Document:

Unassociated Document

    Exhibit
      10.38

    

    Portions
      herein identified by [***] have been omitted pursuant to a request for
      confidential treatment under Rule 406 of the Securities Act of 1933, as amended.
      A complete copy of this document has been filed separately with the Securities
      and Exchange Commission.

    

    RESEARCH
      AND LICENSE AGREEMENT

     

    This
      Agreement is entered into as of October 10, 2006 (“Effective Date”), by and
      between Albert Einstein College of Medicine of Yeshiva University, a Division
      of
      Yeshiva University, a corporation organized and existing under the laws of
      the
      State of New York, having an office and place of business at 1300 Morris Park
      Avenue, Bronx, New York 10461 (“AECOM”) and Hana Biosciences, Inc., a
      corporation organized and existing under the laws of the State of Delaware,
      having an office and place of business at 7000 Shoreline Court, Suite 370,
      South
      San Francisco, CA 94080 (“Licensee”).

     

    Statement

     

    AECOM
      has
      established a laboratory directed by Dr. Roman Perez-Soler (“the Investigator”)
      to conduct research relating, in part, to the use of Vitamin K for prevention
      and treatment of skin rash secondary to anti-EGFR therapy. Licensee wishes
      to
      provide financial support for a research project to be conducted by AECOM in
      the
      Investigator’s laboratory and wishes to acquire an exclusive license in the
      Field (as defined below) from AECOM with respect to certain patent rights
      resulting from such research and certain other patent rights of AECOM, as
      described herein.

     

    NOW,
      THEREFORE, in consideration of the promises and mutual covenants, conditions
      and
      limitations herein contained and other good and valuable consideration, the
      receipt and sufficiency of which is hereby acknowledged, AECOM and Licensee
      agree as follows:

     

    1. Definitions

     

    
      	
              1.01

            	
              “Field”
                means any and all uses of the Agreement
                Patents.

            

    

     

    
      	
              1.02

            	
              “Agreement
                Patents”
                means (1) the provisional and international patent applications listed
                on
                Appendix A, together with any and all patents which issue from or
                are
                based on such patent applications and from any and all divisionals,
                continuations, continuations-in-part and foreign counterparts of
                such
                patent applications, and any and all reissues, renewals and extensions
                or
                the like of such patents and any and all U.S. and foreign patents
                which
                are based on such patents and patent applications; and (2) any and
                all
                Future Inventions. Appendix A shall be updated from time-to-time
                by the
                parties.

            

    

     

    
      
         

      

      
        
        

        
          

        

      

      
         

      

    

     

     

    
      	
              1.03

            	
              “Future
                Inventions”
                means future patents and patent applications owned by AECOM which
                (a) name
                the Investigator as an inventor, and (b) result from the Research
                Project
                and (c) relate to prevention and treatment of skin rash secondary
                to
                anti-EGFR therapy.

            

    

     

    
      	
              1.04

            	
              “Licensed
                Product”
                means any product or service in the Field, the development, manufacture,
                use, provision or sale of which is covered by a claim in an Agreement
                Patent.

            

    

     

    
      	
              1.05

            	
              “Net
                Sales”
                means the total consideration, in any form, received by Licensee,
                Affiliates and Sublicensees as consideration for the sale, lease,
                provision or other disposition of Licensed Products by Licensee and/or
                Affiliates and/or Sublicensees to an independent third party,
                less:

            

    

     

    
      	 	
              (a)

            	
              customary
                and reasonable trade discounts actually allowed, refunds, returns
                and
                recalls; and,

            

    

     

    
      	 	
              (b)

            	
              when
                included in gross sales, customary and reasonable freight, shipping,
                duties, and sales, V.A.T. and/or use taxes based on sales prices,
                but not
                including taxes when assessed on incomes derived from such
                sales.

            

    

     

    If
      Licensee and/or Affiliates and/or Sublicensees accepts from independent third
      parties any non-cash consideration as Net Sales or provides Licensed Products
      at
      no charge or at a reduced charge (e.g. in connection with the sale of anti-EGFR
      therapies), Licensee shall provide written notice of same to AECOM. For any
      non-cash consideration received as Net Sales or any provision of Licensed
      Products at no charge or at a reduced charge, the parties will determine the
      present day value of such consideration or reduction and that value shall be
      added to Net Sales in place of the non-cash consideration or reduction. If
      the
      parties are unable to agree on such value, then the parties shall appoint and
      share the cost of an independent third party to make such determination, which
      determination shall be binding on the parties.

     

    
      
         

      

      
        2

        
          

        

      

      
         

      

    

     

    

     

     

    In
      the
      event that, during a particular calendar quarter, a Licensed Product is sold
      in
      combination with one or more other products, whether or not such other products
      are packaged or otherwise physically combined with such Licensed Product, for
      a
      single price (a “Combination Product”), Net Sales from sales of a Combination
      Product, for purposes of calculating royalties due under this Agreement, shall
      be calculated by multiplying the Net Sales of the Combination Product by the
      fraction A/(A+B), where A is the average per unit sales price for such calendar
      quarter of the Licensed Product sold separately in the country of sale and
      B is
      the average per unit sales price for such calendar quarter of the other
      product(s) sold separately in the country of sale. In the event that no separate
      sales are made of the Licensed Product and/or the other product(s) in the
      country of sale, separate sale prices in commensurate countries may be used
      instead. In the event that no separate sales are made of the Licensed Product
      and/or the other product(s), Net Sales from sales of a Combination Product,
      for
      purposes of determining royalty payments on such Combination Products, shall
      be
      calculated using a method to be agreed to by the parties. If the parties are
      unable to agree on a method or on the resulting calculation, then the parties
      shall appoint and share the expense of an independent third party to make such
      calculation, which calculation shall be binding on the parties.

     

    
      	
              1.06

            	
              “Net
                Proceeds”
                shall mean the total consideration, in any form (including, but not
                limited to, license signing fees, maintenance fees, milestone and
                minimum
                payments, whether or not such fees and payments are creditable against
                future royalties to be paid to Licensee, research and development
                funds
                other than Contract Research, and just that portion of the funds
                received
                for equity purchases of Licensee which exceeds the fair market value
                of
                the equity), but excluding royalties based on Net Sales of Sublicensees,
                that is received by Licensee from a Sublicensee in connection with
                the
                grant to said Sublicensee of rights under the Agreement Patents.
                For any
                non-cash consideration received as Net Proceeds, the parties will
                determine the present day value of such consideration and that value
                shall
                be added to Net Proceeds in place of the non-cash consideration.
                If the
                parties are unable to agree on such value, then the parties shall
                appoint
                and share the cost of an independent third party to determine the
                present
                day value of such consideration, which determination shall be binding,
                and
                that value shall be added to Net Proceeds in place of the non-cash
                consideration. Notwithstanding anything to the contrary contained
                herein,
                Net Proceeds does not include (i) Contract Research and (ii) loans
                to
                Licensee and its Affiliates by a Sublicensee relating to the Agreement
                Patents, except to the extent the interest charged for such loan
                is less
                than the fair market value (in which case only such difference between
                the
                payment due at fair market value and the payment made by Licensee
                shall
                constitute Net Proceeds) or to the extent that the principal of a
                loan is
                forgiven (in which case only such forgiven amount shall constitute
                Net
                Proceeds).

            

    

     

    
      
         

      

      
        3

        
          

        

      

      
         

      

    

     

    
      	
              1.07

            	
              “Affiliate”
                means any entity, that, directly or indirectly, through one or more
                intermediates, controls, is controlled by, or is under common control
                with
                Licensee. For the purposes of this definition, control shall mean
                the
                direct or indirect ownership of at least fifty percent (50%) of (i)
                the
                stock shares entitled to vote for the election of directors or (ii)
                ownership interest.

            

    

     

    
      	
              1.08

            	
              “Sublicensee”
                shall mean any non-Affiliate third party to whom Licensee has granted
                the
                right to make and sell (or otherwise dispose of) Licensed
                Products.

            

    

     

    
      	
              1.09

            	
              “Contract
                Research”
                shall mean those funds received by Licensee from a Sublicensee in
                connection with the grant to said Sublicensee of rights under Agreement
                Patents, which funds are actually used to pay for research and/or
                development by Licensee relating directly to Licensed Products, which
                work
                is to be performed by or for Licensee after the date of the sublicense
                agreement and with results to be reported to and licensed to Sublicensee
                and which is to be performed at a total cost that does not exceed
                Licensee’s direct costs. Notwithstanding the foregoing, Contract Research
                funds received from a Sublicensee which are in excess of [***] percent
                ([***]%) of the total consideration received by Licensee from that
                Sublicensee in any calendar year shall be excluded from the definition
                of
                Contract Research and included in the definition of Net Proceeds,
                unless
                otherwise approved at the time of execution of the relevant sublicense
                by
                AECOM.

            

    

     

    
      
         

      

      
        4

        
          

        

      

      
         

      

    

     

    
      	
              1.10

            	
              “Confidential
                Information”
                means any information designated as such in writing by the disclosing
                party, whether by letter or by the use of an appropriate proprietary
                stamp
                or legend, prior to or at the time any such confidential or proprietary
                materials or information are disclosed by the disclosing party to
                the
                recipient. Notwithstanding the foregoing, information or materials
                which
                are orally or visually disclosed to the recipient by the disclosing
                party,
                or are disclosed in a writing or other tangible form without an
                appropriate letter, proprietary stamp or legend, shall constitute
                Confidential Information if the disclosing party, within thirty (30)
                days
                after such disclosure, delivers to the recipient a written document
                or
                documents describing such information or materials and referencing
                the
                place and date of such oral, visual, written or other tangible
                disclosure.

            

    

     

    
      	
              1.11

            	
              “Research
                Project”
                means research work as defined in Appendix B as well as in amendments
                and
                modifications of Appendix B which are mutually agreed upon in writing
                by
                AECOM and Licensee, the purpose of which is to support the filing on an
                investigational new drug application (“IND”) with the U.S. Food and Drug
                Administration and the commercial development of the Licensed
                Product(s).

            

    

     

    
      	
              2.

            	
              AECOM’s
                Agreements With U.S.
                Government

            

    

     

    
      	
              2.01

            	
              AECOM,
                through its Investigator, has and will perform research sponsored
                in part
                by the United States Government and related to the prevention and
                treatment of skin rash secondary to anti-EGFR therapy. As a result
                of this
                government sponsorship of the aforementioned research, the United
                States
                Government retains certain rights in such research as set forth in
                35
                U.S.C. §200 et. seq. and applicable
                regulations.

            

    

     

    
      	
              2.02

            	
              The
                continuance of such government sponsored research by AECOM and its
                Investigator during the term of this Agreement will not constitute
                a
                breach of this Agreement. All rights reserved to the U.S. Government
                under
                35 U.S.C. §200 et. seq. and applicable regulations shall remain so
                reserved and shall in no way be affected by this Agreement. AECOM
                and its
                Investigator are not obligated under this Agreement to take any action
                which would conflict in any respect with their past, current or future
                obligations to the U.S. Government as to work already performed and
                to be
                performed in the future.

            

    

     

    
      
         

      

      
        5

        
          

        

      

      
         

      

    

     

    
      	
              3.

            	
              Agreement
                Patents

            

    

     

    
      	
              3.01

            	
              Within
                thirty (30) days of the Effective Date Licensee will reimburse AECOM
                for
                all expenses (not to exceed US$[***]) incurred prior to the Effective
                Date
                in connection with the preparation, filing, prosecution and maintenance
                of
                the Agreement Patents. Amounts paid by Licensee pursuant to this
                paragraph
                are non-refundable and not creditable against any other payment due
                to
                AECOM. 

            

    

     

    
      	
              3.02

            	
              As
                of and after the Effective Date, Licensee will pay the cost of preparing,
                filing, prosecuting, maintaining and resisting challenges to the
                validity
                of the Agreement Patents (as well as the cost of preparing, filing,
                prosecuting, maintaining and resisting challenges to the validity
                of
                corresponding applications in at least the United States, Europe
                (an EPO
                filing designating all member countries), Canada, Japan, and Australia)
                using patent counsel selected by Licensee and approved by AECOM,
                which
                approval shall not be unreasonably withheld (“Patent Counsel”). In this
                regard, Licensee will pay the cost of defending and/or prosecuting
                any
                interference, reexamination, reissue, opposition, cancellation and
                nullity
                proceedings involving Agreement Patents. Licensee shall provide direction
                to Patent Counsel regarding the preparation, filing, prosecution,
                maintenance and defense of the Agreement Patents and Patent Counsel
                shall
                keep AECOM informed concerning such patents and applications. The
                parties
                agree to consult with each other concerning the preparation, filing,
                prosecution, maintenance and challenges to the validity of such patents
                and applications. Each party shall cooperate with any reasonable
                request
                of the other in connection with any such preparation, filing, prosecution,
                maintenance and/or defense. In the event that Licensee elects not
                to
                maintain, defend or prosecute any patent or patent application within
                the
                Agreement Patents, Licensee shall give AECOM thirty (30) days prior
                written notice of such election. Any patents or patent applications
                so
                elected shall at the end of the notice period cease to be considered
                Agreement Patents, and AECOM shall then be free, at its election,
                to
                abandon or maintain the prosecution of such patent application or
                issued
                patent or grant rights to such patent application or issued patent
                to
                third parties.

            

    

     

    
      
         

      

      
        6

        
          

        

      

      
         

      

    

     

    
      	
              3.03

            	
              AECOM
                will promptly disclose to the Licensee any potential Future Inventions.
                Within thirty (30) business days of Licensee’s receipt of a disclosure of
                a Future Invention, Licensee shall determine whether it desires that
                a
                patent application should be prepared and filed on such Future Invention
                and shall provide written notification to that effect to AECOM. Following
                a determination by Licensee that it desires that a patent application
                be
                prepared and filed, Licensee will direct Patent Counsel to prepare
                and
                file a patent application in consultation with AECOM, which application
                will be filed within thirty (30) business days of such determination.
                Licensee will pay the cost of preparing, filing, prosecuting and
                maintaining and resisting challenges to the validity of such patent
                applications and patents. Licensee shall provide direction to Patent
                Counsel regarding the preparation, filing, prosecution, maintenance
                and
                defense of such patent applications and patents and Patent Counsel
                shall
                keep AECOM informed concerning such applications and patents. The
                parties
                agree to consult with each other concerning the preparation, filing,
                prosecution, maintenance and challenges to the validity of such
                applications and patents. Each party shall cooperate with any reasonable
                request of the other in connection with any such preparation, filing,
                prosecution, maintenance and/or defense. Such applications and patents
                will be included in the definition of Agreement Patents and added
                to
                Appendix A. In the event that Licensee determines not to file a patent
                application on any Future Invention or otherwise fails to provide
                written
                notification within the timeframe indicated above, (i) the definition
                of
                Agreement Patents will not be amended to include any patent application
                filed on such Future Invention, and (ii) AECOM shall be free to exploit
                such Future Invention with no further obligation to
                Licensee.

            

    

     

    
      
         

      

      
        7

        
          

        

      

      
         

      

    

     

    
      	
              3.04

            	
              Amounts
                paid by Licensee pursuant to Sections 3.02 and 3.03 will be non-refundable
                and not creditable against any other payment due to
                AECOM.

            

    

     

    
      	
              4.

            	
              Research
                Project 

            

    

     

    
      	
              4.01

            	
              AECOM,
                through the Investigator, will conduct the two year Research Project
                and
                AECOM will be solely responsible for the governance of the Research
                Project.

            

    

     

    
      	
              4.02

            	
              AECOM
                and Licensee shall inform each other of any developments that might
                affect
                the Research Project, and shall supply or provide to each other for
                the
                duration of the Research Project any and all relevant materials,
                documentation or information that might be required for the best
                performance of the Research Project. The coordination of decisions
                and the
                exchange of information between the two companies shall be undertaken
                by
                Investigator (for AECOM) and initially by Mark J. Ahn (for
                Licensee).

            

    

     

    
      	
              4.03

            	
              AECOM
                shall keep Licensee informed of the progress and results of the Research
                Project by submitting a written summary report to Licensee every
                six (6)
                months following the Effective
                Date.

            

    

     

    
      	
              4.04

            	
              AECOM
                shall promptly inform Licensee of any invention, discovery, technology,
                device, process or formulation resulting from the Research Project,
                whether or not patentable, but excluding a Future Invention (a “Research
                Project Invention”). Licensee shall then have an exclusive six month
                period from the date of AECOM’s notice to Licensee in which to negotiate a
                license from AECOM of its rights relating to such Research Project
                Invention. The parties shall negotiate the terms of such license
                in good
                faith.

            

    

     

    
      	
              5.

            	
              Research
                Funding

            

    

     

    
      	
              5.01

            	
              In
                consideration of the performance of the Research Project by AECOM,
                Licensee will pay AECOM the sum of [***] Dollars (US$[***]). This
                sum
                shall be deemed to include any applicable tax and overhead and shall
                be
                paid in two installments as set out in the following
                paragraph.

            

    

     

    
      
         

      

      
        8

        
          

        

      

      
         

      

    

     

    
      	
              5.02

            	
              Licensee
                will pay AECOM [***] Dollars (US$[***]) within thirty (30) days of
                the
                Effective Date, and [***] (US$[***]) within [***] ([***]) months
                of the
                Effective Date.

            

    

     

    
      	
              5.03

            	
              AECOM
                will not incur any expense in excess of the amounts budgeted without
                first
                obtaining written authorization from
                Licensee.

            

    

     

    
      	
              5.04

            	
              If
                the Investigator should discontinue working for AECOM, AECOM has
                the right
                to name an alternative. If the alternative is not reasonably acceptable
                to
                Licensee, Licensee has the right to terminate the research part of
                the
                present Agreement without affecting the license part of the present
                Agreement, provided, however, that Licensee shall reimburse AECOM
                for any
                uncancellable salary expenses that AECOM has committed to pay for
                personnel working on the Research
                Project.

            

    

     

    
      	
              6.

            	
              License
                Grant

            

    

     

    
      	
              6.01

            	
              Subject
                to Article 2, AECOM hereby grants to Licensee and Affiliates a worldwide,
                exclusive license, with the right by Licensee only to grant sublicenses
                to
                unaffiliated third parties, under AECOM’s rights in the Agreement Patents
                to import, make, have made, use, provide, offer to sell, and sell
                Licensed
                Products. Licensee will not grant or amend any sublicense under Agreement
                Patents unless it first submits a full and complete draft of any
                such
                proposed sublicense or amendment (as the case may be) to AECOM and
                then
                receives the prior written consent of AECOM, which consent will not
                be
                unreasonably withheld or delayed. Licensee shall provide AECOM with
                a full
                and complete copy of any approved sublicense or amendment within
                thirty
                (30) days of execution thereof by Licensee, which sublicense and
                amendment
                shall be treated as Licensee Confidential Information under Article
                7. The
                terms of any sublicense agreement shall not contradict the terms
                of this
                Agreement and shall include (at least) the following provisions:
                prohibiting any use of AECOM’s name (consistent with Section 11.01),
                requiring indemnification of AECOM (consistent with Section 14.04),
                requiring appropriate insurance (consistent with Section 14.09),
                and
                disclaiming any warranties or representations by AECOM (consistent
                with
                Sections 14.05 and 14.06).

            

    

     

    
      
         

      

      
        9

        
          

        

      

      
         

      

    

     

    
      	
              6.02

            	
              Notwithstanding
                the exclusive rights granted to Licensee pursuant to Section 6.01,
                AECOM
                shall retain the right to make, use and practice Agreement Patents
                in its
                own laboratories solely for non-commercial scientific purposes and
                for
                continued non-commercial research. Further, AECOM shall have the
                right to
                make available to not-for-profit scientific institutions and
                non-commercial researchers materials covered under Agreement Patents,
                solely for non-commercial scientific and research purposes, provided
                this
                is done under a material transfer
                agreement.

            

    

     

    
      	
              6.03

            	
              Nothing
                contained in this Agreement shall be construed or interpreted as
                a grant,
                by implication or otherwise, of any license except as expressly specified
                in Section 6.01 hereof. The license granted herein shall apply to
                the
                Licensee and Affiliates, except that Affiliates shall not have the
                right
                to grant sublicenses. If any Affiliate exercises rights under this
                Agreement, such Affiliate shall be bound by all terms and conditions
                of
                this Agreement, including but not limited to indemnity and insurance
                provisions, which shall apply to the exercise of the rights, to the
                same
                extent as would apply had this Agreement been directly between AECOM
                and
                the Affiliate. In addition, Licensee shall remain fully liable to
                AECOM
                for all acts and obligations of Affiliates such that acts of Affiliates
                shall be considered the acts of
                Licensee.

            

    

     

    
      	
              7.

            	
              Confidentiality

            

    

     

    
      	
              7.01

            	
              Nothing
                herein contained shall preclude AECOM from making required reports
                or
                disclosures to the NIH or to any other philanthropic or governmental
                funding organization, provided, however, that no Licensee Confidential
                Information is disclosed in the
                process.

            

    

     

    
      	
              7.02

            	
              Licensee
                will retain in confidence Confidential Information of AECOM and Licensee
                will not disclose any such Confidential Information to any third
                party
                without the consent of AECOM, except that Licensee shall have the
                right to
                disclose such information to any third party for commercial or research
                and development purposes under written terms of confidentiality and
                non-disclosure which are commercially reasonable. Licensee will keep
                confidential all Confidential Information of AECOM for a period of
                five
                (5) years after termination or expiration of this Agreement, provided,
                however, that the obligation of confidentiality will not apply to
                any such
                information which:

            

    

     

    
      
         

      

      
        10

        
          

        

      

      
         

      

    

     

    
      	 	
              (a)

            	
              was
                known to Licensee or generally known to the public prior to its disclosure
                hereunder; or

            

    

     

    
      	 	
              (b)

            	
              subsequently
                becomes known to the public by some means other than a breach of
                this
                Agreement, including but not limited to publication and/or laying
                open to
                inspection of any patent applications or patents;
                or

            

    

     

    
      	 	
              (c)

            	
              is
                subsequently disclosed to Licensee by a third party having a lawful
                right
                to make such disclosure; or

            

    

     

    
      	 	
              (d)

            	
              is
                required to be disclosed by regulation, law or court order to the
                most
                limited extent necessary to comply therewith, provided AECOM is given
                a
                fair opportunity to defend against such disclosure;
                or

            

    

     

    
      	 	
              (e)

            	
              is
                independently developed by Licensee as evidenced by Licensee’s written
                records.

            

    

     

    
      	
              7.03

            	
              During
                the term of this Agreement, it is contemplated that AECOM may become
                aware
                of Confidential Information of Licensee, including without limitation,
                written, oral, visual or other proprietary and confidential business
                information, scientific information, technology, computer software,
                inventions, technical information, biological materials, processes
                and the
                like which are owned or controlled by Licensee (“Licensee Confidential
                Information”). AECOM agrees to retain such Licensee Confidential
                Information in confidence and not to disclose any such Licensee
                Confidential Information to a third party without prior written consent
                of
                Licensee for a period ending five (5) years after termination or
                expiration of this Agreement, except that such obligations shall
                not apply
                to any information which:

            

    

     

    
      	 	
              (a)

            	
              was
                known to AECOM or generally known to the public prior to its disclosure
                hereunder; or

            

    

     

    
      
         

      

      
        11

        
          

        

      

      
         

      

    

     

    
      	 	
              (b)

            	
              subsequently
                becomes known to the public by some means other than a breach of
                this
                Agreement; or

            

    

     

    
      	 	
              (c)

            	
              is
                subsequently disclosed to AECOM by a third party having a lawful
                right to
                make such disclosure; or

            

    

     

    
      	 	
              (d)

            	
              is
                required to be disclosed by regulation, law or court order to the
                most
                limited extent necessary to comply therewith, provided Licensee is
                given a
                fair opportunity to defend against such disclosure;
                or

            

    

     

    
      	 	
              (e)

            	
              is
                independently developed by AECOM as evidenced by AECOM’s written
                records.

            

    

     

    
      	
              8.

            	
              Royalties
                and Payments

            

    

     

    
      	
              8.01

            	
              Licensee
                will pay to AECOM [***] percent ([***]%) of Net Sales
                and [***] percent ([***]%) of Net Proceeds, provided however, if
                Licensee
                receives non-cash consideration as Net Proceeds and Licensee has
                insufficient cash on hand to satisfy its monetary obligations under
                this
                Agreement with respect to such non-cash consideration, then Licensee
                may
                satisfy such monetary obligations by providing to AECOM either (i)
                shares
                of its common stock representing the value of such monetary obligations
                or
                (ii) an unsecured promissory note having a principal amount equal
                to the
                value of such monetary obligations, which note will provide for the
                payment of interest and be of a term of no longer than five (5) years
                and
                will otherwise include commercially reasonable terms and conditions.
                Licensee will offer both options (i) and (ii) to AECOM and AECOM
                will
                select one of such options.

            

    

     

    
      	
              8.02

            	
              Upon
                execution of this Agreement by all parties, Licensee shall issue
                shares of
                its common stock representing One Hundred Thousand Dollars (US$100,000)
                in
                value to AECOM.
                All stock issued hereunder shall be valued at the last closing price
                on
                the date payable.

            

    

     

    
      	
              8.03

            	
              Licensee
                shall make the following license signing and license maintenance
                payments
                to AECOM:

            

    

     

    
      
         

      

      
        12

        
          

        

      

      
         

      

    

     

    
      	 	
              (a)

            	
              Within
                thirty (30) days of the Effective Date, Licensee will pay to AECOM
                [***]Dollars (US$[***]) as a license signing fee, which payment is
                non-refundable and not creditable against any other payment due to
                AECOM
                pursuant to this Agreement.

            

    

     

    
      	 	
              (b)

            	
              On
                the second anniversary of the Effective Date, Licensee will pay to
                AECOM
                [***] Dollars (US$[***]) as a license maintenance fee. This fee is
                non-refundable but is creditable against actual payments due to AECOM
                pursuant to Section 8.01 during the twelve (12) month period following
                this anniversary.

            

    

     

    
      	 	
              (c)

            	
              On
                the third anniversary of the Effective Date, Licensee will pay to
                AECOM
                [***] Dollars (US$[***]) as a license maintenance fee. This fee is
                non-refundable but is creditable against actual payments due to AECOM
                pursuant to Section 8.01 during the twelve (12) month period following
                this anniversary.

            

    

     

    
      	 	
              (d)

            	
              On
                the fourth anniversary of the Effective Date, Licensee will pay to
                AECOM
                [***] Dollars (US$[***]) as a license maintenance fee. This fee is
                non-refundable but is creditable against actual payments due to AECOM
                pursuant to Section 8.01 during the twelve (12) month period following
                this anniversary.

            

    

     

    
      	 	
              (e)

            	
              On
                the fifth anniversary and every anniversary of the Effective Date
                thereafter, Licensee will pay to AECOM [***] Dollars (US$[***]) as
                a
                license maintenance fee. Each such fee is non-refundable but is creditable
                against actual payments due to AECOM pursuant to Section 8.01 during
                the
                twelve (12) month period following each such
                anniversary.

            

    

     

    
      	
              8.04

            	
              Licensee
                shall make the following milestone payments and stock issuances to
                AECOM
                within thirty (30) days of the occurrence of the relevant
                event:

            

    

     

    
      	 	
              (a)

            	
              Upon
                the first dosing of the first human subject with each Licensed Product
                by
                Licensee or an Affiliate anywhere in the world, Licensee shall (1)
                pay to
                AECOM [***] Dollars (US$[***]) and (2) issue shares of its common
                stock
                representing [***] Dollars (US$[***]) in value to AECOM or pay to
                AECOM an
                additional [***] Dollars (US$[***]), which payments and stock issuances
                are non-refundable and not creditable against any other payment due
                to
                AECOM pursuant to this Agreement and shall be made only once for
                each
                Licensed Product.

            

    

     

    
      
         

      

      
        13

        
          

        

      

      
         

      

    

     

    
      	 	
              (b)

            	
              Upon
                the first dosing of the first human subject with each Licensed Product
                by
                Licensee or an Affiliate as part of a Phase II clinical trial (or
                its
                foreign equivalent), Licensee shall (1) pay to AECOM [***] Dollars
                (US$[***]) and (2) issue shares of its common stock representing
                [***]
                Dollars (US $[***]) in value to AECOM or pay to AECOM an additional
                [***]
                Dollars (US$[***]), which payments and stock issuances are non-refundable
                and not creditable against any other payment due to AECOM pursuant
                to this
                Agreement and shall be made only once for each Licensed
                Product.

            

    

     

    
      	 	
              (c)

            	
              Upon
                the first dosing of the first human subject with each Licensed Product
                by
                Licensee or an Affiliate as part of a Phase III clinical trial (or
                its
                foreign equivalent), Licensee shall (1) pay to AECOM [***] Dollars
                (US$[***]) and (2) issue shares of its common stock representing
                [***]
                Dollars (US $[***]) in value to AECOM or pay to AECOM an additional
                [***]
                Dollars (US$[***]), which payments and stock issuances are non-refundable
                and not creditable against any other payment due to AECOM pursuant
                to this
                Agreement and shall be made only once for each Licensed
                Product.

            

    

     

    
      	 	
              (d)

            	
              Upon
                the approval of a new drug application by the U.S. FDA (or its foreign
                equivalent) for each Licensed Product, Licensee shall (1) pay to
                AECOM
                [***] Dollars (US$[***]) and (2) issue shares of its common stock
                representing [***] Dollars (US $[***]) in value to AECOM or pay to
                AECOM
                an additional [***] Dollars (US$[***]), which payments and stock
                issuances
                are non-refundable and not creditable against any other payment due
                to
                AECOM pursuant to this Agreement and shall be made only once for
                each
                Licensed Product.

            

    

     

    
      
         

      

      
        14

        
          

        

      

      
         

      

    

     

    Notwithstanding
      anything to the contrary contained herein, the milestone payments described
      in
      each of paragraphs (a) through (d), above, shall be payable only once with
      respect to any Licensed Product that incorporates or is comprised of the same
      chemical compound or structure of another Licensed Product for which Licensee
      has already made a milestone payment under this Section 8.04.

     

     

    
      	
              8.05

            	
              Only
                one royalty will be payable on Net Sales by Licensee and Affiliates
                and
                Sublicensees on a Licensed Product under Section 8.01, regardless
                of the
                number of patent claims in Agreement Patents which cover such Licensed
                Product. If Licensee or any Affiliate is required, because of the
                patent
                rights of any third party or parties, to pay royalties to a third
                party or
                parties in order to make, use or sell a specific Licensed Product,
                then
                Licensee may deduct [***] percent ([***]%) of all such royalties
                paid to
                such third party or parties from up to [***] percent ([***]%) of
                the
                royalty due to AECOM on such specific Licensed Product pursuant to
                Section
                8.01.
                In
                no event will the royalty payable to AECOM on any Licensed Product
                be
                reduced by more than [***] percent ([***]%) pursuant to this
                Section.

            

    

     

    
      	
              8.06

            	
              Licensee’s
                failure to pay full royalties or make complete payments or stock
                issuances
                under Sections 8.01, 8.03 or 8.04 shall be a breach of this
                Agreement.

            

    

     

    
      	
              9.

            	
              Payment
                Reports and Records

            

    

     

    
      	
              9.01

            	
              All
                payments required to be made by Licensee to AECOM pursuant to this
                Agreement shall be made to AECOM in U.S. Dollars by wire transfer
                or by
                check payable to AECOM and sent to the address set out in Section
                15.01.

            

    

     

    
      	
              9.02

            	
              All
                payments required to be made by Licensee to AECOM pursuant to this
                Agreement shall be subject to a charge of [***] percent ([***]%)
                per month
                or [***] (US$[***]), whichever is greater, if late. Conversion of
                foreign
                currency to U.S. dollars shall be made at the conversion rate quoted
                by
                the Wall Street Journal, averaged on the last business day of each
                of the
                three (3) consecutive calendar months constituting the calendar quarter
                in
                which the payment was earned. Licensee will bear any loss of exchange
                or
                value and pay any expenses incurred in the transfer or conversion
                to U.S.
                dollars.

            

    

     

    
      
         

      

      
        15

        
          

        

      

      
         

      

    

     

    
      	
              9.03

            	
              Payment
                due from Licensee to AECOM pursuant to Section 8.01 will be paid
                within
                thirty (30) days after the end of each calendar year quarter during
                which
                the payment accrued. If no royalties or other payments are due for
                any
                quarter, Licensee will send a statement signed by an officer of Licensee
                to that effect to AECOM. Payment shall be accompanied by a statement
                of
                the number of Licensed Products and Combination Products sold by
                Licensee
                and Affiliates and Sublicensees in each country, total billings for
                such
                Licensed Products and Combination Products, the values of A and B
                used to
                calculate the Net Sales of Combination Products, deductions applicable
                to
                determine the Net Sales thereof, the amount of Net Sales and Net
                Proceeds
                realized by Licensee and Affiliates and Sublicensees, the amount
                of any
                deduction and a detailed listing thereof, and the total payment due
                from
                Licensee to AECOM (the “Royalty Report”). Such Royalty Report shall be
                signed by an officer of Licensee.

            

    

     

    
      	
              9.04

            	
              Licensee
                and Affiliates shall maintain complete and accurate books of account
                and
                records showing Net Sales, Net Proceeds and Contract Research. Such
                books
                and records of Licensee and Affiliates shall be open to inspection,
                in
                confidence, during usual business hours, upon at least ten (10) business
                days prior notice to Licensee, by an independent certified public
                accountant appointed by AECOM on behalf of AECOM, who has entered
                into a
                written agreement of confidentiality with AECOM which is no less
                protective of Licensee’s Confidential Information than the provisions of
                Section 7.03 hereof and to whom Licensee has no reasonable objection,
                for
                two (2) years after the calendar year to which they pertain, for
                the
                purpose of verifying the accuracy of the payments made to AECOM by
                Licensee pursuant to this Agreement. Licensee will require any
                Sublicensees hereunder to maintain such books and allow such inspection
                by
                Licensee and shall, on request, disclose such information, if available
                to
                Licensee, to AECOM as part of such inspection. Inspection shall be
                at
                AECOM’s sole expense and reasonably limited to those matters related to
                Licensee’s payment obligations under this Agreement and shall take place
                not more than once per calendar year. Any underpayment revealed by
                any
                inspection, plus interest on the underpayment amount at the rate
                of [***]
                percent ([***]%) per month or [***] Dollars (US$[***]), whichever
                is
                greater, shall be promptly paid by Licensee to AECOM. Further, if
                any
                inspection reveals an underpayment to AECOM of [***] percent ([***]%)
                or
                greater, then the cost of the inspection shall be paid by
                Licensee.

            

    

     

    
      
         

      

      
        16

        
          

        

      

      
         

      

    

     

    
      	
              10.

            	
              Infringement

            

    

     

    
      	
              10.01

            	
              Licensee
                shall have the right, in its sole discretion and its expense, to
                initiate
                legal proceedings on its behalf or in AECOM’s name, if necessary, against
                any infringer, or potential infringer, of an Agreement Patent who
                imports,
                makes, uses, sells or offers to sell products in the Field. Licensee
                shall
                notify AECOM of its intention to initiate such proceedings at least
                twenty
                (20) days prior to commencement thereof. Any settlement or recovery
                received from any such proceeding shall be divided [***] percent
                ([***]%)
                to Licensee and [***] percent ([***]%) to AECOM after Licensee deducts
                from any such settlement or recovery its actual counsel fees and
                out-of-pocket expenses relative to any such legal proceeding. If
                Licensee
                decides not to initiate legal proceedings against any such infringer,
                then
                AECOM shall have the right to initiate such legal proceedings. Any
                settlement or recovery received from any such proceeding initiated
                by
                AECOM shall be divided [***] percent ([***]%) to Licensee and [***]
                percent ([***]%) to AECOM after AECOM deducts from any such settlement
                or
                recovery its actual counsel fees and out-of-pocket expenses relative
                to
                any such legal proceeding.

            

    

     

    
      	
              10.02

            	
              In
                the event that either party initiates or carries on legal proceedings
                to
                enforce any Agreement Patent against an alleged infringer, the other
                party
                shall fully cooperate with and supply all assistance reasonably requested
                at the expense of the party requesting such assistance. Further,
                the other
                party, at its expense, shall have the right to be represented by
                counsel
                of its choice in any such proceeding. However, if Licensee initiates
                legal
                proceedings in AECOM’s name, Licensee shall either provide counsel (at
                Licensee’s expense) reasonably acceptable to AECOM or reimburse AECOM for
                any reasonable out-of-pocket counsel fees of AECOM associated with
                the
                legal proceedings . The party who initiates or carries on the legal
                proceedings shall have the sole right to conduct such proceedings
                provided, however, that such party shall consult with the other party
                to
                this Agreement prior to entering into any settlement
                thereof.

            

    

     

    
      
         

      

      
        17

        
          

        

      

      
         

      

    

     

    
      	
              11.

            	
              Prohibition
                on Use of Names; No
                Publicity

            

    

     

    
      	
              11.01

            	
              Neither
                party to this Agreement shall use the name of the other party without
                the
                prior written consent of such other party, except if the use of such
                name
                is required by law, regulation, federal securities law, or judicial
                order,
                in which event the party intending to use such name will promptly
                inform
                the other prior to any such required use. Neither party to this Agreement
                will make any public announcement regarding the existence of this
                Agreement and/or the collaboration hereunder without obtaining the
                prior
                written consent of the other party, except if such announcement is
                required by law, regulation, federal securities law or judicial order,
                in
                which event the party intending to make such announcement will promptly
                inform the other party prior to such
                announcement.

            

    

     

    
      	
              12.

            	
              Term
                and Termination

            

    

     

    
      	
              12.01

            	
              Unless
                terminated earlier under other provisions hereof, this Agreement
                will
                expire upon the expiration of the last Agreement Patent that covers
                a
                Licensed Product made, used or sold by Licensee or an Affiliate or
                a
                Sublicensee. Upon termination or expiration of this Agreement for
                any
                reason, Sections 7, 11, 12.08, 14.01 through 14.10, 14.13 and 15
                shall
                survive and all payment obligations under Articles 3 and 8 hereof
                accrued
                as of the termination date shall be paid by Licensee within thirty
                (30)
                days of such termination or
                expiration.

            

    

     

    
      	
              12.02

            	
              Licensee
                may terminate this Agreement and the licenses granted hereunder by
                giving
                notice to AECOM sixty (60) days prior to such termination. Upon such
                termination, Licensee shall not use Agreement Patents for any purpose
                and
                all of Licensee’s rights in Agreement Patents shall be
                terminated.

            

    

     

    
      
         

      

      
        18

        
          

        

      

      
         

      

    

     

    
      	
              12.03

            	
              If
                either AECOM or Licensee defaults on or breaches any condition of
                this
                Agreement, the aggrieved party may serve notice upon the other party
                of
                the alleged default or breach. If such default or breach is not remedied
                within sixty (60) days from the date of such notice, the aggrieved
                party
                may at its election terminate this Agreement. Any failure to terminate
                hereunder shall not be construed as a waiver by the aggrieved party
                of its
                right to terminate for future defaults or breaches. Licensee’s damages for
                any breach of this Agreement by AECOM will be limited to a reduction
                or
                suspension of the payment obligations of Licensee hereunder. Upon
                termination of this Agreement by AECOM pursuant to this Section 12.03,
                the
                licenses granted by AECOM to Licensee shall terminate and Licensee
                shall
                not use Agreement Patents for any purpose and all of Licensee’s rights in
                Agreement Patents shall be
                terminated.

            

    

     

    
      	
              12.04

            	
              If
                Licensee makes an assignment for the benefit of creditors or if
                proceedings for a voluntary bankruptcy are instituted on behalf of
                Licensee or if Licensee is declared bankrupt or insolvent, AECOM
                may, at
                its election, terminate this Agreement by notice to Licensee. Upon
                termination of this Agreement by AECOM pursuant to this Section 12.04,
                the
                licenses granted by AECOM to Licensee shall terminate and Licensee
                shall
                not use Agreement Patents for any purpose and all of Licensee’s rights in
                Agreement Patents shall be
                terminated.

            

    

     

    
      	
              12.05

            	
              If
                Licensee is convicted of a felony relating to the manufacture, use
                or sale
                of Licensed Products or a felony relating to moral turpitude , AECOM
                may,
                at its election, terminate this Agreement upon thirty (30) days’ notice to
                Licensee. Upon termination of this Agreement by AECOM pursuant to
                this
                Section 12.05, the licenses granted by AECOM to Licensee shall terminate
                and Licensee shall not use Agreement Patents for any purpose and
                all of
                Licensee’s rights in Agreement Patents shall be
                terminated.

            

    

     

    
      	
              12.06

            	
              Notwithstanding
                the provisions of Section 12.03 hereof, should Licensee fail to pay
                AECOM
                any sum (or issue any stock) due and payable under this Agreement
                on
                thirty (30) days written notice, AECOM may, at its election, terminate
                this Agreement, unless Licensee pays AECOM within the thirty (30)
                day
                period all delinquent sums together with interest due and unpaid.
                Upon
                termination of this Agreement by AECOM pursuant to this Section 12.06,
                the
                licenses granted by AECOM to Licensee shall terminate and Licensee
                shall
                not use Agreement Patents for any purpose and all of Licensee’s rights in
                Agreement Patents shall be
                terminated.

            

    

     

    
      
         

      

      
        19

        
          

        

      

      
         

      

    

     

    
      	
              12.07

            	
              Termination
                of this Agreement by Licensee or AECOM shall not prejudice the rights
                of
                either party accruing herein.

            

    

     

    
      	
              12.08

            	
              If
                Licensee terminates this Agreement pursuant to Section 12.02 or if
                AECOM
                terminates this Agreement pursuant to Sections 12.03, 12.04, 12.05
                or
                12.06, then Licensee shall, upon written request, grant to AECOM
                a
                worldwide, royalty-free, non-exclusive license, with the right to
                grant
                sublicenses, under any Dependent Patents or Dependent Know-How (as
                defined
                below) developed by or for Licensee or Affiliates during the term
                of this
                Agreement. As used in this Section 12.08, the term “Dependent Patents”
                means any U.S. or foreign patent application or patent which claims
                an
                invention the practice of which would infringe a claim of a patent
                or
                patent application of the Agreement Patents or the practice of which
                results in a product covered by a claim of a patent or patent application
                of Agreement Patents. “Dependent Know-How” means confidential information,
                including clinical trial information, the practical application of
                which
                would infringe a claim of a patent or patent application of Agreement
                Patents, or which results in a product covered by a claim of a patent
                or
                patent application of Agreement
                Patents.

            

    

     

    
      	
              12.09

            	
              If
                Licensee terminates this Agreement pursuant to Section 12.02 or if
                AECOM
                terminates this Agreement pursuant to Sections 12.03, 12.04, 12.05
                or
                12.06, Licensee shall submit a final Royalty Report to AECOM and
                any
                payments and patent costs due to AECOM hereunder as of the date of
                termination shall be payable within thirty (30) days of the date
                of
                termination.

            

    

     

    
      	
              12.10

            	
              Notwithstanding
                any provision herein to the contrary, no termination of this Agreement
                shall be construed as a termination of any valid sublicense of any
                Sublicensee hereunder, and thereafter each such Sublicensee shall
                be
                considered a direct licensee of AECOM, provided that (i) such Sublicensee
                is not in material breach of its sublicense agreement with Licensee,
                and
                (ii) such Sublicensee agrees in writing to assume all applicable
                obligations of Licensee under this
                Agreement.

            

    

     

    
      
         

      

      
        20

        
          

        

      

      
         

      

    

     

    
      	
              13.

            	
              Amendment
                and Assignment

            

    

     

    
      	
              13.01

            	
              This
                Agreement sets forth the entire understanding between the parties
                pertaining to the subject matter hereof and supersedes the Confidential
                Disclosure and Non-Use Agreement entered into between AECOM and Licensee
                having an effective date of June 9,
                2006.

            

    

     

    
      	
              13.02

            	
              Except
                as otherwise provided herein, this Agreement may not be amended,
                supplemented or otherwise modified, except by an instrument in writing
                signed by both parties.

            

    

     

    
      	
              13.03

            	
              Without
                the prior written approval of the other party, which approval shall
                not be
                unreasonably withheld, no party may assign this Agreement except
                that this
                Agreement may be assigned to an entity acquiring substantially all
                of such
                party’s business to which this Agreement relates, or in the event of a
                merger, consolidation, change in control or similar transaction of
                such
                party. Any attempted assignment in contravention of this Section
                13.03
                shall be null and void.

            

    

     

    
      	
              14.

            	
              Miscellaneous
                Provisions

            

    

     

    
      	
              14.01

            	
              This
                Agreement shall be construed and the rights of the parties governed
                in
                accordance with the laws of the State of New York, excluding its
                law of
                conflict of laws. Any dispute or issue arising hereunder, including
                any
                alleged breach by any party, shall be heard, determined and resolved
                by an
                action commenced in the state or federal courts in New York, New
                York,
                which the parties hereby agree shall have proper jurisdiction and
                venue
                over the issues and the parties. AECOM and Licensee hereby agree
                to submit
                to the jurisdiction of the state or federal courts in New York and
                waive
                the right to make any objection based on jurisdiction or venue. The
                New
                York courts shall have the right to grant all relief to which AECOM
                and
                Licensee are or shall be entitled hereunder, including all equitable
                relief as the Court may deem
                appropriate.

            

    

     

    
      
         

      

      
        21

        
          

        

      

      
         

      

    

     

    
      	
              14.02

            	
              This
                Agreement has been prepared
                jointly.

            

    

     

    
      	
              14.03

            	
              If
                any term or provision of this Agreement or the application thereof
                to any
                person or circumstance shall to any extent be invalid or unenforceable,
                the remainder of this Agreement or the application of such term or
                provision to persons or circumstances other than those as to which
                it is
                held invalid or unenforceable shall not be affected thereby and each
                term
                and provision of this Agreement shall be valid and enforced to the
                fullest
                extent permitted by law.

            

    

     

    
      	
              14.04

            	
              Licensee
                agrees to indemnify AECOM and its current or former directors, governing
                board members, trustees, officers, faculty, medical and professional
                staff, employees, students and agents and their respective successors,
                heirs and assigns (AECOM and each such person being the “Indemnified
                Parties”) for the cost of defense and for damages awarded and losses and
                liabilities incurred, if any, as a result of any third party claims,
                liabilities, suits or judgments based on or arising out of the research,
                development, marketing, manufacture, sale and/or provision of Licensed
                Products by Licensee, Affiliates and Sublicensees, and/or the licenses
                granted under this Agreement, or otherwise related to the conduct
                of
                Licensee’s, Affiliates’ or Sublicensees’ business, so long as such claims,
                liabilities, suits, or judgments are not solely attributable to grossly
                negligent or intentionally wrongful acts or omissions by the Indemnified
                Parties. This indemnity is conditioned upon AECOM’s obligation to: (i)
                advise Licensee of any claim or lawsuit, in writing promptly after
                AECOM
                or the Indemnified Party has received notice of said claim or lawsuit,
                (ii) assist Licensee and its representatives, at Licensee’s expense, in
                the investigation and defense of any lawsuit and/or claim for which
                indemnification is provided, and (iii) permit Licensee to control
                the
                defense of such claim or lawsuit for which indemnification is
                provided.

            

    

     

    
      	
              14.05

            	
              Nothing
                in this Agreement is or shall be construed
                as:

            

    

     

    
      	 	
              (a)

            	
              A
                warranty or representation by AECOM that anything made or used by
                Licensee
                under any license granted in this Agreement is or will be free from
                infringement of patents, copyrights, and other rights of third parties;
                or

            

    

     

    
      
         

      

      
        22

        
          

        

      

      
         

      

    

     

    
      	 	
              (b)

            	
              Granting
                by implication, estoppel, or otherwise any license, right or interest
                other than as expressly set forth
                herein.

            

    

     

    
      	
              14.06

            	
              Except
                as expressly set forth in this Agreement, the parties MAKE NO
                REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS
                OR
                IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, STATUTE OR OTHERWISE,
                AND
                THE PARTIES SPECIFICALLY DISCLAIM ANY IMPLIED WARRANTY OF MERCHANTABILITY
                OR FITNESS FOR A PARTICULAR PURPOSE, OR WARRANTY OF NON-INFRINGEMENT.
                IN
                ADDITION, NEITHER PARTY SHALL BE LIABLE FOR ANY SPECIAL, INDIRECT,
                INCIDENTAL OR CONSEQUENTIAL DAMAGES, HOWEVER CAUSED, UNDER ANY THEORY
                OF
                LIABILITY AND WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OF THE
                POSSIBILITY OF SUCH DAMAGES.

            

    

     

    
      	
              14.07

            	
              AECOM
                and Licensee represent and warrant that, to the best of their knowledge,
                as of the Effective Date:

            

    

     

    
      	 	
              (a)

            	
              they
                have the legal right and authority to enter into this Agreement and
                to
                perform all of their obligations
                hereunder;

            

    

     

    
      	 	
              (b)

            	
              when
                executed by all parties, this Agreement will constitute a valid and
                legally binding obligation and shall be enforceable in accordance
                with its
                terms; and

            

    

     

    
      	 	
              (c)

            	
              there
                are no existing or threatened actions, suits or claims pending or
                threatened against it that may affect the performance of its obligations
                under the Agreement.

            

    

     

    
      	
              14.08

            	
              Licensee
                represents and warrants that it has not relied on any information
                provided
                by AECOM, AECOM’s current or former employees or the Investigator and has
                conducted its own due diligence investigation to its own satisfaction
                prior to entering into this
                Agreement.

            

    

     

    
      
         

      

      
        23

        
          

        

      

      
         

      

    

     

    
      	
              14.09

            	
              Licensee
                represents and warrants that before Licensee, or an Affiliate or
                a
                Sublicensee makes any sales of Licensed Products or performs or causes
                any
                third party to perform any clinical trials or tests in human subjects
                involving Licensed Products, Licensee or Affiliates or Sublicensees
                will
                acquire and maintain in each country in which Licensee or Affiliates
                or
                Sublicensees shall test or sell Licensed Products, appropriate insurance
                coverage reasonably acceptable to AECOM, but providing coverage in
                respect
                of Licensed Products in an amount no less than [***] Dollars (US
                $[***])
                per claim. Licensee or Affiliates will not perform, or cause any
                third
                party to perform, any clinical trials or any tests in human subjects
                involving Licensed Products unless and until it obtains all required
                regulatory approvals with respect to Licensed Products in the applicable
                countries. Prior to instituting any clinical trials or any tests
                in human
                subjects, or sale of any Licensed Product, Licensee shall provide
                evidence
                of such insurance to AECOM. If AECOM determines that such insurance
                is not
                reasonably appropriate, it shall so advise Licensee and Licensee
                shall
                delay such trials, tests or sales until the parties mutually agree
                that
                reasonably appropriate coverage is in place. AECOM shall be listed
                as an
                additional insured in Licensee’s insurance policies. If such insurance is
                underwritten on a ‘claims made’ basis, Licensee agrees that any change in
                underwriters during the term of this Agreement will require the purchase
                of ‘prior acts’ coverage to ensure that coverage will be continuous
                throughout the term of this
                Agreement.

            

    

     

    
      	
              14.10

            	
              Licensee
                shall exercise its rights and perform its obligations hereunder in
                compliance with all applicable laws and regulations. In particular,
                it is
                understood and acknowledged that the transfer of certain commodities
                and
                technical data is subject to United States laws and regulations
                controlling the export of such commodities and technical data, including
                all Export Administration Regulations of the United States Department
                of
                Commerce. These laws and regulations, among other things, prohibit
                or
                require a license for the export of certain types of technical data
                to
                certain specified countries. Licensee hereby agrees and gives written
                assurance that it will comply with all United States laws and regulations
                controlling the export of commodities and technical data, that it
                will be
                solely responsible for any violation of such by Licensee or Affiliates
                or
                Sublicensees, and that it will defend and hold AECOM harmless in
                the event
                of any legal action of any nature occasioned by such
                violation.

            

    

     

    
      
         

      

      
        24

        
          

        

      

      
         

      

    

     

    
      	
              14.11

            	
              Licensee
                agrees (i) to obtain all regulatory approvals required for the manufacture
                and sale of Licensed Products prior to marketing or selling any such
                Licensed Products and (ii) to utilize legally appropriate patent
                marking
                on such Licensed Products. Licensee agrees to register or record
                this
                Agreement as is required by law or regulation in any country where
                the
                license is in effect.

            

    

     

    
      	
              14.12

            	
              Licensee
                agrees that any Licensed Products for use or sale in the United States
                will be manufactured substantially in the United
                States.

            

    

     

    
      	
              14.13

            	
              Any
                tax required to be withheld under the laws of any jurisdiction on
                royalties payable to AECOM by Licensee under this Agreement will
                be
                promptly paid by Licensee for and on behalf of AECOM to the appropriate
                governmental authority, and Licensee will furnish AECOM with proof
                of
                payment of the tax together with official or other appropriate evidence
                issued by the competent governmental authority sufficient to enable
                AECOM
                to support a claim for tax credit with respect to any sum so withheld.
                Any
                tax required to be withheld on payments by Licensee to AECOM will
                be an
                expense of and be borne solely by AECOM, and Licensee’s royalty payment(s)
                to AECOM following the withholding of the tax will be decreased by
                the
                amount of such tax withholding. Licensee will cooperate with AECOM
                in the
                event AECOM elects to assert, at its own expense, exemption from
                any
                tax.

            

    

     

    
      	
              14.14

            	
              Notwithstanding
                any term of this Agreement to the contrary, at Licensee’s sole option, any
                payment required to be made by Licensee to AECOM hereunder by the
                issuance
                of shares of Licensee’s common stock may instead be made by payment of
                cash to AECOM. Further, notwithstanding any term of this Agreement
                to the
                contrary, the maximum number of shares of Licensee’s common stock that may
                be issuable under this Agreement in satisfaction of Licensee’s obligations
                to AECOM may not exceed, in the aggregate, 9.99 percent of the total
                number of shares of Licensee’s common stock outstanding on the date of
                this Agreement (the “Maximum Issuance Amount”). In the event Licensee
                issues to AECOM an aggregate number of shares of its common stock
                that
                equals the Maximum Issuance Amount, all amounts thereafter payable
                by
                Licensee under this Agreement shall be made in
                cash.

            

    

     

    
      
         

      

      
        25

        
          

        

      

      
         

      

    

     

     

    
      	
              15.

            	
              Notices

            

    

     

    
      	
              15.01

            	
              Any
                notice or report required or permitted hereunder shall be given in
                writing, and shall be deemed to have been properly given and effective
                upon delivery, by registered or certified mail, return receipt requested,
                or by facsimile with proof of receipt and a confirmation copy sent
                by
                overnight courier, or by overnight courier, to the following
                addresses:

            

    

     

    To
      Licensee:

    

    Hana
      Biosciences, Inc.

    7000
      Shoreline Court, Suite 370

    South
      San
      Francisco, CA 94080

    Attention:
      Chief Executive Officer

    

    

    To
      AECOM:

    

    Albert
      Einstein College of Medicine

    of
      Yeshiva University

    1300
      Morris Park Avenue

    Bronx,
      New York 10461

    Attention:
      Office of Biotechnology

    

    With
      copy to:

    

    Kenneth
      P. George, Esq.

    Amster,
      Rothstein & Ebenstein, LLP

    90
      Park
      Avenue - 21st Floor

    New
      York,
      New York 10016

    

    
      
         

      

      
        26

        
          

        

      

      
         

      

    

     

    IN
      WITNESS WHEREOF, the parties have entered into this Agreement effective as
      of
      the day and year first above written.

     

     

    

     

    
      

    
      	 	 	
              ALBERT
                EINSTEIN COLLEGE OF

              MEDICINE
                OF YESHIVA UNIVERSITY, 

              A
                DIVISION OF YESHIVA UNIVERSITY

            
	 	 	 
	
              WITNESS:

            	 	
              /s/
                Emanuel Genn

            
	 	 	
              Emanuel
                Genn

            
	
              /s/
                Illegible name

            	 	
               Associate
                Dean for Business Affairs

            
	 	 	 
	
              Date:
                October
                11, 2006

            	 	
              Date:
                October
                11, 2006

            
	 	 	 
	 	 	 
	 	 	
              HANA
                BIOSCIENCES, INC.

            
	 	 	 
	
              WITNESS:

            	 	
              /s/
                Mark J. Ahn

            
	 	 	
              Mark
                J. Ahn, CEO 

            
	
              /s/
                Fred Vitale

            	 	 
	 	 	 
	
              Date:
                October
                6, 2006

            	 	
              Date:
                October
                6, 2006

            
	 	 	 
	 	 	 
	
              AGREED
                TO AND ACCEPTED BY:

            	 	 
	 	 	 
	
              /s/
                Dr. Roman Perez-Soler

            	 	
              Date:October
                10, 2006

            
	
              Dr.
                Roman Perez-Soler

            	 	 
	 	 	 
	 	 	 
	
              /s/
                Dr. Yi-He Ling

            	 	
              Date:October
                10, 2006

            
	
              Dr.
                Yi-He Ling

            	 	 

    

    

    
      
         

      

      
        27

        
          

        

      

      
         

        
        

      

    

    APPENDIX
      A - Agreement Patents

    

    1.
      PCT
      International Patent Application No. PCT/US2006/014158 

    Title: VITAMIN
      K
      FOR PREVENTION AND TREATMENT OF

    SKIN
      RASH
      SECONDARY TO ANTI-EGFR THERAPY

    Applicant: Albert
      Einstein College of Medicine of Yeshiva University

    Inventors: Roman
      Perez-Soler and Yi-He Ling

    Filed: April
      12,
      2006

    AR&E
      File: 96700/1122

    

    

    2.
      U.S.
      Provisional Patent Application No. 60/671,563

    Title: VITAMIN
      K
      FOR PREVENTION AND TREATMENT OF

    SKIN
      RASH
      SECONDARY TO ANTI-EGFR THERAPY

    Inventors: Roman
      Perez-Soler and Yi-He Ling

    AECOM
      Ref.: P-541

    Filed:  April
      15,
      2005

    AR&E
      File: 96700/942  

     

    

     

     

    

     

     

    

     

    
      
         

      

      
        28

        
          

        

      

      
         

        
        

      

    

    APPENDIX
      B Research Project

     

    

    Development
      of topical menadione for the prevention and treatment of skin toxicity secondary
      to EGFR inhibitors

    

    
      	
              Investigator:
                

            	
              Roman
                Perez-Soler, M.D.

            
	 	 
	
              Staff:
                

            	
              Yi-He
                Ling, Ph. D.

            
	 	
              Yiyu
                Zou, Ph.D.

            

    

    

    

    Scope

    

    The
      following topics will be explored during the first year: 

    

    1.
      To develop a model of skin toxicity secondary to EGFR
      inhibitors

    

    It
      is
      essential to exhaust all possibilities to develop a model of skin toxicity
      secondary to EGFR inhibition. AECOM, through the Investigator, has done
      extensive work trying to develop a model of skin toxicity secondary to the
      EGFR
      inhibitor erlotinib. In nude mice (immunosuppressed), only a small proportion
      of
      the animals develop skin desquamation when administered high doses of daily
      erlotinib. Non immunosuppressed mice seem to be more prone to develop toxicity
      thus suggesting that the development of skin toxicity requires a competent
      immune system. However, still the incidence of lesions is low and limited to
      desquamation rather than folliculitis. Recently, other investigators have
      suggested that non immunosuppressed Wistar rats may be a better model of skin
      toxicity secondary to EGFR inhibitors (AACR 2006). Apparently, these rats
      develop a clear follicultitis type of rash with C1033, an irreversible EGFR
      inhibitor. AECOM proposes to administer high doses of erlotinib daily for 3
      weeks to Wistar rats and pathologically characterize the skin lesions observed.
      If these results cannot be reproduced, guinea pigs or minipigs may be tried.
      

    

    2.
      To study the protective effect of menadione on the effects of EGFR tyrosine
      kinase inhibitors and other kinase inhibitors in clinical
      development

    

    The
      protective effect of menadione may not be restricted to EGFR tyrosine kinase
      inhibitors but also to other kinase inhibitors already approved or in advanced
      development that also cause skin toxicity like sorafenib and the MEK inhibitors.
      AECOM proposes to explore the protective effect of menadione on these other
      targets in human keratinocytes. AECOM proposes to attempt to identify the
      specific phosphatase responsible for dephosphorylation of EGFR, and to
      investigate the pharmacology of inhibition of this enzyme by menadione.

    

    The
      following topics will be explored during the second year: 

    
      
         

      

      
        29

        
          

        

      

      
         

      

    

    

    3.
      To test the efficacy of different schedules of menadione in preventing and
      treating the skin toxicity secondary to EGFR inhibitors

    

    Once
      the
      model of skin toxicity in rats is established, and topical formulation has
      been
      developed by Hana, AECOM proposes to test the efficacy of different schedules
      of
      menadione in rats given erlotinib orally for 3 weeks. Efficacy will be assessed
      by determining P-EGFR by immunohistochemistry and western blot analysis and
      pathological evaluation of the lesions in control animals and animals treated
      with menadione. AECOM proposes to initially perform a dose range study to
      determine the highest non-toxic dose of the formulation when using a daily
      schedule.

    

    4.
      To study the biological effects of agents currently used topically to treat
      the
      EGFR induced skin toxicity and on human keratinocytes exposed to EGFR
      inhibitors

    

    The
      EGFR
      induced skin toxicity is currently treated with topical antibiotics,
      corticosteroids and antibiotics (tetracyclines and clindamycin). The effects
      of
      these agents on the viability of human keratinocytes exposed to EGFR inhibitors
      are unknown. AECOM, through the Investigator, has preliminary evidence that
      some
      of these agents may actually potentiate the cytotoxic effect of erlotinib on
      human keratinocytes. Therefore, while exerting an antiinflammatory or
      immunossuppressive effect that should improve the skin toxicity, they may at
      the
      same time enhance the local toxicity of erlotinib on the epidermal basal cells.
      That would explain the mixed results obtained with all these therapies. It
      is
      important to know this information before definitive clinical trials with
      menadione are initiated. 

    

    Budget
      & Personnel (years 1 and 2)

    
      	 	 	 
	
              Yi-He
                Ling, Ph.D.

            	
              10%
                effort

            	
              [***]

            
	
              Yiyu
                Zou, Ph.D.

            	
              25%
                effort

            	
              [***]

            
	
              Research
                technician

            	
              100%
                effort

            	
              [***]

            
	 	 	 
	
              Laboratory
                supplies

            	
               

            	
              [***]

            
	 	 	 
	
              Animals
                (purchase and maintenance)

            	
               

            	
              [***]

            
	 	 	 
	
              Miscellaneous
                including pathology 

            	 	
              [***]

            
	 	 	 
	
              Subtotal

            	 	
              [***]

            
	 	 	 
	
              Overhead
                (66%)

            	 	
              [***]

            
	 	 	 
	 	 	 
	
              TOTAL

            	 	
              [***]

            

    

    

     

    
      
         

      

      
        30Unassociated Document

     

    Exhibit
      10.40

     

    AMENDMENT
      TO NO. 3 TO 

     

    LICENSE
      AND DEVELOPMENT AGREEMENT

     

    THIS
      AMENDMENT NO. 3 TO LICENSE AND DEVELOPMENT AGREEMENT
      (this
“Amendment”),
      dated
      as of December 22, 2006, is entered into by and between NOVADEL
      PHARMA, INC.,
      a
      Delaware corporation (“NovaDel”),
      and
HANA
      BIOSCIENCES, INC.,
      a
      Delaware corporation (the “Licensee”).
      NovaDel and Licensee each may be referred to herein individually as a
“Party,”
or
      collectively as the “Parties.”
      

     

    WHEREAS,
      the
      Parties entered into that certain License and Development Agreement dated
      October 26, 2004 (the “Agreement”),
      as
      amended on August 8, 2005 and again on May 15, 2006, pursuant to which Licensee
      licensed from NovaDel certain exclusive rights to develop and commercialize
      a
      pharmaceutical product containing ondansetron as an active ingredient that
      will
      be administered to humans using the Technology on the terms and conditions
      set
      forth in the Agreement; and

     

    WHEREAS,
      the
      Agreement as amended on August 8, 2005 provided that NovaDel would have certain
      rights to use and reference the Regulatory Documentation with respect to the
      Licensed Product, and to purchase the product from Licensee or its third party
      manufacturer; and 

     

    WHEREAS,
      the
      Parties desire to amend the Agreement to clarify the Parties’ intentions with
      regard to the rights of NovaDel’s Extraterritorial Licensees (as defined in this
      Amendment) to use and reference the Regulatory Documentation with respect to
      the
      Licensed Product, and to purchase such product from Licensee or its third party
      manufacturer. 

     

    NOW,
      THEREFORE,
      in
      consideration of the foregoing premises, the mutual promises and covenants
      of
      the Parties contained herein, and other good and valuable consideration, the
      receipt and sufficiency of which are hereby acknowledged, the Parties hereto,
      intending to be legally bound, do hereby agree as follows:

     

    1. Definition
      of Extraterritorial Licensee.
      A new
      Section 1.54 shall be added to the Agreement, as follows:

     

    “1.54 “Extraterritorial
      Licensee”
      shall
      mean NovaDel’s Affiliates and licensees outside the Territory.”

     

    2. Regulatory
      Approvals.
      Section
      3.5 of the Agreement shall be amended and restated in its entirety to provide
      as
      follows:

     

    “3.5
       Regulatory
      Approvals.
      All
      INDs, NDAs and other filings, applications or requests pursuant to or in
      connection with the Regulatory Approvals required under the Development plan
      shall be the responsibility of Licensee and made in the name of Licensee;
provided,
      however,
      that
      Licensee shall consult with NovaDel with respect to the preparation and
      submission of any such filings, applications or requests in connection with
      Regulatory Approvals. 

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    

     

    3.5(a)
      Licensee
      will be the primary contact for Chemistry, Manufacturing and Control (“CMC”)
      matters in all relevant regulatory applications except to regulatory bodies
      outside the US and Canada. Licensee will keep NovaDel reasonably informed of
      all
      such communications, if any, between Licensee and the Regulatory Authorities
      in
      the US and Canada. 

     

    3.5(b)
      NovaDel
and
      NovaDel’s Extraterritorial Licensees
      shall
      have a perpetual, irrevocable, worldwide right to use and reference the
      Regulatory Documentation with respect to the Licensed Product and any data
      included or referenced therein for all purposes. Licensee agrees to utilize
      the
      Common Technical Document format for its marketing applications in order to
      facilitate any subsequent submissions filed by NovaDel or
      its
      Extraterritorial Licensee’s
      outside
      of the Territory. Licensee shall keep NovaDel reasonably informed as to the
      communications, if any, between Licensee and the Regulatory Authorities.

     

    3.5(c)
      Licensee
      agrees to keep the Common Technical Document except for those sections in the
      Summary Basis of Approval and available through the Freedom of Information
      Act
      (“FOIA”) strictly confidential and will obtain prior written consent from
      NovaDel prior to sharing with any third party.” 

     

    2. Manufacturing
      Section
      3.11 of the Agreement shall be amended and restated in its entirety to provide
      as follows: 

     

    “3.11 Manufacturing

     

    3.11.1
      Subject
      to the other provisions of this Section 3.11.1, Licensee shall be solely
      responsible for the manufacture of Licensed Product, both for clinical
      development and following receipt of Regulatory Approval of the Licensed
      Product, provided, that Licensee may contract with a third party to perform
      such
      manufacturing services. Licensee shall share all data and other information
      relating to the manufacturing process and shall consult with NovaDel with
      respect thereto. Without limiting the generality of the foregoing, NovaDel
      shall
      have the opportunity to review, prior to execution, all agreements with third
      parties relating to the manufacture of the Licensed Product. Any disputes
      between NovaDel and Licensee relating to the manufacture of the Licensed Product
      shall be resolved in the manner set forth in Section 3.4.3 hereof. 

     

    NovaDel
      and
      its Extraterritorial Licensees retain
      the right to purchase product from said third party, if applicable, at the
      same
      costs as Licensee with the exception of an increase of cost due to a
      modification to the packaging/labeling by NovaDel or
      any
      Extraterritorial Licensee.

    
      
         

      

      
        2

        
          

        

      

      
         

      

    

     

    

     

    3.11.2
      Licensee
      agrees that, at all times during the performance of the Development Activities,
      it, or its designee, will act in accordance with GMP and all applicable laws,
      rules and regulations. 

     

    3.11.3
      To the
      extent Licensee contracts with a Third Party to manufacture the Licensed
      Product, such Third Party shall agree in writing to be bound by the obligations
      of confidentiality and non-use at least equivalent in scope to those set forth
      in Article 15 of this Agreement.

     

    3.11.4
      NovaDel
      and its Extraterritorial Licensees may purchase Licensed Product under section
      3.11.1 in the identical packaging and labeling as Licensee purchases such
      Licensed Product for sale in the United States, subject to the requirement
      by
      NovaDel and sublicensees to have such Licensed Product uniquely identified
      by a
      separate batch record identification or other indicia sufficient to distinguish
      sales by NovaDel, or its Extraterritorial Licensees, from those of Licensee.
      

     

    3.11.5
      Licensee
      shall use Commercially Reasonable Efforts to obtain any required licenses,
      permissions needed and documentation (e.g. Certificate of Pharmaceutical
      Product) in order for NovaDel and its Extraterritorial Licensees to buy and
      export Licensed Products from the United States. NovaDel shall reimburse all
      reasonable expenses incurred by Licensee for obtaining such licenses or
      permissions within 30 days of a the Extraterritorial Licensee receipt of an
      invoice from Licensee itemizing such expenses. 

     

    3.11.6
      NovaDel
      warrants, covenants and agrees that any license agreement that NovaDel enters
      into with an Extraterritorial Licensee regarding Licensed Products that are
      subject to this Agreement shall contain an indemnity clause requiring the
      Extraterritorial Licensee to indemnify Licensee and its Affiliates against
      any
      and all claims, proceedings, demands, liability and expenses of any kind,
      including legal expenses and attorneys fees (collectively, “Claims”), arising
      out of or in connection with the manufacture, sale, use, consumption,
      advertisement or other disposition of Licensed Products by the Extraterritorial
      Licensee, its Affiliates or any end user, or arising from any violation of
      law,
      negligence, willful or reckless misconduct, or from any breach of any material
      obligation of such Extraterritorial Licensee under its agreement with NovaDel,
      other than Claims resulting from the gross negligence or willful misconduct
      of
      Licensee; provided,
      however,
      that in
      no event shall the scope of the indemnification to Licensee be any less than
      the
      scope of the Extraterritorial Licensee’s indemnification obligations to
      NovaDel.”
      

     

    3. Confirmation
      of Agreement.
      Except
      as otherwise amended or modified hereby, all terms of the Agreement shall remain
      in full force and effect.

     

    4.
      Capitalized
      Terms.
      Capitalized terms used but not defined in this Amendment shall have the meanings
      ascribed to them in the Agreement.

    
      
         

      

      
        3

        
          

        

      

      
         

      

    

     

    

     

    5. Counterparts.
      This
      Amendment may be executed in one or more counterparts, each of which shall
      be
      deemed an original but all of which taken together shall constitute one and
      the
      same instrument. 

     

    

     

    IN
      WITNESSE WHEREOF,
      the
      duly authorized officers of the Parties have executed this Agreement as of
      the
      dates set forth below their respective signatures.

     

    

    
      	
              NOVALDEL
                PHARMA INC.

            	
              HANA
                BIOSCIENCES, INC.

            
	
               

              By:
                /s/
                Jan Egberts   

            	
               

              By:
                /s/
                Fred L. Vitale  

            
	
              Name:
                Jan
                Egberts   

            	
              Name:
                Fred
                L. Vitale  

            
	
              Title:
                President
                & CEO  

            	
              Title:
                VP
                & CBO   

            
	
              Date:
                1/2/07    

            	
              Date:
                12/22/06   

            

    

     

    

    
      
         

      

        4

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