ex10-13.htm


    
      

    

    EXHIBIT
10.13

     

    FINAL

     

    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.

                  


          

        

      

    

    
      
         


      

      
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                            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.

                          


                  

                

              

            

          

        

      

    

    
      
         


      

      
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                                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.

                              


                      

                    

                  

                

              

            

          

        

      

    

    
      
         


      

      
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                              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

                  


          

        

      

    

    
      
         


      

      
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                                          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

                              


                      

                    

                  

                

              

            

          

        

      

    

    
      
         


      

      
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                                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.

                    
	 
      	 
      	 
      
	 
      	
                      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.

                    


            

          

        

      

    

    
      
         


      

      
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                              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.

                            


                    

                  

                

              

            

          

        

      

    

    
      
         


      

      
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                                         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.

                  
	 
      	 
      	 
      
	
                    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

                  


          

        

      

    

    
      
         


      

      
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                                (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;

                    


            

          

        

      

    

    
      
         


      

      
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                                                        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 written notice to
      HDC.

                                  
	 
      	 
      	 
      
	
                                    6.4

                                  	
                                                HDC Termination
      Right. HDC may unilaterally terminate this Agreement upon
      one-hundred-eighty (180) days written notice to Abbott, which is given
      after Abbott has given written notice to HDC that the Completion Standards
      of Phase 2 were not met and that Abbott is not proceeding with Phase 3 and
      4.

                                  
	 
      	 
      	 
      
	
                                    6.5

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

                                  


                          

                        

                      

                    

                  

                

              

            

          

        

      

    

    
      
         


      

      
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                          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.

                        
	 
      	 
      
	
                          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.

                        


                

              

            

          

        

      

    

    
      
         


      

      
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                          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.

                        
	 
      	 
      
	
                          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.

                        


                

              

            

          

        

      

    

    
      
         


      

      
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                                      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.

                
	 
      	 
      	 
      
	 
      	 
      	
                                      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.

                


        

      

    

    
      
         


      

      
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                                  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.

            
	 
      	 
      	 
      
	 
      	 
      	
                                  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.

            


    

    
      
         


      

      
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                                          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.

                    
	 
      	 
      	 
      
	 
      	 
      	
                                          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.

                    


            

          

        

      

    

    
      
         


      

      
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                      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:

                    


            

          

        

      

    

     

    
      
        
          
            	 
      	
                    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.

                  


          

        

      

    

    
      
         


      

      
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                            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.

                          
	 
      	 
      
	
                            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).

                          


                  

                

              

            

          

        

      

    

    
      
         


      

      
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                    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.

                  
	 
      	 
      
	
                    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 gb: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 is negotiating an
      experimental testing agreement in place with * that will cover the
      performance of Phase 1 and 2. HDC warrants that it will have the right
      under the agreement with * to transfer the data resulting from Phase 1 and
      2 testing to Abbott and that Abbott will have 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,
*%)

                      


              

            

          

        

      

      
        
           


        

        
          Exhibit C
- 3

          
            

          

        

        
           


        

      

      


      
        
          
            	 
      	
                    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.

                  
	 
      	 
      
	 
      	
                    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.

                    


            

          

        

      

      
        
           


        

        
          Exhibit E
- 1

          
            

          

        

        
           


        

      

      


      
        
          	 
      	
                  
                              (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.

                  

                


        

      

       

      
        
          	
                  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.

              


      

      
        
           


        

        
          Exhibit E
- 2

          
            

          

        

        
           


        

      

      


      
        
          	 
      	
                            (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.

                
	 
      	 
      
	 
      	
                            (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