                ARTICLE
                  12 LIABILITIES

              	
                30

              
	 	 
	
                ARTICLE
                  13 PATENT INFRINGEMENT AND EXTENSION

              	
                31

              
	 	 
	
                ARTICLE
                  14 INFRINGEMENT ACTIONS BY THIRD PARTIES

              	
                33

              
	 	 
	
                ARTICLE
                  15 COMPETITIVE PRODUCT

              	
                34

              
	 	 
	
                ARTICLE
                  16 TRADEMARK

              	
                34

              
	 	 
	
                ARTICLE
                  17 WITHHOLDING TAXES

              	
                34

              
	 	 
	
                ARTICLE
                  18 DEVELOPMENT AND MARKETING OF PRODUCT BY SHINYAKU IN
                  JAPAN

              	
                35

              
	 	 
	
                ARTICLE
                  19 DURATION AND TERMINATION

              	
                36

              
	 	 
	
                ARTICLE
                  20 EFFECT OF TERMINATION

              	
                38

              
	 	 
	
                ARTICLE
                  21 NOTICES

              	
                41

              
	 	 
	
                ARTICLE
                  22 FORCE MAJEURE

              	
                41

              
	 	 
	
                ARTICLE
                  23 ASSIGNMENT

              	
                42

              

      

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

       

      
        	
                ARTICLE
                  24 WAIVER

              	
                42

              
	 	 
	
                ARTICLE
                  25 GOVERNING LAW

              	
                43

              
	 	 
	
                ARTICLE
                  26 DISPUTE RESOLUTION

              	
                43

              
	 	 
	
                ARTICLE
                  27 ENTIRE AGREEMENT

              	
                44

              
	 	 
	
                ARTICLE
                  28 MISCELLANEOUS

              	
                44

              
	 	 
	
                ARTICLE
                  29 COUNTERPARTS

              	
                45

              
	 	 
	
                SCHEDULE
                  1(G) DEVELOPMENT PROGRAM

              	
                47

              
	 	 
	
                SCHEDULE
                  1(X) SHINYAKU PATENT

              	
                48

              
	 	 
	
                SCHEDULE
                  13.3(b) INNOVIVE PATENT COUNTRIES

              	
                50

              

      

    

      SCHEDULE
        1(G) DEVELOPMENT
        PROGRAM

      SCHEDULE
        1(X) SHINYAKU
        PATENT

      SCHEDULE
        13.3(b) INNOVIVE
        PATENT COUNTRIES

    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    LICENSE
      AGREEMENT

    

    

    This
      Agreement is made this 28th day of December, 2005 by and between

    

    NIPPON
      SHINYAKU CO., LTD.

    a
      company organized and existing under the laws of Japan, having its principal
      office and place of business at 14, Nishinosho-Monguchi-cho, Kisshoin,
      Minami-ku, Kyoto 601-8550, Japan (hereinafter referred to as
      "SHINYAKU")

     

    and

     

    INNOVIVE
      PHARMACEUTICALS, INC.

    a
      company organized and existing under the laws of the United States, having
      its
      principal office and place of business at 555 Madison Avenue, 25th
      Floor, New York, NY 10022 (hereinafter referred to as "INNOVIVE").

    

    SHINYAKU
      and INNOVIVE are sometimes herein individually referred to as a “PARTY” and
      collectively as the “PARTIES.”

    

    WITNESSETH
      THAT:

    

    WHEREAS
      (A), SHINYAKU is the proprietor of certain patents and patent applications
      relating to the COMPOUND (hereinafter defined) and possesses technical
      information relating to the aforementioned patents and the development, use
      and
      manufacture of the COMPOUND and the PRODUCT (hereinafter defined) formulated
      therefrom;

    

    WHEREAS
      (B), INNOVIVE wishes to obtain an exclusive license in the TERRITORY
      (hereinafter defined) under the patent and technical information referred to
      in
      Recital (A) above to develop, manufacture and commercialize the PRODUCT
      containing the COMPOUND;

    

    
      
        
        

      

      
        1

        
          

        

      

      
        
        

      

    

    WHEREAS
      (C), SHINYAKU represents it has the right to grant such a license and is willing
      to grant to INNOVIVE such a license in the TERRITORY under the terms and
      conditions herein set forth;

    NOW
      THEREFORE, it is hereby agreed as follows:

    

    ARTICLE
      1

    DEFINITIONS

    

    
      	
              1.1

            	
              The
                following terms used in this Agreement shall have the meanings as
                defined
                hereunder:

            

    

    

    
      	 	
              A.

            	
              ADRs
                herein shall mean (i) any untoward medical occurrence in a patient
                or
                clinical investigation subject administered a pharmaceutical product
                and
                which does not necessarily have a causal relationship to the treatment;
                and (ii) a response to a drug which is noxious and unintended and
                which
                occurs at doses normally used in man for prophylaxis, diagnosis or
                therapy
                of disease or for modifications of physiological
                function.

            

    

    

    
      	 	
              B.

            	
              AFFILIATE
                herein shall mean, with respect to a PERSON (hereinafter defined),
                any
                PERSON that controls, is controlled by or is under common control
                with
                such first PERSON. For purposes of this definition only, “control” means
                (a) to possess, directly or indirectly, the power to direct the management
                or policies of a PERSON, whether through ownership of voting securities,
                by contract relating to voting rights or corporate governance or
                otherwise, or (b) to own, directly or indirectly, fifty percent (50%)
                or
                more of the outstanding voting securities or other ownership interest
                of
                such PERSON.

            

    

    

    
      	 	
              C.

            	
              AGREEMENT
                TERM herein shall have the meaning set forth in Section 19.1
                hereof.

            

    

     

    
      
        
        

      

      
        2

        
          

        

      

      
        
        

      

    

     

    
      	 	
              D.

            	
              COMPETITIVE
                PRODUCT herein shall mean any products directly competing with the
                PRODUCT
                that are small molecule inhibitors of
                BCR-ABL.

            

    

    

     

    
      	 	
              E.

            	
              COMPOUND
                herein shall mean (i) the chemical compound with a chemical
                name of [*], of which code name is designated as NS-187, and/or (ii)
                a
                chemical compound, the manufacture, use or sale of which would infringe
                (but for the license granted to INNOVIVE under this Agreement), or
                would
                be covered by, a VALID CLAIM (hereinafter
                defined).

            

    

    

    
      	 	
              F.

            	
              CONFIDENTIAL
                INFORMATION herein shall mean information and data relating to the
                COMPOUND and/or the PRODUCT including, but not limited to the INNOVIVE
                TECHNICAL INFORMATION (hereinafter defined) and the SHINYAKU TECHNICAL
                INFORMATION (hereinafter defined), and any information which is acquired,
                disclosed, exchanged or generated for the purposes of this Agreement.
                

            

    

    

    
      	 	
              G.

            	
              DEVELOPMENT
                PROGRAM shall mean a development program including the timeline of
                each
                study as set forth in SCHEDULE 1(G), which is attached hereto and
                made a
                part hereof.

            

    

    

    
      	 	
              H.

            	
              EFFECTIVE
                DATE herein shall mean the date first appearing
                above.

            

    

    

    
      	 	
              I.

            	
              EMEA
                herein shall mean European Medicines Evaluation
                Agency.

            

    

    

    
      	 	
              J.

            	
              FDA
                herein shall mean the United States Food and Drug
                Administration.

            

    

     

    [*]
      Confidential treatment requested; certain information omitted and filed
      separately with the SEC.

    
      
        
        

      

      
        3

        
          

        

      

      
        
        

      

    

     

    
      	 	
              K.

            	
              FIELD
                herein shall mean the diagnosis, prevention, treatment and cure for
                any
                disease, disorder or condition in human beings in all the therapeutic
                fields.

            

    

     

    
      	 	
              L.

            	
              HEALTH
                REGISTRATION herein shall mean, for any country, all governmental
                authorizations and/or approvals required by the competent authorities
                of
                such a country for manufacturing, marketing and selling of the PRODUCT,
                and for importing of the COMPOUND in such a country, including but
                not
                limited to product registration(s) and price and marketing approvals,
                as
                applicable in such a country.

            

    

    

    
      	 	
              M.

            	
              IND
                herein shall mean an Investigational New Drug Application filed with
                the
                FDA or a similar application filed with an applicable regulatory
                authority
                outside of the United States.

            

    

    

    
      	 	
              N.

            	
              INNOVIVE
                PATENT herein shall mean all patent applications and issued patents,
                owned
                and controlled by INNOVIVE or SUBLICENSEE (hereinafter defined),
                that both
                (i) INNOVIVE or SUBLICENSEE has the right to license to SHINYAKU
                without
                breaching any contractual obligation with a third party and without
                incurring any expense, during AGREEMENT TERM, and (ii) is derived
                from the
                use of a SHINYAKU PATENT (hereinafter defined) during AGREEMENT TERM
                and
                claims an invention or discovery that is a development or improvement
                of
                the COMPOUND or PRODUCT, which invention or discovery would (a) improve
                the PRODUCT’s performance with respect to the inhibition of BCR-ABL, (b)
                reduce production costs of the PRODUCT, (c) increase the service
                life of
                the PRODUCT, or (d) increase the PRODUCT’s marketability. The PARTIES
                agree that as of the Effective Date, no such INNOVIVE PATENT exists.
                INNOVIVE PATENT shall include all provisional applications, divisions,
                continuations, continuations-in-part, additions, registrations,
                confirmations, renewals, extensions, supplemental protection certificates,
                re-examinations and reissues of the above patent applications and
                patents.

            

    

     

    
      
        
        

      

      
        4

        
          

        

      

      
        
        

      

    

     

    
      	 	
              O.

            	
              INNOVIVE
                TECHNICAL INFORMATION herein shall mean the following technical data,
                information, improvements, trade secrets, technology and/or know-how
                relating to the COMPOUND and/or the PRODUCT which is not covered
                by a
                patent or patent application and is necessary and/or useful in making
                the
                COMPOUND or in developing, making, using, selling or registering
                the
                PRODUCT, and which INNOVIVE and its SUBLICENSEES own, control and
                have the
                right to license to SHINYAKU without breaching any contractual obligation
                with a third party or any regulatory or other legal requirement and
                without incurring any expense, during AGREEMENT TERM. The PARTIES
                agree
                that as of the Effective Date, no such INNOVIVE TECHNICAL INFORMATION
                exists. This term includes, without
                limitation:

            

    

    
      	 	
              i)

            	
              specifications
                for the COMPOUND;

            

    

    
      	 	
              ii)

            	
              specifications
                for the PRODUCT;

            

    

    
      	 	
              iii)

            	
              chemical
                data on the COMPOUND;

            

    

    
      	 	
              iv)

            	
              processes,
                instructions, procedures and techniques for the COMPOUND and the
                PRODUCT;

            

    

    
      	 	
              v)

            	
              toxicological,
                pharmacological, pharmacokinetic data on the COMPOUND and the
                PRODUCT;

            

    

    
      	 	
              vi)

            	
              clinical
                data including ADRs;

            

    

    
      	 	
              vii)

            	
              package
                inserts for the PRODUCT; 

            

    

    
      	 	
              viii)

            	
              commercial
                and marketing information;

            

    

    
      	 	
              ix)

            	
              progress
                reports on all studies and tests carried out by or on behalf of INNOVIVE,
                and data and documents obtained on each of such studies and tests,
                during
                the period before filing of an application for HEALTH REGISTRATION
                of the
                PRODUCT in any country in the TERRITORY;
                and

            

    

    
      	 	
              x)

            	
              copy
                of the documents submitted or filed for an IND to the regulatory
                authority
                in the TERRITORY or the application for HEALTH REGISTRATION of the
                PRODUCT
                in the TERRITORY.

            

    

     

    
      
        
        

      

      
        5

        
          

        

      

      
        
        

      

    

     

    
      	 	
              P.

            	
              MHLW
                herein shall mean Ministry of Health, Labor and Welfare, the Japanese
                body
                responsible for granting HEALTH REGISTRATION in
                Japan.

            

    

    

    
      	 	
              Q.

            	
              NET
                SALES herein shall mean the gross invoiced sales price of the PRODUCT
                by
                INNOVIVE and its SUBLICENSEES to unrelated third parties, less the
                following deductions to the extent included in the gross invoiced
                sales
                price for the PRODUCT or otherwise directly paid or incurred by INNOVIVE
                or its SUBLICENSEES with respect to the sale of the
                PRODUCT:

            

    

    
      	 	
              i)

            	
              reasonable
                and customary discounts, credits, rebates, allowances, and adjustments;
                and all rejections, recalls and amounts allowed or credited for
                returns;

            

    

    
      	 	
              ii)

            	
              price
                reductions or rebates retroactively or otherwise imposed by government
                authorities;

            

    

    
      	 	
              iii)

            	
              sales,
                excise, turnover, value-added, and similar taxes assessed on the
                sale of
                the PRODUCT (but excluding income taxes);

            

    

    
      	 	
              iv)

            	
              transportation,
                importation and insurance directly chargeable to the sale of the
                PRODUCT,
                including packaging and freight; and

            

    

    

    
      	 	
              v)

            	
              bad
                debts and uncollected receivables provided that, in any calendar
                year,
                such deduction shall not exceed [*] percent ([*]%) of the amounts
                invoiced
                for sales of PRODUCT
                in that year. 

            

    

     

    [*]
      Confidential treatment requested; certain information omitted and filed
      separately with the SEC.

    
      
        
        

      

      
        6

        
          

        

      

      
        
        

      

    

     

    
      	 	
              R.

            	
              NON-ROYALTY
                SUBLICENSE INCOME herein shall mean sublicense issue fees, sublicense
                maintenance fees, sublicense milestone payments, and similar non-royalty
                payments made by SUBLICENSEES to INNOVIVE on account of sublicenses
                pursuant to this Agreement; provided, however, that NON-ROYALTY SUBLICENSE
                INCOME shall not include payments received for [*] percent ([*]%)
                of newly
                issued equity of INNOVIVE to
                SUBLICENSEE.

            

    

    

    
      	 	
              S.

            	
              PATENT
                COVERAGE herein shall mean, for a particular PRODUCT, that the sale
                of the
                PRODUCT, but for the license granted to INNOVIVE under this Agreement,
                would infringe an issued VALID CLAIM in the country in which the
                PRODUCT
                is sold.

            

    

    

    
      	 	
              T.

            	
              PERSON
                herein shall mean an individual, sole proprietorship, partnership,
                limited
                partnership, limited liability partnership, corporation, limited
                liability
                company, business trust, joint stock company, trust, unincorporated
                association, joint venture or other similar entity or organization,
                including a government or political subdivision, department or agency
                of a
                government.

            

    

    

    
      	 	
              U.

            	
              PRODUCT
                herein shall mean any pharmaceutical preparation suitable for
                administration for human use containing the COMPOUND as an active
                ingredient. 

            

    

    

    
      	 	
              V.

            	
              QUARTER
                herein shall mean each period of three (3) consecutive calendar months,
                ending March 31, June 30, September 30, and December
                31.

            

    

    

    [*]
      Confidential treatment requested; certain information omitted and filed
      separately with the SEC.

    
      
        
        

      

      
        7

        
          

        

      

      
        
        

      

    

    

    
      	 	
              W.

            	
              REASONABLE
                COMMERCIAL EFFORTS herein shall mean efforts which are consistent
                with
                those utilized by INNOVIVE for its own internally developed pharmaceutical
                products of similar market potential at a similar stage of its product
                life taking into account the existence of other competitive products
                in
                the marketplace or under development, the proprietary position of
                the
                product, the profitability of the product and other relevant
                factors.

            

    

    

    
      	 	
              X.

            	
              SHINYAKU
                PATENT herein shall mean (i) all patent applications and issued patents
                listed in SCHEDULE 1(X), and/or (ii) all patent applications filed
                and/or
                patents issued in any country relating to or covering the COMPOUND
                and/or
                the PRODUCT, which may be necessary or useful in developing, making,
                using, selling or registering the PRODUCT and which SHINYAKU owns,
                possesses and controls or has licensed from a third party (with the
                right
                to sublicense to INNOVIVE without breaching any contractual obligation
                with such a third party) during AGREEMENT TERM. SHINYAKU PATENT shall
                include all provisional applications, divisionals, continuations,
                continuations-in-part, additions, registrations, confirmations, renewals,
                extensions, supplemental protection certificates, re-examinations,
                reissues, and foreign equivalents of the above patent applications
                and
                patents. A list of the SHINYAKU PATENTS as of EFFECTIVE DATE is attached
                hereto as SCHEDULE 1(X) and the list shall be updated by SHINYAKU
                during
                AGREEMENT TERM.

            

    

    

    
      	 	
              Y.

            	
              SHINYAKU
                TECHNICAL INFORMATION herein shall mean all technical data, information,
                improvements, trade secrets, technology and/or know-how relating
                to the
                COMPOUND and/or the PRODUCT, which may be necessary or useful in
                developing, making, using, selling or registering the PRODUCT, and
                which
                SHINYAKU or its AFFILIATES or SUBLICENSEES has developed, develops,
                discovers, owns, possesses, controls or has licensed from a third
                party
                (with the right to sublicense to INNOVIVE without breaching any
                contractual obligation with such a third party) as of the EFFECTIVE
                DATE
                or during AGREEMENT TERM. This term includes, without
                limitation:

            

    

    
      	 	
              i)

            	
              specifications
                for the COMPOUND;

            

    

    
      	 	
              ii)

            	
              specifications
                for the PRODUCT; 

            

    

    
      	 	
              iii)

            	
              chemical
                data on the COMPOUND;

            

    

    
      	 	
              iv)

            	
              processes,
                instructions, procedures and techniques for the COMPOUND and the
                PRODUCT;

            

    

    
      	 	
              v)

            	
              toxicological,
                pharmacological, pharmacokinetic data on the COMPOUND and the PRODUCT;
                

            

    

    
      	 	
              vi)

            	
              clinical
                data including ADRs;

            

    

    
      	 	
              vii)

            	
              all
                preclinical evaluations; 

            

    

    
      	 	
              viii)

            	
              all
                safety studies;

            

    

    
      	 	
              ix)

            	
              package
                inserts for the PRODUCT;

            

    

    
      	 	
              x)

            	
              progress
                reports on all studies and tests carried out by or on behalf of SHINYAKU,
                and data and documents obtained on each of such studies and tests,
                during
                the period before filing of an application for HEALTH REGISTRATION
                of the
                PRODUCT in Japan;

            

    

    
      
        	 	
                xi)

              	
                a
                  copy of the documents submitted or filed for an IND to the regulatory
                  authority in Japan; or the application for HEALTH REGISTRATION
                  of the
                  PRODUCT in Japan; 

              

      

      
      

      
      

      
        	 	
                xii)

              	
                
                  without
                    limiting the above, all studies necessary for an IND including
                    the single
                    dose 14 and 28 day toxicity studies, the GLP genotox studies,
                    the GLP
                    protein binding studies, the cardiosafety pharmacology studies,
                    the plasma
                    concentration studies, the tissue distribution studies, the metabolism
                    studies, and the effects on CYP3A4 studies; and 

                

              

 

      
        	 	
                xiii)

              	
                any
                  other SHINYAKU TECHNICAL INFORMATION which shall be made available
                  to
                  INNOVIVE upon reasonable specific written request by INNOVIVE,
                  provided
                  that it is, at the time of the request, in SHINYAKU’s possession and
                  control. 

              

      

        

      
        
          
          

        

        
          8

          
            

          

        

        
          
          

        

      

       

    

    
      	 	
              Z.

            	
              SUBLICENSEE
                herein shall mean any third party including AFFILIATE which is sublicensed
                by INNOVIVE the rights hereafter set forth in Section 2.2, or which
                is
                sublicensed by SHINYAKU the rights hereafter set forth in Section
                2.4.
                

            

    

    

    
      	 	
              AA.

            	
              TERRITORY
                herein shall mean all countries in the world except
                Japan.

            

    

    

    
      	 	
              BB.

            	
              TRADEMARK
                herein shall mean any trademarks to be owned and used for the PRODUCT
                in
                the TERRITORY under this Agreement by INNOVIVE and its
                SUBLICENSEES.

            

    

    

    
      	 	
              CC.

            	
              VALID
                CLAIM herein shall mean a claim of any pending, issued or unexpired
                SHINYAKU PATENT that (a) has not been finally cancelled, withdrawn,
                abandoned or rejected by any administrative agency or other body
                of
                competent jurisdiction not subject to further appeal, (b) has not
                been revoked, held invalid, or declared unpatentable or unenforceable
                in a
                decision of a court or other body of competent jurisdiction that
                is
                unappealable or unappealed within the time allowed for appeal, and
                (c) has
                not been rendered unenforceable through disclaimer, abandonment,
                withdrawal or otherwise. 

            

    

    

    
      	
              1.2

            	
              Rules
                of Construction.
                The singular includes the plural and vice versa, words denoting any
                gender
                include all genders. Where the context so admits or requires, references
                to SHINYAKU, INNOVIVE, their respective AFFILIATES and SUBLICENSEES
                shall
                include their respective employees and
                agents.

            

    

     

    
      
        
        

      

      
        9

        
          

        

      

      
        
        

      

    

     

    
      	
              1.3

            	
              References.
                References to Recitals, ARTICLES, Sections and SCHEDULES are reference
                to
                Recitals, ARTICLES, Sections and SCHEDULES of this
                Agreement.

            

    

    

    
      	
              1.4

            	
              Headings.
                The headings are for ease of reference only and are not part of this
                Agreement for the purpose of
                construction.

            

    

    

    

    ARTICLE
      2

    GRANT
      OF LICENSE

    

    
      	
              2.1

            	
              License
                Grant to INNOVIVE.
                Under the terms and conditions herein set forth, SHINYAKU hereby
                grants to
                INNOVIVE an exclusive (even as to SHINYAKU) right and license, with
                the
                right to grant sublicenses pursuant to Section 2.2, in the FIELD
                in the
                TERRITORY under SHINYAKU PATENT and SHINYAKU TECHNICAL INFORMATION
                to
                make, have made, develop, have developed, import, have imported,
                export,
                have exported, use, have used, offer to sell, sell, and have sold
                the
                COMPOUND and/or the PRODUCT.

            

    

    

    
      	
              2.2

            	
              INNOVIVE’s
                Right to Sublicense.(a)
                The license granted to INNOVIVE under Section 2.1 hereof includes
                the
                right to sublicense to its AFFILIATE(s) and/or independent third
                parties
                in the TERRITORY. INNOVIVE hereby warrants that each Sublicense Agreement
                between INNOVIVE and its SUBLICENSEE shall be in writing and shall
                include
                a provision acknowledging that such a sublicense is subject to the
                terms
                and conditions of the license granted to INNOVIVE under this Agreement.
                INNOVIVE agrees to notify SHINYAKU of every name and address of such
                a
                SUBLICENSEE. (b) Any SUBLICENSEE shall have the right to grant a
                further
                sublicense, provided that (i) such further sublicense is in writing,
                (ii)
                such further sublicense includes a provision acknowledging that such
                sublicense is subject to the terms and conditions of the license
                granted
                to the SUBLICENSEE, and (iii) SUBLICENSEE notifies INNOVIVE of the
                names
                and addresses of such further sublicensees, such that INNOVIVE can
                then
                notify SHINYAKU of such names and addresses. (c) If this Agreement
                terminates for any reason, any SUBLICENSEE shall, from the effective
                date
                of such termination, automatically become a direct licensee of SHINYAKU
                with respect to the rights originally sublicensed to the SUBLICENSEE
                by
                INNOVIVE, and SHINYAKU agrees that it shall confirm the foregoing
                in
                writing at the request and for the benefit of the SUBLICENSEE; provided,
                however, that such SUBLICENSEE is not in breach of its sublicense
                agreement (or cures any such breach within sixty (60) days of the
                termination of this Agreement) and such SUBLICENSEE agrees to comply
                with
                all of the terms of this Agreement to the extent applicable from
                the
                rights originally sublicensed to it by INNOVIVE; and provided further
                that
                SHINYAKU shall not be bound by any duties or obligations contained
                in the
                sublicenses that extend beyond the duties and obligations assumed
                by
                SHINYAKU in this Agreement.

            

    

     

    
      
        
        

      

      
        10

        
          

        

      

      
        
        

      

    

     

    
      	
              2.3

            	
              License
                Grant to SHINYAKU under INNOVIVE PATENT and INNOVIVE TECHNICAL
                INFORMATION.
                Under the terms and conditions herein set forth, INNOVIVE hereby
                grants to
                SHINYAKU an exclusive license, with a right to grant sublicenses
                pursuant
                to Section 2.4, under INNOVIVE PATENT and INNOVIVE TECHNICAL INFORMATION
                to make, have made, develop, have developed, import, have imported,
                use,
                have used, offer to sell, sell, and have sold the COMPOUND and/or
                the
                PRODUCT in the FIELD in Japan. Such a license shall be free of charge
                during and after AGREEMENT TERM.

            

    

    

    
      	
              2.4

            	
              SHINYAKU’s
                Right to Sublicense.
                (a) The license granted to SHINYAKU under Section 2.3 hereof includes
                the
                right to sublicense to its AFFILIATE(s) and/or independent third
                parties
                in Japan. SHINYAKU hereby warrants that each Sublicense Agreement
                between
                SHINYAKU and its SUBLICENSEE shall be in writing and shall include
                a
                provision acknowledging that such a sublicense is subject to the
                terms and
                conditions of the license granted to SHINYAKU under this Agreement.
                SHINYAKU agrees to notify INNOVIVE of every name and address of such
                a
                SUBLICENSEE. (b) Any SUBLICENSEE shall have the right to grant a
                further
                sublicense, provided that (i) such further sublicense is in writing,
                (ii)
                such further sublicense includes a provision acknowledging that such
                sublicense is subject to the terms and conditions of the license
                granted
                to the SUBLICENSEE, and (iii) SUBLICENSEE notifies SHINYAKU of the
                names
                and addresses of such further sublicensees, such that SHINYAKU can
                then
                notify INNOVIVE of such names and addresses. (c) If this Agreement
                terminates for any reason, any SUBLICENSEE shall, from the effective
                date
                of such termination, automatically become a direct licensee of INNOVIVE
                with respect to the rights originally sublicensed to the SUBLICENSEE
                by
                SHINYAKU, and INNOVIVE agrees that it shall confirm the foregoing
                in
                writing at the request and for the benefit of the SUBLICENSEE; provided,
                however, that such SUBLICENSEE is not in breach of its sublicense
                agreement (or cures any such breach within sixty (60) days of the
                termination of this Agreement) and such SUBLICENSEE agrees to comply
                with
                all of the terms of this Agreement to the extent applicable from
                the
                rights originally sublicensed to it by SHINYAKU; and provided further
                that
                INNOVIVE shall not be bound by any duties or obligations contained
                in the
                sublicenses that extend beyond the duties and obligations assumed
                by
                INNOVIVE in this Agreement.

            

    

     

    
      
        
        

      

      
        11

        
          

        

      

      
        
        

      

    

    

    ARTICLE
      3

    DISCLOSURE
      OF INFORMATION

    

    
      	
              3.1

            	
              SHINYAKU
                PATENT
                and
                SHINYAKU TECHNICAL
                INFORMATION.
                Promptly after EFFECTIVE DATE and from time to time thereafter during
                AGREEMENT TERM, SHINYAKU shall disclose to INNOVIVE: (a) all SHINYAKU
                TECHNICAL INFORMATION; (b) all information regarding SHINYAKU PATENT
                necessary or helpful for INNOVIVE (i) to carry out the DEVELOPMENT
                PROGRAM
                , (ii) to manufacture or use the COMPOUND, or PRODUCT and (iii) to
                generally fulfill the purposes of this Agreement.
                

            

    

    

    
      	
              3.2

            	
              INNOVIVE
                PATENT and INNOVIVE TECHNICAL INFORMATION.
                INNOVIVE agrees to disclose to SHINYAKU from time to time during
                AGREEMENT
                TERM all information regarding INNOVIVE PATENT and INNOVIVE TECHNICAL
                INFORMATION which INNOVIVE and its SUBLICENSEES may hereafter develop
                or
                acquire during AGREEMENT TERM. 

            

    

    

    ARTICLE
      4

    ADRs
      REPORTING

    

    
      	
              4.1

            	
              Procedure.
                During AGREEMENT TERM, INNOVIVE shall apprise SHINYAKU of its standard
                operating procedures for the investigation and reporting of ADRs
                concerning the COMPOUND and the PRODUCT. The PARTIES hereto shall
                then
                promptly develop and agree upon procedures for the exchange of ADRs
                concerning the COMPOUND and the PRODUCT. The PARTIES hereto shall
                immediately implement such agreed procedures and shall provide each
                other
                on a regular basis with any information which has become available
                to them
                and which is relevant to the safe use of the COMPOUND or the PRODUCT
                to
                the extent specified in the agreed procedures. Such procedures shall
                also
                apply to INNOVIVE’s and SHINYAKU’s
                SUBLICENSEES.

            

    

     

    
      
        
        

      

      
        12

        
          

        

      

      
        
        

      

    

     

    
      	
              4.2

            	
              Further
                Provisions.
                Both as an integral part of the procedures referred to in Section
                4.1 and
                as a separate obligation under this Agreement, further provisions
                concerning the reporting and notification of ADRs shall be separately
                agreed upon by the PARTIES hereto promptly after EFFECTIVE DATE to
                comply
                with regulatory requirements.

            

    

    

    ARTICLE
      5

    UPFRONT,
      MILESTONE, SUBLICENSE PAYMENTS AND ROYALTIES

     

    
      
        	
                5.1

              	
                Consideration.
                  In consideration of the license and right to sublicense granted
                  to
                  INNOVIVE by SHINYAKU hereunder, INNOVIVE agrees to make the payment
                  in
                  United States Dollars to SHINYAKU pursuant to Sections 5.2, 5.3
                  and 5.4 by
                  bank wire transfer or electronic funds transfer to such an account
                  as
                  SHINYAKU shall designate at least ten (10) days before such a payment
                  is
                  due. For
                  the avoidance of doubt, each payment pursuant to Sections 5.2 and
                  5.3
                  below shall be made at most only once regardless of how many indications
                  are developed.

              

      

      
        	
                5.2

              	
                Upfront
                  and Milestone Payments.
                  Irrespective of whether the PRODUCT is developed by INNOVIVE itself
                  or its
                  SUBLICENSEE, INNOVIVE shall make the following payment to SHINYAKU
                  according to the development stage as
                  follows:

              

      

    

    
      	 	
              i)

            	
              Six
                Hundred Thousand United States Dollars (US$ 600,000) within thirty
                (30)
                days after EFFECTIVE DATE; 

            

    

    
      	 	
              ii)

            	
              Two
                Hundred Thousand (200,000) shares of INNOVIVE common stock within
                thirty
                (30) days after EFFECTIVE DATE;

            

    

    
    

     

    
      
        
        

      

      
        13

        
          

        

      

      
        
        

      

    

     

    
      	 	
              iii)

            	
              Two
                Hundred Thousand (200,000) shares of INNOVIVE common stock to be
                placed in
                escrow within thirty (30) days after the EFFECTIVE DATE and held
                in escrow
                until the acceptance of IND by FDA; provided that, if this Agreement
                expires or is terminated before the acceptance of an IND by FDA,
                then the
                aforementioned shares of INNOVIVE common stock shall be returned
                to
                INNOVIVE;

            

    

    
      	 	
              iv)

            	
              [*]
                United States Dollars (US$ [*]), within thirty (30) days after the
                acceptance of IND by FDA;

            

    

    
      	 	
              v)

            	
              [*]
                United States Dollars (US$ [*]) within thirty (30) days after starting
                the
                pivotal phase II clinical study specified in the DEVELOPMENT PROGRAM.
                The
                start of the said study shall be deemed to have occurred on the enrollment
                of the first patient;

            

    

    
      	 	
              vi)

            	
              [*]
                United States Dollars (US$ [*]) within thirty (30) days after acceptance
                of the filing of the New Drug Application (NDA) for the first indication
                in the United States;

            

    

    
      	 	
              vii)

            	
              [*]
                United States Dollars (US$ [*]) within thirty (30) days after NDA
                approval
                of the first indication in the United States;
                and

            

    

    
      	 	
              viii)

            	
              [*]
                United States Dollars (US$ [*]) within thirty (30) days after obtaining
                the HEALTH REGISTRATION of the first indication in
                Europe.

            

    

    

    
      	
              5.3

            	
              Sublicense
                Payments.
                In addition to Section 5.2, in case of the development by SUBLICENSEE,
                INNOVIVE shall pay the following portion of NON-ROYALTY SUBLICENSE
                INCOME
                to SHINYAKU according to the timing of execution of the Sublicense
                Agreement as follows:

            

    

    
      	 	
              i)

            	
              [*]
                percent ([*]%) of NON-ROYALTY SUBLICENSE INCOME, if INNOVIVE executes
                sublicense between the 

            

    

    EFFECTIVE
      DATE of this Agreement and before the enrollment of the first patient into
      a
      phase I clinical study;

    
      	 	
              ii)

            	
              [*]
                percent ([*]%) of NON-ROYALTY SUBLICENSE INCOME, if INNOVIVE executes
                sublicense between the enrollment of the first patient into a phase
                I
                clinical study and 

            

    

    
      	 	
              iii)

            	
              before
                the enrollment of the first patient into a phase II clinical
                study;

            

    

     

    [*]
      Confidential treatment requested; certain information omitted and filed
      separately with the SEC.

    
      
        
        

      

      
        14

        
          

        

      

      
        
        

      

    

     

     

    
      	 	
              iv)

            	
              [*]
                percent ([*]%) of NON-ROYALTY SUBLICENSE INCOME, if INNOVIVE executes
                sublicense between the enrollment of the first patient into a phase
                II
                clinical study and before NDA approval of
                the first indication in
                the United States
                or before obtaining HEALTH REGISTRATION of
                the first indication in a country outside of the United States;
                and

            

    

    
      	 	
              v)

            	
              [*]
                percent ([*]%) of NON-ROYALTY SUBLICENSE INCOME, if INNOVIVE executes
                sublicense after NDA approval of
                the first indication in the United States or after obtaining HEALTH
                REGISTRATION of the first indication in a country outside of the
                United
                States.

            

    

    

    
      	
              5.4

            	
              Royalties.

            

    

    
      	 	
              (a)

            	
              Royalties
                when PATENT COVERAGE exists.
                INNOVIVE shall pay the following Royalties to SHINYAKU on PRODUCTS
                for
                which PATENT COVERAGE exists:

            

    

    
      	 	
              i)

            	
              [*]
                percent ([*]%) of NET SALES of the PRODUCT by INNOVIVE, if INNOVIVE
                markets and sells the PRODUCT in the TERRITORY;
                or

            

    

    
      	 	
              ii)

            	
              [*]
                percent ([*]%) of (a) the royalty income payable to INNOVIVE from
                the
                SUBLICENSEE based on NET SALES in the TERRITORY, if SUBLICENSEE markets
                and sells the PRODUCT; and (b) the difference between INNOVIVE’s sales of
                the PRODUCT to the SUBLICENSEE and INNOVIVE’s cost of goods for such
                PRODUCT, if INNOVIVE manufactures (or has manufactured) and sells
                the
                PRODUCT to SUBLICENSEE for resale by
                SUBLICENSEE.

            

    

     

    Such
      royalties
      shall be
      payable in each country in the TERRITORY on
      PRODUCTS for which PATENT COVERAGE exists in such country.
      The
      obligation to pay royalty under this Agreement shall be imposed only once with
      respect to the same unit of PRODUCT.

    

    
      	 	
              (b)

            	
              Royalties
                when PATENT COVERAGE does not exist.
                INNOVIVE shall pay the following Royalties to SHINYAKU on PRODUCTS
                for
                which no PATENT COVERAGE exists:

            

    

    
      	 	
              i)

            	
              [*]
                percent ([*]%) of NET SALES of the PRODUCT by INNOVIVE, if INNOVIVE
                markets and sells the PRODUCT in the TERRITORY;
                or

            

    

    
      	 	
              ii)

            	
              [*]
                percent ([*]%) of (a) the royalty income payable to INNOVIVE from
                the
                SUBLICENSEE based on NET SALES in the

            

    

    

    [*]
      Confidential treatment requested; certain information omitted and filed
      separately with the SEC.

    
      
        
        

      

      
        15

        
          

        

      

      
        
        

      

    

     

    TERRITORY,
      if SUBLICENSEE markets and sells the PRODUCT; and (b) the difference between
      INNOVIVE’s sales of the PRODUCT to the SUBLICENSEE and INNOVIVE’s cost of goods
      for such PRODUCT, if INNOVIVE manufactures (or has manufactured) and sells
      the
      PRODUCT to SUBLICENSEE for resale by SUBLICENSEE.

     

    
      Such
        royalties
        shall be
        payable in each country in the TERRITORY on
        PRODUCTS for which PATENT COVERAGE does not exist in such country.
        The
        obligation to pay royalty under this Agreement shall be imposed only once
        with
        respect to the same unit of PRODUCT.

    

     

    (c)
      By way of example, in the event INNOVIVE enters into an agreement to co-promote
      or co-market the PRODUCT, (i) if a sale of such PRODUCT is invoiced and
      accounted for as sale by INNOVIVE, then either Section 5.4(a)(i) or Section
      5.4(b)(i) shall apply; or (ii) if a sale of such PRODUCT is invoiced and
      accounted for as sale by an INNOVIVE SUBLICENSEE, then either Section 5.4(a)(ii)
      or Section 5.4(b)(ii) shall apply.

    

    
      	
              5.5

            	
              Non-Refundability.
                Except as specifically provided in this Agreement, payments by INNOVIVE
                as
                set forth in ARTICLE 5 shall not be creditable or refundable for
                any
                reason.

            

    

    

    
      	
              5.6

            	
              ARTICLE
                5 Definitions.
                Solely for the purposes of this ARTICLE 5, the term “INNOVIVE” shall
                include its AFFILIATES, and the term “SUBLICENSEE” shall not include
                AFFILIATES of INNOVIVE.

            

    

    

    

    ARTICLE
      6

    MINIMUM
      SALES REQUIREMENT

    

    In
      the event that the total sales of the PRODUCT sold by INNOVIVE and its
AFFILIATES
      and SUBLICENSEES for each Period (as hereinafter defined) does not
      reach Minimum Sales for such period as set forth below, INNOVIVE shall
pay
      SHINYAKU the compensation for the balance between such Minimum Sales and the
      actual sales during the said Period. The compensation shall be [*] percent
      ([*]%) of such balance.

     

    [*]
      Confidential treatment requested; certain information omitted and filed
      separately with the SEC.

     

    
      
        
        

      

      
        16

        
          

        

      

      
        
        

      

    

    Minimum
      Sales

    

    Period
      1: [*] U.S. Dollars (US $[*])

    Period
      2 (Full Calendar Year following Period 1): [*] U.S. Dollars (US
      $[*])

    Period
      3 (Full Calendar Year following Period 2): [*] U.S. Dollars (US $[*]
      Million)

    

    The
      Minimum Sales for subsequent Periods shall be agreed by the PARTIES before
      the
      beginning of the applicable period. In determining the appropriate Minimum
      Sales, the PARTIES shall consider all relevant commercial, regulatory and
      scientific factors prevailing at the time including, but not limited to, the
      following: the approved labeling for the PRODUCT; the PRODUCT profile; market
      conditions; and the anticipated order of launch of the PRODUCT within the
      TERRITORY.

    

    In
      this ARTICLE 6, Period 1 shall mean the period starting on and from the date
      of
      the first commercial sale of the PRODUCT by INNOVIVE or its SUBLICENSEES
      in the TERRITORY and ending on December 31 of the following year including
      the
      first anniversary date of such a first commercial sale. Subsequent Periods
      shall
      be the full calendar year following the immediately preceding
      Period.

    

    ARTICLE
      7

    REPORTS
      AND ACCOUNTING 

    

    
      	
              7.1

            	
              Reports,
                Exchange Rates.
                Within seventy five (75) days after the end of each QUARTER in which
                NET
                SALES occurs, INNOVIVE shall make a payment of royalty to SHINYAKU
                together with a written report for such
                QUARTER showing: 

            

    

     

    
      	 	
              i)

            	
              NET
                SALES and the gross sales of the PRODUCT sold by INNOVIVE and its
                SUBLICENSEES for each country in the TERRITORY during
                

            

    

    

    [*]
      Confidential treatment requested; certain information omitted and filed
      separately with the SEC.

    
      
        
        

      

      
        17

        
          

        

      

      
        
        

      

       

    

    the
      QUARTER to which the report is applicable and the calculation of NET SALES
      from
      such gross sales for each such country, including the deductions set forth
      in
      Section 1.1 (Q), if any;

    
      	 	
              ii)

            	
              The
                exchange rates for each currency used in determining the amount of
                United
                States Dollars;

            

    

    
      	 	
              iii)

            	
              the
                dates of the first commercial sales of the PRODUCT in any country
                in the
                TERRITORY during the QUARTER; and

            

    

    
      	 	
              iv)

            	
              the
                aggregation of royalty in each country of the TERRITORY based on
                the
                calculation pursuant to Section
                5.4.

            

    

     

    Payments
      by INNOVIVE to SHINYAKU under this Agreement shall be made in United States
      Dollars. Where payments are based on NET SALES of the PRODUCT in countries
      other
      than the United States, the amount of such NET SALES expressed in the currency
      of such a country shall be converted into United States Dollars at the exchange
      rate of the last business day of the applicable QUARTER. The applicable exchange
      rate shall be the central rate set forth in the Financial Times as Foreign
      Exchange Rates.

    

    
      	
              7.2

            	
              Audits.

            

    

    
      	 	
              i)

            	
              Upon
                the written request of SHINYAKU, INNOVIVE shall permit an independent
                certified public accounting firm of internationally recognized standing,
                selected by SHINYAKU and reasonably acceptable to INNOVIVE, at SHINYAKU’s
                expense, to have access during normal business hours to such records
                of
                INNOVIVE and its SUBLICENSEES as may be reasonably necessary to verify
                the
                accuracy of the reports hereunder for any year ending not more than
                twenty-four (24) months prior to the date of such a request. The
                accounting firm shall disclose to SHINYAKU only whether the records
                are
                correct or not and, if applicable, the specific details concerning
                any
                discrepancies. The accounting firm shall provide a copy of its report
                to
                INNOVIVE.

            

    

    
    

     

    
      
        
        

      

      
        18

        
          

        

      

      
        
        

      

    

     

    
      	 	
              ii)

            	
              If
                the accounting firm concludes that INNOVIVE underpaid royalties during
                the
                audited period, INNOVIVE shall make additional payment within thirty
                (30)
                days after the date SHINYAKU delivers to INNOVIVE such accounting
                firm’s
                written report so concluding, unless INNOVIVE shall have a good faith
                dispute as to the conclusions set forth in such written report, in
                which
                case INNOVIVE shall provide written notice to the SHINYAKU within
                such
                thirty (30) day period of the nature of its disagreement with such
                written
                report. The PARTIES shall thereafter, for a period of sixty (60)
                days,
                attempt in good faith to resolve such dispute and if they are unable
                to do
                so then the matter shall be submitted to dispute resolution in accordance
                with ARTICLE 26 hereof. 

            

    

    
      	 	
              iii)

            	
              The
                fees charged by such an accounting firm shall be paid by SHINYAKU;
                provided, however, if the audit discloses that the amount payable
                by
                INNOVIVE for the audited period is more than [*] percent ([*]%) of
                the
                amount actually paid for such a period, then INNOVIVE shall pay the
                reasonable fees and expenses charged by such an accounting
                firm.

            

    

     

    
      	 	
              iv)

            	
              INNOVIVE
                shall include in each sublicense granted by it pursuant to this Agreement
                a provision requiring the SUBLICENSEE to make reports to INNOVIVE,
                to keep
                and maintain records of sales made pursuant to such sublicense and
                to
                grant access to such records by SHINYAKU’s accounting firm to the same
                extent required of INNOVIVE under this Agreement. Upon the expiration
                of
                twenty-four (24) months following the end of any year, the calculation
                of
                the royalties payable with respect to such a year shall be binding
                and
                conclusive upon SHINYAKU, INNOVIVE and their respective SUBLICENSEES,
                and
                INNOVIVE and its SUBLICENSEES shall be released from any liability
                or
                accountability with respect to the royalties for such a
                year.

            

    

     

    
      	
              7.3

            	
              Confidential
                Financial Information.
                SHINYAKU shall treat all financial information subject to review
                under
                this ARTICLE
                7 or under any Sublicense Agreement as confidential, and shall cause
                its
                accounting firm to retain all such financial information in confidence
                as
                required by this Agreement.

            

    

    

    [*]
      Confidential treatment requested; certain information omitted and filed
      separately with the SEC.

    
      
        
        

      

      
        19

        
          

        

      

      
        
        

      

    

    ARTICLE
      8

    DEVELOPMENT
      PROGRAM

    

    
      	
              8.1

            	
              INNOVIVE
                Responsibility.
                INNOVIVE shall be solely responsible, have the authority to direct,
                and
                bear the full cost and expense, for the performance of pre-clinical
                studies and clinical studies, governmental approval for clinical
                studies,
                HEALTH REGISTRATION, manufacturing, marketing and sales of the PRODUCT
                in
                the TERRITORY. According to the timeline in DEVELOPMENT PROGRAM,
                INNOVIVE
                shall use REASONABLE COMMERCIAL EFFORTS to pursue the performance
                of
                pre-clinical studies, clinical studies, governmental approval for
                clinical
                studies, HEALTH REGISTRATION, manufacturing, and launch of the PRODUCT
                in
                the TERRITORY. SCHEDULE 1(G) contains INNOVIVE's current DEVELOPMENT
                PROGRAM for the PRODUCT in the TERRITORY. Prior to finalizing any
                clinical
                trial protocol or filing NDA or any similar application for HEALTH
                REGISTRATION, INNOVIVE shall advise SHINYAKU and reasonably consult
                with
                SHINYAKU regarding such a matter. Especially regarding the performance
                of
                pre-clinical studies and clinical studies, INNOVIVE agrees that the
                data
                obtained from such studies shall, to the extent permitted by law,
                and
                in compliance with the International Conference on Harmonisation
                Regulation (ICH) standards,
                be used for HEALTH REGISTRATION in Japan, and, therefore, the clinical
                trial protocols should be prepared considering the use of the clinical
                data for the Japanese HEALTH REGISTRATION. Such protocols shall be
                available to SHINYAKU at that time.

            

    

    

    
      	
              8.2

            	
              Progress
                Reports and Meetings.
                Each PARTY shall regularly inform the other PARTY, not less than
                once
                every three (3) months, of reports on any and all ongoing studies
                and
                procedures for HEALTH REGISTRATION conducted by INNOVIVE as specified
                in
                the DEVELOPMENT PROGRAM, or by SHINYAKU, as applicable, and the PARTIES
                shall exchange relevant information as required. Furthermore, both
                PARTIES
                shall have a meeting regularly, but in no event less than semi-annually,
                at such times and at such locations as shall be mutually agreed by
                the
                PARTIES, in order to achieve the purpose of this Section
                8.2.

            

    

    

    
      	
              8.3

            	
              Publication
                of Clinical and Preclinical Data.
                Each PARTY shall provide forty-five (45) days notice to the other
                PARTY
                before publicly disclosing the results of clinical or preclinical
                studies
                conducted by INNOVIVE or by SHINYAKU, as applicable, with respect
                to the
                COMPOUND and/or the PRODUCT.

            

    

     

    
      
        
        

      

      
        20

        
          

        

      

      
        
        

      

    

     

    
      	
              8.4

            	
              COMPOUND
                for DEVELOPMENT PROGRAM.
                At INNOVIVE’s request, SHINYAKU shall supply INNOVIVE at [*] yen per
                kilogram with COMPOUND manufactured and stored as ofEFFECTIVE DATE
                in
                compliance with the GLP of Japan for the support of clinical studies
                under
                an IND for PRODUCT.

            

    

    

    
      	
              8.5

            	
              HEALTH
                REGISTRATIONS.
                INNOVIVE shall be responsible for preparing and filing the application
                for
                HEALTH REGISTRATION to be submitted to the respective regulatory
                authorities in the TERRITORY. As of EFFECTIVE DATE, INNOVIVE shall
                make
                REASONABLE COMMERCIAL EFFORTS to submit NDA or a similar application
                for
                the PRODUCT within [*] following EFFECTIVE DATE in the United States
                and
                to obtain HEALTH REGISTRATION approval in any country in the TERRITORY,
                provided that INNOVIVE shall not be responsible for any delays caused
                by
                circumstances beyond its reasonable control, including but not limited
                to
                delays resulting from actions, inaction or regulatory guidance by
                the FDA
                or other authority. If any delay is anticipated, INNOVIVE shall inform
                SHINYAKU of the reasons for the delay and the PARTIES shall discuss
                whether reasonable measures may be undertaken to minimize or eliminate
                the
                delay.

            

    

     

    
      	
              8.6

            	
              Alteration
                of DEVELOPMENT PROGRAM.
                It is understood by the PARTIES hereto that the DEVELOPMENT PROGRAM
                may be
                unattainable if unforeseen material problems arise beyond the PARTIES’
                reasonable control. In the event that INNOVIVE believes it necessary
                or
                desirable to alter or amend the DEVELOPMENT PROGRAM, it shall promptly
                advise SHINYAKU and provide details to SHINYAKU regarding the reasons
                for
                the proposed alteration or amendment prior to its adoption, and such
                a
                revised DEVELOPMENT PROGRAM shall thereafter be the DEVELOPMENT
                

            

    

    PROGRAM.
      No alteration or amendment shall be made which does not take into account any
      reasonable suggestions made by the other PARTY.

    

    [*]
      Confidential treatment requested; certain information omitted and filed
      separately with the SEC.

    
      
        
        

      

      
        21

        
          

        

      

      
        
        

      

    

    
 

    
      	
              8.7

            	
              Meeting
                with FDA, EMEA or MHLW.
                (a) When INNOVIVE and/or its SUBLICENSEES have a meeting with FDA
                or EMEA
                as to the development of the PRODUCT and organize an investigator
                meeting
                in relation to the clinical trials in the TERRITORY, INNOVIVE and/or
                its
                SUBLICENSEES shall in reasonable advance inform SHINYAKU of the purpose
                and schedule of such a meeting, if requested by SHINYAKU, so that
                SHINYAKU
                can also attend such a meeting as an observer, provided that such
                an
                attendance is acceptable to the FDA or EMEA as appropriate. (b) When
                SHINYAKU and/or its SUBLICENSEES have a meeting with MHLW asto the
                development of the PRODUCT and organize an investigator meeting in
                relation to the clinical trials in Japan, SHINYAKU and/or its SUBLICENSEES
                shall in reasonable advance inform INNOVIVE of the purpose and schedule
                of
                such a

            

    

    meeting,
      if requested by INNOVIVE, so that INNOVIVE can also attend such a meeting as
      an
      observer, provided that such an attendance is acceptable to MHLW as
      appropriate.

    

    

    ARTICLE
      9

    SECRECY

    

    During
      AGREEMENT TERM and for a period of [*] ([*]) years thereafter, each PARTY shall,
      and shall cause its SUBLICENSEES to, hold in confidence the CONFIDENTIAL
      INFORMATION disclosed to it by the other PARTY by using the same degree of
      care
      (but no less than a reasonable degree of care) with which such PARTY maintains
      its own Confidential Information, and shall not disclose, such CONFIDENTIAL
      INFORMATION to any third party, nor use such CONFIDENTIAL INFORMATION for any
      purpose, except pursuant to, and in order to carry out, the purposes
      contemplated by this Agreement or with the prior written consent of the PARTY
      that provided such CONFIDENTIAL INFORMATION. However, this ARTICLE 9 shall
      not
      apply to the following information:

    

    [*]
      Confidential treatment requested; certain information omitted and filed
      separately with the SEC.

    
      
        
        

      

      
        22

        
          

        

      

      
        
        

      

    

     

    
      	 	
              i)

            	
              such
                CONFIDENTIAL INFORMATION which is a part of the public domain prior
                to the
                disclosure by the disclosing party to the receiving party
                hereunder;

            

    

    
      	 	
              ii)

            	
              such
                CONFIDENTIAL INFORMATION which becomes a part of public domain after
                the
                disclosure by the disclosing party hereunder without any breach of
                this
                Agreement by the receiving party;

            

    

    
      	 	
              iii)

            	
              such
                CONFIDENTIAL INFORMATION which the receiving party can demonstrate
                was
                already in its possession prior to the disclosure by the disclosing
                party
                hereunder and at its free disposal;

            

    

    
      	 	
              iv)

            	
              such
                CONFIDENTIAL INFORMATION which is disclosed to the receiving party
                by a
                third party who has the right to make such a disclosure;
                or

            

    

    
      	 	
              v)

            	
              such
                CONFIDENTIAL INFORMATION which the receiving party can demonstrate
                was
                developed by it without reference to the CONFIDENTIAL INFORMATION
                disclosed to it by the disclosing
                party.

            

    

    

    Nothing
      contained herein shall prevent either PARTY and its SUBLICENSEES from disclosing
      such CONFIDENTIAL INFORMATION to the extent that (a) such CONFIDENTIAL
      INFORMATION is disclosed in connection with the securing of HEALTH REGISTRATION
      in the TERRITORY and/or other governmental approval required to commercially
      market the PRODUCT, provided that the disclosing party shall take all reasonable
      steps to seek confidential treatment thereof; or (b) such CONFIDENTIAL
      INFORMATION is required to be disclosed by law for the purpose of complying
      with
      governmental regulations, provided that such a party shall give the other party
      prior written notice thereof and adequate opportunity to object to any such
      disclosure or to take all reasonable steps to seek confidential treatment
      thereof; (c) such CONFIDENTIAL INFORMATION is disclosed under appropriate
      secrecy agreement to AFFILIATES, or to SUBLICENSEES, consultants, outside
      contractors, clinical investigators and outside research institutions performing
      experiments, tests and studies on the COMPOUND and/or the PRODUCT so as to
      perform the purpose of this Agreement; or (d) such CONFIDENTIAL INFORMATION
      is
      disclosed to investors or potential investors, lenders, and other potential
      financing sources, or to a third party in connection with a merger or
      acquisition or proposed merger or acquisition or a license or proposed license
      of the technology or intellectual property licensed hereunder, and to
      affiliates, attorneys, accountants, stockholders, investment bankers, advisers
      or other consultants of the foregoing, in each case provided that the PERSON
      to
      which such disclosure is made is obligated by written agreement to keep such
      information confidential on essentially the same terms as set forth herein
      and
      to use such Confidential Information solely to evaluate such investment,
      financing, acquisition, merger or license.

     

    
      
        
        

      

      
        23

        
          

        

      

      
        
        

      

    

    ARTICLE
      10

    REPRESENTATIONS

    

    
      	
              10.1

            	
              SHINYAKU
                Representations and Warranties.
                SHINYAKU represents and warrants
                that:

            

    

    
      	 	
              i)

            	
              SHINYAKU
                has the full right, power and corporate authority to enter into this
                Agreement and to make the promises set forth in this Agreement and
                that
                there are no outstanding agreements, assignments or encumbrances
                in
                existence in breach of the provisions of this Agreement or which
                would
                otherwise conflict with the rights granted and obligations assumed
                in
                terms of this Agreement;

            

    

    
      	 	
              ii)

            	
              To
                the best of its knowledge, no SHINYAKU PATENT has been or shall be
                obtained through any intentional activity, omission or representation
                by
                SHINYAKU that would limit or affect the validity and/or enforceability
                of
                the SHINYAKU PATENT, and SHINYAKU has no knowledge or information
                as of
                EFFECTIVE DATE that would affect the validity and/or enforceability
                of any
                SHINYAKU PATENT;

            

    

    
      	 	
              iii)

            	
              To
                the best of its knowledge, the SHINYAKU PATENTS are not invalid or
                unenforceable, in whole or in part, except for information disclosed
                to
                INNOVIVE in the written report entitled “Due Diligence concerning
                Intellectual Property for NS-187”; 

            

    

    
      	 	
              iv)

            	
              As
                of the EFFECTIVE DATE and during AGREEMENT TERM, SHINYAKU has and
                shall
                have the full right, power and authority to grant all of the right,
                title
                and interest in the licenses granted or to be granted to INNOVIVE
                under
                this Agreement; 

            

    

    
      	 	
              v)

            	
              As
                of the EFFECTIVE DATE, SHINYAKU owns and controls all SHINYAKU TECHNICAL
                INFORMATION and has the full right, power and authority to disclose,
                deliver and otherwise transfer such SHINYAKU TECHNICAL INFORMATION
                to
                INNOVIVE in accordance with this
                Agreement;

            

    

    
    

     

    
      
        
        

      

      
        24

        
          

        

      

      
        
        

      

    

     

    
      	 	
              vi)

            	
              The
                performance by SHINYAKU of any of the terms and conditions of this
                Agreement on its part to be performed does not and shall not constitute
                a
                breach of any other material agreement or understanding, written
                or oral,
                to which it is a party;

            

    

    
      	 	
              vii)

            	
              SHINYAKU
                has not authorized and shall not authorize any third party to practice
                any
                SHINYAKU PATENT and/or SHINYAKU TECHNICAL INFORMATION or otherwise
                grant
                rights to make, have made, import, use, offer to sell or sell the
                COMPOUND
                and/or the PRODUCT in the FIELD in the TERRITORY in breach of this
                Agreement;

            

    

    
      	 	
              viii)

            	
              For
                each SHINYAKU PATENT, in all material respects, (i) all necessary
                application, annuity, maintenance and renewal fees in connection
                with all
                patent and patent applications have been paid and (ii) all necessary
                documents and certificates in connection therewith have been filed
                with
                the relevant authority for the purpose of maintaining the patent
                registrations or applications;

            

    

    
      	 	
              ix)

            	
              There
                are no adverse proceedings, claims or actions, including but not
                limited
                to cancellation, reexamination, interference, opposition, termination,
                withdrawal or other proceedings, pending or threatened, to the best
                of
                SHINYAKU's knowledge, relating to any SHINYAKU PATENT and SHINYAKU
                TECHNICAL INFORMATION and at the time of disclosure and delivery
                thereof
                to INNOVIVE, SHINYAKU shall, to the best of its knowledge, have the
                full
                right and legal capacity to disclose and deliver the SHINYAKU PATENT
                and
                SHINYAKU TECHNICAL INFORMATION without violating the rights of third
                parties;

            

    

    
      	 	
              x)

            	
              To
                the best of its knowledge, the practice of the licensed technology
                and the
                commercialization of any PRODUCT in the FIELD do not and shall not
                infringe any issued patents or other intellectual property rights
                owned or
                possessed by any third party, except for information disclosed to
                INNOVIVE
                in the written report entitled “Due Diligence concerning Intellectual
                Property for NS-187”; 

            

    

    
      	 	
              xi)

            	
              As
                of EFFECTIVE DATE, neither SHINYAKU nor any of its AFFILIATES has
                received
                any charge, complaint, demand or notices of infringement or any written
                communications relating in any way to the possible infringement of
                any
                third party patent by the activities of SHINYAKU or its AFFILIATES
                prior
                to EFFECTIVE DATE or the activities of SHINYAKU and INNOVIVE contemplated
                by this Agreement, except for the letters dated March 18, 2005 and
                May 17,
                2005 from Joseph A. Grear to SHINYAKU, and is not otherwise aware
                of any
                such possible infringement;

            

    

    
    

     

     

    
      
        
        

      

      
        25

        
          

        

      

      
        
        

      

    

     

    
      	 	
              xii)

            	
              As
                of the EFFECTIVE DATE, there are no claims, judgments or settlements
                against or owed by SHINYAKU, or pending or threatened claims or
                litigation, in either case relating to or affecting the licensed
                technology;

            

    

    
      	 	
              xiii)

            	
              To
                the best of its knowledge, no third party has infringed any licensed
                technology in the FIELD in the
                TERRITORY;

            

    

    
      	 	
              xiv)

            	
              The
                patents and patent applications listed in SCHEDULE 1(X) constitute
                all of
                the patents and patent applications in which SHINYAKU has rights,
                either
                owned or licensed, relating to the manufacture, use or sale of the
                COMPOUND and/or PRODUCT as of EFFECTIVE DATE;

            

    

    
      	 	
              xv)

            	
              As
                of the EFFECTIVE DATE, there are no patent rights owned or controlled
                by
                SHINYAKU, other than the SHINYAKU PATENTS, which cover, or if issued
                would
                cover, the commercialization of any PRODUCT in the FIELD in the
                TERRITORY;

            

    

    
      	 	
              xvi)

            	
              SHINYAKU
                is the exclusive owner of the SHINYAKU PATENTS, all of which are
                free and
                clear of any liens, charges and
                encumbrances;

            

    

    
      	 	
              xvii)

            	
              In
                the event that any of the rights of SHINYAKU PATENTS are licensed
                to
                SHINYAKU from a third party, SHINYAKU shall not amend or modify the
                license agreements granting such rights to SHINYAKU, or waive any
                right
                thereunder, in any manner that would adversely affect INNOVIVE’s rights
                hereunder without the prior written authorization of
                INNOVIVE;

            

    

    
      	 	
              xviii)

            	
              No
                individual or third party has challenged the inventorship of any
                of the
                SHINYAKU PATENTS; SHINYAKU has no information to suggest that any
                individual or third party plans to challenge the inventorship of
                any of
                the SHINYAKU PATENTS; and to the best of SHINYAKU’s knowledge, the
                inventorship of the SHINYAKU PATENTS is
                correct;

            

    

    
      	 	
              xix)

            	
              None
                of the inventions claimed in the SHINYAKU PATENTS was supported with
                government funding or was conceived or reduced to practice in the
                performance of government funded
                research;

            

    

     

    
      
        
        

      

      
        26

        
          

        

      

      
        
        

      

    

     

    
      	 	
              xx)

            	
              All
                maintenance fees, annuity fees, or other fees relating to the prosecution
                and/or maintenance of the SHINYAKU PATENTS have been timely paid;
                and
                

            

    

    
      	 	
              xxi)

            	
              SHINYAKU
                has not employed (and, to the best of its knowledge, has not used
                a
                contractor or consultant that has employed) and in the future shall
                not
                employ (or, to the best of its knowledge, use any contractor or consultant
                that employs) any individual or entity debarred by the FDA (or subject
                to
                similar sanction of EMEA or MHLW) or, to the best knowledge of SHINYAKU,
                any individual who or entity which is the subject of an FDA debarment
                investigation or proceeding (or similar proceeding of EMEA or MHLW),
                in
                the conduct of pre-clinical studies or clinical studies of the COMPOUND
                or
                the PRODUCT.

            

    

    

    
      	
              10.2

            	
              INNOVIVE
                Representations and Warranties.
                INNOVIVE represents and warrants
                that:

            

    

    
      	 	
              i)

            	
              INNOVIVE
                has the full right, power and corporate authority to enter into this
                Agreement and to make the promises set forth in this Agreement and
                that
                there are no outstanding agreements, assignments or encumbrances
                in
                existence in breach of the provisions of this Agreement or which
                would
                otherwise conflict with the rights granted and obligations assumed
                in
                terms of this Agreement;

            

    

    
      	 	
              ii)

            	
              to
                the best of its knowledge, no INNOVIVE PATENT shall be obtained through
                any intentional activity, omission or representation by INNOVIVE
                that
                would limit or destroy the validity and/or enforceability of the
                INNOVIVE
                PATENT;

            

    

    
      	 	
              iii)

            	
              the
                performance by INNOVIVE of any of the terms and conditions of this
                Agreement on its part to be performed shall not constitute a breach
                of any
                other material agreement or understanding, written or oral, to which
                it is
                a party;

            

    

    
      	 	
              iv)

            	
              INNOVIVE
                shall not authorize any third party to practice any INNOVIVE PATENT
                and/or
                INNOVIVE TECHNICAL INFORMATION, or otherwise grant rights, to make,
                have
                made, import, use, offer to sell or sell the PRODUCT in the FIELD
                in
                Japan;

            

    

    
      	 	
              v)

            	
              at
                the time of disclosure of any INNOVIVE PATENT and INNOVIVE TECHNICAL
                INFORMATION to SHINYAKU, INNOVIVE shall, to the best of its knowledge,
                have the full right and legal capacity to disclose the INNOVIVE PATENT
                and
                INNOVIVE TECHNICAL INFORMATION without violating the rights of third
                parties; and

            

    

    
      	 	
              vi)

            	
              INNOVIVE
                shall not employ (or, to the best of its knowledge, use any contractor
                or
                consultant that employs) any individual or entity debarred by the
                FDA (or
                subject to similar sanction of EMEA or MHLW) or, to the best knowledge
                of
                INNOVIVE,
                any individual who or entity which is the subject of an FDA debarment
                investigation or proceeding (or similar proceeding of EMEA or MHLW),
                in
                the conduct of pre-clinical studies or clinical studies of the COMPOUND
                or
                the PRODUCT.

            

    

     

    
      
        
        

      

      
        27

        
          

        

      

      
        
        

      

    

     

    
      	
              10.3

            	
              Compliance
                with Law.
                INNOVIVE and SHINYAKU each represent and warrant that it shall use
                its
                best efforts to comply with all applicable laws and regulations (including
                e.g. cGMP, cGCP) in connection with that PARTY’S performance of its
                obligations and rights pursuant to this Agreement, including the
                regulations of the United States, EU, Japan and any other relevant
                nation
                concerning any export or other transfer of technology, services or
                products.

            

    

    

    
      	
              10.4

            	
              No
                Representations on Patent Validity.
                Subject to Sections 10.1 and 10.2, nothing in this Agreement or any
                license pursuant to this Agreement shall be construed or implied
                as a
                representation or warranty by either PARTY that any SHINYAKU PATENT
                or
                INNOVIVE PATENT is valid or enforceable, or that manufacture, exercise,
                use or sale of the PRODUCT under this Agreement is not an infringement
                of
                any patent owned by third parties or that such manufacture, exercise,
                use
                or sale of the PRODUCT does not otherwise infringe the rights of
                third
                parties.

            

    

    

    
      	
              10.5

            	
              Non-Warranty
                of any ADRs.
                (a) As of EFFECTIVE DATE, that the PRODUCT and the COMPOUND under
                SHINYAKU
                PATENT and/or SHINYAKU TECHNICAL INFORMATION are still in the developing
                stage and need further research and development, and therefore SHINYAKU
                shall not warrant that either the PRODUCT or the COMPOUND shall not
                bring
                about any ADRs. (b) Any PRODUCT or COMPOUND developed under INNOVIVE
                PATENT and/or INNOVIVE TECHNICAL INFORMATION shall be in the developing
                stage and need further research and development, and therefore INNOVIVE
                does not and shall not warrant that either the PRODUCT or the COMPOUND
                shall not bring about any ADRs.

            

    

    

    
      	
              10.6

            	
              Non-Warranty
                of Marketability.
                The PARTIES shall not represent or warrant that HEALTH REGISTRATION
                shall
                be obtained in all or any part of the TERRITORY or Japan and that
                the
                PRODUCT can be commercially or legally marketed in the future. SHINYAKU
                further represents that it is not in possession of any information,
                other
                than what has been disclosed to INNOVIVE, which indicates that the
                PRODUCT
                may not be legally marketed in the TERRITORY or
                Japan.

            

    

     

    
      
        
        

      

      
        28

        
          

        

      

      
        
        

      

    

     

    
      	
              10.7

            	
              Disclaimers
                and Liability Limitations.
                Both PARTIES agree that:

            

    

    
      	 	
              i)

            	
              Except
                as explicitly stated in this Agreement, the patents and technical
                information licensed hereunder are provided “as is” and neither PARTY
                makes any additional representation or warranty, express or implied,
                with
                respect thereto. By way of example but not of limitation, neither
                PARTY
                makes any representation or warranty (a) of commercial utility, (b)
                of
                merchantability or fitness for a particular purpose, or (c) that
                the use
                of the patents and technical information licensed hereunder shall
                not
                infringe any patent, copyright or trademark or other proprietary
                rights of
                others.

            

    

    
      	 	
              ii)

            	
              Except
                as explicitly stated herein, neither PARTY shall be liable for
                consequential, incidental or special damages or lost profits of any
                nature
                arising from such PARTY’S activities under this Agreement; provided,
                however, that this limitation shall not limit the indemnification
                obligation of such a PARTY under ARTICLE 12 below for consequential,
                incidental or special damages or lost profits recovered by a third
                party

            

    

    

    

    ARTICLE
      11

    SALES
      PROMOTION

    

    
      	
              11.1

            	
              Marketing.
                Within [*] following the date of HEALTH REGISTRATION (including pricing
                approval) in any country in the TERRITORY, INNOVIVE or its SUBLICENSEES
                shall use REASONABLE COMMERCIAL EFFORTS to commence marketing and
                commercial sales of the PRODUCT in each such
                country.

            

    

    

    
      	
              11.2

            	
              Sales
                Organization.
                Upon obtaining HEALTH REGISTRATION in any country in the TERRITORY,
                INNOVIVE, or its SUBLICENSEES, shall establish a sufficient sales
                organization with qualified personnel for

            

    

     

    [*]
      Confidential treatment requested; certain information omitted and filed
      separately with the SEC.

    
      
        
        

      

      
        29

        
          

        

      

      
        
        

      

    

    sales
      promotion of the PRODUCT and use REASONABLE COMMERCIAL EFFORTS, at its sole
      responsibility and expense, to market and promote the PRODUCT in each such
      country.

    

    
      	
              11.3

            	
              Sales
                Reports.
                INNOVIVE agrees to give SHINYAKU every three (3) months general
                information of the market situation including the progress of
                implementation of such sales and promotion plan in the
                TERRITORY.

            

    

    

    
      	
              11.4

            	
              Samples.
                INNOVIVE shall undertake to furnish SHINYAKU with samples of the
                PRODUCT,
                specimens of all packages, labels and package inserts, as used in
                the
                TERRITORY.

            

    

    

    ARTICLE
      12

    LIABILITIES

    

    
      	
              12.1

            	
              Cross
                Indemnity.
                Each PARTY (the “Indemnifying
                Party”)
                agrees to defend, indemnify and hold the other PARTY (the “Indemnified
                Party”),
                its AFFILIATES and their respective directors, officers, employees
                and
                agents and their respective heirs and assigns harmless from all third
                party claims, actions, losses, damages, liabilities or expenses
                (including, but not limited to, reasonable attorneys’ fees) (each, a
                “Loss”)
                arising as a result of (a) development, manufacture, use, offer for
                sale,
                sale, or distribution of the COMPOUND and/or the PRODUCT by the
                Indemnifying Party or its AFFILIATES or SUBLICENSEES, (b) negligence
                or
                willful misconduct of the Indemnifying Party in the performance of
                its
                obligations under this Agreement, or (c) a breach by the Indemnifying
                Party of any of its representations, warranties or obligations under
                this
                Agreement.

            

    

    

    
      	
              12.2

            	
              Limitation
                on Indemnity Obligations.
                A PARTY, its AFFILIATES and their respective directors, officers,
                employees and agents shall not be entitled to the indemnities set
                forth in
                ARTICLE 12 to the extent the Loss for which indemnification is sought
                was
                caused by the negligence, or by the reckless or intentional misconduct
                or
                omission, of such PARTY or its directors, officers, employees or
                agents.

            

    

     

    
      
        
        

      

      
        30

        
          

        

      

      
        
        

      

    

     

    
      	
              12.3

            	
              Indemnification
                Procedure.
                If an Indemnified Party intends to claim indemnification under ARTICLE
                12,
                the Indemnified Party shall notify the Indemnifying Party of any
                Loss in
                respect of which the Indemnified Party intends to claim such
                indemnification, and the Indemnifying Party shall assume the defense
                thereof. The failure to deliver notice to the Indemnifying Party
                within a
                reasonable time after the commencement of any such action shall relieve
                such Indemnifying Party of liability to the Indemnified Party under
                ARTICLE 12 only to the extent that the delay adversely affects
                Indemnifying Party's rights or ability to defend such claim or action.
                The
                Indemnified Party under ARTICLE 12 shall provide reasonable assistance
                to
                the Indemnifying Party and its legal representatives, at the Indemnifying
                Party’s expense, in the investigation of any action, claim or liability
                covered by this indemnification. The indemnity agreement in this
                ARTICLE
                12 shall not apply to amounts paid in settlement of any Loss if such
                settlement is effected without the consent of the Indemnifying Party,
                which consent shall not be withheld unreasonably or delayed. Indemnifying
                Party shall not, without the written consent of Indemnified Party,
                settle
                or compromise any Loss or consent to the entry of any judgment with
                respect to any Loss (a) that does not release Indemnified Party from
                all
                liability with respect to such Loss or (b) which may materially adversely
                affect Indemnified Party or under which Indemnified Party would incur
                any
                obligation or liability, other than one as to which Indemnifying
                Party has
                an indemnity obligation hereunder. If Indemnifying Party, within
                ten (10)
                days of receiving notice of a Loss or such shorter period as may
                be
                necessary for submitting or filing a response, fails to assume the
                defense
                of such Loss or fails to notify Indemnified Party that is assuming
                such
                defense, Indemnified Party shall have the right to assume the defense,
                compromise or settlement of such Loss at the risk and expense of
                Indemnifying Party.

            

    

    

    ARTICLE
      13

    PATENT
      INFRINGEMENT AND EXTENSION

    

    
      	
              13.1

            	
              Third
                Party Infringers.
                If either PARTY hereto becomes aware of any third party infringement
                of
                any SHINYAKU PATENT in the TERRITORY, it shall promptly inform the
                other
                PARTY and shall supply the other PARTY with all evidence possessed
                by the
                notifying PARTY pertaining to such an infringement. INNOVIVE shall
                have
                the sole right and opportunity to enforce any SHINYAKU PATENT in
                the
                TERRITORY and shall bear the full cost and expense of such an enforcement
                action. INNOVIVE shall reasonably consult with SHINYAKU prior to
                beginning
                and during such an enforcement action. SHINYAKU agrees to be joined
                as a
                party to the action at the request of INNOVIVE and to cooperate reasonably
                in such an action, including providing good faith testimony. All
                monies
                recovered upon the final judgment or settlement of any such suit
                shall be
                retained by INNOVIVE.

            

    

    

    
      	
              13.2

            	
              Patent
                Extensions.
                INNOVIVE agrees to reasonably assist SHINYAKU in taking all and any
                steps
                necessary to seek extension of any SHINYAKU PATENT in the TERRITORY
                wherever possible upon request of SHINYAKU
                thereof.

            

    

     

    
      
        
        

      

      
        31

        
          

        

      

      
        
        

      

    

     

    
      	
              13.3

            	
              Patent
                Maintenance.

            

    

     

    
      
        	 	
                (a)

              	
                
                  SHINYAKU
                    PATENTS. Subject to the following sentence, SHINYAKU shall diligently
                    and at its expense take all steps required to file, prosecute
                    (including
                    any interferences, reissue proceedings and re-examination proceedings)
                    and
                    maintain (including payment of any maintenance and annuity fees)
                    the
                    SHINYAKU PATENT in the countries listed in SCHEDULE 1(X) in the
                    TERRITORY
                    in full force and effect. If SHINYAKU elects not to pursue or
                    continue the
                    filing, prosecution (including any interferences, reissue proceedings
                    and
                    re-examinations) or maintenance of a SHINYAKU PATENT in a particular
                    country listed in SCHEDULE 1(X), SHINYAKU shall so notify INNOVIVE
                    promptly in writing and in good time to enable INNOVIVE to meet
                    any
                    deadlines by which an action must be taken to establish or preserve
                    any
                    such rights in such SHINYAKU PATENT in such country. Upon receipt
                    of any
                    such notice by SHINYAKU, INNOVIVE shall have the right, but not
                    the
                    obligation, to pursue the filing or registration, or support
                    the continued
                    prosecution (including any interferences, reissue proceedings
                    and
                    re-examinations) or maintenance, of such SHINYAKU PATENT, at
                    its expense
                    in such country. INNOVIVE shall have no obligation to pay SHINYAKU
                    royalties on NET SALES or other consideration with respect to
                    PRODUCT
                    covered only by SHINYAKU PATENT in such country that INNOVIVE
                    pursues or
                    supports pursuant to the preceding
                    sentence.

                

              

      

      

        
          	 	
                  (b)

                	
                  
                    INNOVIVE
                      PATENTS. Subject to the following sentence, INNOVIVE shall diligently
                      and at its expense take all steps required to file, prosecute
                      (including
                      any interferences, reissue proceedings and re-examination proceedings)
                      and
                      maintain (including payment of any maintenance and annuity
                      fees) the
                      INNOVIVE PATENT in the countries listed in SCHEDULE 13.3(b)
                      in full force
                      and effect. If INNOVIVE elects not to pursue or continue the
                      filing,
                      prosecution (including any interferences, reissue proceedings
                      and
                      re-examinations) or maintenance of a INNOVIVE PATENT in a particular
                      country listed in SCHEDULE 13.3(b), INNOVIVE shall so notify
                      SHINYAKU
                      promptly in writing and in good time to enable SHINYAKU to
                      meet any
                      deadlines by which an action must be taken to establish or
                      preserve any
                      such rights in such INNOVIVE PATENT in such country. Upon receipt
                      of any
                      such notice by INNOVIVE, SHINYAKU shall have the right, but
                      not the
                      obligation, to pursue the filing or registration, or support
                      the continued
                      prosecution (including any interferences, reissue proceedings
                      and
                      re-examinations) or maintenance, of such INNOVIVE PATENT, at
                      its expense
                      in such country. SHINYAKU shall have no obligation to pay INNOVIVE
                      royalties on NET SALES (solely for the purposes of this Section
                      13.3(b),
                      NET SALES shall apply to sales by SHINYAKU, and its AFFILIATES
                      or
                      SUBLICENSEES) or other consideration with respect to PRODUCT
                      covered only
                      by INNOVIVE PATENT in such country that SHINYAKU pursues or
                      supports
                      pursuant to the preceding
                      sentence.

                  

                

        

         

        
          
            
            

          

          
            32

            
              

            

          

          
            
            

          

        

         

      

    

    
      	 	
              (c)

            	
              Cooperation.
                Each PARTY shall, and shall cause its SUBLICENSEES to, assist and
                cooperate with the other PARTY, and shall instruct its counsel to
                do the
                same, as such other PARTY may reasonably request from time to time
                in
                connection with its activities under Sections 13.3(a) and 13.3(b).
                Each
                PARTY shall keep the other PARTY currently informed of all steps
                to be
                taken in the preparation and prosecution of all applications filed
                by such
                first PARTY (the “Prosecuting Party”) according to Section 13.3(a) or
                13.3(b) and shall furnish the non-Prosecuting Party with copies of
                such
                applications for Patents, amendments thereto and other related
                correspondence to and from patent offices. The Prosecuting Party
                shall
                provide the non-Prosecuting Party with drafts of all papers to be
                filed
                with a patent office (“Drafts”) and shall instruct its counsel to do the
                same. The Prosecuting Party shall provide the non-Prosecuting Party
                a
                reasonable opportunity to: (i) confer with the Prosecuting Party
                about the
                substance of Drafts, and (ii) propose changes (which proposals shall
                be
                given reasonable consideration and not be unreasonably rejected)
                to such
                Drafts before the Prosecuting Party files the submission with a patent
                office. The non-Prosecuting Party shall offer its comments, if any,
                promptly, but in no event shall the Prosecuting Party be required
                to delay
                any such submission.

            

    

    

    

    ARTICLE
      14

    INFRINGEMENT
      ACTIONS BY THIRD PARTIES

    

    (a)
      If INNOVIVE, or to its knowledge any of its SUBLICENSEES or customers, shall
      be
      sued by a third party for infringement of a patent because of the development,
      manufacture, import, use or sale of the COMPOUND or the PRODUCT in the
      TERRITORY, INNOVIVE shall promptly notify SHINYAKU in writing of the institution
      of such a suit. In such occasions, SHINYAKU shall cooperate in the defense
      of
      such a suit and furnish to INNOVIVE available evidence and assistance in its
      control. INNOVIVE agrees to keep SHINYAKU informed with respect to all material
      developments in such a lawsuit and to reasonably consult with SHINYAKU regarding
      the defense and any settlement of such a lawsuit. In
      the event that INNOVIVE shall be sued by a third party for infringement of
      a
      patent or shall receive threat of suit, then INNOVIVE shall be entitled to
      control the defense of and/or settle such suit or claim in its sole
      discretion.
      SHINYAKU shall promptly notify INNOVIVE in writing of the institution of a
      suit
      against SHINYAKU, or to its knowledge any of its SUBLICENSEES or customers,
      by a
      third party for infringement of a patent because of the development,
      manufacture, import, use or sale of the COMPOUND or the PRODUCT in Japan.
(b)
      INNOVIVE
      shall have the right to credit against the royalty and other payments to be
      paid
      by INNOVIVE to SHINYAKU with respect to the sale of the PRODUCTS under ARTICLE
      5
      all (i) damages or costs awarded against INNOVIVE, and royalties or other
      payments that INNOVIVE is ordered to or agrees to pay, with respect to a suit
      or
      claim by a third party for patent infringement, including without limitation
      any
      settlement amounts paid, and (ii) any costs (including reasonable attorney
      fees)
      incurred by INNOVIVE in the defense or settlement of such suit or claim
      (together, the “Offset
      Amount”);
      provided, however, that such offset shall not exceed [*] percent ([*]%) of
      such
      payments otherwise due to SHINYAKU in each QUARTER pursuant to Section 7.1
      under
      this Agreement, and further provided that any portion of the Offset Amount
      that
      is not offset in a particular QUARTER may be carried forward for offset in
      subsequent QUARTERS.

    

    [*]
      Confidential treatment requested; certain information omitted and filed
      separately with the SEC.

    
      
        
        

      

      
        33

        
          

        

      

      
        
        

      

    

    ARTICLE
      15

    COMPETITIVE
      PRODUCT

    

    During
      AGREEMENT TERM, INNOVIVE shall not sell, and its SUBLICENSEES shall agree in
      a
      sublicense agreement not to sell, COMPETITIVE PRODUCT in any country of the
      TERRITORY without the prior written consent of SHINYAKU.

    

    ARTICLE
      16

    TRADEMARK

    

    
      	
              16.1

            	
              Selection.
                INNOVIVE shall be responsible for the selection, registration and
                maintenance of all TRADEMARKS which it employs in connection with
                the
                PRODUCT in each country of the TERRITORY
                and shall own and control such TRADEMARKS and pay all related costs
                thereto.

            

    

    

    
      	
              16.2

            	
              Third
                Party Infringers.
                Each PARTY shall notify the other promptly upon learning of any actual,
                alleged or threatened infringement of the TRADEMARKS applicable to
                the
                PRODUCT or of any unfair trade practices, trade dress imitation,
                passing
                off of counterfeit goods, or like offences. Only INNOVIVE shall be
                authorized to initiate at its own discretion legal proceedings against
                any
                infringement or threatened infringement of TRADEMARKS applicable
                to the
                PRODUCT.

            

    

    

    

    ARTICLE
      17

    WITHHOLDING
      TAXES

    

    Where
      any sum due to be paid to SHINYAKU hereunder is subject to any withholding
      or
      similar tax, the PARTIES shall use their reasonable best efforts to do all
      such
      acts and things and to sign all such deeds and documents as shall enable them
      to
      take advantage of any exemption from or reduction in such taxes under any
      applicable double taxation agreement or treaty. In the event there is no
      applicable double taxation agreement or treaty, or if an applicable double
      taxation agreement or treaty reduces but does not eliminate such a withholding
      or similar tax, INNOVIVE shall pay such a withholding or similar tax, deduct
      the
      amount paid from the amount due SHINYAKU, and secure and send to SHINYAKU proof
      of such a withholding or similar tax as evidence of such a payment.

    

    
      
        
        

      

      
        34

        
          

        

      

      
        
        

      

    

    ARTICLE
      18

    DEVELOPMENT
      AND MARKETING OF PRODUCT BY SHINYAKU IN JAPAN

    

    If
      SHINYAKU decides to develop, market and sell the PRODUCT in Japan, SHINYAKU
      shall provide written notice thereof to INNOVIVE and the PARTIES agree to
      commence a good-faith negotiation of a supply agreement under which INNOVIVE
      would supply the COMPOUND and/or PRODUCT to SHINYAKU. Such agreement would
      include without limitation provisions under which: (a) PRODUCT supplied by
      INNOVIVE to SHINYAKU shall be at the cost of goods plus a premium of [*] percent
      ([*]%) of the cost of goods; (b) in the event that SHINYAKU decides to purchase
      the COMPOUND from INNOVIVE for the formulation of the PRODUCT, such COMPOUND
      shall be supplied at the cost of goods plus a premium of [*] percent ([*]%)
      of
      the cost of goods; and (c) if the availability of COMPOUND and/or PRODUCT is
      limited, then (i) INNOVIVE shall have no obligation to supply any COMPOUND
      and/or PRODUCT to SHINYAKU until after INNOVIVE meets supply needs in the United
      States; and (ii) after meeting supply needs in the United States, INNOVIVE
      shall
      supply COMPOUND and/or PRODUCT to SHINYAKU to meet SHINYAKU’s supply needs in
      Japan before INNOVIVE meets supply needs in the remainder of the
      TERRITORY.

     

    [*]
      Confidential treatment requested; certain information omitted and filed
      separately with the SEC.

    
      
        
        

      

      
        35

        
          

        

      

      
        
        

      

    

    ARTICLE
      19

    DURATION
      AND TERMINATION

    

    
      	
              19.1

            	
              AGREEMENT
                TERM.
                This Agreement shall commence on EFFECTIVE DATE and shall, unless
                sooner
                terminated pursuant to any provision of this Agreement, continue
                to be in
                full force as
                long as INNOVIVE, any AFFILIATE of INNOVIVE or any SUBLICENSEE of
                INNOVIVE
                is selling PRODUCT in any country of the TERRITORY, irrespective
                of
                the expiration, abandonment, or existence of the VALID CLAIM under
                the
                SHINYAKU PATENTS in any country of the TERRITORY.
                

            

    

    

    
      	
              19.2

            	
              Breach.
                If either PARTY fails to fulfill any of its material obligations
                hereunder
                and if such failure is not cured by the breaching PARTY within sixty
                (60)
                days after receipt of written notice thereof from
                the

            

    

    

    
      	
              19.3

            	
              non-breaching
                PARTY, then the non-breaching PARTY may elect, in its sole discretion,
                to
                terminate this Agreement in whole or with respect to any portion
                of the
                rights licensed hereunder.

            

    

    

    
      	
              19.4

            	
              Termination
                by INNOVIVE.
                INNOVIVE may terminate this Agreement, with or without cause, in
                whole or
                with respect to any portion of the rights licensed hereunder, by
                giving
                written notice to SHINYAKU, which notice shall be effective ninety
                (90)
                days after receipt by SHINYAKU. In no event may either PARTY claim
                against
                the other PARTY any right or any compensation of damages or losses
                caused
                by the termination pursuant to this
                paragraph.

            

    

    

    
      	
              19.5

            	
              No
                HEALTH REGISTRATION in the TERRITORY.
                In the event that, despite INNOVIVE’s REASONABLE COMMERCIAL EFFORTS to
                obtain HEALTH REGISTRATION from both FDA and EMEA, both FDA and EMEA
                refuse to approve HEALTH REGISTRATION, INNOVIVE shall give full
                explanation and evidences of the circumstance, including the reasons
                alleged for such a refusal, to SHINYAKU so that SHINYAKU may supply
                arguments and documentation such as to remove said refusal. In case
                that
                both FDA and EMEA should maintain its position, INNOVIVE shall have
                the
                right to terminate this Agreement forthwith in all or part of the
                TERRITORY by giving a written notice of termination of this Agreement
                to
                SHINYAKU. In no event may either PARTY claim against the other PARTY
                any
                right or any compensation of damages or losses caused by the termination
                pursuant to this paragraph.

            

    

     

    
      
        
        

      

      
        36

        
          

        

      

      
        
        

      

    

     

    
      	
              19.6

            	
              Termination
                if Stoppage of PRODUCT Sales.
                In the event that, despite INNOVIVE’s REASONABLE COMMERCIAL EFFORTS to
                maintain sales of the PRODUCT both in United States and EU, both
                FDA and
                EMEA should order INNOVIVE to stop the sales of the PRODUCT in United
                States and EU because of possible danger to human health, INNOVIVE
                shall
                have the right to terminate this Agreement in all or part of the
                TERRITORY
                forthwith by giving a written notice of termination of this Agreement
                to
                SHINYAKU, provided that INNOVIVE gives SHINYAKU sufficient reports
                thereof
                and reasonable explanation of INNOVIVE’s decision. In no event may either
                PARTY claim against the other PARTY any right or any compensation
                of
                damages or losses caused by the termination pursuant to this
                paragraph.

            

    

    

    
      	
              19.7

            	
              Termination
                for Bankruptcy.
                Either PARTY shall have the right to terminate this Agreement immediately
                by delivering written notice to the other PARTY, or either PARTY
                may
                exercise its rights under Section 28.5 immediately by delivering
                written
                notice to the other PARTY, in the event that the other PARTY files
                for
                protection under the bankruptcy laws, makes an assignment for the
                benefit
                of creditors, appoints or suffers appointment of a receiver or trustee
                over its property, files a petition under any bankruptcy or insolvency
                act
                or has any such petition filed against it and such proceeding remains
                undismissed or unstayed for a period of more than ninety (90)
                days.

            

    

    

    
      	
              19.8

            	
              Termination
                if No Marketing Activity.
                SHINYAKU may terminate this Agreement as to a specific country by
                giving
                written notice to INNOVIVE at the expiry of [*] years after EFFECTIVE
                DATE
                only in countries where no commercial sales of PRODUCT have been
                commenced
                by INNOVIVE or its SUBLICENSEE, unless INNOVIVE or its SUBLICENSEE
                are
                making REASONABLE COMMERCIAL EFFORTS to market the PRODUCT in such
                country
                and the commencement of commercial sales has been delayed by regulatory
                action, inaction or guidance affecting a PRODUCT or by other factors
                beyond the reasonable control of INNOVIVE or its SUBLICENSEE, in
                which
                case this
                [*] year period shall be extended for a period of time equal to the
                length
                of any such delay(s).

            

    

    

    [*]
      Confidential treatment requested; certain information omitted and filed
      separately with the SEC.

    
      
        
        

      

      
        37

        
          

        

      

      
        
        

      

    

    ARTICLE
      20

    EFFECT
      OF TERMINATION

    

    
      	
              20.1

            	
              Effect
                of Termination.
                The termination of this Agreement
                shall:

            

    

    
      	 	
              i)

            	
              be
                without prejudice of the obligation of INNOVIVE to pay to SHINYAKU
                any
                sums accrued, due and payable under ARTICLES 5 and 6 hereof as though
                the
                date of termination was the last day of
                QUARTER;

            

    

    
      	 	
              ii)

            	
              be
                without prejudice to any right of, or remedy available to, either
                PARTY
                against the other in respect of anything done or omitted hereunder
                prior
                to such a termination; and

            

    

    
      	 	
              iii)

            	
              not
                release either PARTY from the confidentiality or liability obligations
                set
                forth in ARTICLES 9 and 12. 

            

    

    

    
      	 	
              o

            	
              SHINYAKU’s
                Rights.
                If this Agreement is terminated by SHINYAKU pursuant to Section 19.2
                or
                19.6 hereof, subject to final resolution of any proceedings brought
                under
                ARTICLE 26:

            

    

    
      	 	
              i)

            	
              INNOVIVE
                shall promptly return or furnish to SHINYAKU all written SHINYAKU
                TECHNICAL INFORMATION and, to the extent permitted by law and subject
                to
                mutual agreement of the PARTIES on reasonable confidentiality,
                indemnification and other provisions regarding transfer and use of
                the
                information, all INNOVIVE TECHNICAL INFORMATION in INNOVIVE’s possession.
                Subject to ARTICLE 9, INNOVIVE shall immediately cease to use and
                thereafter refrain from using SHINYAKU PATENT, SHINYAKU TECHNICAL
                INFORMATION and any TRADEMARK that has been used by INNOVIVE only
                in
                connection with marketing PRODUCT. 

            

    

    
      	 	
              ii)

            	
              except
                as expressly provided herein, all rights and licenses granted to
                INNOVIVE
                by SHINYAKU shall forthwith cease and
                terminate;

            

    

    
    

    
      	 	
              iii)

            	
              
                the
                  license granted under Section 2.3 shall survive termination and
                  shall
                  automatically become a non-exclusive, irrevocable, fully paid up
                  royalty-free (only in case of the termination pursuant to Section
                  19.2)
                  license, with a right to sublicense, under INNOVIVE PATENT and
                  INNOVIVE
                  TECHNICAL INFORMATION existing as of the termination date of this
                  Agreement, to make, have made, develop, have developed, import,
                  have
                  imported, use, have used, offer to sell, sell and have sold the
                  COMPOUND
                  and/or the PRODUCT in the FIELD in any country of the
                  world; 

              

            

 

    
      
        
        

      

      
        38

        
          

        

      

      
        
        

      

    

     

    
      	 	
              iv)

            	
              at
                the option of SHINYAKU, and for each country in the TERRITORY, INNOVIVE
                shall either (a) transfer, free of charge, to SHINYAKU or the company
                designated by SHINYAKU, HEALTH REGISTRATION and other relevant
                authorizations, permits or licenses which INNOVIVE and its SUBLICENSEE
                hold in connection with the PRODUCT on the date of termination if
                and to
                the extent permissible under the laws of such a country, or (b) cancel
                some or all of such HEALTH REGISTRATION in such a country;
                and

            

    

    
      	 	
              v)

            	
              SHINYAKU
                shall have the right to claim to INNOVIVE any compensation of damages
                or
                losses caused by the termination.

            

    

    

    INNOVIVE
      shall make its personnel and other resources reasonably available to SHINYAKU
      as
      necessary to effect an orderly transition of development or commercialization
      responsibilities with the cost of such resources and personnel to be borne
      by
      SHINYAKU after the effective date of termination.

    

    
      	
              20.2

            	
              INNOVIVE’s
                Rights.
                If this Agreement is terminated by INNOVIVE pursuant to Section 19.2
                or
                19.6 hereof, subject to final resolution of any proceedings brought
                under
                ARTICLE 26:

            

    

    
      	 	
              i)

            	
              SHINYAKU
                shall promptly return or furnish to INNOVIVE all written INNOVIVE
                TECHNICAL INFORMATION and SHINYAKU TECHNICAL INFORMATION in SHINYAKU’s
                possession and SHINYAKU shall immediately cease to use and thereafter
                refrain from using all such
                information;

            

    

    
      	 	
              ii)

            	
              except
                as expressly provided herein, all rights and licenses granted to
                SHINYAKU
                by INNOVIVE shall forthwith cease and terminate;
                

            

    

    
      	 	
              iii)

            	
              the
                license granted under Section 2.1 shall survive termination and shall
                automatically become a non-exclusive, fully paid up, irrevocable,
                royalty-free license, with a right to sublicense, in the FIELD in
                the
                TERRITORY under SHINYAKU PATENT and SHINYAKU TECHNICAL INFORMATION
                to
                make, have made, develop, have developed, import, have imported,
                use, have
                used, offer to sell, sell, and have sold the COMPOUND and/or the
                PRODUCT;
                and

            

    

    
      	 	
              iv)

            	
              INNOVIVE
                shall have the right to claim to SHINYAKU any compensation of damages
                or
                losses caused by the termination.

            

    

     

    
      
        
        

      

      
        39

        
          

        

      

      
        
        

      

    

     

    
      	
              20.3

            	
              Additional
                Rights.
                Any termination under Section 19.2 above shall be in addition to,
                and not
                in substitution for or condition to, the pursuit of other remedies
                that
                might be available to the terminating PARTY under this Agreement
                or in law
                or equity. Without limiting the foregoing, in the event of a breach
                of
                this Agreement, the non-breaching PARTY, without exercising any right
                of
                termination otherwise available to it, may pursue remedies for damages
                or
                other relief under the procedures set forth in ARTICLE 26 of this
                Agreement.

            

    

     

    
      	
              20.4

            	
              Termination
                Pursuant to Section 19.3, 19.4 or 19.5.
                If this Agreement is terminated by INNOVIVE pursuant to Section 19.3,
                19.4
                or 19.5 hereof, subject to final resolution of any proceedings brought
                under ARTICLE 26, SHINYAKU shall have the rights set forth in Section
                20.2(i), Section 20.2(ii), Section 20.2(iii) except for “fully
                paid
                up royalty-free”
                and Section
                20.2(iv).

            

    

    
    

     

    
      	
              20.5

            	
              
                Termination
                  Pursuant to Section 19.7.
                  If
                  this Agreement is terminated with respect to a specific country
                  pursuant
                  to Section 19.7, subject to final resolution of any proceedings
                  brought
                  under ARTICLE 26, SHINYAKU shall have the rights set forth in Section
                  20.2(i), Section 20.2(ii), Section 20.2(iii) except for “fully paid up
                  royalty-free” and Section 20.2(iv), but shall have such rights solely in
                  such specific country.

              

            

    

     

    
      	
              20.6

            	
              
                Termination
                  Pursuant to Section 19.3, 19.4, 19.5, 19.6 or 19.7.
                  If
                  this Agreement is terminated pursuant to Section 19.3, Section
                  19.4,
                  Section 19.5 or Section 19.6 hereof, or is terminated with respect
                  to a
                  specific country pursuant to Section 19.7 hereof, SHINYAKU shall
                  pay
                  INNOVIVE [*]% of NET SALES (solely for the purposes of this Section
                  20.7,
                  NET SALES shall apply to sales by SHINYAKU, and its AFFILIATES
                  or
                  SUBLICENSEES) in the TERRITORY in the event that SHINYAKU’s manufacturing,
                  using, selling, offering for sale, developing or importing the
                  COMPOUND or
                  the PRODUCT employs an INNOVIVE PATENT or INNOVIVE TECHNICAL INFORMATION,
                  or would infringe (but for the license granted to INNOVIVE under
                  this
                  Agreement), or would be covered by, a
                  VALID
                  CLAIM (solely for purposes of this Section 20.7, VALID CLAIM shall
                  apply
                  to claims
                  of
                  INNOVIVE PATENTS
                  and not to claims of SHINYAKU PATENTS).

              

            

    

     

    [*]
      Confidential treatment requested; certain information omitted and filed
      separately with the SEC.

    
      
        
        

      

      
        40

        
          

        

      

      
        
        

      

    

    ARTICLE
      21

    NOTICES

    

    Any
      notice, request, demand or other communication to be given or made to either
      PARTY shall, unless otherwise expressly provided herein or subsequently
      agreed to in writing, be deemed to have been delivered upon the fifth (5th)
      business day after having been deposited in first class airmail, postage
      prepaid, return receipt requested, in an envelope addressed, or if sent by
      confirmed telefax (with a mailed copy as aforesaid) or by express mail courier
      with confirmed receipt, the next business day after transmitted, to the
      following:

     

    
      
        	 	
                If
                  to SHINYAKU:

              	
                Licensing
                  & Business Development Dept.

              
	 	 	
                NIPPON
                  SHINYAKU CO., LTD.

              
	 	 	
                14,
                  Nishinosho-monguchi-cho
                  Kisshoin, Minami-ku,

              
	 	 	
                Kyoto
                  601-8550, JAPAN

              
	 	 	
                Telefax:
                  +81-75-321-9019

              
	 	 	 
	 	
                If
                  to INNOVIVE:

              	
                Business
                  Development

              
	 	 	
                INNOVIVE
                  PHARMACEUTICALS, INC.

              
	 	 	
                555
                  Madison Avenue, 25th
                  Floor, New York, NY 10022

              
	 	 	
                Telefax:
                  +1-212-716-1811

              

      

    

     

    The
      PARTIES shall designate contact persons to communicate with respect to normal
      activities associated with the DEVELOPMENT PROGRAM, ADRs and marketing
      activities.

    

    

    ARTICLE
      22

    FORCE
      MAJEURE

    

    Neither
      PARTY hereto shall be liable to the other PARTY for any failure or delay in
      the
      performance of any of its obligations hereunder for the period and to the extent
      such a failure or delay is caused by riots, civil commotion, wars, hostilities,
      laws, orders, regulations, embargoes, action by the government or any government
      agency, acts of God, earthquakes, floods, storms, fires, accidents, explosions,
      epidemics, quarantine restrictions, or other similar or different contingencies
      beyond the reasonable control of the respective PARTIES. The PARTY affected
      shall immediately notify the other of the circumstances and shall take such
      a
      reasonable action as may be necessary to avoid, minimize or remove the cause
      of
      such a non-performance.

    

    
      
        
        

      

      
        41

        
          

        

      

      
        
        

      

    

    ARTICLE
      23

    ASSIGNMENT

    

    This
      Agreement, licenses granted hereby or any of rights, duties and obligations
      hereof shall not be assigned by either PARTY hereto either totally or in part,
      to any third party without the prior written consent of the other PARTY;
      provided, however, that INNOVIVE or SHINYAKU may without such a consent but
      with
      prior written notice to the other PARTY, assign this Agreement and its rights
      and obligations hereunder: (i) to an AFFILIATE; or (ii) in the event of its
      sale
      of substantially all of its assets, merger, consolidation, change in control
      or
      similar transaction. Any permitted assignee shall assume all obligations of
      its
      assignor under this Agreement. The rights and obligations of the PARTIES under
      this Agreement shall inure to the benefit of and shall be binding upon the
      successors and assignees of the PARTIES.

    

    

    ARTICLE
      24

    WAIVER

    

    The
      failure on the part of SHINYAKU or INNOVIVE to exercise or enforce any rights
      conferred upon it hereunder shall not be deemed to be a waiver of any such
      rights nor a bar of the exercise or enforcement thereof at any time or times
      thereafter.

     

    
      
        
        

      

      
        42

        
          

        

      

      
        
        

      

    

    ARTICLE
      25

    GOVERNING
      LAW

    

    This
      Agreement shall be governed and construed under the laws of the State of New
      York in the United States.

    

    

    ARTICLE
      26

    DISPUTE
      RESOLUTION

    

    
      	
              26.1

            	
              Negotiation
                of PARTIES.
                In the event of any dispute, claim or controversy arising out of,
                relating
                to or in any way connected to the interpretation of any provision
                of this
                Agreement, the performance of either PARTY under this Agreement or
                any
                other matter under this Agreement, including any action in tort,
                contract
                or otherwise, at equity or law (a “Dispute”), either PARTY may at any time
                provide the other PARTY written notice specifying the terms of such
                Dispute in reasonable detail. As soon as practicable after receipt
                of such
                notice, the Chief Executive Officers of both INNOVIVE and SHINYAKU
                (“Heads”) shall meet at a mutually agreed upon time and location for the
                purpose of resolving such Dispute. The Heads shall engage in good
                faith
                discussions and/or negotiations for a period of up to thirty (30)
                days to
                resolve the Dispute or negotiate an interpretation or revision of
                the
                applicable portion of this Agreement which is mutually agreeable
                to both
                PARTIES, without the necessity of formal procedures relating
                thereto.

            

    

    

    
      	
              26.2

            	
              Arbitration.
                In the event any Dispute is not resolved by the Heads pursuant to
                Section 26.1, then the PARTIES shall resolve such Dispute by final
                and binding arbitration in accordance with the Rules of Conciliation
                and
                Arbitration of the International Chamber of Commerce except to the
                extent
                such rules are inconsistent with this ARTICLE 26. The arbitration
                shall be
                held in English in New York, United States if requested by SHINYAKU,
                and
                in Osaka, Japan if requested by INNOVIVE. Whenever a PARTY decides
                to
                institute arbitration proceedings, it shall give written notice to
                that
                effect to the other PARTY. Any arbitrator chosen hereunder shall
                have
                educational training and industry experience sufficient to demonstrate
                a
                reasonable level of relevant scientific, financial, medical and industry
                knowledge. Any arbitrator eligible to conduct the arbitration must
                agree
                to render his or her opinion within thirty (30) days of the final
                arbitration hearing. No arbitrator (nor the panel of arbitrators)
                shall
                have the power to award punitive damages under this Agreement regardless
                of whether any such damages are contained in a Proposal, and such
                award is
                expressly prohibited. The proceedings and decisions of the arbitrators
                shall be confidential, final and binding on all of the Parties. Judgment
                on the award so rendered may be entered in a court having jurisdiction
                thereof. Each PARTY shall bear its own attorneys’ fees for the
                arbitration. The PARTIES shall share equally the costs of arbitration.
                Nothing in this Section 26.2 will preclude either PARTY from seeking
                equitable relief or interim or provisional relief from a court of
                competent jurisdiction, including a temporary restraining order,
                preliminary injunction or other interim equitable relief, concerning
                a
                Dispute either prior to or during any arbitration if necessary to
                protect
                the interests of such PARTY or to preserve the status quo pending
                the
                arbitration proceeding. 

            

    

    

    

    
      
        
        

      

      
        43

        
          

        

      

      
        
        

      

    

    ARTICLE
      27

    ENTIRE
      AGREEMENT

    

    This
      Agreement constitutes the entire agreement by and between the PARTIES hereto
      with respect to any and all subject matter covered herein and shall supersede
      all previous negotiations, understandings and agreements between the PARTIES
      relating thereto. This Agreement may be amended, modified, altered, or changed
      only by written instrument duly executed by authorized representatives of the
      PARTIES hereto.

    

    

    ARTICLE
      28

    MISCELLANEOUS

    

    
      	
              28.1

            	
              Publicity.
                Neither PARTY shall issue any press release or other publicity material
                or
                make representation which refers to the terms of this Agreement without
                the prior written consent of the other PARTY. However, this restriction
                shall not apply to announcements required by law or regulations including
                without limiting announcements to be made to the shareholders of
                either
                PARTY and to any Stock Exchange on which the shares or other securities
                of
                such a PARTY are quoted or listed. It is, however, the PARTIES’ intent
                that they shall co-ordinate to such an extent as may be reasonably
                possible with respect to the wording of any such
                announcements.

            

    

    

    
      	
              28.2

            	
              Agreement
                Language.
                The English language version of this Agreement shall be controlling
                in all
                respects, notwithstanding any translation hereof made for any purpose
                whatever. All communications and notices, assistance, disclosure
                and
                technical information permitted or intended hereunder among the PARTIES
                shall be in English.

            

    

    

    
      	
              28.3

            	
              Late
                Payments.
                Unless otherwise provided in this Agreement, INNOVIVE shall pay interest
                to SHINYAKU on the aggregate amount of any undisputed payments by
                INNOVIVE
                that are not paid on or before the date such payments are due under
                this
                Agreement, at a rate of [*] percent ([*]%) per annum, calculated
                on the
                number of days such payment is
                delinquent.

            

    

    

    
      	
              28.4

            	
              Conflict
                with Applicable Law.
                Should any part of this Agreement be in conflict with any applicable
                law,
                all other provisions of this Agreement shall remain in force and
                the
                PARTIES hereto shall mutually and in good faith modify the conflicting
                provisions so as to maintain essentially the spirit hereof and the
                original intent of the PARTIES.

            

    

    

    
      	
              28.5

            	
              §365(n)
                Acknowledgement.
                All rights and licenses now or hereafter granted under or pursuant
                to any
                Section of this Agreement, including ARTICLE 2, are rights to
                “intellectual property” (as defined in Section 101(35A) of Title 11
                of the United States Code, as amended (such Title 11, the “Bankruptcy
                Code”)). Each PARTY hereby grants to the other PARTY and all of said
                PARTY’s AFFILIATES a right of access and to obtain possession of and to
                benefit from (i) SHINYAKU 

            

    

     

    [*]
      Confidential treatment requested; certain information omitted and filed
      separately with the SEC.

    

    
      
        
        

      

      
        44

        
          

        

      

      
        
        

      

    

    TECHNICAL
      INFORMATION and INNOVIVE TECHNICAL INFORMATION, (ii) copies of research data,
      (iii) laboratory samples, (iv) product samples and inventory, (v) formulas,
      (vi)
      laboratory notes and notebooks, (vii) data and results related to clinical
      trials, (viii) regulatory filings and approvals, (ix) rights of reference in
      respect of regulatory filings and approvals, (x) pre-clinical research data
      and
      results, and (xi) marketing, advertising and promotional materials, all  of
      which constitute “embodiments” of intellectual property pursuant  to
      Section 365(n) of the Bankruptcy Code, and (xii) all other
 embodiments of such intellectual property, whether any of the
 foregoing are in either PARTY’s possession or control or in the
 possession and control of third parties. Each PARTY agrees not to
 interfere with the exercise by the other PARTY, its AFFILIATES, and its
 SUBLICENSEES of rights and licenses to intellectual property licensed
 hereunder and embodiments thereof in accordance with this  Agreement
      and agrees to use commercially reasonable efforts to  assist the other
      PARTY, its AFFILIATES, and its SUBLICENSEES to obtain  such intellectual
      property and embodiments thereof in the  possession or control of third
      parties as reasonably necessary or  desirable for either PARTY, its
      AFFILIATES and its SUBLICENSEES to  exercise such rights and licenses in
      accordance with this  Agreement. Notwithstanding anything to the contrary
      herein, the  acknowledgement of this section 28.5 and the associated rights
      of  access granted herein are limited to each PARTY’s rights and
 licenses granted under this agreement.

    

    The
      PARTIES hereto acknowledge and agree that all payments by INNOVIVE to SHINYAKU
      hereunder, other than royalty payments pursuant to Section 5.4, do not
      constitute royalties within the meaning of Bankruptcy Code §365(n) or relate to
      licenses of intellectual property hereunder.

    

    ARTICLE
      29

    COUNTERPARTS

    

    This
      Agreement may be executed in two counterparts, each of which shall be deemed
      an
      original, but all of which together shall constitute one and the same
      instrument.

     

    
      
        
        

      

      
        45

        
          

        

      

      
        
        

      

    

    IN
      WITNESS WHEREOF, the PARTIES have made out two originals in English and have
      executed them by their duly authorized representatives.

    

    
      	NIPPON SHINYAKU CO., LTD. 	 	 	INNOVIVE PHARMACEUTICALS,
              INC. 
	 	 	 	 
	 	 	 	 
	By: 	 	 	By: 
	
              
                

              
Kazuto Hatsuyama	 	 	
              
                

              
Steven Kelly
	Title: President	 	 	Title: President
              and CEO
	Date: 	 	 	Date: 
	
              
                
  

            	 	 	
              
                
  

            

    

     

       

    
      
        
        

      

      
        46

        
          

        

      

      
        
        

      

    

    
      SCHEDULE
        1(G)

      DEVELOPMENT
        PROGRAM

    

     

    [*]

     

    [*]
      Confidential treatment requested; certain information omitted and filed
      seperately with the SEC.

    

    

    
      
        
        

      

      
        47

        
          

        

      

      
        
        

      

    

    SCHEDULE
      1(X)

    SHINYAKU
      PATENT

    

    [*]

     

    
      
        
          	
                  Country

                	
                  Application
Date

                	
                  Application
                    No.

                	
                  Publication
date

                	
                  Publication
                    No.

                	
                  Grant
Date

                	
                  Grant
No.

                
	
                  PCT

                	
                  [*]

                	
                  [*]

                	
                  [*]

                	
                  [*]

                	 	 
	
                  Brazil

                	
                  [*]

                	
                  [*]

                	 	 	 
	
                  Canada

                	
                  [*]

                	 	 	 	 
	
                  China

                	
                  [*]

                	 	 	 	 
	
                  EP

                	
                  [*]

                	
                  [*]

                	
                  [*]

                	 	 
	
                  Japan

                	
                  [*]

                	 	 	 	 
	
                  Korea

                	
                  [*]

                	 	 	 	 
	
                  Mexico

                	
                  [*]

                	 	 	 	 
	
                  Russia

                	
                  [*]

                	 	 	 	 
	
                  United
                    States

                	
                  [*]

                	 	 	 	 

        

      

Priority
      Date: [*]

    

    When
      the application has been granted a patent in EP, it will be entered into the
      following designated countries: Germany, France, the United Kingdom, Italy,
      Spain, Belgium, Holland, Switzerland, Sweden, Austria, Portugal, Greece,
      Finland, Denmark, Turkey, Luxemburg, Monaco, Ireland, and Hungary.

    

     

     

    [*]
      Confidential treatment requested; certain information omitted and filed
      separately with the SEC.

    
      
        
        

      

      
        48

        
          

        

      

      
        
        

      

    

    [*]

    

    
      	
              Country

            	
              Application
Date

            	
              Application
                No.

            	
              Publication
date

            	
              Publication
                No.

            	
              Grant
                Date

            	
              Grant
                No.

            
	
              PCT

            	
              [*]

            	
              [*]

            	
              [*]

            	
              [*]

            	 	 

    

    Priority
      Date: [*]

    

    The
      application will be entered into the following countries at the national phase:
      Japan, the United States, Canada, China, Korea, Brazil, Mexico, Russia,
      Australia, India, Germany,
      France, the United Kingdom, Italy, Spain, Belgium, Holland, Switzerland, Sweden,
      Austria, Portugal, Greece, Finland, Denmark, Turkey, Poland, Luxemburg, Monaco,
      Ireland, and Hungary.

    

    

    
 

    [*]
      Confidential treatment requested; certain information omitted and filed
      separately with the SEC.

    
      
        
        

      

      
        49

        
          

        

      

      
        
        

      

    

    SCHEDULE
      13.3(b)

    INNOVIVE
      PATENT COUNTRIES

    
 

     

    
      
        
        

      

      
        50Form of Amended Stock Option Agreement between Xenomics, Inc. and Christoph
      Bruening dated April 18, 2006

     

    Exhibit
      10.1

    XENOMICS,
      INC.

    

    AMENDED
      STOCK OPTION GRANT AGREEMENT

    FOR
      NONSTATUTORY STOCK OPTIONS

    

    Xenomics,
      Inc., a Florida corporation (the “Company”)
      hereby
      amends as of April 18, 2006 the January 16, 2006 option (the “Option”)
      grant
      to Christoph
      Bruening
      (the
“Optionee”),
      that
      is NOT intended to qualify as an incentive stock option (“ISO”)
      pursuant to Section 422(b) of the Internal Revenue Code, to purchase shares
      of
      the Company’s common stock (“Stock”)
      in the
      number and subject to terms and conditions of this Stock Option Grant Agreement
      (the “Grant
      Agreement”),
      the
      Company’s 2004 Stock Option Plan (the “Plan”)
      and
      the Terms of Option Agreement for Nonstatutory Stock Options (the “Option
      Agreement”).
      The
      provisions of the Plan and the Option Agreement are incorporated herein by
      reference, and copies of the Plan and Option Agreement have been given to
      Optionee. The following are the general terms of the Option for shares of Stock
      (“Option
      Shares”)
      granted to Optionee by this Grant Agreement.

    

    The
      grant
      date of the Option (“Grant
      Date”)
      is
January
      16, 2006.

    

    The
      number of Option Shares granted to Optionee is 40,000
      shares
      of Stock.

    

    The
      exercise price (“Exercise
      Price”)
      at
      which Optionee can purchase Option Shares is $1.80
      per
      share.

    

    This
      Option shall be immediately vested.

    

    Notwithstanding
      Section 6 of the Option Agreement and Section 6.6 of the Plan, this Option
      shall
      expire, and be of no further force or effect, on the tenth anniversary of the
      Grant Date.

    

    Net
      Exercise is available to Optionee.

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    The
      Optionee represents that he/she is familiar with the terms and provisions of
      the
      Option Agreement, including the Unvested Share Repurchase Option, and hereby
      accepts this Option subject to all of the terms and provisions thereof. The
      Optionee hereby agrees to accept as binding, conclusive and final all decisions
      or interpretations of the Board upon any questions arising under the Option.
      The
      Optionee acknowledges receipt of a copy of the Plan. 

     

    
      	OPTIONEE	XENOMICS, INC.
	 	 
	 	 
	________________________	By:_______________
	 	 
	Address:_________________	Its:_______________
	________________________

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