Exhibit
10.11

     

    PUBLIC
HEALTH SERVICE

     

    PATENT
LICENSE AGREEMENT – EXCLUSIVE

     

    COVER
PAGE

     

    For PHS
internal use only:

     

    License
Number:

    


    License
Application Number: A-286-2006

     

    Serial
Number(s) of Licensed Patent(s) or Patent Application(s):

     

    
      	
               
      

            	
              I.

            	
              U.S.
      Provisional Patent Application No. 60/771,163, filed February 6, 2006,
      entitled “Use of Phosphatases To Treat Glioblastomas” (HHS Ref. No.
      E-123-2006/0-US-01);

            


    

     

    
      	
               
      

            	
              II.

            	
              U.S.
      Provisional Patent Application No. 60/797,201, filed May 2, 2006, entitled
      “Use of Phosphatases To Treat Glioblastomas” (HHS Ref. No.
      E-123-2006/1-US-01)

            


    

     

    
      	
               
      

            	
              III.

            	
              U.S.
      Patent Application Serial No. 11/703,401, filed February 6, 2007, entitled
      “Use of Phosphatases To Treat Glioblastomas” (HHS Ref. No.
      E-123-2006/0-US-03)

            


    

     

    
      	
               
      

            	
              IV.

            	
              PCT
      International Application No. PCT/US2007/003095, filed February 6, 2007
      entitled “Use of Phosphatases To Treat Glioblastomas” (HHS Ref. No.
      E-123-2006/0-PCT-02)

            


    

     

    
      	
               
      

            	
              V.

            	
              U.S.
      Provisional Patent Application No. 60/963,307, filed August 3, 2007
      entitled “Use of Phosphatases To Treat Neuroblastomas and
      Medulloblastomas” (HHS Ref. No.
      E-123-2006/2-US-01)

            


    

     

    
      	
               
      

            	
              VI.

            	
              U.S.
      Provisional Patent Application No. 60/063,970, filed February 6, 2008
      entitled “Use of  Phosphatases To Treat Neuroblastomas and
      Medulloblastomas”.

            


    

     

    
      	
               
      

            	
              VII.

            	
              U.S.
      Application in preparation corresponding to Cooper and Dunham Referene No.
      4101/79251.

            


    

     

    Licensee:

     

    Lixte
Biotechnology, Inc.

     

    Cooperative
Research and Development Agreement (CRADA) Number (if a subject
invention):

     

    CRADA No.
02165 (C-026-2006/0) and Four Amendments

     

    Additional
Remarks:

     

    N/A

     

    Public
Benefit(s):

     

    
      
         


      

      
         


        
          

        

      

      
         


      

    

     

    Novel
methods of treating glioblastomas and other tumors of the central nervous
system.

    This
Patent License Agreement, hereinafter referred to as the “Agreement”, consists of this
Cover Page, an attached Agreement, a Signature Page,
Appendix A (List of Patent(s) or Patent Application(s)), Appendix B (Fields of
Use and Territory), Appendix C (Royalties), Appendix D (Benchmarks and
Performance), Appendix E (Commercial Development Plan), Appendix F (Example
Royalty Report), and Appendix G (Royalty Payment Options).  The
Parties to this Agreement
are:

     

    
      	
               
      

            	
              1)

            	
              The
      National Institutes of Health (“NIH”) or the Food and
      Drug Administration (“FDA”), hereinafter
      singly or collectively referred to as “PHS”, agencies of the
      United States Public Health Service within the Department of Health and
      Human Services (“HHS”);
    and

            


    

     

    
      	
               
      

            	
              2)

            	
              The
      person, corporation, or institution identified above or on the Signature
      Page, having offices at the address indicated on the Signature Page,
      hereinafter referred to as “Licensee”.

            


    

     

    
      
         


      

      
         


        
          

        

      

      
         


      

    


    
      	
               
      

            	
              PHS
      PATENT LICENSE AGREEMENT – EXCLUSIVE

            


    

     

    PHS and Licensee agree as
follows:

     

    
      	
              1.

            	
              BACKGROUND

            


    

     

    
      	
               
      

            	
              1.1

            	
              In
      the course of conducting biomedical research, PHS investigators made
      inventions that may have commercial
  applicability.

            


    

     

    
      	
               
      

            	
              1.2

            	
              By
      assignment of rights from PHS employees and other
      inventors, HHS, on
      behalf of the Government, owns intellectual property rights claimed in any
      United States or foreign patent applications or patents corresponding to
      the assigned inventions.  HHS also owns any
      tangible embodiments of these inventions actually reduced to practice by
      PHS.

            


    

     

    
      	
               
      

            	
              1.3

            	
              The
      Secretary of HHS
      has delegated to PHS the authority to
      enter into this Agreement
      for the licensing of rights to these
  inventions.

            


    

     

    
      	
               
      

            	
              1.4

            	
              PHS desires to transfer
      these inventions to the private sector through commercialization licenses
      to facilitate the commercial development of products and processes for
      public use and benefit.

            


    

     

    
      	
               
      

            	
              1.5

            	
              Licensee
      desires to acquire commercialization rights to certain of these inventions
      in order to develop processes, methods, or marketable products for public
      use and benefit.

            


    

     

    
      	
              2.

            	
              DEFINITIONS

            


    

     

    
      	
               
      

            	
              2.1

            	
              “Benchmarks” mean the
      performance milestones that are set forth in Appendix
  D.

            


    

     

    
      	
               
      

            	
              2.2

            	
              “Commercial Development
      Plan” means the written commercialization plan attached as Appendix
      E.

            


    

     

    
      	
               
      

            	
              2.3

            	
              “First Commercial Sale”
      means the initial transfer by or on behalf of Licensee or its
      sublicensees of Licensed
      Products or the initial practice of a Licensed Process by or
      on behalf of Licensee or its
      sublicensees in exchange for cash or some equivalent to which value can be
      assigned for the purpose of determining Net
    Sales.

            


    

     

    
      	
               
      

            	
              2.4

            	
              “Government” means the
      Government of the United States of
America.

            


    

     

    
      	
               
      

            	
              2.5

            	
              “Licensed Fields of Use”
      means the fields of use identified in Appendix
  B.

            


    

     

    
      	
               
      

            	
              2.6

            	
              “Licensed Patent Rights”
      shall mean:

            


    

     

    
      	
               
      

            	
              (a)

            	
              Patent
      applications (including provisional patent applications and PCT patent
      applications) or patents listed in Appendix A, all divisions and
      continuations of these applications, all patents issuing from these
      applications, divisions, and continuations, and any reissues,
      reexaminations, and extensions of these
patents;

            


    

     

    
      	
               
      

            	
              (b)

            	
              to
      the extent that the following contain one or more claims directed to the
      invention or inventions disclosed in
2.6(a):

            


    

     

    
      	
               
      

            	
              (i)

            	
              continuations
      in part of 2.6(a);

            


    

     

    
      	
               
      

            	
              (ii)

            	
              all
      divisions and continuations of these continuations in
  part;

            


    

     

    
      
         


      

      
         


        
          

        

      

      
         


      

    

     

    
      	
               
      

            	
              (iii)

            	
              all
      patents issuing from these continuations in part, divisions, and
      continuations;

            


    

     

    
      	
               
      

            	
              (iv)

            	
              priority
      patent application(s) of, and application(s) claiming priority of, 2.6(a);
      and

            


    

     

    
      	
               
      

            	
              (v)

            	
              any
      reissues, reexaminations, and extensions of these
  patents;

            


    

     

    
      	
               
      

            	
              (c)

            	
              to
      the extent that the following contain one or more claims directed to the
      invention or inventions disclosed in 2.6(a): all counterpart foreign and
      U.S. patent applications and patents to 2.6(a) and 2.6(b), including those
      listed in Appendix A; and

            


    

     

    
      	
               
      

            	
              (d)

            	
              Licensed Patent Rights
      shall not include 2.6(b) or 2.6(c) to the extent that they contain one or
      more claims directed to new matter which is not the subject matter
      disclosed in 2.6(a).

            


    

     

    
      	
               
      

            	
              2.7

            	
              “Licensed Processes”
      means processes which, in the course of being practiced, would be within
      the scope of one or more claims of the Licensed Patent Rights
      that have not been held unpatentable, invalid or unenforceable by an
      unappealed or unappealable judgment of a court of competent
      jurisdiction.

            


    

     

    
      	
               
      

            	
              2.8

            	
              “Licensed Products” means
      tangible materials which, in the course of manufacture, use, sale, or
      importation, would be within the scope of one or more claims of the Licensed Patent Rights
      that have not been held unpatentable, invalid or unenforceable by an
      unappealed or unappealable judgment of a court of competent
      jurisdiction.

            


    

     

    
      	
               
      

            	
              2.9

            	
              “Licensed Territory”
      means the geographical area identified in Appendix
  B.

            


    

     

    
      	
               
      

            	
              2.10

            	
              “Net
      Sales” means the total gross receipts for sales of Licensed Products or
      practice of Licensed
      Processes by or on behalf of Licensee or its
      sublicensees, and from leasing, renting, or otherwise making Licensed Products
      available to others without sale or other dispositions, whether invoiced
      or not, less returns and allowances, packing costs, insurance costs,
      freight out, taxes or excise duties imposed on the transaction (if
      separately invoiced), and wholesaler and cash discounts in amounts
      customary in the trade to the extent actually granted.  No
      deductions shall be made for commissions paid to individuals, whether they
      are with independent sales agencies or regularly employed by Licensee, or
      sublicensees, and on its payroll, or for the cost of
      collections.

            


    

     

    
      	
               
      

            	
              2.11

            	
              “Practical Application”
      means to manufacture in the case of a composition or product, to practice
      in the case of a process or method, or to operate in the case of a machine
      or system; and in each case, under these conditions as to establish that
      the invention is being utilized and that its benefits are to the extent
      permitted by law or Government regulations
      available to the public on reasonable
terms.

            


    

     

    
      	
               
      

            	
              2.12

            	
              “Research License” means
      a nontransferable, nonexclusive license to make and to use Licensed Products or
      Licensed Processes
      as defined by the Licensed Patent Rights
      for purposes of research and not for purposes of commercial manufacture or
      distribution or in lieu of
purchase.

            


    

     

    
      	
               
      

            	
              2.13

            	
              "Affiliate(s)" means a
      corporation or other business entity, which, directly or indirectly, is
      controlled by, controls, or is under common control with Licensee.  For
      this purpose, the term "control" shall mean ownership of more than fifty
      percent (50%) of the voting stock or other ownership interest of the
      corporation or other business entity, or the power to elect or appoint
      more than fifty percent (50%) of the members of the governing body of the
      corporation or other business
entity.

            


    

     

    
      
         


      

      
        2

        
          

        

      

      
         


      

    

     

    
      	
              3.

            	
              GRANT OF
      RIGHTS

            


    

     

    
      	
               
      

            	
              3.1

            	
              PHS hereby grants and
      Licensee accepts,
      subject to the terms and conditions of this Agreement, an exclusive
      license under the Licensed Patent Rights
      in the Licensed
      Territory to make and have made, to use and have used, to sell and
      have sold, to offer to sell, and to import any Licensed Products in the
      Licensed Fields of Use and to practice and have practiced any Licensed Processes in
      the Licensed Fields of
      Use.

            


    

     

    
      	
               
      

            	
              3.2

            	
              This
      Agreement confers
      no license or rights by implication, estoppel, or otherwise under any
      patent applications or patents of PHS other than the Licensed Patent Rights
      regardless of whether these patents are dominant or subordinate to the
      Licensed Patent
      Rights.

            


    

     

    
      	
              4.

            	
              SUBLICENSING

            


    

     

    
      	
               
      

            	
              4.1

            	
              Upon
      written approval, which shall include prior review of any sublicense
      agreement by PHS
      and which shall not be unreasonably withheld, Licensee may enter into
      sublicensing agreements under the Licensed Patent
      Rights.

            


    

     

    
      	
               
      

            	
              4.2

            	
              Licensee agrees that any
      sublicenses granted by it shall provide that the obligations to PHS of Paragraphs 5.1
      5.4, 8.1, 10.1, 10.2, 12.5, and 13.8-13.10 of this Agreement shall be
      binding upon the sublicensee as if it were a party to this Agreement.  Licensee further agrees
      to attach copies of these Paragraphs to all sublicense
      agreements.

            


    

     

    
      	
               
      

            	
              4.3

            	
              Any
      sublicenses granted by Licensee shall provide
      for the termination of the sublicense, or the conversion to a license
      directly between the sublicensees and PHS, at the option of
      the sublicensee, upon termination of this Agreement under Article
      13.  This conversion is subject to PHS approval which will
      not be unreasonably withheld and contingent upon acceptance by the
      sublicensee of the remaining provisions of this Agreement.

            


    

     

    
      	
               
      

            	
              4.4

            	
              Licensee agrees to
      forward to PHS a
      complete copy of each fully executed sublicense agreement postmarked
      within thirty (30) days of the execution of the agreement.  To
      the extent permitted by law, PHS agrees to maintain
      each sublicense agreement in
confidence.

            


    

     

    
      	
              5.

            	
              STATUTORY AND PHS
      REQUIREMENTS AND RESERVED GOVERNMENT
  RIGHTS

            


    

     

    
      	
               
      

            	
              5.1        
        (a)

            	
              PHS reserves on behalf
      of the Government
      an irrevocable, nonexclusive, nontransferable, royalty free license for
      the practice of all inventions licensed under the Licensed Patent Rights
      throughout the world by or on behalf of the Government and on behalf
      of any foreign government or international organization pursuant to any
      existing or future treaty or agreement to which the Government is a
      signatory.  Prior to the First Commercial Sale,
      Licensee agrees to
      provide PHS with
      reasonable quantities of Licensed Products or
      materials made through the Licensed Processes for
      PHS research use;
      and

            


    

     

    
      
         


      

      
        3

        
          

        

      

      
         


      

    


    
      	
               
      

            	
              (b)

            	
              In
      the event that the Licensed Patent Rights
      are Subject Inventions made under a Cooperative Research and
      Development Agreement (“CRADA”), Licensee grants to the
      Government,
      pursuant to 15 U.S.C. §3710a(b)(1)(A), a nonexclusive, nontransferable,
      irrevocable, paid up license to practice Licensed Patent Rights
      or have Licensed Patent
      Rights practiced throughout the world by or on behalf of the Government.  In
      the exercise of this license, the Government shall not
      publicly disclose trade secrets or commercial or financial information
      that is privileged or confidential within the meaning of 5 U.S.C.
      §552(b)(4) or which would be considered as such if it had been obtained
      from a non Federal party.  Prior to the First Commercial Sale,
      Licensee agrees to
      provide PHS
      reasonable quantities of Licensed Products or
      materials made through the Licensed Processes for
      PHS research
      use.

            


    

     

    
      	
               
      

            	
              5.2

            	
              Licensee agrees that
      products used or sold in the United States embodying Licensed Products or
      produced through use of Licensed Processes shall
      be manufactured substantially in the United States, unless a written
      waiver is obtained in advance from PHS.

            


    

     

    
      	
               
      

            	
              5.3

            	
              Licensee acknowledges
      that PHS may enter
      into future CRADAs
      under the Federal Technology Transfer Act of 1986 that relate to the
      subject matter of this Agreement.  Licensee agrees not to
      unreasonably deny requests for a Research License from future
      collaborators with PHS when acquiring these
      rights is necessary in order to make a CRADA project
      feasible.  Licensee may request an
      opportunity to join as a party to the proposed CRADA.

            


    

     

    
      	
               
      

            	
              5.4

            	
              (a)

            	
              In
      addition to the reserved license of Paragraph 5.1, PHS reserves the right
      to grant Research
      Licenses directly or to require Licensee to grant Research Licenses on
      reasonable terms.  The purpose of these Research Licenses is to
      encourage basic research, whether conducted at an academic or corporate
      facility.  In order to safeguard the Licensed Patent Rights,
      however, PHS shall
      consult with Licensee before granting
      to commercial entities a Research License or providing to them research
      samples of materials made through the Licensed Processes;
      and

            


    

     

    
      	
               
      

            	
              (b)

            	
              In
      exceptional circumstances, and in the event that Licensed Patent Rights
      are Subject Inventions made under a CRADA, the Government, pursuant to
      15 U.S.C. §3710a(b)(1)(B), retains the right to require the Licensee to grant to a
      responsible applicant a nonexclusive, partially exclusive, or exclusive
      sublicense to use the Licensed Patent Rights
      in the Licensed Field of
      Use on terms that are reasonable under the circumstances, or if
      Licensee fails to
      grant this license, the Government retains the
      right to grant the license itself.  The exercise of these rights
      by the Government
      shall only be in exceptional circumstances and only if the Government
      determines:

            


    

     

    
      	
               
      

            	
              (i)

            	
              the
      action is necessary to meet health or safety needs that are not reasonably
      satisfied by Licensee;

            


    

     

    
      	
               
      

            	
              (ii)

            	
              the
      action is necessary to meet requirements for public use specified by
      Federal regulations, and these requirements are not reasonably satisfied
      by the Licensee;
      or

            


    

     

    
      	
               
      

            	
              (iii)

            	
              the
      Licensee has
      failed to comply with an agreement containing provisions described in 15
      U.S.C. §3710a(c)(4)(B); and

            


    

     

    
      	
               
      

            	
              (c)

            	
              The
      determination made by the Government under this
      Paragraph 5.4 is subject to administrative appeal and judicial review
      under 35 U.S.C. §203(2).

            


    

     

    
      	
              6.

            	
              ROYALTIES AND
      REIMBURSEMENT

            


    

     

    
      	
               
      

            	
              6.1

            	
              Licensee agrees to pay
      PHS a
      noncreditable, nonrefundable license issue royalty as set forth in
      Appendix C.

            


    

     

    
      
         


      

      
        4

        
          

        

      

      
         


      

    


    
      	
               
      

            	
              6.2

            	
              Licensee agrees to pay
      PHS a
      nonrefundable minimum annual royalty as set forth in Appendix
      C.

            


    

     

    
      	
               
      

            	
              6.3

            	
              Licensee agrees to pay
      PHS earned
      royalties as set forth in Appendix
C.

            


    

     

    
      	
               
      

            	
              6.4

            	
              Licensee agrees to pay
      PHS benchmark
      royalties as set forth in Appendix
C.

            


    

     

    
      	
               
      

            	
              6.5

            	
              Licensee agrees to pay
      PHS sublicensing
      royalties as set forth in Appendix
C.

            


    

     

    
      	
               
      

            	
              6.6

            	
              A
      patent or patent application licensed under this Agreement shall cease to
      fall within the Licensed
      Patent Rights for the purpose of computing earned royalty payments
      in any given country on the earliest of the dates
  that:

            


    

     

    
      	
               
      

            	
              (a)

            	
              the
      application has been abandoned and not
  continued;

            


    

     

    
      	
               
      

            	
              (b)

            	
              the
      patent expires or irrevocably lapses,
or

            


    

     

    
      	
               
      

            	
              (c)

            	
              the
      claim has been held to be invalid or unenforceable by an unappealed or
      unappealable decision of a court of competent jurisdiction or
      administrative agency.

            


    

     

    
      	
               
      

            	
              6.7

            	
              No
      multiple royalties shall be payable because any Licensed Products or
      Licensed Processes
      are covered by more than one of the Licensed Patent
      Rights.

            


    

     

    
      	
               
      

            	
              6.8

            	
              On
      sales of Licensed
      Products by Licensee to sublicensees
      or on sales made in other than an arms length transaction, the value of
      the Net Sales attributed under this Article 6 to this transaction shall be
      that which would have been received in an arms length transaction, based
      on sales of like quantity and quality products on or about the time of
      this transaction.

            


    

     

    
      	
               
      

            	
              6.9

            	
              PHS has not incurred any
      expenses associated with the preparation, filing, prosecution, and
      maintenance of the patent applications and patents included within the
      Licensed Patent
      Rights prior to the effective date of this
    Agreement.

            


    

     

    
      	
               
      

            	
              6.10

            	
              With
      regard to expenses associated with the preparation, filing, prosecution,
      and maintenance of all patent applications and patents included within the
      Licensed Patent
      Rights and incurred by PHS on or after the
      effective date of this Agreement, PHS, at its sole option,
      may require Licensee:

            


    

     

    
      	
               
      

            	
              (a)

            	
              to
      pay PHS on an
      annual basis, within sixty (60) days of PHS’ submission of a
      statement and request for payment, a royalty amount equivalent to these
      patent expenses incurred during the previous calendar
    year(s);

            


    

     

    
      	
               
      

            	
              (b)

            	
              to
      pay these expenses directly to the law firm employed by PHS to handle these
      functions.  However, in this event, PHS and not Licensee shall be the
      client of the law firm; or

            


    

     

    
      	
               
      

            	
              (c)

            	
              in
      limited circumstances, Licensee may be given
      the right to assume responsibility for the preparation, filing,
      prosecution, or maintenance of any patent application or patent included
      with the Licensed Patent
      Rights.  In that event, Licensee shall directly
      pay the attorneys or agents engaged to prepare, file, prosecute, or
      maintain these patent applications or patents and shall provide PHS with copies of each
      invoice associated with these services as well as documentation that these
      invoices have been paid.

            


    

     

    
      
         


      

      
        5

        
          

        

      

      
         


      

    


    
      	
               
      

            	
              6.11

            	
              PHS agrees, upon written
      request, to provide Licensee with summaries
      of patent prosecution invoices for which PHS has requested
      payment from the Licensee under
      Paragraphs 6.9 and 6.10.  Licensee agrees that all
      information provided by PHS related to patent
      prosecution costs shall be treated as confidential commercial information
      and shall not be released to a third party except as required by law or a
      court of competent jurisdiction.

            


    

     

    
      	
               
      

            	
              6.12

            	
              Licensee may elect to
      surrender its rights in any country of the Licensed Territory under
      any of the Licensed
      Patent Rights upon ninety (90) days written notice to PHS and owe no payment
      obligation under Paragraph 6.10 for patent-related expenses incurred in
      that country after ninety (90) days of the effective date of the written
      notice.

            


    

     

    
      	
              7.

            	
              PATENT FILING,
      PROSECUTION, AND MAINTENANCE

            


    

     

    
      	
               
      

            	
              7.1

            	
              Licensee shall file,
      prosecute, and maintain patent application(s) relating to the Licensed Patent Rights
      and shall promptly provide to PHS all serial numbers
      and filing dates, together with copies of all these applications,
      including copies of all Patent Office actions, responses, and all other
      Patent Office communications.  In addition, Licensee shall file with
      Patent Offices a Power of Attorney that names both Licensee and PHS or names inventors
      of the Licensed Patent
      Rights who are obligated to assign to Licensee or PHS.  This
      Power of Attorney shall be filed with every Patent Office involved in
      prosecuting all patent applications pertaining to Licensed Patent
      Rights.  Licensee shall consult
      with PHS, when so
      requested, prior to communicating with any Patent Office with respect to
      the Licensed Patent
      Rights.  PHS shall timely provide
      to Licensee or its
      attorneys any formal document necessary to file, prosecute, and maintain
      patents and patent applications relating to the Licensed Patent
      Rights.

            


    

     

    
      	
               
      

            	
              7.2

            	
              Licensee shall make an
      election with respect to foreign filing, upon consultation with PHS, including which
      countries foreign filing shall be done prior to the election, within eight
      (8) months of any United States filing.  If any foreign patent
      applications are filed, Licensee shall promptly
      provide to PHS all
      serial numbers and filing dates.  Licensee also shall
      provide PHS copies
      of foreign patent applications and Patent Office actions.  Licensee shall consult
      with PHS, when so
      requested, prior to communication with any Patent Office with respect to
      the Licensed Patent
      Rights.

            


    

     

    
      	
               
      

            	
              7.3

            	
              Licensee shall promptly
      record available Assignments of domestic Licensed Patent Rights
      in the United States Patent and Trademark Office and shall promptly
      provide PHS with
      the original of each recorded Assignment with respect to PHS.

            


    

     

    
      	
               
      

            	
              7.4

            	
              Notwithstanding
      any other provision of this Agreement, Licensee shall not
      abandon the prosecution of any patent application, including provisional
      patent applications (except for purposes of filing continuation
      application(s)) or the maintenance of any patent contemplated by this
      Agreement, without prior written notice to PHS.  Upon
      receiving the written notice, PHS may, at its sole
      option, take over the prosecution of any patent application, or the
      maintenance of any patent. Licensee agrees to
      furnish written notice to PHS as soon as possible
      after Licensee’s
      decision to abandon prosecution, and Licensee will not
      abandon prosecution within thirty (30) days of a prosecution deadline.
      Licensee shall
      promptly provide PHS with copies of all
      issued patents under this
Agreement.

            


    

     

    
      	
               
      

            	
              7.5

            	
              Licensee shall promptly
      provide PHS with
      copies of all issued patents under this
  Agreement.

            


    

     

    
      	
               
      

            	
              7.6

            	
              In
      the event that Licensee anticipates the
      possibility of any extraordinary expenditures arising from the
      preparation, filing, prosecution, licensing, or defense of any patent
      application or patent contemplated by this Agreement, including, without
      limitation, interferences, reexaminations, reissues and oppositions, Licensee shall provide
      PHS with all
      relevant information.

            


    

     

    
      
         


      

      
        6

        
          

        

      

      
         


      

    


    
      	
              8.

            	
              RECORD
      KEEPING

            


    

     

    
      	
               
      

            	
              8.1

            	
              Licensee agrees to keep
      accurate and correct records of Licensed Products made,
      used, sold, or imported and Licensed Processes
      practiced under this Agreement appropriate to determine the amount of
      royalties due PHS.  These
      records shall be retained for at least five (5) years following a given
      reporting period and shall be available during normal business hours for
      inspection, at the expense of PHS, by an accountant or
      other designated auditor selected by PHS for the sole purpose
      of verifying reports and royalty payments hereunder.  The
      accountant or auditor shall only disclose to PHS information relating
      to the accuracy of reports and royalty payments made under this
      Agreement.  If an inspection shows an underreporting or
      underpayment in excess of five percent (5%) for any twelve (12) month
      period, then Licensee shall reimburse
      PHS for the cost
      of the inspection at the time Licensee pays the
      unreported royalties, including any additional royalties as required by
      Paragraph 9.8.  All royalty payments required under this
      Paragraph shall be due within thirty (30) days of the date PHS provides Licensee notice of the
      payment due.

            


    

     

    
      	
               
      

            	
              8.2

            	
              Licensee agrees to have
      an audit of sales and royalties conducted by an independent auditor at
      least every two (2) years if annual sales of the Licensed Products or
      Licensed Processes
      are over ten (10) million dollars.  The audit shall address, at
      a minimum, the amount of gross sales by or on behalf of Licensee during the
      audit period, terms of the license as to percentage or fixed royalty to be
      remitted to the Government, the amount
      of royalties owed to the Government under this
      Agreement, and whether the royalties owed have been paid to the Government and is
      reflected in the records of the Licensee.  The
      audit shall also indicate the PHS license number,
      product, and the time period being audited.  A report certified
      by the auditor shall be submitted promptly by the auditor directly to
      PHS on
      completion.  Licensee shall pay for
      the entire cost of the audit.

            


    

     

    
      	
              9.

            	
              REPORTS ON PROGRESS,
      BENCHMARKS, SALES, AND
PAYMENTS

            


    

     

    
      	
               
      

            	
              9.1

            	
              Prior
      to signing this Agreement, Licensee has provided
      PHS with the Commercial Development Plan
      in Appendix E, under which Licensee intends to
      bring the subject matter of the Licensed Patent Rights
      to the point of Practical
      Application.  This Commercial Development Plan
      is hereby incorporated by reference into this Agreement.  Based
      on this plan, performance Benchmarks are
      determined as specified in Appendix
D.

            


    

     

    
      	
               
      

            	
              9.2

            	
              Licensee shall provide
      written annual reports on its product development progress or efforts to
      commercialize under the Commercial Development Plan
      for each of the Licensed Fields of Use
      within sixty (60) days after December 31 of each calendar
      year.  These progress reports shall include, but not be limited
      to: progress on research and development, status of applications for
      regulatory approvals, manufacturing, sublicensing, marketing, importing,
      and sales during the preceding calendar year, as well as, plans for the
      present calendar year.  PHS also encourages
      these reports to include information on any of Licensee's public
      service activities that relate to the Licensed Patent
      Rights.  If reported progress differs from that projected
      in the Commercial
      Development Plan and Benchmarks, Licensee shall explain
      the reasons for these differences.  In the annual report, Licensee may propose
      amendments to the Commercial Development
      Plan, acceptance of which by PHS may not be denied
      unreasonably.  Licensee agrees to
      provide any additional information reasonably required by PHS to evaluate Licensee's performance
      under this Agreement.  Licensee may amend the
      Benchmarks at any
      time upon written approval by PHS. PHS shall not
      unreasonably withhold approval of any request of Licensee to extend the
      time periods of this schedule if the request is supported by a reasonable
      showing by Licensee of diligence in
      its performance under the Commercial Development
      Plan and toward bringing the Licensed Products to the
      point of Practical
      Application as defined in 37 CFR §404.3(d).  Licensee shall amend the
      Commercial Development
      Plan and Benchmarks at the
      request of PHS to
      address any Licensed Fields of Use not specifically addressed in the plan
      originally submitted.

            


    

     

    
      
         

      

      
        7

        
          

        

      

      
         

      

    

     

    
      	
               
      

            	
              9.3

            	
              Licensee shall report to
      PHS the dates for
      achieving Benchmarks specified in
      Appendix D and the First
      Commercial Sale in each country in the Licensed Territory
      within thirty (30) days of such
occurrences.

            


    


    
      	
               
      

            	
              9.4

            	
              Licensee shall submit to
      PHS, within sixty
      (60) days after each calendar half year ending June 30 and December 31, a
      royalty report, as described in the example in Appendix F, setting forth
      for the preceding half year period the amount of the Licensed Products sold
      or Licensed
      Processes practiced by or on behalf of Licensee in each country
      within the Licensed
      Territory, the Net
      Sales, and the amount of royalty accordingly due.  With
      each royalty report, Licensee shall submit
      payment of earned royalties due.  If no earned royalties are due
      to PHS for any
      reporting period, the written report shall so state.  The
      royalty report shall be certified as correct by an authorized officer of
      Licensee and shall
      include a detailed listing of all deductions made under Paragraph 2.10 to
      determine Net
      Sales made under Article 6 to determine royalties
    due.

            


    

     

    
      	
               
      

            	
              9.5

            	
              Licensee agrees to
      forward semi annually to PHS a copy of these
      reports received by Licensee from its
      sublicensees during the preceding half year period as shall be pertinent
      to a royalty accounting to PHS by Licensee for activities
      under the sublicense.

            


    

     

    
      	
               
      

            	
              9.6

            	
              Royalties
      due under Article 6 shall be paid in U.S. dollars and payment options are
      listed in Appendix G.  For conversion of foreign currency to
      U.S. dollars, the conversion rate shall be the New York foreign exchange
      rate quoted in The Wall
      Street Journal on the day that the payment is due.  Any
      loss of exchange, value, taxes, or other expenses incurred in the transfer
      or conversion to U.S. dollars shall be paid entirely by Licensee.  The
      royalty report required by Paragraph 9.4 shall be mailed to PHS at its address for
      Agreement Notices indicated on the Signature
  Page.

            


    

     

    
      	
               
      

            	
              9.7

            	
              Licensee shall be solely
      responsible for determining if any tax on royalty income is owed outside
      the United States and shall pay the tax and be responsible for all filings
      with appropriate agencies of foreign
  governments.

            


    

     

    
      	
               
      

            	
              9.8

            	
              Additional
      royalties may be assessed by PHS on any payment that
      is more than ninety (90) days overdue at the rate of one percent (1%) per
      month.  This one percent (1%) per month rate may be applied
      retroactively from the original due date until the date of receipt by
      PHS of the overdue
      payment and additional royalties.  The payment of any additional
      royalties shall not prevent PHS from exercising any
      other rights it may have as a consequence of the lateness of any
      payment.

            


    

     

    
      	
               
      

            	
              9.9

            	
              All
      plans and reports required by this Article 9 and marked “confidential” by
      Licensee shall, to
      the extent permitted by law, be treated by PHS as commercial and
      financial information obtained from a person and as privileged and
      confidential, and any proposed disclosure of these records by the PHS under the Freedom of
      Information Act (FOIA), 5 U.S.C. §552 shall be subject to the
      predisclosure notification requirements of 45 CFR
  §5.65(d).

            


    

     

    
      
         


      

      
        8

        
          

        

      

      
         


      

    

     

    
      	
              10.

            	
              PERFORMANCE

            


    

     

    
      	
               
      

            	
              10.1

            	
              Licensee shall use its
      reasonable commercial efforts to bring the Licensed Products and
      Licensed Processes
      to Practical
      Application.  “Reasonable commercial efforts” for the
      purposes of this provision shall include adherence to the Commercial Development
      Plan in Appendix E and performance of the Benchmarks in Appendix
      D.  The efforts of a sublicensee shall be considered the efforts
      of Licensee.

            


    

     

    
      	
               
      

            	
              10.2

            	
              Upon
      the First Commercial
      Sale, until the expiration or termination of this Agreement, Licensee shall use its
      reasonable commercial efforts to make Licensed Products and
      Licensed Processes
      reasonably accessible to the United States
  public.

            


    

     

    
      	
               
      

            	
              10.3

            	
              Licensee agrees, after
      its First Commercial
      Sale, to make reasonable quantities of Licensed Products or
      materials produced through the use of Licensed Processes
      available on a compassionate use basis to patients, either through the
      patient’s physician(s) or the medical center treating the
      patient.

            


    

     

    
      	
               
      

            	
              10.4

            	
              Licensee agrees, after
      its First Commercial
      Sale and as part of its marketing and product promotion, to develop
      educational materials (e.g., brochures, website, etc.) directed to
      patients and physicians detailing the Licensed Products or
      medical aspects of the prophylactic and therapeutic uses of the Licensed
      Products.

            


    

     

    
      	
               
      

            	
              10.5

            	
              Licensee agrees to
      supply, to the Mailing Address for Agreement Notices indicated on the
      Signature Page, the Office of Technology Transfer, NIH with inert samples
      of the Licensed
      Products or Licensed Processes or
      their packaging for educational and display purposes
  only.

            


    

     

    
      	
              11.

            	
              INFRINGEMENT AND
      PATENT ENFORCEMENT

            


    

     

    
      	
               
      

            	
              11.1

            	
              PHS and Licensee agree to notify
      each other promptly of each infringement or possible infringement of the
      Licensed Patent
      Rights, as well as, any facts which may affect the validity, scope,
      or enforceability of the Licensed Patent Rights
      of which either party becomes
aware.

            


    

     

    
      	
               
      

            	
              11.2

            	
              Pursuant
      to this Agreement and the provisions of Chapter 29 of Title 35, United
      States Code, Licensee
      may:

            


    

     

    
      	
               
      

            	
              (a)

            	
              bring
      suit in its own name, at its own expense, and on its own behalf for
      infringement of presumably valid claims in the Licensed Patent
      Rights;

            


    

     

    
      	
               
      

            	
              (b)

            	
              in
      any suit, enjoin infringement and collect for its use, damages, profits,
      and awards of whatever nature recoverable for the infringement;
      or

            


    

     

    
      	
               
      

            	
              (c)

            	
              settle
      any claim or suit for infringement of the Licensed Patent Rights
      provided, however, that PHS and appropriate
      Government
      authorities shall have the first right to take such actions;
      and

            


    

     

    
      
         


      

      
        9

        
          

        

      

      
         


      

    


    
      	
               
      

            	
              (d)

            	
              If
      Licensee desires
      to initiate a suit for patent infringement, Licensee shall notify
      PHS in
      writing.  If PHS does not notify
      Licensee of its
      intent to pursue legal action within ninety (90) days, Licensee shall be free
      to initiate suit.  PHS shall have a
      continuing right to intervene in the suit.  Licensee shall take no
      action to compel the Government either to
      initiate or to join in any suit for patent infringement.  Licensee may request the
      Government to
      initiate or join in any suit if necessary to avoid dismissal of the suit.
      Should the Government be made a
      party to any suit, Licensee shall reimburse
      the Government for
      any costs, expenses, or fees which the Government incurs as a
      result of the motion or other action, including all costs incurred by the
      Government in
      opposing the motion or other action.  In all cases, Licensee agrees to keep
      PHS reasonably
      apprised of the status and progress of any litigation.  Before
      Licensee commences
      an infringement action, Licensee shall notify
      PHS and give
      careful consideration to the views of PHS and to any potential
      effects of the litigation on the public health in deciding whether to
      bring suit.

            


    

     

    
      	
               
      

            	
              11.3

            	
              In
      the event that a declaratory judgment action alleging invalidity or non
      infringement of any of the Licensed Patent Rights
      shall be brought against Licensee or raised by
      way of counterclaim or affirmative defense in an infringement suit brought
      by Licensee under
      Paragraph 11.2, pursuant to this Agreement and the provisions of Chapter
      29 of Title 35, United States Code or other statutes, Licensee
      may:

            


    

     

    
      	
               
      

            	
              (a)

            	
              defend
      the suit in its own name, at its own expense, and on its own behalf for
      presumably valid claims in the Licensed Patent
      Rights;

            


    

     

    
      	
               
      

            	
              (b)

            	
              in
      any suit, ultimately to enjoin infringement and to collect for its use,
      damages, profits, and awards of whatever nature recoverable for the
      infringement; and

            


    

     

    
      	
               
      

            	
              (c)

            	
              settle
      any claim or suit for declaratory judgment involving the Licensed Patent
      Rights-provided, however, that PHS and appropriate
      Government
      authorities shall have the first right to take these actions and shall
      have a continuing right to intervene in the suit;
  and

            


    

     

    
      	
               
      

            	
              (d)

            	
              If
      PHS does not
      notify Licensee of
      its intent to respond to the legal action within a reasonable time, Licensee shall be free
      to do so.  Licensee shall take no
      action to compel the Government either to
      initiate or to join in any declaratory judgment action.  Licensee may request the
      Government to
      initiate or to join any suit if necessary to avoid dismissal of the
      suit.  Should the Government be made a
      party to any suit by motion or any other action of Licensee, Licensee shall reimburse
      the Government for
      any costs, expenses, or fees, which the Government incurs as a
      result of the motion or other action.  If Licensee elects not to
      defend against the declaratory judgment action, PHS, at its option, may
      do so at its own expense.  In all cases, Licensee agrees to keep
      PHS reasonably
      apprised of the status and progress of any litigation.  Before
      Licensee commences
      an infringement action, Licensee shall notify
      PHS and give
      careful consideration to the views of PHS and to any potential
      effects of the litigation on the public health in deciding whether to
      bring suit.

            


    

     

    
      	
               
      

            	
              11.4

            	
              In
      any action under Paragraphs 11.2 or 11.3 the expenses including costs,
      fees, attorney fees, and disbursements, shall be paid by Licensee.  The
      value of any recovery made by Licensee through court
      judgment or settlement shall be treated as Net Sales and subject to
      earned royalties.

            


    

     

    
      	
               
      

            	
              11.5

            	
              PHS shall cooperate
      fully with Licensee in connection
      with any action under Paragraphs 11.2 or 11.3.  PHS agrees promptly to
      provide access to all necessary documents and to render reasonable
      assistance in response to a request by Licensee.

            


    

     

    
      	
              12.

            	
              NEGATION OF WARRANTIES
      AND INDEMNIFICATION

            


    

     

    
      	
               
      

            	
              12.1

            	
              PHS offers no warranties
      other than those specified in Article
1.

            


    

     

    
      
         


      

      
        10

        
          

        

      

      
         


      

    


    
      	
               
      

            	
              12.2

            	
              PHS does not warrant the
      validity of the Licensed
      Patent Rights and makes no representations whatsoever with regard
      to the scope of the Licensed Patent Rights,
      or that the Licensed
      Patent Rights may be exploited without infringing other patents or
      other intellectual property rights of third
  parties.

            


    

     

    
      	
               
      

            	
              12.3

            	
              PHS MAKES NO WARRANTIES,
      EXPRESSED OR IMPLIED, OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
      PURPOSE OF ANY SUBJECT MATTER DEFINED BY THE CLAIMS OF THE LICENSED PATENT
      RIGHTS OR TANGIBLE MATERIALS RELATED
THERETO.

            


    

     

    
      	
               
      

            	
              12.4

            	
              PHS does not represent
      that it shall commence legal actions against third parties infringing the
      Licensed Patent
      Rights.

            


    

     

    
      	
               
      

            	
              12.5

            	
              Licensee shall indemnify
      and hold PHS, its
      employees, students, fellows, agents, and consultants harmless from and
      against all liability, demands, damages, expenses, and losses, including
      but not limited to death, personal injury, illness, or property damage in
      connection with or arising out of:

            


    

     

    
      	
               
      

            	
              (a)

            	
              the
      use by or on behalf of Licensee, its
      sublicensees, directors, employees, or third parties of any Licensed Patent Rights;
      or

            


    

     

    
      	
               
      

            	
              (b)

            	
              the
      design, manufacture, distribution, or use of any Licensed Products, Licensed Processes or
      materials by Licensee, or other
      products or processes developed in connection with or arising out of the
      Licensed Patent
      Rights.

            


    

     

    
      	
               
      

            	
              12.6

            	
              Licensee agrees to
      maintain a liability insurance program consistent with sound business
      practice.

            


    

     

    
      	
              13.

            	
              TERM, TERMINATION, AND
      MODIFICATION OF RIGHTS

            


    

     

    
      	
               
      

            	
              13.1

            	
              This
      Agreement is effective when signed by all parties, unless the provisions
      of Paragraph 14.16 are not fulfilled, and shall extend to the expiration
      of the last to expire of the Licensed Patent Rights
      unless sooner terminated as provided in this Article
  13.

            


    

     

    
      	
               
      

            	
              13.2

            	
              In
      the event that Licensee is in default
      in the performance of any material obligations under this Agreement,
      including but not limited to the obligations listed in Paragraph 13.5, and
      if the default has not been remedied within ninety (90) days after the
      date of notice in writing of the default, PHS may terminate this
      Agreement by written notice and pursue outstanding royalties owed through
      procedures provided by the Federal Debt Collection
  Act.

            


    

     

    
      	
               
      

            	
              13.3

            	
              In
      the event that Licensee becomes
      insolvent, files a petition in bankruptcy, has such a petition filed
      against it, determines to file a petition in bankruptcy, or receives
      notice of a third party's intention to file an involuntary petition in
      bankruptcy, Licensee shall
      immediately notify PHS in
      writing.  Furthermore, PHS shall have the right
      to terminate this Agreement immediately upon Licensee's receipt of
      written notice.

            


    

     

    
      	
               
      

            	
              13.4

            	
              Licensee shall have a
      unilateral right to terminate this Agreement or any licenses in any
      country or territory by giving PHS sixty (60) days
      written notice to that effect.

            


    

     

    
      	
               
      

            	
              13.5

            	
              PHS shall specifically
      have the right to terminate or modify, at its option, this Agreement,
      subject to paragraph 13.2, if PHS determines that the
      Licensee:

            


    

     

    
      
         


      

      
        11

        
          

        

      

      
         


      

    


    
      	
               
      

            	
              (a)

            	
              is
      not executing the Commercial Development
      Plan submitted with its request for a license and the Licensee cannot
      otherwise demonstrate to PHS’ reasonable
      satisfaction that the Licensee has taken, or
      can be expected to take within a reasonable time, effective steps to
      achieve Practical
      Application of the Licensed Products or
      Licensed
      Processes;

            


    

     

    
      	
               
      

            	
              (b)

            	
              has
      not achieved the Benchmarks as may be
      modified under Paragraph 9.2;

            


    

     

    
      	
               
      

            	
              (c)

            	
              has
      willfully made a false statement of, or willfully omitted a material fact
      in the license application or in any report required by the license
      Agreement;

            


    

     

    
      	
               
      

            	
              (d)

            	
              has
      committed a material breach of a covenant or agreement contained in this
      Agreement;

            


    

     

    
      	
               
      

            	
              (e)

            	
              is
      not keeping Licensed
      Products or Licensed Processes
      reasonably available to the public after commercial use
      commences;

            


    

     

    
      	
               
      

            	
              (f)

            	
              cannot
      reasonably satisfy unmet health and safety needs;
  or

            


    

     

    
      	
               
      

            	
              (g)

            	
              cannot
      reasonably justify a failure to comply with the domestic production
      requirement of Paragraph 5.2 unless
waived.

            


    

     

    
      	
               
      

            	
              13.6

            	
              In
      making the determination referenced in Paragraph 13.5, PHS shall take into
      account the normal course of such commercial development programs
      conducted with sound and reasonable business practices and judgment and
      the annual reports submitted by Licensee under Paragraph
      9.2.  Prior to invoking termination or modification of this
      Agreement under Paragraph 13.5, PHS shall give written
      notice to Licensee
      providing Licensee
      specific notice of, and a ninety (90) day opportunity to respond to, PHS’ concerns as to the
      items referenced in 13.5(a)-13.5(g).  If Licensee fails to
      alleviate PHS’
      concerns as to the items referenced in 13.5(a)-13.5(g) or fails to
      initiate corrective action to PHS’ reasonable
      satisfaction, PHS
      may terminate this Agreement.

            


    

     

    
      	
               
      

            	
              13.7

            	
              When
      the public health and safety so require, and after written notice to Licensee providing Licensee a sixty (60)
      day opportunity to respond, PHS shall have the right
      to require Licensee to grant
      sublicenses to responsible applicants, on reasonable terms, in any
      Licensed Fields of Use under the Licensed Patent Rights,
      unless Licensee
      can reasonably demonstrate that the granting of the sublicense would not
      materially increase the availability to the public of the subject matter
      of the Licensed Patent
      Rights.  PHS shall not require
      the granting of a sublicense unless the responsible applicant has first
      negotiated in good faith with Licensee.

            


    

     

    
      	
               
      

            	
              13.8

            	
              PHS reserves the right
      according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if
      it is determined that this action is necessary to meet the requirements
      for public use specified by federal regulations issued after the date of
      the license and these requirements are not reasonably satisfied by Licensee.

            


    

     

    
      	
               
      

            	
              13.9

            	
              Within
      thirty (30) days of receipt of written notice of PHS' unilateral decision
      to modify or terminate this Agreement, Licensee may, consistent
      with the provisions of 37 CFR §404.11, appeal the decision by written
      submission to the designated PHS
      official.  The decision of the designated PHS official shall be
      the final agency decision.  Licensee may thereafter
      exercise any and all administrative or judicial remedies that may be
      available.

            


    

     

    
      
         


      

      
        12

        
          

        

      

      
         


      

    

     

    
      	
              
              

            	
              13.10

            	
              Within
      ninety (90) days of expiration or termination of this Agreement under this
      Article 13, a final report shall be submitted by Licensee.  Any
      royalty payments, including those incurred but not yet paid (such as the
      full minimum annual royalty), and those related to patent expense, due to
      PHS shall become
      immediately due and payable upon termination or expiration.  If
      terminated under this Article 13, sublicensees may elect to convert their
      sublicenses to direct licenses with PHS pursuant to
      Paragraph 4.3.  Unless otherwise specifically provided for under
      this Agreement, upon termination or expiration of this Agreement, Licensee shall return
      all Licensed
      Products or other materials included within the Licensed Patent Rights
      to PHS or provide
      PHS with
      certification of the destruction
thereof.

            


    

     

    
      	
              14.

            	
              GENERAL
      PROVISIONS

            


    

     

    
      	
               
      

            	
              14.1

            	
              Neither
      party may waive or release any of its rights or interests in this
      Agreement except in writing.  The failure of the Government to assert a
      right hereunder or to insist upon compliance with any term or condition of
      this Agreement shall not constitute a waiver of that right by the Government or excuse a
      similar subsequent failure to perform any of these terms or conditions by
      Licensee.

            


    

     

    
      	
               
      

            	
              14.2

            	
              This
      Agreement constitutes the entire agreement between the parties relating to
      the subject matter of the Licensed Patent Rights,
      Licensed Products
      and Licensed
      Processes, and all prior negotiations, representations, agreements,
      and understandings are merged into, extinguished by, and completely
      expressed by this Agreement.

            


    

     

    
      	
               
      

            	
              14.3

            	
              The
      provisions of this Agreement are severable, and in the event that any
      provision of this Agreement shall be determined to be invalid or
      unenforceable under any controlling body of law, this determination shall
      not in any way affect the validity or enforceability of the remaining
      provisions of this Agreement.

            


    

     

    
      	
               
      

            	
              14.4

            	
              If
      either party desires a modification to this Agreement, the parties shall,
      upon reasonable notice of the proposed modification by the party desiring
      the change, confer in good faith to determine the desirability of the
      modification.  No modification shall be effective until a
      written amendment is signed by the signatories to this Agreement or their
      designees.

            


    

     

    
      	
               
      

            	
              14.5

            	
              The
      construction, validity, performance, and effect of this Agreement shall be
      governed by Federal law as applied by the Federal courts in the District
      of Columbia.

            


    

     

    
      	
               
      

            	
              14.6

            	
              All
      Agreement notices required or permitted by this Agreement shall be given
      by prepaid, first class, registered or certified mail or by an
      express/overnight delivery service provided by a commercial carrier,
      properly addressed to the other party at the address designated on the
      following Signature Page, or to another address as may be designated in
      writing by the other party. Agreement notices shall be considered timely
      if the notices are received on or before the established deadline date or
      sent on or before the deadline date as verifiable by U.S. Postal Service
      postmark or dated receipt from a commercial carrier.  Parties
      should request a legibly dated U.S. Postal Service postmark or obtain a
      dated receipt from a commercial carrier or the U.S. Postal
      Service.  Private metered postmarks shall not be acceptable as
      proof of timely mailing.

            


    

     

    
      	
               
      

            	
              14.7

            	
              This
      Agreement may not be assigned without prior written permission from PHS except to an
      Affiliate, which permission shall not be unreasonably
      withheld.  Licensee shall provide
      PHS a minimum of
      sixty (60) days to grant the written permission.  In the event
      that no response from PHS during the sixty
      (60) day period is received, Licensee shall consider
      the permission granted.  Licensee shall pay PHS, as an additional
      royalty, one percent (1%) of the fair market value of any consideration
      received for any assignment of this Agreement within thirty (30) days of
      the assignment.

            


    

     

    
      
         


      

      
        13

        
          

        

      

      
         


      

    

     

    
      	
               
      

            	
              14.8

            	
              Licensee agrees in its
      use of any PHS
      supplied materials to comply with all applicable statutes, regulations,
      and guidelines, including PHS and HHS regulations and
      guidelines.  Licensee agrees not to
      use the materials for research involving human subjects or clinical trials
      in the United States without complying with 21 CFR Part 50 and 45 CFR Part
      46.  Licensee agrees not to
      use the materials for research involving human subjects or clinical trials
      outside of the United States without notifying PHS, in writing, of the
      research or trials and complying with the applicable regulations of the
      appropriate national control authorities.  Written notification
      to PHS of research
      involving human subjects or clinical trials outside of the United States
      shall be given no later than sixty (60) days prior to commencement of the
      research or trials.

            


    

     

    
      	
               
      

            	
              14.9

            	
              Licensee acknowledges
      that it is subject to and agrees to abide by the United States laws and
      regulations (including the Export Administration Act of 1979 and Arms
      Export Control Act) controlling the export of technical data, computer
      software, laboratory prototypes, biological material, and other
      commodities.  The transfer of these items may require a license
      from the appropriate agency of the U.S. Government or written
      assurances by Licensee that it shall
      not export these items to certain foreign countries without prior approval
      of this agency.  PHS neither represents
      that a license is or is not required or that, if required, it shall be
      issued.

            


    

     

    
      	
              
              

            	
              14.10

            	
              Licensee agrees to mark
      the Licensed
      Products or their packaging sold in the United States with all
      applicable U.S. patent numbers and similarly to indicate “Patent Pending”
      status.  All Licensed Products
      manufactured in, shipped to, or sold in other countries shall be marked in
      a manner to preserve PHS patent rights in
      those countries.

            


    

     

    
      	
              
              

            	
              14.11

            	
              By
      entering into this Agreement, PHS does not directly or
      indirectly endorse any product or service provided, or to be provided, by
      Licensee whether
      directly or indirectly related to this Agreement.  Licensee shall not state
      or imply that this Agreement is an endorsement by the Government, PHS, any other Government
      organizational unit, or any Government
      employee.  Additionally, Licensee shall not use
      the names of NIH,
      FDA, PHS, or HHS or the Government or their
      employees in any advertising, promotional, or sales literature without the
      prior written approval of PHS.

            


    

     

    
      	
              
              

            	
              14.12

            	
              The
      parties agree to attempt to settle amicably any controversy or claim
      arising under this Agreement or a breach of this Agreement, except for
      appeals of modifications or termination decisions provided for in Article
      13.  Licensee agrees first to
      appeal any unsettled claims or controversies to the designated PHS official, or
      designee, whose decision shall be considered the final agency
      decision.  Thereafter, Licensee may exercise
      any administrative or judicial remedies that may be
    available.

            


    

     

    
      	
              
              

            	
              14.13

            	
              Nothing
      relating to the grant of a license, nor the grant itself, shall be
      construed to confer upon any person any immunity from or defenses under
      the antitrust laws or from a charge of patent misuse, and the acquisition
      and use of rights pursuant to 37 CFR Part 404 shall not be immunized from
      the operation of state or Federal law by reason of the source of the
      grant.

            


    

     

    
      	
              
              

            	
              14.14

            	
              Any
      formal recordation of this Agreement required by the laws of any Licensed Territory as a
      prerequisite to enforceability of the Agreement in the courts of any
      foreign jurisdiction or for other reasons will be carried out by Licensee at its expense,
      and appropriately verified proof of recordation will be promptly furnished
      to PHS.

            


    

     

    
      	
              
              

            	
              14.15

            	
              Paragraphs
      4.3, 8.1, 9.5-9.7, 12.1-12.5, 13.9, 13.10, and 14.13 of this Agreement
      shall survive termination of this
Agreement.

            


    

     

    
      
         


      

      
        14

        
          

        

      

      
         


      

    


    
      	
              
              

            	
              14.16

            	
              The
      terms and conditions of this Agreement shall, at PHS’ sole option, be
      considered by PHS
      to be withdrawn from Licensee’s consideration
      and the terms and conditions of this Agreement, and the Agreement itself
      to be null and void, unless this Agreement is executed by the Licensee and a fully
      executed original is received by PHS within sixty (60)
      days from the date of PHS signature found at
      the Signature Page.

            


    

     

    SIGNATURES
BEGIN ON NEXT PAGE


    
      
         


      

      
        15

        
          

        

      

      
         


      

    


    PHS
PATENT LICENSE AGREEMENT – EXCLUSIVE

     

    SIGNATURE
PAGE

    


    
      
        
          
            
              
                
                  
                    
                      
                        
                          	
                                  For
      PHS:

                                	 	 
      
	
                                    

                                	 	 	
                                    

                                
	
                                  Richard
      U. Rodriguez.
      M.B.A.             Date

                                	 	
                                  Date

                                
	
                                  Director,
      Division of Technology Development and Transfer

                                	 	 
      
	
                                  Office
      of Technology Transfer

                                	 	 
      
	
                                  National
      Institutes of Health

                                	 	 
      
	 
      	 	 
      
	
                                  Mailing
      Address for Agreement
      notices:

                                	 	 
      
	 
      	 	 
      
	
                                  Chief,
      Monitoring & Enforcement Branch, DTDT

                                	 	 
      
	
                                  Office
      of Technology Transfer

                                	 	 
      
	
                                  National
      Institutes of Health

                                	 	 
      
	
                                  6011
      Executive Boulevard, Suite 325

                                	 	 
      
	
                                  Rockville,
      Maryland  20852-3804 U.S.A.

                                	 	 
      
	 
      	 	 
      
	
                                  For
      Licensee (Upon,
      information and belief, the undersigned expressly certifies or affirms
      that the contents of any statements of Licensee made or
      referred to in this document are truthful and accurate.):

                                   

                                
	
                                  by:

                                	 	 
      
	
                                    

                                	 	 	 
      
	
                                  Signature
      of Authorized Official

                                	 	      
                                  Date 
      

                                
	 
      	 	
                                   

                                
	
                                    

                                	 	 
      
	
                                  John
      S. Kovach

                                	 	 
      
	
                                  Printed
      Name

                                	 	 
      
	 
      	 	 
      
	
                                    

                                	 	 
      
	
                                  Chief
      Executive Officer

                                	 	 
      
	
                                  Title

                                	 	 
      


                        

                      

                    

                  

                

              

            

          

        

      

    

     

    
      
         


      

      
        16

        
          

        

      

      
         


      

    

    


    
      
        
          
            	
                    I.    
      Official and Mailing Address for Agreement
      notices:

                  
	 	 
	
                    John S.
      Kovach                                      

                  	 
      
	
                    Name

                  	 
      
	 
      	 
      
	
                    Chief
      Executive
      Officer                                           

                  	 
      
	
                    Title

                  	 
      
	 
      	 
      
	
                    Mailing
      Address

                  	 
      
	 	 
	
                    Lixte
      Biotechnology, Inc.

                  	 
      
	
                    248
      Route 25A #2

                  	 
      
	
                    East
      Setauket, NY 11733

                  	 
      
	 
      	 
      
	
                    Email
      Address:

                  	 
      
	 
      	 
      
	
                    Phone:       631-942-7959

                  	 
      
	
                    Fax:           631-982-5050

                  	 
      
	 
      	 
      
	
                    II.    Official
      and Mailing Address for Financial notices (Licensee’s contact
      person for royalty payments)

                  
	 
	
                    John S.
      Kovach                                      

                  	 
      
	
                    Name

                  	 
      
	 
      	 
      
	
                    Chief
      Executive
      Officer                                           

                  	 
      
	
                    Title

                  	 
      
	 
      	 
      
	
                    Mailing
      Address:

                  	 
      
	 
      	 
      
	
                    Lixte
      Biotechnology, Inc.

                  	 
      
	
                    248
      Route 25A #2

                  	 
      
	
                    East
      Setauket, NY 11733

                  	 
      
	 
      	 
      
	
                    Email
      Address:

                  	 
      
	 
      	 
      
	
                    Phone:      
      631-942-7959

                  	 
      
	
                    Fax:           631-982-5050

                  	 
      
	 
      	 
      
	
                    Any
      false or misleading statements made, presented, or submitted to the Government, including
      any relevant omissions, under this Agreement and during the
      course of negotiation of this Agreement are subject to
      all applicable civil and criminal statutes including Federal statutes 31
      U.S.C. §§3801-3812 (civil liability) and 18 U.S.C. §1001 (criminal
      liability including fine(s) or
imprisonment).

                  


          

        

      

    

     

    
      
         


      

      
        17

        
          

        

      

      
         


      

    


    APPENDIX
A – PATENT(S) OR PATENT APPLICATION(S)

     

    Patent(s)
or Patent Application(s):

     

    
      	
              I.

            	
              U.S.
      Provisional Patent Application No. 60/771,163, filed February 6, 2006,
      entitled “Use of Phosphatases To Treat Glioblastomas” (HHS Ref. No.
      E-123-2006/0-US-01);

            


    

     

    
      	
              II.

            	
              U.S.
      Provisional Patent Application No. 60/797,201, filed May 2, 2006, entitled
      “Use of Phosphatases To Treat Glioblastomas” (HHS Ref. No.
      E-123-2006/1-US-01)

            


    

     

    
      	
              III.

            	
              U.S.
      Patent Application Serial No. 11/703,401, filed February 6, 2007, entitled
      “Use of Phosphatases To Treat Glioblastomas” (HHS Ref. No.
      E-123-2006/0-US-03)

            


    

     

    
      	
              IV.

            	
              PCT
      International Application No. PCT/US2007/003095, filed February 6, 2007
      entitled “Use of Phosphatases To Treat Glioblastomas” (HHS Ref. No.
      E-123-2006/0-PCT-02)

            


    

     

    
      	
              V.

            	
              U.S.
      Provisional Patent Application No. 60/963,307, filed August 3, 2007
      entitled “Use of Phosphatases To Treat Neuroblastomas and
      Medulloblastomas” (HHS Ref. No.
      E-123-2006/2-US-01)

            


    

     

    
      	
              VI.

            	
              U.S.
      Provisional Patent Application No. 60/063,970, filed February 6, 2008
      entitled “Use of Phosphatases To Treat Neuroblastomas and
      Medulloblastomas”.

            


    

     

    
      	
              VII.

            	
              U.S.
      Application in preparation corresponding to Cooper and Dunham Referene No.
      4101/79251.

            


    

     

    
      
         


      

      
         


        
          

        

      

      
         


      

    


    APPENDIX
B – LICENSED FIELDS OF USE AND TERRITORY

     

    
      	
              I.

            	
              Licensed Fields of
      Use:

            


    

     

    
      	
               
      

            	
              (a)

            	
              Treatment
      of Glioblastomas and other Central Nervous System (CNS)
    tumors

            


    

     

    
      	
              II.

            	
              Licensed
      Territory:

            


    

     

    
      	
               
      

            	
              (a)

            	
              Worldwide

            


    

     

    
      
         


      

      
         


        
          

        

      

      
         


      

    


    APPENDIX C –
ROYALTIES

     

    Royalties:

     

    
      	
              I.

            	
              Licensee agrees to pay
      to PHS a
      noncreditable, nonrefundable license issue royalty in the amount of Twenty
      Five Thousand dollars ($25,000) within sixty (60) days from the effective
      date of this Agreement.

            


    

     

    
      	
              II.

            	
              Licensee agrees to pay
      PHS a
      nonrefundable minimum annual royalty in the amount of Thirty Thousand
      ($30,000) on January 1 of each calendar year following the year during
      which the March 22, 2006 CRADA agreement, as appended, between the parties
      is terminated and may be credited against any earned royalties due for
      sales made in that year.

            


    

     

    
      	
              III.

            	
              Licensee agrees to pay
      PHS earned
      royalties of Four and one-half percent (4.5%) on Net Sales by or on
      behalf of Licensee
      and its sublicensees.

            


    

     

    
      	
              IV.

            	
              Licensee agrees to pay
      PHS Benchmark royalties
      within thirty (30) days of achieving each Benchmark:

            


    

     

    
      	
               
      

            	
              (a)

            	
              Fifty
      Thousand dollars ($50,000) upon starting Phase I Clinical
      Trials;

            


    

     

    
      	
               
      

            	
              (b)

            	
              One
      Hundred Thousand dollars ($100,000) upon starting Phase II Clinical
      Trials;

            


    

     

    
      	
               
      

            	
              (c)

            	
              Two
      Hundred Thousand dollars ($200,000) upon starting Phase III Clinical
      Trials;

            


    

     

    
      	
               
      

            	
              (d)

            	
              Three
      Hundred Thousand dollars ($300,000) upon filing an IND submission;
      and

            


    

     

    
      	
               
      

            	
              (e)

            	
              Six
      Hundred Twenty Five Thousand dollars ($625,000) upon the First Commercial
      Sale

            


    

     

    
      	
              V.

            	
              Licensee agrees to pay
      PHS additional
      sublicensing royalties of fifteen percent (15%) on the fair market value
      of any consideration received for granting each sublicense within sixty
      (60) days of the execution of each
sublicense.

            


    


    
      
         


      

      
         


        
          

        

      

      
         


      

    


    APPENDIX
D – BENCHMARKS AND PERFORMANCE

     

    Licensee agrees to the
following Benchmarks for
its performance under this Agreement and, within thirty
(30) days of achieving a Benchmark, shall notify PHS that the Benchmark has been
achieved.

     

    
      	
              I.

            	
              Initiation
      of Phase I Clinical Trials – Est. Second Quarter,
  2010

            


    

     

    
      	
              II.

            	
              Initiation
      of Phase II Clinical Trials – Est. Second Quarter,
  2011

            


    

     

    
      	
              III.

            	
              Initiation
      of Phase III Clinical Trials – Est. Third Quarter,
  2012

            


    

     

    
      	
              IV.

            	
              Filing
      of an IND Submission – Est. Fourth Quarter,
2009

            


    

     

    
      	
              V.

            	
              First
      Commercial Sale Expected Timeline – Est. First Quarter,
    2015

            


    

     


    
      
         


      

      
         


        
          

        

      

      
         


      

    


    APPENDIX E – COMMERCIAL
DEVELOPMENT PLAN

     

    The
ultimate objective of the CRADA is to identify, characterize, and bring to
clinical trial regimens for the treatment of human brain tumors (GBMs) and other
Central Nervous System (CNS) tumors.  Lixte Biotechnology Holdings,
Inc., the parent company of Licensee will most likely
conduct such a clinical trial in association with NINDS.

     

    Licensee is in contact with
several large pharmaceutical companies with major programs in development and
evaluation of anti-cancer drugs about co-developing one or more phosphatase
ligands shown to have anti-cancer activity in vitro and in vivo in the CRADA
studies.  Licensee, however, is prepared
to work with NINDS and /or other branches of NIH to develop these compounds
through pre-clinical evaluation and clinical testing without the addition of a
larger pharmaceutical partner.

     

    To
facilitate this approach, NINDS has submitted an application to the NIH RAID
PILOT program to be reviewed in the summer of 2008.  If approved,
NINDS would collaborate with Licensee to complete
pre-clinical development of one lead compound under the RAID program through to
submission of an IND to the FDA for a Phase I trial.  The Phase I
trial could be done with one of several large academic brain tumor centers in
the US, including the surgical neurology branch of NINDS.  Following
completion of Phase I testing, Licensee is committed to
supporting Phase II evaluations with or without an additional partner from the
pharmaceutical industry.


    
      
         


      

      
         


        
          

        

      

      
         


      

    


    APPENDIX
F – EXAMPLE ROYALTY REPORT

     

    Required
royalty report information includes:

     

    
      	
               
      

            	
              ·

            	
              OTT
      license reference number
(L-XXX-200X/0)

            


    

     

    
      	
               
      

            	
              ·

            	
              Reporting
      period

            


    

     

    
      	
               
      

            	
              ·

            	
              Catalog
      number and units sold of each Licensed Product (domestic and
      foreign)

            


    

     

    
      	
               
      

            	
              ·

            	
              Gross
      Sales per catalog number per
country

            


    

     

    
      	
               
      

            	
              ·

            	
              Total
      Gross Sales

            


    

     

    
      	
               
      

            	
              ·

            	
              Itemized
      deductions from Gross Sales

            


    

     

    
      	
               
      

            	
              ·

            	
              Total
      Net Sales

            


    

     

    
      	
               
      

            	
              ·

            	
              Earned
      Royalty Rate and associated
calculations

            


    

     

    
      	
               
      

            	
              ·

            	
              Gross
      Earned Royalty

            


    

     

    
      	
               
      

            	
              ·

            	
              Adjustments
      for Minimum Annual Royalty (MAR) and other creditable payments
      made

            


    

     

    
      	
               
      

            	
              ·

            	
              Net
      Earned Royalty due

            


    

     

    Example

    
      
        
          
            	
                    Catalog Number

                  	 	
                    Product Name

                  	 	
                    Country

                  	 	
                    Units Sold

                  	 	 	
                    Gross Sales (US$)

                  	 
	
                    1

                  	 	 	
                    A

                  	 	
                    US

                  	 	 	250	 	 	 	62,500	 
	
                    1

                  	 	 	
                    A

                  	 	
                    UK

                  	 	 	32	 	 	 	16,500	 
	
                    1

                  	 	 	
                    A

                  	 	
                    France

                  	 	 	25	 	 	 	15,625	 
	
                    2

                  	 	 	
                    B

                  	 	
                    US

                  	 	 	0	 	 	 	0	 
	
                    3

                  	 	 	
                    C

                  	 	
                    US

                  	 	 	57	 	 	 	57,125	 
	
                    4

                  	 	 	
                    D

                  	 	
                    US

                  	 	 	12	 	 	 	1,500	 
	 
      	 	 	 	 	 
      	 	 	 	 	 	 	 	 
	 
      	 	 	 	 	 
      	 	
                    Total
      Gross Sales

                  	 	 	 	153,250	 
	 
      	 	 	 	 	 
      	 	
                    Less
      Deductions:

                  	 	 	 	 	 
	 
      	 	 	 	 	 
      	 	
                    Freight

                  	 	 	 	3,000	 
	 
      	 	 	 	 	 
      	 	
                    Returns

                  	 	 	 	7,000	 
	 
      	 	 	 	 	 
      	 	
                    Total
      Net Sales

                  	 	 	 	143,250	 
	 
      	 	 	 	 	 
      	 	
                    Royalty
      Rate

                  	 	 	 	8	%
	 
      	 	 	 	 	 
      	 	
                    Royalty
      Due

                  	 	 	 	11,460	 
	 
      	 	 	 	 	 
      	 	
                    Less
      Creditable Payments

                  	 	 	 	10,000	 
	 
      	 	 	 	 	 
      	 	
                    Net
      Royalty Due

                  	 	 	 	1,460	 


          

        

      

    


    
      
         


      

      
         


        
          

        

      

      
         


      

    


    APPENDIX
G – ROYALTY PAYMENT OPTIONS

    


    NIH/PHS License
Agreements

     

    *In order to process payment
via Electronic Funds Transfer sender MUST supply the following
information:

     

    Procedure
for Transfer of Electronic Funds to NIH for Royalty Payments

     

    Bank
Name: Federal Reserve Bank

    ABA#
021030004

    TREAS
NYC

    BNF=/AC-75080031

    OBI=Licensee
Name and OTT Reference Number

    Dollar
Amount Wired=$$

     

    NOTE:  Only
U.S. banks can wire directly to the Federal Reserve Bank. Foreign banks cannot
wire directly to the Federal Reserve Bank, but must go through an intermediary
U.S. bank. Foreign banks may send the wire transfer to the U.S. bank of their
choice, who, in turn forwards the wire transfer to the Federal Reserve
Bank.

     

    Checks
drawn on a U.S. bank account should be sent directly to the following
address:

     

    National
Institutes of Health (NIH)

    P.O. Box
979071

    St.
Louis, MO 63197-9000

     

    Overnight
or courier deliveries should be sent to the following address:

     

    US
Bank

    Government
Lockbox SL-MO-C2GL

    1005
Convention Plaza

    St.
Louis, MO 63101

    Phone:
314-418-4087

     

    Checks
drawn on a foreign bank account should be sent directly to the following
address:

     

    National
Institutes of Health (NIH)

    Office of
Technology Transfer

    Royalties
Administration Unit

    6011
Executive Boulevard

    Suite
325, MSC 7660

    Rockville,
Maryland 20852

    Phone:
301-496-7057

     

    All
checks should be made payable to “NIH Patent Licensing”.

     

    The OTT Reference Number
MUST appear on checks, reports and correspondence