Document:

REDACTED
                - AS FILED

            	
              Exhibit
                10.26

            

    

     

    THE
      MARKED PORTIONS OF THIS QUOTATION AMENDMENT HAVE BEEN
      OMITTED

    AND
      FILED SEPARATELY WITH THE COMMISSION PURSUANT TO

    A
      REQUEST FOR CONFIDENTIAL TREATMENT

    

    CONFIDENTIAL

    Quotation
      Amendment for 

    Contract
      Manufacturing of Ora-lynTM

    Prepared
      for Rose C. Perri, Generex Biotechnology Corporation

    

      
        	
                Section
                  1.

              	 	
                Amendment
                  Number

              	 	
                QAR-01

              
	 	 	 	 	 
	
                Section
                  2.

              	 	
                Product

              	 	
                Ora-lyn

              
	 	 	 	 	 
	
                Section
                  3.

              	 	
                Original
                  Quotation Number

              	 	
                QTE-GFV-0001.01

              
	 	 	 	 	 
	
                Section
                  4.

              	 	
                Original
                  Estimated Total Project Cost

              	 	
                [REDACTED]

              
	 	 	 	 	 
	
                Section
                  5.

              	 	
                Additional
                  Estimated Project Cost

              	 	 

      

    

     

    Table
      1:  QAR
      Version History

     

    
      	
              QAR
                Number

            	 	
              Additional
                Cost ($)

            
	
              01

            	 	
              [REDACTED]

            
	
              Revised
                Total Estimated Project Cost

            	 	
              [REDACTED]

            

    

     

    Section
      6.  Reasons
      for Amendment

     

    1)
      Reference to Standard Terms and Conditions

     

    In
      order
      to expedite the project initiation, the project related activities and
      analytical methods transfer will be performed subject to the Standard Terms
      and
      Conditions (STC), effective June 20, 2006, between Cardinal Health and Generex
      Biotechnology Corporation. All other activities (Engineering Batch Production
      and Evaluation, Process Qualification, and Production of Clinical Supplies)
      will
      be performed per the Master Development and Clinical Services Agreement (MDCSA),
      pending negotiation, as specified in the original quotation. Should the MDCSA
      become fully executed prior to the completion of the project related activities
      and analytical methods transfer, the MDCSA will become the applicable legal
      agreement and will supercede the STC.

     

    2)
      Full Release Testing

     

    Generex
      Biotechnology Corporation has requested that Cardinal Health include full
      release testing of clinical batches of the Ora-lyn drug product produced at
      Cardinal Health’s RTP, NC facility. The original quotation included reduced
      release testing by “Identification by HPLC” (GNX-005), “Leak Rate/Net Content”
(GNX-017), and “Fill Weight Finished Product” (GNX-024), “Microbial Limits” (USP
<61>). Additional activities to be included are: 

     

    
      	–  	
              Cardinal
                Health will transfer in-house Generex’s Particle Size Distribution by
                Cascade Impaction method (assumed to be performed using an eight-stage
                cascade impactor)

            

    

    
      	 	 

    

    
      	–  	
              It
                is assumed that the transfers included in the original quotation
                for
                GNX-005 and GNX-020 bulk product methodology will be sufficient for
                the
                transfer of GNX-006 and GNX-021 finished product
                methodology.

            

    

    
      	 	 

    

    
      	–  	
              Full
                release analyses will be performed as listed in Table
                2.

            

    

     

     

    
      
        

      

      160
        Cardinal Health Way • Morrisville, NC 27560 • PO Box 13341 • RTP, NC
        27709

      Direct:
        (919) 481-4855 • Facsimile: (919) 481-4908 • www.cardinal.com/pts

    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    

      
        	
                QAR-01
                  for QTE-GFV-0001.01

              	
                CONFIDENTIAL

              	
                Page
                  2 

              

      

    

     

    Table
      2:  Full
      Release Methods for Reference

     

    
      	
              Reference

            	 	
              Method

            	 	
              Replicates
                per Batch Release

            
	 	 	 	 	 
	
              GNX-002

            	 	
              Physical
                Appearance of Finished Product (Oral-lyn)

            	 	
              [REDACTED]

            
	 	 	 	 	 
	
              GNX-004

            	 	
              pH
                of Finished Product for Aerosol can

            	 	
              [REDACTED]

            
	 	 	 	 	 
	
              GNX-006

            	 	
              HPLC
                Potency and Identity Determination for Insulin in Buccal Formulations
                (Finished Product Oral-lyn by Un-Crimped Method)

            	 	
              [REDACTED]

            
	 	 	 	 	 
	
              GNX-017

            	 	
              Leak
                Rate/Net Content (Aerosol Finished Product)

            	 	
              [REDACTED]

            
	 	 	 	 	 
	
              GNX-021

            	 	
              High
                Molecular Weight Protein (HMWP) Content of Insulin Drug Substance
                and Drug
                Product by Size Exclusion HPLC (Oral-lyn Finished Product)

            	 	
              [REDACTED]

            
	 	 	 	 	 
	
              GNX-022

            	 	
              HPLC
                Assay (Potency) and Identity Determination for Insulin in Buccal
                Formulations 

              (Finished
                Product Oral-lyn by Actuation Method)1

            	 	
              [REDACTED]

            
	 	 	 	 	 
	
              GNX-024

            	 	
              Fill
                Weight Finish Product

            	 	
              [REDACTED]

            
	 	 	 	 	 
	
              TBD

            	 	
              Particle
                Size Distribution by Cascade Impaction

            	 	
              [REDACTED]

            
	 	 	 	 	 
	
              USP
                <61> & <1227>

            	 	
              Microbial
                Limits

            	 	
              [REDACTED]

            

    

     

    1
      It is
      assumed that this HPLC Assay method will be used as the dose content analytical
      method.

     

    Table
      3:  Amended
      Cost Detail

     

    
      	
              Analysis

            	 	
              Cost
                ($)

            
	
              Method
                Transfer

            	 	
              [REDACTED]

            
	
              Batch
                Release 

              (Per
                the methods listed in Table 2)

            	 	
              [REDACTED]
                per batch of [REDACTED] Units1 

              ([REDACTED]
                per unit)

            

    

     

    1
      With
      full batch release, the total clinical supplies production cost for three
      batches is $[REDACTED], or $[REDACTED] above the $[REDACTED] cost quoted for
      reduced release testing in the original quotation.

     

    Section
      7.  Comments

     

    This
      QAR,
      revised to include method transfer and full release testing activities,
      supercedes the “00” version issued June 21, 2006.

     

    Section
      8.   Approvals

     

    
      	
              Generex
                Biotechnology Corporation

            	 	
              Cardinal
                Health PTS, LLC

            
	
              /s/
                Rose C. Perri
                
                

              

              Signature

            	 	
              /s/
                Annette Shanley
                
                

              

              Signature

            
	 	 	 
	
              Rose
                C. Perri
                
                

              

              Printed
                Name

            	 	
              Annette
                Shanley
                
                

              

              Printed
                Name

            
	 	 	 
	
              Chief
                Operating Officer
                
                

              

              Title

            	 	
              Manager,
                Contract Management
                
                

              

              Title

            
	 	 	 
	
              _______________

              Date

            	 	
              _______________

              Date

            

    

     

     

    
      	
              

            	
              Contract
                Management:

              Project
                Coordination:

              Date:

              CAH
                Reference:

            	
              Wally
                Heritage

              David
                Shirley

              August
                17, 2006

              QAR-GFV-0001.01

            

    

     

     

    
      

    

    
      160
        Cardinal Health Way • Morrisville, NC 27560 • PO Box 13341 • RTP, NC
        27709

      Direct:
        (919) 481-4855 • Facsimile: (919) 481-4908 • www.cardinal.com/ptsExhibit
      10.27

     

    REDACTED
      - AS FILED    

     

    THE
      MARKED PORTIONS OF THIS CLINICAL SUPPLY AGREEMENT HAVE BEEN
      OMITTED

    AND
      FILED SEPARATELY WITH THE COMMISSION PURSUANT TO

    A
      REQUEST FOR CONFIDENTIAL TREATMENT

    

    CARDINAL
      HEALTH 

    

    CLINICAL
      SUPPLY AGREEMENT

     

    This
      Clinical Supply Agreement (“Agreement”)
      is
      made as of this ___day of September, 2006 (“Effective
      Date”),
      by
      and between Generex Biotechnology Corporation, a Delaware corporation, with
      a
      place of business at 33 Harbour Square, Toronto, ON, Canada M5J 2G2 (hereinafter
      “Client”)
      and
      Cardinal Health PTS, LLC, a Delaware limited liability company, with a place
      of
      business at 160 Cardinal Health Way, Morrisville, NC 27560 (hereinafter
“Cardinal
      Health”).
      

     

    RECITALS

    

    A. Client
      is
      a pharmaceutical company that develops pharmaceutical products; and

    

    B. 
      Cardinal
      Health provides a complete range of analytical, development and clinical
      services to the pharmaceutical industry; and

    

    C. 
      Client
      and Cardinal Health desire to enter into this Agreement to provide the terms
      and
      conditions upon which Client may engage Cardinal Health to provide services
      as
      defined in individual Project Plans (as defined below) specifying the details
      of
      the services and the related terms and conditions. 

    

    THEREFORE,
      in
      consideration of the mutual covenants, terms and conditions set forth below,
      the
      parties agree as follows:

    

    ARTICLE
      1

    DEFINITIONS

    

    The
      following terms have the following meanings in this Agreement:

    

    1.1  “Affiliate(s)”
means
      any corporation, firm, partnership or other entity that controls, is controlled
      by or is under common control with a party. For purposes of this definition,
      “control” shall mean the ownership of at least fifty percent (50%) of the voting
      share capital of such entity or any other comparable equity or ownership
      interest.

    

    1.2  “API”
means
      the active pharmaceutical ingredient used in the performance of a Project as
      defined in the Project Plan.

    

    1.3  “Applicable
      Laws”
means
      all laws, ordinances, rules and regulations within the Territory applicable
      to
      the Processing of the Product or any aspect thereof and the obligations of
      Cardinal Health or Client, as the context requires under this Agreement,
      including, without limitation, (A) all applicable federal, state and local
      laws
      and regulations of each Territory; (B) the U.S. Federal Food, Drug and Cosmetic
      Act, and (C) the Good
      Manufacturing Practices (“GMPs”),
      Good
      Laboratory Practices (“GLPs”)
      or
      Good Clinical Practices (“GCPs”)
      promulgated by the Regulatory Authorities, as amended from time to time, as
      applicable to the Project. 

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    

    1.4  “Cardinal
      Health Inventions”
has
      the
      meaning set forth in Article 7.3.

    

    1.5  “Change
      Order”
means
      an amendment to a Project Plan agreed to by the parties in writing in accordance
      with the terms set forth in Article 2.2.

    

    1.6  “Client
      Inventions”
has
      the
      meaning set forth in Article 7.2.

    

    1.7  “Client-Supplied
      Materials”
means
      any API or other materials provided by Client to Cardinal Health.

    

    1.8  “Confidential
      Information”
has
      the
      meaning set forth in Article 6.2.

    

    1.9  “Dispute”
means
      any dispute, controversy or disagreement between the parties in connection
      with
      this Agreement.

    

    1.10  “Facility”
means
      the Cardinal Health facility defined in the applicable Project Plan

    

    1.11  “Initial
      Term”
has
      the
      meaning set forth in Article 12.1.

    

    1.12  “Intellectual
      Property”
means
      all intellectual property (whether or not patented), including without
      limitation, patents, patent applications, know-how, trade secrets, copyrights,
      trademarks, designs, concepts, technical information, manuals, standard
      operating procedures, instructions or specifications.

    

    1.13  “Product”
means
      the product or material that is the subject of the services to be provided
      pursuant to a Project Plan.

    

    1.14  “Project
      Plan”
means
      a
      separate quotation or project plan agreed to by the parties in writing
      substantially in the form set out in Attachment A and specifically incorporating
      by reference this Agreement. A Project Plan shall define the scope of the
      services to be performed by Cardinal Health and the responsibilities of the
      parties with respect to such services.

    

    1.15  “Regulatory
      Authority”
means
      any governmental regulatory authority within a Territory involved in regulating
      any aspect of the development, manufacture, market approval, sale, distribution,
      packaging or use of the Product.

    

    1.16  “Services”
means
      all work performed by Cardinal Health for Client pursuant to a Project
      Plan.

     

    1.17  “Specifications”
means
      all written specifications agreed to by the parties in the Project Plan, and
      applicable master batch records, protocols, or standard operating
      procedures.

     

    
      
        
        

      

      
        -2-

        
          

        

      

      
        
        

      

    

    

    1.18  “Territory”
means
      the United States of America, Canada, the European Union and any other country
      which the Parties agree in writing to add to this definition of Territory in
      an
      amendment to this Agreement.

    

    ARTICLE
      2

    SCOPE

    

    2.1 Definition
      of Scope.
      Cardinal Health will perform the services in accordance with the specific terms
      set forth in a Project Plan. Each Project Plan shall clearly define the Project,
      the Product, and the responsibilities of the parties with respect to such
      Project. Each
      Project Plan will include, as appropriate, the scope of work, pricing and
      payment schedule. Each Project Plan shall be subject to all of the terms and
      conditions of this Agreement, in addition to the specific details set forth
      in
      the Project Plan. To the extent any terms or conditions of a Project Plan
      conflict with the terms and conditions of this Agreement, the terms and
      conditions of this Agreement shall control, except to the extent that the
      applicable Project Plan expressly and specifically states an intent to supersede
      this Agreement on a specific matter. Unless specifically agreed to by the
      parties, this Agreement shall not apply to softgel, Zydis,
      inhalation or
      other
      proprietary drug delivery proprietary technologies owned or licensed by Cardinal
      Health. This Agreement shall supersede the terms of any
      purchase order, acknowledgement or delivery document. 

    

    2.2 Amendments
      to Scope/Change Orders.
      Any
      material change in the details of a Project Plan or the assumptions upon which
      the Project Plan is based (including, but not limited to, changes in an agreed
      starting date for a Project or suspension of the Project by Client) may require
      changes in the pricing and/or time lines, and shall require a written amendment
      to the Project Plan (a “Change
      Order”).
      Each
      Change Order shall detail the requested changes to the applicable task,
      responsibility, duty, pricing, time line or other matter. The Change Order
      will
      become effective upon the execution of the Change Order by both parties, and
      Cardinal Health will be given a reasonable period of time within which to
      implement the changes. Both parties agree to act in good faith and promptly
      when
      considering a Change Order requested by the other party. Without limiting the
      foregoing, Client agrees that it will not unreasonably withhold approval of
      a
      Change Order if the proposed changes in pricing or time lines result from,
      among
      other appropriate reasons, forces outside the reasonable control of Cardinal
      Health or changes in the assumptions upon which the initial pricing or time
      lines were based. Cardinal Health reserves the right to postpone effecting
      material changes in the Project’s scope until such time as the parties agree to
      and execute the corresponding Change Order. Notwithstanding the foregoing,
      the
      original Project Plan shall remain in full force and effect and actively
      performed by Cardinal Health until implementation of any Change
      Order.

    

    ARTICLE
      3

    PRICING
      AND PAYMENT TERMS

    

    3.1 Price
      and Price Changes.
       

     

    A.  Price.
      Client
      shall pay for the services as provided in this Agreement and all Project
      Plans.

     

    
      
        
        

      

      
        -3-

        
          

        

      

      
        
        

      

    

     

    B.  Price
      Changes.
      Cardinal Health may revise the prices provided in a Project Plan if (1) the
      parties agree to materially revise a technical test protocol, (2) any
      information relating to a Project which is provided by Client is materially
      inaccurate or materially incomplete, (3) Client materially revises Cardinal
      Health’s responsibilities, the Specifications, applicable test methods, final
      review of test methods, procedures, assumptions, development processes, test
      methods or analytical requirements, (4) Client requests a materially different
      report format, (5) Client requests material revisions to laboratory reports,
      (6)
      Client requests copies of laboratory records (excluding a single copy of batch
      records which will be provided for each batch manufactured hereunder), or (7)
      unforeseen circumstances materially affect the work required to complete the
      Project. 

    

    C. Retesting.
      All
      retesting performed that is not directly due to a Cardinal Health error will
      be
      billed to the Client. All required investigational studies or additional Client
      requests not outlined in the Project Plan will be invoiced for the cost of
      performance at the current standard hourly rate, plus any associated fees.
      If,
      as
      the outcome of an investigation, causality is not determined for retesting,
      Cardinal Health and Client will share equally the additional expenditures
      required to determine causality

    

    D. Out
      Of
      Specification Investigations and Reporting.
      Cardinal Health reserves the right to expend up to 16 hours per occurrence
      to
      complete all required investigational work (such as OOS investigations, trouble
      shooting chromatographic methods, etc.) without prior approval from the Client.
      If the additional work requires going beyond 16 hours, the Client will be
      contacted prior to continuation. The additional work will be performed based
      on
      written agreement from the Client and will be documented on a Cardinal Health
      Quotation Amendment Request (QAR).

    

    E. Cancellations
      and Postponements by Client. 

    

    If
      Client
      cancels or materially postpone a scheduled batch manufacture as outlined in
      the
      Project Plan with less than thirty (30) days notice, Client shall pay an
      accommodation fee as follows:

    

    
      	
              Notification
                prior to Date of Compounding

            	 	
              Fee
                (% of Total Batch Cost)

            
	
              20
                - 29 days

            	 	
              [REDACTED]

            
	
              10
                - 19 days

            	 	
              [REDACTED]

            
	
              4
                -
                9 days

            	 	
              [REDACTED]

            
	
              0
                -
                3 days

            	 	
              [REDACTED]

            

    

    

    If
      Client
      cancels any portion of a Project outlined in the Project Plan which is not
      batch
      manufacture or packaging, Client shall pay all costs for materials purchased
      and
      all services rendered by Cardinal Health prior to termination, plus: (1)
      [REDACTED] of the total quoted value of the services set forth in the Project
      Plan, if the project is cancelled after signing the Project Plan, but prior
      to
      commencement of the Project work, (2) [REDACTED] of the Project Plan value
      if
      cancelled after the Project work has commenced, and (3) the [REDACTED] Project
      Plan value if cancelled after more than fifty percent of the Project work has
      been completed. If Client signs a Project Plan and the Project is delayed by
      more than ninety (90) days at Client’s request, Cardinal Health, at its option,
      may consider the Project cancelled and will charge Client the applicable
      charges.

     

    
      
        
        

      

      
        -4-

        
          

        

      

      
        
        

      

    

    

    F.
      Postponements
      by Cardinal Health. 

    

    If
      Cardinal Health materially postpones a scheduled batch manufacture as outlined
      in the Project Plan due to an inability to provide the facilities necessary
      for
      manufacture for reasons other than Force Majeure for a period of greater than
      five business days from scheduled date, then Cardinal Health shall reduce the
      batch manufacture cost by a percentage as follows:

    

    
      	
              Period
                of postponement

            	 	
              Reduction
                in Batch Cost

            
	
              6
                -
                10 days

            	 	
              [REDACTED]

            
	
              11
                - 20 days

            	 	
              [REDACTED]

            
	
              21
                - 30 days

            	 	
              [REDACTED]

            
	
              Over
                30 days

            	 	
              [REDACTED]

            

    

    

    Notwithstanding
      the foregoing, both parties will attempt to accommodate batch manufacture
      material postponements of less than five business days.

    

    3.2 
      Invoicing. Cardinal
      Health shall invoice Client as follows:
      

    

    A. For
      lot
      manufacture and/or packaging, upon the earliest to occur of the following:
      (1)
      release of a Product lot by Cardinal Health’s Quality Department, whether or not
      Client has approved such release; (2) shipment of the Product by Cardinal
      Health; or (3) if a third party is to perform finished product testing, then
      35
      days following shipment of Product samples to a third party testing agency,
      but
      only if such testing agency has not yet delivered its test results for such
      Product and Cardinal Health has performed all of its responsibilities except for
      those responsibilities which incorporate test results from the third party
      testing agency, 

     

    B. For
      any
      project that can be completed within 30 days (other than lot manufacture),
      Cardinal Health shall invoice Client upon completion of the project;
      or

     

    C. For
      any
      project that cannot be completed within 30 days (other than lot manufacture),
      Cardinal Health shall invoice Client on a monthly basis.

    

    3.3 Payment
      Terms. In
      the
      event payment is not received by Cardinal Health on or before the [REDACTED]
      day
      after the date of the invoice, then Cardinal Health may, in addition to any
      other remedies available at equity or in law, at its option elect to do any
      one
      or more of the following remedies: (i) charge a late payment fee on such unpaid
      amount equal to one percent (1%) per month until paid in full; (ii) suspend
      any
      further deliveries hereunder until such invoice is paid in full; or (iii)
      terminate the Agreement pursuant to Section 12.3.

    

    3.4 Advance
      Payment.
      If at
      any time, in Cardinal Health’s sole discretion exercised in a reasonable and
      objective manner, Client’s credit is materially impaired, Cardinal Health shall
      have the right to require payment in advance before making any further shipment
      of the Product. If Client shall fail, within a reasonable time, to make such
      payment in advance, or if Client shall fail to make payment when due, Cardinal
      Health shall have the right, at its option, to suspend any further deliveries
      hereunder until such default is corrected, without thereby releasing Client
      from
      its obligations under this Agreement.

     

    
      
        
        

      

      
        -5-

        
          

        

      

      
        
        

      

    

    

    3.5 Taxes.
      All
      taxes, duties and other amounts assessed (excluding tax based on net income
      and
      franchise taxes) on the services, components, API or the Product prior to or
      upon sale to Client and on any Client owned tooling and equipment are the
      responsibility of Client, and Client shall reimburse Cardinal Health for any
      such taxes, duties or other expenses paid by Cardinal Health.

    

    3.6 Shipments.
      All
      product, raw materials, components and Batch Documentation shipped by Cardinal
      Health are shipped EXW, Facility. 

     

    ARTICLE
      4

    CLINICAL
      MANUFACTURING AND PACKAGING

    

    4.1 Applicability
      of Terms.
      The
      terms set forth in this Article shall apply only in the event that Cardinal
      Health is providing pre-commercial manufacturing and/or packaging services
      pursuant to this Agreement.

    

    4.2 Non-Conforming
      Product.
      Subject
      to Section 4.4, Client shall notify Cardinal Health within thirty (30) days
      following delivery of Product to Client if
      Client
      has determined that such Product does not conform to Specifications and shall
      provide Cardinal Health a sample of such non-conforming Product. If the batch
      is
      non-conforming, Client shall not be responsible to pay for such batch, and
      Cardinal Health shall, at Client’s option, either (A) reperform the Services at
      Client’s expense, or (B) credit any payments made by Client for such batch.
THE
      OBLIGATIONS OF CARDINAL HEALTH UNDER THE PRECEDING SENTENCE SHALL BE CLIENT’S
      SOLE AND EXCLUSIVE REMEDY UNDER THIS AGREEMENT FOR PRODUCT THAT HAS NOT BEEN
      RELEASED. If
      Cardinal Health does not agree with Client’s determination that such Product
      fails to meet the Specifications, then after reasonable efforts to resolve
      the
      disagreement, either party may submit a sample of such Product to a mutually
      agreed upon independent and appropriately qualified third party laboratory
      to
      determine whether the Product meets the Specifications. The independent party’s
      results shall be final and binding. Unless otherwise agreed to by the parties
      in
      writing, the costs associated with such testing and review shall be borne by
      the
      non-prevailing party.

    

    4.3 Supply
      of Client-Supplied Material for Defective Product.
      In the
      event Cardinal Health re-performs the Services pursuant to Article 4.2, above,
      Client shall supply, at Client’s sole cost, sufficient quantities of the
      Client-Supplied Materials for Cardinal Health to complete such
      replacement.

     

    4.4 Development/Initial
      Batches.
      Each
      batch of Product manufactured under this Agreement will be considered to be
      a
“Development Batch” until Cardinal Health has manufactured three consecutive
      batches of Product that meet the applicable Specifications. The term
“Development Batch” shall include without limitation any batch manufactured
      following (i) a change in Specifications, or (ii) a scale-up in the
      manufacturing process to produce greater quantities of Product, until Cardinal
      Health has manufactured three consecutive batches of Product meeting the new
      Specifications. Client shall be responsible for the cost of each Development
      Batch that fails to meet the Specifications unless Cardinal Health was negligent
      in the manufacture of the out of Specification batch.. Cardinal Health and
      Client shall cooperate in good faith to resolve any problems causing the
      out-of-Specification batch.

     

    
      
        
        

      

      
        -6-

        
          

        

      

      
        
        

      

    

    

    4.5 Unlabeled
      Product.
      If
      Cardinal Health is to provide Client with Product that is not labeled, Client
      represents and warrants that it will comply with all applicable regulations,
      including without limitation 21 CFR § 201.150.

    

    4.6 Failure
      to Take Delivery.
      If
      Client fails to take delivery on any scheduled delivery date, Client shall
      be
      invoiced for the stored Product and invoiced
      on a monthly basis thereafter for reasonable
      administration and storage costs. Any such Product shall be stored by Cardinal
      Health in accordance with the Specifications. For
      each
      such batch of undelivered Product, Client agrees that: (A) Client has made
      a
      fixed commitment to purchase such Product, (B) title and risk of ownership
      for
      such Product passes to Client, (C) such Product shall be on a bill and hold
      basis for legitimate business purposes, (D) if no delivery date is determined
      at
      the time of billing, Cardinal Health shall have the right to ship the Product
      to
      Client within four (4) months after billing, and (E) Client will be responsible
      for any decrease in market value of such Product that relates to factors and
      circumstances outside of Cardinal Health’s control. Within five (5) days
      following a written request from Cardinal Health, Client shall provide Cardinal
      Health with a letter confirming items (A) through (E) of this Article
      for each
      Batch of undelivered Product.

    

    ARTICLE
      5

    REGULATORY

    

    5.1 Audit.
      Prior
      to the commencement of the Services, and subject to Cardinal Health’s
      obligations of confidentiality to third parties, Client shall be permitted
      to
      conduct an audit of those portions of the Facility where Services will be
      conducted. Once annually during
      the
      Term of this Agreement, and subject to Cardinal Health’s obligations of
      confidentiality to third parties, Cardinal Health will permit Client to conduct
      an audit of those portions of the Facility where Services are being conducted
      upon reasonable advance notice during regular business hours. Upon agreement
      of
      the parties, Client may conduct additional audits, provided that Client shall
      reimburse Cardinal Health for reasonable time and reasonable expenses incurred
      by Cardinal Health in connection with such audit. Any and all cited observations
      from any Client audit shall be addressed by Cardinal Health in a timely
      manner.

    

    5.2 Observation.
      Client
      may have up to two (2) representatives at the Facilities to observe the Services
      provided that Client provides Cardinal Health at least ten (10) days’ advance
      written notice of the attendance of such Client representatives. Such
      representatives shall comply with Cardinal Health’s reasonable rules and
      regulations. Client shall indemnify and hold harmless Cardinal Health for any
      action or activity of such representatives while on Cardinal Health’s
      premises.

    

    5.3 Regulatory
      Inspections.
      Each
      party shall: (1) notify the other party promptly of any inspection or inquiry
      by
      any Regulatory Authority concerning any Project or Product of Client; and (2)
      forward to the other party copies of any correspondence from any Regulatory
      Authority relating to such a Project or Product, including, but not limited
      to,
      Form FD-483 notices, FDA refusal to file, rejection or warning letters. Where
      reasonably practicable, each party will be given the opportunity to have a
      representative present during an inspection by a Regulatory Authority. Each
      party acknowledges that it may not direct the manner in which the other party
      fulfills its obligations to permit inspection by a Regulatory Authority.

     

    
      
        
        

      

      
        -7-

        
          

        

      

      
        
        

      

    

     

    5.4 Record
      Retention.
      Unless
      the parties otherwise agree in writing, Cardinal Health will retain batch,
      laboratory and other technical records for the minimum period required by
      applicable laws, rules, regulations and guidelines. Should any such records
      be
      scheduled for destruction, Cardinal Health shall provide 30 days’ advance
      written notice to Client, where disposition change may be permitted; Client
      may
      request in writing the following: “Return Records to Client”.

    

    5.5 Quality
      Agreement.
      Any
      quality agreement executed by the parties related to the Services shall in
      no
      way determine liability or financial responsibility of the parties for the
      responsibilities set forth therein. In the event of a conflict between the
      terms
      of this Agreement and the quality agreement, this Agreement shall
      control.

    

    5.6 Regulatory
      Compliance.
      Client
      shall be solely responsible for all permits and licenses required by any
      Regulatory Authority with respect to the Product and the Services under this
      Agreement, including any product licenses, applications and amendments in
      connection therewith. Cardinal Health will be responsible to maintain all
      permits and licenses required by any Regulatory Authority with respect to the
      Facility. During the Term, Cardinal Health will assist Client with all
      regulatory matters relating to Services under this Agreement, at Client’s
      request and at Client’s expense. Each party intends and commits to cooperate to
      satisfy all Applicable Laws relating to Services under this
      Agreement.

    

    ARTICLE
      6

    CONFIDENTIALITY
      AND NON-USE

    

    6.1 Mutual
      Obligation.
      Cardinal
      Health and Client agree that they will neither use the other party’s
      Confidential Information except in the performance of this Agreement nor
      disclose the other party’s Confidential Information (defined below) to any third
      party without the prior written consent of the other party except as required
      by
      law, regulation or court or administrative order; provided, however, that prior
      to making any such legally required disclosure, the party making such disclosure
      shall give the other party as much prior notice of the requirement for and
      contents of such disclosure as is practicable under the circumstances.
      Notwithstanding the foregoing, each party may disclose the other party’s
      Confidential Information to any of its Affiliates
      that
      (A) need to know such Confidential Information for the purpose of performing
      under this Agreement, (B) are advised of the contents of this Article, and
      (C)
      agree to be bound by the terms of this Article.

    

    6.2 Definition.
      As used
      in this Agreement, the term “Confidential
      Information”
      includes all such information furnished by Cardinal Health or Client, or any
      of
      their respective representatives or Affiliates,
      to the
      other or its representatives or Affiliates,
      whether furnished before, on or after the date of this Agreement and furnished
      in any form, including but not limited to written, verbal, visual, electronic
      or
      in any other media or manner. Confidential Information includes all proprietary
      technologies, know-how, trade secrets, discoveries, inventions and any other
      Intellectual Property (whether or not patented), analyses, compilations,
      business or technical information and other materials prepared by either party,
      or any of their respective representatives, containing or based in whole or
      in
      part on any such information furnished by the other party or its
      representatives. Confidential Information also includes the existence of this
      Agreement and its terms.

     

    
      
        
        

      

      
        -8-

        
          

        

      

      
        
        

      

    

    

    6.3 Exclusions.
      Notwithstanding Section 6.2, Confidential Information does not include
      information that (A) is or becomes generally available to the public or within
      the industry to which such information relates other than as a result of a
      breach of this Agreement, or (B) is already known by the receiving party at
      the
      time of disclosure as evidenced by the receiving party’s written records, or (C)
      becomes available to the receiving party on a non-confidential basis from a
      source that is entitled to disclose it on a non-confidential basis, or (D)
      was
      or is independently developed by or for the receiving party without reference
      to
      the Confidential Information, as evidenced by the receiving party’s written
      records.

     

    6.4 No
      Implied License.
      The
      receiving party will obtain no right of any kind or license under any patent
      application or patent by reason of this Agreement. All Confidential Information
      will remain the sole property of the party disclosing such information or
      data.

    

    6.5 Return
      of Confidential Information.
      Upon
      termination of this Agreement, the receiving party shall, upon request, promptly
      return within thirty (30) days all such information, including any copies
      thereof, and cease its use or, at the request of the disclosing party, shall
      promptly destroy the same and certify such destruction to the disclosing party;
      except for a single copy thereof, which may be retained for the sole purpose
      of
      determining the scope of the obligations incurred under this
      Agreement.

    

    6.6 Survival. The
      obligations of this Article 6 will terminate five (5) years from the expiration
      or termination of this Agreement.

    

    ARTICLE
      7

    INTELLECTUAL
      PROPERTY

    

    7.1 Ownership
      of Existing Technologies.
      All
      rights to and interests in Client’s Intellectual Property and Client’s
      Confidential Information shall remain vested solely in Client and no right
      or
      interest therein is transferred or granted to Cardinal Health under this
      Agreement except for use in performing Services hereunder or as expressly set
      forth herein. All rights to and interests in Cardinal Health’s Intellectual
      Property and Cardinal Health’s Confidential Information shall remain vested
      solely in Cardinal Health and no right or interest therein is transferred or
      granted to Client under this Agreement except for use in performing services
      hereunder or as expressly set forth herein. 

    

    7.2 Client
      Inventions.
      Subject
      to the limitations of Sections 7.1 and 7.3, Client shall own all data, work
      product, results, reports, inventions, developments, technologies and
      information, whether or not patentable, that are generated by Cardinal Health
      in
      connection with the performance of any Project and arise from, are based upon,
      or relate to Cardinal Health’s use of Client’s Confidential Information
      (“Client
      Inventions”);
      provided however, that Client Inventions shall not include any Process
      Invention. As used herein, “Process
      Invention”
means
      any discovery, development, technology or information, including, without
      limitation, any manufacturing, packaging or analytical process or methodology,
      developed by Cardinal Health, whether or not patentable, that does not relate
      exclusively to the use of Client’s patent-protected Product and/or
      patent-protected API. Client will be responsible for obtaining patent protection
      on inventions relating to the Client Inventions at its own cost. Cardinal Health
      agrees to execute all documents necessary to perfect title in any Client
      Inventions in Client. 

     

    
      
        
        

      

      
        -9-

        
          

        

      

      
        
        

      

    

    

    7.3 Cardinal
      Health Inventions.
      Subject
      to the limitations of Sections 7.1 and 7.2, Cardinal Health shall own Process
      Inventions and all inventions, developments, technologies and information,
      whether or not patentable that arise from, are based upon, or relate to the
      Process Inventions or Cardinal Health’s Confidential Information or Intellectual
      Property, provided that no such invention or development shall exclusively
      relate to any Client’s Confidential Information (“Cardinal
      Health Inventions”).
      Cardinal Health will be responsible for obtaining patent protection on Cardinal
      Health Inventions at its own cost. Client agrees to execute all documents
      necessary to perfect title in any Cardinal Health Inventions in Cardinal Health.
      Cardinal Health hereby grants to Client a non-exclusive, royalty free license
      to
      use the Process Inventions solely in connection with the Product that is the
      subject of the Project in which such Process Invention was developed solely
      during the Term.

    

    ARTICLE
      8

    REPRESENTATIONS
      AND WARRANTIES

    

    8.1 Cardinal
      Health.
      Cardinal Health represents and warrants to Client that, unless
      otherwise agreed to by the parties in the Project Plan, Cardinal Health will
      perform each Project Plan in accordance with (A) the Specifications, (B) the
      quality agreement, as indicated in the “Responsibility Delegation checklist”,
      and (C) all Applicable Laws.

    

    8.2 Client.
      Client
      represents and warrants to Cardinal Health that: 

     

    A. The
      Client-Supplied Materials will comply with all applicable Specifications and
      will have been produced in compliance with the Applicable Laws and the
      applicable Project Plan;

    

    B. It
      has
      all necessary authority and all right, title and interest in and to any
      Intellectual Property related to each Product or that is otherwise provided
      by
      Client under this Agreement;

    

    C. It
      has
      provided all safe
      handling instructions, health and environmental information and material safety
      data sheets applicable to the Product or to and any Client-Supplied Materials,
      except as disclosed to Cardinal Health in writing by Client in sufficient time
      for review and training by Cardinal Health prior to delivery; 

    

    D. All
      Product delivered to Client by Cardinal Health will be held, used and/or
      disposed of by Client in accordance with all Applicable Laws;

    

    E. Client
      will comply with all Applicable Laws applicable to Client’s performance under
      this Agreement and its use of any materials or Products provided by Cardinal
      Health under this Agreement or any Project Plan; and

     

    
      
        
        

      

      
        -10-

        
          

        

      

      
        
        

      

    

    

    F. Unless
      otherwise agreed by the parties in writing or in the Project Plan, Client has
      (1) provided complete and accurate scientific data regarding each Project and
      Client’s requirements for each Project, including without limitation test
      methods and development, formulation, fill and finish of the Product if
      applicable, (2) provided Cardinal Health with complete and accurate information
      necessary to develop the scope of work, and estimated or fixed costs for the
      Projects, (3) reviewed and approved all Specifications, (4) if applicable,
      reviewed and approved all in-process and finished Product test results to ensure
      conformity of such results with the Specifications, regardless of which party
      is
      responsible for finished Product release, and (5) if applicable, prepared all
      submissions to Regulatory Authorities.

    

    8.3 Mutual. Each
      party hereby represents and warrants to the other party that:

    

    A. Existence
      and Power.
      Such
      party (1) is duly organized, validly existing and in good standing under the
      laws of the state in which it is organized, (2) has the power and authority
      and
      the legal right to own and operate its property and assets, and to carry on
      its
      business as it is now being conducted, and (3) is in compliance with all
      requirements of Applicable Laws, except to the extent that any noncompliance
      would not materially adversely affect such party's ability to perform its
      obligations under this Agreement;

    

    B. Authorization
      and Enforcement of Obligations.
      Such
      party (1) has the power and authority and the legal right to enter into this
      Agreement and to perform its obligations hereunder and (2) has taken all
      necessary action on its part to authorize the execution and delivery of this
      Agreement and the performance of its obligations hereunder. 

    

    C. Execution
      and Delivery.
      This
      Agreement has been duly executed and delivered on behalf of such party, and
      constitutes a legal, valid, binding obligation, enforceable against such party
      in accordance with its terms;

    

    D. No
      Consents.
      All
      necessary consents, approvals and authorizations of all Regulatory Authorities
      and other persons required to be obtained by such party in connection with
      the
      Agreement have been obtained; and

    

    E. No
      Conflict.
      The
      execution and delivery of this Agreement and the performance of such party's
      obligations hereunder (1) do not conflict with or violate any requirement of
      Applicable Laws; and (2) do not materially conflict with, or constitute a
      material default or require any consent under, any contractual obligation of
      such party.

    

    8.4 Limitations.
      THE
      REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS ARTICLE 8 ARE THE SOLE AND
      EXCLUSIVE REPRESENTATIONS AND WARRANTIES MADE BY EACH PARTY TO THE OTHER AND
      NEITHER PARTY MAKES ANY OTHER REPRESENTATIONS, WARRANTIES OR GUARANTEES OF
      ANY
      KIND WHATSOEVER, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF
      MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR
      PURPOSE.

     

    
      
        
        

      

      
        -11-

        
          

        

      

      
        
        

      

    

    

     

    ARTICLE
      9

    INDEMNIFICATION

    

    9.1 Indemnification
      by Cardinal Health.
      Cardinal Health shall indemnify and hold harmless Client, its Affiliates, and
      their respective directors, officers, employees and agents (“Client
      Indemnitees”)
      from
      and against any and all
      suits,
      claims, losses, demands, liabilities, damages, costs and expenses (including
      reasonable attorneys’ fees) in connection with any suit, demand or action by any
      third party (“Losses”)
      arising out of or resulting from (A) any breach of its representations,
      warranties or obligations set forth in this Agreement or (B) any negligence
      or
      willful misconduct by Cardinal Health, except to the extent that any of the
      foregoing arises out of or results from any Client Indemnitee’s negligence,
      willful misconduct or breach of this Agreement.

     

    9.2 Indemnification
      by Client.
      Client
      shall indemnify and hold harmless Cardinal Health, its Affiliates, and their
      respective directors, officers, employees and agents (“Cardinal
      Health Indemnitees”)
      from
      and against all Losses arising out of or resulting from (A) any breach of its
      representations, warranties or obligations set forth in this Agreement; (B)
      any
      manufacture, sale, promotion, distribution, use of or exposure to the Product
      or
      any Client-Supplied Materials, including, without limitation, product liability
      or strict liability; (C) Client’s exercise of control over the Project to the
      extent that Client's instructions or directions violate Applicable Law; (D)
      the
      conduct of any clinical trials relating to any material or Product which is
      the
      subject of this Agreement or any Project Plan; (E) any actual or alleged
      infringement or violation of any patent, trade secret, copyright, trademark
      or
      other proprietary rights provided by Client; or (F) any negligence or willful
      misconduct by Client, except to the extent that any of the foregoing arises
      out
      of or results from any Cardinal Health Indemnitee’s negligence, willful
      misconduct or breach of this Agreement.

    

    9.3  Indemnification
      Procedures.
      All
      indemnification obligations in this Agreement are conditioned upon the party
      seeking indemnification: (A) promptly notifying the indemnifying party of any
      claim or liability of which the party seeking indemnification becomes aware
      (including a copy of any related complaint, summons, notice or other
      instrument); provided, however, that failure to provide such notice within
      a
      reasonable period of time shall not relieve the indemnifying party of any of
      its
      obligations hereunder except to the extent the indemnifying party is prejudiced
      by such failure; (B) cooperating with the indemnifying party in the defense
      of
      any such claim or liability (at the indemnifying party's expense); and (C)
      not
      compromising or settling any claim or liability without prior written consent
      of
      the indemnifying party. 

     

    
      
        
        

      

      
        -12-

        
          

        

      

      
        
        

      

    

     

    ARTICLE
      10

    LIMITATIONS
      OF LIABILITY

    

    10.1 CARDINAL
      HEALTH’S LIABILITY UNDER THIS AGREEMENT FOR ANY AND ALL CLAIMS FOR LOST, DAMAGED
      OR DESTROYED API OR CLIENT-SUPPLIED MATERIALS WHETHER OR NOT SUCH API OR
      CLIENT-SUPPLIED MATERIALS ARE INCORPORATED INTO FINISHED PRODUCT SHALL NOT
      EXCEED [REDACTED] PER PROJECT PLAN EXCEPT FOR LOSSES RESULTING FROM BATCH
      MANUFACTURE, IN WHICH CASE CARDINAL HEALTH’S LIABILITY SHALL NOT EXCEED
      [REDACTED] PER BATCH 

    

    10.2  CARDINAL
      HEALTH’S TOTAL LIABILITY, WHETHER IN CONTRACT OR TORT, INCLUDING WITHOUT
      LIMITATION ANY OF CARDINAL HEALTH’S INDEMNITY OR OTHER FINANCIAL OBLIGATIONS
      UNDER ARTICLE 9, SHALL IN NO EVENT EXCEED, THE TOTAL FEES PAID BY CLIENT TO
      CARDINAL HEALTH UNDER THE APPLICABLE PROJECT PLAN GIVING RISE TO THE
      CLAIM.

    

    NOTWITHSTANDING
      THE FOREGOING, THE TOTAL LIABILITY AMOUNT CALCULATED IN SHALL BE REDUCED BY
      ANY
      COSTS OR EXPENSES INCURRED BY CARDINAL HEALTH TO PROCURE COMPARATOR PRODUCT.
      

    

    10.3 NEITHER
      PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL, SPECIAL
      OR
      CONSEQUENTIAL DAMAGES ARISING OUT OF PERFORMANCE UNDER THIS
      AGREEMENT,
      INCLUDING WITHOUT LIMITATION, LOSS OF REVENUES, PROFITS OR DATA, WHETHER IN
      CONTRACT OR TORT, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF
      SUCH
      DAMAGES.

    

    ARTICLE
      11

    INSURANCE

    

    11.1. Cardinal
      Health.
      Cardinal
      Health shall, at its own cost and expense, obtain and maintain in full force
      and
      effect the following insurance during the term of this Agreement:

    

    
      	(A)  	
              Commercial
                General Liability insurance with a per-occurrence limit of not less
                than
                $1,000,000; 

            

    

    
      	 	 

    

    
      	(B)  	
              Products
                and Completed Operations Liability Insurance with a per-occurrence
                limit
                of not less than $5,000,000; 

            

    

    
      	 	 

    

    
      	(C)  	
              Workers’
                Compensation and Employer’s Liability Insurance with statutory limits for
                Workers’ Compensation and Employer’s Liability insurance limits of not
                less than $1,000,000 per accident;
                and

            

    

    
      	 	 

    

    
      	(D)  	
              Professional
                Services Errors & Omissions Liability Insurance with per claim and
                aggregate limits of not less than $1,000,000.

            

    

     

    The
      parties hereby acknowledge and agree that Cardinal Health may self-insure all
      or
      any portion of the above-required insurance. In the event that any of the
      required policies of insurance are written on a claims made basis, then such
      policies shall be maintained during the entire term of this Agreement and for
      a
      period of not less than three (3) years following the termination or expiration
      of this Agreement. Cardinal Health shall obtain a waiver from any insurance
      carrier with whom Cardinal Health carries Workers’ Compensation insurance
      releasing its subrogation rights against Client. Cardinal Health shall furnish
      certificates of insurance evidencing the required insurance policies to Client
      as soon as practicable after the effective date of the Agreement and within
      thirty (30) days after renewal of such policies. Each insurance policy that
      is
      required under this Agreement shall be obtained from an insurance carrier with
      an A.M. Best rating of at least A- VII.

     

    
      
        
        

      

      
        -13-

        
          

        

      

      
        
        

      

    

    

    11.2. Client
      Insurance.
      Client
      shall, at its own cost and expense, obtain and maintain in full force and effect
      the following insurance during the term of this Agreement: 

    

    
      	(A)  	
              Commercial
                General Liability Insurance with a per occurrence limit of not less
                than
                $1,000,000;

            

    

    
      	 	 

    

    
      	(B)  	
              Products
                and Completed Operations Liability Insurance with a per occurrence
                limit
                of not less than $10,000,000; 

            

    

    
      	 	 

    

    
      	(C)  	
              Workers’
                Compensation and Employer’s Liability Insurance with statutory limits for
                Workers’ Compensation and Employer’s Liability insurance limits of not
                less than $1,000,000 per accident;
                and

            

    

    
      	 	 

    

    
      	(D)  	
              All
                Risk Property Insurance, including transit coverage, in an amount
                equal to
                full replacement value covering Client’s property while it is at Cardinal
                Health’s facilities or in transit to, from or between Cardinal Health’s
                facilities. 

            

    

    

    The
      parties hereby acknowledge and agree that Client may self-insure all or any
      portion of the above-required insurance. Client shall maintain levels of
      insurance or self insurance sufficient to meet its obligations under this
      Agreement. In the event that any of the required policies of insurance are
      written on a claims made basis, then such policies shall be maintained during
      the entire term of this Agreement and for a period of not less than three (3)
      years following the termination or expiration of this Agreement. Client shall
      obtain a waiver from any insurance carrier with whom Client carries Property
      Insurance releasing its subrogation rights against Cardinal Health. Client
      shall
      not seek reimbursement for any property claim or portion thereof that is not
      fully recovered from Client’s Property Insurance policy. Client shall obtain a
      waiver from any insurance carrier with whom Client carries Workers’ Compensation
      insurance releasing its subrogation rights against Cardinal Health. Cardinal
      Health, Inc. and its subsidiaries and affiliates shall be named as additional
      insureds under the Products and Completed Operations Liability insurance
      policies with respect to the products and completed operations outlined in
      this
      Agreement. Client shall furnish certificates of insurance evidencing the
      required insurance policies and additional insured status to Cardinal Health
      as
      soon as practicable after the effective date of the Agreement and within thirty
      (30) days after renewal of such policies. Each insurance policy that is required
      under this Agreement shall be obtained from an insurance carrier with an A.M.
      Best rating of at least A- VII.

     

    
      
        
        

      

      
        -14-

        
          

        

      

      
        
        

      

    

     

    ARTICLE
      12

    TERM
      AND TERMINATION

    

    12.1 Term. The
      term
      of this Agreement shall commence as of the date set forth above and shall
      continue until either party terminates this Agreement as set forth in Section
      12.2 or 12.3 (“Term”). 

    

    12.2 Termination.
      Client
      may terminate this Agreement or any Project Plan without cause at any time
      during the Term of the Agreement on [REDACTED] days’ prior written notice to the
      other party 

    

    12.3 Immediate
      Termination.
      Either
      party shall have the right to immediately terminate this Agreement if (A) the
      other party files a petition in bankruptcy, or enters into an agreement with
      its
      creditors, or applies for or consents to the appointment of a receiver or
      trustee, or makes an assignment for the benefit of creditors, or suffers or
      permits the entry of any order adjudicating it to be bankrupt or insolvent
      and
      such order is not discharged within thirty (30) days; or (B) if the other party
      materially breaches any of the provisions of this Agreement, and such breach
      is
      not cured or corrective actions started within thirty (30) days after the giving
      of written notice; provided, however, that in the case of a failure of Client
      to
      make payments in accordance with the terms of this Agreement, Cardinal Health
      may terminate this Agreement if such payment breach is not cured within thirty
      (30) days of receipt notice from Cardinal Health.

    

    12.4 Effect
      of Termination.
      Expiration
      or termination of this Agreement shall be without prejudice to any rights or
      obligations that accrued to the benefit of either party prior to such expiration
      or termination. In
      the
      event that this Agreement or any Project Plan is terminated, otherwise than
      by
      Client pursuant to Section 12.3, Client shall pay Cardinal Health for all
      Services performed in accordance with the applicable Project Plan up to the
      date
      of termination plus any applicable cancellation fees, and will reimburse
      Cardinal Health for all costs and expenses incurred, and all non-cancelable
      commitments made, in the performance of Services pursuant to an approved Project
      Plan. In the event that this Agreement or any Project Plan is terminated, all
      non-fabricated materials and semi-finished and finished Products shall be
      returned to Client at Client’s expense, except in the event that termination is
      due to breach by Cardinal Health, in which case materials and Products shall
      be
      returned to Client at Cardinal Health’s expense. 

    

    ARTICLE
      13

    NOTICE

    

    All
      notices and other communications hereunder shall be in writing and shall be
      deemed given: (A) when delivered personally; (B) when delivered by facsimile
      transmission (receipt verified); (C) when received or refused, if mailed by
      registered or certified mail (return receipt requested), postage prepaid; or
      (D)
      when delivered if sent by express courier service, to the parties at the
      following addresses (or at such other address for a party as shall be specified
      by like notice; provided, that notices of a change of address shall be effective
      only upon receipt thereof):

    

    To
      Client:    
      Generex
      Biotechnology Corporation

          
            Attn:
      Rose Perri, Chief Operating Officer

                                      
      33
      Harbour Square, Suite 202

          
            Toronto,
      Ontario, Canada M5J 2G2

    

    To
      Cardinal
      Health:                        
Cardinal
      Health PTS, LLC

          
            Attn:
      Manager, Contract Management

          
            160
      Cardinal Health Way 

          
            Morrisville,
      NC 27560

     

    
      
        
        

      

      
        -15-

        
          

        

      

      
        
        

      

    

     

    With
      a
      copy to:              
      Cardinal
      Health, Inc. 

          
            7000
      Cardinal Place

          
            Dublin,
      Ohio 43017 

          
            Attn:
      Associate General Counsel,  

          
            Pharmaceutical
      Technologies and Services 

          
            Facsimile:
      (614) 757-5051

     

    ARTICLE
      14

    MISCELLANEOUS

    

    14.1 Entire
      Agreement; Amendments.
      This
      Agreement, the attachments, Project Plans and any amendments thereto constitute
      the entire understanding between the parties and supersede any contracts,
      agreements or understanding (oral or written) of the parties with respect to
      the
      subject matter hereof. No term of this Agreement may be amended except upon
      written agreement of both parties, unless otherwise provided in this
      Agreement.

    

    14.2 Captions. The
      captions in this Agreement are for convenience only and are not to be
      interpreted or construed as a substantive part of this Agreement

    

    14.3 Further
      Assurances. The
      parties agree to execute, acknowledge and deliver such further instruments
      and
      to take all such other incidental acts as may be reasonably necessary or
      appropriate to carry out the purpose and intent of this Agreement.

    

    14.4 No
      Waiver. Failure
      by either party to insist upon strict compliance with any term of this Agreement
      in any one or more instances will not be deemed to be a waiver of its rights
      to
      insist upon such strict compliance with respect to any subsequent
      failure.

    

    14.5 Severability.
      If any
      term of this Agreement is declared invalid or unenforceable by a court or other
      body of competent jurisdiction, the remaining terms of this Agreement will
      continue in full force and effect.

     

    14.6 Independent
      Contractors.
      The
      relationship of the parties is that of independent contractors, and neither
      party will incur any debts or make any commitments for the other party except
      to
      the extent expressly provided in this Agreement. Nothing in this Agreement
      is
      intended to create or will be construed as creating between the parties the
      relationship of joint ventures, co-partners, employer/employee or principal
      and
      agent.

     

    
      
        
        

      

      
        -16-

        
          

        

      

      
        
        

      

    

    

    14.7 Successors
      and Assigns.
      This
      Agreement will be binding upon and inure to the benefit of the parties, their
      successors and permitted assigns. Neither party may assign this Agreement,
      in
      whole or in part, without the prior written consent of the other party, except
      that either party may, without the other party's consent, assign this Agreement
      to an Affiliate or to a successor to substantially all of the business or assets
      of the assigning company.

    

    14.8 Governing
      Law.
      This
      Agreement shall be governed by and construed under the laws of the State of
      Ohio, excluding its conflicts of law provisions. The
      United Nations Convention on Contracts for the International Sale of Goods
      shall
      not apply to this Agreement.

    

    14.9 Alternative
      Dispute Resolution.
      If any
      Dispute arises between the parties, such Dispute shall be presented to the
      respective presidents or senior executives of Cardinal Health and Client for
      their consideration and resolution. If such parties cannot reach a resolution
      of
      the Dispute, then such Dispute shall be resolved by binding alternative dispute
      resolution in accordance with the then existing commercial arbitration rules
      of
      CPR, The International Institute for Conflict Prevention & Resolution, 575
      Lexington Avenue, 21st
      Floor,
      New York, NY 10022. Arbitration shall be conducted in New York, NY. 

    

    14.10 Prevailing
      Party.
      In any
      dispute resolution proceeding between the parties in connection with this
      Agreement, the prevailing party will be entitled to its reasonable attorney's
      fees and costs in such proceeding.

    

    14.11 Counterparts.
      This
      Agreement may be executed in one or more counterparts, each of which will be
      deemed an original but all of which together will constitute one and the same
      instrument. Any photocopy, facsimile or electronic reproduction of the executed
      Agreement shall constitute an original. 

    

    14.12 Publicity.
      Neither
      party will make any press release or other public disclosure regarding this
      Agreement or the transactions contemplated hereby without the other party's
      express prior written consent, except as required under Applicable Laws or
      by
      any governmental agency, in which case the party required to make the press
      release or public disclosure shall use commercially reasonable efforts to obtain
      the approval of the other party as to the form, nature and extent of the press
      release or public disclosure prior to issuing the press release or making the
      public disclosure. Cardinal Health hereby acknowledges and agrees that Client
      will be obligated to issue a press release and file a Form 8-K Current Report
      in
      respect of this Agreement in accordance with Applicable Laws, and such press
      release and public disclosure shall accord with the provisions of this
      Section.

    

    14.13 Setoff. Without
      limiting Cardinal Health’s rights under law or in equity, Cardinal Health and
      its Affiliates, parent or related entities, collectively or individually, may
      exercise a right of set-off against any and all amounts due to Cardinal Health
      from Client. For purposes of this Article, Cardinal Health, its Affiliates,
      parent or related entities shall be deemed to be a single creditor.

     

    
      
        
        

      

      
        -17-

        
          

        

      

      
        
        

      

    

    

    14.14 Survival.
      The
      rights and obligations of the parties shall continue under Articles 6
      (Confidentiality), 7 (Intellectual Property), 9 (Indemnification), 10
      (Limitations of Liability), 11 (Insurance), to the extent expressly stated
      therein, 13 (Notice), 14 (Miscellaneous) and Section 12.4 (Effect of
      Termination), notwithstanding expiration or termination of this
      Agreement.

    

    14.15 Force
      Majeure.
      Except
      as to payments required under this Agreement, neither party shall be liable
      in
      damages for, nor shall this Agreement be terminable or cancelable by reason
      of,
      any delay or default in such party’s performance hereunder if such default or
      delay is caused by events beyond such party’s reasonable control including, but
      not limited to, acts of God, regulation or law or other action or failure to
      act
      of any government or agency thereof, war or insurrection, civil commotion,
      destruction of production facilities or materials by earthquake, fire, flood
      or
      storm, labor disturbances, epidemic, or failure of suppliers, public utilities
      or common carriers; provided however, that the party seeking relief hereunder
      shall immediately notify the other party of such cause(s) beyond such party’s
      reasonable control. The party that may invoke this section shall use all
      reasonable endeavors to reinstate its ongoing obligations to the other. If
      the
      cause(s) shall continue unabated for one hundred eighty (180) days, then both
      parties shall meet to discuss and negotiate in good faith what modifications
      to
      this Agreement should result from this force majeure.

    

    IN
      WITNESS WHEREOF,
      the
      parties have caused their duly authorized representative to execute this
      Agreement effective as of the date first written above.

    

    
      	 	 	 	 
	CARDINAL HEALTH PTS,
              LLC	 	 	GENEREX BIOTECHNOLOGY CORPORATION
	 	 	 	 
	By: 
/s/
              Shailesh Maingi	 	 	By:
/s/
              Anna E. Gluskin
	
              
                

              
Name: Shailesh Maingi	 	 	
              
                

              
Name: Anna E. Gluskin
	
              
                

              

              Its:
                VP, Business Division

            	 	 	
               

              Its: President,
                Chief Executive Officer

            
	
              
                

              

            	 	 	
               

            

    

     

      	 	 	 	 
	 	 	 	By: /s/
              Rose C. Perri
	
            	 	 	
              
                

              
Name: Rose
              C. Perri
	 	 	 	
              Its: Chief
                Operating Officer

            

    

     

    
      
        
        

      

      
        -18-

        
          

        

      

      
        
        

      

    

     

    ATTACHMENT
      A

    

    PROJECT
      PLAN

    

    Scope
      of
      Work

    Activities/Specifications

    Scheduling/Deliverables

    Cost
      Proposal

    Invoicing
      and Payment Terms

    Additional
      Project Terms

    Project
      Approval Authorization

     

    All
      work
      performed under this Project Plan is subject to the terms and conditions of
      the
      Clinical Supply Agreement between Client and Cardinal Health dated June __,
      2006. 

     

    
      
        
        

      

      
        -19-

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