ex10-1.htm


    
      

    

    Exhibit 10.1

    
      


       

      LICENSE
AGREEMENT

       

      This
License Agreement (“Agreement”) is
entered into as of January 30, 2009 (the “Effective Date”) by
and between Health Discovery
Corporation, a Georgia corporation having its principal place of business
at 2 East Bryan Street, Suite #601, Savannah, GA 31401 (“HDC”), and Abbott Molecular Inc., a
Delaware corporation having its principal place of business at 1300 East Touhy
Avenue, Des Plaines, IL 60018 and its Affiliates (as defined below)
(collectively “Abbott”).

      


      WHEREAS,
HDC and Abbott each desires to establish a collaboration and license
relationship between them.

       

      NOW,
THEREFORE, the parties agree as follows:

       

      Article 1 –
Definitions

       

      The
following capitalized terms shall have the following meanings:

      


      
        	
                1.1

              	
                “Affiliate” of a
      party shall mean a corporation or other business entity controlled by,
      controlling or under common control with, such party.  For this
      purpose, control of a corporation or other business entity shall mean
      direct or indirect beneficial ownership of more than fifty percent (50%)
      of the voting interest in, or a greater than fifty percent (50%) interest
      in the equity of, such corporation or other business
    entity.

              
	 	 
	
                1.2

              	
                “Analyte Specific
      Reagent” or "ASR" shall mean
      the finished, packaged and labeled assembly of a Licensed Product in the
      form of assay components, purchased by commercial laboratories to test for
      the detection and/or quantification of an analyte under the United States
      Code of Federal Regulations, Title 21, Paragraphs 809.10, 809.30, 864.4010
      and 864.4020.

              
	 	 
	
                1.3

              	
                “Change of
      Control” means (a) the acquisition of a party by another
      entity by means of any transaction or series of related transactions
      (including, without limitation, any reorganization, merger or
      consolidation) that results in the transfer of fifty percent (50%) or more
      of the voting securities of such party, (b) a sale of all or
      substantially all of the assets of a party, or (c) the acquisition by any
      person or other entity (other than a party and its Affiliates or employee
      benefit plans), including any person or group as defined in Paragraphs
      3(a)(9) and 13(d), 14(d) and Rule 13d-5 of the Exchange Act of more than
      fifty percent (50%) of the voting securities of such party; provided,
      however, that no Change in Control shall occur by reason of (i) an initial
      public offering, or (ii) a reorganization, merger, consolidation or sale,
      the sole purpose of which is to change the state of a party’s
      incorporation or to create a holding company that will be owned in
      substantially the same proportions by the persons who held such party’s
      securities immediately before such
transaction.

              


      

      

         

         

        Confidential
treatment has been requested pursuant to Rule 24b-2 promulgated under the
Securities Exchange Act of 1934.

        This
exhibit has been provided to the Securities and Exchange Commission in
unredacted form.

      

      
        
          
          

        

        
          1

          
            

          

        

        
          
          

        

      

       

      
        	
                1.4

              	
                "Collaboration"
      shall mean that term as it is defined in Paragraph 2.1.

              
	 	 
	
                1.5

              	
                "Collaboration Term" means
      the time period commencing upon the Effective Date and continuing until
      the first to occur of the date three (3) years after such date or
      completion of the research contemplated by the FDA Submission
      Plan.

              
	 	 
	
                1.6

              	
                “Confidential
      Information” shall mean the terms and conditions of this Agreement,
      and all information developed by the parties pursuant to the Collaboration
      and all other disclosed by one party to the other in writing and clearly
      marked “Confidential” or, if communicated orally, specified as
      confidential at the time of disclosure and confirmed in writing within
      thirty (30) days after such oral communication and clearly marked
      “Confidential”; provided, however, that Confidential Information shall not
      include information that:

              


      

       

      1.6.1                   is
already in the public domain, or on or after the Effective Date comes into the
public domain other than as a result of the wrongful disclosure by either party
to this Agreement;

       

      1.6.2                   is
already known to the recipient as evidenced by prior-dated written documents
already in the recipient’s possession, which documents were not furnished by the
other party to this Agreement;

       

      1.6.3                   is
disclosed to the other party by any third party having the right to make that
disclosure;

       

      1.6.4                   is
required by law to be disclosed in connection with the registration or filing
with, or approval or certification from any governmental agency or body
including, without limitation, the United States Food and Drug Administration,
provided that the information is not the inventive subject matter of an
unpublished patent application, or is required to be disclosed to comply with
the terms of contractual relationships and provided that each party undertakes
to use its best endeavors to maintain to the maximum extent possible and to make
any third parties to whom such information is disclosed aware of the
confidentiality of such information; or

       

      1.6.5                   can
be proven to have been independently developed by the party receiving the
information under this Agreement without the aid, application or use in any way
of Confidential Information received from the disclosing party.

       

      
        	 
      1.7	
                "FDA Submission
      Plan" shall mean the plan for the Collaboration attached hereto as
      Exhibit
C.

              


      

       

      
        	
                1.8

              	
                “Field” shall
      mean the use of a molecular diagnostic assay using the Licensed Prostate
      Markers in in
      vitro diagnostics relating to prostate cancer, including the
      detection of the presence or risk of prostate cancer, or the selection of
      therapy, or in a Research Application related to prostate
      cancer.

              


      

       

      
        
          
          

        

        
          2

          
            

          

        

        
          
          

        

      

       

      
        	
                1.9

              	
                “First Commercial
      Sale” or “FCS” shall mean
      the first time, except in the context of a clinical trial, Abbott
      transfers title of Licensed Product to an independent third party for
      monetary consideration or provides a Diagnostic Test Service using
      Licensed Product to an independent third party for monetary
      consideration.

              
	 	 
	
                1.10

              	
                “IVD” shall mean
      an assay which claims an intended use, and is approved by a governmental
      regulatory body for sale, as an in vitro diagnostic
      kit, and which is not an ASR or labeled for “Research Use Only”, including
      an assay that is CE Marked.

              
	 	 
	
                1.11

              	
                "Joint
      Inventions" shall mean all new inventions jointly made, by the
      parties as part of the Collaboration.

              
	 	 
	
                1.12

              	
                “Joint Patent Rights” shall mean all patents
      and/or patent applications for Joint Inventions.

              
	 	 
	
                1.13

              	
                “Know-How” shall
      mean, without limitation, all trade secrets and technology, as well as
      non-patented, non-public inventions, improvements, discoveries, formulae,
      processes, data, and reagents discovered or developed by HDC, and owned or
      legally acquired by or licensed to HDC without restriction on
      dissemination and licensing, before or during the Collaboration Term,
      whether patentable or not, and which relate to the Field and the use of
      Licensed Prostate Markers in the Field.

              
	 	 
	
                1.14

              	
                “Laboratory Developed
      Test” shall mean the provision of test results from use of a
      Licensed Product or Licensed Products to assay a patient urine or prostate
      biopsy sample, to be entered into the medical history record of the
      patient providing the urine or prostate biopsy sample.

              
	 	 
	
                1.15

              	
                “Licensed
      Product(s)” shall mean finished products consisting of one or more
      nucleic acid detection reagents for the assay of one or more Prostate
      Marker(s) for use in the Field, the manufacture, use, sale or importation
      of which, but for the rights granted herein, would infringe a Valid Claim
      within Patent Rights.

              
	 	 
	
                1.16

              	
                “Net Sales”
      shall mean:

              


      

       

      1.16.1                  The
amount charged for Licensed Product to a non-Affiliated third party, less a lump
sum of five percent (5%) to cover all usual deductions, such as cash discounts
allowed and taken; amounts for transportation, insurance or shipping; amounts
repaid, credited or rebated for rejections or returns of Licensed Product; and
taxes and duties.  Net Sales shall not include Licensed Products used
for clinical trials, research, evaluation of customer acceptance, charitable or
humanitarian donations, commercial samples or other noncommercial uses as long
as Abbott receives no financial compensation for such use or
donation.

       

      
        
          
          

        

        
          3

          
            

          

        

        
          
          

        

      

       

      1.16.2                  If
the price of Licensed Product sold by Abbott or its Affiliates is increased to
include an amount to cover the amortized cost of an instrument system or other
equipment or the cost of supplying maintenance for such system or equipment
under a Reagent Agreement Plan, Reagent Rental Plan or other successor similar
plan (collectively referred to as “RAP”), the Net Sales
for such Licensed Product shall be reduced an additional ten percent
(10%).

       

      1.16.3                  In
the event that Abbott or its Affiliates sells Licensed Product to a third party
together with one or more other products (each a “Combination
Product”), the Net Sales with respect to such Combination Product shall
mean the price of such Combination Product billed to customers, less the
allowances and adjustments above, multiplied by a percentage equal to the
fraction A/(A+B), where A is the stand-alone market value of the Licensed
Product and B is the stand-alone market value of the other
product(s).

       

      1.16.4                  The
amount charged for Laboratory Developed Test to a non-Affiliated third party,
less (i) any shortfall in the reimbursement amount from the amount charged, and
(ii) a lump sum of five percent (5%) to cover all usual deductions, such as cash
discounts allowed and taken; amounts for transportation, insurance or shipping;
amounts repaid, credited or rebated for rejections or returns of Licensed
Product; and taxes and duties.  Net Sales shall not include Laboratory
Developed Tests used for clinical trials, research, evaluation of customer
acceptance, charitable or humanitarian donations, commercial samples or other
noncommercial uses as long as Abbott receives no direct financial compensation
for such use or donation.

       

      
        	
                1.17

              	
                “Patent Rights”
      shall mean:

              


      

       

      1.17.1                  all
patent(s) and/or patent applications listed in Exhibit A hereto that are owned
or controlled by HDC as of the Effective Date that are applicable to the use of
the Licensed Prostate Markers in the Field;

       

      1.17.2                  any
additional patent and/or patent application(s) which, after the Effective Date
and during the Collaboration Term, are solely owned or controlled by HDC and are
free to be licensed and/or sublicensed by HDC and that are applicable to the
Field (for the avoidance of doubt, such additional patent and/or patent
application(s), including, without limitation, (a) patents and applications
acquired or licensed by HDC from third parties that are applicable to the Field,
and (b) such patents and applications covering New Inventions owned solely by
HDC that are applicable to the Field; and

       

      
        
          
          

        

        
          4

          
            

          

        

        
          
          

        

         

      

      1.17.3                  any
and all divisions, continuations, continuations-in-part, renewals, reissues,
extensions and supplemental protection certificates of any of the patent
applications and patents described in the foregoing clauses of this Paragraph
1.17.

       

      
        	
                1.18

              	
                 “Licensed
      Prostate Markers” shall mean one or
      more of the nucleic acid detection targets identified in Exhibit B that
      are present in a urine or prostate biopsy sample useful for the diagnostic
      identification, classification, therapeutic response prediction or
      monitoring of prostate cancer.

              
	 	 
	
                1.19

              	
                "Research
      Application" shall mean use of a Licensed Product or component
      thereof for research and clinical research applications.  For
      purposes herein, the performance of a clinical trial using a Licensed
      Product during the Collaboration shall be deemed a Research
      Application.

              
	 	 
	
                1.20

              	
                "FDA
      Submission Plan" shall mean the plan for the Collaboration attached
      hereto as Exhibit
  C.

              
	 	 
	
                1.21

              	
                “RUO” shall mean
      "research use only", as defined in United States Code of Federal
      Regulations, Title 21, Paragraph 809.10(c)(2)(i).

              
	 	 
	
                1.22

              	
                “Territory”
      shall mean all the countries in the world.

              
	 	 
	
                1.23

              	
                “Utility” means
      the application for a Licensed Product, being (a) RUO, (b) an ASR, or (c)
      an IVD for any medical utility.

              
	 	 
	
                1.24

              	
                “Valid Claim”
      shall mean any claim of an issued and unexpired patent within Patent
      Rights or Joint Patent Rights exclusively licensed to Abbott, which claim
      has not been held invalid or unenforceable by a non-appealable decision of
      a court or governmental agency having competent
    jurisdiction.

              


      

       

      Article 2 - The
Collaboration, Materials and Data

       

      
        	
                2.1

              	
                Collaboration.  During
      the Collaboration Term and pursuant to the FDA Submission Plan, Abbott and
      HDC agree to collaborate on the performance of the necessary validation
      studies and clinical trial(s), and the preparation of and submission to
      the U.S. Food and Drug Administration (“FDA’) of either a 510(k) or PMA
      application seeking the necessary authorization from the FDA for the U.S.
      marketing, use and sale with associated claims of medical utility of a
      prostate cancer diagnostic assay (the “Collaboration”).  For purposes of
      the Collaboration, the parties acknowledge and agree
  that:

              


      

       

      2.1.1                    The
FDA Submission Plan specifies the responsibilities of the parties for the
clinical trial activities, and may be modified only by a writing executed by
both parties; and

       

      2.1.2                    Initially,
Abbott will be solely responsible for the preparation and submission of the
510(k) or PMA application to the FDA.  Abbott will provide a draft of
the submission to HDC for its comment at least thirty (30) days before the
actual filing with the FDA. However, the parties may agree in writing to a
change in the allocation of responsibility.  In this event, any such
writing will modify the FDA Submission Plan to establish each party’s
responsibilities and whether any additional time or funding is
required.

       

      
        
          
          

        

        
          5

          
            

          

        

        
          
          

        

      

       

      
        	 
      	
                During
      the Collaboration Term, HDC agrees to exclusively collaborate with Abbott
      on the performance of the clinical trials and submission to the
      FDA.

              
	 	 
	
                2.2

              	
                Exchange of
      Materials.  During the Collaboration Term, HDC will
      provide materials (“HDC Materials”),
      including, without limitation, test reagent samples and clinical samples,
      to Abbott, and Abbott will provide materials, including, without
      limitation, test reagents and clinical samples necessary to complete the
      Collaboration (collectively, “Abbott
      Materials”) to HDC for the purposes described in the FDA Submission
      Plan.  Each shall do so at its sole cost and
      expense.  The parties shall comply with all applicable laws,
      rules and regulations in the packaging and shipment of the HDC Materials
      and Abbott Materials, as applicable (collectively, “Materials”).  Abbott Materials
      are and shall remain the sole property of Abbott.  HDC Materials
      are and shall remain the sole property of HDC. Each
      party shall use Materials of the other party solely for the Collaboration
      and shall not provide them to any third party for any purpose without the
      other party’s prior written consent.  Materials shall not be
      used for purposes of reporting of patient results, except in the course of
      a clinical trial whose protocol expressly provides for such
      reporting.

              
	 	 
	
                2.3

              	
                Additional and New
      Prostate Markers.  Abbott and HDC may each separately
      bring additional prostate markers (“Additional Prostate Markers”) into the
      Collaboration for investigation in combination with one or more of the
      Licensed Prostate Markers identified in Exhibit B.  The parties
      may also decide to collaborate on discovery of new prostate markers (“New
      Prostate Markers”), with either Abbott or HDC providing urine or tissue
      samples that may exhibit such New Prostate Markers.  Any such
      New Prostate Markers discovered in the Collaboration will be jointly owned
      by Abbott and HDC and subject to the provisions of Paragraphs 8.5 and 8.6
      hereof.

              
	 	 
	
                2.4

              	
                Disclosure of
      Data.  All data and other relevant information generated
      by a party pursuant to the Collaboration shall be promptly and fully
      disclosed to the other party, and shall be freely usable for internal use
      and any regulatory submission by the other party subject to the
      confidentiality provisions of Article 7 and intellectual property
      provisions of Article 8.

              
	 	 
	
                2.5

              	
                Reporting.  At
      regular intervals to be determined and documented by the parties, each
      party shall submit progress and other written status reports as reasonably
      requested by the other party.  Additionally, the parties shall
      hold regular meetings, alternating between their respective headquarters,
      at least quarterly, to review and discuss such
  progress.

              


      

      


      
        
          
          

        

        
          6

          
            

          

        

        
          
          

        

      

       

      Article 3 -
Payments

       

      
        	
                3.1

              	
                Signing
      Fee. Promptly after execution of this Agreement by both
      parties, Abbott shall pay to HDC a one-time Signing Fee of
      One-Hundred-Thousand U.S. Dollars ($100,000.00).  This Signing
      Fee shall be non-refundable and non-creditable towards
      royalties.

              
	 	 
	
                3.2

              	
                Phase 1 and 2
      Completion Milestone Fee.

              


      

       

      3.2.1                    Upon
completion of both Phases 1 and 2 described in the FDA Submission Plan,
Abbott shall pay to HDC a one-time Phase 1 and 2 Completion Milestone Fee of
Two-Hundred-Fifty-Thousand U.S. Dollars ($250,000.00).  This Phase 1
and 2 Completion Milestone Fee shall be non-refundable and non-creditable
towards royalties.

       

      
        	
                3.3

              	
                Phase 3 and 4
      Completion Milestone Fee.  Upon completion of
      both Phases 3 and 4 described in the FDA Submission Plan, Abbott
      shall pay to HDC a one-time Phase 3 and 4 Completion Milestone Fee of
      Two-Hundred-Fifty-Thousand U.S. Dollars ($250,000.00).  This
      Phase 3 and 4 Completion Milestone Fee shall be non-refundable and
      non-creditable towards royalties.

              
	 
      	 
      
	
                3.4

              	
                FDA
      Submission Milestone Fee.  Promptly after the
      filing by Abbott with the FDA of either a 510(k) or PMA submission, Abbott
      shall pay to HDC a one-time FDA Submission Fee of Five-Hundred-Thousand
      U.S. Dollars ($500,000.00).  This Fee shall also be irrevocable
      and non-creditable against any royalty obligation.

              
	 
      	 
      
	
                3.5

              	
                FDA
      Approval Fee.  Promptly after the receipt by
      Abbott of a written notification from the FDA of the approval of the
      applicable 510(k) or PMA submission, Abbott shall pay to HDC a one-time
      FDA Approval Fee of Five-Hundred-Thousand U.S. Dollars
      ($500,000.00).  This Fee shall also be irrevocable and
      non-creditable against any royalty
obligation.

              


      

      


      Article 4 - License Terms
and Royalty.

       

      
        	
                4.1

              	
                License
      Grant.

              


      

       

      4.1.1
          
Exclusive License: HDC hereby grants Abbott an exclusive, worldwide,
royalty-bearing license and right to make, have made, use, sell and import
Licensed Products, with the right to sublicense, under Patent Rights, under
HDC’s interest in Joint Patent Rights and Know-How.  The exclusive
license granted herein shall be exclusive even as to HDC with respect to the
making, have made, sale and import of Licensed Products.

       

      4.1.2           
Co-Exclusive License:  HDC hereby grants Abbott a, co-exclusive,
worldwide, royalty-bearing license for the performance of Laboratory Developed
Tests, including the right to make and have made and import Licensed Products
used in the performance of Laboratory Developed Tests, which co-exclusive
license will be shared with the co-licensees identified in Exhibit D
hereto.    For as long as this Agreement remains in effect,
apart from the identified co-licensees, HDC shall not retain nor have any right
to grant further sublicenses.

       

      
        
          
          

        

        
          7

          
            

          

        

        
          
          

        

      

       

      
        	
                4.2

              	
                Royalty.

              


      

       

      4.2.1                    For
each Licensed Product that is sold by Abbott, Abbott shall pay HDC a running
royalty equal to:

       

      (a)    For
Licensed Products with medical utility claims solely for use on prostate tissue
samples, ten percent (10%) of Abbott’s Net Sales of such Licensed Product;
and

       

      (b)    For
Licensed Products with medical utility claims solely for use on urine samples,
five percent (5%) of Abbott’s Net Sales of such Licensed Product

      


      4.2.2                    For
each Laboratory Developed Test that is sold by Abbott, Abbott shall pay
HDC:

       

      (a)    a
running royalty equal to ten percent (10%) of Abbott’s Net Sales of such
Laboratory Developed Test performed on a prostate tissue; or

       

      (b)    a
running royalty equal to five percent (5.0%) of Abbott’s Net Sales of such
Laboratory Developed Test performed on a urine sample.

       

      4.2.3           
Abbott shall make all such payments in respect of running royalties within
forty-five (45) days after the end of each calendar quarter following the
FCS.

       

      
        	
                4.3

              	
                Sales
      Milestones.  Upon the sale by Abbott of the specified
      number of Licensed Products with a medical utility claim for use on a
      urine sample, Abbott agrees to pay HDC, promptly after reaching each Sales
      Milestone:

              


      

       

      (a)               1st Sales
Milestone:  After the sale of Fifty-thousand (50,000) tests in
a calendar year, a one-time 1st Sales Milestone Fee of Two-Hundred-Thousand U.S.
Dollars ($200,000.00);

       

      (b)               2nd Sales
Milestone: After the sale of Two-hundred-thousand (200,000) tests in a calendar
year, a one-time 2nd Sales
Milestone Fee of Seven-Hundred-Fifty-Thousand U.S. Dollars ($750,000.00);
and

       

      
        
          
          

        

        
          8

          
            

          

        

        
          
          

        

      

       

      (c)               3rd Sales
Milestone:  After the sale of Five-hundred-thousand (500,000) tests in
a calendar year, a one-time 3rd Sales
Milestone Fee of One-Million-Five-Hundred-Thousand U.S. Dollars
($1,500,000.00);

      


      
        	 
      	
                The
      fees payable under Paragraph 4.3 shall not be creditable against the
      running royalty obligation of Paragraph 4.2.  Abbott shall make
      all such payments under Paragraph 4.2.3 within forty-five (45) days after
      the end of each calendar quarter in which the Sales Milestone is
      reached.

              
	 
      	 
      
	
                4.4

              	
                Required Third Party
      Licenses.  In the event one or more third party licenses
      are required, in Abbott’s reasonable judgment, for Abbott to commercialize
      a Licensed Product or Laboratory Developed Test, then Abbott may reduce
      the running royalty otherwise payable to HDC for such Licensed Product
      under Paragraph 4.2.1 and 4.2.2 by the percentage amount of any running
      royalty payable by Abbott under such third-party license; provided, that
      such reduction may not be more than fifty percent (50%) of the rates
      specified in Paragraphs 4.2.1 and
4.2.2.

              


      

      


      Article 5- Warranties and
Representations

       

      
        	
                5.1

              	
                HDC.  HDC
      warrants and represents to Abbott
that:

              


      

       

      5.1.1                    to
the best of its knowledge, it has the full legal right to grant Abbott the
licenses to Patent Rights provided herein;

       

      5.1.2                    during
the Collaboration Term, HDC will not collaborate with any third party with
respect to any portion of the Collaboration or the development of any IVD assay
covered by Patent Rights;

       

      5.1.3                    to
the best of its knowledge, no third party is challenging in any jurisdiction the
validity of any of the Patent Rights;

       

      5.1.4                    Exhibit A lists all
patent(s) and/or patent applications owned or controlled by HDC as of the
Effective Date that are applicable to the Field;

       

      5.1.5                    it
has not received any written or oral communication asserting that the HDC 4-gene
expression assay for prostate cancer to be tested in Phase 1 of the Validity
Studies of the FDA Submission Plan, infringes any intellectual property right,
including any patent right, owned or controlled by any third party;

       

      5.1.6                    it
has the corporate power and authority to enter into this Agreement and the
person executing this Agreement on behalf of HDC has been authorized to do
so;

       

      
        
          
          

        

        
          9

          
            

          

        

        
          
          

        

      

       

      5.1.7                    the
terms of this Agreement do not conflict with or violate any contract binding
upon HDC; and

       

      5.1.8                    it has not granted and will
not grant to any third party, including the co-exclusive licensees listed in
Exhibit D, any rights under  Patent Rights to make, have made, import
or sell Licensed Products.

       

      
        	
                5.2

              	
                Abbott.  Abbott
      warrants and represents to HDC that it has the corporate power and
      authority to enter into this Agreement, that the person executing this
      Agreement on behalf of Abbott has been authorized to do so, and that the
      terms of this Agreement do not conflict with or violate any contract
      binding upon Abbott.

              
	 	 
	
                5.3

              	
                Limitation of
      Liability.  IN NO EVENT WILL EITHER PARTY BE LIABLE TO
      THE OTHER UNDER ANY CIRCUMSTANCES FOR ANY INDIRECT, CONSEQUENTIAL,
      INCIDENTAL OR SPECIAL DAMAGES, INCLUDING LOST PROFITS, RESULTING FROM THE
      PARTY’S PERFORMANCE OR FAILURE TO PERFORM UNDER THIS
      AGREEMENT.

              


      

       

      Article 6 - Term and
Termination

       

      
        	
                6.1

              	
                Term.  This
      Agreement shall become effective on the Effective Date and shall terminate
      upon the expiration of the last to expire of Patent Rights licensed
      hereunder, unless sooner terminated as provided herein.

              
	 	 
	
                6.2

              	
                Termination for
      Cause.  Either HDC or Abbott may unilaterally terminate
      this Agreement upon thirty (30) days written notice to the other in the
      event of:

              


      

       

      6.2.1                    the
non-terminating party’s insolvency; or

       

      6.2.2                    a
material breach of the Agreement by a party, which breach is not cured within
thirty (30) days of notice of such breach by the other party.

       

      
        	
                6.3

              	
                Abbott’s Termination
      Right.  Abbott may unilaterally and without cause
      terminate this Agreement upon ninety (90) days notice to
      HDC.  .

              
	 	 
	
                6.4

              	
                Survival.  Paragraph
      5.3, Articles 7, 8, 9 (subject to Paragraph 9.4) and 10 shall survive
      termination of this Agreement.

              


      

       

      Article 7 - Confidential
Information

       

      
        	
                7.1

              	
                Confidential
      Treatment.  A party receiving the Confidential
      Information (“Receiving Party”) of
      the other party (“Disclosing Party”)
      agrees to hold that Confidential Information in trust and confidence for
      Disclosing Party.  A Receiving Party will not use Confidential
      Information other than for the purposes of this Agreement.  Each
      party shall, to the extent applicable hereunder, provide the other party
      with patient information as allowed by law and the Receiving Party shall
      maintain the confidentiality of all such patient information as required
      by law.

              


      

       

      
        
          
          

        

        
          10

          
            

          

        

        
          
          

        

      

       

      
        	
                7.2

              	
                Limitation of
      Dissemination.  A Receiving Party will only disclose
      Confidential Information received hereunder, whether oral or in writing,
      in tangible, intangible or electronic format, to those persons within the
      Receiving Party’s organization or its agents (a) who have a need to know
      the Confidential Information in order to perform the Receiving Party’s
      obligations under this Agreement, (b) who have been informed of the
      confidential nature of the Confidential Information, and (c) who are
      obligated to maintain the confidentiality of the Confidential Information
      consistent with the terms of this Agreement.

              
	 	 
	
                7.3

              	
                Standard of
      Care.  A Receiving Party will treat the Confidential
      Information of the Disclosing Party with the same care as the Receiving
      Party’s own proprietary information of like kind.

              
	 	 
	
                7.4

              	
                Handling of
      Information.  A Receiving Party shall not (a) reverse
      engineer or otherwise exploit the Confidential Information in violation of
      this Agreement, and (b) remove or export from the United States or
      re-export any of such Confidential Information or any direct product
      thereof except in compliance with and with all licenses and approvals
      required under applicable export laws and regulations, including, without
      limitation, those of the U.S. Department of Commerce.

              
	 	 
	
                7.5

              	
                Compelled
      Disclosure.  In the event that a Receiving Party is
      ordered by a court of competent jurisdiction or is compelled by law, order
      or regulation of a governmental agency or by subpoena to disclose all or
      any portion of the Confidential Information of the Disclosing Party to a
      third party, the Receiving Party shall give the Disclosing Party prompt
      notice of such order or subpoena, together with a copy thereof, so that
      the Disclosing Party may seek an appropriate protective order, if
      applicable.  If, in the absence of a protective order, the
      Receiving Party is nonetheless compelled to disclose Confidential
      Information, the Receiving Party may disclose such information without
      liability hereunder; provided, however, that the Receiving Party gives the
      Disclosing Party notice of the Confidential Information to be disclosed as
      far in advance of its disclosure as is practicable and the Receiving Party
      uses its best efforts to obtain assurances that confidential treatment
      will be accorded to such Confidential Information.

              
	 	 
	
                7.6

              	
                Return of Confidential
      Information.  Upon termination of this Agreement, the
      Receiving Party will return to the Disclosing Party or destroy all written
      Confidential Information, as well as any copies thereof, and will promptly
      destroy all memoranda, notes and other writings (whether in tangible,
      intangible or electronic format) prepared by the Receiving Party or on the
      Receiving Party’s behalf based upon the Confidential Information of the
      Disclosing Party, except that the Receiving Party may retain one (1) copy
      of such Confidential Information for archival purposes, which copy shall
      be subject to obligations set forth herein.  The Receiving Party
      shall also provide the Disclosing Party with a certificate of an
      appropriate representative of the Receiving Party to the effect that the
      Receiving Party has fully complied with the requirements of this
      Paragraph.

              


      

       

      
        
          
          

        

        
          11

          
            

          

        

        
          
          

        

      

       

      
        	
                7.7

              	
                Injunctive
      Relief.  Receiving Party acknowledges that the
      Confidential Information of Disclosing Party has been developed by
      Disclosing Party with substantial effort and at substantial cost and
      therefore has value to Disclosing Party, and that the breach of any of the
      provisions of this Agreement could cause Disclosing Party irreparable
      injury for which no adequate remedy at law exists.  Accordingly,
      Disclosing Party shall have the right, in addition to any other rights it
      may have to seek from any court having jurisdiction a temporary or
      permanent restraining order or injunction restraining or enjoining
      Receiving Party from any violation of this
  Agreement.

              


      

       

      Article 8 -
Inventions

       

      
        	
                8.1

              	
                Ownership of Existing
      Inventions.  Existing inventions and technologies of HDC
      and Abbott as of the Effective Date (including, without limitation,
      Licensed Prostate Markers and Additional Prostate Markers that each
      separately bring to the Collaboration) shall respectively remain the sole
      and separate property of HDC and Abbott and the ownership thereof shall
      not be affected by this Agreement.  Except for the license
      granted Abbott hereunder, neither party shall have any claims to or rights
      in such existing inventions and technologies of the other
      party.

              
	 	 
	
                8.2

              	
                Ownership of New
      Inventions.  Any new invention, development or discovery
      relating to the Field or New Prostate Markers for the Field conceived,
      made or reduced to practice by either party as part of the Collaboration,
      the FDA Submission Plan or with the use of Materials of the other party
      (each a “New Invention”) shall be promptly disclosed in
      writing to the other party.  Each party shall retain sole
      ownership in each Invention made solely by that party.

              
	 	 
	
                8.3

              	
                Patent Prosecution and
      Maintenance.

              


      

       

      8.3.1                    HDC
shall pay all costs associated with the filing, prosecution and maintenance of
patent applications and issued patents within the Patent Rights.

       

      8.3.2                    HDC
shall notify Abbott of any change in status of patents and/or patent
applications listed in Exhibit A and of the
filing of any patent applications within the scope of the Patent Rights within
sixty (60) days of any such change.  HDC shall update Exhibit A at least
annually to reflect any such changes.  In the event any of the Patent
Rights shall become involved in an opposition or interference proceeding, HDC
shall manage the proceeding, at its own expense, and shall keep Abbott informed
of the status of any such proceeding and may consider Abbott’s views in
formulating HDC’s strategy in the proceeding.

       

      
        
          
          

        

        
          12

          
            

          

        

        
          
          

        

      

       

      8.3.3                    For
New Inventions owned solely by HDC, HDC shall prepare, apply for and maintain
issued patents for such New Inventions throughout the Territory in such
countries and in such manner as HDC shall determine after reasonable
consideration of the views of Abbott.

       

      8.3.4                    If
HDC elects not to file a patent application for a New Invention solely owned by
HDC or to abandon an existing issued patent or pending patent application within
the Patent Rights or do so in any particular jurisdiction within the Territory,
HDC shall notify Abbott within a time sufficient for Abbott to familiarize
itself with the case and make a decision before abandoning or failing to pursue
the relevant issued patent or pending application.  Abbott shall have
thirty (30) days from the date of such notice within which it may notify HDC
that Abbott has elected to assume the obligation and costs of filing and
prosecuting or maintaining such patent application or issued
patent.  If Abbott elects to assume such obligation and costs, HDC
shall assign its rights in the relevant patent application or issued patent to
Abbott for only the affected jurisdiction(s); provided, however, that such
assignment shall be coupled with the grant by Abbott to HDC of a fully-paid,
nonexclusive license, without the right to sublicense, in the assigned patent
application or issued patent for internal research purposes only.  Any
patent application or issued patent assigned to and maintained by Abbott
provided in this subparagraph shall not be considered Patent Rights under this
Agreement and Abbott shall have no royalty or fee obligations to HDC for
Abbott’s commercial use under such patent applications or issued
patents.

       

      
        	
                8.4

              	
                Joint
      Inventions.

              


      

       

      8.4.1                    Each
Joint Invention shall be jointly owned by the parties and each party shall have
an undivided interest in such Joint Inventions and any Joint Patent Rights
resulting therefrom, including the rights to commercialize Joint Inventions and
grant licenses to third parties under the Joint Patent
Rights.  Inventorship for Joint Patent Rights shall be determined in
accordance with U.S. patent law.

       

      8.4.2                    Neither
party will file applications for U.S. or foreign patents for a Joint Invention
without first consulting the other party.  In the event that both
parties agree to file an application for a patent for a Joint Invention, the
parties will share equally all costs associated with filing, prosecuting, and
maintaining Joint Patent Rights directed to any Joint Invention.  The
parties will mutually agree which of them will be responsible for filing,
prosecution, and maintenance of a particular patent application or patent based
upon the relative contribution of each party to the related Joint
Invention.

       

      8.4.3                    The
filing party shall make commercially reasonable efforts to minimize the cost of
the filing and prosecution of patent applications for Joint Inventions and
neither shall charge the other for overhead costs associated with prosecution
undertaken by employed, in-house patent counsel of the filing
party.  The filing party shall promptly provide the non-filing party
with copies of papers regarding the prosecution of such applications (including,
without limitation, all patent office actions, any response to any office action
affecting the scope or nature of the Joint Invention) and will use commercially
reasonable efforts to consult with the non-filing party regarding its interest
in the application and seek claims reasonably consistent with the interests of
the non-filing party prior to making any such claims or responding to any office
action relating thereto.

       

      
        
          
          

        

        
          13

          
            

          

        

        
          
          

        

      

       

      8.4.4                    The
non-filing party agrees to provide all reasonable assistance and cooperation to
the filing party, including the execution of documents.

       

      8.4.5                    Either
party may elect at any time not to participate in the filing of a patent
application or maintaining an issued patent for a Joint Invention by giving
notice to the other and assigning all of its rights in such Joint Invention
(including, without limitation, all related Joint Patent Rights) to the other
party.  The party making such election shall have no further
obligations to undertake or underwrite the cost, as the case may be, to
prosecute, maintain, and enforce any such Joint Patent Right, except as to costs
and expenses that have accrued prior to such assignment.

       

      8.4.6                    Each
party will bring to the attention of the other party any third party
infringement of any patent for a Joint Invention of which it becomes
aware.  Neither party will enforce any U.S. or foreign patents for a
Joint Invention against a third party without the prior written consent of the
other party, which consent shall not be unreasonably withheld or
delayed.  In the event that both parties agree to enforce a patent for
a Joint Invention, the parties will use good faith efforts to determine which
party will be responsible for enforcement of such Joint Patent Rights against
such third party infringers and apportion the costs of enforcement based upon
the commercial interest of each party to the infringing activity.  The
parties will apportion any recoveries based upon their contributions to the cost
of enforcing such patent.

       

      8.4.7                    Neither
party will grant a license to any third party to any U.S. or foreign patents for
a Joint Invention without the prior written consent of the other
party.  In the event that either party grants a license to a patent
for a Joint Invention, the parties will share equally in the gross revenues,
including, but not limited to, license fees and royalties, realized for the
license to the Joint Invention by the licensing party.  Payments shall
be made within forty-five (45) days after the end of each calendar quarter and
accompanied by a report, setting forth the gross amounts received from the
license).  Upon reasonable request, the reporting party shall provide
the requesting party copies of applicable reports due from the license under the
license relating to royalties payable to the licensor party.  Such
reports shall constitute the licensor party’s Confidential Information and shall
be returned to the licensor party after the requesting party has had a
reasonable opportunity to review the reports.

       

      
        
          
          

        

        
          14

          
            

          

        

        
          
          

        

      

       

      8.4.8                    If
after good faith negotiations the parties cannot reach agreement as to any
dispute regarding Joint Inventions and Joint Patent Rights, the dispute may be
submitted to Alternative Dispute Resolution as provided for in Paragraph
10.12.

       

      Article 9-
Indemnification

       

      
        	
                9.1

              	
                HDC.  HDC
      shall indemnify, defend and hold harmless Abbott and its Affiliates,
      employees, officers, directors and agents from and against any suit,
      proceeding, claim, liability, loss, damage, costs or expense, including
      reasonable attorneys’ fees, which Abbott may hereinafter incur, suffer, or
      be required to pay arising out of or resulting from (a) any breach by HDC
      of the representations and warranties set forth in Paragraph 5.1 of this
      Agreement, and (b) any injury or other harm caused solely by HDC in
      carrying out its obligations pursuant to the
  Collaboration.

              
	 	 
	
                9.2

              	
                Abbott.  Abbott
      shall indemnify, defend, and hold harmless HDC and its Affiliates,
      employees, officers, directors and agents from and against any suit,
      proceeding, claim, liability, loss, damage, costs or expense, including
      reasonable attorneys’ fees, which HDC may hereinafter incur, suffer or be
      required to pay arising out of or resulting from (a) any breach by Abbott
      of the representations and warranties set forth in Paragraph 5.2 of this
      Agreement, and (b) any injury or other harm caused solely by Abbott in
      carrying out its obligations pursuant to the
  Collaboration.

              
	 	 
	
                9.3

              	
                Notice and
      Cooperation.  With respect to any claim for which a party
      seeks indemnification from the other hereunder, the party seeking
      indemnification shall provide prompt notice to the other of the claim for
      which indemnification is sought, shall provide reasonable cooperation and
      assistance to the indemnifying party in the defense of such claim, and
      shall not settle or otherwise compromise such claim without the
      indemnifying party’s prior written consent.

              
	 	 
	
                9.4

              	
                Termination of
      Indemnification Obligations.  All obligations for
      indemnification on the part of parties hereto shall expire two (2) years
      from the date of termination of this Agreement, except with respect to
      claims for indemnification made prior to the end of such two (2) year
      period.

              


      

       

      Article 10 -
Miscellaneous

       

      
        	10.1	
                Notices.  Any
      notice, report, payment or statement required or permitted under this
      Agreement shall be considered to be given in writing when sent by
      certified mail (return receipt requested), postage prepaid, or faxed then
      mailed, or if sent via courier and addressed to the party for whom it is
      intended at its address of record.  The record addresses of the
      parties are as follows:

              


      

       

      
        
          
          

        

        
          15

          
            

          

        

        
          
          

        

      

       

      
        	 	
                If
      to HDC:

              	
                Chairman
      and CEO

              	 
      
	 	 
      	
                Health
      Discovery Corporation

              	 
      
	 	 
      	
                2
      East Bryan Street, Suite #601

              	 
      
	 	 
      	
                Savannah,
      GA 31401

              	 
      
	 	 
      	
                FAX:
      (912) 443-1989

              	 
      
	 	 
      	 
      	 
      
	 	 
      	
                with
      a copy to:

              	 
      
	 	 
      	
                Procopio,
      Cory, Hargreaves & Savitch LLP

              	 
      
	 	 
      	
                530
      B Street, Suite 2100

              	 
      
	 	 
      	
                San
      Diego, CA 92101

              	 
      
	 	 
      	
                Fax:  619-744-5478

              	 
      
	 	 
      	
                Attn:  Eleanor
      M. Musick, Esq.

              	 
      
	 	 
      	 
      	 
      
	 	
                If
      to Abbott:

              	
                Director,
      Licensing & Business Development

              	 
      
	 	 
      	
                Abbott
      Molecular Inc.

              	 
      
	 	 
      	
                1300
      E. Touhy Ave, 3C

              	 
      
	 	 
      	
                Des
      Plaines, IL 60018-3315

              	 
      
	 	 
      	
                Fax:
      (224) 361-7054

              	 
      
	 	 
      	
                With
      a copy to:

              	 
      
	 	 
      	 
      	 
      
	 	 
      	
                VP,
      Domestic Legal

              	 
      
	 	 
      	
                Abbott
      Laboratories

              	 
      
	 	 
      	
                Dept.
      322, Bldg. AP-6A

              	 
      
	 	 
      	
                100
      Abbott Park Road

              	 
      
	 	 
      	
                Abbott
      Park, IL 60064-6049

              	 
      
	 	 
      	
                Fax:
      (847) 938-1206

              	 
      


      

       

      
        	
                10.2

              	
                Compliance with
      Laws.  The parties will comply with applicable laws in
      conducting the Collaboration, including, if applicable, any requirements
      for Institutional Review Board approval.

              
	 	 
	
                10.3

              	
                No
      Partnership.  The parties do not intend to create any
      partnership, joint venture or agency relationship under this
      Agreement.

              
	 	 
	
                10.4

              	
                Use of a Party’s
      Name.  Neither party will, without the prior written
      consent of the other party, (a) use in advertising, publicity or
      otherwise, the name of any employee or agent, any trade-name, trademark,
      trade device, service mark, symbol, or any abbreviation, contraction or
      simulation thereof owned by the other party, or (b) represent, either
      directly or indirectly, that any product or service of the other party is
      a product or service of the representing party or that it is made in
      accordance with or utilizes the information or documents of the other
      party.

              


      

       

      
        
          
          

        

        
          16

          
            

          

        

        
          
          

        

      

       

      
        	
                10.5

              	
                Entire
      Agreement.  This Agreement and all attached Exhibits
      contain the entire agreement and understanding between the parties as to
      its subject matter.  It merges all prior discussions between the
      parties and neither party will be bound by conditions, definitions,
      warranties, understandings, or representations concerning such subject
      matter except as provided in this Agreement or as specified on or
      subsequent to the Effective Date of this Agreement in a writing signed by
      properly authorized representatives of the parties.  This
      Agreement may only be modified by written agreement duly signed by persons
      duly authorized on behalf of both HDC and Abbott.

              
	 	 
	
                10.6

              	
                Assignment.  This
      Agreement shall be binding upon and inure to the benefit of the parties
      hereto and their successors and assigns.  Notwithstanding the
      foregoing, neither party may assign, delegate or otherwise transfer any of
      its rights or obligations under this Agreement without the prior written
      consent of the other party which will not be unreasonably withheld;
      provided, however, that either party may transfer its rights and
      obligations without the consent of the other party (a) upon a Change in
      Control, or (b) to any of its Affiliates provided that the assigning party
      guarantees the performance of its Affiliate.

              
	 	 
	
                10.7

              	
                Waiver.  The
      failure of a party in any instance to insist upon the strict performance
      of the terms of this Agreement will not be construed to be a waiver or
      relinquishment of any of the terms of this Agreement, either at the time
      of the party’s failure to insist upon strict performance or at any time in
      the future, and such terms will continue in full force and
      effect.

              
	 	 
	
                10.8

              	
                Severability.  Each
      clause of this Agreement is a distinct and severable clause and if any
      clause is deemed illegal, void or unenforceable, the validity, legality or
      enforceability of any other clause or portion of this Agreement will not
      be affected thereby.

              
	 	 
	
                10.9

              	
                Governing
      Law.  The rights and obligations of this Agreement will
      be governed and construed in accordance with the laws of the State of
      Delaware, United States of America (excluding and without regard to its or
      any other jurisdiction’s rules concerning conflicts of
    laws).

              
	 	 
	
                10.10

              	
                Titles.  All
      titles and articles headings contained in this Agreement are inserted only
      as a matter of convenience and reference.  They do not define,
      limit, extend or describe the scope of this Agreement or the intent of any
      of its provisions.

              
	 	 
	
                10.11

              	
                Alternative Dispute
      Resolution.  The parties recognize that a dispute as to
      certain matters (other than those specified in Exhibit E) may arise from time to time
      during the term of this Agreement which relates to either party's rights
      and/or obligations under this Agreement.  The parties agree to
      resolve any such dispute exclusively according to the provisions set forth
      in Exhibit
      E.  Notwithstanding the foregoing, any dispute between
      the parties relating to patent validity and enforceability shall not be
      resolved under this Paragraph 10.11, nor by any other form of alternative
      dispute resolution, but rather by litigation in U.S. Federal
      Court.

              


      

       

      
        
          
          

        

        
          17

          
            

          

        

        
          
          

        

      

       

      
        	
                10.12

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

              


      

       

      In
witness thereof, HDC and Abbott have duly executed this Agreement as of the
Effective Date.

      


      
        	
                ABBOTT
      MOLECULAR INC.

              	 	
                HEALTH
      DISCOVERY CORPORATION

              	 
	 	 	 	 
	 	 	 	 
	
                By

              	
                /s/ Stafford
      O’Kelly

              	 	
                By

              	
                /s/ Stephen D.
      Barnhill, M.D.

              	 
	 
      	
                     
      Stafford O’Kelly

              	 	 
      	
                     
      Stephen D. Barnhill, M.D.

              	 
	 
      	
                     
      President

              	 	 
      	
                     
      Chairman and CEO

              	 
	 	 	 	 	 	 
	
                Date

              	
                January 30,
      2009

              	 	
                Date

              	
                January 30,
      2009

              	 


      

      


      
        
          
          

        

        
          18

          
            

          

        

        
          
          

        

      

       

      Exhibit
A

      


      Patent(s) or Patent
Application(s)

      


      


      


      
        	
                Country/Region

              	
                Patent/
      Publication/

                Application
      No.

              	
                Title

              
	
                U.S.

              	
                7,117,188

              	
                Method
      of Identifying Patterns in Biological Systems and Uses
    Thereof

              
	
                U.S.

              	
                12/025,724

              	
                Biomarkers
      Upregulated in Prostate Cancer

              
	
                U.S.

              	
                12/242,264

              	
                Biomarkers
      Overexpressed in Prostate Cancer

              
	
                U.S.

              	
                12/327,823

              	
                Methods
      for Screening, Predicting and Monitoring Prostate
Cancer

              
	
                U.S.

              	
                12/349,437

              	
                Methods
      for Screening, Predicting and Monitoring Prostate
Cancer

              
	
                Australia

              	
                2002253879

              	
                Methods
      of Identifying Patterns in Biological Systems and Uses
    Thereof

              
	
                Canada

              	
                2,435,254

              	
                Method
      of Identifying Patterns in Biological Systems and Uses
    Thereof

              
	
                Europe

              	
                1459235

              	
                Method
      of Identifying Patterns in Biological Systems and Uses
    Thereof

              
	
                Japan

              	
                2002-560076

              	
                Method
      of Identifying Patterns in Biological Systems and Uses
    Thereof

              
	
                Europe

              	
                1828917

              	
                Biomarkers
      for Screening, Predicting, and Monitoring Prostate
  Disease

              


      

      


      


      
        
          
          

        

        
          Exhibit A
- 1

          
            

          

        

        
          
          

        

      

      


      Exhibit
B

      


      LICENSED PROSTATE
MARKERS

       

       

      
        	
                Num

              	 	
                Archival

                Unigene ID

              	 	
                Current

                Unigene ID

              	 	
                Symbol

              	 	
                Affy probe

              	 	
                Pathway

              	 	
                Target Description

              
	
                12337

              	 	
                Hs.7780

              	 	
                Hs.480311

              	 	
                DKFZp564

              	 	
                212412_at

              	 	
                Unknown

              	 	
                Consensus
      includes :AV715767 /FEA=EST

                /DB_XREF=gi:10797284
      /DB_XREF=est:AV715767

                /CLONE=DCBATH02
      /UG=Hs.7780 Homo sapiens

                mRNA;
      cDNA DKFZp564A072 (from clone

                DKFZp564A072)

              
	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                9373

              	 	
                Hs.21293

              	 	
                Hs.492859

              	 	
                UAP1/AGX-1

              	 	
                209340_at

              	 	
                Aminosugar
      metabolism

              	 	
                gb:S73498.1
      /DEF=Homo sapiens AgX-1 antigen

                mRNA;
      complete cds. /FEA=mRNA /PROD=AgX-1 antigen /DB_XREF=gi:688010
      /UG=Hs.21293 UDP-N-

                acteylglucosamine
      pyrophosphorylase 1

                /FL=gb:AB011004.1
      gb:NM_003115.1 gb:S73498.1

              
	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                876

              	 	
                Hs.79037

              	 	
                Hs.476231

              	 	
                HSPD1

              	 	
                200807_s_at

              	 	
                Mitochondrial
      control of apoptosis

              	 	
                gb:NM_002156.1
      /DEF=Homo sapiens heat shock

                60kD
      protein 1 (chaperonin) (HSPD1); mRNA.

                /FEA=mRNA
      /GEN=HSPD1 /PROD=heat shock 60kD

                protein
      1 (chaperonin) /DB_XREF=gi:4504520

                /UG=Hs.79037
      heat shock 60kD protein 1 (chaperonin)

                /FL=gb:BC002676.1
      gb:BC003030.1 gb:M34664.1 gb:M22382.1 gb:NM_002156.1

              
	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                1961

              	 	
                 
      

              	 	
                Hs.75432

              	 	
                IMPDH2

              	 	
                201892_s_at

              	 	
                de
      novo guanine nucleotide biosynthesis

              	 	
                gb:NM_000884.1
      /DEF=Homo sapiens IMP (inosine

                monophosphate)
      dehydrogenase 2 (IMPDH2); mRNA.  /FEA=mRNA /GEN=IMPDH2
      /PROD=IMP

                (inosine
      monophosphate) dehydrogenase 2

                /DB_XREF=gi:4504688
      /UG=Hs.75432 IMP (inosine

                monophosphate)
      dehydrogenase 2 /FL=gb:J04208.1

                gb:NM_000884.1

              


      

      


      
        
          
          

        

        
          Exhibit B
- 1

          
            

          

        

        
          
          

        

      

      


      Exhibit
C

      


      FDA Submission
Plan

      


      


      Feasibility & Validation
Studies

      


      I.         Costs and Performance Site
for Phase 1 and 2:

      


      Abbott
and HDC agree to have the experimental testing of Phase 1 and 2 performed at *,
with *, as the principal investigator.  HDC already has a experimental
testing agreement in place with * that will cover the performance of Phase 1 and
2.  HDC warrants that it has the right under the agreement with * to
transfer the data resulting from Phase 1 and 2 testing to Abbott and that Abbott
has the  royalty-free right to use the data in any regulatory
submission.  Abbott shall be responsible for payment to HDC of *’s
actual costs for performance of the Phase 1 and 2 experimental testing, up to a
maximum of One-Hundred-Thousand Dollars ($100,000.00).  HDC shall be
responsible for payment to * of all costs in excess of the One-Hundred-Thousand
Dollars ($100,000.00).  Abbott shall make the payments to HDC within
thirty (30) days of receipt of invoice from HDC, and HDC shall make the payment
to * for any excess costs within thirty (30) days of receipt of notice from
Abbott.

      


      II.        Phase
1 (expected duration 1.5 months):  Develop an assay for the 4-gene
prostate cancer test in prostate cancer cells present in urine.

       

      The
objective of this phase of the study is to develop the HDC 4-gene expression
assay in urine. The assay may be done in up to four separate RT-PCR reactions or
in one or more multiplex groupings.  The urine sediment containing the
tumor cells, obtained after centrifugation, will be extracted to obtain
mRNA.   Primers and probes for real time, RT-PCR assays will be
developed by HDC for the 4 genes of interest and for 5 potential candidates to
serve as the reference (housekeeping) genes.  While the B2M was the
most stable gene in the preliminary studies, a re-evaluation of all five gene
candidates will be required.  One or more may be selected as the
reference gene(s) for the 4-gene assay.  In this first phase of the
study, prostate cancer cells obtained from tissue culture will be used, and
preparations of tissue culture cells will be spiked into urine containing RNAse
enzyme inhibitors.

       

      The
collection of patient urine, serum and tissue specimens for both Phase 1 and 2
will be initiated and the specimens properly stored beginning immediately upon
IRB approval. This will allow specimen collection to be completed in advance of
the start of Phase 2.

       

      
        
          
          

        

        
          Exhibit C
- 1

          
            

          

        

        
          
          

        

      

       

      Phase 1
Feasibility Results Completion Standard:

      


      The
successful completion of Phase I will be the demonstration of “Feasibility” for
the assay, and will be determined by Abbott in its sole
discretion.  Feasibility will be demonstrated by showing an ability of
the assay to identify prostate cancer as present based on an elevated expression
of the genes of interest in prostate cells in urine specimens compared to the
background expression levels of the normal epithelial cells, using a cut-off
that will have *% sensitivity and *% specificity.

      


      III.                 
Phase 2 (expected duration 2 months):  Assess the utility of the
4-gene urine test for prostate cancer detection.

      


      The
objective of the Phase 2 validation study is to determine if the assay can
detect cancer cells in urine from patients with prostate cancer with a high
degree of sensitivity.  Urine samples obtained from * patients with
prostate cancer will be tested. The testing will be done on urine samples
obtained pre and post prostatectomy.  Greater than or equal to *%
sensitivity on pre-op specimens is expected, with all urine positive patients
becoming negative when tested one month post-prostatectomy.

      


      A control
group of * non-prostate cancer subjects will be tested in a similar fashion on
two specimens collected one month apart.  One control group of *
subjects will be less than 30 years old and have a serum PSA value less than 1.0
ng/mL and the second control group will have serum PSA value greater than 2.5
ng/mL and less than 10ng/mL and will have had one previous negative
biopsy.  The HDC 4-gene test developed in Phase 1 will be performed on
these patients before the second biopsy is performed. The result of the HDC
4-gene test will then be compared to the result of the second biopsy. Control
subjects with low PSA are likely to have no prostatic enlargement, while
subjects with PSA values greater than 2.5 ng/mL will likely have some degree of
prostatic enlargement (BPH).  All of the subjects in the control group
with a PSA value less than 1ng/mL are expected to have negative results for the
urine gene test. Greater than or equal to *% specificity is expected. Serum PSA
testing will be performed on all subjects at each time of a urine
collection.

      


      For the *
cancer subjects, the Gleason Score will be determined and the total tumor volume
obtained from the prostatectomy tissue will be measured.  The urine
HDC 4-gene score for low grade (Gleason Score), low volume subjects as well as
those with high grade, high volume cancers will be compared.

      


      In
addition, in the * cancer subjects, cancer cells from the formalin fixed tissue
slide will be obtained by micro dissection after being carefully identified by
the pathologist, and the assay tissue score will be compared with the respective
assay urine score.

      


      
        
          
          

        

        
          Exhibit C
- 2

          
            

          

        

        
          
          

        

      

       

      Phase 2 Results Completion
Standard:

      


      The
successful completion of Phase 2 will be determined by Abbott in its sole
discretion, and will be: (i) the demonstration of performance for the assay of
sensitivity greater than or equal to *% and specificity greater than or equal to
*%, and (ii) demonstration of informative test results for informative urine
specimens collected without DRE (success rate) based on sufficient quantity of
tumor mRNA for evaluation of greater than or equal to *%.  Specificity
will be reported against normal and BPH subjects.

       

      IV.                 
Phase 3 and 4 studies (below) will be initiated only upon the review and acceptance of Phase 1
& 2 as meeting the Result Completion Standards.

      


      Costs and Performance Site
for Phase 3 and 4:

      


      Abbott at
its sole discretion shall select the institution to perform the Phase 3 and 4
testing.  Abbott shall be responsible for negotiating and signing the
test performance agreement with the institution selected.  Abbott
shall be responsible for the costs of the selected institution for the
performance of Phase 3 and 4.

       

      V.                  
Phase 3 (expected duration 1 month): Determine if DRE performed prior to
collection of urine specimens will increase the sensitivity of prostate cancer
detection.

      


      The
effect of the digital rectal examination to enhance the detection rate will be
assessed using urine samples collected from * prostate cancer patients and *
non-cancer patients.   This data will determine if a random urine
collection will give a 4-gene test result that is equivalent to a post-DRE
sample.

      


      Phase
3 Results Completion Standard:

      


      Demonstrate
a preferred method of urine specimen collection with a success rate (%
informative) of greater than or equal to the success rate reported for
competitor’s assays (PCA3, *%)

       

      Phase
4 (expected duration 4 Months): Specificity and Assay Optimization
Studies

      


      The
optimal reaction conditions for the urine assay will be developed, and detection
limits and the inter and intra precision for assay will be
established.

       

      
        
          
          

        

        
          Exhibit C
- 3

          
            

          

        

        
          
          

        

      

       

      Stability
of the mRNA in urine tumor cells under various storage conditions, i.e. * and *
will be determined and optimal urine collection and storage conditions will be
defined.

      


      With the
optimized assay, a preliminary assessment or test specificity of the 4-gene
urine test will be accomplished by a) assessing the interference of leukocytes
in urine as a result of inflammation or by blood contamination of the urine
sample by spiking negative and positive urine samples with leukocytes and b)
assessing the tissue specificity of the assay by a survey of urine samples from
* patients with cancer types that could interfere with the assay, such
as  bladder, kidney and others.

      


      The mRNA
or c-DNA from the phase 1-4 validation studies will be stored at -70 degrees C
for future use in validating any new RT-PCR platform which might be used in an
FDA clearance study.

      


      With the
optimized assay, detection of tumors with a range of Gleason scores, stages, and
various patient characteristics (age, ethnic characteristic) will be
evaluated.

       

      Phase 4 Results Completion
Standard:

      


      1) The
test should demonstrate no cross-reactivity with cancer types that could
interfere with the assay, such as bladder, kidney and others.

      2) The
test should demonstrate reproducible performance under specimen storage/shipping
conditions compatible with standard laboratory workflow.

      3) The
test should demonstrate utility in a range of patient populations and tumor
characteristics (grade, stage) with a sensitivity and specificity each greater
than or equal to *%. 

      


      FDA Submission
Study

      


      To be
developed and performed by Abbott after successful completion of the Phase 1
through 4 Studies above.

       

      
        
          
          

        

        
          Exhibit C
- 4

          
            

          

        

        
          
          

        

      

       

      Exhibit
D

       

      Co-Exclusive
Licensees

      


      HDC has
granted or intends to grant to the following companies co-exclusive licenses in
the indicated Territories and Fields to perform, use, market and sell Laboratory
Developed Tests based on the Licensed Prostate Markers:

      


      Quest
Diagnostics, Inc. (Madison, NJ):

      
        	 
      	
                Territory:  United
      States of America, its territories and possessions.

              
	 
      	
                Field:  Laboratory
      Developed Tests in urine

              


      

      


      Clarient,
Inc.(Aliso Viejo, CA):

      
        	 
      	
                Territory:  Worldwide

              
	 
      	
                Field:  Laboratory
      Developed Tests in biopsied prostate
tissue

              


      

      


      
        
          
          

        

        
          Exhibit D
- 1

          
            

          

        

        
          
          

        

      

      


      Exhibit
E

      


      Alternative Dispute
Resolution

      The
parties recognize that bona fide disputes as to certain matters may arise from
time to time during the term of this Agreement which relate to either party’s
rights and/or obligations.  To have such a dispute resolved by this
Alternative Dispute Resolution (”ADR") provision, a
party first must send written notice of the dispute to the other party for
attempted resolution by good faith negotiations between their respective
presidents (or their designees) of the affected subsidiaries, divisions, or
business units within twenty-eight (28) days after such notice is received (all
references to "days" in this ADR provision are to calendar days).

      


      If the
matter has not been resolved within twenty-eight (28) days of the notice of
dispute, or if the parties fail to meet within such twenty-eight (28) days,
either party may initiate an ADR proceeding as provided herein.  The
parties shall have the right to be represented by counsel in such a
proceeding.

      


      
        	
                1.

              	
                To
      begin an ADR proceeding, a party shall provide written notice to the other
      party of the issues to be resolved by ADR.  Within fourteen (14)
      days after its receipt of such notice, the other party may, by written
      notice to the party initiating the ADR, add additional issues to be
      resolved within the same ADR.

              
	 
      	 
      
	
                2.

              	
                Within
      twenty-one (21) days following receipt of the original ADR notice, the
      parties shall select a mutually acceptable neutral to preside in the
      resolution of any disputes in this ADR proceeding.  If the
      parties are unable to agree on a mutually acceptable neutral within such
      period, either party may request the President of the CPR Institute for
      Dispute Resolution (”CPR"), 366
      Madison Avenue, 14th Floor, New York, New York  10017, to select
      a neutral pursuant to the following
procedures:

              


      

      


      (a)         The
CPR shall submit to the parties a list of not less than five (5) candidates
within fourteen (14) days after receipt of the request, along with a Curriculum Vitae for each
candidate.  No candidate shall be an employee, director or shareholder
of either party or any of their subsidiaries or affiliates.

      


      (b)         Such
list shall include a statement of disclosure by each candidate of any
circumstances likely to affect his or her impartiality.

      


      (c)         Each
party shall number the candidates in order of preference (with the number one
(1) signifying the greatest preference) and shall deliver the list to the CPR
within seven (7) days following receipt of the list of candidates.  If
a party believes a conflict of interest exists regarding any of the candidates,
that party shall provide a written explanation of the conflict to the CPR along
with its list showing its order of preference for the candidates.  Any
party failing to return a list of preferences on time shall be deemed to have no
order of preference.

      


      (d)         If
the parties collectively have identified fewer than three (3) candidates deemed
to have conflicts, the CPR immediately shall designate as the neutral the
candidate for whom the parties collectively have indicated the greatest
preference.  If a tie should result between two candidates, the CPR
may designate either candidate.  If the parties collectively have
identified three (3) or more candidates deemed to have conflicts, the CPR shall
review the explanations regarding conflicts and, in its sole discretion, may
either (i) immediately designate as the neutral the candidate for whom the
parties collectively have indicated the greatest preference, or (ii) issue a new
list of not less than five (5) candidates, in which case the procedures set
forth in subparagraphs 2(a) - 2(d) shall be repeated.

       

      
        
          
          

        

        
          Exhibit E
- 1

          
            

          

        

        
          
          

        

      

       

      
        	
                3.

              	
                No
      earlier than twenty-eight (28) days or later than fifty-six (56) days
      after selection, the neutral shall hold a hearing to resolve each of the
      issues identified by the parties.  The ADR proceeding shall take
      place at a location agreed upon by the parties.  If the parties
      cannot agree, the neutral shall designate a location other than the
      principal place of business of either party or any of their subsidiaries
      or affiliates.

              
	 
      	 
      
	
                4.

              	
                At
      least seven (7) days prior to the hearing, each party shall submit the
      following to the other party and the
neutral:

              


      

      


      (a)         a
copy of all exhibits on which such party intends to rely in any oral or written
presentation to the neutral;

      


      (b)         a
list of any witnesses such party intends to call at the hearing, and a short
summary of the anticipated testimony of each witness;

      


      (c)         a
proposed ruling on each issue to be resolved, together with a request for a
specific damage award or other remedy for each issue.  The proposed
rulings and remedies shall not contain any recitation of the facts or any legal
arguments and shall not exceed one (1) page per issue.

      


      (d)         a
brief in support of such party’s proposed rulings and remedies, provided that
the brief shall not exceed twenty (20) pages.  This page limitation
shall apply regardless of the number of issues raised in the ADR
proceeding.

       

      
        	 
      	
                Except
      as expressly set forth in subparagraphs 4(a) - 4(d), no discovery shall be
      required or permitted by any means, including depositions,
      interrogatories, requests for admissions, or production of
      documents.

              
	 
      	 
      
	
                5.

              	
                The
      hearing shall be conducted on two (2) consecutive days and shall be
      governed by the following rules:

              


      

      


      (a)         Each
party shall be entitled to five (5) hours of hearing time to present its
case.  The neutral shall determine whether each party has had the five
(5) hours to which it is entitled.

      


      (b)         Each
party shall be entitled, but not required, to make an opening statement, to
present regular and rebuttal testimony, documents or other evidence, to
cross-examine witnesses, and to make a closing
argument.  Cross-examination of witnesses shall occur immediately
after their direct testimony, and cross-examination time shall be charged
against the party conducting the cross-examination.

       

      
        
          
          

        

        
          Exhibit E
- 2

          
            

          

        

        
          
          

        

      

       

      (c)         The
party initiating the ADR shall begin the hearing and, if it chooses to make an
opening statement, shall address not only issues it raised but also any issues
raised by the responding party.  The responding party, if it chooses
to make an opening statement, also shall address all issues raised in the
ADR.  Thereafter, the presentation of regular and rebuttal testimony
and documents, other evidence, and closing arguments shall proceed in the same
sequence.

      


      (d)         Except
when testifying, witnesses shall be excluded from the hearing until closing
arguments.

       

      (e)        
Settlement
negotiations, including any statements made therein, shall not be admissible
under any circumstances.  Affidavits prepared for purposes of the ADR
hearing also shall not be admissible.  As to all other matters, the
neutral shall have sole discretion regarding the admissibility of any
evidence.

      


      
        	
                6.

              	
                Within
      seven (7) days following completion of the hearing, each party may submit
      to the other party and the neutral a post-hearing brief in support of its
      proposed rulings and remedies, provided that such brief shall not contain
      or discuss any new evidence and shall not exceed ten (10)
      pages.  This page limitation shall apply regardless of the
      number of issues raised in the ADR proceeding.

              
	 
      	 
      
	
                7.

              	
                The
      neutral shall rule on each disputed issue within fourteen (14) days
      following completion of the hearing.  Such ruling shall adopt in
      its entirety the proposed ruling and remedy of one of the parties on each
      disputed issue but may adopt one party’s proposed rulings and remedies on
      some issues and the other party’s proposed rulings and remedies on other
      issues.  The neutral shall not issue any written opinion or
      otherwise explain the basis of the ruling.

              
	 
      	 
      
	
                8.

              	
                The
      neutral shall be paid a reasonable fee plus expenses.  These
      fees and expenses, along with the reasonable legal fees and expenses of
      the prevailing party (including all expert witness fees and expenses), the
      fees and expenses of a court reporter, and any expenses for a hearing
      room, shall be paid as follows:

              


      

      


      (a)         If
the neutral rules in favor of one party on all disputed issues in the ADR, the
losing party shall pay 100% of such fees and expenses.

      


      (b)         If
the neutral rules in favor of one party on some issues and the other party on
other issues, the neutral shall issue with the rulings a written determination
as to how such fees and expenses shall be allocated between the
parties.  The neutral shall allocate fees and expenses in a way that
bears a reasonable relationship to the outcome of the ADR, with the party
prevailing on more issues, or on issues of greater value or gravity, recovering
a relatively larger share of its legal fees and expenses.

       

      
        
          
          

        

        
          Exhibit E
- 3

          
            

          

        

        
          
          

        

      

       

      
        	
                9.

              	
                The
      rulings of the neutral and the allocation of fees and expenses shall be
      binding, non-reviewable, and non-appealable, and may be entered as a final
      judgment in any court having jurisdiction.

              
	 
      	 
      
	
                10.

              	
                Except
      as provided in paragraph 9 or as required by law, the existence of the
      dispute, any settlement negotiations, the ADR hearing, any submissions
      (including exhibits, testimony, proposed rulings, and briefs), and the
      rulings shall be deemed Confidential Information.  The neutral
      shall have the authority to impose sanctions for unauthorized disclosure
      of Confidential Information.

              
	 
      	 
      
	
                11.

              	
                All
      disputes referred to ADR, the statute of limitations, and the remedies for
      any wrong that may be found, shall be governed by the laws of the State of
      Illinois.

              
	 
      	 
      
	
                12.

              	
                The
      neutral may not award punitive damages.  The parties hereby
      waive the right to punitive damages.

              
	 
      	 
      
	
                13.

              	
                The
      hearings shall be conducted in the English
  language.

              


      

    

     

     

    Exhibit E - 4