Exhibit 10.1


    RESEARCH
      SPONSORSHIP AND LICENSE AGREEMENT

    


    Effective
      this 24th
      day of
      January, 2006 (“EFFECTIVE DATE”), President and Fellows of Harvard College, a
      charitable corporation of Massachusetts having an office at 25 Shattuck Street,
      Boston, MA 02115 (“HARVARD”), and DNAPrint Genomics, Inc. a corporation
      organized and existing under the laws of Utah and having its principal offices
      at 900 Cocoanut Ave., Sarasota FL 34231 (“COMPANY”) agree as follows:


    


    BACKGROUND

    


    A. HARVARD,
      by virtue of its role as an educational institution, carries out scientific
      research through its faculty, staff and students and is committed to bringing
      the results of that research into widespread use to the extent it is permitted
      to do so by its “Statement of Policy in Regard to Inventions, Patents and
      Copyrights” (dated November 3, 1975 and amended on March 17, 1986, February 9,
      1998 and August 10, 1998), by its agreements with sponsors of research, and
      by
      the provisions of 35 USC §§200-212
      and 37 CFR §401 et seq. and regulations pertaining thereto. 

    


    B. HARVARD
      holds certain rights in and to certain technology relating to diabetes, which
      technology was developed with the support of the National Institutes of Health.
      

    


    C. COMPANY
      wishes to provide research sponsorship under which Dr. Jose A. Halperin
      (“PRINCIPAL INVESTIGATOR”) will lead at Harvard Medical School a research
      project that relates to such technology.

    


    D. PRINCIPAL
      INVESTIGATOR wishes to perform such research project in accordance with the
      terms and conditions set forth in this Research Sponsorship and License
      Agreement (hereinafter, “Agreement”).

    


    E. COMPANY
      wishes to obtain from HARVARD an exclusive license under the LICENSED PATENT
      RIGHTS, as defined below, to develop, make and sell LICENSED PRODUCTS, as
      defined below.  

    


    F. COMPANY
      is prepared and intends to diligently develop LICENSED PRODUCTS and to bring
      them to market in accordance with the terms of this Agreement. 

    


    1.
      DEFINITIONS

    


      As
      used
      in this Agreement, the following terms shall have the following meanings:


    


    1.1 “AFFILIATE”
      means: with respect to COMPANY and SUBLICENSEES, any person, corporation,
      company, partnership, joint venture, firm and/or other form of entity which
      controls, is controlled by or is under common control with COMPANY or a
      SUBLICENSEE. For purposes of this definition only, “control” of another person,
      organization or entity shall mean the possession, directly or indirectly, of
      the
      power to direct or cause the direction of the activities, management or policies
      of such person, organization or entity, whether through the ownership of voting
      securities, by contract or otherwise. Without limiting the foregoing, control
      shall be presumed to exist when a person, organization or entity (i) owns or
      directly controls twenty percent (20%) or more of the outstanding voting stock
      or other ownership interest of the other organization or entity, or (ii)
      possesses, directly or indirectly the power to elect or appoint twenty percent
      (20%) or more of the members of the governing body of the organization or other
      entity.

    


    1.2 “COMPANY
      REPRESENTATIVE” means: Mr. Richard Gabriel or such other representative as
      COMPANY may subsequently designate in writing. 

    


    1.3 “HARVARD
      PATENT RIGHTS” means the following PATENT RIGHTS, in each case to the extent
      owned and controlled by HARVARD: 

    


    (a) provisional
      patent application U.S.S.N. 60/203,254, utility patent applications U.S.S.N.
      09/835,752, U.S.S.N. 10/833,581 and U.S.S.N. 10/870,342, and international
      patent application PCT/US04/19392; 

    


    (b) any
      and
      all PATENT RIGHTS that claim, and are entitled to, priority from the
      application(s) set forth in clause (a), but only with respect to claims in
      PATENT RIGHTS that claim the subject matter specifically disclosed in the
      applications set forth in clause (a) and are dominated by the claims of the
      applications set forth in clause (a); and

    


    (c) any
      and
      all PATENT RIGHTS that claim RESEARCH RESULTS, but only to the extent they
      claim
      subject matter included in the RESEARCH RESULTS. 

    


    1.4 “JOINT
      INVENTION” means: Any invention made jointly by (a) the PRINCIPAL INVESTIGATOR
      and/or any other HARVARD employee, student, trainee (including without
      limitation post-doctoral research fellows) or contractor, in the performance
      of
      the RESEARCH during the RESEARCH PERIOD, and (b) one or more employees or
      consultants of COMPANY. 

    


    1.5 “JOINT
      PATENT RIGHTS” means: Any and all PATENT RIGHTS that claim, and only to the
      extent they so claim, a JOINT INVENTION. To the extent that any such claim
      covers subject matter that is not a JOINT INVENTION, such subject matter and
      any
      and all rights in it shall be excluded from JOINT PATENT RIGHTS. 

    


    1.6 “JOINT
      TECHNOLOGY”
      means:
      JOINT PATENT RIGHTS and JOINT INVENTIONs.

    


    1.7
       “KIT”
      means: Any product for the detection of glycated CD-59 protein in any human
      or
      animal body fluid, tissue or sample for the generation of Clinical Diagnostic
      Information, which product contains multiple components for the performance
      of
      any immunoassay, at least one of which component(s) is an antibody directed
      at
      glycated CD-59 protein, or any portion or fragment thereof. As used herein,
      the
      term “Clinical Diagnostic Information” means information obtained through
      analysis of a sample derived from an individual human- or animal clinical
      patient and used in the elucidation of that patient’s medical or veterinary
      condition in the management of that human or animal patient’s
      health.

    


    1.8 “LICENSED
      PRODUCT” means: Any KIT the production, use, sale or importation of which falls
      within the scope of a VALID CLAIM in the country in which such product is
      produced, used or sold, or into which such product is imported. 

    


    1.9 “LICENSED
      PATENT RIGHTS” means: HARVARD PATENT RIGHTS and HARVARD’s interest in any JOINT
      PATENT RIGHTS. 

    


    1.10 “NET
      SALES” means:  The
      gross
      amount billed, invoiced, or received (whichever occurs first) by COMPANY,
      AFFILIATES and any SUBLICENSEE(s) (each, an “INVOICING PARTY”) for sales,
      leases, or other transfers of LICENSED PRODUCT(s), less: 

    


    (a)
      customary trade, quantity or cash discounts and non-affiliated brokers’ or
      agents’ commissions actually allowed and taken; 

    


    (b)
      amounts repaid or credited by reason of rejection or return; 

    


    (c)
      amounts credited by INVOICING PARTY for amounts not actually collected despite
      INVOICING PARTY taking all reasonable action in order to collect such amounts;
      and

    


    (d)
      to
      the extent separately stated on purchase orders, invoices, or other documents
      of
      sale, taxes and/or other governmental charges levied on the production, sale,
      transportation, delivery or use of such LICENSED PRODUCT(s) and paid by or
      on
      behalf of such INVOICING PARTY. 

    


    NET
      SALES
      also includes the fair market value of any non-cash consideration received
      by
      COMPANY, AFFILIATES and any SUBLICENSEE(s) in connection with the sale, lease
      or
      transfer of LICENSED PRODUCTs. Fair market value will be calculated as of the
      time of transfer of such non-cash consideration to COMPANY, AFFILIATE or such
      SUBLICENSEE(s). Transfer of a LICENSED PRODUCT, or a component of a LICENSED
      PRODUCT, between an INVOICING PARTY and an AFFILIATE of such INVOICING PARTY,
      or
      between COMPANY and a SUBLICENSEE for sale by the transferee (or in the case
      of
      components of LICENSED PRODUCTS, for incorporation into a LICENSED PRODUCT
      to be
      sold by transferee) shall not be considered NET SALES for purposes of
      ascertaining royalty charges. In such circumstances, the gross sales price
      and
      resulting NET SALES price shall be based upon the sale of the LICENSED PRODUCT
      by the transferee.

    


    1.11 “NON-COMMERCIAL
      RESEARCH PURPOSES” means: Use or practice of LICENSED PATENT RIGHTS for academic
      research and other not-for-profit or scholarly purposes which are undertaken
      at
      a non-profit or governmental institution that does not involve the production
      or
      manufacture of products for sale or the performance of services for a fee.
      Without limiting the foregoing: (i) “academic research and other not-for-profit
      or scholarly purposes” includes, in non-limiting fashion, research that leads,
      or may lead, to patentable or unpatentable inventions that may be licensed
      or
      otherwise transferred, either directly or indirectly, to third parties; and
      (ii)
      neither (A) receipt of license revenues on account of such inventions or receipt
      of reimbursements for the costs of preparation and shipping of samples of
      materials provided to third parties as a professional courtesy, in response
      to
      post-publication requests or otherwise in accordance with academic custom nor
      (B) receipt of funding to cover the direct and/or indirect costs of research,
      shall constitute sale of products or performance of service for a fee.


     

    1.12 “NON-ROYALTY
      SUBLICENSE INCOME” means: All amounts received by COMPANY or an AFFILIATE of
      COMPANY on account of, or in connection with, any SUBLICENSE(s), or the grant
      of
      an option to obtain a SUBLICENSE, except for royalties based on NET SALES.
      NON-ROYALTY SUBLICENSE INCOME also includes the fair market value of any
      non-cash consideration received by COMPANY and/or AFFILIATES of COMPANY on
      account of, or in connection with a SUBLICENSE, or the grant of an option to
      obtain a SUBLICENSE. 

    


    1.13 “PATENT
      RIGHTS” means:
      any
      and
      all (a) patents, (b) pending patent applications, including, without
      limitation, all provisional applications, substitutions, continuations,
      continuations-in-part, divisions, reissues, renewals, and all patents granted
      thereon, and (c) all patents-of-addition, reissue patents, reexaminations
      and extensions or restorations by existing or future extension or restoration
      mechanisms, including, without limitation, supplementary protection certificates
      or the equivalent thereof.

    


    1.14 “PROOF
      OF
      CONCEPT DATE” means:
      the date on which the PRINCIPAL INVESTIGATOR or HARVARD notifies COMPANY that
      PRINCIPAL INVESTIGATOR and/or members of his research team have detected
      glycated CD-59 in human urine or saliva by means of a monoclonal antibody that
      recognizes glycated CD-59.  

     

    1.15 “RESEARCH”
      means:
      The research actually conducted under the direction of the PRINCIPAL
      INVESTIGATOR by PRINCIPAL INVESTIGATOR and/or other employees, students,
      trainees (including without limitation post-doctoral research fellows) and
      contractors of HARVARD in accordance with the research plan set forth in
      Appendix A (“RESEARCH PLAN”) of this Agreement, as may be amended by mutual
      agreement of COMPANY and HARVARD, during the RESEARCH PERIOD and funded by
      COMPANY pursuant to this Agreement. 

    


    1.16 “RESEARCH
      PERIOD” means:
      The period beginning on the EFFECTIVE DATE and ending on the date three years
      thereafter,
      which
      period may be extended by mutual written agreement of duly-authorized
      representatives of HARVARD and COMPANY. 

    


    1.17 “RESEARCH
      RESULTS” means: Any and all inventions, materials, methods, processes, know-how
      and results discovered or acquired by, or on behalf of, PRINCIPAL INVESTIGATOR
      and/or any other employees, students, trainees (including without limitation
      post-doctoral research fellows) or contractors of HARVARD in performance of
      the
      RESEARCH, except JOINT INVENTIONS.

     

    1.18 “SERVICES”
      means: The performance by or on behalf of COMPANY, any SUBLICENSEE, or any
      AFFILIATE of COMPANY or any SUBLICENSEE, of clinical diagnostics using one
      or
      more LICENSED PRODUCTS on a for-fee basis for any third party. 

    


    1.19 “SERVICE
      INCOME” means: All amounts and other consideration received by COMPANY, any
      SUBLICENSEE, or any AFFILIATE of COMPANY or any SUBLICENSEE, for or in
      connection with the performance of SERVICES; provided that in the event that
      COMPANY or an AFFILIATE of COMPANY receives non-monetary consideration in
      connection with any such services or in the case of transactions not at arm’s
      length, SERVICE INCOME shall be calculated based on the fair market value of
      such consideration or transaction, assuming an arm’s length transaction made in
      the ordinary course of business. 

     

    1.20 “SUBLICENSE”
      means: Any right granted, license given, or agreement entered into, by COMPANY
      to or with any other person or entity, under or with respect to or permitting
      any use of any of the LICENSED PATENT RIGHTS (or any part thereof) or otherwise
      permitting the development, manufacture, marketing, distribution and/or sale
      of
      LICENSED PRODUCTS (regardless of whether such grant of rights, license given
      or
      agreement entered into is referred to or is described as a sublicense or as
      an
      agreement with respect to the development and/or manufacture and/or sale and/or
      distribution and/or marketing of LICENSED PRODUCTS). For clarity, “SUBLICENSE”
does not include a grant by COMPANY, a SUBLICENSEE or an AFFILIATE as part
      of a
      sale of a LICENSED PRODUCT to an independent third party of the implied license
      (a) to use such LICENSED PRODUCT or (b) to resell such LICENSED PRODUCT,
      provided that the only consideration (whether monetary or non-monetary) received
      by COMPANY, such SUBLICENSEE or such AFFILIATE in connection with such grant
      is
      the fair market value of the LICENSED PRODUCT sold.

    


    1.21 “VALID
      CLAIM” means: A claim within a patent or patent application of HARVARD PATENT
      RIGHTS or JOINT PATENT RIGHTS so long as: (a) such claim shall not have been
      held invalid in a final non-appealable court judgment or patent office decision
      and (b) the patent or patent application that includes such claim shall not
      have
      been held unenforceable in a final non-appealable or unappealable court
      judgment. 

    


    1.22
       The
      terms
“35 USC §§200-212”
      and “37 CFR §401” include all amendments to those statutes. 

    


    1.23 The
      terms
“sold”, “sale” and “sell” include, without limitation, leases and other
      transfers and similar transactions. 

    


    2.
      SPONSORED RESEARCH

    


    2.1 PRINCIPAL
      INVESTIGATOR will use reasonable efforts to perform the RESEARCH in accordance
      with the RESEARCH PLAN; however, failure to complete all aspects of the RESEARCH
      or to achieve any particular result(s) shall not be deemed a breach of this
      Agreement. 

    


    2.2.
      The
      RESEARCH will be directed and supervised by the PRINCIPAL INVESTIGATOR, who
      shall have primary responsibility for the performance of the RESEARCH.


    


    2.3 (a) If
      the
      PRINCIPAL INVESTIGATOR ceases to supervise the RESEARCH for any reason, HARVARD
      will so notify COMPANY, and HARVARD may attempt to find, among the scientists
      at
      HARVARD, a scientist or scientists acceptable to COMPANY to assume the
      supervision of the RESEARCH in place of such PRINCIPAL INVESTIGATOR. If HARVARD
      does not propose to COMPANY any scientist(s) to assume supervision of the
      RESEARCH, or if the scientist(s) so proposed is/are unacceptable to COMPANY,
      within sixty (60) days after HARVARD’s notice to COMPANY, COMPANY may, in its
      sole discretion, elect to terminate the funding of the RESEARCH. COMPANY shall
      promptly advise HARVARD in writing if COMPANY so elects. Nothing contained
      in
      this subparagraph 2.3(a), shall be deemed to impose an obligation on HARVARD
      to
      propose or successfully find a replacement for the PRINCIPAL INVESTIGATOR.
      

    


    (b) If
      the
      PRINCIPAL INVESTIGATOR determines that it is not technologically feasible to
      accomplish the goals of the RESEARCH, he will so notify COMPANY in writing.
      COMPANY thereafter may elect, in its sole discretion: (i) to discontinue the
      funding of the RESEARCH at any time following the date one (1) year after the
      EFFECTIVE DATE on 90 days’ written notice to HARVARD; or (ii) to negotiate with
      HARVARD a mutually-acceptable, revised RESEARCH PLAN to be performed pursuant
      to
      this Agreement. 

    


    Termination
      of funding pursuant to subparagraphs (a) or (b) of this Paragraph shall
      terminate HARVARD’S obligations pursuant to Paragraph 2.1 above with respect to
      the RESEARCH, and shall be COMPANY’s sole remedy with regard to same, but shall
      not terminate this Agreement or any of the other rights or obligations of the
      parties under this Agreement. In the event that the research funding is so
      terminated by COMPANY, COMPANY shall reimburse HARVARD for all uncancellable
      obligations to third parties incurred or committed to by HARVARD in accordance
      with the budget set forth in Appendix C with regard to the RESEARCH through
      the
      date of such termination of funding. These include uncancellable obligations
      such as salaries and associated fringe benefits through any applicable required
      termination notice period and obligations under contracts or purchase orders
      entered into or made prior to such termination of the funding.

    


    2.4 The
      scope
      of work attempted to be directed by PRINCIPAL INVESTIGATOR under this Agreement
      shall be limited to the RESEARCH and the RESEARCH PERIOD.

    


    2.5 (a) COMPANY
      shall pay HARVARD in support of the RESEARCH during the RESEARCH PERIOD an
      aggregate amount of of
      two-million-five-hundred-thirty-four-thousand-six-hundred-ninety-nine dollars
      ($2,534,699). Such amount shall be paid in accordance with the schedule set
      forth in Appendix B of this Agreement, entitled, “Research Sponsorship Payment
      Schedule”. The above amounts shall be used to further the RESEARCH in accordance
      with the budget set forth in the attached Appendix C, entitled,
“Budget”.

    


    (b) Checks
      should be made payable to President
      and Fellows of Harvard College
      and
      should identify COMPANY and the PRINCIPAL INVESTIGATOR and be sent
      to:

     

    Sponsored
      Programs Administration

    Gordon
      Hall, Room 509

    25
      Shattuck Street

    Boston,
      MA 02115

    


    Attn.:
      Director

    


    (c) HARVARD
      shall not be obliged to expend funds in excess of those provided under this
      Article to conduct the RESEARCH. HARVARD and COMPANY each acknowledges that
      funds provided under this Agreement supplement research funding provided by
      the
      National Institutes of Health and, therefore, constitute partial support for
      the
      RESEARCH.

    


    (d) Nothing
      in this Agreement shall be interpreted to prohibit HARVARD or the PRINCIPAL
      INVESTIGATOR from seeking and receiving funding from non-commercial
      sources,
      including government agencies and foundations, or from commercial entities
      for
      non-commercial purposes, to further support the RESEARCH; provided that such
      funding shall not be on terms that give such entity(ies) any rights to use
      any
      INVENTION(s) or JOINT INVENTION(s) (subject to any non-exclusive license for
      governmental purposes or other governmental or non-commercial rights reserved
      by
      a sponsor(s) as a condition of award of such funding). The PRINCIPAL
      INVESTIGATOR shall notify HARVARD’s Office of Technology Development and COMPANY
      (i) upon making application for- and (ii) upon receipt of any such
      funding.

    


    2.6 PRINCIPAL
      INVESTIGATOR shall keep COMPANY reasonably informed and updated concerning
      the
      RESEARCH, its progress and its results on a regular oral basis, and shall meet
      with representatives of COMPANY on a quarterly basis, at a time and in a place
      that is mutually convenient for those concerned, to discuss the progress of
      the
      RESEARCH. In addition, PRINCIPAL INVESTIGATOR shall submit written, semi-annual
      reports to COMPANY, setting forth the RESEARCH RESULTS in sufficient detail
      to
      keep COMPANY reasonably apprised of the progress of the RESEARCH. The first
      such
      report will be due on- or before the date six (6) months after the EFFECTIVE
      DATE. Within sixty (60) days after the earlier of (i) expiration of the RESEARCH
      PERIOD or (ii) termination of this Agreement, the PRINCIPAL INVESTIGATOR shall
      submit a comprehensive, final written report to COMPANY. 

    


    2.7 (a) Prior
      to
      public presentation or submission to a journal, the PRINCIPAL INVESTIGATOR
      agrees to submit for review to COMPANY Representative the content of any
      manuscript, abstract, or presentation containing data and results of the
      RESEARCH. 

     

    (b) Within
      30
      days of receipt of an early draft manuscript or 10 days after receipt of an
      abstract or presentation from PRINCIPAL INVESTIGATOR, COMPANY shall submit
      its
      comments, if any, to the PRINCIPAL INVESTIGATOR. The PRINCIPAL INVESTIGATOR
      shall not be bound to incorporate COMPANY’s comments. The PRINCIPAL INVESTIGATOR
      has sole decision-making authority over publication content.

    


    (c) If
      COMPANY has reason to believe that any such manuscript or abstract reveals
      a
      potentially patentable invention within the RESEARCH RESULTS or JOINT INVENTION,
      COMPANY shall so notify HARVARD and PRINCIPAL INVESTIGATOR in writing promptly
      and within the time periods indicated in subparagraph 2.7(b), above. In such
      case, PRINCIPAL INVESTIGATOR agrees to delay publication or public presentation,
      for purposes of patent filing, until the earliest to occur of the following:
      (i)
      a U.S. patent application has been filed by HARVARD (or COMPANY, if HARVARD
      declines to file such a patent application with regard to a JOINT INVENTION);
      (ii) HARVARD’s Office of Technology Development has determined, in consultation
      with COMPANY, that no patentable invention within the RESEARCH RESULTS exists;
      or (iii) 30 days have passed from the date of such notification by
      COMPANY.

    (d) Any
      obligations assumed by HARVARD under subparagraphs (a), (b) and (c) of this
      Paragraph shall be excused in the event of termination of this Agreement or
      termination of rights granted to COMPANY pursuant to Article 3 hereof.


    


    2.8 PRINCIPAL
      INVESTIGATOR will promptly report any invention within the RESEARCH RESULTS
      or
      JOINT INVENTION to HARVARD. HARVARD will advise COMPANY, promptly and in
      writing, of each such invention disclosed to HARVARD. Similarly, COMPANY shall
      notify HARVARD, promptly and in writing, of any such invention of which COMPANY
      becomes aware.

    


    2.9 COMPANY
      will not have the right to direct or control the activities of HARVARD or
      PRINCIPAL INVESTIGATOR in performing the RESEARCH. HARVARD and PRINCIPAL
      INVESTIGATOR shall act hereunder only as independent contractors, and nothing
      contained in this Agreement shall be construed to be inconsistent with that
      relationship or status. Under no circumstances shall HARVARD or any of its
      faculty, staff, students or agents, including without limitation PRINCIPAL
      INVESTIGATOR, be considered to be an employee or agent of COMPANY. 

    


    3.
      TITLE

    


    3.1. As
      between the parties, all rights, title and interest in and to the HARVARD PATENT
      RIGHTS and the RESEARCH RESULTS are and shall be owned solely and exclusively
      by
      HARVARD.

    


    3.2. Subject
      to the terms of this Agreement, as between the parties, all rights, title and
      interest in and to the JOINT TECHNOLOGY are and shall be owned jointly by
      COMPANY and HARVARD. 

    


    3.3  All
      determinations of inventorship under this Agreement shall be made in accordance
      with United States patent law. In case of dispute between COMPANY and HARVARD
      over inventorship, mutually acceptable outside patent counsel shall make the
      determination of the inventor(s) by applying the standards contained in United
      States patent law.

    


    4.
      GRANT OF LICENSE

    


    4.1. HARVARD
      hereby grants to COMPANY, and COMPANY hereby accepts, an exclusive, worldwide
      license under the LICENSED PATENT RIGHTS, with the right to grant SUBLICENSEs
      subject to the terms of this Agreement, to practice the HARVARD PATENT RIGHTS
      and JOINT PATENT RIGHTS solely (i) to develop, make and have made, use, sell,
      and import LICENSED PRODUCTs, and (ii) to provide SERVICES. In order to provide
      COMPANY with commercial exclusivity for so long as the license under the
      LICENSED PATENT RIGHTS remains exclusive, HARVARD agrees that it will not grant
      licenses to others to make, sell or import LICENSED PRODUCTS or to provide
      SERVICES, except as required or permitted under Paragraphs 4.2 or 4.3, for
      any
      commercial purpose. 

    


    4.2 The
      granting and exercise of this license is subject to the following conditions:
      

    


    (a)
      HARVARD’s “Statement of Policy in Regard to Inventions, Patents and Copyrights,”
(dated November 3, 1975 and amended on March 17, 1986, February 9, 1998 and
      August 10, 1998), 35 USC §§200-212,
      37 CFR §401 et seq., applicable governmental implementing regulations and
      HARVARD’s obligations under agreements with other sponsors of research. Any
      right granted in this Agreement greater than that permitted under 35 USC
§§200-212
      or 37 CFR §401 et seq. shall be subject to modification as may be required to
      conform to the provisions of those statutes. 

    


    (b)
      HARVARD reserves the right, for itself and others, to make, use and import
      LICENSED PRODUCTS for NON-COMMERCIAL RESEARCH PURPOSES. 

    


    4.3 All
      rights reserved to the United States Government and others under 35 USC
§§200-212
      and 37 CFR §401 shall remain and shall in no way be affected by this Agreement.


    


    5.
      DEVELOPMENT AND COMMERCIALIZATION

    


    5.1 Appendix
      D sets forth the development and commercialization plan under which COMPANY
      intends to develop and sell LICENSED PRODUCTs (the “PLAN”). COMPANY shall be
      entitled, from time to time, to make such adjustments to the then-applicable
      PLAN as COMPANY believes, in its good faith judgment, are needed in order to
      improve COMPANY’s ability to meet the PERFORMANCE MILESTONES, as defined below.


    


    5.2 COMPANY
      shall use commercially reasonable efforts (including, without limitation,
      funding consistent therewith) and/or shall cause its AFFILIATES or SUBLICENSEES
      to use commercially reasonable efforts (including, without limitation, funding
      consistent therewith):  (i)
      to
      develop LICENSED PRODUCTs in accordance with the PLAN during the periods and
      within the timetable specified therein, (ii) to
      carry
      out all efficacy, pharmaceutical, safety, toxicological and clinical tests,
      trials and studies and all other activities necessary in order to obtain
      approval under applicable governmental regulations (e.g., those of the United
      States Food and Drug Administration or equivalent agency or government body
      of
      another country) for the production, use and sale of LICENSED
      PRODUCTs,
      (iii) to
      introduce LICENSED PRODUCTS into the commercial market and (iv) to market
      LICENSED PRODUCTS, and to keep each LICENSED PRODUCT reasonably available to
      the
      public, following introduction thereof into the market. In
      addition, COMPANY shall achieve the following within the designated time
      periods:

    


    
      	 	
              (a)

            	
              within
                one (1) year after PROOF OF CONCEPT DATE , establish a Scientific
                Advisory
                Board that will oversee the development of LICENSED PRODUCTs;
                

            


    

    


    
      	 	
              (b)

            	
              commence
                a human clinical trial of a first LICENSED PRODUCT as follows: (i)
                if the
                patient data collected in the RESEARCH can be used to support the
                filing
                of an investigational device exemption (IDE), within two (2) years
                of the
                PROOF OF CONCEPT DATE or, (ii) if the patient data collected in the
                RESEARCH cannot be used to support the filing of an investigational
                device
                exemption (IDE), then within three (3) years of the PROOF OF CONCEPT
                DATE;
                and

            


    

    


    
      	 	
              (c)

            	
              within
                two years of commencement of the human clinical trial described in
                clause
                (b), conclude analysis of data from such clinical trial and submit
                to the
                FDA any and all documentation required for marketing approval of
                a first
                LICENSED PRODUCT.

            


    

    


    Each
      of
      the activities recited in this Paragraph 5.2 shall be referred to herein as
      a
“PERFORMANCE MILESTONE”.

    


    5.3 COMPANY
      shall inform HARVARD, on
      or
      before the deadline for meeting any PERFORMANCE MILESTONE, whether such
      PERFORMANCE MILESTONE has been met.

    


    5.4 The
      COMPANY’s Chief Executive Officer, the PRINCIPAL INVESTIGATOR and the head of
      HARVARD’s Office of Technology Development shall meet at HARVARD no less than
      once every six (6) months during the term commencing with the EFFECTIVE DATE
      and
      ending upon the first commercial sale of a LICENSED PRODUCT, at times to be
      mutually agreed upon by the parties, (i) to review the progress being made
      under
      the PLAN (including, if progress differs from that anticipated in the PLAN,
      an
      explanation by the COMPANY of the reasons for such difference) and the progress
      being made in any other research and development activities conducted by COMPANY
      and any SUBLICENSEE(s) relating to LICENSED PRODUCTs, (ii)
      to
      review any necessary or desired revisions to the PLAN, either as filed pursuant
      to Paragraph 5.1 of this Agreement or as subsequently modified, (iii)
      to
      review the progress being made towards meeting the PERFORMANCE MILESTONES and
      (iv) to discuss intended efforts for meeting such PERFORMANCE MILESTONES.


    


    5.5. No
      later
      than sixty (60) days after December 31st
      of each
      calendar year, COMPANY shall provide to HARVARD a written annual progress report
      describing progress by COMPANY and any SUBLICENSEE(s) on research and
      development, regulatory approvals, manufacturing, sublicensing, marketing and
      sales during the most recent twelve (12) month period ending December
      31st
      and
      plans for the forthcoming year. If multiple technologies are covered by the
      license granted hereunder, the progress report shall provide the information
      set
      forth above for each technology. COMPANY also shall provide any additional
      data
      HARVARD reasonably requires to evaluate COMPANY’s performance and compliance
      with the terms of this Agreement. 

    


    5.6. If
      COMPANY breaches any of its obligations pursuant to Article 5, HARVARD shall
      notify COMPANY in writing of COMPANY’s failure and shall allow COMPANY ninety
      (90) days to cure. COMPANY’s failure to cure such breach within such ninety (90)
      day period shall constitute a material breach of this Agreement and HARVARD
      shall have the right to terminate this Agreement forthwith. 

    


    5.7. Without
      limiting in any way Harvard’s rights under this Article 5 or any other provision
      of this Agreement, the parties understand that nothing contained in this
      Agreement shall be construed as a representation, warranty or guarantee by
      COMPANY that it will succeed in developing LICENSED PRODUCTS in accordance
      with
      the PLAN.

    


    


    6.
      SUBLICENSE

    


    6.1 SUBLICENSEs
      are subject to HARVARD’s approval, which approval shall not be unreasonably
      withheld. SUBLICENSEs shall
      only be granted pursuant to written agreements, which shall be in compliance
      and
      not inconsistent with and shall be subject and subordinate to the terms and
      conditions of this Agreement. 

    


    6.2 To
      the
      extent applicable, SUBLICENSEs must include provisions necessary to enable
      COMPANY to perform its obligations under this Agreement and include all of
      the
      rights of and obligations due to HARVARD and sponsors of research (which may
      include, without limitation, the United States Government) contained in this
      Agreement, including without limitation the rights and obligations set forth
      in
      Paragraphs 6.3, 6.4, 6.5, 6.7, 10.4, 10.9, 11.1, 23.3, 23.4 and 23.7, and
      Articles 4, 16, 17, 18 and 19 hereof. 

    


    6.3 No
      third
      party to whom COMPANY grants a SUBLICENSE may make a further grant of rights
      under LICENSED PATENT RIGHTS to any other third party.

    


    6.4 COMPANY
      shall promptly provide HARVARD with a copy of each SUBLICENSE issued. COMPANY
      shall also pay to HARVARD all payments due HARVARD on account of sales of
      LICENSED PRODUCTs by SUBLICENSEEs. COMPANY shall summarize and deliver all
      information from SUBLICENSEEs required to be included in reports due to
      HARVARD.

    


    6.5 In
      the
      event of termination of this Agreement, or of the license granted under
      Paragraph 4.1 above (whether in whole or in part - e.g., termination of
      COMPANY’s rights under a portion of the LICENSED PATENT RIGHTS or in a
      particular country), each agreement that contains a SUBLICENSE shall terminate,
      but only to the extent of the SUBLICENSE and, in the event of partial
      termination of the license granted under Paragraph 4.1 above, only to the extent
      of any of COMPANY’s terminated rights contained in such agreement. COMPANY shall
      provide to HARVARD within ten (10) days of termination current contact
      information for each SUBLICENSEE whose SUBLICENSE is in effect and in good
      standing as of the date of termination (i.e., any SUBLICENSEE not then in breach
      of its SUBLICENSE such that COMPANY would have the right to terminate such
      SUBLICENSE). Each such SUBLICENSEE then shall have ninety (90) days from the
      date of termination to notify HARVARD, in a written notice that complies with
      the requirements of Article 22 of this Agreement, that it wishes to negotiate
      with HARVARD a direct license under LICENSED PATENT RIGHTS. If any SUBLICENSEE
      fails to provide such notice to HARVARD, such SUBLICENSEE shall have no further
      rights under LICENSED PATENT RIGHTS. If any SUBLICENSEE provides such notice
      to
      HARVARD, HARVARD shall negotiate in good faith with such SUBLICENSEE for a
      period of up to ninety (90) days from the date of such notice in order to enter
      into a license agreement consistent with the terms of this Agreement, including,
      without limitation, the financial terms hereof. HARVARD shall not assume, and
      shall not be responsible to such SUBLICENSEE for, any representations,
      warranties or obligations of COMPANY to such SUBLICENSEE. HARVARD shall be
      under
      no obligation to negotiate a license with any SUBLICENSEE not reported by
      COMPANY to HARVARD as having a SUBLICENSE that is in effect and in good standing
      as of the date of termination of this Agreement or of the date of termination
      of
      any of the rights granted to COMPANY pursuant to Paragraph 4.1 hereof.


    


    6.6 COMPANY
      shall not grant to any SUBLICENSEE any right to participate or otherwise be
      involved in suing infringers under or otherwise enforcing or defending HARVARD
      PATENT RIGHTS or JOINT PATENT RIGHTS. 

    


    6.7 In
      the
      event that COMPANY becomes aware of any breach by a SUBLICENSEE of the terms
      of
      the licenses granted hereby, and/or of any terms of a SUBLICENSE agreement
      in a
      manner that adversely affects HARVARD, or if HARVARD provides COMPANY with
      evidence of such a breach, then COMPANY shall enforce its rights with respect
      thereto under COMPANY’s agreement with such SUBLICENSEE, including, if requested
      by HARVARD, terminating such agreement, at the cost and expense of COMPANY.
      COMPANY shall indemnify HARVARD for, and hold it harmless from, any and all
      damages or losses caused to HARVARD as a result of any such breach by a
      SUBLICENSEE. 

    


    7.
      LICENSE ISSUE FEE

    


    COMPANY
      shall pay to HARVARD a non-cancelable, non-refundable, non-creditable license
      issue fee in the sum of fifty-thousand dollars ($50,000) within ten (10) days
      of
      the EFFECTIVE DATE. 

    


    8.
      ANNUAL LICENSE FEE

    


    COMPANY
      shall
      pay to HARVARD an annual license fee, as follows:

     

    
      	·  	
              On
                January 1, 2008, fifty-thousand dollars
                ($50,000);

            


    

    


    
      	·  	
              On
                January 1, 2009, one-hundred-thousand dollars
                ($100,000);

            


    

    


    
      	·  	
              On
                January 1, 2010, one-hundred-fifty-thousand dollars ($150,000); and
                

            


    

    


    
      	·  	
              On
                January 1, 2011 and each January 1 thereafter during the term of
                the
                Agreement, two-hundred-fifty-thousand dollars ($250,000);
                

            


    

    


    Each
      annual license fee due on January 1, 2013 and every January 1 thereafter, and
      actually paid, shall be creditable against royalties due under Paragraph 9.1
      of
      this Agreement for LICENSED PRODUCTs sold and SERVICES performed after the
      due
      date of such payment. 

    


    9.
      OTHER LICENSE PAYMENTS

    


    9.1 COMPANY
      shall pay to HARVARD a royalty of six percent (6%) of all NET SALES and SERVICE
      INCOME.

     

    9.2 COMPANY
      shall pay to HARVARD an amount of thirty percent (30%) of all NON-ROYALTY
      SUBLICENSE INCOME. 

    


    10.
      REPORTING AND PAYMENT BY COMPANY

    


    10.1 COMPANY
      shall report to HARVARD the date of first sale of LICENSED PRODUCT in each
      country within thirty (30) days of occurrence. 

    


    
      	
              10.2
                

            	
              COMPANY
                shall submit to HARVARD within forty-five (45) days after each calendar
                quarter year ending March 31, June 30, September 30 and December
                31, a
                report setting forth for such quarter year at least the following
                information: 

            


    

    


    (i)
       the
      number of each LICENSED PRODUCT sold by COMPANY and any SUBLICENSEE(s) in each
      country; 

    


    (ii)
       total
      billings for such LICENSED PRODUCTs; 

    


    (iii)
       deductions
      applicable to determine NET SALES; 

    


    (iv)
      the
      amount of SERVICE INCOME and NON-ROYALTY SUBLICENSE INCOME received by COMPANY;
      and 

    


    (v)
       the
      total
      amount payable to HARVARD in U.S. dollars on NET SALES, SERVICE INCOME and
      NON-ROYALTY SUBLICENSE INCOME for the applicable calendar quarter, together
      with
      the exchange rates used for conversion; or, if no payment is due to HARVARD
      for
      any reporting period, the statement that no payment is due. 

    


    Such
      report shall be certified as correct by the Chief Financial Officer of COMPANY.
      Such Officer shall have a reasonable knowledge of, and access to, information
      on
      which such report is based. 

    


    10.3 Within
      45
      days of end of each such calendar quarter, COMPANY shall pay HARVARD all amounts
      due with respect to NET SALES, SERVICE INCOME and NON-ROYALTY SUBLICENSE INCOME
      for the applicable calendar quarter. The last such payment shall be due within
      forty-five (45) days after termination of this Agreement.

    


    10.4 COMPANY
      shall furnish to HARVARD, and shall cause its AFFILIATES who make, use, market,
      offer for sale or sell LICENSED PRODUCTs and SUBLICENSEE(s) to furnish HARVARD,
      within ninety (90) days after the end of each calendar year, commencing at
      the
      end of the calendar year in which first commercial sale of a LICENSED PRODUCT
      is
      made, with a report, signed by an independent certified public accountant,
      relating to royalties and other payments due to HARVARD pursuant to this
      Agreement in respect to the previous calendar year and containing the same
      details as those specified in Paragraph 10.2 above in respect to the previous
      calendar year. If during any calendar year no NET SALES and no SERVICE INCOME
      is
      generated and no NON-ROYALTY SUBLICENSE INCOME is received, the COMPANY shall
      deliver a statement to HARVARD signed by an officer of the COMPANY stating
      such
      fact and the COMPANY shall not be required to submit a report signed by an
      independent certified public accountant to HARVARD for such year.

     

    10.5 All
      payments due under this Agreement shall be deemed received when funds are
      credited to HARVARD’s bank account and shall be payable by check or wire
      transfer in United States dollars. If made by wire transfer, such payments
      shall
      be marked so as to refer to this Agreement. Conversion of foreign currency
      to
      U.S. dollars shall be made at the conversion rate existing in the United States
      (as reported in the Wall Street Journal or, if not so reported, then as reported
      in the New York Times) on the last working day of each royalty period. No
      transfer, exchange, collection or other charges shall be deducted from such
      payments. 

    


    10.6 In
      the
      event that any payment due under this Agreement is not made when due, such
      payment shall be subject to a charge of interest at one and one half percent
      (1
      1/2%) per month, or $250, whichever is greater. Interest shall accrue beginning
      on the first day following the due date as herein specified and shall be
      compounded quarterly. HARVARD shall not be precluded from exercising any other
      rights it may have as a consequence of the lateness of any payment.

    


    10.7 COMPANY
      shall notify HARVARD of any acquisition of COMPANY, merger in which the COMPANY
      is not the surviving corporation or change of corporate name within thirty
      (30)
      days of its occurrence. 

    


    10.8 In
      addition to the contact information contained within Article 22 (“Notices”) of
      this Agreement, COMPANY immediately shall provide HARVARD with contact
      information for a financial officer responsible for receipt and approval of
      invoices for patent costs and handling of inquiries related to payments and
      reports due hereunder. COMPANY shall report any change in either or both of
      the
      contact information required under this Paragraph or Article 22 within thirty
      (30) days of its occurrence.

    


    10.9 If
      COMPANY, any SUBLICENSEE and/or any holder of an option to obtain a SUBLICENSE
      does not qualify, or at any point during the term of this Agreement ceases
      to
      qualify, as a “small entity” as provided by the United States Patent and
      Trademark Office (USPTO), COMPANY shall so notify HARVARD immediately, in order
      to permit HARVARD to comply with USPTO regulations as regards payment of fees.
      

    


    11.
      RECORD KEEPING

    


    11.1 COMPANY
      shall keep, and shall require each SUBLICENSEE, and each AFFILIATE of COMPANY
      and/or any SUBLICENSEE who makes, uses or sells LICENSED PRODUCTS or SERVICES,
      or who receives payment for same, to keep accurate records (together with
      supporting documentation) of efforts to meet PERFORMANCE MILESTONEs and of
      LICENSED PRODUCTs and SERVICES made, used or sold under this Agreement,
      appropriate to determine the amount of payments due to HARVARD hereunder and
      compliance with the terms of this Agreement. Such records shall be retained
      for
      at least five (5) years following the end of the reporting period to which
      they
      relate. They shall be available during normal business hours for examination
      by
      an auditor selected by HARVARD, for the sole purpose of verifying reports,
      payments due or made hereunder and compliance with the terms of this Agreement.
      In conducting examinations pursuant to this paragraph, HARVARD’s auditor shall
      have access to all records which HARVARD reasonably believes to be relevant
      to
      the accuracy of reports, calculation of payments due under Article 9 and
      compliance with the terms of this Agreement. 

    


    11.2 HARVARD’s
      auditor shall be bound by a confidentiality agreement prepared by COMPANY,
      the
      terms of which confidentiality agreement shall be usual, customary and
      reasonable under the circumstances, and shall not disclose to HARVARD any
      information other than information relating to the accuracy of reports and
      payments made hereunder and compliance with the terms of this Agreement.


    


    11.3 Such
      examination by HARVARD’s auditor shall be at HARVARD’s expense, except that if
      such examination shows an underreporting or underpayment in excess of five
      percent (5%) for any twelve (12) month period, then COMPANY shall pay the cost
      of such examination as well as any additional sum that would have been payable
      to HARVARD had the COMPANY reported correctly, plus interest on said sum at
      the
      rate of one-and-one-half percent (1 1/2%) per
      month
      pursuant to the terms of Paragraph 10.6 of this Agreement. 

    


    12.
      CONFIDENTIALITY

    


    12.1 Except
      as
      otherwise provided in Paragraph 12.2, below, neither party shall disclose to
      any
      third party(ies), including without limitation any governmental patent office
      or
      agency, nor use except for the purpose of this Agreement, any CONFIDENTIAL
      INFORMATION, as defined below, of the other party for a period of five (5)
      years
      from the date of provision to the receiving party of such CONFIDENTIAL
      INFORMATION. Each party shall restrict the dissemination of the other party’s
      CONFIDENTIAL INFORMATION to its employees or agents who have a need to know
      such
      information in order to exercise such party’s rights under this Agreement and
      are bound by obligations of confidentiality and non-use comparable to those
      set
      forth in this Article 12.

    


    12.2 Nothing
      in this Agreement shall limit in any way (i) disclosure of information required
      by any applicable law, governmental regulator or court of competent jurisdiction
      or (ii) disclosure of information that is necessary to prevent imminent danger
      to the safety of one or more persons. Should either party be required to
      disclose CONFIDENTIAL INFORMATION provided by or on behalf of the other pursuant
      to part (i) of the preceding sentence, the receiving party shall notify the
      disclosing party reasonably in advance of such disclosure and shall take all
      reasonable measures to limit the amount of CONFIDENTIAL INFORMATION that must
      be
      disclosed.

    


    12.3 “CONFIDENTIAL
      INFORMATION” of a party means: (i) with respect to COMPANY, any written report
      that COMPANY is required to provide to HARVARD pursuant to Articles 5 or 10
      of
      this Agreement and (ii) with respect to HARVARD, any information disclosed
      by or
      on behalf of HARVARD (including by any of its employees, students, other
      trainees or contractors) to COMPANY under this Agreement including, in
      non-limiting fashion, any information regarding HARVARD PATENT RIGHTS and
      RESEARCH RESULTS. Notwithstanding the foregoing, information disclosed to either
      party by the other shall not be deemed CONFIDENTIAL INFORMATION, and the
      recipient party will have no obligation with respect to such
      information:

    


    (a) if,
      as of
      the date of disclosure, such information is part of the public domain;


    


    (b) if
      such
      information subsequently becomes part of the public domain through no act or
      omission of the recipient party;

    


    (c) if
      the
      recipient party can show that such information was in its possession, as
      evidenced by written records, and had not been wrongfully acquired, directly
      or
      indirectly, from the provider party; or

    


    (d) if
      such
      information is subsequently disclosed to the recipient by a third party not
      in
      violation of any obligation of confidentiality to the provider party;
      or

    


    (e) if
      such
      information is independently developed by receiving party without the use of
      or
      reference to disclosing party’s confidential information. 

    


    13.
      PATENT FILING, PROSECUTION AND MAINTENANCE

    


    13.1 Within
      fifteen (15) days of the EFFECTIVE DATE, COMPANY shall reimburse HARVARD for
      all
      documented, out-of-pocket expenses incurred by HARVARD prior to the EFFECTIVE
      DATE for the preparation, filing, prosecution and maintenance of HARVARD PATENT
      RIGHTS. Such patent costs are approximately $97,527.58 as of the EFFECTIVE
      DATE.
      Thereafter, COMPANY shall reimburse HARVARD for all costs associated with patent
      prosecution, patent maintenance fees and annuities, and all costs associated
      with any ex
      parte
      patent
      proceedings (including, but not limited to, patent interference proceedings)
      related to the HARVARD PATENT RIGHTS and JOINT PATENT RIGHTS and incurred during
      the term of this Agreement within thirty (30) days of the date of any invoice
      by
      HARVARD, as indicated thereon.  HARVARD
      shall be responsible for the preparation, filing, prosecution, protection and
      maintenance of all U.S. and foreign patent applications and patents included
      within the HARVARD PATENT RIGHTS and JOINT PATENT RIGHTS. HARVARD shall consult
      COMPANY on each step of preparation, filing, prosecution and maintenance of
      any
      patent application or patent within the HARVARD PATENT RIGHTS and JOINT PATENT
      RIGHTS and under HARVARD’s management, and HARVARD shall incorporate COMPANY’s
      comments where reasonably practicable, but final decision making authority
      shall
      vest in HARVARD. 

    


    13.2 HARVARD
      and COMPANY shall cooperate fully in the preparation, filing, prosecution and
      maintenance of HARVARD PATENT RIGHTS and JOINT PATENT RIGHTS and of all patents
      and patent applications licensed to COMPANY hereunder, executing all papers
      and
      instruments or requiring members of HARVARD (and, if applicable, COMPANY) to
      execute such papers and instruments so as to enable HARVARD to apply for, to
      prosecute and to maintain patent applications and patents in HARVARD’s (and, if
      applicable, COMPANY’s) name in any country. Each party shall provide to the
      other prompt notice as to all matters which come to its attention and which
      may
      affect the preparation, filing, prosecution or maintenance of any such patent
      applications or patents. 

    


    13.3 During
      the term of this Agreement, COMPANY may elect to surrender its license under
      (and, in the case of JOINT PATENT RIGHTS, its rights in) any patent(s) and/or
      patent application(s) within HARVARD PATENT RIGHTS or JOINT PATENT RIGHTS in
      any
      country upon one-hundred-twenty (120) days written notice to HARVARD. Such
      notice shall not relieve COMPANY from responsibility to reimburse HARVARD for
      patent-related expenses incurred prior to the expiration of the
      one-hundred-twenty (120)-day notice period (or such longer period specified
      in
      COMPANY’s notice). From the date of its notice, COMPANY shall have no further
      rights to HARVARD’s interest in such PATENT RIGHTS (and any license thereto
      granted under this Agreement shall immediately terminate) and HARVARD shall
      have
      the rights (i) to prosecute and maintain any such PATENT RIGHTS, at its own
      or
      another’s expense, and (ii) to seek other commercial licensees for the rights
      granted hereunder with respect to such PATENT RIGHTS. In addition, in the event
      that such PATENT RIGHTS are JOINT PATENT RIGHTS, COMPANY hereby assigns all
      of
      its interest in and to such abandoned PATENT RIGHTS to HARVARD.  

    


    13.4 Nothing
      in the Agreement shall affect any right of HARVARD to own and control HARVARD
      PATENT RIGHTS or its interest in any JOINT PATENT RIGHTS or cause any such
      right
      to vest in COMPANY.

    


    14.
      INFRINGEMENT 

    


    14.1 So
      long
      as COMPANY remains the exclusive licensee of any issued VALID CLAIM under this
      Agreement, COMPANY shall have the first right, subject to the terms of this
      Article, to prosecute in its own name and at its own expense any infringement
      of
      such issued VALID CLAIM with respect to LICENSED PRODUCTs and/or SERVICES
      (“INFRINGEMENT”). Each party agrees to notify the other promptly of each
      INFRINGEMENT of which such party is or becomes aware. Before COMPANY commences
      an action with respect to any INFRINGEMENT, COMPANY shall consider in good
      faith
      the views of HARVARD and potential effects on the public interest in making
      its
      decision whether or not to sue. The decision whether or not COMPANY brings
      suit,
      however, shall be at the COMPANY’s sole discretion. 

    


    
      	
              14.2

            	
              (a)
                If COMPANY elects to commence an action as described above, HARVARD
                may,
                to the extent permitted by law, elect to join as a party in that
                action.
                Regardless of whether HARVARD elects to join as a party, HARVARD
                shall
                cooperate fully with COMPANY in connection with any such action.
                In
                addition, in the event that COMPANY is unable to initiate or prosecute
                an
                action as described above solely in its own name, HARVARD will join
                such
                action at the request of COMPANY and, subject to the other terms
                of this
                Article 14, will execute those documents necessary for COMPANY to
                initiate, prosecute and maintain such action, provided that COMPANY
                shall
                indemnify and hold HARVARD harmless from and against any costs, expenses
                and liability that HARVARD incurs in connection with such action.
                

            


    

    


    (b)
      Whether or not HARVARD becomes a party in any INGRINGEMENT action brought by
      COMPANY, COMPANY shall keep HARVARD reasonably informed of the progress of
      the
      action and shall give HARVARD a reasonable opportunity in advance to consult
      with COMPANY and offer its views about major decision affecting the litigation.
      COMPANY shall give careful consideration to those views, but shall have the
      right to control the action, provided, however, that if COMPANY fails to defend
      in good faith the validity and enforceability of the PATENT RIGHTS in the action
      or fails to comply with its obligations under this Article 14, or if COMPANY’s
      license to a VALID CLAIM in suit terminates or becomes non-exclusive, HARVARD
      may elect to take control of the action. 

    


    (c)
      COMPANY shall promptly reimburse HARVARD for any costs HARVARD incurs
      (including, without limitation, reasonable attorneys’ fees) either in providing
      any cooperation requested by COMPANY or in connection with HARVARD’s involvement
      in any such action that it joins at the request of COMPANY. 

    


    14.3 No
      settlement, consent judgment or other voluntary final disposition of such an
      action may be entered into without the prior written consent of HARVARD, which
      consent shall not be unreasonably withheld, conditioned or delayed.


    


    14.4 Recoveries
      or reimbursements from actions commenced by COMPANY pursuant to this Article
      (including, without limitation, from any settlement or other voluntary
      disposition thereof) shall first be applied to reimburse COMPANY and HARVARD
      (to
      the extent COMPANY has not already reimbursed HARVARD) for all litigation costs.
      With respect to any remaining recoveries or reimbursements, HARVARD shall
      receive thirty percent (30%) and COMPANY shall retain seventy percent (70%).
      

    


    14.5 If
      COMPANY elects not to exercise its right to prosecute an infringement of PATENT
      RIGHTS pursuant to this Article, HARVARD may do so at its own expense,
      controlling such action. COMPANY shall cooperate fully with HARVARD in
      connection with any such action. HARVARD shall reimburse COMPANY for any costs
      COMPANY incurs (including, without limitation, reasonable attorneys’ fees) in
      providing any cooperation requested by HARVARD. Recoveries or reimbursements
      from actions commenced by HARVARD pursuant to this Article (including, without
      limitation, from any settlement or other voluntary disposition thereof) shall
      first be applied to reimburse HARVARD for all litigation costs and COMPANY
      (with
      respect to costs for which HARVARD has not already reimbursed COMPANY) for
      any
      costs COMPANY incurs (including, without limitation, reasonable attorneys’ fees)
      in providing any cooperation requested by HARVARD. With respect to any remaining
      recoveries or reimbursements, HARVARD shall retain seventy percent (70%) and
      COMPANY shall receive thirty percent (30%). 

    


    14.6 Without
      limiting the generality of Paragraph 14.5, HARVARD may, at its election and
      by
      written notice to COMPANY, establish a period, ending on the earlier of (x)
      ninety (90) days from the date of such notice or (y) thirty (30) days prior
      to
      the last date by which an infringement action may be filed to recover damages
      for all the infringing acts in question, for COMPANY to decide whether to
      prosecute any infringement of which HARVARD is or becomes aware. If COMPANY
      has
      not commenced such an action by the end of that period, COMPANY shall be deemed
      to have elected not to exercise its right to prosecute such infringement and
      HARVARD may prosecute such infringement in accordance with Paragraph 14.5.
      

    


    14.7 If
      a
      declaratory judgment action is brought naming COMPANY and/or any SUBLICENSEE
      as
      a defendant and alleging invalidity or unenforceability of any claims within
      PATENT RIGHTS, COMPANY shall promptly notify HARVARD in writing and,
      notwithstanding the above, HARVARD may elect, upon written notice to COMPANY
      within thirty (30) days after HARVARD receives notice of the commencement of
      such action, to take over the sole defense of the invalidity or unenforceability
      aspect of the action at its own expense. 

    


    15.
      TERMINATION OF AGREEMENT 

    


    15.1 This
      Agreement, unless terminated as provided herein, shall remain in effect until
      the date upon which the last VALID CLAIM has expired or been abandoned.


    


    15.2
       HARVARD
      may terminate this Agreement as follows: 

    


    (a)
      If
      COMPANY does not make a payment due hereunder (including, without limitation,
      any payment under Paragraph 2.5) and fails to cure such non-payment (including
      the payment of interest in accordance with Paragraph 10.6) within thirty (30)
      days after the date of notice in writing of such non-payment by HARVARD.


    


    (b)
      Pursuant to the terms of Paragraph 18.5, if COMPANY defaults in its obligations
      under Paragraph 18.3 to procure and maintain insurance or, if COMPANY has in
      any
      event failed to comply with the notice requirements contained therein, then
      immediately without notice or additional waiting period. 

     

    (c)
      If
      HARVARD is permitted to terminate the Agreement pursuant to
      Paragraph 5.6.

    


    (d)
      If
      COMPANY shall become insolvent, shall make an assignment for the benefit of
      creditors, or shall have a petition in bankruptcy filed for or against it.
      Such
      termination shall be effective immediately upon HARVARD giving written notice
      to
      COMPANY. 

    


    (e)
      If an
      examination by HARVARD’s auditor pursuant to Article 11 shows an underreporting
      or underpayment by COMPANY in excess of 20% for any twelve (12) month period
      and
      the underreporting is not the result of fraud or intentional misconduct on
      the
      part of a SUBLICENSEE, in which case COMPANY shall immediately enforce its
      rights against such SUBLICENSEE in accordance with Paragraph 6.7. 

    


    (f)
      If
      COMPANY is convicted of a felony relating to the manufacture, use, or sale
      of
      LICENSED PRODUCT(s). Such
      termination shall be effective immediately upon HARVARD giving written notice
      to
      COMPANY. 

    


    (g)
      Except as provided in subparagraphs (a), (b), (c), (d), (e) and (f) above,
      if
      COMPANY defaults in the performance of any obligation under this Agreement,
      then
      within ninety (90) days of written notice by HARVARD to LICENSEE of such
      default, if such default then remains uncured. 

    


    15.3 COMPANY
      may terminate this Agreement as follows: 

    


    (a) At
      any
      time upon ninety (90) days prior written notice to HARVARD, provided
      however,
      that,
      except as provided in Paragraph 2.3, (i) if COMPANY provides notice of
      termination on or prior to the date twenty (20) months from the EFFECTIVE DATE,
      it shall continue to fund the RESEARCH through the end of the second year of
      the
      RESEARCH PERIOD, but shall not be required to fund the third year of the
      RESEARCH PERIOD and (ii) if COMPANY provides notice of termination after the
      date twenty (20) months from the EFFECTIVE DATE, it shall continue to fund
      the
      RESEARCH through the end of the RESEARCH PERIOD. COMPANY shall remain
      responsible for patent expenses incurred by HARVARD through the end of such
      ninety (90) days, and shall pay such expenses within 30 days of invoice to
      COMPANY by HARVARD. 

    


    (b) In
      the
      event that HARVARD commits a material breach of its obligations under this
      Agreement and fails to cure that breach within ninety (90) days after receiving
      written notice thereof from COMPANY, the COMPANY may terminate this Agreement
      immediately upon written notice to HARVARD. If COMPANY terminates this Agreement
      pursuant to this subparagraph 15.3(b), COMPANY shall not be responsible for
      payment of any further obligations to HARVARD, including but not limited to
      funding RESEARCH or patent expenses, but shall remain responsible for all
      payment obligations incurred during the term hereof.

    


    15.4 Upon
      termination, COMPANY shall submit a final Royalty Report to HARVARD and all
      payment obligations accruing under this Agreement prior to the date of
      termination shall become immediately payable, subject to the limitation of
      subparagraph 15.3(b). 

    


    15.5 Upon
      termination pursuant to Paragraph 15.2 or 15.3, whether by HARVARD or by
      COMPANY, 

    


    (a) 
      the
      rights and licenses granted to COMPANY under Paragraph 4.1 of this Agreement
      shall terminate; 

    


    (b) COMPANY,
      SUBLICENSEE(s) and the AFFILIATE(s) of either shall not be entitled to develop,
      make, have made, use, offer to sell, sell, have sold, import, export, otherwise
      transfer physical possession of- or otherwise transfer title to any LICENSED
      PRODUCTs; 

    


    (c)
       any
      agreement(s) in effect as of the date of termination and containing any
      SUBLICENSE(s) shall be treated in accordance with Paragraph 6.5 of this
      Agreement;

    


    (d)
       each
      party shall have a fully-paid up, non-exclusive, worldwide license (with the
      right to grant sublicenses) under the other party’s interest in and to the JOINT
      PATENT RIGHTS (except for any JOINT PATENT RIGHTS in which COMPANY previously
      has abandoned its interest pursuant to this Agreement) for any and all purposes;
      and

    


    (e)
       if,
      after
      termination of this Agreement, either COMPANY or HARVARD declines or fails
      to
      support a fifty percent (50%) share of costs incurred in preparation, filing,
      prosecution and maintenance of any of the JOINT PATENT RIGHTS, such party shall
      have no further rights in such JOINT PATENT RIGHTS and the other party’s license
      in such JOINT PATENT RIGHTS shall become exclusive, and such other party will
      have the right either to maintain such JOINT PATENT RIGHTS or to allow such
      JOINT PATENT RIGHTS to become abandoned without further accounting to the
      non-paying party; provided,
      however,
      that
      HARVARD shall, in any event, retain the right, for itself and others, to
      practice such JOINT PATENT RIGHTS for NON-COMMERCIAL RESEARCH PURPOSES.


    


    15.6. In
      addition, in the event of termination by COMPANY pursuant to Paragraph 15.3(a)
      or by HARVARD pursuant to Paragraph 15.2 hereof, upon such termination
COMPANY
      shall promptly deliver and assign to HARVARD all
      documents and other materials filed by or on behalf of COMPANY and its
      AFFILIATEs with regulatory agencies in furtherance of applications for
      regulatory approval in the relevant country with respect to LICENSED PRODUCTs
      (“ASSIGNED MATERIALS”), subject to the following:

    


    (a) If
      this
      Agreement is terminated after January 1, 2010 and HARVARD thereafter grants
      a
      license under- or with respect to- or otherwise delivers any of the ASSIGNED
      MATERIALS to a third party as part of a license under any HARVARD PATENT RIGHTS
      and/or JOINT PATENT RIGHTS, Harvard shall pay COMPANY royalties in the amount
      of
      twenty-five percent (25%) of all NET HARVARD RECEIPTS, as defined below,
      actually received by HARVARD. All such royalties shall be paid by HARVARD
      concurrently with the distributions it makes for its other technologies within
      twelve months of receipt, but in any case no later than June 30 of each year.
      With such distribution, Harvard shall provide a financial accounting showing
      HARVARD RECEIPTS, as defined below, received during the preceding twelve months
      and all deductions therefrom, and HARVARD’s reports shall be CONFIDENTIAL
      INFORMATION of HARVARD.

    


    (b) “NET
      HARVARD RECEIPTS” shall mean HARVARD RECEIPTS less HARVARD EXPENSES, as defined
      below.

    


    (c) “HARVARD
      RECEIPTS” shall mean all amounts in cash and other consideration actually
      received by HARVARD in connection with the grant of a license under any of
      the
      HARVARD PATENT RIGHTS and/or JOINT PATENT RIGHTS, in which license HARVARD
      also
      grants rights in the ASSIGNED MATERIALS; provided that “HARVARD RECEIPTS” shall
      not include payments specifically committed to cover future costs to be actually
      incurred by HARVARD (including customary overhead) in accordance with detailed
      budgets and research work plans included in sponsored research or research
      and
      license agreements relating to the HARVARD PATENT RIGHTS or JOINT PATENT
      RIGHTS.

    


    (d) “HARVARD
      EXPENSES” shall mean all out-of-pocket expenses and professional fees, including
      legal fees, patent agent fees and fees paid to other experts, incurred by
      HARVARD in connection with: (a) the preparation, filing, prosecution,
      maintenance or enforcement of any patent application or patent included in
      the
      HARVARD PATENT RIGHTS or JOINT PATENT RIGHTS; or (b) the preparation,
      negotiation, execution and/or enforcement of any agreement relating to the
      grant
      of licenses under or with respect to any or all of the HARVARD PATENT RIGHTS,
      JOINT PATENT RIGHTS and/or the ASSIGNED MATERIALS.

    


    For
      clarity, if this Agreement is terminated by COMPANY pursuant to Paragraph
      15.3(a) or by HARVARD pursuant to Paragraph 15.2 hereof prior to January 1,
      2010, COMPANY shall not be entitled to any consideration if HARVARD thereafter
      grants a license under or with respect to or otherwise delivers any of the
      ASSIGNED MATERIALS to a third party. 

    


    15.7 Paragraphs
      6.5, 6.7, 10.3, 10.4 (but only to the extent of a report that covers the year
      in
      which termination occurs), 10.6, 13.2, 15.3, 15.4, 15.5, 15.6, 15.7, 23.1,
      23.8,
      23.9, 23.10, 23.11, 23.12, ; Paragraphs 14.2, 14.3 and 14.4 (each only with
      regard to litigation that (i) is brought after expiration, but not earlier
      termination by either party, of this Agreement, or (ii) is commenced prior
      to
      termination by either party of this Agreement); and Articles 11, 12, 17, 18
      and
      19 of this Agreement shall survive termination. 

    


    16.
      WARRANTY

    


    16.1 HARVARD
      does not warrant the validity of any of the PATENT RIGHTS licensed hereunder
      and
      makes no representations whatsoever with regard to the scope of the HARVARD
      PATENT RIGHTS or JOINT PATENT RIGHTS (if any) or that such PATENT RIGHTS may
      be
      exploited by COMPANY or any SUBLICENSEE without infringing other patents.
      COMPANY does not warrant the validity of any of the JOINT PATENT RIGHTS (if
      any)
      or that the JOINT PATENT RIGHTS may be exploited by any party without infringing
      other patents. COMPANY does not warrant the validity of the JOINT PATENT RIGHTS
      (if any) or that such JOINT PATENT RIGHTS may be exploited by any party without
      infringing other patents.

    


    16.2 HARVARD
      EXPRESSLY DISCLAIMS ANY AND ALL IMPLIED OR EXPRESS WARRANTIES AND MAKES NO
      EXPRESS OR IMPLIED WARRANTIES AS TO ANY MATTER WHATSOEVER, INCLUDING, WITHOUT
      LIMITATION, OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE
      PATENT RIGHTS, OR INFORMATION SUPPLIED BY HARVARD, OR OF LICENSED PRODUCTS
      OR
      SERVICES CONTEMPLATED BY THIS AGREEMENT. HARVARD ALSO MAKES NO WARRANTIES,
      EXPRESS OR IMPLIED, AS TO ANY TANGIBLE RESEARCH PROPERTY, INTELLECTUAL PROPERTY,
      INFORMATION OR DATA LICENSED OR OTHERWISE PROVIDED TO COMPANY, OR AS TO THE
      CONDITION, ORIGINALITY OR ACCURACY OF THE RESEARCH OR ANY INVENTION(S) OR
      PRODUCT(S), CONCEIVED, DISCOVERED, OR DEVELOPED UNDER THIS AGREEMENT; OR THE
      OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF THE RESULTS
      OF THE RESEARCH. 

    


    17. LIMITATION
      OF LIABILITY

    


    IN
      NO
      EVENT SHALL HARVARD BE LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL OR
      CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF
      PROFITS OR EXPECTED SAVINGS OR OTHER ECONOMIC LOSSES, OR FOR INJURY TO PERSONS
      OR PROPERTY) ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR ITS SUBJECT
      MATTER, REGARDLESS OF WHETHER HARVARD KNOWS OR SHOULD KNOW OF THE POSSIBILITY
      OF
      SUCH DAMAGES. HARVARD’S
      AGGREGATE LIABILITY FOR ALL DAMAGES OF ANY KIND RELATING TO THIS AGREEMENT
      OR
      ITS SUBJECT MATTER SHALL NOT EXCEED THE AMOUNT PAID BY COMPANY TO HARVARD UNDER
      THIS AGREEMENT. THE FOREGOING EXCLUSIONS AND LIMITATIONS SHALL APPLY TO ALL
      CLAIMS AND ACTIONS OF ANY KIND, WHETHER BASED ON CONTRACT, TORT (INCLUDING
      BUT
      NOT LIMITED TO NEGLIGENCE), OR ANY OTHER GROUNDS. 

    


    18.
      INDEMNIFICATION

    


    18.1 COMPANY
      shall indemnify, defend and hold harmless HARVARD and its current or former
      directors, governing board members, trustees, officers, faculty, medical and
      professional staff, employees, students, and agents and their respective
      successors, heirs and assigns (collectively, the “INDEMNITEES”) from and against
      any claim, liability, cost, expense, damage, deficiency, loss or obligation
      or
      any kind or nature (including, without limitation, reasonable attorney’s fees
      and other costs and expenses of litigation) (collectively, “CLAIMS”), based
      upon, arising out of, or otherwise relating to this Agreement, including without
      limitation any cause of action relating to product liability concerning any
      product, process, or service made, used or sold pursuant to any right or license
      granted under this Agreement. Neither COMPANY nor HARVARD shall settle any
      CLAIM
      without the prior written consent of the other, which consent shall not be
      unreasonably withheld.

    


    18.2 COMPANY
      shall, at its own expense, provide attorneys reasonably acceptable to HARVARD
      to
      defend against any actions brought or filed against any INDEMNITEE hereunder
      with respect to the subject of indemnity contained herein, whether or not such
      actions are rightfully brought. 

    


    18.3 Beginning
      at the time any such product, process or service is being commercially
      distributed or sold (other than for the purpose of obtaining regulatory
      approvals) by COMPANY, or by a SUBLICENSEE or agent of COMPANY, COMPANY shall,
      at its sole cost and expense, procure and maintain commercial general liability
      insurance in amounts not less than $5,000,000 per incident and $5,000,000 annual
      aggregate and naming the INDEMNITEES as additional insureds. During clinical
      trials of any such product, process or service, COMPANY shall, at its sole
      cost
      and expense, procure and maintain commercial general liability insurance in
      such
      equal or lesser amount as HARVARD shall require, naming the INDEMNITEES as
      additional insureds. Such commercial general liability insurance shall provide
      

    


    (a)
      product liability coverage and 

    


    (b)
      broad
      form contractual liability coverage for COMPANY’s indemnification under this
      Agreement. 

    


    18.4 If
      COMPANY elects to self-insure all or part of the limits described above in
      Paragraph 18.3 (including deductibles or retentions which are in excess of
      $250,000 annual aggregate) such self-insurance program must be acceptable to
      HARVARD and the Risk Management Foundation of the Harvard Medical Institutions,
      Inc. in their sole discretion. The minimum amounts of insurance coverage
      required shall not be construed to create a limit of COMPANY’s liability with
      respect to its indemnification under this Agreement. 

    


    18.5 COMPANY
      shall provide HARVARD with written evidence of such insurance upon request
      of
      HARVARD. COMPANY shall provide HARVARD with written notice at least fifteen
      (15)
      days prior to the cancellation, non-renewal or material change in such
      insurance; if COMPANY does not obtain replacement insurance providing comparable
      coverage within such fifteen (15) day period, HARVARD shall have the right
      to
      terminate this Agreement effective at the end of such fifteen (15) day period
      without notice or any additional waiting periods. 

    


    18.6 COMPANY
      shall maintain such commercial general liability insurance beyond the expiration
      or termination of this Agreement during 

    


    (a)
      the
      period that any product, process, or service, relating to, or developed pursuant
      to, this Agreement is being commercially distributed or sold by COMPANY or
      by a
      SUBLICENSEE or agent of COMPANY and 

    


    (b)
      a
      reasonable period after the period referred to in (a) above
      which in no event shall be less than fifteen (15) years.

    


    19.
      USE OF NAMES

    


    Neither
      party shall use the other party’s name or insignia, or any adaptation of them,
      and COMPANY shall not use the name of the PRINCIPAL INVESTIGATOR or other
      HARVARD researcher(s), in any advertising, promotional or sales literature,
      including without limitation any press release or any document employed to
      obtain funds, without the prior written approval of the other party. This
      restriction shall not apply to (i) annual- or other periodical reports prepared
      by either party in the normal course of business, and (ii) to any information
      required by law to be disclosed to any governmental entity. In addition, the
      parties may acknowledge COMPANY’s support for the investigations being pursued
      under this Agreement. In any such statement, the relationship of the parties
      shall be accurately and appropriately described.

    


    20.
      SECURITY INTERESTS

    


    COMPANY
      shall not enter into any agreement under which COMPANY grants to- or otherwise
      creates in any third party a security interest in this Agreement or any of
      the
      rights granted to COMPANY herein. Any such interest purported
      or attempted to be created in violation of the terms of this Article 20 shall
      be
      null and void and of no legal effect. 

    


    21.
      ASSIGNMENTS

    


    Without
      the prior written consent of the other party in each instance, neither party
      shall assign this Agreement or any of the rights granted- or obligations assumed
      hereunder to any third party, whether voluntarily or involuntarily, by operation
      of law or otherwise. Any assignment purported or attempted to be made in
      violation of the terms of this Article 21 shall be null and void and of no
      legal
      effect. 

    


    22.
      NOTICES

    


    Any
      notices to be given hereunder shall be sufficient if signed by the party (or
      party’s attorney) giving same and either 

    


    (a)
      delivered in person, 

    


    (b)
      mailed certified mail return receipt requested, 

    


    (c)
      made
      by overnight delivery, or 

    


    (d)
      faxed
      to other party if
      the
      sender has evidence of successful transmission and if
      the
      sender promptly sends the original by ordinary mail, in any event to the
      following addresses: 

     

    If
      to
      COMPANY: 

    


    DNAPrint
      Genomics, Inc.

    900
      Cocoanut Avenue

    Sarasota,
      FL 34231

    


    Attn.:
      Richard Gabriel

    


    facsimile:
      (941) 921-2821

    


    with
      a
      copy to: 

    


    Thomas
      P.
      McNamara, P.A.

    2909
      Bay
      to Bay Blvd.

    Suite
      309

    Tampa,
      FL
      33629

    


    Attn:
      Robert C. Sanchez, Esq.

    


    facsimile:
      (813) 837-1532

    


    If
      to
      HARVARD: 

    


    Office
      of
      Technology Development

    Harvard
      Medical School 

    Gordon
      Hall, Room 414 

    25
      Shattuck Street 

    Boston,
      MA 02115 

    


    Attn.:
      Director

     

    facsmile:
      (617) 432-2788 

    


    with
      a
      copy to:

    


    Office
      of
      Technology Development

    Harvard
      University

    Holyoke
      Center 727

    1350
      Massachusetts Avenue

    Cambridge,
      Massachusetts 02138

    


    Attn.:
      Chief Technology Development Officer

    


    facsimile:
      (617) 495-9568

    


    By
      such
      notice either party may change their address for future notices. 

    


    Notices
      delivered in person shall be deemed given on the date delivered. Notices mailed
      shall be deemed given on the date postmarked on the envelope. Notices sent
      by
      overnight carrier shall be deemed given on the date received by such carrier,
      as
      indicated on the shipping manifest or waybill. Notices sent by fax shall be
      deemed given on the date faxed. 

    


    23.
      MISCELLANEOUS

    


    23.1 The
      interpretation and application of the provisions of this Agreement shall be
      governed by the laws of the Commonwealth of Massachusetts and the United States
      of America. Sole jurisdiction is granted to the competent courts in Boston,
      Massachusetts. 

    


    23.2 COMPANY
      shall comply with all applicable laws and regulations. The transfer of certain
      commodities and technical data is subject to United States laws and regulations
      controlling the export of such commodities and technical data, including all
      Export Administration Regulations of the United States Department of Commerce.
      These laws and regulations among other things prohibit or require a license
      for
      the export of certain types of technical data to certain specified countries.
      COMPANY hereby agrees and gives written assurance that it will comply with
      all
      United States laws and regulations controlling the export of commodities and
      technical data, that it will be solely responsible for any violation of such
      by
      COMPANY and/or any SUBLICENSEE(s), or by any AFFILIATE(s) of either, and that
      it
      will defend and hold HARVARD harmless in the event of any legal action of any
      nature occasioned by such violation. 

    


    23.3 COMPANY
      and/or any SUBLICENSEE(s), as appropriate, shall obtain all regulatory approvals
      required for the manufacture and sale of LICENSED PRODUCTs.

    


    23.4 COMPANY
      and/or any SUBLICENSEE(s), as appropriate, shall utilize appropriate patent
      and/or trademark marking on LICENSED PRODUCTs. 

    


    23.5 Notwithstanding
      anything in this Agreement to the contrary, neither party shall be deemed to
      be
      in breach of its obligations under this Agreement as a result of non-performance
      or partial performance of any of its obligations under this Agreement due to
      any
      cause beyond the non-performing party’s reasonable control, including any (i)
      act of God, (ii) failure or shortage of power supplies, (iii) fire, (iv) strike,
      lock-out, trade dispute or other labor disturbance, wherein such strike,
      lockout, dispute or disturbance does not involve employees of the non-performing
      party, (v) the act or omission of Government or governmental authority,
      including but not limited to the FDA (including FDA recommendations relating
      to
      market withdrawals), public telecommunications operators or administrative
      or
      other competent authority, (vi) war, military operations or public riot, or
      (vii) delay or failure in manufacture, production or supply by third parties
      of
      any goods or services, wherein alternate sources of such goods or services
      are
      not reasonably available to the non-performing party.

    


    23.6 COMPANY
      shall register or record this Agreement as is required by law or regulation
      in
      any country where the license is in effect. 

    


    23.7 During
      the period of exclusivity of this license in the United States, COMPANY shall
      cause any LICENSED PRODUCT produced for sale in the United States to be
      manufactured substantially in the United States.

    


    23.8 This
      Agreement shall not constitute, create, or in any way be interpreted as a joint
      venture, partnership, or formal business organization of any kind. 

    


    23.9 Waiver
      by
      either party of any obligation under this Agreement shall not be construed
      as
      waiver of any such subsequent or other obligation of the party hereunder.


    


    23.10 Should
      a
      court of competent jurisdiction hold any provision of this Agreement to be
      invalid, illegal, or unenforceable, and such holding is not reversed on appeal,
      it shall be considered severed from this Agreement. All other provisions, rights
      and obligations shall continue without regard to the severed provision, provided
      that the remaining provisions of this Agreement are in accordance with the
      intention of the parties. 

    


    23.11 This
      Agreement constitutes the entire understanding between the parties and neither
      party shall be obligated by any condition or representation other than those
      expressly stated herein or as may be subsequently agreed to in a writing signed
      by the duly-authorized representative of each of the parties. 

     

    23.12 This
      Agreement shall be binding upon the respective successors, legal representatives
      and assignees of HARVARD and COMPANY. 

    


    23.13
      This Agreement may be executed in multiple counterparts, each
      of
      which shall be deemed an original, but all of which, taken together, shall
      constitute one and the same instrument. 

    


    


    IN
      WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
      by
      their duly authorized representatives. 

     

    


    PRESIDENT
      AND FELLOWS    DNAPRINT
      GENOMICS, INC.

    OF
      HARVARD COLLEGE

     

    /s/
      Isaac
      Kohlberg                                                         
/s/ Richard
      Gabriel                                                 

    Isaac
      Kohlberg                                                               Richard
      Gabriel

    Chief
      Technology Development
      Officer                   
 President 

    Harvard
      University                                                        
DNA Print Genomics, Inc.

    


     

    _____________________                       
     _____________________ 

    Date                                                                               
       Date

    


     

    


     

     

    I,
      the
      undersigned, hereby confirm that I have read the Agreement, that its contents
      are acceptable to me and that I will act in accordance with its
      terms.

     

    


    


    /s/
      Jose A. Halperin

    Jose
      A.
      Halperin

    


    


    ______________________

    Date


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    Appendix
      A

    RESEARCH
      PLAN

    


    Studies
      of the diagnostic use of glycated CD59:

    


    
      	1)  	
              As
                a surrogate marker of vascular complications of diabetes.
                

            


    

    
      	2)  	
              As
                a marker for early detection of impaired glucose tolerance
                (IGT)

            


    

    


    The
      work
      described herein will be carried out at the Laboratory of Translational
      Research, Harvard Medical School and will be sponsored in part by DNAPrint
      Genomics, Inc. pursuant to this Agreement. The objectives of this RESEARCH
      PLAN
      are: 

    


    


    A)
      Generating the basic tools for an ELISA-based assay that will allow the
      demonstration of proof-of-concept through analysis of clinical samples generated
      under NIH award number RFA-DK 02-016, which covers the funding period September
      30, 2002 through September 29, 2007 and which will be supplemented by support
      provided by DNAPrint under this Agreement. 

    


    B)
      Optimization of reagents and method development. In an effort to shorten time
      needed for entering preclinical development we will work simultaneously on
      two
      above mentioned objectives.

    


    


    Toward
      the goal of meeting the above objectives, the following research activities
      are
      planned to be performed under this Agreement, with times measured from the
      EFFECTIVE DATE:

    


    A)
      Generating the basic tools for an ELISA-based assay that will allow the
      demonstration of proof-of-concept through analysis of clinical samples in the
      NIH sponsored grant.

    


    I.
        Develop
      an ELISA-type assay for the detection of glycated CD59 in body fluids
      (duration
      10 to 12 months, within months 1 to 12).

    


    
      	1.  	
              Generation
                of a monoclonal antibody (mouse or rabbit) that recognizes specifically
                glycated CD59 in the body fluids (urine and/or plasma and/or saliva)
                for
                use in an ELISA-type assay. 

            


    

    
      	2.  	
              Generation
                of a monoclonal antibody that recognizes specifically total CD59
                (total
                means glycated and non glycated) to be used as capture antibody in
                an
                ELISA type assay.

            


    

    
      	3.  	
              Establishment
                and validation of the appropriate method to quantitatively measure
                the
                glycated CD59/total CD59 ratio in body fluids.


            


    

    


    II.
      Analyze a clinical study on glycated CD59 as a surrogate marker of diabetic
      complications (duration
      10 to 12 months, within months 8 to 20)

    


    Clinical
      work is aimed at determining the diagnostic value of glycated CD59,
      including:

    


    1.
       Correlation
      between glycated CD59 and hemoglobin A1C in diabetic patients.

    2.
       As
      a
      marker of diabetic nephropathy.

    3.
       To
      identify the population at risk of developing diabetic nephropathy.

    
      	 	
              4.
                

            	
              As
                a marker of the population at risk of developing accelerated
                cardiovascular diseases as a consequence of
                diabetes.

            


    

    5.
       To
      identify the population with IGT.

    


    B)
      Optimization of reagents and method development. In an effort to shorten time
      needed for entering preclinical development we will work simultaneously on
      two
      above mentioned objectives.

     

    I.
      Antibody Selection and Basic Characterization (duration
      14 to 18 months, within months 6 to 24)

    


    
      	1.  	
              Determination
                of saturation curves.

            


    

    
      	2.  	
              Determination
                of specificity.

            


    

    
      	3.  	
              Determination
                of affinity constants.

            


    

    
      	4.  	
              Development
                of quality control protocols to establish reproducibility of
                results.

            


    

    For
      these
      purposes we will use secondary antibodies with traditional ELISA-compatible
      detection systems

    


    II.
      Peptide Immunogens Optimization (duration
      10 to 14 months, within months 10 to 24)

    


    For
      research purposes, the Harvard team has used as immunogens the 14-amino acid
      synthetic peptide hCD5937-50
      and its
      glycated form. In an effort to raise higher affinity and specificity antibodies
      for commercial utilization, we may need to optimize the immunogenic CD59
      peptides.

    


    Synthesis
      of immunogenic peptides of different length and presentations derived from
      different epitopes in human CD59: 

    


    
      	1.  	
              the
                active non-glycated site,

            


    

    
      	2.  	
              the
                active glycated site, and 

            


    

    
      	3.  	
              an
                immunogenic sequence that does not overlap with the active site.
                

            


    

    


    Synthesis
      of non-glycated immunogens will be carried out by BioSynthesis,
      Lewisville, TX, or Advanced
      ChemTech,
      Leuisville, Kentucky.

    


    III.
      Monoclonal Antibody Development (duration
      10 to 14 months, within months 17 to 30)

    


    A
      menu of
      monoclonal anti-bodies will be developed to select the optimal based on
      affinity, specificity, and stability of the clone. These antibodies will
      recognize specifically glycated CD59 in body fluids (urine and/or plasma and/or
      saliva):

    


    
      	1.  	
              Rabbit
                Monoclonal Antibodies against different immunogens will be developed
                with
                Epitomics,
                in Burlingame, California, using their proprietary Rabbit fusion
                partner
                cells.

            


    

    
      	2.  	
              Mouse
                monoclonal antibodies will be developed at Neoclone,
                in Madison, Wisconsin using their exclusive AML-MYC retrovirus
                transfection method. 

            


    

    


    IV.
      Assay
      Development and Optimization as a Research Tool (duration
      10 to 12 months, during months 24 to 36)

    


    1.
      Selection of either primary or secondary antibody-based assay

    2.
      Assay
      configuration (immobilization, blocking, bound from free separation,
      capture-detection antibody pair selection, enzyme/substrate selection, and
      incubation conditions). 

    3.
      Optimization of detection system for maximal sensitivity and
      reproducibility

    4.
      Establishing standard curves for glycated- and non-glycated CD59 using the
      immunogens as standards

    


    Efforts
      outlined under entries II-IV aim to continue and address issues important to
      understanding in detail the biochemistry, physioogical and pathophysiological
      role of CD59 glycation in different sites. In addition, it is hoped that these
      efforts will provide a timely back-up for the different components of the
      immunoassay namely, antigen, antibody and analyzers and may identify new
      applications of this immunoassay. In the event that DNAPrint faces technical
      problems in performance of the work detailed in the Product Development Plan,
      we
      hope to be able to provide expertise and optional components with which they
      might reconfigure the immunoassay.


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    Appendix
      B

    Research
      Sponsorship Payment Schedule

    


    Amounts
      owed by COMPANY to HARVARD pursuant to this Agreement for support of the
      RESEARCH are payable on the following schedule and in the amounts specified
      therein:

    


    (i) two-hundred-sixteen-thousand-two-hundred-thirty-three
      dollars ($216,233) upon execution of this Agreement;

    


    (ii) two-hundred-sixteen-thousand-two-hundred-thirty-three
      dollars ($216,233) on- or before the date three (3) months after the EFFECTIVE
      DATE;

    


    (iii) two-hundred-sixteen-thousand-two-hundred-thirty-three
      dollars ($216,233) on- or before the date six (6) months after the EFFECTIVE
      DATE;

    


    (iv) two-hundred-sixteen-thousand-two-hundred-thirty-two
      dollars ($216,232) on- or before the date nine (9) months after the EFFECTIVE
      DATE;

    


    (v) two-hundred-six-thousand-ninety-seven
      dollars ($206,097) on- or before the first anniversary of the EFFECTIVE
      DATE;

    


    (vi) two-hundred-six-thousand-ninety-seven
      dollars ($206,097) on- or before the date three (3) months after the first
      anniversary of the EFFECTIVE DATE;

    


    (vii) two-hundred-six-thousand-ninety-seven
      dollars ($206,097) on- or before the date six (6) months after the first
      anniversary of the EFFECTIVE DATE;

    


    (viii) two-hundred-six-thousand-ninety-six
      dollars ($206,096) on- or before the date nine (9) months after the first
      anniversary of the EFFECTIVE DATE;

    


    (ix) two-hundred-eleven-thousand-three-hundred-forty-six
      dollars ($211,346) on- or before the second anniversary of the EFFECTIVE
      DATE;

    


    (x) two-hundred-eleven-thousand-three-hundred-forty-five
      dollars ($211,345) on- or before the date three (3) months after the second
      anniversary of the EFFECTIVE DATE;

    


    (xi) two-hundred-eleven-thousand-three-hundred-forty-five
      dollars ($211,345) on- or before the date six (6) months after the second
      anniversary of the EFFECTIVE DATE; and

    


    (xii) two-hundred-eleven-thousand-three-hundred-forty-five
      dollars ($211,345) on- or before the date nine (9) months after the second
      anniversary of the EFFECTIVE DATE, 


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    Appendix
      C

    Budget

    


    


    


    


    


    <see
      attached>


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    Appendix
      D

    Product
      Development Plan

    


    I. Overview

    


    Diagnostic
      use of glycated CD59:

    


    As
      a
      surrogate marker of vascular complications of diabetes; and

    As
      a
      marker for early detection of impaired glucose tolerance (IGT)

    


    This
      Product Development Plan takes into account the RESEARCH PLAN of Appendix B
      of
      this Agreement.

     

    The
      work
      described herein will be the responsibility of COMPANY. It will be carried
      out
      by COMPANY and/or a SUBLICENSEE(s), or outsourced to a third partner of either.
      Its essential components are:

    


    1.  Preclinical
      Development

    


    To
      develop a robust, sensitive, reproducible, and cost-effective prototype ELISA
      assay for the determination of glycated CD59 in body fluids in general and
      in
      urine in particular. The company will be responsible for developing these
      methods in compliance with FDA’s regulatory guidelines for the development of in
      vitro diagnostic (IVD) tests of this type. 

    


    2.  Clinical
      Trials

    


    Use
      of
      the prototype ELISA assay of part I, above, in conducting clinical trials that
      will demonstrate the clinical utility of this immunoassay for the
      above-mentioned applications, following clinical research regulatory guidelines
      for this type of diagnostic test.

    


    3. Supervision,
      Consultants, Manufacturing, Regulatory Process And Commercial
      Development

    


    (a)
      To
      prepare and file for approval the optimized ELISA assay, an IVD, as a medical
      device to the FDA. 

    


    (b)
      To
      develop a commercialization strategy for manufacturing and marketing the
      diagnostic test. 

    


    This
      Product Development Plan outlines in a very schematic manner the main activities
      that will be performed to translate results generated in the RESEARCH PLAN
      into
      an FDA-approved diagnostic kit for the indication mentioned above. In addition,
      sets forth the key steps that will be performed in order to bring this
      diagnostic kit to market.

    



    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    II. Development
      Timetable
      (measured from the EFFECTIVE DATE).

    


    1. Preclinical
      Development

    


    (a) Develop
      a
      prototype ELISA assay for the detection of glycated CD59 in body fluids,
      primarily in urine.

    


    (i) Selection
      and Characterization (duration 8-12 months, within months 12-24)


    


    A.Selection
      of either primary or secondary antibody-based 

    assay;
      

    


    
      	 	 	 	
              B.

            	
              Assay
                configuration including general purpose reagents (GPR) and other
                components of the diagnostic kit such as, immobilization, blocking,
                bound
                from free separation, capture-detection antibody pair selection,
                enzyme/substrate selection, and incubation
                conditions;

            


    

    


    C. Assay
      optimization, for maximal sensitivity and 

    reproducibility;

    


    D. Linear
      range of assay;

    


    E. Determination
      of saturation curves;

    


    F. Determination
      of specificity;

    


    
      	G.  	
              Determination
                of affinity constants;

            


    

    


    
      	H.  	
              Establishing
                standard curves for glycated- and non-glycated CD59 using the immunogens
                as standards.

            


    

    


    (ii) Formulation
      of the Gold Standard (duration 6-12 months, within months
      14-26)

    


    
      	 	 	
              A.

            	
              Optimize
                method to generate pure human CD59 for assay kit (CHO cells vs
                baculovirus); 

            


    

    


    B. Optimization
      of a glycation method for glycated CD59 

    standard;

    


    
      	 	 	
              C.

            	
              Characterization
                and quantification of glycated- and non-glycated CD59 standards by
                mass-spec characterization;

            


    

    


    
      	 	 	
              D.

            	
              Preparation
                of human CD59-depleted serum to control for matrix
                effects.

            


    

    


    (iii) Securing
      the supply of reagents included in the prototype ELISA assay and experimental
      kit production (duration 10-12 months, within months 16-28)

    


    
      	 	 	
              A.

            	
              Establish/outsource
                the large-scale production of antibodies required and develop quality
                control protocols for these products (incoming component validation);
                

            


    

    


    
      	 	 	
              B.

            	
              If
                appropriate, in-license antibodies needed for the prototype ELISA
                assay;

            


    

    


    
      	 	 	
              C.

            	
              Establish/outsource
                the assembly of the experimental ELISA kit for the clinical studies
                and
                develop a distribution/storage and testing
                instructions;

            


    

    


    D. Establish
      QA procedures for testing production version of 

    kit;
      and

    


    E. Undertake
      failure analysis.

    


    (b) Assay
      Validation (duration
      4 to 6 months, within months 26 to 32)

    


    (i) Compliance
      of assay with the Clinical Laboratory Standards Institute (CLSI) guidelines.
      Establish parameters such as sensitivity, coefficients of variation for both
      within-day, day-to-day and within-run precision;

    


    (ii) Initiate
      stability studies (accelerated and real-time). 

    


    2. Clinical
      Trials

     

    (a) Study
      Design (duration
      2 to 4 months, within months 28 to 32)

    


    i) Setting-up
      objectives and criteria for selecting population, sites, size and
      duration;

    


    (ii) Establish
      collection precautions (e.g. patient preparation, frequency, handling and
      storage);

    


    (iii) Setting
      end-point criteria; and

    


    (iv) Staffing
      with study coordinators and a statistician.

    


    (b) Clinical
      Trials and Results Analysis (duration
      10 to 12 months, within months 32 to 44)

    


    (i) Statistical
      evaluation;

    


    (ii) Establish
      performance characteristics;

    


    (iii) Specificity,
      cross-reactivity/interference studies;

    


    (iv) Correlate
      results with HbA1c and other clinical parameters;

    


    (v) Establish
      reference ranges; and

    


    (vi) Identify
      limitations of the IVD test.   

    


    3.  Supervision,
      Consultants, Manufacturing, Regulatory Process And Commercial
      Development

    


    (a) Within
      3
      months, retain appropriate consultant in diagnostic test development in general
      and immunoassay development in particular;

    


    (b) Within
      6
      months, negotiate a tentative contract with mAb supplier;

    


    (c) Within
      4
      to 6 months, hire appropriate scientific personnel, e.g. expert(s) in immunology
      assay development to work closely with the research laboratory in preparation
      for the technology transfer and preclinical development. (Dr. Barbara Handelin
      has been hired as Director of Diagnostics at DNAPrint Inc.);

    


    (d) Within
      6
      to 8 months, establish a Scientific Advisory Board to monitor the progress
      of
      the Harvard (LTR)-DnaPrint Genomics Inc. sponsored research;

    


    (e) Within
      14
      to 18 months, submit production plan for kits needed for the clinical
      trials;

    


    (f) Within
      18
      to 24 months, submit detailed Development Plan;

    


    (g) Within
      30
      to 32 months, start the Clinical Trial required for FDA approval;

    


    (h) Within
      30
      to 34 months, generate a tentative Production Plan;

    


    (i) Prepare
      the documentation for filing and file with the FDA:

    


    A. Within
      26
      months, pre-IDE - informal pre-submission process;

    


    B. Within
      30
      months, investigational device exemption (IDE); and

    


    C. Within
      44
      months, if needed, submit a Premarket notification 510(k)]. Review of a 510(k)
      is based on the evaluation of the analytical performance characteristics of
      the
      new device compared to the predicate and includes data such as:

    


    
      	·  	
              the
                bias or inaccuracy of the new device;


            


    

    


    
      	·  	
              the
                imprecision of the new device;

            


    

    


    
      	·  	
              the
                analytical specificity and
                sensitivity;

            


    

    


    
      	·  	
              substantial
                equivalency (SE) of a new device to a predicate
                device;

            


    

    


    
      	·  	
              quality
                control (QC) - monitors the analytical performance of the entire
                test
                system or only one aspect of it;
                and

            


    

    


    
      	·  	
              GMP
                requirements, part of the Quality System Regulations, which require
                that
                the manufacturer will have in place a quality system for the design,
                manufacture, packaging, labeling, storage, installation, and servicing
                of
                finished medical devices intended for commercial distribution in
                the
                United States.