Unassociated Document


    

      Confidential
        Treatment Requested. Confidential portions of this document have been redacted
        and separately filed with the Commission.

    

     

    LICENSE
      AGREEMENT

    


    This
      LICENSE
      AGREEMENT
      (this
“Agreement”),
      effective as of June 2, 2004 (the “Effective
      Date”),
      is
      between CUBIST
      PHARMACEUTICALS, INC.,
      a
      corporation organized and existing under the laws of Delaware (together with
      its
      Affiliates referred to herein as “CUBIST”)
      and
XTL
      BIOPHARMACEUTICALS LTD.,
      a
      corporation organized and existing under the laws of Israel (together with
      its
      Affiliates referred to herein as “XTL”).
      XTL
      and CUBIST are sometimes hereinafter referred to each as a “Party”
      and
      collectively as the “Parties.”

    Background

    


    XTL
      has
      developed monoclonal antibodies that are active against Hepatitis B using XTL
      Know-How and has rights to XTL Patent Rights. CUBIST desires to obtain a license
      under the XTL Patent Rights and XTL Know-How upon the terms and conditions
      set
      forth herein in order to Obtain Regulatory Approval and commercialize such
      monoclonal antibodies, and XTL desires to grant such a license. In consideration
      of the foregoing premises and the mutual covenants herein contained, the Parties
      hereby agree as follows:

    


    Terms

    


    Section
      1. DEFINITIONS.

    


    1.1 Defined
      Terms.
      Unless
      specifically set forth to the contrary herein, the following terms, whether
      used
      in the singular or plural, shall have the respective meanings set forth
      below:

    


    “Additional
      HBV Products”
      shall
      mean any and all compounds, products, methods or systems, other than a Product
      or a Directly Competitive Product, in any formulation for the treatment or
      prevention of Hepatitis B, that is Controlled by XTL as of the Effective Date
      or
      at any time during the term of this Agreement.

    


    “Affiliate”
      shall
      mean, with respect to any Person, (a) any other Person of which fifty percent
      (50%) or more of the securities or other ownership interests representing the
      equity, the voting stock or general partnership interest are owned, controlled,
      or held, directly or indirectly by, or under common ownership or control with,
      such Person; or (b) any other Person that, directly or indirectly, owns,
      controls, or holds fifty percent (50%) or more of the securities or other
      ownership interests representing the equity, the voting stock or, if applicable,
      the general partnership interest, of such Person. 

    


    “Aggregate
      Designated Costs”
      shall
      have the meaning set forth in Section 7.4.

    


    “Approved
      Third Party Licenses”
      shall
      have the meaning set forth in Section 12.10(c).

    


    “Change
      of Control”
      shall
      mean, with respect to either Party, that a Third Party shall have become the
      beneficial owner of securities representing at least fifty percent (50%) or
      more
      of the aggregate voting power of the then outstanding voting securities of
      such
      Party, or any sale by such Party of all or substantially all of such Party’s
      assets; provided
      that in
      no event shall the sale by a Party of securities in connection with a financing
      or offering undertaken to raise working capital be deemed to be a Change of
      Control unless, as a result of such financing or offering, a Person owns 50%
      or
      more of the voting power of the Party.

    


    “Code”
      shall
      have the meaning set forth in Section 13.6(d).

    


    “Combination
      Product”
      shall
      mean (a) any product, or biologic or pharmaceutical composition comprising,
      among other things, at least two distinct active ingredients, one of which
      shall
      be a Product and at least one of the other active ingredients is not a Product,
      or (b) two or more products, or biologic or pharmaceutical compositions that
      are
      marketed and sold together in the same package, where at least one of such
      products, or biologic or pharmaceutical compositions is a Product and at least
      one of the other products, or biologic or pharmaceutical compositions are not
      Products (including, without limitation, (i) a pharmaceutical or biologic
      composition containing an active ingredient distinct from the active ingredient
      of such Product, (ii) a delivery device or (iii) a delivery system).


    


    “Commercialize”
      shall
      mean all activities relating to the commercialization of a Product including,
      without limitation, promotion, marketing, sales and distribution, whether
      conducted by a Party or for such Party by another, and “Commercialization”
      shall
      be interpreted accordingly.

    


    
      
        
        

      

      
        
        

        
          

        

      

      
        
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            Commission.

        

      

    

     

    “Commercially
      Reasonable Efforts”
      means
      (a) with respect to any objective by any Party, commercially reasonable,
      diligent, good faith efforts to accomplish such objective as such Party would
      normally use to accomplish a similar objective under similar circumstances;
      and
      (b) with respect to any CUBIST objective to Obtain Regulatory Approval of or
      Commercialize any Product, efforts and resources normally used by such Party
      with respect to a product owned by such Party or to which such Party has similar
      rights which is of similar market potential at a similar stage in the
      development or life of such product, taking into account all relevant factors
      in
      all relevant jurisdictions, taken as a whole, including, but not limited to,
      issues of safety, efficacy, product profile, the competitiveness of the
      marketplace, the proprietary position of the product (including whether the
      Product is reasonably likely to infringe the intellectual property or other
      proprietary rights of a Third Party in any jurisdiction), the regulatory
      structure involved and the Regulatory Approval for the Product in each
      jurisdiction (including but not limited to, the extent of the indications for
      such Product has been approved), the level of reimbursement available for the
      Product in each jurisdiction, and the perceived market potential of the Product
      (including the anticipated profitability of the Product). 

    


    “Consent
      Agreement”
      shall
      mean that certain Consent and Amendment Agreement by and among CUBIST, XTL,
      and
      Yeda executed on or about the Effective Date.

    


    “Contract
      Year”
      shall
      mean each twelve month period during the term of this Agreement commencing
      on
      January 1, and ending on December 31; provided
      that the
      first Contract Year during the term of this Agreement will commence on the
      Effective Date and end on December 31 and the last Contract Year during the
      term
      of this Agreement will commence on January 1 and end upon expiration or
      termination of this Agreement.

    


    “Control”
      shall
      mean with respect to (a) any item of information or (b) any intellectual
      property right or (c) any HBV Antibody (including any intellectual property
      or
      other proprietary right embodied therein or related thereto, including without
      limitation any method or process of manufacturing thereof or any use thereof),
      the possession of the right (whether directly or indirectly and whether by
      ownership, license or otherwise, other than pursuant to this Agreement) by
      a
      Party to grant to the other Party access or a license as provided in this
      Agreement under such item of information or intellectual property right without
      violating the terms of any agreement or other arrangements existing before
      or
      after the Effective Date between such Party and any Third Party, and the term
      “Controlled”
      shall be
      interpreted accordingly.

    


    “Coordinator”
      shall
      have the meaning set forth in Section 3.2.

    


    “CUBIST
      Designated Costs”
      shall
      mean, with respect to any period, the Designated Costs attributed to
      CUBIST.

    


    “CUBIST
      Indemnitees”
      shall
      have the meaning set forth in Section 11.3(b).

    


    “CUBIST
      Inventions”
      shall
      have the meaning set forth in Section 12.1.

    


    “CUBIST
      Know-How”
      shall
      mean all inventions (including without limitation all CUBIST Inventions),
      discoveries, improvements, methods, processes, formulas, materials, data,
      know-how, technology, trade secrets and information, whether or not patentable,
      that (a) are owned or Controlled by CUBIST as of the Effective Date or at any
      time during the term of this Agreement, (b) are not, as of the Effective Date
      or
      at any time thereafter, in the public domain or generally known or available
      to
      the public or disclosed in any CUBIST Patents, and (c) are necessary or useful
      to Obtain Regulatory Approval, manufacture, market, promote, sell, import or
      export Products in the Territory.

    


    “CUBIST
      Patents”
      shall
      mean any and all Patents that: (a) are owned or Controlled by CUBIST as of
      the
      Effective Date or at any time during the term of this Agreement; and (b) claim
      or cover any invention (including, without limitation, any CUBIST Invention),
      discovery, improvement, method, process, formula, material, trade secret,
      technology, data or information, solely to the extent necessary or useful to
      Obtain Regulatory Approval, manufacture, market, promote, sell, import or export
      Products in the Territory; provided,
      however, that the CUBIST Patents are all to the extent and only to the extent
      that CUBIST has the right to grant licenses or sublicenses
      thereunder.

    


    “CUBIST
      Trademark”
      shall
      mean any Trademark Controlled by CUBIST.

    


    
      
        
        

      

      
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            Confidential material redacted and filed separately with the
            Commission.

        

      

    

     

    “Designated
      Costs”
      shall
      mean the direct costs and expenses, in Dollars, excluding any general and
administrative
      overhead costs and expenses, actually incurred from and after the Effective
      Date
      in performing those activities that are necessary or advisable to Obtain
      Regulatory Approval for a commercially viable formulation of HepeX-B for the
      prevention of recurrent Hepatitis B infections in liver transplant patients
      in
      the Territory. Subject to the foregoing provisions of this definition,
      Designated Costs shall include: internal human resources costs of either Party
      (calculated using actual local salary and employee benefit rates for
      each
      Full Time Equivalent), expenses paid to contractors, consultants or other third
      parties (such as testing laboratories, clinical consultants, clinical research
      organizations, contract manufacturing organizations and preclinical
      laboratories), including costs and expenses associated with regulatory fees
      (such as PDUFA fees), laboratory supplies, office supplies, travel expenses,
      and
      reasonable allocations of facility and information technology costs. Designated
      Costs shall not include expenses for corporate overhead, profit margin, expenses
      for market research, manufacture or supply for commercial use, commercial launch
      and other Commercialization activities, post-marketing studies not required
      as a
      condition to Obtaining Regulatory Approval in the Territory, or participation
      on
      the Joint Alliance Team. If the Parties are unable to agree whether a particular
      cost or expense is a Designated Cost, either Party may submit the matter to
      the
      dispute resolution procedures set forth in Section 14.

    


    “Directly
      Competitive Product”
      shall
      mean any pharmaceutical or biologic composition (other than a Product
      Commercialized by or for CUBIST or its Affiliates or Sublicensees) that contains
      an HBV Antibody in any formulation for the treatment or prevention of Hepatitis
      B.

    


    “Disagreement
      Notice”
      shall
      have the meaning ascribed to it in Section 2.2.

    


    “Dollars”
      shall
      mean U.S. dollars.

    


    “ECACC”
      shall
      mean the European Collection of Cell Cultures.

    


    “FDA”
      shall
      mean the United States Food and Drug Administration and any successor
      agency.

    


    “First
      Commercial Sale”
      shall
      mean, with respect to a Product, any transfer for value in an arm’s-length
      transaction to a Third Party distributor, agent or end user in a country or
      jurisdiction after obtaining all necessary Regulatory Approvals as may be
      necessary for such transfer in such country or jurisdiction.

    


    “HBIg”
      shall
      mean the immunoglobulin product containing polyclonal antibodies (derived from
      human plasma) to hepatitis B surface antigen, and occasionally referred to
      as
“HBIg”.

    


    “HBV
      Antibody”shall
      mean any and all human or humanized monoclonal immunoglobulins, including intact
      immunoglobulin molecules and any portion or fragment of an immunoglobulin
      molecule, *****, that is directed to and binds to the Hepatitis B virus or
      any
      portion of the Hepatitis B virus.

    


    “HepeX-B”
      shall
      mean, without regard to the actual trade name used, any Product containing
      the
      human monoclonal antibody *****,
      and the
      human monoclonal antibody *****,
      and no
      other antibodies or fragments of other antibodies.

    


    “HepeX-B
      Plan”
      shall
      have the meaning set forth in Section 5.2.

    


    “ICC”
      shall
      have the meaning set forth in Section 14.2(a).

    


    “ICC
      Rules”
      shall
      have the meaning set forth in Section 14.2(a).

    


    “IND”
      shall
      mean an Investigational New Drug Application, or its foreign equivalent,
      regarding Product filed with a Regulatory Authority.

    


    “Joint
      Alliance Team”
      shall
      have the meaning set forth in Section 3.1.

    


    “Joint
      Invention”
      shall
      have the meaning set forth in Section 12.1.

    


    “Joint
      Patent”
      shall
      have the meaning set forth in Section 12.2.

    


    
      
        
        

      

      
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            Confidential material redacted and filed separately with the
            Commission.

        

      

       

    

    “Know-How
      Royalty Rate”
      shall
      have the meaning set forth in Section 10.2.

    


    “Legal
      Opinion”
      shall
      mean a legal opinion that satisfies each of the following conditions: (a) is
      addressed to CUBIST for CUBIST’s benefit, (b) provides that CUBIST’s exercise of
      its rights and licenses under, and its activities under and pursuant to, this
      Agreement, to Obtain Regulatory Approval, make, have made, use, promote, market,
      sell, have sold, offer to sell, import, export, and Commercialize HepeX-B,
      would
      not infringe or misappropriate the intellectual property rights addressed in
      that opinion (including by literal infringement and infringement under the
      doctrine of equivalents and/or other applicable legal standards), or that such
      intellectual property rights are invalid or unenforceable, (c) is provided
      by a
      nationally recognized United States law firm reasonably acceptable to both
      Parties, and (d) was obtained in connection with a joint defense agreement
      pursuant to which such nationally recognized law firm enters into an
      attorney-client relationship with both XTL and CUBIST for the purpose of
      providing such legal opinion.

    


    “Losses”
      shall
      have the meaning set forth in Section 11.3(a).

    


    “Marketing
      Inquiry”
      shall
      have the meaning ascribed to it in Section 2.2.

    


    “Major
      Markets” shall
      mean the United States of America, the United Kingdom, Spain, Italy, France,
      Germany and Japan.

    


    “Milestone
      Event”
      shall
      have the meaning set forth in Section 9.2(a).

    


    “Net
      Sales”
      shall
      mean the aggregate gross sales actually received by CUBIST from sales of a
      Product sold directly by CUBIST or its Affiliate to a Third Party (that is
      not
      an Affiliate or Sublicensee of CUBIST unless the Affiliate or Sublicensee is
      the
      end user of the Product) after deducting, if not previously deducted, from
      the
      amount received the following amounts related specifically to such sales and
      not
      otherwise recovered or reimbursed to CUBIST or its Affiliate: (a) trade and
      quantity discounts in amounts customary in the trade and actually allowed and
      taken; (b) returns, rebates, credits and allowances in amounts customary in
      the
      trade; (c) chargebacks paid on sale or dispensing of Product; and (d) sales
      or
      excise taxes, freight, postage, transportation, insurance charges, custom duties
      and other governmental charges. 

    


    For
      purposes of clarification, sales of a Product sold directly by a Sublicensee
      shall not be included in the calculation of Net Sales, and amounts
      received by CUBIST and its Affiliates for the sale of Products among CUBIST
      and
      its Affiliates for resale shall not be included in the computation of Net Sales
      hereunder.

    


    In
      the
      event that a Product is sold as a component of a Combination Product, then
      Net
      Sales shall be determined by multiplying the Net Sales of the Combination
      Product by the fraction A/(A+B) where A
      equals
      the
      average selling price of such Product sold separately in finished form and
      B
      equals
      the
      aggregate average selling price of the relevant other product sold separately
      in
      finished form, in
      each case
      in the
      relevant country in which sales were made. In the event that no separate sale
      of
      either Product or the relevant other product is made during the applicable
      royalty reporting period and in the relevant country in which the sale of the
      Combination Product was made, then Net Sales shall be determined by multiplying
      the Net Sales of the Combination Product by a fraction (C/(C+D)), where
C
      equals
      CUBIST’s
      standard fully-absorbed cost of Product and D
      equals
      the
      standard fully-absorbed cost of the relevant other product, in
      each case
      determined in accordance with United States generally accepted accounting
      principles for the relevant country in which sales were made. If the relevant
      other product is sold separately in finished form and Product is not, then
      Net
      Sales shall be determined by multiplying the Net Sales of the Combination
      Product by the fraction (E - B)/E, where E
      equals
      the
      average selling price of the Combination Product for the country in which sales
      were made.

    


    “Obtain
      Regulatory Approval”
      shall
      mean those actions required or advisable to prepare and submit commercially
      viable Products for Regulatory Approval as soon as reasonably practicable,
      including without limitation formulation, modification and refinement
      activities, determination of dosage, conducting clinical trials, and labeling
      the Products.

    


    “OCS”
      shall
      have the meaning set forth in Section 11.2(h).

    


    “OCS
      Technology”
      shall
      have the meaning set forth in Section 12.1.

    


    “Patent
      Royalty Rate”
      shall
      have the meaning set forth in Section 10.1.

     

    
      
        
        

      

      
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            Confidential material redacted and filed separately with the
            Commission.

        

      

    

     

    “Patents”
      shall
      mean (a) unexpired letters patent (including inventor’s certificates) which have
      not been revoked or cancelled by a government agency or held invalid or
      unenforceable by a court of competent jurisdiction, from which no appeal can
      be
      taken or has been taken within the required time period, including without
      limitation any substitution, extension, registration, confirmation, reissue,
      re-examination, renewal or any like filing thereof; (b) pending applications
      for
      letters patent, including without limitation any provisional application,
      utility application, continuing prosecution or continuation application,
      divisional application, reissue application and/or continuation in part thereof
      and (c) any foreign or international equivalents or counterparts of such
      unexpired letters patent and pending applications for letters
      patent.

    


    “Person”
      shall
      mean any individual, entity, association, corporation, partnership, limited
      liability company, government (or agency or subdivision thereof), trust, joint
      venture, or proprietorship. 

    


    “Product(s)”
      shall
      mean any or all pharmaceutical or biological composition(s) containing an HBV
      Antibody Controlled by XTL as of the Effective Date or any time thereafter
      during the term of this Agreement, alone or in combination with another
      antibody, antibody fragment or other active compound, for all indications,
      in
      any formulation, by any route of administration, including without limitation,
      HepeX-B. Each distinct formulation of any of the items referred to in the
      foregoing sentence shall be treated as a separate Product.

    


    “Proprietary
      Information”
      shall
      mean all inventions, discoveries, improvements, processes, formulas, materials,
      know-how and trade secrets, and all other scientific, clinical, regulatory,
      marketing, financial and commercial information or data, whether communicated
      in
      writing or orally or by sensory detection, which is provided by, or on behalf
      of, one Party to the other Party in connection with this Agreement.


    


    “Recalculated
      Royalties”
      shall
      have the meaning set forth in Section 10.1.

    


    “Regulatory
      Approval”
      shall
      mean any approvals (including supplements, variations, amendments, pre- and
      post-approvals), licenses, registrations or authorizations of any national,
      state or local regulatory agency, department, bureau, commission, council or
      other governmental entity, necessary for the sale, import or Commercialization
      of Products in the Territory.

    


    “Regulatory
      Authority” shall
      mean the FDA or any foreign counterpart of the FDA, as applicable.

    


    “Retroactive
      Payment Quarter”
      shall
      have the meaning set forth in Section 10.1.

    


    “Retroactive
      Royalty Country”
      shall
      have the meaning set forth in Section 10.1.

    


    “Retroactive
      Royalty Year”
      shall
      have the meaning set forth in Section 10.1.

    


    “Retroactive
      Valid Claim”
      shall
      have the meaning set forth in the definition of Valid Claim.

    


    “Sublicensee”
      shall
      mean, without derogating from the Consent Agreement, any Person (other than
      an
      Affiliate of CUBIST) to whom CUBIST
      grants a
      sublicense to the license rights granted by XTL to CUBIST
      hereunder.

    


    “Sublicensee
      Revenues”
      shall
      mean the aggregate upfront, milestone, royalty and other payments actually
      received by CUBIST or its Affiliates from each of its Sublicensees (other than
      XTL, if applicable) with respect to XTL Technology or Products, excluding
      payments made to reimburse CUBIST for any verifiable costs actually incurred
      by
      CUBIST in connection with (a) activities to Obtain Regulatory Approval,
      manufacture, market, promote, sell, offer to sell, import or export Product
      and
      (b) the transaction contemplated between CUBIST and such
      Sublicensee.

    


    “Territory”
      shall
      mean all countries of the world.

    


    “Third
      Party” shall
      mean a Person other than CUBIST or XTL or an Affiliate of either
      Party.

    


    “Third
      Party Infringement Claim”
      shall
      have the meaning set forth in Section 12.6(a).

    


    “Third
      Party Transaction”
      shall
      have the meaning set forth in Section 2.3.

    


    
      
        
        

      

      
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            Confidential material redacted and filed separately with the
            Commission.

        

      

       

    

    “TM
      Infringement”
      shall
      have the meaning set forth in Section 12.5.

    


    "Trademark"
      shall
      mean any word, phrase, slogan, design, symbol or product packaging used or
      intended to be used to identify the Products or distinguish them from
      competitive or related products, and shall include any application to register
      or registration of or common law rights of the foregoing.

    


    “Unlicensed
      Product”
      shall
      mean, with respect to any given country or jurisdiction within the Territory,
      any pharmaceutical or biological composition containing an HBV Antibody (except
      for HBIg), for sale or use for the treatment or prevention of Hepatitis B
      infection or re-infection in such country within the Territory, other
      than
      as a result of any license, sublicense, distribution or
      other arrangement
      with respect to a Product or the rights or licensees granted by XTL to CUBIST
      hereunder granted or entered into by CUBIST or any of its Affiliates or
      distributors.

    


    “Valid
      Claim”
      shall
      mean an unexpired claim of an issued patent within XTL Patents which has not
      been found to be invalid or unenforceable by a court or other competent
      authority in the subject country, from which decision no appeal is taken or
      can
      be taken. In the event a claim in a pending patent application Controlled by
      XTL
      issues in a country and such issued claim has not been found to be invalid
      or
      unenforceable by a court or other competent authority in the subject country,
      from which decision no appeal is taken or can be taken, such claim shall
      retroactively be deemed a Valid Claim in such country for the purposes of
      royalty and Sublicensee Revenues payments under Section 10.1(b) and Section
      10.3(e) as of the date the applicable patent application was filed in such
      country (a “Retroactive
      Valid Claim”).

    


    “XTL
      Activities”
      shall
      have the meaning set forth in Section 5.1(b).

    


    “XTL
      Designated Costs”
      shall
      mean, with respect to any period, the Designated Costs attributed to
      XTL.

    


    “XTL
      Indemnitees”
      shall
      have the meaning set forth in Section 11.3(a).

    


    “XTL
      Inventions”
      shall
      have the meaning set forth in Section 12.1.

    


    “XTL
      Know-How”
      shall
      mean all inventions (including without limitation all XTL Inventions),
      discoveries, improvements, methods, processes, formulas, materials, data,
      know-how, technology, trade secrets and information, whether or not patentable,
      that (a) are owned or Controlled by XTL as of the Effective Date or at any
      time
      during the term of this Agreement, (b) are not, as of the Effective Date or
      at
      any time thereafter, in the public domain or generally known or available to
      the
      public or disclosed in any XTL Patents, and (c) are necessary or reasonably
      useful to Obtain Regulatory Approval, manufacture, market, promote, sell, import
      or export Products in the Territory. 

    


    “XTL
      Licensor Payments”
      shall
      mean any amounts that are required to be paid to Yeda pursuant to the XY
      Agreement as supplemented by the Consent Agreement, or any amounts that XTL
      is
      required to pay to any other Third Party licensors pursuant to written
      agreements entered into prior to the Effective Date which are identified on
      Exhibit
      E
      to the
      extent that such payments are required (a) with respect to sales of Product,
      or
      (b) with respect to milestone or royalty payments that XTL receives, or is
      deemed to have received under XTL’s agreements with such Third Parties, from
      CUBIST.

    


    “XTL
      Patents”
      shall
      mean any and all Patents that: (a) are owned or Controlled by XTL as of the
      Effective Date or at any time during the term of this Agreement; and (b) claim
      or cover any invention (including, without limitation, any XTL Invention),
      discovery, improvement, method, process, formula, material, trade secret,
      technology, data or information, solely to the extent necessary or reasonably
      useful to Obtain Regulatory Approval, manufacture, market, promote, sell, import
      or export Products in the Territory (including, without limitation, those
      Patents listed on Exhibit
      A);
      provided,
      however, that the XTL Patents are all to the extent and only to the extent
      that
      XTL has the right to grant licenses or sublicenses thereunder.

    


    “XTL
      Technology”
      shall
      mean XTL Patents and XTL Know-How.

    


    “XTL
      Trademarks”
      shall
      mean the trademarks Controlled by XTL as of the Effective Date and set forth
      on
Exhibit
      B
      hereto.

    


    
      
        
        

      

      
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          *****
            Confidential material redacted and filed separately with the
            Commission.

        

      

    

     

    “XY
      Agreement”
      shall
      mean that certain Research and License Agreement between Xenograft Technologies
      Ltd. (now known as XTL Biopharmaceuticals Ltd.) and Yeda Research and
      Development Company Ltd. (hereinafter “Yeda”)
      executed on or about April 7, 1993, as amended on or about August 31, 1995,
      January 25, 1998, and January 26, 2003 and as further amended as of the
      Effective Date.

    


    “Yeda
      Technology”
      shall
      have the meaning set forth in Section 12.1.

    


    Section
      2. LICENSE;
      DILIGENCE; RIGHT OF FIRST NEGOTIATION.

    


    2.1 License
      Grant.
      Subject
      to the terms and conditions of this Agreement and the provisions of the Consent
      Agreement, XTL hereby grants to CUBIST the
      exclusive right and license (even as to XTL), including the right, subject
      to
      the Consent Agreement, to sublicense (which includes the sublicense to XTL
      under
      Section 2.5 below), under the XTL Technology and XTL Trademarks to Obtain
      Regulatory Approval, make, have made (including under Section 3.3 below), use,
      promote, market, sell, have sold, offer to sell, import or export Products
      in
      the Territory. CUBIST (excluding Cubist Affiliates) may grant sublicenses of
      the
      rights licensed to CUBIST pursuant to this Section 2.1 (subject to the
      limitations and obligations imposed pursuant to the Consent Agreement). Any
      sublicense by CUBIST to a Sublicensee of the rights licensed by XTL to CUBIST
      hereunder shall be consistent with the terms and conditions of this Agreement
      and the Consent Agreement, and shall include an obligation for the Sublicensee
      to comply with the obligations of this Agreement applicable to Sublicensees,
      including, without limitation, the applicable obligations contained in Section
      4.1(b) pertaining to reports, Section 8.1 pertaining to confidentiality and
      Section 8.5 pertaining to records and audits. CUBIST hereby agrees to remain
      liable for performance under this Agreement by all Sublicensees (including
      CUBIST Affiliates).

    


    2.2 CUBIST
      Diligence. (a)
      Subject
      to, and in accordance with, the terms and conditions of this Agreement and
      all
      requirements of applicable laws, rules and regulations, CUBIST shall use
      Commercially Reasonable Efforts to Obtain Regulatory Approval for HepeX-B in
      each of the Major Markets, and subsequent to obtaining Regulatory Approval
      in a
      Major Market, to Commercialize HepeX-B in such Major Market. The sole remedy
      of
      XTL for any breach by CUBIST of its obligations under this Section 2.2 with
      respect to any Major Market is to terminate CUBIST’s rights and licenses under
      this Agreement with respect to such Major Market pursuant to Section 13.4.
      In
      the event CUBIST breaches its obligations under Section 2.2 with respect to
      ***** or more Major Market countries, XTL shall also have the right pursuant
      to
      Section 13.4 to terminate CUBIST’s rights and licenses under this Agreement with
      respect to each country that is not a Major Market country in which CUBIST
      is
      not then using Commercially Reasonable Efforts to Obtain Regulatory Approval
      for
      HepeX-B, and subsequent to obtaining Regulatory Approval in such country, to
      Commercialize HepeX-B in such country. For the avoidance of doubt, CUBIST shall
      not be considered to be in violation of its diligence obligations under this
      Section 2.2 if the failure to use Commercially Reasonable Efforts as required
      under this Section 2.2 is caused in material part by the wrongful acts or
      omissions of XTL or any breach of this Agreement by XTL.

     

    (b) CUBIST
      shall be deemed to have used Commercially Reasonable Efforts for all purposes
      of
      this Section 2.2 at all times following such time as CUBIST (and its Affiliates
      and Sublicensees) has achieved worldwide Net Sales and Sublicensee Revenues
      which, combined, exceed the aggregate amount of $50,000,000. Notwithstanding
      anything to the contrary in this Agreement, the “safe harbor” provisions of this
      Section 2.2(b) are not intended to set minimum standards of performance by
      CUBIST, and CUBIST shall be entitled to demonstrate that other efforts with
      respect to the Product should be deemed to be Commercially Reasonable
      Efforts.

    


    (c) As
      set
      forth in Section 2.2(a), the parties agree that XTL’s sole and exclusive remedy
      with respect to a material breach by CUBIST of its obligations set forth in
      Section 2.2(a) shall be to terminate the rights and licenses granted by XTL
      to
      CUBIST under this Agreement with respect to those jurisdictions within the
      Territory in which CUBIST shall have failed to use Commercially Reasonable
      Efforts; provided
      that
      within sixty (60) days after receipt of any report provided by CUBIST under
      Section 4.1(b), XTL shall have delivered to CUBIST written notice (a
“Disagreement
      Notice”)
      of
      such failure, which notice shall set forth in reasonable detail the nature
      of
      the alleged failure; provided
      further
      that such failure has not been cured or waived within 60 calendar days following
      delivery of such notice. If XTL does not deliver a Disagreement Notice under
      this Section 2.2(c) within such sixty (60) day period, CUBIST shall
      be
      deemed to be in full compliance with the terms of Section 2.2(a) with
      respect to the time period covered by such CUBIST report. XTL shall not bring,
      commence, continue or prosecute any claim, legal action or proceeding under,
      in
      relation to, arising out of or in connection with a breach of Section 2.2(a),
      except as set forth in Section 2.2(d). 

     

    
      
        
        

      

      
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    (d) If
      XTL
      and CUBIST are not able to resolve their disagreement with respect to CUBIST’s
      compliance with Section 2.2(a) within sixty (60) days after CUBIST’s
      receipt of a Disagreement Notice, then either XTL or CUBIST, acting alone,
      may
      at any time following receipt of such Disagreement Notice by delivery to the
      other party of a written notice indicating such party’s election to have the
      disagreement resolved by arbitration (a “Marketing
      Inquiry”),
      cause
      the matter to be submitted to binding arbitration under Section 14.2;
provided
      that (i)
      the
      arbitrators shall be entitled to review and resolve only whether or not CUBIST
      failed to materially comply with its obligations under Section 2.2(a) during
      the
      applicable reporting period of time that is the subject of the Marketing
      Inquiry, and (ii) the arbitrators shall be individuals who are knowledgeable
      in
      the field of the development, manufacture, and sale of drugs and drug products,
      and shall have no current or prior business relationships with any of XTL,
      CUBIST, or any of their respective Affiliates.

     

    2.3 Rights
      to Additional HBV Product.
      Subject
      to the limitation set forth below in this Section 2.3, in the event that XTL
      intends to grant a license or sublicense (or to otherwise transfer rights other
      than pursuant to a Change of Control of XTL) to a Third Party to obtain
      regulatory approval or commercialize Additional HBV Products (a "Third
      Party Transaction"),
      XTL
      shall so notify CUBIST (and shall provide together with such notice all such
      information necessary or useful to CUBIST to determine whether to exercise
      its
      rights under this Section 2.3 with respect to the Additional HBV Products as
      is
      in XTL’s possession or control) prior to entering into negotiations or
      discussions with such Third Party Transaction. If, within *****
      days
      after CUBIST has received such notice (and information) from XTL, CUBIST
      notifies XTL in writing that it wishes to negotiate to obtain a license or
      sublicense (or otherwise acquire rights to) such Additional HBV Products, then
      the Parties shall negotiate in good faith for a period of *****
      days to
      see if the Parties can reach agreement on commercially reasonable terms pursuant
      to which XTL would license or sublicense (or otherwise transfer rights to)
      such
      Additional HBV Products to CUBIST. During the *****
      day
      period in which CUBIST and XTL are negotiating pursuant to this Section 2.3,
      such negotiations shall be exclusive and XTL cannot carry on discussions or
      negotiations with any Third Party regarding the grant of a license or sublicense
      (or other transfer of rights) to such Third Party to obtain regulatory approval
      or commercialize Additional HBV Products in any country or jurisdiction within
      the Territory. If XTL and CUBIST cannot reach agreement on such terms within
      such *****
      days,
      then XTL shall be free to enter into negotiations and discussions with such
      Third Party, and enter into a Third Party Transaction; provided,
      however, in no event will XTL enter into an agreement with such Third Party
      to
      obtain regulatory approval or commercialize such Additional HBV Products on
      terms, considered in the totality of the circumstances, any less favorable
      than
      the terms last offered or proposed by CUBIST pursuant to the preceding
      provisions of this Section 2.3 without providing CUBIST with written notice
      of
      such terms and giving CUBIST *****
      days to
      accept them. Notwithstanding anything expressed or implied in the foregoing
      provisions of this Section 2.3, in the event of a Change of Control of XTL,
      CUBIST’s rights under this Section 2.3 shall terminate with respect to any
      Additional HBV Product of which CUBIST was informed by XTL in writing pursuant
      to Section 15.4 (without copies to legal counsel) at least thirty (30) days
      prior to the Change of Control of XTL; provided
      that if
      CUBIST notifies XTL in writing that it wishes to negotiate to obtain a license
      or sublicense (or otherwise acquire rights to) such Additional HBV Product
      within *****
      days
      after XTL informed CUBIST of such Additional HBV Product, CUBIST’s rights under
      this Section 2.3 shall not terminate with respect to such Additional HBV Product
      unless and until XTL has negotiated in good faith for a period of up to
*****
      days and
      has failed to reach agreement on commercially reasonable terms pursuant to
      which
      XTL would license or sublicense (or otherwise transfer rights to) such
      Additional HBV Product to CUBIST.

    


    2.4 Directly
      Competitive Product.
      During
      the term of this Agreement and until the earlier to occur of (a) the first
      anniversary of the effective date of expiration or termination of this Agreement
      in its entirety, and (b) the effective date of *****;
      XTL
      shall not develop, research, market, sell, distribute or otherwise Commercialize
      a Directly Competitive Product in the Territory, nor will XTL provide any
      services, data or information to any Third Party in the furtherance of, or
      with
      respect to, any of the foregoing; provided,
      however, that the restrictions in this Section 2.4 shall not apply in any
      jurisdictions with respect to which Cubist’s rights and licenses granted by XTL
      under this Agreement have been terminated pursuant to Section 2.2.

    


    2.5 Sublicensing. (a)
      If
      CUBIST proposes to sublicense to a Third Party any rights to distribute promote,
      market or sell Product in the United States and/or in more than *****
      Major
      Markets in the European Union, then CUBIST will notify XTL in writing thereof.
      If, within thirty (30) days after XTL has received such notice from XTL, XTL
      notifies CUBIST in writing that it wishes to negotiate to become CUBIST’s
      Sublicensee with respect to the activities to distribute, promote, market or
      sell Product described in CUBIST’s notice with respect to such countries, then
      the Parties shall negotiate in good faith for a period of *****
      days to
      see if the Parties can reach agreement on commercially reasonable terms pursuant
      to which XTL would serve as such Sublicensee. During the *****
      day
      period in which CUBIST and XTL are negotiating pursuant to this Section 2.5,
      such negotiations shall be exclusive and CUBIST cannot carry on discussions
      or
      negotiations with any Third Party regarding the opportunity to serve as such
      Sublicensee in such countries. If XTL and CUBIST cannot reach agreement on
      such
      terms within such *****
      days,
      then CUBIST shall be free to enter into negotiations and discussions with such
      Third Party, and grant such a sublicense to such Third Party; provided,
      however, in no event will CUBIST grant such a sublicense to such Third Party
      on
      terms, considered in the totality of the circumstances, any less favorable
      to
      CUBIST than the terms last offered or proposed by XTL pursuant to the preceding
      provisions of this Section 2.5 without providing XTL with written notice of
      such
      terms and giving XTL *****
      days to
      accept them. 

    


    
      
        
        

      

      
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    (b) Without
      limiting clause (a) above, if CUBIST proposes to sublicense to a Third Party
      any
      rights to distribute promote, market, and sell Product *****,
      then
      CUBIST will notify XTL in writing thereof and thereafter, XTL, to the extent
      that it remains so interested, shall be included among the interested parties
      with whom CUBIST holds discussions for such rights until such time as CUBIST
      selects the party with whom it wishes to enter into negotiations for a
      definitive agreement for such rights. XTL acknowledges that beyond inclusion
      and
      participation in the discussions for such rights, XTL has no additional right
      or
      expectation whatsoever, and CUBIST has no additional obligation to XTL in
      respect of such rights under this Section 2.5(b).

    


    (c) Notwithstanding
      anything expressed or implied in this Section 2.5, in the event of a Change
      of
      Control of CUBIST, XTL’s rights under this Section 2.5 shall terminate
      (except
      with respect to any separate written agreement entered into between CUBIST
      and
      XTL prior to the effective date of such Change of Control;
      provided
      that
      CUBIST has promptly complied with the notice provisions set forth in this
      Section 2.5 prior to such Change of Control).

    


    2.6 Trademarks.
      XTL
      hereby grants CUBIST an exclusive, royalty-free license under its entire right,
      title and interest in and to the XTL Trademarks, if any, to use and display
      the
      XTL Trademarks in connection with the Commercialization of Product within the
      Territory. CUBIST shall not be obligated to use XTL Trademarks, and shall be
      free to select, create and use its own trade names and marks for its use, in
      connection with the Commercialization of Product in the Territory.

    


    Section
      3. COORDINATION.

    


    3.1 Joint
      Alliance Team.

    


    (a)   Within
      thirty (30) days after the Effective Date, CUBIST and XTL shall establish
      a
      committee to exchange information regarding, and to discuss activities to Obtain
      Regulatory Approval and manufacture and supply of Product in the Territory
      (the
“Joint
      Alliance Team”),
      which
      shall (i) monitor activities to Obtain Regulatory Approval under the
      HepeX-B Plan, (ii) discuss, formulate, and recommend proposed modifications
      to
      the HepeX-B Plan for review by CUBIST and XTL, (iii) serve as a forum for the
      review and discussion of the Parties’ efforts to Obtain Regulatory Approval and
      efforts to manufacture Product, (iv) serve as a vehicle to facilitate the
      transfer to CUBIST of certain information, data and technology related to
      Products, and (v) serve as a forum for the discussion of disputes between the
      Parties before resorting to the dispute resolution mechanism in Section 14
      of
      this Agreement.

    


    (b)   The
      Joint
      Alliance Team shall be composed of named representatives of CUBIST and named
      representatives of XTL. Each Party shall appoint its respective representatives
      to the Joint Alliance Team from time to time, and may substitute one or more
      of
      its representatives, in its sole discretion, effective upon notice to the other
      Party of such change. Of the initial representatives to be designated by each
      Party, there shall be expertise in preclinical development, process development,
      regulatory activities, clinical development, and manufacturing and supply
      matters. The Parties shall be free to change their representatives from time
      to
      time and at any time. Each representative serving on the Joint Alliance Team
      shall have appropriate technical credentials, experience and knowledge, and
      ongoing familiarity in the specific area of such representative’s expertise. The
      chief business officer, or his/her designee, of each Party shall serve as
      co-chair to the Joint Alliance Team. Additional representatives or consultants
      may from time to time, by mutual consent of the Parties, be invited to attend
      Joint Alliance Team meetings, subject to compliance with the provisions of
      Section 8.1 of this Agreement. The co-chairpersons shall be responsible for
      calling meetings, preparing and circulating an agenda in advance of each
      meeting, and preparing and issuing minutes of each meeting within thirty (30)
      days thereafter.

    


    (c)   The
      Joint
      Alliance Team shall hold meetings at such times as it elects to do so, but
      in no
      event shall
      such meetings be held less frequently than once every three (3) months unless
      otherwise agreed by the Parties. The first meeting of the Joint Alliance Team
      shall be held no later than sixty (60) days after the Effective Date. Meetings
      of the Joint Alliance Team may be held by audio or video teleconference with
      the
      consent of each Party; provided
      that at
      least two (2) meetings per year shall be held in person, one (1) per year at
      the
      location of each party or such other location as the Parties may mutually agree.
      Each Party shall be responsible for all of its own expenses of participating
      in
      the Joint Alliance Team. The co-chairpersons will alternate responsibility
      for
      preparing minutes of each meeting of the Joint Alliance Team, which minutes
      will
      not be finalized until the co-chairperson that did not prepare such minutes
      reviews and confirms the accuracy of such minutes in writing.

    


    
      
        
        

      

      
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    (d) The
      Joint
      Alliance Team shall operate by consensus. If the Joint Alliance Team is unable
      to reach consensus on any particular issue, CUBIST shall have the right in
      its
      sole discretion to make the final decision. The Joint Alliance Team shall not
      have the power resolve any disputes concerning the validity, interpretation
      or
      construction of, or the compliance with or breach of, this Agreement, which
      disputes shall be resolved pursuant to Section 14. The rights and
      responsibilities of each Party shall be governed by this Agreement, including
      the exhibits hereto, and the Joint Alliance Team shall not have any power to
      amend, modify or waive compliance with this Agreement.

    


    (e) Notwithstanding
      anything express or implied to the contrary in this Agreement, CUBIST may
      terminate the Joint Alliance Team and its functions hereunder, in whole or
      in
      part, in its sole discretion upon thirty (30) days’ prior written notice to XTL.
      Upon termination of the Joint Alliance Team, CUBIST shall assume sole
      responsibility to update the HepeX-B Plan from time to time in accordance with
      Section 5.2.

    


    3.2   Coordinators.  Each
      Party shall appoint a designee (a “Coordinator”)
      to
      coordinate its activities under this Agreement. The Coordinators shall serve
      as
      primary contacts between the Parties with respect to this Agreement. Each Party
      shall notify the other Party within thirty (30) days of the date of this
      Agreement of the appointment of its Coordinator and shall notify the other
      Party
      as soon as practicable upon changing such appointment. The Coordinator appointed
      by each Party shall be responsible for (a) preparing such Party’s
      representatives serving on the Joint Alliance Team for meetings of the Joint
      Alliance Team, (b) coordinating the distribution and exchange of
      information to, from and among such Party’s representatives serving on the Joint
      Alliance Team, and (c) assisting in the coordination of the day-to-day
      activities of such Party’s representatives serving on the Joint Alliance Team so
      that the Joint Alliance Team can function effectively and such representatives
      can more effectively discharge their responsibilities as members of the Joint
      Alliance Team.

    


    3.3 Non-exclusive
      Right of Negotiation for Manufacturing Rights.
      Subject
      to the provisions of this Section 3.3, CUBIST hereby grants XTL a non-exclusive
      right of negotiation during the term of this Agreement to obtain all or any
      portion of the rights to manufacture and supply Product in the Territory. In
      the
      event that CUBIST proposes to engage a Third Party manufacturer to manufacture
      and supply Product in the Territory, then CUBIST will notify XTL in writing
      thereof and thereafter, XTL, to the extent that it remains so interested, shall
      be included among the interested parties with whom CUBIST holds discussions
      for
      the right to manufacture Products in the Territory until such time as CUBIST
      selects the party with whom it wishes to enter into negotiations for a
      definitive agreement for such rights. XTL acknowledges that beyond inclusion
      and
      participation in the discussions for such rights, XTL has no additional right
      or
      expectation whatsoever, and CUBIST has no additional obligation to XTL in
      respect of such non-exclusive negotiation rights. CUBIST shall consider
      commercially reasonable criteria in selecting its Third Party manufacturers,
      including without limitation, the Product specifications, the cost of goods
      sold, regulatory requirements and prior experience and performance. Without
      limiting the generality of the foregoing, XTL acknowledges that CUBIST shall
      have complete liberty to select its manufacturing partners, and to determine
      all
      manufacturing activities, as CUBIST, in its sole discretion, sees fit, but
      consistent with CUBIST’s obligations to use Commercially Reasonable Efforts as
      set forth in Section 2.2. Notwithstanding anything expressed or implied to
      the
      contrary in this Section 3.3, XTL shall be afforded the opportunity to
      participate in such negotiations only once during the term of this Agreement
      and
      in the event that XTL foregoes its non-exclusive right of negotiation for the
      manufacture and supply of a particular Product, or if XTL participates in such
      negotiations but is not selected by CUBIST, then XTL’s non-exclusive rights
      under this Section 3.3 shall terminate. XTL’s
      rights under this Section 3.3 will terminate upon a Change of Control of CUBIST
      (except
      with respect to any separate written manufacturing agreement entered into
      between CUBIST and XTL prior to the effective date of such Change of
      Control;
      provided
      that
      CUBIST has promptly complied with the notice provisions set forth in this
      Section 3.3 prior to such Change of Control).

    


    3.4 Independence.  Subject
      to the terms of this Agreement, the activities and resources of each Party
      shall
      be managed by such Party, acting independently and in its individual capacity.
      The relationship between CUBIST and XTL is that of independent contractors,
      and
      neither Party shall have the power to bind or obligate the other Party in any
      manner, other than as is expressly set forth in this Agreement.

    


    
      
        
        

      

      
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    Section
      4. INFORMATION
      SHARING.

    


    4.1 Product
      Information.
       (a) During
      the term of this Agreement, XTL shall have an ongoing obligation to transfer
      to
      CUBIST all information, including technical data, in XTL’s possession or Control
      and related to the Product as CUBIST may reasonably require; provided
      that in
      the event that XTL is unable to transfer any information or technology to CUBIST
      required to be transferred under this Agreement, upon CUBIST’s written request,
      XTL shall arrange for the prompt transfer of such information or technology
      to
      an Israeli subsidiary of CUBIST at XTL’s expense. On the first business day of
      each quarter during the term of this Agreement, XTL shall provide CUBIST with
      a
      written report detailing the activities undertaken by XTL under the HepeX-B
      Plan
      and the results obtained from such activities. At any time during the term
      of
      this Agreement, upon reasonable request by CUBIST, XTL shall deliver to CUBIST
      or its designee copies of all files in the possession or control of XTL or
      its
      agents that relate to the Product or activities undertaken by XTL under the
      HepeX-B Plan. During
      the term of this Agreement and for one (1) year thereafter, XTL shall maintain
      all data and other records in XTL’s possession that are obtained or generated by
      XTL, its Affiliates or its Third Party service providers in the course of
      providing services under the HepeX-B Plan (collectively, “Records”)
      in a
      safe and secure manner and in accordance with all applicable laws and
      regulations. XTL shall make available all Records to CUBIST for examination
      and
      duplication, during normal business hours and at mutually agreeable times.
      During
      the term of this Agreement, XTL shall provide CUBIST with reasonable access
      to
      pertinent XTL employees or members of Third Party contractors that are engaged
      in the activities undertaken by XTL under the HepeX-B Plan or have experience
      with or information related to any Products. For the purposes of calculating
      Designated Costs, XTL’s activities under this Section 4.1(a) (with the exception
      of XTL’s obligation to transfer information or technology to an Israeli
      subsidiary of CUBIST) in connection with HepeX-B shall be considered to be
      activities necessary or advisable to Obtain Regulatory Approval for a
      commercially viable formulation of HepeX-B for the prevention of recurrent
      Hepatitis B infections in liver transplant patients in the
      Territory.

    


    (b) On
      or
      before February 1st and August 1st of each Contract Year, CUBIST shall provide
      to XTL written progress reports summarizing in reasonable detail CUBIST’s
      activities to Obtain Regulatory Approval during the six- (6) month period ending
      on the preceding December 31st and June 30th,
      respectively, as well as anticipated activities to be undertaken during the
      subsequent six-month period. CUBIST shall also notify XTL in writing of any
      material developments as a result of CUBIST’s activities to Obtain Regulatory
      Approval within thirty (30) days thereafter. 

    


    4.2 Pre-Clinical
      and Clinical Data; Regulatory Filings.
      XTL
      will
      provide to CUBIST
      all
      relevant pre-clinical or clinical information (including without limitation
      that
      with respect to Product safety) relating to or in connection with Product in
      a
      timely fashion and to permit CUBIST to comply with any applicable law or
      regulation. No
      later
      than five (5) days after the Effective Date, XTL will provide CUBIST copies
      of
      all regulatory filings, INDs, and orphan drug designations, and the results
      of
      all pre-clinical and clinical testing of Products performed by or on behalf
      of
      XTL. On an ongoing basis during the term of this Agreement, XTL will provide
      to
      CUBIST (i) all information in XTL’s possession or control regarding pre-clinical
      testing and clinical testing performed or to be performed by or on behalf of
      XTL
      with respect to the Products (including, without limitation, information
      concerning the design and plans with respect to such pre-clinical testing or
      clinical testing) as such information becomes available, (ii) the results of
      all
      pre-clinical and clinical testing performed by or on behalf of XTL with respect
      to the Products as such information becomes available, (iii) all information
      in
      XTL’s possession regarding Products necessary or useful for making regulatory
      filings in the Territory with respect to Products as such information becomes
      available, and (iv) copies of all regulatory filings made by or on behalf of
      XTL
      with respect to Products promptly after such regulatory filings are made. CUBIST
      shall have a right of access, a right of reference and the right to use and
      incorporate all information provided to it pursuant to this Section 4.2 in
      its
      applications for Regulatory Approval of Products within the Territory and for
      all other purposes related to Obtaining Regulatory Approval, manufacture and
      Commercialization of Products. For the purposes of calculating Designated Costs,
      XTL’s activities under this Section 4.2 in connection with HepeX-B shall be
      considered to be activities necessary or advisable to Obtain Regulatory Approval
      for a commercially viable formulation of HepeX-B for the prevention of recurrent
      Hepatitis B infections in liver transplant patients in the
      Territory.

    


    4.3 No
      Retained Rights.
      Notwithstanding
      anything expressed or implied in the foregoing provisions of this Section 4
      to
      the contrary, nothing in this Section 4 or elsewhere in this Agreement is
      intended to diminish the scope of the exclusive rights licensed by XTL to CUBIST
      pursuant to Section 2 or to suggest that, from and after the Effective Date,
      XTL
      retains any rights to Obtain Regulatory Approval for, manufacture, use or
      Commercialize any Product for the prevention or treatment of Hepatitis B, except
      to the extent necessary for XTL to perform its obligations under the HepeX-B
      Plan in accordance with the provisions of this Agreement.

    


    
      
        
        

      

      
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    Section
      5. REGULATORY
      APPROVAL ACTIVITIES.

    


    5.1 Regulatory
      Approval Activities. (a) Subject
      to, and in accordance with, the terms and conditions of this Agreement and
      all
      requirements of applicable laws, rules, and regulations, XTL shall use
      Commercially Reasonable Efforts to conduct its activities to Obtain Regulatory
      Approval set forth in the HepeX-B Plan; provided,
      however, that subject to Section 5.1(b), XTL shall not have any obligation
      to
      perform activities to Obtain Regulatory Approval under the HepeX-B Plan or,
      prior to the first iteration of the HepeX-B Plan, under the guidelines attached
      as Exhibit
      C
      (other
      than the XTL Activities and such other XTL obligations as are expressly set
      forth in this Agreement) to which XTL has not consented if (i) prior to the
      first iteration of the HepeX-B Plan, CUBIST attempts to impose obligations
      that
      materially deviate in scope from the guidelines set forth in Exhibit
      C,
      (ii)
      the initial HepeX-B Plan materially deviates in scope from the guidelines
      attached in Exhibit
      C,
      and/or
      (iii) material changes are made to the HepeX-B Plan without XTL’s prior written
      consent; provided
      that in
      all cases, XTL may not refuse to provide any data or information pursuant to
      Sections 4.1(a) or 4.2. XTL hereby acknowledges and agrees that it shall not
      be
      entitled to engage in any activities to Obtain Regulatory Approval with respect
      to any Product intended for treatment or prevention of Hepatitis B, unless
      and
      until such activities have been incorporated into the HepeX-B Plan and CUBIST
      shall have provided written consent to XTL engaging in such development
      activities. The Parties shall use Commercially Reasonable Efforts to minimize
      the costs and expenses incurred by them as a result of the performance of their
      obligations under this Section 5. Notwithstanding anything in this Section
      5 or
      elsewhere in this Agreement to the contrary, XTL shall cease any activities
      to
      Obtain Regulatory Approval, including any pre-clinical and clinical activity
      for
      Products, upon receipt of written notice from CUBIST to cease such activity,
      or
      as soon as practicable thereafter. 

    


    (b) If
      and to
      the extent requested by CUBIST and included in the HepeX-B Plan, XTL shall
      use
      Commercially Reasonable Efforts to deliver to CUBIST the following
      (collectively, as described in Exhibit
      D
      and as
      revised from time to time by mutual written consent of the Parties, the
“XTL
      Activities”):
      (i) a
      commercially viable method to manufacture Product using *****,
      including development and implementation of a testing plan to demonstrate
      comparability to Products produced from *****;
      (ii) a
      commercially viable, concentrated parenteral formulation of Product for both
      intravenous and subcutaneous injection; (iii) complete the phase 2b study and
      the PK/PD bridging study for HepeX-B undertaken by XTL and underway as of the
      Effective Date.

    


    5.2. HepeX-B
      Plan.
      All
      activities of the Parties (including allocation of responsibilities of each
      Party or its designee) contemplated under this Agreement to Obtain Regulatory
      Approval, including without limitation, pre-clinical and clinical Product
      activities, any XTL Activities requested by CUBIST, and all scientific,
      clinical, manufacturing, regulatory and other activities to be undertaken for
      a
      commercially viable Product, and a budget for the foregoing, shall be set forth
      in a plan, as modified from time to time (the “HepeX-B
      Plan”).
      In
      addition, the HepeX-B Plan will indicate whether any budgeted costs are
      Designated Costs. Within *****
      days
      after the Effective Date, the Joint Alliance Team shall propose a detailed
      initial HepeX-B Plan for each Party’s review. An initial guideline identifying
      major concepts for inclusion in the HepeX-B Plan is attached as Exhibit
      C;
      if
      requested by CUBIST, any or all of the XTL Activities shall also be included
      in
      the HepeX-B Plan. The Joint Alliance Team will propose recommended changes
      to
      the HepeX-B Plan at least *****.
      No
      modification to the HepeX-B Plan will be effective unless and until approved
      by
      CUBIST and provided to XTL pursuant to Section 15.4 (without copies to legal
      counsel). CUBIST will have the sole right to determine whether to *****
      CUBIST’s
      sole discretion, but subject to *****.
      XTL has
      the right to review *****
      to the
      HepeX-B Plan for the purpose of (a) *****
      under
      the HepeX-B Plan should constitute *****;
      and (b)
      to *****
      under
      the modified HepeX-B Plan (other than XTL Activities) as contemplated in Section
      5.1(a). XTL shall have *****
      days
      from receipt of any proposed modified HepeX-B Plan pursuant to Section 15.4
      (without copies to legal counsel) to inform CUBIST whether it disputes the
      categorization of any such costs as Designated Costs. If XTL timely informs
      CUBIST that *****,
      the
      Parties shall then have *****
      business
      days to discuss *****,
      and if
      the Parties cannot agree after good faith discussions whether any *****,
      the
      matter shall be resolved in accordance with the dispute resolution process
      set
      forth in Section 14. If XTL does not inform CUBIST within *****
      days
      after receipt of any proposed modified HepeX-B Plan that it agrees to
*****
      proposed
      under the modified HepeX-B Plan as contemplated in Section 5.1(a), XTL will
      be
      deemed to have elected *****.
      

    


    5.3 Use
      of Data by XTL.
      All
      data generated by XTL from any activities engaged in by XTL pursuant to, and
      in
      accordance with, the provisions of this Section 5 shall not be used by XTL
      and
      its Affiliates, except to support Regulatory Approval in the Territory of
      Product or to Commercialize Product in the Territory without the prior written
      consent of CUBIST, which shall not be unreasonably withheld.

    


    
      
        
        

      

      
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    5.4 Costs
      and Expenses.
      The
      costs and expenses incurred by both Parties in connection with any and all
      activities engaged in pursuant to, and in accordance with, the provisions of
      this Section 5, shall be allocated in the manner set forth in Section
      7.

    


    5.5 Health
      Hazards.
      Each
      Party will notify the other Party of any material health hazards with respect
      to
      Products that may impact employees involved in the activities to Obtain
      Regulatory Approval, manufacture, production or supply of Products as soon
      as
      practicable, and in any event within forty-eight (48) hours, after such Party
      becomes aware of such hazards.

    


    5.6 XTL
      Compliance.
      In
      connection with any activities undertaken by XTL to Obtain Regulatory Approval
      in connection with any Product, XTL shall comply with all applicable laws,
      rules
      and regulations regarding such activities, as such laws, rules and regulations
      are in effect where such activities are undertaken. 

    


    5.7
       No
      Debarred Personnel.  In
      the course of the development of Product or any component thereof, XTL has
      not
      used prior to the Effective Date, and neither XTL nor CUBIST shall not use
      during the term of this Agreement, the services of any employee, consultant,
      contractor, or clinical investigator that has been debarred by the FDA or any
      other Regulatory Authorities or that is the subject of debarment proceedings
      by
      the FDA or any other Regulatory Authority.

    


    Section
      6. REGULATORY
      ACTIVITIES

    


    6.1 Regulatory
      Activities.
      Subject
      to, and in accordance with, the terms and conditions of this Agreement
      (including Section 6.3), and all requirements of applicable laws, rules, and
      regulations, CUBIST shall be responsible for filing and obtaining Regulatory
      Approvals for Products in the Territory. XTL shall not be entitled to engage
      in
      any regulatory activities with respect to any Product without the prior written
      consent of CUBIST. XTL shall use Commercially Reasonable Efforts to assist
      CUBIST in complying with all requirements of applicable laws, rules, and
      regulations related to Regulatory Approval of Product in the Territory.
      Notwithstanding anything in this Section 6 or elsewhere in this Agreement to
      the
      contrary, XTL shall cease any regulatory activity and all attempts to Obtain
      Regulatory Approval with respect to any Product upon receipt of written notice
      from CUBIST to cease such activity, or as soon as practicable
      thereafter.

    


    6.2 Regulatory
      Approvals.  To
      the extent permitted by applicable laws, rules and regulations, CUBIST
      shall file in its own name, and own, all drug, biologic and device approval
      applications and Regulatory Approvals for Products in the Territory, and shall
      be solely responsible for all communications with Regulatory Authorities in
      such
      countries relating thereto. Upon CUBIST’s reasonable request, XTL shall
      cooperate with and assist CUBIST in the communication with any Regulatory
      Authority or in the preparation and submission of any regulatory filing
      regarding Product, and will provide such information and data in XTL’s
      possession or control that is necessary to Obtain Regulatory Approval. If XTL
      is
      required by applicable laws or regulations or a Regulatory Authority having
      jurisdiction in the Territory to disclose information directly to such
      Regulatory Authority relating to Product, XTL shall notify CUBIST in writing
      of
      the requirement and the particulars of the information required to be disclosed,
      and XTL shall coordinate with CUBIST in making any such disclosure. Further,
      with respect to any such required disclosures, CUBIST shall have the right
      to be
      present and to participate at all face-to-face meetings and scheduled conference
      calls between XTL and such Regulatory Authority with respect to Product and
      CUBIST shall have the right to lead any such face-to-face meetings or scheduled
      conference calls. Promptly after the Effective Date, XTL shall transfer and
      assign to CUBIST any and all such drug, biologic and device approval
      applications, INDs, orphan drug designations or Regulatory Approvals held by
      XTL
      as of the Effective Date. 

    


    6.3 Costs
      and Expenses.
      The
      costs and expenses incurred by both Parties in connection with any and all
      regulatory activities engaged in pursuant to, and in accordance with, the
      provisions of this Section 6, shall be allocated in the manner set forth in
      Section 7. 

     

    
      
        
        

      

      
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      Section
        7. PRODUCT
        COSTS AND EXPENSES.

    

     

    7.1 Collaboration
      Support.
      The
      Parties acknowledge that XTL will incur costs from and after the Effective
      Date
      in furtherance of its activities set forth in the HepeX-B Plan. Subject to
      the
      last sentence of this Section 7.1, CUBIST shall pay XTL $2,000,000 in
      contemplation of costs, of which (a) *****
      after
      the Joint Alliance Team’s initial presentation of the HepeX-B Plan for approval,
      unless CUBIST dissolves the Joint Alliance Team prior to such initial
      presentation, in which case, CUBIST will pay such amount within *****
      days
      after *****;
      (b)
*****
      shall be
      paid on or prior to *****;
      and (c)
*****
      shall be
      paid on the last business day of *****.
      Notwithstanding anything to the contrary express or implied in this Section
      7.1,
      CUBIST shall have no obligation to make any payment under this Section 7.1
      if
      XTL is in material breach of its obligations under this Agreement.

    


    7.2 Overall
      Designated Costs.
      The
      Parties shall use Commercially Reasonable Efforts to minimize the Designated
      Costs. It is the intent of the Parties, to the extent practicable, to endeavor
      to limit the Designated Costs to not more than $33,900,000. 

    


    7.3 Designated
      Costs. (a)
      In
      addition to the payments under Section 7.1, and subject to Section 7.4, CUBIST
      shall bear all Designated Costs; provided
      that any
      XTL Designated Costs are incurred in the performance of activities that are
      set
      forth in an approved HepeX-B Plan in effect as of the time XTL incurred such
      Designated Costs or became obligated to incur such Designated Costs. XTL shall
      submit quarterly invoices in Dollars to CUBIST no later than *****
      after
      the end of each quarter which set forth in reasonable detail the XTL Designated
      Costs for the immediately preceding quarter. If not previously approved by
      CUBIST in writing, CUBIST shall inform XTL within *****
      days of
      receipt of an invoice whether it disputes the categorization of any such costs
      listed in such invoice as Designated Costs. The Parties shall have *****
      business
      days to discuss such costs, and if the Parties cannot agree after good faith
      discussions whether any itemized costs listed in such invoice are Designated
      Costs, the matter shall be resolved in accordance with the dispute resolution
      process set forth in Section 14. CUBIST shall not be responsible for any costs
      set forth in an invoice that are not Designated Costs. Subject to the
      immediately preceding sentence and Section 7.4 below, CUBIST shall reimburse
      Designated Costs that are not subject to a good faith dispute within
*****
      days
      after receipt of such invoice.

    


    (b) CUBIST
      shall provide to XTL, no later than *****
      days
      after the end of each quarter, a report which sets forth in reasonable detail
      the CUBIST Designated Costs for the immediately preceding quarter. XTL shall
      inform CUBIST within *****
      days of
      receipt of any such report whether it disputes the categorization of any such
      costs listed in such invoice as Designated Costs. The Parties shall have
*****
      business
      days to discuss such costs, and if the Parties cannot agree after good faith
      discussions whether any itemized costs listed in such report are Designated
      Costs, the matter shall be resolved in accordance with the dispute resolution
      process set forth in Section 14.

    


    7.4 CUBIST
      Designated Costs Cap.
      Notwithstanding
      anything express or implied to the contrary contained herein, CUBIST shall
      be
      responsible for up to $33,900,000 of the Designated Costs (whether incurred
      by
      CUBIST or XTL). Thereafter, the Parties shall each bear fifty percent (50%)
      of
      the Designated Costs in excess of $33,900,000. From and after the date that
      the
      aggregate amount of undisputed Designated Costs is equal to or greater than
      $33,900,000, after receipt of each invoice from XTL, CUBIST shall determine
      the
      aggregate Designated Costs for such quarter by adding the undisputed XTL
      Designated Costs for such quarter (to the extent such Designated Costs are
      in
      excess of the aggregate Designated Costs of $33,900,000) plus the undisputed
      CUBIST Designated Costs for such quarter (to the extent such Designated Costs
      are in excess of the aggregate Designated Costs of $33,900,000) (the sum of
      the
      XTL Designated Costs and the CUBIST Designated Costs for such quarter referred
      to herein as the “Aggregate
      Designated Costs”).
      If
      the undisputed XTL Designated Costs for such quarter are greater than fifty
      percent (50%) of the Aggregate Designated Costs for such quarter, then CUBIST
      shall pay to XTL an amount equal to (i) the XTL Designated Costs for such
      quarter minus (ii) the result of the Aggregate Designated Costs for such quarter
      divided by two (2). CUBIST shall pay such amount within *****
      days of
      receipt of the invoice for XTL Designated Costs for such quarter. If the
      undisputed CUBIST Designated Costs for such quarter are greater than fifty
      percent (50%) of the Aggregate Designated Costs for such quarter, then XTL
      shall
      pay to CUBIST an amount equal to (I) the CUBIST Designated Costs for such
      quarter minus (II) the result of the Aggregate Designated Costs for such quarter
      divided by two (2). CUBIST shall deliver an invoice to XTL for such amount,
      which invoice shall set forth in reasonable detail the CUBIST Designated Costs
      for the immediately preceding calendar quarter. XTL may either make such payment
      within *****
      days
      of
      receipt of the invoice or *****
      under
*****
      hereunder such that the *****
      are no
      less than the *****,
      until
      XTL’s share of Designated Costs is offset in full. A one-time fee of
*****
      shall be
      assessed on every amount that *****
      pursuant
      to this Section 7.4. In addition, interest shall accrue pursuant to Section
      10.8
      on all *****
      that XTL
*****
      pursuant
      to this Section 7.4 beginning *****
      months
      after XTL’s receipt of CUBIST’s invoice therefor. XTL shall have no obligation
      to pay any Designated Costs that have not been *****
      as of
      the termination or expiration of this Agreement. XTL shall have no obligation
      to
      share in any Designated Costs incurred *****,
      and
      interest shall cease to accrue with respect to any previously incurred
      Designated Costs. For the avoidance of doubt, XTL’s obligation to share in any
      Designated Costs under this Section 7.4 shall be limited to HepeX-B, unless
      otherwise agreed by the Parties in writing.

    


    
      
        
        

      

      
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    7.5 Practices.
      XTL will
      perform its activities under the HepeX-B Plan in accordance with then current
      Good Laboratory Practices, Good Clinical Practices (as required of a sponsor
      of
      a clinical trial), and Good Manufacturing Practices, if and to the extent
      required by the HepeX-B Plan, and in such event, XTL will include in each
      agreement with each of its subcontractors, if any, performing any such
      activities contemplated under the HepeX-B Plan a requirement that such
      subcontractors perform its activities in accordance with then current Good
      Laboratory Practices, Good Clinical Practices, and Good Manufacturing Practices,
      as and if applicable.

    


    Section
      8. CONFIDENTIALITY;
      PUBLICATION; RECORDS.

    


    8.1 Nondisclosure
      Obligation.
      All
      Proprietary Information disclosed by or on behalf of one Party to the other
      Party under this Agreement that is marked “confidential” or “proprietary”, and
      in the case of oral information, is summarized in a writing that is marked
      “confidential” or “proprietary” and delivered to the other Party within thirty
      (30) days of disclosure of such information, shall be maintained in confidence
      by the receiving Party and shall not be disclosed to a non-Party or used for
      any
      purpose whatsoever without the prior written consent of the other Party, except
      to the extent that such Proprietary Information:

    


    (a) is
      known
      by recipient at the time of its receipt, and not through a prior disclosure
      by
      or on behalf of the disclosing Party, as documented by contemporaneous business
      records;

    


    (b) is
      properly in the public domain through no fault of the recipient;

    


    (c) is
      subsequently disclosed to a receiving Party by a Third Party who may lawfully
      do
      so and is not directly or indirectly under an obligation of confidentiality
      to
      the disclosing Party, as documented by written business records in existence
      prior to the receipt of such information from the disclosing Party;

    


    (d) is
      developed by the recipient independently of, and without reference to or use
      of,
      Proprietary Information received from the disclosing Party;

    


    (e) is
      required to be disclosed to governmental or other regulatory agencies in order
      to obtain patents, to obtain approval to conduct clinical trials or to market
      Products, or to comply with applicable governmental or stock exchange or
      quotation system regulations; provided,
      however, that such disclosure may be only to the extent reasonably necessary
      to
      obtain patents or approval, or to comply with laws or regulations as appropriate
      and that confidential treatment will be sought to the extent reasonably
      practicable;

    


    (f) is
      disclosed to actual or potential permitted sublicensees or permitted assignees
      and/or other third parties (1) for the purpose of conducting activities under
      this Agreement (or for such actual or potential permitted sublicensees or
      permitted assignees and/or other third parties to determine their interest
      in
      performing such activities) in accordance with this Agreement or (2) for the
      purpose of allowing the Party making such disclosure to effectively exploit
      its
      rights under this Agreement and obtain all of the benefits under this Agreement
      to which such Party is entitled as contemplated by this Agreement; provided,
      however, that such actual or potential permitted sublicensees or permitted
      assignees and/or other third parties have agreed to be bound by confidentiality
      obligations substantially equivalent to the terms herein for no less than five
      years from the date of disclosure; 

    


    (g) is
      disclosed to employees, officers, directors, consultants, agents, investors
      or
      potential investors of, or lenders or potential lenders to, the Party making
      such disclosure; provided,
      however, that such employees, officers, directors, consultants, agents,
      investors, potential investors, lenders and potential lenders have agreed to
      be
      bound by confidentiality obligations substantially equivalent to the terms
      herein for no less than five years from the date of disclosure; and provided
      further
      that notwithstanding the provisions set forth above in this subsection (g),
      neither Party shall disclose Proprietary Information of the other Party to
      potential investors or potential lenders except to the extent that such
      disclosure is made in the context of such potential investors’ or potential
      lenders’ due diligence
      investigation of the Party making such disclosure;

    


    (h) is
      used
      by the receiving Party for the purpose of conducting activities under this
      Agreement in accordance with its respective terms or is used by the receiving
      Party for the purpose of allowing the receiving Party to effectively exploit
      its
      rights under this Agreement and obtain all of the benefits under this Agreement
      to which such receiving Party is entitled as contemplated by this Agreement;
      or

    


    
      
        
        

      

      
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    (i) is
      required to be disclosed by law, regulation or court order; provided
      that
      notice is promptly delivered to the other Party in order to provide an
      opportunity to challenge or limit the disclosure obligations; and provided further
      that
      such disclosure may be only to the extent reasonably necessary to comply with
      the applicable law, regulation or court order.

    


    The
      disclosing Party shall identify any Proprietary Information delivered to the
      receiving Party that is confidential information of a Third Party and the
      disclosing Party shall inform the receiving Party of any restrictions,
      limitations and qualifications imposed on such Proprietary Information by such
      Third Party. XTL agrees that with respect to any CUBIST Proprietary Information
      disclosed to Yeda as contemplated by the XY Agreement and the Consent Agreement,
      that XTL shall mark all such CUBIST Proprietary Information as “confidential” or
“proprietary”, and in the case of oral information, XTL shall summarize such
      CUBIST Proprietary Information in a writing that is marked “confidential” or
“proprietary” and deliver such summary to Yeda within thirty (30) days of
      disclosure of such CUBIST Proprietary Information.

    


    8.2 No
      Disclosure of Terms.
      Either
      Party may disclose the existence of this Agreement, but, except to the extent
      otherwise provided below in this Section 8.2, neither Party shall disclose
      the
      terms of this Agreement without the prior written consent of the other Party.
      Notwithstanding the foregoing, either Party may disclose the terms of this
      Agreement pursuant to the provisions of subparagraphs (b), (e), (f) (with
      financial terms redacted), (g), or (i) of Section 8.1 to the same extent as
      if
      the terms of this Agreement were Proprietary Information of the non-disclosing
      Party.

    


    8.3 No
      Publication.
      XTL
      shall not publish or publicly present any information (a) relating to this
      Agreement, (b) any activities conducted under or in relation to this Agreement,
      or (c) relating to any Product, in all cases without the prior written consent
      of CUBIST. Neither Party shall make public use of the other Party’s name or
      identifying marks except as otherwise permitted under this Agreement, with
      the
      prior written consent of the other Party or as required by applicable law or
      regulation. CUBIST shall not use the names of Yeda, the Weizmann Institute
      of
      Science, Rehovot, or Professor Yair Reisner in any advertising, sales
      literature, or promotional material unless (i) the prior written approval of
      Yeda thereto has been obtained or (ii) such use or disclosure is to governmental
      authorities for the purposes of obtaining approval or permission for the
      exercise of its license rights to any XTL Technology licensed to XTL pursuant
      to
      the XY Agreement or is in the fulfillment of any legal duty owed to any
      governmental authority or is required by applicable law. Nothing in this Section
      8.3 shall limit XTL’s ability to apply for any patent protection. 

    


    8.4 Press
      Releases, Etc.
      Notwithstanding anything set forth in Section 8.1, 8.2 or 8.3 above to the
      contrary, XTL may not issue any news release or other public announcement
      relating to this Agreement or to the Parties’ performance hereunder, without the
      prior written consent of CUBIST, which shall not be unreasonably withheld or
      delayed, except to the extent required by applicable law, regulation or stock
      exchange or quotation system requirement; provided
      that XTL
      uses Commercially Reasonable Efforts to submit to CUBIST a draft of such news
      release or public announcement at least five (5) days prior to the date of
      planned issuance thereof and shall review and consider in good faith any
      comments provided by CUBIST. CUBIST may issue any news release or other public
      announcement relating to Product without the prior written consent of XTL,
      subject to the confidentiality provisions of Sections 8.1, 8.2 and 8.3;
provided,
      however, that CUBIST may not issue any news release or other public announcement
      relating to this Agreement or to XTL’s performance hereunder, without the prior
      written consent of XTL, which shall not be unreasonably withheld or delayed,
      except to the extent required by applicable law, regulation or stock exchange
      or
      quotation system requirement; and provided further that, unless precluded by
      applicable law, regulation or stock exchange or quotation system requirement,
      CUBIST will use Commercially Reasonable Efforts to submit to XTL a draft of
      such
      news release or public announcement at least five (5) days prior to the date
      of
      planned issuance thereof so as to afford XTL the opportunity to object if such
      proposed press release would violate applicable Israeli law, regulation or
      stock
      exchange or quotation system requirement. In the event of such objection, the
      parties will diligently cooperate to arrive at a revised draft of such proposed
      press release that does not so violate such applicable Israeli law, regulation
      or stock exchange or quotation system requirement.

    


    8.5 Records;
      Audit Rights.
      Each
      Party shall keep or cause to be kept full and accurate books of account and
      records containing all particulars that may be necessary to determine, in a
      manner consistent with generally accepted accounting principles in the United
      States, the sums or credits due under this Agreement, including, but not limited
      to Designated Costs, Net Sales and Sublicensee Revenues. At the written request
      (and expense) of either Party, the other Party and its Affiliates, and in the
      case of CUBIST, its licensees and sublicensees shall permit an independent
      certified public accountant appointed by such Party and reasonably acceptable
      to
      the other Party, accompanied by representatives of the financial department
      of
      the audited Party at reasonable times, upon reasonable notice and no more
      frequently than once per Contract Year, to examine only those records as may
      be
      necessary to determine the correctness or completeness of any report or payment
      made under this Agreement, including but not limited to Designated Costs, Net
      Sales and Sublicensee Revenues (including a breakdown of the components thereof
      so as to enable calculation of royalties payable to Yeda under the XY
      Agreement), with respect to any Contract Year ending not more than *****
      prior to
      such Party’s request. Results of any such examination shall be (i) made
      available to both Parties, (ii) limited to information necessary to report
      any
      error in any payment or report made under this Agreement and (iii) subject
      to
      the provisions of this Section 8. The Party requesting the audit shall bear
      the
      full cost of the performance of any such audit, unless such audit discloses
      a
      variance of more than *****
      from the
      amount of the original report, royalty or payment calculation. In such case,
      the
      Party being audited shall bear the full cost of the performance of such
      audit.

    


    
      
        
        

      

      
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    Section
      9. LICENSE
      AND MILESTONE PAYMENTS.

    


    9.1 Consideration
      for License.
      In
      consideration for the licenses granted to CUBIST under Section 2, CUBIST shall
      make a cash payment to XTL of USD $1,000,000 within three (3) business
      days
      after the Effective Date of this Agreement.

    


    9.2 Milestones.
      (a)
      Subject
      to the terms and conditions in this Agreement (including, without limitation,
      the provisions of Sections 9.2(b), 9.2(c) and 9.3 below), CUBIST shall make
      cash
      payments to XTL in the respective amounts set forth below upon attainment of
      the
      milestones events (each a “Milestone
      Event”)
      set
      forth below:

    


    
      	
              Milestone
                Event

            	 	
               Payment
                Amount

            
	
              *****

            	 	
              USD
                $*****

               

            
	
              *****

            	 	
              USD
                $*****

               

            


    

    


    (b) CUBIST
      shall promptly notify XTL in writing upon the achievement of any of the
      milestones set forth above in Section 9.2(a) and CUBIST shall have *****
      days
      after the occurrence of the Milestone Event to make the corresponding milestone
      payment due. All milestone payments shall be in Dollars.

    


    (c) CUBIST
      shall make only one of the payments set forth in Section 9.2(a) and only upon
      the first achievement of the applicable Milestone Event by the first iteration
      of HepeX-B to achieve such milestone. After the achievement of a given Milestone
      Event and the payment required to be made by CUBIST pursuant to Section 9.2(a),
      no further payment shall be due or owed by CUBIST in connection with any
      Milestone Event, regardless of how many times the same Milestone Event is
      achieved by different or multiple Products. If the first achievement of the
      Milestone Event occurs after December 31, 2008, then no payment shall be due
      or
      owed by CUBIST pursuant to Section 9.2(a). 

    


    9.3 Reduction
      of Milestone Payments.
      Notwithstanding
      any provision in this Section 9 or elsewhere in this Agreement to the contrary,
      CUBIST shall be entitled to reduce payments required pursuant to Section 9.2
      above as set forth in Section 7.4, Section 11.3, or Section 12.10, or pursuant
      to the Consent Agreement, as further contemplated under Section
      10.4.

    


    Section
      10. ROYALTIES.

    


    10.1 Royalties
      on Net Sales of HepeX-B covered by a Valid Claim. (a) For
      each
      Contract Year during the term of this Agreement, CUBIST shall pay to XTL,
      subject to the terms and conditions of this Agreement (including, without
      limitation, the provisions of Sections 10.2, 10.4, 10.5 and 10.9), a royalty
      with respect to Net Sales of HepeX-B sold by CUBIST or its Affiliates, in any
      and all countries where the manufacture, use or sale of HepeX-B are covered
      by a
      Valid Claim in such country (each a “Patent
      Country”),
      equal
      to: 

    


    (i) if
      Net
      Sales of HepeX-B in Patent Countries during such Contract Year are equal to
      or
      less than *****,
      ten
      percent (10%) of the aggregate Net Sales for HepeX-B sold in Patent Countries
      during such Contract Year, and 

    


    
      
        
        

      

      
        17

        
          

        

      

      
        
          *****
            Confidential material redacted and filed separately with the
            Commission.

        

      

       

    

    (ii)  if
      Net
      Sales of HepeX-B in Patent Countries during such Contract Year are greater
      than
*****,
      then
      the lesser of (A) the Patent Royalty Rate, and (B) seventeen percent (17%);
      multiplied by the aggregate Net Sales for HepeX-B sold in Patent Countries
      during such Contract Year. 

    


    For
      purposes of this Section 10, the “Patent
      Royalty Rate”
      shall
      equal:

     

    

     

    For
      purposes of illustration only, if aggregate Net Sales of HepeX-B in Patent
      Countries during a Contract Year is equal to *****,
      then
      the Patent Royalty Rate shall equal to *****,
      or
*****.
      

    


    (b) In
      the
      event of the issuance of a Retroactive Valid Claim in a country that was not
      a
      Patent Country prior to such filing (the “Retroactive
      Royalty Country”),
      for
      each Contract Year during which the application for the Retroactive Valid Claim
      was pending (but in no event more than *****
      prior to
      the date of issuance of such Retroactive Valid Claim in the Retroactive Royalty
      Country), through the date of issuance (each such Contract Year, a “Retroactive
      Royalty Year”),
      CUBIST shall recalculate the aggregate royalties payable under Sections 10.1(a)
      and 10.2 for each such Retroactive Royalty Year by including the Net Sales
      of
      such Retroactive Royalty Country in the calculations for Patent Countries under
      Section 10.1(a), and reducing by such amount the Net Sales in the calculations
      for Know-How Countries under Section 10.2 (collectively the “Recalculated
      Royalties”).
      CUBIST will pay to XTL, subject to the terms and conditions of this Agreement
      (including, without limitation, the provisions of Sections 10.2, 10.4, 10.5
      and
      10.9), a retroactive royalty with respect to each Retroactive Royalty Year
      in an
      amount equal to (i) the Recalculated Royalties, minus
      (ii) any
      amounts paid or payable to XTL under Section 10.1(a) and Section 10.2 for such
      Retroactive Royalty Year prior to effecting any setoffs or offsets under this
      Agreement. For the first Retroactive Royalty Year, such retroactive payment
      will
      only apply for Net Sales effected after the effective date of filing of the
      application for the Retroactive Valid Claim. Such retroactive royalty payments
      will be paid in *****,
      each
*****
      after
      each of the next *****
      (each a
*****;
      provided
      that if
      such aggregate payment together with amounts payable under Section 10.3(e)
      for
      the same Retroactive Valid Claim(s) exceeds *****
      of the
      royalties paid or payable prior to effecting any setoffs or offsets under this
      Agreement for the Contract Year immediately preceding the Contract Year in
      such
      Retroactive Valid Claim issued, then CUBIST may elect to pay such retroactive
      royalty payments in *****
      after
      each of the next *****.
      If
      CUBIST elects to pay in *****,
      interest shall accrue pursuant to Section 10.8 on all such retroactive royalty
      payments beginning on the thirty-first (31st)
      day
      after the *****
      that are
      then unpaid.

    


    10.2 Know-How
      Royalties.
      Notwithstanding
      any provision in this Section 10 or elsewhere in this Agreement to the contrary
      but subject to Section 10.4(a), for each Contract Year during the term of this
      Agreement, CUBIST shall pay to XTL a royalty with respect to annual Net Sales
      of
      HepeX-B sold by CUBIST or its Affiliates in any country where the manufacture,
      use or sale of HepeX-B is not covered by a Valid Claim in such country (each
      a
“Know-How
      Country”)
      in an
      amount equal to:

    


    (a) if
      Net
      Sales of HepeX-B in the Territory during such Contract Year are equal to or
      less
      than *****
      of the
      aggregate Net Sales for HepeX-B sold in Know-How Countries during such Contract
      Year, and 

    


    (b) if
      Net
      Sales of HepeX-B in the Territory during such Contract Year are greater than
      $*****,
      then
      the lesser of (i) the Know-How Royalty Rate, and (ii) *****;
      multiplied by the aggregate Net Sales for HepeX-B sold in all Know-How Countries
      during such Contract Year.

    


    For
      purposes of this Section 10, the “Know-How
      Royalty Rate”
      shall
      equal:

    


    
      
        
        

      

      
        18

        
          

        

      

      
        
          *****
            Confidential material redacted and filed separately with the
            Commission.

        

      

    

    


    

    


    
    

    For
      purposes of illustration only, if aggregate Net Sales of HepeX-B by CUBIST
      or
      its Affiliates during a Contract Year in the Territory is equal to *****
      (representing *****
      of
      aggregate Net Sales in Patent Countries and $*****
      of
      aggregate Net Sales in Know-How Countries), then the Know-How Royalty Rate
      under
      this Section 10.2 shall equal *****,
      or
*****.
      

    


    10.3 Royalties
      on Net Sublicensee Revenues. (a)
      Subject
      to Sections 10.3(b), (c) and (d), for each Contract Year during the term of
      this
      Agreement, CUBIST shall pay to XTL, subject to the terms and conditions of
      this
      Agreement, an amount equal to *****
      of the
      aggregate annual Sublicensee Revenues for such Contract Year.

    


    (b) Notwithstanding
      anything to the contrary in Section 10.3(a) above, but subject to the other
      terms and conditions of this Agreement, for each Contract Year during the term
      of this Agreement, CUBIST shall pay to XTL an amount equal to (i)
      *****
      of the
      aggregate annual Sublicensee Revenues for such Contract Year with respect to
      rights to Commercialize Product in the United States of America, and (ii)
      if
      CUBIST sublicenses rights to Commercialize Product in more than *****
      European
      Major Markets, CUBIST shall pay to XTL *****
      of the
      aggregate annual Sublicense Revenues for such Contract Year with respect to
      rights to Commercialize Product in the *****
      European
      Major Market country in which CUBIST has sublicensed rights to Commercialize
      Product. In the event it is not clear which of several countries are the
*****
      European
      Major Market countries in which CUBIST has sublicensed rights to Commercialize
      Product, CUBIST shall have the right in its sole discretion to identify which
      *****
      of those
      countries are the *****
      European
      Major Market countries; provided
      that
      such determination may not be subsequently changed by CUBIST without XTL’s prior
      written consent. To the extent that Sublicensee Revenues are applicable to
      more
      than one country listed above, the percentage of such Sublicensee Revenues
      that
      CUBIST shall be required to pay to XTL shall be calculated based on an
      appropriate weighted average of the applicable countries.

    


    (c) With
      respect to Sublicensee Revenues that relate solely to Know-How Countries in
      a
      particular Contract Year, the amount payable by CUBIST to XTL under Sections
      10.3(a) or 10.3(b) will be reduced by *****.

    


    (d) With
      respect to Sublicensee Revenues (other than Sublicensee Revenues based on sales)
      from a particular Sublicensee that relate to both Patent Countries and Know-How
      Countries in a particular Contract Year, the amount payable by CUBIST to XTL
      under Sections 10.3(a) and 10.3(b) will be reduced by a percentage between
      *****
      (in the
      event that all countries are Know-How Countries) calculated using a weighted
      average. The weighted average shall be based on the reasonable estimate provided
      in good faith by CUBIST to XTL within thirty (30) days after execution of the
      underlying sublicense agreement of *****.
      If XTL
      disputes such good faith estimate, then XTL may submit the matter to the dispute
      resolution procedures set forth in Section 14.

    


    (e) For
      each
      Retroactive Royalty Year applicable for a particular country that was not a
      Patent Country during such Retroactive Royalty Year absent such Retroactive
      Valid Claim, CUBIST will pay to XTL, subject to the terms and conditions of
      this
      Agreement (including, without limitation, the provisions of Sections 10.2,
      10.4,
      10.5 and 10.9), a retroactive royalty in an amount equal to (i) the amounts
      that
      would have been payable with respect to such country under Sections 10.3(a),
      (b), or (d), minus (ii) any amounts paid or payable to XTL under Section 10.3
      with respect to such country prior to effecting any setoffs or offsets. For
      the
      first Retroactive Royalty Year, such retroactive payment will only apply for
      Sublicensee Revenues received after the effective date of filing of the
      application for the Retroactive Valid Claim. Such retroactive royalty payments
      will be paid in *****
      after
      each of the next *****;
      provided
      that if
      such aggregate payment together with amounts payable under Section 10.1(b)
      for
      the same Retroactive Valid Claim(s) exceeds *****
      of the
      royalties paid for the Contract Year immediately preceding the Contract Year
      in
      such Retroactive Valid Claim issued, then CUBIST may elect to pay such
      retroactive payments in *****.
      If
      CUBIST elects to pay in *****,
      interest shall accrue pursuant to Section 10.8 on all such retroactive royalty
      payments beginning on the thirty-first (31st)
      day
      after the *****
      that are
      then unpaid.

    


    10.4 Setoffs
      and Offsets. (a)
      Notwithstanding
      any provision in this Section 10 or elsewhere in this Agreement to the contrary
      but subject to Section 10.4(b), CUBIST shall be entitled to reduce payments
      otherwise required pursuant to this Section 10 pursuant to Section 7.4, 11.3,
      or
      12.10, or pursuant to the Consent Agreement. In addition, notwithstanding any
      provision in this Agreement to the contrary except Section 10.4(b), for any
      given country within the Territory, CUBIST shall have no obligation to make
      payments to XTL under Section 10.2 or 10.3 for any Contract Year with respect
      to
      a country where Product is not covered by a Valid Claim, if the aggregate unit
      sales of Unlicensed Products during such Contract Year by all Third Parties
      in
      such country constitute more than ***** of the market share on a per unit basis
      with respect to all unit sales of both such Unlicensed Products and HepeX-B
      in
      such country. CUBIST shall have no obligation to make payments to XTL under
      Section 10.2 or Section 10.3 for any Contract Year in any country within the
      Territory: (i) that is not a *****; (ii) where HepeX-B is *****; and (iii)
      where
      unit sales of Unlicensed Product that is also covered
      by a Valid Claim by all Third Parties in such country constitute more than
      *****
      of the
      market share on a per unit basis with respect to all unit sales of both such
      Unlicensed Product and HepeX-B.

    


    
      
        
        

      

      
        19

        
          

        

      

      
        
          *****
            Confidential material redacted and filed separately with the
            Commission.

        

      

       

    

    (b) With
      respect to any amount payable by CUBIST to XTL under Section 9 or Section 10,
      in
      no event may CUBIST setoff or offset amounts under Section 7.4, Section 11.3,
      or
      Section 12.10 or pursuant to the Consent Agreement against such payment in
      an
      amount exceeding such amount payable. Setoffs and offsets permitted pursuant
      to
      Section 9.3, Section 11.3, and Section 10.4 will be applied in the following
      order: (i) first to reductions pursuant to *****;
      and
      (ii) second to reductions pursuant to *****;
      (iii)
      third to reductions pursuant to *****;
      and
      (iv) fourth to reductions pursuant to *****;
      provided
      that in
      no event will such offsets or setoffs reduce any such payment to an amount
      less
      than the amount of the XTL Licensor Payment applicable for such payment period.
      Any amounts setoff or offset amounts that are not actually setoff or offset
      against a particular payment amount, will be carried forward to the next
      milestone or royalty payment period.

    


    (c) XTL
      shall
      use any XTL Licensor Payment amount received under this Section 10.4 for the
      sole and exclusive purpose of paying such Third Parties; if XTL fails to use
      such amounts for such purpose, and does not remedy such failure as soon as
      reasonably practicable, and in any event no later than *****
      days
      after receipt of written notice from CUBIST, and except as otherwise agreed
      in
      the Consent Agreement with respect to Yeda, CUBIST may withhold XTL Licensor
      Payment amounts from subsequent payments under Section 9 or Section 10 to apply
      against any setoffs or offsets under Section 7.4, Section 11.3, or Section
      12.10.

    


    (d) It
      is
      agreed that the references to the Consent Agreement in the definition of the
      XTL
      Licensor Payments and in Sections 9.3 and 10.4(a) and (b) shall not derogate
      from the rights of Yeda under the Consent Agreement, and for the purpose of
      those rights, shall be deemed not to have been made.

    


    10.5 Term
      of Royalties.
      XTL’s
      right to receive (and CUBIST’s obligation to pay) royalties under this Section
      10 with respect to any country in the Territory shall expire (and Net Sales
      in
      such country after expiration will not be applied in the calculation of any
      royalty rates hereunder) upon the later of (a) ten (10) years from the First
      Commercial Sale of HepeX-B in such country, or (b) the expiration of the last
      to
      expire Valid Claim, if any, covering the manufacture, use, or sale of HepeX-B
      in
      such country;
      provided
      that if
      there is no such Valid Claim in such country, then the period described in
      clause (a) above shall control;
      and
      further provided that if clause (a) controls and if the XY Agreement requires
      XTL to pay royalties with respect to sales of HepeX-B under this Agreement
      for
      up to an additional two (2) years after such ten (10) year period, then during
      such additional period, CUBIST will pay directly to Yeda on behalf of XTL,
      such
      royalty amount to which Yeda is entitled under the XY Agreement and the Consent
      Agreement, calculated as if CUBIST were to continue to pay to XTL the amounts
      due to XTL under this Agreement and the Consent Agreement during the said two
      (2) year period. In the event that, in accordance with the provisions of this
      Section 10.5, the right of XTL to receive (and CUBIST’s obligation to pay)
      royalties under this Section 10 in connection with sales of HepeX-B in any
      country in the Territory expires, CUBIST shall nevertheless remain obligated
      to
      pay accrued royalties to XTL in connection with all sales of HepeX-B in such
      country that occurred prior to the effective date of such expiration.


    


    10.6 Royalty
      Payments and Reports.
      Royalties shall be calculated by converting all applicable Net Sales and
      Sublicensee Revenues into Dollars in accordance with the provisions of Section
      10.8 below and applying the appropriate royalty percentages set forth in, or
      determined in accordance with, Section 10.1 or Section 10.2 or Section 10.3,
      as
      applicable. During the term of this Agreement, royalties accrued to XTL pursuant
      to this Section 10 shall be paid within *****
      days
      after the close of each Contract Year. Royalty payments shall be made in
      Dollars. Within *****
      days of
      the end of each Contract Year, CUBIST shall furnish to XTL a report showing:
      (i)
      the calculation of Net Sales for HepeX-B that were sold in the Territory on
      a
      country-by-country basis during such Contract Year, (ii) the calculation of
      Sublicensee Revenues attributed to HepeX-B that was sold in the Territory on
      a
      country-by-country basis during such Contract Year, (iii) royalties accrued
      to
      XTL pursuant to Section 10.1 and pursuant to Section 10.2 during such Contract
      Year, and (v) the currency exchange rates used in determining the amount of
      Dollars payable to XTL. If no royalty payments are due for any Contract Year
      hereunder, CUBIST shall so report. All reports delivered pursuant to this
      Section 10.6 and any information that can be derived therefrom shall constitute
      Proprietary Information of CUBIST for purposes of Section 8.1. 

    


    
      
        
        

      

      
        20

        
          

        

      

      
        
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            Confidential material redacted and filed separately with the
            Commission.

        

      

       

    

    10.7 Exchange
      Rate.
      The rate
      of exchange to be used in computing Designated Costs, Net Sales and Sublicensee
      Revenues in each country within the Territory shall be made at the average
      rate
      of exchange for such country’s currency published in the Wall
      Street Journal
      (New
      York Edition) for the last business day of each month in the applicable
      period.

    


    10.8 Interest
      on Overdue Payments.
      Any
      amounts not paid by CUBIST or XTL when due under this Agreement shall be subject
      to interest from and including the date payment is due through and including
      the
      date upon which CUBIST or XTL has made such payment calculated at the annual
      rate equal to the prime rate plus *****
      percent,
      as prime is reported in the Wall
      Street Journal (New
      York
      Edition), as determined for each month on the last business day of the previous
      month. For the avoidance of doubt, this Section 10.8 shall not apply to amounts
      XTL has elected to have CUBIST offset against future payments pursuant to
      Section 7.4.

    


    10.9 Taxes.
      If
      CUBIST is required by law, rule or regulation to withhold taxes from any
      payments due to XTL from CUBIST hereunder, CUBIST will (i) deduct those taxes
      from the remittable amount, (ii) pay the taxes to the proper taxing authority,
      and (iii) send evidence of the obligation together with proof of payment to
      XTL
      within thirty (30) business days following that payment. CUBIST will provide
      to
      XTL such assistance as XTL may reasonably require at XTL’s expense (including
      without limitation submission of documents to relevant revenue authorities)
      in
      claiming exemption from any such withholding requirements or seeking deductions
      under any double taxation or other similar treaty or agreement from time to
      time
      in force. In the event that XTL delivers to CUBIST an opinion from legal counsel
      reasonably acceptable to CUBIST that tax withholding is not
      required, CUBIST
      shall not make such withholding, in which case, XTL shall, pursuant to the
      procedures in Section 11.3, indemnify, defend and hold harmless the CUBIST
      Indemnitees with respect to any Losses resulting from a Third Party claim
      arising out of CUBIST’s not making such withholding. Without limiting the
      generality of the foregoing provisions of this Section 10.9, but subject to
      the
      immediately preceding sentence, CUBIST shall be responsible for all taxes
      imposed on or attributable to it under applicable law, and XTL shall be
      responsible for all taxes imposed on or attributable to it under applicable
      law.

    


    10.10 Products
      other than HepeX-B. (a)
      If, at
      any time during the term of this Agreement before sales of HepeX-B are being
      made by CUBIST or a Sublicensee, CUBIST ceases to conduct any material
      activities to Obtain Regulatory Approval for HepeX-B, CUBIST shall be obligated,
      at all times during the remainder of the term of this Agreement, under the
      diligence requirements under Section 2.2 with respect to at least one other
      Product.

    


    (b) Prior
      to
      Commercializing any Product other than HepeX-B (irrespective of whether sales
      of
      HepeX-B are made or not): (i) by written notice to XTL, CUBIST may elect to
      abide by the royalty provisions of this Section 10 with respect to such Product,
      and references to “HepeX-B” in Section 10, except with respect to this Section
      10.10, will be deemed to include such Product, except that CUBIST shall have
      the
      right to make setoffs and offsets
      pursuant to Section 10.4 only with respect to Designated Costs, infringement
      claims and payments pursuant to Third Party licenses in connection with HepeX-B,
      which CUBIST could not setoff or offset against royalties or milestones
      otherwise payable to XTL with respect to HepeX-B; or (ii) if requested by
      CUBIST, the Parties agree to negotiate in good faith the financial terms and
      diligence obligations associated with such Product to account for any material
      increases in costs and expenses with respect to such Product.
      


      (c) In
        the
        event CUBIST invokes clause (ii) of Section 10.10(b), if after good faith
        negotiation, the Parties are unable to mutually agree upon financial terms
        for
        such Product, then the matter shall be submitted to the dispute resolution
        procedures set forth in Section 14. In the event of arbitration, the arbitrator
        will determine commercially reasonable financial terms in light of (i) any
        additional costs required to Obtain Regulatory Approval for such new Product,
        (ii) the anticipated market for such new Product, (iii) the commercial viability
        of HepeX-B and the respective investment of the Parties in HepeX-B, and (iv)
        financial and due diligence terms for other similarly situated products in
        the
        marketplace.

    

     

    
      Section
        11. RISK
        ALLOCATION.

      


      11.1 Mutual
        Representations and Warranties.
        Each
        Party hereby represents and warrants to the other Party
        that:


    

    
      
        
        

      

      
        21

        
          

        

      

      
        
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            Confidential material redacted and filed separately with the
            Commission.

        

      

    

     

    (a) it
      is a
      corporation duly organized, validly existing and in good standing under the
      laws
      of the jurisdiction in which it is incorporated, and has full corporate 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 as contemplated in
      this Agreement;

    


    (b) it
      has
      the corporate power and authority and the legal right to enter into this
      Agreement and perform its obligations hereunder; it has taken all necessary
      corporate action on its part required to authorize the execution and delivery
      of
      this Agreement and the performance of its obligations hereunder; and this
      Agreement has been duly executed and delivered on behalf of such Party, and
      constitutes a legal, valid and binding obligation of such Party that is
      enforceable against it in accordance with its terms;

    


    (c) it
      has
      not entered, and will not enter, into any agreement with any Third Party that
      is
      in conflict with the rights granted to the other Party under this Agreement,
      and
      has not taken and will not take any action that would in any way prevent it
      from
      granting the rights granted to the other Party under this Agreement, or that
      would otherwise materially conflict with or adversely affect the rights granted
      to the other Party under this Agreement; and

    


    (d) its
      performance and execution of this Agreement will not result in a breach of
      any
      other contract to which it is a party.

    


    11.2 XTL
      Representations and Warranties.
      XTL
      represents and warrants that: 

    


    (a) XTL
      has
      not taken any action or omission to encumber any of its right, title and
      interest in and to the XTL Technology in the Territory in any way that would
      have a material adverse effect on the rights and licenses granted to CUBIST
      hereunder; 

    


    (b) XTL
      has
      sufficient rights in and to the XTL Patents and XTL Know-How to grant the rights
      set forth in this Agreement to CUBIST, and XTL will do all such things and
      take
      all such actions as may be necessary to maintain such sufficient rights in
      good
      standing during the term of this Agreement, including the payment of any amounts
      and the performance of any obligations to any Third Party licensor of XTL
      Technology as required under any agreement or arrangement with any such Third
      Party (including without limitation the XY Agreement);

    


    (c) XTL
      has
      not misappropriated the trade secrets (or, to XTL’s knowledge after due and
      reasonable investigation, infringed) the intellectual property rights of any
      other Person in its activities to Obtain Regulatory Approval hereunder, and,
      to
      XTL’s knowledge after due and reasonable investigation, the exercise of the
      licenses granted to CUBIST under the XTL Patents and XTL Know-How, including
      to
      Obtain Regulatory Approval, Commercialize, or manufacture Products in the
      Territory do not infringe any patent rights Controlled by any Third Party which
      such patent is granted or published as a patent application on or prior to
      the
      Effective Date;

    


    (d) XTL
      is
      unaware of any activities by any Third Party that would constitute infringement
      of any XTL Patents or misappropriation of any XTL Know-How;

    


    (e) XTL
      is
      not aware of any claims, judgments or settlements against or owed by XTL and
      has
      not received notice of any pending or threatened claims or litigation relating
      to Product, the XTL Patents or XTL Know-How;

    


    (f) to
      XTL’s
      knowledge, after due and reasonable investigation, XTL has not used, prior
      to
      the Effective Date, in connection with HepeX-B, the services of any employee,
      consultant or clinical investigator that has been debarred by the FDA or any
      other regulatory authority or is the subject of debarment proceedings by the
      FDA
      or any other regulatory authority;

    


    (g) XTL
      has
      obtained the consent of the Office of the Chief Scientist of Israel (the
“OCS”)
      to the
      transfer out of Israel of manufacturing rights as detailed under this Agreement
      by XTL and no provision of this Agreement, including the license grant set
      forth
      in Section 2.1, or the performance by either Party of their respective
      obligations hereunder will violate or be in conflict with any statute,
      regulation, rule, judgment, order, decree or injunction of any governmental
      agency or body of
      Israel; 

    


    (h) CUBIST
      is
      not and will not be liable to OCS for any loan or obligation incurred by XTL
      without CUBIST’s prior express, written consent; 

    


    
      
        
        

      

      
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    (i) neither
      the execution and delivery of this Agreement by XTL nor the performance of
      its
      obligations hereunder will constitute a violation of, or be in conflict with,
      or
      constitute or create a default or accelerate or adversely affect any obligations
      under, any agreement or commitment to which XTL is a party or by which any
      XTL
      Patent or XTL Know-How is subject, including without limitation the XY
      Agreement; 

    


    (j) there
      is
      no fact known to XTL that has not been disclosed in writing to CUBIST (i) that
      could reasonably be expected to have a material adverse effect upon the right
      to
      the XTL Patents or the XTL Know-How granted hereunder, or (ii) that could
      reasonably be expected to materially and adversely affect the ability of XTL
      to
      perform its obligations under this Agreement; 

    


    (k) XTL
      owns
      or Controls the human monoclonal antibody *****,
      as
      referred to and described in *****,
      and the
      human monoclonal antibody *****,
      as
      referred to and described in *****;
      and

    


    (l) to
      XTL's
      actual knowledge, (i) any clinical studies of HepeX-B undertaken by or on behalf
      of XTL complied with applicable then current Good Clinical Practices, (ii)
      any
      HepeX-B manufactured by or on behalf of XTL for use in humans complied with
      applicable then current Good Manufacturing Practices and (iii) any pre-clinical
      activities undertaken by or on behalf of XTL and intended by XTL for inclusion
      in an application for Regulatory Approval complied with applicable then current
      Good Laboratory Practices.

    


    11.3
       Indemnity.
      (a)
      CUBIST
      hereby agrees to defend, hold harmless and indemnify XTL and its agents,
      directors, officers and employees (the “XTL
      Indemnitees”)
      from
      and against any and all suits, claims, actions, demands, liabilities, expenses
      and/or losses, including, without limitation, reasonable legal expenses and
      attorneys’ fees (collectively “Losses”)
      resulting directly or indirectly from a claim of a Third Party with respect
      to:
      (i) the manufacture, handling, storage, use, promotion, sale, offer for sale,
      distribution, importation or exportation of Products by or on behalf of CUBIST
      or its Sublicensees (other
      than by XTL or other than such Losses that result from claims arising out of
      an
      XTL indemnification obligation under Section 11.3(b)),
      (ii) a
      material breach of any of the provisions of this Agreement by CUBIST or any
      of
      its agents or employees; or (iii) the negligence, recklessness, or willful
      misconduct by CUBIST or any of its agents or employees in the performance of
      any
      obligations of CUBIST under this Agreement. The
      foregoing indemnification obligations will not apply in the event and to the
      extent that such Losses arose as a result of any XTL Indemnitee’s negligence,
      willful misconduct, or breach of this Agreement.

    


    (b) XTL
      hereby agrees to defend, hold harmless and indemnify CUBIST and its agents,
      directors, officers, employees, Sublicensees and distributors (the “CUBIST
      Indemnitees”)
      from
      and against any and all Losses resulting directly or indirectly from a claim
      of
      a Third Party with respect to: (i) a material breach of any of the provisions
      of
      this Agreement by XTL or any of its agents or employees; (ii) the negligence,
      recklessness, or willful misconduct by XTL or any of its agents or employees
      in
      the performance of any obligations of XTL under this Agreement; (iii) the
      infringement of any Third Party intellectual property right which such
      intellectual property is issued or published prior to the Effective Date caused
      by Obtaining Regulatory Approval, Commercialization, or the manufacture, use,
      promotion, marketing, sale, offer for sale, importation or exportation of
      HepeX-B in the Territory by CUBIST and its sublicensees or distributors; or
      (iv)
      the misappropriation of any Third Party intellectual property right by XTL
      or
      any of its agents or employees which is known after due and reasonable
      investigation as of the Effective Date.

    


    (c) XTL
      hereby agrees to defend, hold harmless and indemnify CUBIST Indemnitees from
      and
      against fifty percent (50%) of any and all Losses resulting directly or
      indirectly from a claim of a Third Party with respect to: (i) the infringement
      of any Third Party intellectual property right which such intellectual property
      is not issued or published prior to the Effective Date caused by Obtaining
      Regulatory Approval, Commercialization, and the manufacture, use, promotion,
      marketing, sale, offer for sale, importation or exportation of HepeX-B in the
      Territory by CUBIST and its Sublicensees or distributors; and (ii) the
      misappropriation of any Third Party intellectual property right by XTL or any
      of
      its agents or employees which is not known or knowable as of the Effective
      Date.

    


    (d) If
      either
      Party is seeking indemnification under this Section 11.3 in connection with
      a
      Third Party claim: (i) it shall inform the indemnifying Party of such Third
      Party claim giving rise to the obligation to indemnify as soon as reasonably
      practicable after receiving notice of the claim; (ii) except as provided in
      Section 11.3(d)(iii) with respect to claims under Section 11.3(b)(iii), Section
      11.3(b)(iv) or Section 11.3(c), the indemnifying Party shall have the right
      to
      assume the defense of, and take control of, any such Third Party claim for
      which
      it is obligated to indemnify the indemnified Party under this Section 11.3,
      the
      indemnified Party shall cooperate with the indemnifying Party (and its insurer)
      as the indemnifying Party may reasonably request, the indemnified Party shall
      have the right to participate, at its own expense and with counsel of its
      choice, in the defense of any claim or suit that has been assumed by the
      indemnifying Party, and neither Party shall have any obligation to indemnify
      the
      other Party in connection with any settlement made without the indemnifying
      Party’s written consent, provided that the indemnifying Party does not
      unreasonably withhold or delay any such written consent; and (iii) with respect
      to claims under Section 11.3(b)(iii), Section 11.3(b)(iv) or Section 11.3(c),
      CUBIST shall have the right to assume the defense of, and take control of,
      any
      such claim, XTL will cooperate with CUBIST as CUBIST may reasonably request,
      XTL
      shall have the right to participate, at its own expense and with counsel of
      its
      choice, in the defense of any such claim or suit that has been assumed by
      CUBIST, and XTL shall not have any obligation to indemnify CUBIST in connection
      with any settlement made without XTL’s written consent, provided that XTL does
      not unreasonably withhold or delay any such written consent.

    


    
      
        
        

      

      
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    (e) Notwithstanding
      anything expressed or implied to the contrary in this Section 11, the amount
      of
      any Losses subject to indemnification shall be reduced by the amount of any
      insurance proceeds received by the indemnified Party with respect to such
      Losses; and there shall be no obligation under this Agreement to indemnify
      such
      indemnified Party for the amount of Losses so reduced.

    


    (f) XTL
      *****
      under
      its indemnification obligations as set forth in Section 11.3(b)(iii) and (iv)
      and under Section 11.3(c), or *****
      such
      that the *****
      are no
      less than the *****,
      until
      XTL’s indemnification payment obligations under Section 11.3(b)(iii) and (iv)
      and under Section 11.3(c) are *****.
      Interest shall begin to accrue on any such XTL payment obligations commencing
      as
      of the date first due at a rate determined in accordance with Section 10.8
      on
      any such amounts *****.
      XTL
      shall have no obligation to pay any amounts under its indemnification
      obligations as set forth in Section 11.3(b)(iii) and (iv) and under Section
      11.3(c) that have not been *****
      as of
      the termination or expiration of this Agreement.

    


    11.4 Limitation
      of Liability.
      EXCEPT
      (i) AS A RESULT OF ANY INFRINGEMENT BY A PARTY OF THE INTELLECTUAL PROPERTY
      RIGHTS OF THE OTHER PARTY, (ii) AS A RESULT OF THE FAILURE OF SUCH PARTY TO
      PERFORM AND OBSERVE ITS CONFIDENTIALITY OBLIGATIONS TO THE OTHER PARTY UNDER
      THIS AGREEMENT OR (iii) PURSUANT TO A PARTY’S INDEMNIFICATION OBLIGATIONS UNDER
      SECTION 11.3, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR LOST PROFITS
      OR FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, PUNITIVE OR EXEMPLARY
      DAMAGES OF THE OTHER PARTY IN CONNECTION WITH THIS AGREEMENT OR THE TRANSACTIONS
      CONTEMPLATED BY THIS AGREEMENT, HOWEVER CAUSED, UNDER ANY THEORY OF
      LIABILITY.

    


    11.5 Insurance.
      XTL and
      CUBIST shall each procure and maintain insurance, including product liability
      insurance, adequate to cover its obligations hereunder and that are consistent
      with normal business practices of prudent companies similarly situated. It
      is
      understood that such insurance shall not be construed to create a limit of
      the
      Parties’ liability with respect to its indemnification obligations under this
      Section 11. CUBIST and XTL shall provide each other with written evidence of
      such insurance upon request (which evidence need not necessarily be insurance
      certificates). CUBIST and XTL shall provide the other with written notice at
      least ten (10) days prior to the cancellation, non-renewal or material change
      in
      such insurance that materially adversely affects the other Party’s rights
      hereunder.

    


    Section
      12. INTELLECTUAL
      PROPERTY.

    


    12.1 Inventions.
      (a) The
      entire right, title and interest in and to all discoveries, improvements,
      processes, formulas, data, inventions, enhancements, know-how and trade secrets,
      patentable or otherwise, that arise from activities under this Agreement or
      that
      are necessary or useful in connection with Obtaining Regulatory Approval,
      manufacture, marketing, promotion, sale, import or export of Products, and
      that
      were or are developed or invented: (i) solely by employees of CUBIST
      (“CUBIST
      Inventions”)
      shall
      be owned solely by CUBIST; (ii) solely by employees of XTL (“XTL
      Inventions”)
      shall
      be owned solely by XTL; and (iii) jointly by employees of CUBIST and XTL
      (“Joint
      Inventions”)
      shall
      be owned jointly by CUBIST and XTL; provided,
      however, that if the joint ownership by CUBIST and XTL of any Joint Invention
      conceived using technology funded in whole or in part by OCS (“OCS
      Technology”)
      would
      result in the transfer of any rights outside of Israel in breach or violation
      of
      Section 19b1 of the Israeli Encouragement of Development and Research in
      Industry Law, 1984, then such Joint Invention shall be solely owned by XTL,
      and
      XTL hereby grants to CUBIST, for any such Joint Invention: (A) an exclusive,
      perpetual, worldwide, irrevocable, fully paid up license (with the right to
      sublicense) to Obtain Regulatory Approval, make, have made, use, promote,
      market, sell, have sold, offer to sell, import or export Products, and (B)
      a
      co-exclusive perpetual, worldwide, irrevocable, fully paid up license (with
      each
      Party having the right to sublicense) for any and all other purposes.
      Notwithstanding anything to the contrary above, none of the foregoing shall
      serve to or require (x) CUBIST to assign or transfer, or otherwise relinquish,
      any of CUBIST’s right, title or interest in or to any CUBIST Invention, Joint
      Invention, CUBIST Patent, Joint Patent or CUBIST Know-How without the prior
      written consent of CUBIST, or (y) XTL to assign or transfer, or otherwise
      relinquish, any of XTL’s right, title or interest in or to any XTL Invention,
      Joint Invention, XTL Patent, Joint Patent or XTL Know-How without the prior
      written consent of XTL. Commencing as of the Effective Date, XTL shall not
      use
      any OCS Technology in the performance of its obligations under this Agreement
      unless prior to such use (1) XTL notifies CUBIST in writing of XTL’s intent to
      use OCS Technology, (2) XTL specifically identifies the OCS Technology
      contemplated to be used and the purpose for which XTL intends to use it, and
      (3)
      CUBIST gives its prior written consent to such use of such OCS Technology.
      Inventorship shall be determined in accordance with U.S. patent law. All
      clinical data collected pursuant to services paid for in whole or in part by
      CUBIST will be owned by CUBIST.

    


    
      
        
        

      

      
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    (b) Notwithstanding
      anything to the contrary in this Agreement, in the case any CUBIST Invention,
      XTL Invention or Joint Invention is conceived through the use of the Licensed
      Technology or Licensed Patents (as such terms are defined under the XY
      Agreement) (excluding
      the human monoclonal antibody *****,
      as
      referred to and described in *****,
      and the
      human monoclonal antibody *****,
      as
      referred to and described in *****,
      including any portions or fragments thereof)
      (collectively the “Yeda
      Technology”),
      the
      parties shall not *****,
      which
      shall include the terms and conditions for such registration or use of the
      CUBIST Invention, XTL Invention or Joint Invention and relating to the ownership
      thereof. It is agreed, without derogating from the Consent Agreement, that
      commencing as of the Effective Date, XTL shall not use any Yeda Technology
      in
      the performance of its obligations under this Agreement unless prior to such
      use
      (i) XTL notifies CUBIST in writing of XTL’s intent to use Yeda Technology (in
      which case XTL shall also deliver a copy of such notice to Yeda), (ii) XTL
      specifically identifies the Yeda Technology contemplated to be used and the
      purpose for which XTL intends to use it, and (iii) CUBIST gives its prior
      written consent to such use of such Yeda Technology.
      

    


    12.2 Filing,
      Prosecution and Maintenance of Patents. (a)
      CUBIST
      shall be entitled to file, prosecute and maintain in the Territory all patent
      applications and patents that claim any CUBIST Inventions at its sole expense.
      

    


    (b) XTL
      agrees to file, prosecute and maintain the XTL Patents at its sole expense,
      provided,
      however,
      that
      XTL shall (i) use outside counsel reasonably acceptable to CUBIST, (ii)
      provide CUBIST with all material documentation and correspondence from, sent
      to
      or filed with patent offices in the Territory regarding any XTL Patent,
      (iii) provide CUBIST with a reasonable opportunity to review and comment
      upon all filings with such patent offices in advance of submissions to such
      patent offices, and (iv) shall consider, in good faith, incorporating any
      comments provided by CUBIST. In the event that XTL is unwilling, unable or
      otherwise fails to file or prosecute any XTL Patent in any country in the
      Territory, CUBIST shall have the right, but not the obligation, and XTL
      shall
      provide CUBIST with thirty (30) days written notice to permit CUBIST to, file,
      prosecute and/or maintain such XTL Patent in such country, and XTL shall execute
      such documents and perform such acts as may be reasonably necessary to allow
      CUBIST to file, prosecute and maintain such XTL Patent in such country in a
      timely manner; provided
      that in
      any event any such XTL Patents shall always be registered in XTL’s name or in
      the name of the relevant licensor of XTL as identified in writing to CUBIST
      by
      XTL. 

    


    (c) With
      respect to all filings, prosecution and maintenance of any Patent pursuant
      to
      this Section 12.2, the filing Party shall be responsible for payment of all
      costs and expenses related to such Patent filing, prosecution or maintenance.
      

    


    (d) With
      respect to any Joint Inventions, CUBIST shall have the first right to file,
      prosecute and maintain in the Territory, upon appropriate consultation with
      XTL,
      Patents that claim or cover any Joint Invention (a “Joint
      Patent”);
      however,
      in the
      event that CUBIST elects not to file any patent application in the Territory
      with respect to any Joint Invention, XTL shall have such right and upon exercise
      by XTL of such right, XTL shall have the right to prosecute and maintain in
      the
      Territory, upon appropriate consultation with CUBIST, the Joint Patents to
      which
      such Joint Invention relates. Each of XTL and CUBIST shall execute such
      documents and perform such acts as may be reasonably necessary to allow CUBIST,
      in the first instance, and XTL, in the second instance, to file, prosecute
      and
      maintain Joint Patents in any country within the Territory in a timely basis.
      CUBIST shall promptly give notice to XTL of the grant, lapse, revocation,
      surrender, invalidation or abandonment in the Territory of any Joint Patent
      being prosecuted by CUBIST. XTL shall promptly give notice to CUBIST of the
      grant, lapse, revocation, surrender, invalidation or abandonment of any Joint
      Patent being prosecuted by XTL.

    


    
      
        
        

      

      
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    12.3 Option
      of the Parties to Prosecute and Maintain Patents.
      Each
      Party shall give notice to the other Party of any desire to cease prosecution
      of
      patent applications and/or maintenance in the Territory of XTL Patents that
      such
      Party is then prosecuting or maintaining, and, in such case, shall permit the
      other Party, in its sole discretion, to continue such prosecution or maintenance
      in the Territory at its own expense. If the other Party then elects to continue
      prosecution or maintenance in the Territory, each Party shall execute such
      documents and perform such acts as may be reasonably necessary to allow
      continuation of such prosecution or maintenance in the Territory.

    


    12.4 Legal
      or Administrative Proceedings.
      (a) Each
      Party shall, within ten (10) days of learning of such event, inform the other
      of
      any request for, or filing or declaration of, any interference, opposition,
      reexamination, revocation, nullity proceeding or declaration of non-infringement
      and/or invalidity, whether by administrative or legal proceeding, sounding
      in
      equity or in law (or the equivalent of any of the foregoing), whether initiated
      by a Third Party or any patent office, in the Territory relating to any XTL
      Patent. XTL and CUBIST shall thereafter consult and cooperate fully to determine
      a course of action with respect to any such proceeding. Each Party shall have
      the right to review and comment upon any submission to be made in connection
      with such proceeding and the Party responsible for prosecuting or maintaining
      the Patent at issue in such proceeding shall consider, in good faith,
      incorporating any comments provided by the other Party.

    


    (b) Neither
      Party shall initiate any reexamination, interference, reissue, revocation,
      nullity or declaration of non-infringement proceeding in the Territory with
      respect to XTL Patents or Joint Patents without the prior written consent of
      the
      other Party. 

    


    (c) In
      connection with any interference, opposition, reexamination, revocation, nullity
      proceeding or declaration of non-infringement and/or invalidity, whether by
      administrative or legal proceeding, sounding in equity or in law (or the
      equivalent of any of the foregoing), whether initiated by a Third Party or
      any
      Patent Office, in the Territory relating to any XTL Patent or Joint Patent,
      XTL
      and CUBIST will cooperate fully and will provide each other with any information
      or assistance that either may reasonably request. The Parties shall keep each
      other informed of developments in any such action or proceeding, including
      to
      the extent permissible by law and contracts, the status of any settlement
      negotiations and the terms of any offer related thereto.

    


    (d) XTL,
      in
      the case of XTL Patents, shall bear the expense of any interference, opposition,
      reexamination, revocation, nullity proceeding or declaration of non-infringement
      and/or invalidity, whether by administrative or legal proceeding, sounding
      in
      equity or in law (or the equivalent of any of the foregoing), whether initiated
      by a Third Party or any Patent Office, relating thereto. The expenses of any
      interference, opposition, reexamination, revocation, nullity proceeding or
      declaration of non-infringement and/or invalidity, whether by administrative
      or
      legal proceeding, sounding in equity or in law (or the equivalent of any of
      the
      foregoing), whether initiated by a Third Party or any Patent Office, with
      respect to Joint Patents shall be shared equally by the Parties.

    


    (e) This
      Section 12.4 applies to any proceeding before the United States Patent and
      Trademark Office or
      similar patent authority in the Territory and to any proceeding before a court,
      arbitration panel or similar body of competent jurisdiction.

    


    12.5 Enforcement.
      (a) Either
      Party shall give written notice to the other Party of (i) any actual, alleged
      or
      threatened infringement of any XTL Trademark or CUBIST Trademark or of any
      unfair trade practices, trade dress imitation, passing off of counterfeit goods,
      or like offenses, or any such claims brought by a Third Party against a Product
      (hereinafter “TM
      Infringement”),
      (ii)
      any infringement of any XTL Patent and/or CUBIST Patent, and/or Joint Patent,
      and (iii) any misappropriation or misuse of XTL Know-How and/or CUBIST Know-How
      and/or Joint Inventions; in each case that such Party has knowledge of. XTL
      and
      CUBIST shall thereafter consult and cooperate fully to determine a course of
      action, including but not limited to the commencement of legal action by either
      or both XTL and CUBIST, to terminate any infringement of XTL Patents Joint
      Patents, or Joint Inventions or to terminate any misappropriation or misuse
      of
      XTL Know-How. CUBIST shall have the first right to initiate and prosecute legal
      action anywhere in the Territory, at CUBIST’s expense and in its own name, and,
      as necessary, in the name of XTL, with respect to XTL Patents, XTL Know-How,
      Joint Patents, and Joint Inventions. Subject to the provisions of this Section
      12.5, CUBIST shall control and conduct such legal action in its sole discretion,
      including without limitation, the terms and conditions of any settlement. In
      the
      event that CUBIST notifies XTL in writing that it elects not to initiate and/or
      prosecute any such legal action, or if CUBIST does not take material action
      to
      abate any such actual, alleged or threatened infringement within ninety (90)
      days after the date of notice to CUBIST of such actual, alleged or threatened
      infringement, XTL shall thereafter have the right to initiate and prosecute
      such
      action in the Territory in its own name.

    


    
      
        
        

      

      
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    (b) For
      any
      infringement action concerning XTL Patents or Joint Patents or any
      misappropriation or misuse of XTL Know-How or Joint Inventions, in the event
      that CUBIST elects to initiate or prosecute such action but is unable to do
      so
      solely in its own name, XTL will join such action voluntarily, and at CUBIST’s
      expense, will execute all documents necessary for CUBIST to initiate, prosecute
      and/or maintain such action. In the event that XTL elects to be represented
      by
      its own counsel in connection with any matter pertaining to such action, XTL
      shall pay all of the costs and expenses of its own counsel. In connection with
      any such action, XTL and CUBIST will cooperate fully and will provide each
      other
      with any information or assistance that either may reasonably request,
provided,
      however,
      CUBIST
      shall control and conduct such legal action in its sole discretion, including
      without limitation, the terms and conditions of any settlement. The Parties
      shall keep each other informed of developments in any such action or proceeding,
      including to the extent permissible by law and contracts, the status of any
      settlement negotiations and the terms of any offer related thereto.

    


    (c) Any
      recovery of damages or an award received by either or both of XTL and CUBIST
      in
      connection with or as a result of any action contemplated by this Section 12.5
      or Section 12.6 below, whether by settlement or otherwise, shall be shared
      in
      order as follows:

    


    (i) the
      Party
      or Parties that prosecuted the action shall recoup all of its or their costs
      and
      expenses incurred in connection with the action;

    


    (ii) the
      other
      Party (to the extent that it did not prosecute the action) shall then, from
      funds remaining, recover its costs and expenses incurred in connection with
      the
      action to the extent that such costs and expenses are reasonably incurred to
      comply with such Party’s obligations under Section 12.5 or to the extent that
      such other Party participates in the prosecution of such action but not as
      a
      party thereto; and

    


    (iii) any
      amount remaining shall be included for royalty payment purposes under Section
      10.1 within Net Sales in Patent Countries for the royalty period in which such
      amount was received.

    


    12.6 Avoidance
      of Third Party Infringement Claims.
      If
      a
      Product becomes the subject of a claim by a Third Party that the activities
      undertaken to Obtain Regulatory Approval, manufacture, use, sell, Commercialize
      or export or import Product constitutes, causes or results in infringement
      of
      any patent rights of such Third Party or other related intellectual property
      rights (any such claim, a “Third
      Party Infringement Claim”),
      the
      Party first having notice of such Third Party Infringement Claim shall promptly
      notify the other Party. In the event that there is a Third Party Infringement
      Claim that arises from the use or practice of any XTL Patents or XTL Know-How
      in
      connection or associated with the activities undertaken to Obtain Regulatory
      Approval, manufacture, use, sell, offer for sale, Commercialize, export or
      import Product, the Parties shall confer in good faith as promptly as
      practicable after both Parties become aware of such Third Party Infringement
      Claim as to whether it is feasible to alter their approach to their activities
      with respect to the Product so as to avoid such Third Party Infringement Claim
      without adversely affecting their rights under this Agreement. In the event
      the
      Parties determine in good faith that it is feasible to alter their approach
      to
      such activities without adversely affecting their rights under this Agreement,
      the Parties shall implement such alternative approach to such activities.


    


    12.7 Patent
      Term Restoration and Regulatory Data Exclusivity.
      The
      Parties shall cooperate with each other in obtaining patent term restoration
      or
      extension, supplementary protection certificates, or their equivalents, with
      respect to XTL Patents, CUBIST Patents, Joint Patents, and regulatory data
      exclusivity and the like, with respect to HepeX-B, in the
      Territory.

    


    12.8 Patent
      Marking.
      CUBIST
      shall mark all Products sold with appropriate patent numbers or indicia at
      XTL’s
      request to the extent required and/or permitted by law.

    


    12.9 Trademarks. (a)
      CUBIST
      shall have the right to determine appropriate trademark, trade dress and other
      related intellectual property usage in connection with marketing Products under
      this Agreement. CUBIST shall have the exclusive right to use any trademarks
      in
      connection with marketing Products under this Agreement in the Territory.


    


    (b) XTL
      agrees to file, prosecute and maintain the XTL Trademarks at its sole expense,
      provided,
      however,
      that
      XTL shall (i) use outside counsel reasonably acceptable to CUBIST, (ii)
      provide CUBIST with all material documentation and correspondence from, sent
      to
      or filed with trademark offices in the Territory regarding any XTL Trademark,
      (iii) provide CUBIST with a reasonable opportunity to review and comment
      upon all filings with such trademark offices in advance of submissions to such
      patent offices, and (iv) shall consider, in good faith, incorporating any
      comments provided by CUBIST. In the event that XTL is unwilling, unable or
      otherwise fails to file or prosecute any XTL Trademark in any country in the
      Territory, XTL shall provide CUBIST with thirty (30) days notice to permit
      CUBIST to file, prosecute and/or maintain such XTL Trademark in such country,
      and XTL shall execute such documents and perform such acts as may be reasonably
      necessary to allow CUBIST to file, prosecute and maintain such XTL Trademark
      in
      such country in a timely manner.

    


    
      
        
        

      

      
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    (c) With
      respect to all filings, prosecution and maintenance of any Trademark pursuant
      to
      this Section 12.9, the filing Party shall be responsible for payment of all
      costs and expenses related to such Trademark filing prosecution or
      maintenance.

    


    12.10 Third
      Party Licenses. (a)
      The
      Parties shall confer and discuss whether any license from a Third Party is
      necessary or advisable to avoid, settle, resolve or satisfy any claim that
      the
      activities to Obtain Regulatory Approval, make, have made, use, promote, market,
      sell, have sold, offer to sell, import or export HepeX-B by CUBIST or its
      Sublicensees in any country within the Territory infringes or misappropriates
      any intellectual property rights of such Third Party. Prior to September 30,
      2004, the Parties shall confer and agree upon a strategy as to how to address
      any Third Parties, if any, then known to the Parties from whom it would be
      necessary or advisable to obtain a license to avoid, settle resolve, or satisfy
      any claim that the activities to Obtain Regulatory Approval, Commercialize,
      manufacture, use, promote, market, sell, offer, import or export of HepeX-B
      by
      CUBIST or its Sublicensees in any country within the Territory infringes or
      misappropriates any intellectual property rights of such Third Party (the
“Strategy”).
      To
      assist in devising the Strategy, CUBIST shall engage the services of a
      nationally recognized law firm with sufficient knowledge and expertise in the
      field of patent rights. If the parties, after good faith discussion and due
      consideration of the input of such law firm, are unable to mutually agree upon
      the Strategy, then CUBIST may, acting in good faith, make final decisions with
      respect to devising the Strategy. The Strategy may be modified from time to
      time
      pursuant to the mutual agreement of the Parties; provided
      that if
      the parties, after good faith discussion and due consideration of the input
      from
      the above-referenced law firm, are unable to mutually agree, then CUBIST may,
      acting in good faith, make final decisions with respect to revising the
      Strategy.

    


    (b) CUBIST
      shall be responsible for obtaining licenses identified in the Strategy on
      commercially reasonable terms. CUBIST will provide XTL with five (5) business
      days to review and *****
      the
      scope of such license is reasonably limited to permit CUBIST to exercise its
      rights and licenses under, and its activities under and pursuant to, this
      Agreement to Obtain Regulatory Approval, make, have made, use, promote, market,
      sell, have sold, offer to sell, import, export, and Commercialize HepeX-B,
      and
      whether such license contains commercially reasonable terms; such *****.
      If XTL
      does not *****
      within
      such *****,
      XTL
      will be deemed to have *****.
      CUBIST
      shall pay all amounts required to be paid to the Third Parties pursuant to
      such
      licenses described in Section 12.10(b). If and to the extent practicable, CUBIST
      shall endeavor to use reasonable efforts to obtain a clause in any such license
      permitting assignment of such license to XTL; provided
      that in
      no event shall CUBIST be in breach of this Agreement or in any way otherwise
      liable for any failure to obtain any such assignment clause in any such license;
      and further
      provided
      that
      CUBIST will have no obligation to include or accept an assignment clause that
      requires CUBIST to retain or incur any further liability under such license
      subsequent to such assignment. XTL may not reject any such license due to the
      failure of such license to contain such assignment clause as contemplated under
      this Section 12.10(b).

    


    (c) With
      respect to licenses obtained pursuant to Section 12.10(b) which were
*****,
      or with
      respect to which *****
      (“Approved
      Third Party Licenses”)
      wherein the intellectual property rights were described in an issued patent
      or
      published in a patent application as of the Effective Date, unless with respect
      to any such licenses that were not mutually agreed-upon in the Strategy, XTL
      obtains a Legal Opinion, at XTL’s expense, that is in form and substance
      reasonably acceptable to CUBIST (provided
      that
      CUBIST must notify XTL within thirty (30) days after receipt of the executed
      Legal Opinion if CUBIST deems such Legal Opinion to not be reasonably
      acceptable), CUBIST shall have the right to reduce milestone and royalty
      payments otherwise owed to XTL pursuant to Sections 9 and 10 by the amounts
      paid
      to such Third Parties for such licenses such that the reduced milestone and
      royalty payments are no less than the *****.
      In the
      event that CUBIST cannot fully offset such amounts against milestone and royalty
      payments otherwise owed to XTL, unless paid by XTL, interest shall begin to
      accrue as of the date CUBIST first makes such payment to such Third Party at
      a
      rate determined in accordance with Section 10.8 on any such amounts not able
      to
      be offset. CUBIST will reasonably cooperate with the law firm agreed to by
      the
      Parties to provide such information as may be reasonably necessary to enable
      the
      law firm to render its opinion.

    


    After
      a
      Change of Control of CUBIST, (i) amounts previously paid by CUBIST with respect
      to the licenses described under this Section 12.10(c), plus any accrued interest
      through the date of the Change of Control, and not yet paid by XTL or offset
      pursuant to this Section 12.10(c), will continue to be offset against milestone
      and royalty payments otherwise owed to XTL pursuant to Sections 9 and 10 before
      any other offsets pursuant to this Agreement; provided
      that
      such milestones and royalties shall not be reduced by more than fifty percent
      (50%), (ii) only fifty percent (50%) of amounts required to be paid by CUBIST
      pursuant to such licenses after a Change of Control of CUBIST shall be offset
      against milestone and royalty payments otherwise owed to XTL pursuant to
      Sections 9 and 10 before any other offsets pursuant to this Agreement;
provided
      that
      such milestones and royalties shall not be reduced by more than fifty percent
      (50%), and (iii) interest shall cease to accrue on all amounts paid by CUBIST
      pursuant to the licenses obtained or to be obtained under this Section 12.10(c)
      but not otherwise offset as permitted under this Agreement.

    


    
      
        
        

      

      
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    (d) With
      respect to Approved Third Party Licenses wherein the intellectual property
      rights were neither described in an issued patent nor published in a patent
      application as of the Effective Date, unless with respect to any such licenses
      that were not mutually agreed-upon in the Strategy, XTL obtains a Legal Opinion,
      at XTL’s expense, that is in form and substance reasonably acceptable to CUBIST
      (provided
      that
      CUBIST must notify XTL within thirty (30) days after receipt of the executed
      Legal Opinion if CUBIST deems such Legal Opinion to not be reasonably
      acceptable), CUBIST shall have the right to reduce milestone and royalty
      payments otherwise owed to XTL pursuant to Sections 9 and 10 by fifty percent
      (50%) of the amounts paid to such Third Parties for such licenses such that
      the
      reduced milestone and royalty payments are no less than the XTL Licensor
      Payments. In the event that CUBIST cannot fully offset such amounts against
      milestone and royalty payments otherwise owed to XTL, unless paid by XTL,
      interest shall begin to accrue as of the date CUBIST first makes such payment
      to
      such Third Party at a rate determined in accordance with Section 10.8 on any
      such amounts not able to be offset. CUBIST will reasonably cooperate with the
      law firm agreed to by the Parties to provide such information as may be
      reasonably necessary to enable the law firm to render its opinion.

    


    After
      a
      Change of Control of CUBIST, (i) amounts previously paid by CUBIST with respect
      to the licenses described under this Section 12.10(d), plus any accrued interest
      through the date of the Change of Control, and not yet paid by XTL or offset
      pursuant to this Section 12.10(d), will continue to be offset against milestone
      and royalty payments otherwise owed to XTL pursuant to Sections 9 and 10 before
      any other offsets pursuant to this Agreement; provided
      that
      such milestones and royalties shall not be reduced by more than fifty percent
      (50%), and (ii) interest shall cease to accrue on all amounts paid by CUBIST
      pursuant to the licenses obtained or to be obtained under this Section 12.10(d)
      but not otherwise offset as permitted under this Agreement.

    


    (e) XTL
      shall
      have no obligation to pay any amounts incurred by CUBIST pursuant to the Third
      Party licenses obtained under this Section 12.10, which amounts have not been
      offset against milestone and royalty payments as of the termination or
      expiration of this Agreement.

     

    12.11 Limitation.
      Notwithstanding
      any other provision in this Section 12, except with respect to the Patents
      listed in Exhibit
      A,
      (a)
      neither Party shall be obligated to prepare, file, prosecute and maintain
      Patents, or to bring or pursue
      enforcement proceedings or defend declaratory judgment actions under this
      Section 12 if, and to the extent that, such Party is not entitled to do so
      under
      its licenses from Third Parties, and (b) any rights conveyed under this Section
      12 permitting a Party to prepare, file, prosecute and maintain certain Patents,
      or to bring and pursue enforcement proceedings, or defend declaratory judgment
      actions shall be subject to all applicable licenses from Third Parties, and
      are
      conveyed only to the extent permitted under such agreements. With respect to
      Patents Controlled by XTL after the Effective Date, XTL shall promptly notify
      CUBIST in writing if XTL is not entitled under its licenses to such Patents
      from
      Third Parties to perform the activities listed in (a) above, or if any rights
      listed in (b) above that have been conveyed to CUBIST are restricted by XTL’s
      licenses from Third Parties to such Patents.

    


    Section
      13. TERM
      AND TERMINATION.
      

    


    13.1 Term.
      This
      Agreement shall be effective as of the Effective Date and remain in effect
      until
      the earlier of (a) the effective date of termination pursuant to Section 13.2
      or
      Section 13.3 below, and (b) the expiration of the term of this Agreement on
      the
      date on which CUBIST is no longer obligated, pursuant to this Agreement, to
      make
      payment to XTL of any royalties in connection with sales of Products in the
      Territory. In the event that the term of this Agreement expires pursuant to
      clause (b) of this Section 13.1, then the licenses granted by
      XTL to
      CUBIST shall survive such expiration and shall be fully paid-up, royalty-free,
      perpetual and irrevocable licenses. 

    


    13.2 Termination
      by CUBIST. (a)
      This
      Agreement may be terminated by CUBIST at any time during the term of this
      Agreement for any reason or no reason if CUBIST gives at least one hundred
      and
      eighty (180) days prior written notice of termination to XTL. 

    


    
      
        
        

      

      
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    (b) CUBIST
      may terminate this Agreement upon twenty (20) days’ prior written notice to XTL
      if (i) in CUBIST’s judgment continuation of the activities contemplated
      hereunder is inappropriate, impractical, or inadvisable either for reasons
      of
      safety or efficacy; or (ii) the emergence of any adverse event or side effect
      with the Product is of such magnitude or incidence in the opinion of CUBIST
      to
      support termination. Upon CUBIST’s delivery of such notice to XTL, CUBIST shall
      have no further obligations under this Agreement except as provided under
      Section 13.5.

    


    (c) CUBIST
      may terminate this Agreement pursuant to this Section 13.2 on a Product by
      Product or country by country basis.

    


    13.3 Termination
      By Either Party Upon Bankruptcy or Insolvency.
      This
      Agreement may be terminated in its entirety by either Party by giving written
      notice of termination to the other Party in the event that such other Party
      files or institutes any bankruptcy, liquidation or receivership proceedings,
      or
      in the event that such other Party makes an assignment of a substantial portion
      of the assets of such other Party for the benefit of its creditors; provided,
      however, that, in the case of any involuntary bankruptcy proceeding such right
      to terminate shall only become effective if such other Party consents to the
      involuntary bankruptcy or such proceeding is not dismissed within sixty (60)
      days after the filing thereof.

    


    13.4 Termination
      for Breach. (a)
       
      If either Party (the “Non-Breaching
      Party”)
      believes that the other Party (the “Breaching
      Party”)
      is in
      material breach of this Agreement with respect to one or more Products, then
      the
      Non-Breaching Party may deliver notice of such breach to the Breaching Party.
      The Breaching Party shall have thirty (30) days to cure such breach;
provided
      that, if
      cure cannot be reasonably effected within such thirty (30) day period, the
      Breaching Party may elect to deliver to the Non-Breaching Party within such
      thirty (30) day period a plan to cure such breach within a timeframe that is
      reasonably prompt in light of the circumstances then prevailing, and the
      Non-Breaching Party shall have the right to approve or reject in writing such
      proposed plan in its absolute discretion. If the Non-Breaching Party approves
      in
      writing such proposed plan, then the cure period will be extended in accordance
      with the terms of such plan and the Breaching Party shall use Commercially
      Reasonable Efforts to carry out such plan and cure the breach in
      accordance with the provisions of such plan. 

    


    (b)
       
      If the Breaching Party fails to cure such breach as provided for in
      Section 13.4(a), the Non-Breaching Party may terminate this Agreement
      either in its entirety or with respect to one or more Products upon written
      notice to the Breaching Party; provided
      that,
      the Non-Breaching Party gives such written notice of termination within six
      (6)
      months after the Breaching Party has failed to cure such breach as provided
      for
      in Section 13.4(a).

    


    (c)
       
      If the Non-Breaching Party gives notice of termination under this
      Section 13.4 and the Breaching Party disputes whether such termination
      is
      proper under this Section 13.4, then the issue of whether this Agreement
      may properly be terminated upon expiration of the notice period (unless such
      breach is cured as provided in Section 13.4(a)) shall be resolved in
      accordance with Section 14 (Dispute Resolution). If as a result of such
      dispute resolution process it is determined that the notice of termination
      was
      proper, then such termination shall be deemed to have been effective thirty
      (30)
      days following the date of the notice of termination. If as a result of such
      dispute resolution process it is determined that the notice of termination
      was
      improper, then no termination shall have occurred and this Agreement shall
      remain in effect. 

    


    13.5 Effect
      of Expiration or Termination of this Agreement.
      (a)
      In the
      event of termination or expiration of this Agreement, then, except to the extent
      otherwise provided in this Section 13.5(a) and Section 13.5(f) below, neither
      Party shall have any liability or obligation to the other Party under this
      Agreement. Notwithstanding the foregoing sentence, the licenses granted to
      CUBIST under Section 2 shall survive expiration of this Agreement pursuant
      to
      Section 13.1(b), and in such event, such licenses shall be deemed to be fully
      paid up, irrevocable and perpetual.

    


    (b) In
      the
      event that CUBIST terminates this Agreement pursuant to Section 13.4, then
      this
      Agreement shall terminate, and, except to the extent otherwise provided in
      Section 13.5(f) below, neither Party shall have any liability or obligation
      to
      the other Party under this Agreement. 

    


    (c) In
      the
      event that CUBIST terminates this Agreement pursuant to Section 13.2, or in
      the
      event that XTL terminates this Agreement pursuant to Section 13.4, then this
      Agreement shall terminate, and, except to the extent otherwise provided in
      this
      Section 13.5(c), Section 13.5(d) and Section 13.5(f) below, neither Party shall
      have any further liability or obligation to the other Party under this
      Agreement, including with respect to Section 9 and Section 10. The licenses
      granted to CUBIST under Section 2 shall terminate. Notwithstanding anything
      to
      the contrary in this Section 13.5(c), in the event that CUBIST terminates this
      Agreement pursuant to Section 13.2 or XTL terminates this Agreement pursuant
      to
      Section 13.4, CUBIST shall have the right to sell in the Territory all of its
      inventory of Products for a period of twelve (12) months from the effective
      date
      of termination, subject to CUBIST’s payment obligations under Section
      10.

    


    
      
        
        

      

      
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    (d) If
      requested by XTL within ten (10) days after the effective date of a termination
      pursuant to Section 13.2 or a termination by XTL pursuant to Section 13.4,
      either with respect to this Agreement in its entirety, or with respect to a
      particular Product in one or more countries, CUBIST will: (i) transfer to XTL
      all INDs, Regulatory Approval applications, Regulatory Approvals and orphan
      drug
      designations for such terminated Products in the terminated countries in effect
      as of the time of any such termination, (ii) subject to the scope of use
      limitations described in clause (iii) below, provide to XTL a copy of all
      information, data, records and reports (but specifically excluding know-how
      of
      CUBIST and CUBIST Patents) in Cubist's Control created or obtained in the
      performance of CUBIST's or XTL’s activities under this Agreement that are
      directly related to the Products (or in the event of a termination with respect
      to a particular Product, such terminated Product) and necessary or reasonably
      useful for XTL to
      Obtain
      Regulatory Approval and Commercialize the
      Products (or in the event of a termination with respect to a particular Product,
      such terminated Product) in the terminated countries (collectively, the
“Data”),
      and
      (iii) grant to XTL a non-exclusive license in the terminated countries in and
      to
      the Data solely for the purpose of using and incorporating the Data in its
      applications for and in the maintenance of Regulatory Approval of Products
      (or
      in the event of a termination with respect to a particular Product, such
      terminated Product) within the terminated countries and to Obtain Regulatory
      Approval, manufacture and Commercialize Products (or in the event of a
      termination with respect to a particular Product, such terminated Product)
      in
      the terminated countries, and (iv) if permitted under any Third Party licenses
      obtained by CUBIST after the Effective Date pursuant to the Strategy, CUBIST
      will assign to XTL such licenses, or if any such license covers countries other
      than the terminated countries will grant to XTL a sublicense under such license
      with respect to the terminated countries, to Obtain Regulatory Approval, make,
      have made, use, promote, market, sell, have sold, offer to sell, import
      or export HepeX-B in the terminated countries; provided
      that if
      any such license requires consents of the Third Party licensor to effect such
      assignment, CUBIST will request such consent and if such consent is not provided
      or is otherwise qualified, CUBIST will have no obligation to assign such
      license. In addition, upon any such termination, CUBIST shall either (y)
      negotiate in good faith with XTL to enter into an agreement to supply such
      terminated Product to XTL on commercially reasonable terms, or (z) if such
      termination terminated this Agreement in its entirety, provide to XTL all
      biological materials in CUBIST’s Control created or obtained under this
      Agreement with respect to Products (subject to CUBIST’s sell-off rights with
      respect to inventory under Section 13.5(c)), and a copy of all information,
      data, records and reports (but specifically excluding know-how of CUBIST and
      CUBIST Patents) in Cubist's Control created or obtained in the performance
      of
      CUBIST's or XTL’s activities under this Agreement that are directly related to
      the terminated Products and necessary or reasonably useful for XTL to
      manufacture such terminated Products, and such data and information shall be
      deemed to be included within the Data. Notwithstanding
      the foregoing, CUBIST will have no obligation to assign or otherwise transfer
      to
      XTL any INDs, Regulatory Approval applications, Regulatory Approvals or orphan
      drug designations if any of the foregoing are in effect with respect to any
      country other than the terminated countries. XTL and CUBIST will negotiate
      in
      good faith with respect to mutually agree upon reasonable and appropriate
      compensation to CUBIST for the commercial value received as a result of the
      transfers and licenses provided as set forth in this Section 13.5(d); if the
      Parties are unable to so mutually agree within ninety (90) days after the
      effective date of termination of this Agreement the Parties shall refer the
      matter to the dispute resolution process set forth in Section 14, and in any
      arbitration, the arbitrator will take into consideration, among other factors,
      the investment of CUBIST in creating or obtaining the Data and the Parties’
      investment in obtaining such transferred INDs, Regulatory Approval applications,
      Regulatory Approvals and orphan drug designations, and amounts paid by CUBIST
      but offset under Section 10.4 with respect to any assigned Third Party licenses.
      

    


    (e) In
      the
      event this Agreement is terminated due to the rejection of this Agreement by
      or
      on behalf of a Party under Section 365 of the United States Bankruptcy Code
      (the
“Code”),
      and
      the equivalent provisions, if any, of the bankruptcy laws of other countries
      in
      which CUBIST exercises the license granted hereunder, all licenses and rights
      to
      licenses granted under or pursuant to this Agreement by one Party to the other
      are, and shall otherwise be deemed to be, for purposes of Section 365(n) of
      the
      Code, and any such equivalent law, licenses of rights to “intellectual property”
      as defined under Section 101(35A) of the Code. The Parties agree that the
      licensed Party, as a licensee of such rights under this Agreement, shall retain
      and may fully exercise all of its rights and elections under the Code, and
      any
      such equivalent law, and that upon commencement of a bankruptcy proceeding
      by or
      against a Party under the Code, the other Party shall be entitled to a complete
      duplicate of or complete access to, any such intellectual property and all
      embodiments of such intellectual property. Such intellectual property and all
      embodiments thereof shall be promptly delivered to the other Party (i) upon
      any
      such commencement of a bankruptcy proceeding upon written request therefor
      by a
      Party, unless the Party elects to continue to perform all of its obligations
      under this Agreement or (ii) if not delivered under (i) above, upon the
      rejection of this Agreement by or on behalf of the Party upon written request
      therefor. The foregoing is without prejudice to any rights either Party may
      have
      arising under the Code or other applicable law. 

    


    
      
        
        

      

      
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    (f) Termination
      of this Agreement shall not relieve either Party of any obligation of such
      Party
      accruing prior to such termination. Any termination of this Agreement shall
      be
      without prejudice to the rights of either Party against the other accrued or
      accruing under this Agreement prior to termination. The provisions of Section
      1,
      Section 8.2, Section 8.3, Section 8.4, Section 11.3, Section 11.4, Section
      12.1,
      Section 13, Section 14 and Section 15 shall survive the termination of this
      Agreement. Section 8.1 and Section 8.5 shall survive termination of this
      Agreement for a period of five (5) years.

    


    (g) CUBIST
      shall reimburse XTL for all non-cancelable out-of-pocket expenses XTL incurs
      after a termination of this Agreement (by CUBIST pursuant to Section 13.2,
      or by
      XTL pursuant to Section 13.4) with respect to Third Party service providers
      contracted by XTL to assist in the performance of XTL’s obligations hereunder;
provided
      that (i)
      such obligations are set forth in a written agreement between XTL and such
      Third
      Party service provider, (ii) the terms and provisions of such written agreement,
      including those relating to such non-cancelable expenses, are commercially
      reasonable, (iii) XTL has used commercially reasonable efforts to minimize
      such
      non-cancelable expenses; and (iv) such non-cancelable expenses relate solely
      and
      directly to the performance of XTL obligations under this
      Agreement.

    


    Section
      14. DISPUTE
      RESOLUTION.

    


    14.1 Escalation.
      The
      Parties recognize that disputes as to certain matters may from time to time
      arise during the term of this Agreement which relate to either Party’s rights
      and/or obligations hereunder. It is the objective of the Parties to establish
      procedures to facilitate the resolution of disputes arising under this Agreement
      in an expedient manner by mutual cooperation and without resort to litigation.
      To accomplish this objective, the Parties agree to follow the procedures set
      forth in this Section 14.1 if and when a dispute arises under this Agreement.
      Any dispute arising under this Agreement shall, by either Party providing
      written notice to the other Party, be referred to the respective chief executive
      officers of the Parties for attempted resolution by good faith negotiations
      within fourteen (14) days after such notice is received. In the event that
      the
      designated officers are not able to resolve such dispute within such fourteen
      (14) day period, and do not agree to extend the time period for resolving the
      dispute, or if the terms and conditions of the resolution or settlement of
      the
      dispute are breached, the dispute shall be submitted for mediation by a mutually
      acceptable Third Party within thirty (30) days after expiration of the previous
      fourteen (14) day period, unless the Parties agree to extend the period for
      submitting the dispute for mediation. In the event that such dispute is not
      resolved within thirty (30) days after such dispute is submitted for mediation,
      unless the parties otherwise agree to extend the time period for resolving
      the
      dispute, then such dispute shall be resolved by arbitration pursuant to the
      provisions of Section 14.2. Pending resolution of any dispute covered by this
      Section 14.1, both Parties will continue their performance under this Agreement
      of any obligations (including, without limitation, payment obligations) that
      are
      not the subject of such dispute.

    


    14.2 Arbitration.
      (a)
      Any
      claim, dispute, or controversy arising out of or relating to this Agreement
      that
      is not resolved in accordance with the provisions of Section 14.1 and that
      the
      Parties agree to submit to binding arbitration pursuant to this Section 14.2
      will be submitted by the parties to arbitration under rules then in effect
      (“ICC
      Rules”)
      of the
      International Chamber of Commerce (“ICC”)
      in New
      York City, New York, U.S.A. as modified herein or by agreement of the Parties.
      Any such arbitration shall be conducted in New York City, New York, U.S.A.
      by
      three (3) arbitrators. Each Party shall select one (1) arbitrator and such
      arbitrators shall jointly appoint the third arbitrator who shall act as the
      chairman. If either Party fails to appoint an arbitrator within thirty (30)
      days
      of a request by the other Party, or if the arbitrators selected by the parties
      cannot agree on a chairman within thirty (30) days after they have been
      selected, then either Party may request the ICC to appoint such co-arbitrator
      (for the non-responsive Party) or the chairman. Such appointment shall be
      binding on the Parties. Each Party irrevocably and unconditionally (i) consents
      to the jurisdiction of any such proceeding and waives any objection that it
      may
      have to personal jurisdiction or the laying of venue of any such proceeding;
      and
      (ii) knowingly and voluntarily waives its rights to have disputes tried and
      adjudicated by a judge and jury except as otherwise expressly provided herein.
      The Parties will cooperate with each other in causing the arbitration to be
      held
      in as efficient and expeditious a manner as practicable. Unless the Parties
      agree otherwise, they shall be limited in their discovery to directly relevant
      documents. Responses or objections to a document request shall be served twenty
      (20) days after receipt of the request. The arbitrators shall resolve any
      discovery disputes. Nothing herein shall prevent the Parties from settling
      any
      dispute by mutual agreement at any time. 

    


    
      
        
        

      

      
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    (b) The
      arbitration shall be of each Party’s individual claims only, and no claim of any
      other Party shall be subject to arbitration in such proceeding. Except as
      otherwise required by law, the Parties and the arbitrator(s) shall maintain
      as
      confidential all information or documents obtained during the arbitration
      process, including the resolution of the dispute. The arbitration shall be
      conducted in English language. 

    


    (c) The
      arbitrator(s) shall not have the authority to award any injunctive relief or
      to
      award exemplary or punitive damages, and the Parties expressly waive any right
      to such damages. The arbitrator(s) shall have the authority to award actual
      money damages (including interest on unpaid amounts from the date due). The
      costs and expenses of the arbitration, but not the costs and expenses of the
      Parties, shall be shared equally by the Parties; provided
      that the
      non-prevailing Party in any arbitration shall pay the other Party’s costs and
      expenses (including travel expenses) and reimburse such Party for its portion
      of
      the arbitration costs. In the event that neither Party wins totally,
      reimbursement shall be made proportionally in accordance with the ICC Rules.
      Any
      award rendered by the arbitrator(s) shall be final and binding upon the Parties.
      Judgment upon the award may be entered in any court of competent jurisdiction.
      If a Party fails to proceed with arbitration, unsuccessfully challenges the
      arbitration award, or fails to comply with the arbitration award, the other
      Party is entitled to costs, including reasonable attorneys’ fees, for having to
      compel arbitration or defend or enforce the award.

    


    Section
      15. MISCELLANEOUS.

    


    15.1 Force
      Majeure.
      Neither
      Party shall be held liable or responsible to the other Party nor be deemed
      to
      have defaulted under or breached the Agreement for failure or delay in
      fulfilling or performing any term of the Agreement when such failure or delay
      is
      caused by or results from causes beyond the reasonable control of the affected
      Party including, but not limited to, earthquakes, fire, floods, embargoes,
      insurrections, riots, civil commotions, strikes, lockouts or other labor
      disturbances, acts of God, acts of war or terrorism, or acts, omissions or
      delays in acting by any governmental authority or the other Party. The affected
      Party shall notify the other Party of such force majeure circumstances as soon
      as reasonably practical.

    


    15.2 Assignment. Neither
      party may assign its rights or obligations hereunder without the prior written
      consent of the other party which will not be unreasonably withheld or delayed;
      provided
      that
      either may assign this Agreement to one of its Affiliates, or pursuant to a
      merger, consolidation or sale of substantially all of its assets or stocks
      or
      other ownership interests without such prior written consent. The Parties agree
      that the issue of whether prior written consent to an assignment was
      unreasonably withheld or delayed by a Party shall be governed by the laws of
      the
      Commonwealth of Massachusetts without reference to any rules of conflicts of
      laws. This Agreement will bind and inure to the benefit of the parties hereto
      and their respective successors and permitted assigns.

    


    15.3 Severability.
      In the
      event any one or more of the provisions contained in this Agreement should
      be
      held invalid, illegal or unenforceable in any respect, the validity, legality
      and enforceability of the remaining provisions contained herein shall not in
      any
      way be affected or impaired thereby, unless the absence of the invalidated
      provision(s) adversely affect the substantive rights of the Parties. The Parties
      shall in such an instance use their best efforts to replace the invalid, illegal
      or unenforceable provision(s) with valid, legal and enforceable provision(s)
      that, insofar as practical, implement the purposes of this
      Agreement.

    


    15.4 Notices.
      All
      notices or other communications that are required or permitted hereunder shall
      be in writing and sufficient if delivered personally, sent by telecopier (and
      promptly confirmed by personal delivery, registered or certified mail or
      overnight courier), sent by internationally-recognized overnight courier,
      addressed as follows:

    


    
      
        	
                If
                  to CUBIST, to:

              	 	
                If
                  to XTL, to:

              
	
                CUBIST
                  Pharmaceuticals, Inc.

                65
                  Hayden Avenue

                Lexington,
                  MA 02421

                Attention:
                  Chief Executive Officer

                Telecopier
                  No.: (781) 861-1412

              	 	
                XTL
                  Biopharmaceuticals Ltd.

                Building
                  3 

                Kiryat
                  Weizmann 

                Rehovot
                  76100 

                Israel

                Attention:
                  Chief Executive Officer

                Telecopier
                  No.: (972) 8.940.5017 

              


      

       

      
        
          
          

        

        
          33

          
            

          

        

        
          
            *****
              Confidential material redacted and filed separately with the
              Commission.

          

        

         

      

      
        	
                With
                  a copy to:

              	 	
                With
                  a copy to:

              
	
                CUBIST
                  Pharmaceuticals, Inc.

                65
                  Hayden Avenue

                Lexington,
                  MA 02421

                Attention:
                  General Counsel

                Telecopier
                  No.: (781) 860-1407

                 

                And

                 

                Bingham
                  McCutchen LLP

                150
                  Federal Street

                Boston,
                  MA 02110

                Attention:
                  Julio E. Vega, Esq.

                Telecopier
                  No.: (617) 951-8736

              	 	
                Heller
                  Ehrman White & McAuliffe LLP

                4350
                  La Jolla Village Drive, 7th Floor

                San
                  Diego, CA 92122

                Attention:
                  Stephen C. Ferruolo

                Telecopier
                  No.: (858) 450-8499

              


      

    

    


    or
      to
      such other address as the Party to whom notice is to be given may have furnished
      to the other Party in writing in accordance herewith. Any such communication
      shall be deemed to have been given when delivered if personally delivered or
      sent by telecopier on a business day, on the business day after dispatch if
      sent
      by internationally-recognized overnight courier.

    


    15.5 English
      Language.
      All
      notices, disclosures or information delivered or made available by either Party
      or its employees and agents to the other Party and its employees or agents
      pursuant to this Agreement shall be made in English. The English language
      version of this Agreement shall control notwithstanding the translation of
      this
      Agreement into any other language.

    


    15.6 Applicable
      Law.
      Except
      as otherwise expressly set forth in Section 15.2, this Agreement shall be
      governed by and construed in accordance with the laws of the United States
      and
      the State of New York without reference to any rules of conflict of laws. The
      Parties irrevocably consent to the exclusive personal jurisdiction (except
      as to
      actions for the enforcement of a judgment, in which case such jurisdiction
      shall
      be non-exclusive) of the federal and state courts located in New York, New
      York,
      and venue in New York, New York.

    


    15.7 Entire
      Agreement.
      The
      Agreement contains the entire understanding of the Parties with respect to
      the
      subject matter hereof. All express or implied agreements and understandings,
      either oral or written, heretofore made are expressly merged in and made a
      part
      of the Agreement. Except as expressly set forth in this Agreement, the Agreement
      may be amended, or any term hereof modified, only by a written instrument duly
      executed by both Parties.

    


    15.8 Headings.
      The
      captions to the several sections hereof are not a part of the Agreement, but
      are
      merely guides or labels to assist in locating and reading the several sections
      hereof.

    


    15.9 Independent
      Contractors.
      It is
      expressly agreed that CUBIST and XTL shall be independent contractors and that
      the relationship between the two Parties shall not constitute a partnership,
      joint venture or agency. Neither CUBIST nor XTL shall have the authority to
      make
      any statements, representations or commitments of any kind, or to take any
      action, which shall be binding on the other, without the prior consent of the
      other Party.

    


    15.10 Waiver.
      The
      waiver by either Party hereto of any right hereunder or the failure to perform
      or of a breach by the other Party shall not be deemed a waiver of any other
      right hereunder or of any other breach or failure by said other Party whether
      of
      a similar nature or otherwise.

    


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

    


    15.12 Waiver
      of Rule of Construction.
      Each
      Party has had the opportunity to consult with counsel in connection with the
      review, drafting and negotiation of this Agreement. Accordingly, the rule of
      construction that any ambiguity in this Agreement shall be construed against
      the
      drafting Party shall not apply.

    


    15.13 Third
      Party Beneficiaries.
      Except
      as otherwise expressly provided in this Agreement, nothing herein expressed
      or
      implied is intended or shall be construed to confer upon or to give to any
      Third
      Party any rights or remedies by reason of this Agreement. Except as otherwise
      expressly provided in this Agreement, there are no intended Third Party
      beneficiaries under or by reason of this Agreement.

     

    [The
      remainder of this page is intentionally left blank.]

    


    
      
        
        

      

      
        34

        
          

        

      

      
        
          *****
            Confidential material redacted and filed separately with the
            Commission.

        

      

    

     

    IN
      WITNESS WHEREOF, the Parties have executed this License Agreement as of the
      Effective Date.

    


    
      
        
          	 	XTL BIOPHARMACEUTICALS
                  LTD.  	 	CUBIST PHARMACEUTICALS,
                  INC. 
	 	 	 	 
	By:  	/s/ Martin
                  Becker   	By:   	/s/ Oliver
                  Fetzer  
	 	
                  
 Name:
                  Martin
                  Becker         	 	
                  
 Name:
                  Oliver Fetzer 
	 	Title: CEO and
                  President  	 	Title: SVP, Corporate Development
                  and
                  CBO  


        

      

       

       

    

    [SIGNATURE
      PAGE TO LICENSE AGREEMENT]

    
 

    
      
        
        

      

      
        35

        
          

        

      

      
        
          *****
            Confidential material redacted and filed separately with the
            Commission.

        

      

    

     

    Exhibit
      A

    (XTL
      Patents as of the Effective Date)

     

    
      	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            
	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            
	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            
	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            
	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            
	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            
	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            


    

    


    Antibody
      17 Patents

     

    
      
        	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              
	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              
	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              
	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              
	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              
	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              
	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              


      

       

       Antibody19
[Combination]

       

      
        	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              
	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              
	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              	
                *****

              


      

    

     

    Note
      that
      confidential
      treatment has been requested and one (1) page of material from this Exhibit
      B
      has been omitted and filed separately with the Commission.

    


    
      
        
        

      

      
        36

        
          

        

      

      
        
          *****
            Confidential material redacted and filed separately with the
            Commission.

        

      

    

     

    
      Exhibit
        B

      (XTL
        Trademarks)

      


      Note
        that
        confidential
        treatment has been requested and one (1) page of material from this Exhibit
        B
        has been omitted and filed separately with the Commission.

    

     

    
      	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            
	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            
	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            
	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            
	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            
	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            
	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            
	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            
	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            
	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            
	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            
	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            	
              *****

            


    

     

    
      
        
        

      

      
        37

        
          

        

      

      
        
          *****
            Confidential material redacted and filed separately with the
            Commission.

        

      

    

     

    Exhibit
      C

    (HepeX-B
      Plan Guidelines)

    


    Note
      that
      confidential
      treatment has been requested and one (1) page of material from this Exhibit
      C
      has been omitted and filed separately with the Commission.

    


    Exhibit
      C
      provides guidelines for developing the detailed HepeX-B Plan. The Guidelines
      outline the scientific, clinical, regulatory and manufacturing activities that
      are currently contemplated to be required
      to
      Obtain
      Regulatory Approval for a commercially viable formulation of HepeX-B for the
      prevention of recurrent Hepatitis B infections in liver transplant patients
      in
      the US and the EU. A preliminary budget for 2004 and 2005 is included and
      subject to change as the detailed HepeX-B Plan is developed. These guidelines
      are subject to section 5.2 of the Agreement. Activities include: 

    


    
      	1.  	
              *****

            


    

    
      	2.  	
              *****

            


    

    
      	3.  	
              *****

            


    

    
      	4.  	
              *****

            


    

    
      	5.  	
              *****

            


    

    
      	6.  	
              *****

            


    

    


    It
      is
      contemplated that the HepeX-B Plan will also *****. However, the Parties
      recognize that additional activities ***** may also be required, and cannot
      be
      specified at this stage.

    


    *****

    


    Note:
      There might be some redundancy in costs identified in *****. The preliminary
      budget does not include costs of ***** 

    


    
      
        
        

      

      
        38

        
          

        

      

      
        *****
          Confidential material redacted and filed separately with the
          Commission.

      

    

     

    Exhibit
      D

    (XTL
      Obligations)

     

    Specific
      XTL obligations are identified in the following
      activities:

     

    
      	1.  	
              Complete
                production of material for *****

            


    

    


    
      	2.  	
              Complete
                the development of an ***** of
                HepeX-B]

            


    

    


    
      	3.  	
              Complete
                the following clinical studies

            


    

    


    
      	a.  	
              *****

            


    

    


    
      	i.  	
              *****
                to be completed by April 2005

            


    

    


    
      	ii.  	
              *****
                to be completed by April 2006

            


    

    


    
      	b.  	
              *****
                to be completed by January 2005]

            


    

     

    Complete
      production of material for *****

    


    *****

    


    *****
      clones ***** and for ***** were selected and adapted to ***** produced were
      ***** and found similar to the ***** produced in *****.

    


    *****
      for
      each ***** was produced by *****

    


    *****:
      Preparation of a ***** consisting of ***** was completed. The ***** was tested
      by *****, and passed all ***** required by*****; however, a ***** result was
      obtained by ***** with the *****. ***** will perform necessary testing to
      demonstrate that the results do not represent an ***** (e.g., ***** of three
      ***** to a study using *****. ***** will deliver a ***** that is fully compliant
      with ***** and is acceptable for entry to ***** (i.e., must pass ***** testing)
      by *****. Additionally, ***** will provide ***** with all reports and data
      associated with the *****.

    


    *****:
      Preparation of a ***** consisting of ***** was completed. The ***** was tested
      by *****, and passed all ***** required by *****; *****, in light of the *****
      test result obtained above, ***** will perform all tests that may be necessary
      (in the same manner as is being done for the *****) should the ***** in any
      relevant *****. ***** will deliver a ***** that is fully compliant with
      *****-required tests and is acceptable for entry to ***** (i.e., must pass
      *****
      testing) by *****. Additionally, ***** will provide ***** with all reports
      and
      data associated with the *****.

     

    
      
        
        

      

      
        39

        
          

        

      

      
        
          *****
            Confidential material redacted and filed separately with the
            Commission.

        

      

    

    


    *****

    


    About
      ***** was produced in *****. Material was ***** is stored until *****. The
      *****
      described above must be complete prior to release of this material *****, which
      is to be completed by *****. If the ***** does not meet the requirements
      described above, this lot of ***** (i.e. the lot produced from the *****) must
      be rejected. ***** will provide ***** with the ***** and all ***** associated
      with its production (e.g., batch records, results of in-process testing).


    


    Production
      of ***** is expected to start during *****. The retesting of the ***** described
      above must be complete prior to ***** of this *****, which is to be completed
      by
      *****. If the ***** does not meet the requirements described above, ***** (i.e.
      the lot produced from the *****) must be *****. ***** will provide ***** with
      the ***** associated with its *****. 

    


    Purified
      ***** will be formulated in the same***** and will be vialed in the *****.
      Because the ***** studies are not ***** and ***** must be done with the *****
      formulated in *****, as was done in earlier studies. 

    


    *****
      will have completed real ***** for each ***** produced at *****. 

    


    *****
      will provide to ***** all records and data in ***** possession or control that
      are associated with the ***** work to enable ***** to continue *****, including
      ***** and full *****. 

    


    The
      material manufactured at ***** is intended for use in the ***** referenced
      below
      and this ***** must be comparable (based upon acceptance criteria) ***** must
      so
      that the ***** may be included in this *****. 

    


    *****

    


    *****

    


    *****
      will develop an ***** to ***** the ***** for the HepeX-B ***** (based on *****.
      ***** will provide ***** with all ***** reports and data related to this *****,
      as well as ***** and subsequent technical support.

    


    In
      addition to performing ***** on the ***** will also aid in ***** for all other
      ***** previously developed for and relevant to the HepeX-B program.


    


    Complete
      development of an *****
      for HepeX-B

    


    *****
      studies were performed at ***** to develop a ***** at a high concentration
      *****. ***** was completed. Three lead ***** were selected in which the *****.
      ***** will provide ***** with all records, including final study reports,
      relating to the ***** and the *****. ***** development for ***** will be
      completed by *****. ***** will provide ***** with all records, including final
      study reports, relating to the ***** and the *****. Until further testing to
      ***** is completed, the ***** must be ***** separately for *****.

    


    By
      *****,
      ***** will complete an ***** on the ***** in combination at one ***** in the
      same *****. 

     

    
      
        
        

      

      
        40

        
          

        

      

      
        
          *****
            Confidential material redacted and filed separately with the
            Commission.

        

      

    

    


    Complete
      the following clinical studies:

     

    Clinical
      Activities - *****
      -
      Synopsis

     

    
      
        
          	
                  Name
                    of Sponsor:

                  *****

                	
                  Name
                    of Active Ingredient:

                  HepeX-BÔ

                	
                  Study
                    number: 

                  *****

                
	
                  Title
                    of study:
                    A
                    ***** Study to Compare the ***** of HepeX-BÔ,
                    a
                    Mixture of Two Monoclonal Antibodies, as Compared to ***** for
                    Treatment
                    of *****

                
	
                  Investigators:
                    Approximately
                    ***** investigators in *****

                  Study
                    centers: *****

                
	
                  Study
                    period: Approximately *****
                    (***** weeks of recruitment
                    + *****
                    weeks treatment in the *****, with the possibility of enrolling
                    in the
                    ***** of the trial for an additional ***** weeks of treatment.
                    All
                    patients will be observed for ***** after completion of treatment).
                    

                	
                  Phase
                    of development:
                    *****

                
	
                  Objectives:
                    The primary objective will be to compare the ***** of HepeX-BÔ to
                    ***** as measured by *****, in patients who have received *****
                    for
                    treatment of *****. ***** is the primary measure of ***** and
                    is defined
                    as ***** measured on two consecutive assessments ***** days apart.
                    Secondary objectives will be to compare the ***** concentrations
                    and to
                    describe the safety of the reference and test agents.

                
	
                  Methodology:
                    This is a ***** study of the ***** of HepeX-BÔ as
                    compared to standard ***** in patients who have received *****
                    for
                    treatment of ***** and who are currently receiving ***** and
                    concomitant
                    treatment with an *****. Up to ***** patients may be enrolled
                    in order to
                    achieve at least ***** evaluable patients (***** patients per
                    treatment
                    group). Eligible patients will be *****. Patients will receive
                    an ***** of
                    study medication every ***** for ***** in the *****, with the
                    possibility
                    of an additional ***** all patients enrolled in the ***** of
                    the trial.
                    All patients will be observed for ***** after completion of treatment.
                    Periodic ***** will be collected for determination of *****.
                    ***** will be
                    monitored by a Data and Safety Monitoring Board (DSMB). After
                    successful
                    completion of this study, patients may be eligible for participation
                    in a
                    12-month follow-on study to examine *****.

                
	
                  Number
                    of subjects:
                    Up
                    to ***** patients may be enrolled in order to obtain ***** evaluable
                    patients *****. To be considered evaluable, patients must either
                    receive
                    ***** and complete the ***** follow-up visit, or must have met
                    the
                    criteria for treatment failure. Patients who terminate the study
                    prematurely for reasons other than treatment failure will be
                    replaced.
                    

                
	
                  Main
                    Inclusion Criteria:
                    Patients who are at least ***** post first ***** for treatment
                    of *****,
                    who have received ***** from the time of ***** through the time
                    of entry
                    into the study, who have received an ***** for at least the *****
                    immediately prior to entry into the study, and who have undetectable
                    *****
                    on two consecutive tests within the ***** screening period, are
                    eligible
                    for the study. 

                
	
                  Main
                    Exclusion Criteria: Patients
                    who are *****, or who have received other ***** are ineligible
                    to
                    participate.

                


        

         

        
          
            
            

          

          
            41

            
              

            

          

          
            
              *****
                Confidential material redacted and filed separately with the
                Commission.

            

          

        

         

        
          	
                  Test
                    product, dose and mode of administration:
                    HepeX-BÔ will
                    be *****. 

                  ·
                    HepeX-BÔ *****
                    every ***** for ***** for all patients enrolled in the *****,
                    with the
                    possibility of an additional ***** for all patients enrolled
                    in the *****
                    of the trial. All patients will be observed for ***** after completion
                    of
                    treatment. 

                  ·
                    HepeX-BÔ *****
                    every ***** for***** for all patients enrolled in the *****,
                    with the
                    possibility of an additional ***** for all patients enrolled
                    in the *****
                    of the trial. All patients will be observed for ***** after completion
                    of
                    treatment. 

                
	
                  Reference
                    therapy, dose and mode of administration:
                    *****. 

                  ·
                    ***** for all patients enrolled in the *****, with the possibility
                    of an
                    additional ***** for all patients enrolled in the ***** of the
                    trial. All
                    patients will be observed for ***** after completion of treatment.
                    

                
	
                  Duration
                    of treatment and observation:
                    ***** for all patients enrolled in the *****, with the possibility
                    of an
                    additional ***** for all patients enrolled in the ***** phase
                    of the
                    trial. All patients will be observed for ***** after completion
                    of
                    treatment. 

                
	
                  Anti-viral
                    assessments:
                    ***** will be determined prior to and ***** following each *****.
                    *****
                    results will be confirmed by repeat testing at least *****.

                  *****
                    assessments:
                    ***** will be determined immediately prior to each *****, at
                    the end of
                    each *****, ***** after the completion of each *****, and at*****
                    after
                    each *****. The ***** determined immediately prior to each *****
                    will be
                    considered the *****. 

                  Safety
                    assessments:
                    Safety will be evaluated by periodic ***** and reported and observed
                    *****. Emergence of ***** (as indicated by detectable *****)
                    will also be
                    reviewed as a safety measure. Selected safety measures, including
                    *****
                    status, will be reviewed periodically by an independent Data
                    Safety
                    Monitoring Board (DSMB). Criteria will be prospectively established
                    to
                    terminate one or both of the experimental arms in the event of
                    unacceptable risk to study participants.

                
	
                  Criteria
                    for Evaluation:
                    The primary
                    endpoint will be the ***** in each treatment regimen without
                    *****. *****
                    is defined as the ***** of detectable ***** measured on two consecutive
                    assessments ***** apart. Secondary endpoints will be a comparison
                    of
                    *****, including the proportion of subjects in each arm of the
                    study with
                    *****, and a description of safety (i.e., *****) throughout the
                    study.
                    

                
	
                  Statistical
                    Methods: Hypothesis
                    testing will be done for the primary endpoint using a ***** approach
                    at an
                    alpha of *****. 

                  *****:
                    HepeX-BÔ
                    is
                    not inferior to the active comparator, *****, using a maximum
                    delta of
                    *****

                  To
                    test the null hypothesis, the lower bound of the two-sided 95%
                    confidence
                    interval (CI) of the difference between the proportions of response
                    in
                    HepeX-BÔ
                    and the active comparator will be compared to the pre-set threshold
                    (*****
                    difference). The difference will be calculated HepeX-BÔ
                    minus active comparator. 

                  Categorical
                    variables (nominal or ordinal) will be summarized by sample size,
                    number
                    (frequency), and percentage of subjects at each level of the
                    variable.
                    Continuous variables will be summarized by sample size, mean,
                    median,
                    standard deviation (SD), minimum, and maximum values. 

                  For
                    the efficacy analyses, the proportion of patients without *****
                    breakthrough will be presented by treatment regimen for each
                    analysis
                    population. Summaries of ***** will be presented for the evaluation
                    of
                    safety. Listings of ***** will be provided as well as summaries
                    of the
                    *****.
                    The primary analysis for the study will be conducted when the
                    last patient
                    enrolled has received ***** and completed ***** of follow-up.
                    At this
                    time, the ***** data for all patients will be analyzed. A secondary
                    analysis will be performed when ***** has been completed by *****
                    patients
                    and will include all of the data accumulated during the
                    *****,

                


        

      

    

     

    
      
        
        

      

      
        42

        
          

        

      

      
        
          *****
            Confidential material redacted and filed separately with the
            Commission.

        

      

    

    


    *****
      Study
      - Synopsis

     

    
      It
        is
        understood that Cubist will determine the precise timing and scope of
*****
        prior
        to their start, and that *****
        will
        be responsible for study execution.


    

    
      
        
          
            	
                    
                      1.1.1.1.1
                        Name of Sponsor

                    

                    *****

                  	
                    Name
                      of Active Ingredient

                    *****

                  	
                    Study
                      number: 

                  
	
                    Title
                      of study:
                      ***** 

                  
	
                    Investigator:

                  
	
                    Study
                      center: 

                  
	
                    Study
                      period: *****

                  	
                    Phase
                      of development:
                      *****

                  
	
                    Objectives:
                      The primary objectives of this study are to

                    
                      ·  assess
                        the *****, as determined from ***** administered by *****
                        (prepared from
                        *****) administered by *****

                    

                    
                      ·  assess
                        the relative *****, as determined from *****, of single doses
                        of *****
                        (prepared from *****) administered by ***** (prepared from
                        *****)
                        administered by *****

                    

                    The
                      secondary objectives of this study are to

                    
                      ·  assess
                        the relative *****, as determined from *****, of single doses
                        *****
                        (prepared from *****) administered by ***** (prepared from
                        *****)
                        administered by *****

                    

                    
                      ·  evaluate
                        the safety of the ***** of single doses of ***** (prepared
                        from *****)
                        compared to ***** (prepared from *****) 

                    

                  
	
                    Methods:
                      This study will be conducted in *****. Subjects will be screened
                      for
                      eligibility. Subjects will be randomly assigned to receive
                      a
                      *****:

                    Group
                      1: ***** subjects will receive a ***** prepared from *****

                    Group
                      2: ***** subjects will receive a ***** prepared from *****
                      and
                      administered over *****.

                    Group
                      3: ***** subjects will receive a ***** prepared from *****
                      and
                      administered over *****.

                    Subjects
                      will remain at the study center for at least ***** after the
                      ***** for
                      collection of ***** and safety monitoring. Subjects will return
                      to the
                      study center on Study Days ***** for collection of ***** and
                      safety
                      monitoring. Subjects will return to the study center on Study
                      Day *****
                      for collection of ***** and completion of a Follow-up
                      visit].

                  


          

        

      

    

     

    
      
        
        

      

      
        43

        
          

        

      

      
        
          *****
            Confidential material redacted and filed separately with the
            Commission.

        

      

    

    

      
        	
                [Population:
                  ***** volunteers, *****, who are *****, and who have a body mass
                  index
                  (BMI) between *****. Subjects who received ***** and those who
                  use any
                  concomitant medications that may impact ***** within 30 days prior
                  to
                  study entry are not eligible to participate.

              
	
                Number
                  of subjects:
                  ***** volunteers will be entered randomly into one of three dose
                  groups
                  (*****). Subjects who terminate prematurely before completing the
                  sample
                  collections through Study Day ***** will be replaced. 

              
	
                Test
                  product, dose and mode of administration:
                  ***** (prepared from *****) administered as a ***** 

                
                  ·  *****
                    

                

                
                  ·  *****
                    (the route of administration, *****, will be based on the results
                    of *****
                    efforts currently ongoing).

                

              
	
                Reference
                  therapy, dose and mode of administration:
                  ***** (prepared from *****) administered as a ***** 

              
	
                Duration
                  of treatment and observation:
                  On
                  Study Day ***** subjects will receive a *****. Subjects will remain
                  at the
                  study center for at least ***** hours after commencement of the
                  *****.
                  ***** will be collected at intervals while the subjects remain
                  at the
                  study center, and the subjects will be monitored regularly for
                  safety.
                  Subjects will return to the study center on Study Days ***** for
                  collection of ***** and safety monitoring. Subjects will return
                  to the
                  study center on Study Day ***** for collection of ***** and for
                  completion
                  of a Termination Visit. 

              
	
                *****
                  assessments: *****
                  concentrations will be determined in ***** collected at the following
                  times:

                
                  §  Study
                    Day *****: immediately prior to commencement of the *****, and
                    at
                    approximately Hours *****

                

                
                  §  Study
                    Day *****: at approximately *****

                

                
                  §  Study
                    Day *****: at approximately *****

                

                
                  §  Study
                    Day *****: at approximately *****

                

                
                  §  Study
                    Days *****

                

                Safety
                  assessments:
                  Safety will be evaluated by periodic
                  *****.

              


      

       

    

    
      
        
        

      

      
        44

        
          

        

      

      
        
          *****
            Confidential material redacted and filed separately with the
            Commission.

        

      

    

     

    
      

        
          	
                  Statistical
                    Methods: 

                   

                  *****:
                    

                   

                  The
                    ***** analysis will be based on all subjects who have evaluable
                    *****. The
                    individual concentration-time profiles of ***** will be evaluated
                    using
                    *****. Data permitting, the following pharmacokinetic parameters
                    will be
                    determined:

                  *****

                   

                  Descriptive
                    statistics (N, mean, standard deviation, CV, median, minimum,
                    and maximum)
                    will be used to summarize ***** concentration data at each planned
                    sampling time point for each treatment. ***** parameters calculated
                    from
                    the concentrations will also be summarized by treatment using
                    descriptive
                    statistics.

                   

                  Bioequivalence
                    will be evaluated for ***** (prepared from *****) compared to
                    *****
                    (prepared from *****) with an analysis of their log-transformed
                    *****.
                    ***** with terms for subject and treatment will be performed
                    for the
                    parameters ***** From these analyses, 90% confidence intervals
                    (CIs) for
                    the geometric test/reference mean ratios will be obtained. Group
                    1 will be
                    compared with Group 2, with Treatment Group 2 as the reference.
                    Bioequivalence will be declared if the 90% confidence limits
                    for the test
                    to reference ratios fall within *****. 

                   

                  Bioeavailability
                    will be evaluated for ***** (prepared from *****) compared to
                    both *****
                    (prepared from *****) ***** (prepared from *****) using the same
                    *****
                    model described above. Group 3 will be compared with Group 1
                    as well as
                    Group 2, with Treatment Group 1 and Treatment Group 2 as the
                    reference,
                    respectively. For these comparisons, the bioavailability ratio
                    and 95%
                    C.I. will be calculated using the difference between the
                    *****

                   

                  A
                    sample size of ***** per group has been calculated to provide
                    greater than
                    90% power to demonstrate equivalence using a CV of *****. The
                    CV of *****
                    was the largest CV calculated for the log transformed ***** parameters
                    using data from the following study: *****

                   

                  Safety:
                    Descriptive summaries will be provided by treatment group for
                    demographics. The frequency of adverse events will be tabulated.
                    Baseline,
                    within study and end-of-study, and change from baseline clinical
                    laboratories, and vital signs will be summarized. Descriptive
                    statistics
                    will be computed for safety parameters as appropriate. Further
                    statistical
                    evaluations will be applied for select endpoints, if warranted.
                    All
                    baseline data and safety data collected during the study will
                    be listed
                    for each subject and dose group]. 

                   

                


        

         

        
          
            
            

          

          
            45

            
              

            

          

          
            
              *****
                Confidential material redacted and filed separately with the
                Commission.

            

          

        

      

    

     

    
      *****
        Study
        - Synopsis

    

     

    
      
        
          	
                  1.1.1.1.2
                    [Name of
                    Sponsor

                  *****

                	
                  Name
                    of Active Ingredient

                  *****

                	
                  Study
                    number: 

                
	
                  Title
                    of study:
                    *****

                
	
                  Investigator:
                    *****

                
	
                  Study
                    center: *****

                
	
                  Study
                    period: *****

                	
                  Phase
                    of development:
                    *****

                
	
                  Objectives:
                    The primary objectives of this study are to

                  
                    ·  Compare
                      the *****, as determined by the relative changes in ***** in
                      response to a
                      ***** (prepared from *****) administered by ***** (prepared
                      from *****)
                      *****.

                  

                  
                    ·  Compare
                      the *****, as determined by the relative changes in ***** in
                      response to a
                      ***** (prepared from *****) administered by ***** (prepared
                      from *****)
                      administered by *****.

                  

                  The
                    secondary objectives of this study are to

                  
                    ·  Compare
                      the *****, as determined by the relative changes in ***** in
                      response to a
                      ***** (prepared from *****) administered by ***** (prepared
                      from *****)
                      administered by *****.

                  

                  
                    ·  Evaluate
                      the safety of the ***** (prepared from *****) compared to *****
                      (prepared
                      from *****). 

                  

                
	
                  Methods:
                    This study will be conducted in an *****. Subjects will be screened
                    for
                    eligibility and randomly assigned to receive each of the following
                    treatments on Study Day *****. ***** washout period between study
                    doses
                    will separate each treatment period.

                  Treatment
                    A: *****
                    prepared from *****

                  Treatment
                    B:  *****
                    prepared from ***** and administered over *****.

                  Treatment
                    C: ***** prepared from ***** and administered over *****.

                  During
                    each treatment period, subjects will remain at the study center
                    for at
                    least ***** after the administration of study medication for
                    collection of
                    ***** and safety monitoring. Following period *****, subjects
                    will return
                    to the study center on Study Day ***** for completion of a Follow-up
                    visit].

                


        

         

        
          
            
            

          

          
            46

            
              

            

          

          
            
              *****
                Confidential material redacted and filed separately with the
                Commission.

            

          

        

         

        
          
            	
                    Population:
                      Eligible patients will be *****, with
                      a minimum *****
                      at screening for subject inclusion to allow better cross-over
                      comparison.

                  
	
                    Number
                      of subjects:
                      ***** subjects will be entered into the study. Subjects who
                      terminate
                      prematurely before completing the ***** will be replaced.
                      

                  
	
                    Test
                      product, dose and mode of administration:
                      ***** (prepared from *****) administered as ***** 

                    
                      ·  *****
                        

                    

                    
                      ·  *****
                        (the route of administration, *****, will be based on the
                        results of *****
                        efforts currently ongoing).

                    

                  
	
                    Reference
                      therapy, dose and mode of administration:
                      *****

                  
	
                    Duration
                      of treatment and observation:
                      The study duration will be approximately ***** for each subject.
                      Subjects
                      will be screened within ***** of administration of *****. During
                      each
                      treatment period, subjects will receive *****. Subjects will
                      remain at the
                      study center for at least ***** after commencement of *****.
                      Subjects will
                      check out on Day ***** following the ***** and return on Day
                      ***** for the
                      *****. Subjects will be monitored regularly for safety. A washout
                      of *****
                      between doses will separate each treatment period. Following
                      period *****,
                      subjects will return to the study center between Day *****
                      for completion
                      of a Follow-up visit. 

                  
	
                    *****
                      and
                      *****
                      assessments:
                      *****
                      concentrations and***** concentrations will be determined in
                      *****
                      collected at screening and at the following times during each
                      treatment
                      period:

                    
                      §  Study
                        Day *****: immediately prior to commencement of *****, and
                        at
                        approximately *****
                        commencement

                    

                    
                      §  Study
                        Day *****: ***** commencement

                    

                    
                      §  Study
                        Day *****: ***** commencement

                    

                    Safety
                      assessments:
                      Safety will be evaluated by periodic *****.

                  
	
                    Criteria
                      for evaluation:

                    *****: 
                      The primary variable for comparison of the ***** is the change
                      in *****
                      (in percent) following ***** administration compared to the
                      concentration
                      immediately prior to administration on Day ***** of each treatment
                      period.

                     

                    *****:
                      As
                      secondary variable for comparison, ***** concentration-time
                      data will be
                      compared for the *****. ***** in healthy normal volunteers
                      has been
                      previously evaluated. However, the ***** has not been previously
                      evaluated
                      in patients with *****. ***** are expected to be highly variable
                      between
                      patients due to the complex relationship to ***** concentration,
                      changes
                      in ***** over time will be evaluated for each treatment.

                     

                    *****.

                  


          

           

          
            
              
              

            

            
              47

              
                

              

            

            
              
                *****
                  Confidential material redacted and filed separately with the
                  Commission.

              

            

          

           

          
            	
                    Statistical
                      Methods: 

                    Pharmacodynamics:

                    The
                      pharmacodynamic analysis will be based on all subjects who
                      have evaluable
                      change in ***** For each concentration-time point, a change
                      from baseline
                      value (in percent) will be calculated as follows: ***** The
                      individual
                      percent change from baseline values of ***** will be evaluated
                      using
                      model-independent methods as implemented in *****. Data permitting,
                      the
                      following pharmacodynamic parameters will be determined:
                      *****

                    The
                      rational for deriving partial average changes from baseline
                      for select
                      time intervals is the *****:

                    a)
                      ***** concentrations appears to be correlated to the baseline
                      *****
                      concentration which could affect interpretation of the changes
                      in ***** in
                      the later portion of the concentration-time profile

                    b)
                      Intersubject variability due to the severity of the disease
                      state is
                      likely to affect the rate of ***** which could affect interpretation
                      of
                      the changes in ***** in the later portion of the concentration-time
                      profile

                    c)
                      The potential of differences in ***** may affect the *****

                    Descriptive
                      statistics (N, mean, standard deviation, CV, median, minimum,
                      and maximum)
                      will be used to summarize the percent change from baseline
                      concentration
                      data at each planned sampling time point for each treatment.
                      Change from
                      baseline pharmacodynamic parameters will also be summarized
                      by treatment
                      using descriptive statistics. 

                     

                    Similarity
                      in ***** will be evaluated for the percent change from baseline
                      pharmacodynamic parameters for ***** (prepared from *****)
                      relative to
                      ***** (prepared from *****)] with an analysis of their pharmacodynamic
                      parameters. An ***** with terms for subject, period, sequence,
                      and
                      treatment will be performed for the parameters ***** above.
                      One-sided 95%
                      confidence intervals (CI) for the test/reference mean ratios
                      will be
                      estimated from the ***** to assess ***** of the test treatments
                      using
                      *****. The test treatment will be compared with the reference
                      treatment
                      and ***** will be declared if the 95% confidence limit for
                      the test to
                      reference ratios are greater than ***** for all of the identified
                      parameters. 

                     

                    Similarity
                      in ***** be evaluated for the percent change from baseline
                      pharmacodynamic
                      parameters for ***** (prepared from *****) relative to both
                      *****
                      (prepared from *****) and ***** (prepared from *****)] using
                      the same
                      ***** model described above. One-sided 95% confidence intervals
                      (CIs) for
                      the test/reference mean ratios will be estimated from the *****
                      to assess
                      ***** of the test treatments using *****. Treatment A will
                      be compared to
                      Treatment C and to Treatment B, with Treatments C and B treated
                      as
                      reference. Non-inferiority will be declared if the 95% confidence
                      limit
                      for the test to reference ratios are greater than ***** for
                      all of the
                      identified parameters.

                     

                    A
                      sample size of *****
                      yields just over 80% power to show *****
                      in
                      the cross-over design using the following assumptions. 

                    ·        
                      There is no difference between the *****.
                              
                      *****
                      defined as the test treatment yielding responses no less than
*****
                      of
                      the reference treatment. The intra-patient CV is at most *****.
                      *****
                      one-sided significance level.

                     

                    Pharmacokinetics:

                    Descriptive
                      statistics (N, mean, standard deviation, CV, median, minimum,
                      and maximum)
                      will be used to summarize ***** concentration data at each
                      planned
                      sampling time point for each treatment. An attempt will be
                      made to perform
                      a pharmacokinetic analysis for those subjects who have *****
                      that follow a
                      traditional pattern of *****. The individual concentration-time
                      profiles
                      of ***** will be evaluated using model-independent methods
                      as implemented
                      in *****. Data permitting, the following pharmacokinetic parameters
                      will
                      be determined:

                    *****

                     

                    *****
                      pharmacokinetic parameters calculated from the concentrations
                      will also be
                      summarized by treatment using descriptive statistics. Differences
                      in
                      concentration-time data and/or pharmacokinetic parameters will
                      be
                      evaluated graphically.

                     

                    Safety:
                      Descriptive summaries will be provided by treatment group for
                      demographics. The frequency of adverse events will be tabulated.
                      Baseline,
                      within study and end-of-study, and change from baseline clinical
                      laboratories, and vital signs will be summarized. Descriptive
                      statistics
                      will be computed for safety parameters as appropriate. Further
                      statistical
                      evaluations will be applied for select safety endpoints, if
                      warranted. All
                      baseline data and safety data collected during the study will
                      be listed
                      for each subject and dose group.


                  


          

        

      

    

     

    
      
        
        

      

      
        48

        
          

        

      

      
        
          *****
            Confidential material redacted and filed separately with the
            Commission.

        

      

    

     

    Exhibit
      E

    (XTL
      Licensor Payments)

    


    Note
      that
      confidential
      treatment has been requested and one (1) page of material from this Exhibit
      E
      has been omitted and filed separately with the Commission.

     

    *****

     

    
      
        
        

      

      
        49

        
          

        

      

      
        
          *****
            Confidential material redacted and filed separately with the
            Commission.

        

      

    

     

    Exhibit
      E

    (XTL
      Licensor Payments)

    


    Note
      that
      confidential
      treatment has been requested and one (1) page of material from this Exhibit
      E
      has been omitted and filed separately with the Commission.

     

    *****

     

    
      
        
        

      

      
        50