Unassociated Document


    Exhibit
      10.2

    


    INFORMATION
      MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL
      TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH
THE SECURITIES
      AND EXCHANGE COMMISSION.

    


    AMENDED
      AND RESTATED

    LICENSE
      AND DEVELOPMENT AGREEMENT

     

    THIS
      AMENDED AND RESTATED LICENSE AND DEVELOPMENT AGREEMENT
      (this
“Agreement”),
      dated
      as of July 31, 2007 (the “Execution
      Date”),
      is
      entered into by and between NovaDel
      Pharma, Inc.,
      a
      Delaware corporation (“NovaDel”),
      and
Hana
      Biosciences, Inc.,
      a
      Delaware corporation (the “Licensee”).
      NovaDel and Licensee each may be referred to herein individually as a
“Party,”
or
      collectively as the “Parties.”

    


    WHEREAS,
      NovaDel
      has certain proprietary rights and intellectual property (including to certain
      patents) with respect to lingual sprays for the metered delivery of
      pharmaceutical products to humans (the “Technology”);
      and

     

    WHEREAS,
      pursuant to that certain License and Development Agreement by and between
      NovaDel and Licensee, effective as of October 26, 2004 (the “Effective
      Date”),
      as
      amended by that certain Amendment No. 1 To License and Development Agreement
      dated August 3, 2005, as amended by that certain Amendment No. 2 To License
      and
      Development Agreement dated May 15, 2006, and as amended by that certain
      Amendment No. 3 To License and Development Agreement dated December 22, 2006,
      (collectively, the “Initial
      Agreement”),
      Licensee obtained from NovaDel, and NovaDel granted to Licensee, an exclusive,
      restricted, sublicensable license to develop and
      commercialize a pharmaceutical product containing ondansetron as an active
      ingredient that will be administered only to humans using the Technology;
      and

     

    WHEREAS,
      the
      Parties desire to amend and restate the Initial Agreement in its entirety upon
      the terms and conditions as set forth herein in connection with the PAR
      Sublicense Agreement.

     

    NOW,
      THEREFORE, in
      consideration of the foregoing premises, the mutual promises and covenants
      of
      the Parties contained herein, and other good and valuable consideration, the
      receipt and sufficiency of which are hereby acknowledged, the Parties hereto,
      intending to be legally bound, do hereby agree as follows:

     

    ARTICLE
      1

    DEFINITIONS

     

    For
      the
      purposes of this Agreement, the following words and phrases shall have the
      following meanings, unless otherwise specifically provided herein:

     

    1.1 “AAA”
shall
      have the meaning set forth in Section 9.1.

     

    1.2 “Affiliate”
shall
      mean, with respect to any Entity, any other Entity that directly or indirectly
      through one or more intermediaries, controls, is controlled by or is under
      common control with such Entity. For purposes of this Section 1.2 only,
“control” and, with correlative meanings, the terms “controlled by” and “under
      common control with” shall mean (a) the possession, directly or indirectly, of
      the power to direct the management or policies of an Entity, whether through
      the
      ownership of voting securities, by contract or otherwise, or (b) the ownership,
      directly or indirectly, of at least fifty percent (50%) of the voting securities
      or other ownership interest of an Entity. 

     

    
      
        
        

      

      
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    1.3 “Agreement”
shall
      have the meaning set forth in the preamble.

     

    1.4 “Agreement-Related
      Assets”
shall
      have the meaning set forth in Section 8.7.2.

     

    1.5 “Anticipated
      Filing Date”
shall
      have the meaning set forth in Section 3.2.2.

     

    1.6 “Applicable
      Law”
shall
      mean the applicable laws, rules, regulations, guidelines and requirements of
      the
      Regulatory Authorities, in the Territory.

     

    1.7 “Claims”
shall
      have the meaning set forth in Section 3.10.6.

     

    1.8 “CMC”
shall
      have the meaning set forth in Section 3.4.1.

     

    1.9 “Commercially
      Reasonable Efforts”
shall
      mean, with respect to the development or commercialization of a Licensed
      Product, efforts and resources commonly used in the research-based
      pharmaceutical industry for a product of similar commercial potential at a
      similar stage in its lifecycle, taking into consideration its safety and
      efficacy, its cost to develop, the competitiveness of alternative products,
      its
      proprietary position, the likelihood of regulatory approval, its profitability,
      and all other relevant factors. Commercially Reasonable Efforts shall be
      determined on a market-by-market basis for each Licensed Product without regard
      to the particular circumstances of a Party, including any other product
      opportunities of such Party.

     

    1.10 “Confidential
      Information”
shall
      have the meaning set forth in Article 15.

     

    1.11 “Common
      Technical Document”
shall
      have the meaning set forth in the International Conference on Harmonization
      of
      the Technical Requirements for Registration of Pharmaceuticals for Human Use
      (ICH) Guideline M4, Organization
      of the Common Technical Document,
      as
      revised on January 13, 2004.

     

    1.12 “Control”
shall
      mean, with respect to any item of Information and Inventions, Patents or other
      intellectual property right, possession of the ability, whether directly or
      indirectly, and whether by ownership, license or otherwise, to assign, or grant
      a license, sublicense or other right to or under, such item, Patent or right
      as
      provided for herein without violating the terms of any agreement or other
      arrangement with any Third Party.

     

    1.13 “Designated
      Compound”
shall
      mean ondansetron.

     

    1.14 “Development
      Activities”
      shall
      mean the activities performed by the Parties under the Development Plan pursuant
      to Article 3.

     

    1.15 “Development
      Budget”
shall
      have the meaning set forth in Section 3.2.2.

     

    1.16 “Development
      Committee”
      shall
      have the meaning set forth in Section 3.3.1.

     

    
      
        
        

      

      
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    1.17 “Development
      Plan”
      shall
      have the meaning set forth in Section 3.2.1.

     

    1.18 “Effective
      Date”
shall
      have the meaning set forth in the preamble.

     

    1.19 “Execution
      Date”
shall
      have the meaning set forth in the preamble.

     

    1.20 “Entity”
shall
      mean any individual, sole proprietorship, corporation, limited liability
      company, association, joint venture, partnership, limited partnership, limited
      liability partnership, trust, university, business, government or political
      subdivision thereof, including an agency, or any other organization that
      possesses independent legal standing.

     

    1.21 “Exploit”
      shall
      mean to make, have made, import, use, sell, or offer for sale, including to
      research, develop, register, modify, improve, manufacture, have manufactured,
      store, have used, export, transport, distribute, promote, market or have sold
      or
      otherwise dispose of a Licensed Product or Licensed Process.

     

    1.22 “Exploitation”
shall
      mean the making, having made, importation, use, sale, offering for sale of
      a
      licensed product or process, including the research, development, registration,
      modification, improvement, manufacture, storage, optimization, import, export,
      transport, distribution, promotion, marketing, sale or other disposition of
      a
      Licensed Product or Licensed Process.

     

    1.23 “Extraterritorial
      Licensees”
shall
      mean NovaDel’s Affiliates and licensees outside of the Territory.

     

    1.24 “FDA”
shall
      mean the United States Food and Drug Administration, or any successor agency
      responsible for the evaluation and approval of pharmaceutical
      products.

     

    1.25 “GAAP”
shall
      mean Generally Accepted Accounting Principles as consistently
      applied.

     

    1.26 “Improvement” shall
      mean any modification, variation or revision to an apparatus, method, product
      or
      technology, or any discovery, technology, device, process or formulation related
      to an apparatus, method, product or technology, whether or not patented or
      patentable, including any enhancement in the manufacture or steps or processes
      thereof, ingredients, preparation, presentation, formulation, means of delivery,
      packaging or dosage of an apparatus, method, product or technology, any
      discovery or development of any new or expanded indications for an apparatus,
      method, product or technology, or any discovery or development that improves
      the
      stability, safety or efficacy of an apparatus, method, product or technology,
      in
      each case, to the extent related to the Licensed Process, Licensed Product
      or
      Licensed Technology. 

     

    1.27 “IND”
shall
      mean an investigational new drug application filed with the FDA for approval
      to
      commence human clinical trials, and its equivalent in other countries or
      regulatory jurisdictions in the Territory.

     

    1.28 “Indemnification
      Claim Notice”
      shall
      have the meaning set forth in Section 10.3.1.

     

    
      
        
        

      

      
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    1.29 “Indemnified
      Party”
      shall
      have the meaning set forth in Section 10.3.1.

     

    1.30 “Initial
      Commercial Sale”
      shall
      mean the first sale for use or consumption by the general public of the Licensed
      Product by Licensee or its Affiliates or Sublicensee in the Territory following
      Regulatory Approval of the Licensed Product. Sales for clinical studies,
      compassionate use, named patient programs, sales under a treatment IND, test
      marketing, any nonregistrational studies, or any similar instance where the
      Licensed Product is supplied without charge shall not constitute an Initial
      Commercial Sale.

     

    1.31 “Initial
      Agreement”
shall
      have the meaning set forth in the preamble.

     

    1.32 “Infringement
      Suit”
shall
      have the meaning set forth in Section 6.8.2.

     

    1.33 “Information
      and Inventions”
shall
      mean all technical, scientific and other know-how and information, trade
      secrets, knowledge, technology, means, methods, processes, practices, formulas,
      instructions, skills, techniques, procedures, experiences, ideas, technical
      assistance, designs, drawings, assembly procedures, computer programs,
      apparatuses, specifications, data, results and other material, including
      pre-clinical and clinical trial results, manufacturing procedures and test
      procedures and techniques, (whether or not confidential, proprietary, patented
      or patentable) in written, electronic or any other form now known or hereafter
      developed, and all Improvements, whether to the foregoing or otherwise, and
      other discoveries, developments, inventions, and other intellectual property
      (whether or not confidential, proprietary, patented or patentable), in each
      case, to the extent related to the Licensed Process, Licensed Product or
      Licensed Technology.

     

    1.34 “Knowledge”
shall
      mean the good faith understanding of the vice presidents, senior vice
      presidents, executive vice presidents, president or chief executive officer
      of
      the respective Party of the facts and information then in their possession
      without any duty to conduct any investigation with respect to such facts and
      information.

     

    1.35 “Licensed
      Process”
shall
      mean the proprietary lingual spray technology for the delivery of pharmaceutical
      compounds through the mucosal membrane of the mouth in humans using an aerosol
      or pump spray device that is under the Control of NovaDel as of the Effective
      Date and any Improvements thereto that are conceived and reduced to practice
      by
      NovaDel in the course of performing the Development Activities.

     

    1.36 “Licensed
      Product”
shall
      mean any dosage of pharmaceutical composition or preparation in finished form
      labeled and packaged for sale by prescription, over-the-counter or any other
      method only for human application that contains, as the sole ingredient, the
      Designated Compound delivered by means of the Licensed Process.

     

    1.37 “Licensed
      Technology”
shall
      mean the NovaDel Patents, the NovaDel Know-How and the Drug Master File,
      collectively, but only with respect to the Exploitation of the Licensed
      Product.

     

    1.38 “Licensee”
shall
      have the meaning set forth in the preamble.

     

    1.39 “Licensee
      Shares”
shall
      have the meaning set forth in Section 4.4.

     

    
      
        
        

      

      
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    1.40 “Losses”
shall
      have the meaning set forth in Section 10.1.

     

    1.41 “NDA”
shall
      mean a New Drug Application filed pursuant to the requirements of the FDA,
      as
      more fully defined in 21 C.F.R. § 314.5 et
      seq.,
      and
      any equivalent application required by any Regulatory Authority for the
      marketing, sale or use of the Licensed Product in the Territory for human
      application.

     

    1.42 “Net
      Sales”
shall
      mean [***]

     

    
      
        
        

      

      
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    1.43 “NovaDel”
shall
      have the meaning set forth in the preamble.

     

    1.44 “NovaDel Know-How”
shall
      mean all Information and Inventions Controlled by NovaDel or an Affiliate of
      NovaDel as of the Effective Date or, from time to time, during the Term that
      (a)
      (i) are necessary for the use of the Licensed Process to Exploit the Licensed
      Product or (ii) relate to Improvements to the Licensed Product or Licensed
      Process that are conceived and/or reduced to practice in the course of
      Exploiting the Licensed Product or Licensed Process, and (b) are not generally
      known, but excluding any Information and Inventions to the extent claimed by
      any
      NovaDel Patents.

     

    1.45 “NovaDel
      Patents”
shall
      mean the Patents that NovaDel Controls (a) as of the Effective Date that are
      listed on Exhibit A hereto and (b) from time to time during the Term that claim
      (i) the Licensed Process, (b) the Licensed Product, (c) NovaDel Know-How, or
      (d)
      any Improvements that are conceived and/or reduced to practice in the course
      of
      Exploiting the Licensed Product or Licensed Process.

     

    1.46 “PAR”
shall
      have the meaning set forth in Section 3.2.1.

     

    1.47 “PAR
      Sublicense Agreement”
shall
      have the meaning set forth in Section 3.2.1.

     

    1.48 “Parties”
shall
      have the meaning set forth in the preamble.

     

    1.49 “Party”
shall
      have the meaning set forth in the preamble.

     

    1.50 “Patents”
shall
      mean any of the following: (a) United States patents; (b) United States patent
      applications (both provisional and non-provisional), PCT patent applications,
      and divisionals, continuations and claims of continuation-in-part applications
      which shall be directed to subject matter specifically described in such United
      States and/or PCT patent applications, and the resulting patents (whether such
      divisionals, continuations or continuation-in-part applications are based upon
      a
      United States patent, United States patent application or PCT application);
      (c)
      any patents resulting from reissues or reexaminations of the United States
      patents described in (a) and (b) above; (d) foreign patents; (e) foreign patent
      applications and, to the extent applicable, divisionals, continuations and
      claims of continuation-in-part applications which shall be directed to subject
      matter specifically described in such foreign patent applications, and the
      resulting patents (whether such divisionals, continuations or
      continuation-in-part applications are based upon a foreign patent application
      or
      a foreign patent); and (f) any foreign patents, resulting from foreign
      procedures similar to United States reissues and reexaminations, of the foreign
      patents and applications described in (d) and (e) above.

     

    1.51 “Regulatory
      Approval”
shall
      mean approval by the FDA to market the Licensed Product in the United States,
      or
      equivalent Regulatory Authority in Canada to market the Licensed Product in
      Canada, including the issuance by the FDA or such other Regulatory Authority
      of
      an action letter indicating the approval of the NDA and the manufacturing
      processes and facilities for commercial supplies of the Licensed
      Product.

     

    
      
        
        

      

      
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    1.52 “Regulatory
      Authority”
shall
      mean any applicable supra-national, federal, national, regional, state,
      provincial or local regulatory agencies, departments, bureaus, commissions,
      councils or other government entities regulating or otherwise exercising
      authority with respect to the Licensed Technology or the Licensed Product in
      the
      Territory.

     

    1.53 “Regulatory
      Documentation”
shall
      mean all applications, registrations, licenses, authorizations and approvals
      (including all Regulatory Approvals), all correspondence submitted to or
      received from Regulatory Authorities (including minutes and official contact
      reports relating to any communications with any Regulatory Authority), all
      supporting documents and all clinical studies and tests, relating to any
      Licensed Product, and all data contained in any of the foregoing, including
      all
      regulatory drug lists, advertising and promotion documents, adverse event files
      and complaint files.

     

    1.54 “Sublicensee”
shall
      mean any Third Party to which Licensee grants a sublicense pursuant to Section
      2.4 under the licenses granted to Licensee by NovaDel under Section
      2.1.

     

    1.55 “Technology”
shall
      have the meaning set forth in the preamble.

     

    1.56 “Term”
shall
      have the meaning set forth in Section 7.1.

     

    1.57 “Territory”
shall
      mean the United States of America and Canada.

     

    1.58 “Third
      Party”
shall
      mean any Entity other than NovaDel, Licensee and their respective
      Affiliates.

     

    1.59 “Third
      Party Claim”
shall
      have the meaning set forth in Section 10.3.2.

     

    1.60 “Trademark”
      shall
      include any word, name, symbol, color, designation or device or any combination
      thereof, including any trademark, trade dress, brand mark, trade name, brand
      name, logo or business symbol.

     

    1.61 “Valid
      Claim”
shall
      mean, with respect to a particular country, a claim of a Patent in such country
      that (a) has not been revoked or held unenforceable or invalid by a decision
      of
      a court or governmental agency of competent jurisdiction from which no appeal
      can be taken or has been taken within the time allowed for appeal, and (b)
      has
      not been abandoned, disclaimed, denied or admitted to be invalid or
      unenforceable through reissue or disclaimer or otherwise in such country, except
      if a claim, or the subject matter thereof, of a pending patent application
      shall
      not have issued within four (4) years after the filing date from which such
      claim, or subject matter thereof, takes priority, such claim shall not
      constitute a valid claim for purposes of this agreement unless and until such
      claims shall issue.

     

    ARTICLE
      2
GRANT
      OF RIGHTS

     

    2.1 License
      Grants to Licensee. Subject
      to Section 2.3 and the other terms and conditions of this Agreement, NovaDel
      hereby grants to Licensee and Licensee accepts, a non-transferable (except
      as
      provided in Article 12), sublicenseable (only as provided in Section 2.4),
      royalty-bearing, exclusive right and license under the Licensed Technology
      to
      Exploit the Licensed Product in the Territory, to the full end of the Term
      for
      which the Licensed Technology is licensed, unless sooner terminated as herein
      after provided.

     

    
      
        
        

      

      
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    2.2 License
      Grant to NovaDel.
      Licensee
      hereby grants to NovaDel a limited, royalty-free, non-exclusive right and
      license in the Territory in and to the Licensed Technology to the extent
      necessary to perform its Development Activities under Article 3. 

     

    2.3 Retained
      Rights.
      NovaDel
      retains all right, title and interest, including the right to grant licenses
      to
      Third Parties, in and to the Licensed Technology. Licensee shall have no rights,
      express or implied, with respect to the Licensed Technology, except as expressly
      set forth in Section 2.1, and Licensee covenants to NovaDel that none of
      Licensee, its Affiliates or Sublicensees shall use the Licensed Technology,
      directly or indirectly, for any purpose other than for administration of the
      Designated Compound in connection with the Exploitation of Licensed Product
      hereunder. Notwithstanding anything in this Agreement to the contrary, NovaDel
      does hereby retain, without any duty of accounting or otherwise to Licensee
      or a
      Sublicensee, as applicable,:

     

    2.3.1 The
      right
      to enter into collaborations or other agreements with, and to grant licenses
      and
      other rights under the NovaDel
      Patents and NovaDel Know-How to Third Parties to Exploit products containing
      compounds other than the Designated Compound and to use the Licensed Process
      in
      connection therewith; and 

     

    2.3.2 The
      right
      to independently Exploit products containing compounds other than the Designated
      Compound and to use the Licensed Process in connection therewith;
      and

     

    2.3.3 An
      irrevocable, non-exclusive, royalty-free right to use the Licensed Technology
      (including the Licensed Process) with respect to the Designated Compound, for
      its internal, non-commercial research and development activities; and


     

    2.3.4 The
      rights for all other territories other than the Territory and non-human uses
      of
      the Designated Compound. 

     

    2.4 Sublicenses.
      Licensee
      shall have the right to grant sublicenses under the grants in Section 2.1 to
      Third Parties pursuant to a separate written agreement, subject to the following
      requirements and conditions:

     

    2.4.1 Licensee
      must obtain NovaDel’s prior written consent in respect of each such sublicense,
      such consent not to be unreasonably withheld but in no case will exceed thirty
      (30) days. Except to the extent the Parties otherwise agree pursuant to the
      terms of a particular sublicense granted under this Section 2.4, any sublicense
      agreement must be fully consistent with the terms and conditions of this
      Agreement, and provide that Sublicensee will indemnify NovaDel and its
      Affiliates to the extent provided in Article 10.

     

    2.4.2 Within
      five (5) days after execution or receipt thereof, as applicable, Licensee shall
      provide NovaDel with a full and complete copy of each sublicense agreement
      granted hereunder and shall deliver copies of all reports (including relating
      to
      royalties and other payments) received by Licensee from such Sublicensees.
      

     

    
      
        
        

      

      
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    2.4.3 Termination
      of this Agreement by NovaDel pursuant to Section 8.3 with respect to Licensee
      shall not terminate any sublicense granted by Licensee pursuant to this Section
      2.4 with respect to a Sublicensee, provided that (a) such Sublicensee is not
      in
      breach of any provision of this Agreement or the applicable sublicense
      agreement, (b) such Sublicensee shall perform all obligations of Licensee under
      this Agreement, (c) NovaDel shall have all rights with respect to any and all
      Sublicensees as it had hereunder with respect to Licensee prior to termination
      of this Agreement with respect to Licensee, and (d) Licensee shall include
      in
      any sublicense a provision in which said Sublicensee acknowledges its
      obligations to NovaDel hereunder and the rights of NovaDel to terminate such
      sublicense agreement for a breach of such sublicense agreement by such
      Sublicensee. The failure of Licensee to include in a sublicense the provisions
      referenced in clause (d) shall render the affected sublicense void.

     

    ARTICLE
      3

    DEVELOPMENT
      AND COMMERCIALIZATION ACTIVITIES

     

    3.1 Development
      and Commercialization.
      Licensee or its Sublicensee shall have the sole right and obligation to develop
      and commercialize the Licensed Product in the Territory. NovaDel shall perform
      or cause to be performed, on behalf of Licensee, certain Development Activities
      in accordance with this Article 3. Except as set forth herein or in an
      applicable sublicense, Licensee shall be solely responsible for all costs and
      expenses in connection with all development and commercialization activities,
      including the Development Activities performed by NovaDel on behalf of Licensee.
      

     

    3.2 Development
      Activities. Except
      as
      the Parties otherwise agree pursuant to the terms of a sublicense agreement:
       

     

    3.2.1 Election
      Upon Termination of Par Sublicense.
      If that
      certain Product Development and Commercialization Sublicense Agreement by and
      between Licensee, NovaDel and PAR Pharmaceutical, Inc. (“PAR”),
      dated
      as of the Execution Date (the “PAR
      Sublicense Agreement”)
      is
      terminated, Licensee shall notify NovaDel within sixty (60) days following
      such
      termination of Licensee’s election to undertake further development of Licensed
      Product. Within sixty (60) days following delivery of such notice to NovaDel,
      Licensee will adopt and provide to NovaDel a development plan describing its
      strategy and principal activities in seeking Regulatory Approval and
      commercializing the Licensed Product in accordance with the terms of this
      Agreement (the “Development
      Plan”).
      If
      Licensee fails to notify NovaDel within the sixty (60) day period of its
      election to undertake further development, fails to provide NovaDel within
      the
      sixty (60) day period a Development Plan, or elects not to continue development
      of Licensed Product, this Agreement shall terminate in accordance with the
      provisions of Section 8.4

     

    3.2.2 General.
      Under
      the direction and supervision of the Development Committee, NovaDel and Licensee
      each shall perform, or cause to be performed, its respective Development
      Activities in accordance with the Development Plan and corresponding development
      budget (the “Development
      Budget”).
      Notwithstanding the foregoing, the Parties acknowledge and agree that there
      can
      be no assurances that the objectives of the Development Activities can be
      achieved, or that they can be achieved in the manner or in the time set forth
      in
      the Development Plan. Although outcomes cannot be guaranteed, each Party shall
      use Commercially Reasonable Efforts to perform or cause to be performed its
      respective Development Activities in good scientific manner, and in material
      compliance with Applicable Law. In addition, and without limiting Licensee’s
      obligations under this Section 3.2.2, Licensee or its Sublicensee shall file
      the
      NDA with the FDA on or before the last day of the thirty-second (32nd) month
      after the Execution Date (the “Anticipated
      Filing Date”);
      provided, however, that Licensee or its Sublicensee may extend the Anticipated
      Filing Date by four (4) months by delivering, at any time after the second
      (2nd)
      anniversary of the Execution Date, written notice of such extension to NovaDel.
      The Anticipated Filing Date, as extended, may thereafter be extended only upon
      the mutual agreement of Licensee or its Sublicensee and NovaDel.

     

    
      
        
        

      

      
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    3.2.3 Reports.
      Within
      thirty (30) days after the end of each calendar quarter in which Development
      Activities are performed, each Party shall provide to the Development Committee
      a written progress report, which shall describe the Development Activities
      it
      has performed, or cause to be performed, during such calendar quarter, evaluate
      the work performed in relation to the goals of the Development Plan and in
      relation to the Development Budget, and provide such other information as may
      be
      required by the Development Plan or reasonably requested by the Development
      Committee with respect to the Development Activities. Minutes from periodic
      project team meetings or other meetings between the Parties can serve as a
      substitute for the required progress reports outlined in this Section
      3.2.3.

     

    3.2.4 Development
      Plan and Budget. The
      Development Committee shall review the Development Plans and the Development
      Budgets at least quarterly and shall have the right to make such modifications
      or updates to the Development Plans or Development Budgets that it deems
      appropriate. The Parties acknowledge and agree that the amounts set forth in
      the
      Development Budgets are estimates and, given the unpredictability of the
      Development Activities, there can be no assurances that the Development
      Activities can be completed within the Development Budgets, provided, however,
      that the Parties agree to use their Commercially Reasonable Efforts to adhere
      to
      the Development Budgets not to exceed the amounts set forth in such Development
      Budgets without written approval of the Development Committee.

     

    3.3 Development
      Committee.
      Except
      as the Parties otherwise agree pursuant to the terms of a sublicense
      agreement:

     

    3.3.1 Formation
      and Authority of Development Committee. NovaDel
      and Licensee shall establish a development committee (the “Development
      Committee”),
      which
      shall oversee the Development Activities performed by the Parties, review and
      approve the Development Budget and approve any changes to the Development Plan
      and Development Budget. Each Party shall appoint an equal number of
      representatives with the requisite experience and seniority to enable them
      to
      make decisions on behalf of the Parties with respect to the Development
      Activities. From time to time, each Party may substitute its representatives
      on
      written notice to the other Party.

     

    3.3.2 Procedural
      Rules of Development Committee. The
      Development Committee shall meet monthly, or as otherwise agreed to by the
      Parties. The Development Committee shall adopt such standing rules as shall
      be
      necessary for its work. A quorum of the Development Committee shall exist
      whenever there is present at a meeting at least one representative appointed
      by
      each Party. Members of the Development Committee may attend a meeting either
      in
      person or by telephone, video conference or similar means in which each
      participant can hear what is said by the other participants. Representation
      by
      proxy shall not be allowed. The Development Committee shall take action by
      unanimous consent of NovaDel and Licensee, with each such Party having a single
      vote, irrespective of the number of representatives actually in attendance
      at a
      meeting, or by a written resolution signed by the designated representatives
      of
      each of NovaDel and Licensee.

     

    
      
        
        

      

      
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    3.3.3 Dispute
      Resolution. If
      the
      Development Committee cannot, or does not, reach agreement on an issue, then
      either Party shall have the right to refer such issue to the Chief Executive
      Officers of the Parties who shall confer on the resolution of the issue. Any
      final decision mutually agreed to by the Chief Executive Officers of the Parties
      shall be in writing and shall be conclusive and binding on the Parties. If
      such
      officers are not able to agree on the resolution of an issue within twenty
      (20)
      days after such issue was first referred to them, either Party shall have the
      right to refer such dispute to arbitration pursuant to Article 9.

     

    3.3.4 Limitations
      on Authority of Development Committee. Each
      Party to this Agreement shall retain the rights, powers, and discretion granted
      to it under this Agreement, and no such rights, powers, or discretion shall
      be
      delegated to or vested in the Development Committee unless such delegation
      or
      vesting of rights is expressly provided for in this Agreement or the Parties
      expressly so agree in writing. The Development Committee shall not have the
      power to amend or modify this Agreement, which may only be amended or modified
      as provided in Section 16.4.

     

    3.4 Regulatory
      Approvals.
      Except
      as the Parties otherwise agree pursuant to the terms of a sublicense, all INDs,
      NDAs and other filings, applications or requests pursuant to or in connection
      with the Regulatory Approvals required under the Development Plan shall be
      made
      in the name of Licensee; provided, however, that Licensee shall consult with
      NovaDel with respect to the preparation and submission of any such filings,
      applications or requests in connection with Regulatory Approvals.

     

    3.4.1 Licensee
      will be the primary contact for Chemistry, Manufacturing and Control
      (“CMC”)
      matters in all relevant regulatory applications except to regulatory bodies
      outside the United States and Canada. Licensee will keep NovaDel reasonably
      informed of all such communications, if any, between Licensee and the Regulatory
      Authorities in the United States and Canada.

     

    3.4.2 NovaDel
      and NovaDel’s Extraterritorial Licensees shall have a perpetual, royalty-free,
      irrevocable, worldwide right to use and reference the Regulatory Documentation
      with respect to the Licensed Product and any data included or referenced therein
      for all purposes. Licensee agrees to utilize the Common Technical Document
      format for its marketing applications in order to facilitate any subsequent
      submissions filed by NovaDel or its Extraterritorial Licensee’s outside of the
      Territory. Licensee shall keep NovaDel reasonably informed as to the
      communications, if any, between Licensee and the Regulatory
      Authorities.

     

    3.4.3 Licensee
      agrees to keep the Common Technical Document, except for those sections in
      the
      Summary Basis of Approval and available through the Freedom of Information
      Act,
      strictly confidential in accordance with Article 15.

     

    
      
        
        

      

      
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    3.5 Regulatory
      Records. NovaDel
      and Licensee each shall maintain, or cause to be maintained, records of its
      respective Development Activities in sufficient detail and in good scientific
      manner appropriate for patent and regulatory purposes, which shall be complete
      and accurate and shall fully and properly reflect all work done and results
      achieved in the performance of its respective Development Activities, and which
      shall be retained by such Party for at least five (5) years after the
      termination of this Agreement, or for such longer period as may be required
      by
      Applicable Law. Each Party shall have the right, during normal business hours
      and upon reasonable notice, to inspect and copy any such records; provided,
      however, that neither Party shall have the right to conduct more than one such
      inspection in any twelve (12)-month period.

     

    3.6 Development
      Expenses. Except
      as
      the Parties otherwise agree pursuant to the terms of a sublicense:

     

    3.6.1 Licensee’s
      Obligation. In
      consideration of NovaDel’s performance of its Development Activities, Licensee
      shall reimburse NovaDel for the reasonable and documented costs and expenses
      incurred by NovaDel in performing such activities in accordance with the
      Development Budget (as may be amended in accordance with Section 3.2.4).
      Licensee shall bear all costs and expenses incurred by or on behalf of Licensee
      in connection with the performance of its Development Activities.

     

    3.6.2 Invoices
      and Payments. Within
      thirty (30) days after the end of each month in which Development Activities
      are
      performed, NovaDel shall invoice Licensee for any costs and expenses incurred
      by
      NovaDel or its Affiliates in such month. Each invoice shall be payable to
      NovaDel within thirty (30) days after invoice date.

     

    3.6.3 Books
      and Records.
      Each
      Party shall
      maintain complete and accurate books, records and accounts that, in reasonable
      detail, fairly reflect any reimbursable costs and expenses incurred by it or
      its
      Affiliates in performance of the Development Activities in conformity with
      GAAP.
      Each Party shall
      retain such books, records and accounts until the later of (a) three (3) years
      after the end of the period to which such books, records and accounts pertain,
      and (b) the expiration of the applicable tax statute of limitations (or any
      extensions thereof), or for such longer period as may be required by Applicable
      Law. Each Party shall have the right to have its certified public accountant,
      who shall be reasonably acceptable to NovaDel and Licensee, as applicable,
      audit
      the books and financial records of the other Party and their respective
      Affiliates relating to its Development Activities during one or more calendar
      quarters; provided, however, that Licensee shall not have the right to audit
      a
      calendar quarter more than two (2) years after the end of such quarter, to
      conduct more than one such audit in any twelve-month period, or to audit any
      calendar quarter more than once; and provided further that each Party shall
      bear
      the cost of such audit unless the audit reveals a variance of more than five
      percent (5%) from the reported results, in which case audited Party shall bear
      the cost of the audit. The results of such accounting firm shall be final,
      absent manifest error.

     

    3.7 Cooperation.
      Each
      Party shall cooperate with any and all reasonable requests for assistance from
      the other Party with respect to the Development Activities, including by making
      its employees, consultants and other scientific staff available upon reasonable
      notice during normal business hours at their respective places of employment
      to
      consult with such other Party on issues arising in connection with the
      performance of such Development Activities.

     

    
      
        
        

      

      
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    3.8 Development
      and Use of Trademarks. Licensee
      shall have the sole right to determine the Trademarks to be used with respect
      to
      the Exploitation of the Licensed Product in the Territory, provided that the
      product labeling and promotional materials disclose that the Licensed Product
      are delivered using the Licensed Process.

     

    3.9 Diligence
      Obligations. Following
      receipt of Regulatory Approval of the Licensed Product by the FDA, Licensee
      (or
      its Sublicensees) shall use Commercially Reasonable Efforts to Exploit the
      Licensed Product in the United States. Licensee shall have the right, but not
      the obligation, to Exploit the Licensed Product in Canada. In addition, Licensee
      directly or through a Sublicensee will consummate the Initial Commercial Sale
      in
      the United States within nine (9) months after receipt of Regulatory Approval
      from the FDA for the Licensed Product. Licensee (or its Sublicensee if there
      is
      a sublicense agreement) shall have responsibility for all advertising,
      marketing, promotion, distribution, selling and other commercialization
      activities, including developing strategies and tactics related to such
      activities for the Licensed Product. Licensee (or its Sublicensee if a there
      is
      a sublicense agreement) shall, at all times during the Term of this Agreement,
      use efforts, including but not limited to appropriate promotional campaigns
      and
      materials, and qualified commercial personnel, consistent with those typically
      used in the pharmaceutical industry and equal to those committed to products
      of
      similar size and expected value to seek to commercialize the Licensed Product
      in
      the Territory after receipt of Regulatory Approval for those formulations and
      indications for which Licensee (or its Sublicensee if a there is a sublicense
      agreement) is commercializing the Licensed Product. Should Licensee (or its
      Sublicensee if a there is a sublicense agreement) fail to meet the above
      'standard', the Parties will discuss Licensee’s (or its Sublicensee’s if a there
      is a sublicense agreement) continued commitment to commercialize the Licensed
      Product and the termination of this Agreement or sublicense agreement, if
      applicable.

     

    3.10 Manufacturing.
      Except
      as the Parties otherwise agree pursuant to the terms of an applicable
      sublicense: 

     

    3.10.1 Subject
      to the other provisions of this Section 3.10.1, Licensee shall be solely
      responsible for the manufacture of the Licensed Product, both for clinical
      development and following receipt of Regulatory Approval of the Licensed
      Product; provided that Licensee may contract with a Third Party to perform
      such
      manufacturing services. Licensee shall share all data and other information
      relating to the manufacturing process and shall consult with NovaDel with
      respect thereto. Without limiting the generality of the foregoing, NovaDel
      shall
      have the opportunity to review, prior to execution, all agreements with Third
      Parties relating to the manufacture of the Licensed Product. Any disputes
      between NovaDel and Licensee relating to the manufacture of the Licensed Product
      shall be resolved in the manner set forth in Section 3.3.3 hereof. NovaDel
      and
      its Extraterritorial Licensees retain the right to purchase product from said
      Third Party, if applicable, at the same costs as Licensee with the exception
      of
      an increase of cost due to a modification to the packaging/labeling by NovaDel
      or any Extraterritorial Licensee.

     

    3.10.2 Licensee
      agrees that, at all times during the performance of the Development Activities,
      it, or its designee, will act in accordance with all Applicable
      Laws.

     

    
      
        
        

      

      
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    3.10.3 To
      the
      extent Licensee contracts with a Third Party to manufacture the Licensed
      Product, such Third Party shall agree in writing to be bound by the obligations
      of confidentiality and non-use at least equivalent in scope to those set forth
      in Article 15 of this Agreement.

     

    3.10.4 NovaDel
      and its Extraterritorial Licensees may purchase Licensed Product under Section
      3.10.1 in the identical packaging and labeling as Licensee purchases such
      Licensed Product for sale in the United States, subject to the requirement
      by
      NovaDel and Sublicensees to have such Licensed Product uniquely identified
      by a
      separate batch record identification or other indicia sufficient to distinguish
      sales by NovaDel, or its Extraterritorial Licensees, from those of
      Licensee.

     

    3.10.5 Licensee
      shall use Commercially Reasonable Efforts to obtain any required licenses,
      permissions needed and documentation (e.g., Certificate of Pharmaceutical
      Product) in order for NovaDel and its Extraterritorial Licensees to buy and
      export Licensed Product from the United States. NovaDel shall reimburse all
      reasonable expenses incurred by Licensee for obtaining such licenses or
      permissions within thirty (30) days of an Extraterritorial Licensee’s receipt of
      an invoice from Licensee itemizing such expenses.

     

    3.10.6 NovaDel
      warrants, covenants and agrees that any license agreement that NovaDel enters
      into with an Extraterritorial Licensee regarding Licensed Product that are
      subject to this Agreement shall contain an indemnity clause requiring the
      Extraterritorial Licensee to indemnify Licensee and its Affiliates against
      any
      and all claims, proceedings, demands, liability and expenses of any kind,
      including legal expenses and attorneys’ fees (collectively, “Claims”),
      arising out of or in connection with the manufacture, sale, use, consumption,
      advertisement or other disposition of Licensed Product by the Extraterritorial
      Licensee, its Affiliates or any end user, or arising from any violation of
      law,
      negligence, willful or reckless misconduct, or from any breach of any material
      obligation of such Extraterritorial Licensee under its agreement with NovaDel,
      other than Claims resulting from the gross negligence or willful misconduct
      of
      Licensee; provided, however, that in no event shall the scope of the
      indemnification to Licensee be any less than the scope of the Extraterritorial
      Licensee’s indemnification obligations to NovaDel. 

     

    ARTICLE
      4

    ROYALTIES
      AND OTHER CONSIDERATION

     

    4.1 Royalties.
      As
      consideration for the rights, privileges and licenses granted hereunder and
      the
      Development Activities performed by NovaDel pursuant to Article 3, Licensee
      shall make the following payments to NovaDel:

     

    4.1.1 Licensee
      shall pay to NovaDel royalties as follows: (i) [***]
      percent
      ([***]%)
      of up
      to the first $[***]
      of
      Net
      Sales by Licensee or any Affiliate or Sublicensee of Licensee of the Licensed
      Product during each calendar year in the Territory plus (ii) [***]
      percent
      ([***]%)
      of Net
      Sales greater than $[***]
      and up
      to $[***]
      by
      Licensee or any Affiliate or Sublicensee of Licensee of the Licensed Product
      during each calendar year in the Territory plus (iii) [***]
      percent
      ([***]%)
      of Net
      Sales greater than $[***]
      by
      Licensee or any Affiliate or Sublicensee of Licensee of the Licensed Product
      during each calendar year in the Territory (see Exhibit B for schedule of
      royalty calculation).

     

    
      
        
        

      

      
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    4.1.2 The
      conversion rate for payments under Section 4.1.1, as it pertains to sales in
      Canada, shall be calculated by using the conversion rate on the last day of
      the
      calendar quarter for which the sales apply. The conversion rate to be used
      will
      be taken from the currency converter at www.oanda.com.
      Canadian dollar sales will be converted into U.S. dollars and then the royalty
      rates outlined in Section 4.1.1 will apply.

     

    4.1.3 Notwithstanding
      anything to the contrary contained herein, any and all royalties to be received
      by Licensee pursuant to the PAR Sublicense Agreement shall be paid to a lock-box
      account. Accordingly, the Parties agree that, within thirty (30) days after
      the
      Execution Date, the Parties and the Sublicensee will take such actions
      reasonably requested by NovaDel, and enter into documentation in form and
      substance reasonably satisfactory to NovaDel (including, without limitation,
      a
      security agreement, lockbox agreement and irrevocable payment instructions),
      in
      order to (i) grant to NovaDel a first priority, perfected security interest
      in
      all of Licensee’s right, title and interest under the Par Sublicense Agreement
      (including without limitation its right to receive payments of the sublicense
      fees and other amounts payable by Par thereunder) and in and to any lockbox
      account(s) to which royalty payments thereunder may be made, (ii) perfect
      NovaDel’s security interest in such lockbox account(s) and provide for
      remittances therefrom in accordance with the terms in this Agreement and (iii)
      irrevocably instruct PAR to make all royalty payments under the PAR Sublicense
      Agreement directly to such lockbox account(s). 

     

    4.2 Royalty
      Term.
      Except
      as the Parties otherwise agree pursuant to the terms of an applicable
      sublicense, Licensee’s royalty obligations under Section 4.1.1 shall terminate,
      on a country-by-country basis, with respect to the Licensed Product upon the
      later of (a) the expiration or invalidation in such country of the last NovaDel
      Patent that includes at least one Valid Claim covering the Licensed Product
      in
      such country and (b) the twentieth (20th) anniversary of the Execution Date;
      provided, however, if (i) the last NovaDel Patent that includes at least one
      Valid Claim covering the Licensed Product in such country expires or is
      invalidated prior to the twentieth (20th) anniversary of the Execution Date
      and
      (ii) and no regulatory exclusivity with respect to such Licensed Product exists
      in such country (whether as a result of expiration of the exclusivity period
      or
      otherwise), then the royalty obligations under Section 4.1.1 in such country
      shall be reduced in accordance with the terms of Section 4.6.

     

    4.3 Royalty
      Payments. Royalties
      under Section 4.1.1 shall be payable to NovaDel on a calendar quarterly basis,
      within forty-five (45) days after the end of each calendar quarter. Licensee
      will submit to NovaDel documentation to support the total amount of funds spent
      by the Licensee on pharmaceutical development and clinical studies for the
      Licensed Product. Licensee will submit along with payment to NovaDel, a
      quarterly royalty statement in a format mutually agreed by both Parties. Along
      with the statement will be all supporting documentation comprising of a
      statement of net sales for the period and copies of actual paid invoices
      covering clinical supplies, consultants, clinical studies, investigator fees,
      document preparation, regulatory fees and other direct fees related to
      development of the Licensed Product, 

     

    
      
        
        

      

      
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    4.4 Licensee
      Fee & Equity. Simultaneously
      with the execution of the Initial Agreement, Licensee issued and sold to NovaDel
      73,121 shares of its common stock (the “Licensee
      Shares”)
      totaling a value of $500,000. Upon execution of this Agreement, NovaDel will
      transfer and assign to Licensee all of its right, title and interest in and
      to
      the Licensee Shares and Licensee will redeem the Licensee Shares. Such transfer
      and assignment by NovaDel will be evidenced by a duly executed stock power
      or
      other form of assignment and shall be accompanied by the original certificate
      representing the Licensee Shares.

     

    4.5 Milestone
      Payments. 

     

    4.5.1 Licensee
      has paid, and NovaDel hereby acknowledges receipt of, the Milestone Payments
      in
      the total sum of $[***],
      as
      described in Sections 4.5.1, 4.5.2 and 4.5.3 of the Initial
      Agreement.

     

    4.5.2 Licensee
      shall pay to NovaDel the additional sum of $[***]
      within
      ten (10) Business Days from the date on which the NDA for the Licensed Product
      is approved by the FDA.

     

    4.6 Reduction
      of Payments.
      In the
      event that, or from and after the date on which, (a) no Valid Claim of a NovaDel
      Patent covering the Licensed Product exists in a country and (b) no regulatory
      exclusivity with respect to such Licensed Product exists in such country
      (whether as a result of expiration of the exclusivity period or otherwise),
      the
      royalty payments set forth in Section 4.1.1 with respect to the Licensed Product
      in such country shall be reduced by [***]
      percent
      ([***]%).
      

     

    4.7 Mode
      of Payment.
      All
      payments to NovaDel under this Agreement shall be paid in United States Dollars
      to a bank account in the United States as NovaDel may reasonably designate.
      

     

    4.8 Non-Refundable,
      Non-Creditable. Subject
      to Sections 4.9 and 5.2, the amounts paid or payable under this Article 4 shall
      be non-refundable and non-creditable against any other amounts due NovaDel
      under
      this Agreement.

     

    4.9 Accounting.
      The
      Parties acknowledge that any expenses or costs deducted from Net Sales under
      this Agreement may be based upon accruals, which accruals will be compliant
      with
      GAAP, consistently applied; provided that when the actual results become known
      relative to any accrued amount, any difference between the actual results and
      the accrual is reported and accounted for in the next payment due hereunder.
      To
      the extent that the difference between such accruals and the actual results
      has
      led to an underpayment, Licensee shall pay NovaDel the amount of such
      underpayment on the next date payment is due to NovaDel hereunder. To the extent
      that the difference between such accruals and the actual results has led to
      an
      overpayment to NovaDel, Licensee may set-off such overpayments against
      subsequent payments to be made to NovaDel; additionally, if any overpayments
      remain upon the expiration or termination of this Agreement, NovaDel shall
      refund such overpayments to Licensee within thirty (30) days of receiving an
      invoice for such overpayment together with applicable supporting documentation.
      

     

    
      
        
        

      

      
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    ARTICLE
      5

    REPORTS
      AND RECORDS

     

    5.1 Record
      Retention. Licensee
      shall maintain (and shall ensure that its Affiliates and any Sublicensee and
      its
      Affiliates shall maintain) complete and accurate books, records and accounts
      that fairly reflect their respective Net Sales, other income and any milestones
      payable with respect to Licensed
      Product in sufficient detail to confirm the accuracy of any payments required
      hereunder and in accordance with GAAP, which books, records and accounts shall
      be retained by Licensee until the later of (a) three (3) years after the end
      of
      the period to which such books, records and accounts pertain, and (b) the
      expiration of the applicable tax statute of limitations (or any extensions
      thereof), or for such longer period as may be required by Applicable
      Law.

     

    5.2 Audit.
      NovaDel
      shall have the right to have an independent certified public accounting firm
      of
      nationally recognized standing, reasonably acceptable to Licensee, to have
      access during normal business hours, and upon reasonable prior written notice,
      to such of the records of Licensee and its Affiliates as may be reasonably
      necessary to verify the accuracy of such Net Sales, Milestone Payments for
      any
      calendar quarter ending not more than thirty-six (36) months prior to the date
      of such request, and NovaDel may, at its expense, request Licensee to have
      such
      an audit conducted of its Sublicensee and its Affiliates, as applicable;
      provided, however, that in each case NovaDel shall not have the right to conduct
      more than one such audit in any twelve (12)-month period. The accounting firm
      shall disclose to each Party whether such Net Sales, Other Income or milestone
      payments are correct or incorrect and the specific details concerning any
      discrepancies. NovaDel shall bear the cost of such audit unless the audit
      reveals an under-reporting or underpayment in excess of the greater of
[***]
      dollars
      ($[***])
      or
[***]
      percent
      ([***]%)
      of
      royalties, Milestone Payments or Sublicense Income payable for such period,
      in
      which case Licensee shall bear the cost of the audit, rectify such underpayment
      and pay NovaDel applicable interest as required by Section 5.5. All payments
      required under this Section 5.2 shall be due within thirty (30) days of the
      date
      NovaDel provides Licensee notice of the payment due. The results of such
      accounting firm shall be final, absent manifest error.

     

    5.3 Reports.
      Within
      forty-five (45) days of the end of each quarter of each calendar year, Licensee
      shall deliver to NovaDel complete and accurate reports, giving such particulars
      of the business conducted by Licensee during the preceding quarter under this
      Agreement as shall be pertinent to an accounting for royalties, milestone
      payments and Other Income hereunder. These shall include at least the
      following:

     

    5.3.1 All
      Licensed Product used, leased or sold, by or for Licensee or its
      Affiliates.

     

    5.3.2 Total
      amounts invoiced for Licensed Product used, leased or sold, by or for Licensee
      or its Affiliates.

     

    5.3.3 Deductions
      applicable in computed “Net Sales” as defined in Section 1.42.

     

    5.3.4 Total
      milestone payments due based on achievement of milestones.

     

    5.3.5 Total
      Net
      Sales and the royalties due by or for Licensee or its Affiliates or its
      Sublicensees, including any adjustments pursuant to Section 4.1.

     

    
      
        
        

      

      
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    5.3.6 Names
      and
      addresses of all Sublicensees and their respective Affiliates and Affiliates
      of
      Licensee.

     

    5.4 Financial
      Statements. Within
      one hundred twenty (120) days of the end of each fiscal year of Licensee,
      Licensee shall provide NovaDel with a copy of Licensee’s audited financial
      statements for such year to NovaDel.

     

    5.5 Interest.
      Amounts
      which are not paid when due and which are not the subject of a bona fide dispute
      shall accrue interest from the due date until paid, at a rate equal to the
      then
      prevailing prime rate of Citibank, N.A., plus [***]
      percent
      ([***]%),
      but
      in no event exceeding the amount permitted by Applicable Law.

     

    5.6 Confidentiality.
      Each
      report received by NovaDel shall be treated by NovaDel as if it were
“Confidential Information” subject to the terms of Article 15.

     

    ARTICLE
      6

    PATENT
      PROSECUTION AND MAINTENANCE

     

    6.1 Ownership
      of Information and Inventions. Subject
      to Section 6.2 and the license grants under Article 2, as between the Parties,
      NovaDel shall own and retain all right, title and interest in and to any and
      all: (a) Information and Inventions that are conceived, discovered, developed
      or
      otherwise made by or on behalf of either Party (or its Affiliates or its
      Sublicensees), whether or not patented or patentable, and any and all Patent
      and
      other intellectual property rights with respect thereto; and (b) other
      Information and Inventions, and Patent and other intellectual property rights
      with respect thereto that are Controlled (other than pursuant to the license
      grants set forth in Article 2) by either Party, its Affiliates or Sublicensees.
      Subject to the license grants to Licensee under Article 2, as between the
      Parties, NovaDel shall own and retain all right, title and interest in and
      to
      all Licensed Technology.

     

    6.2 Ownership
      of the Licensed Process. Subject
      to the license grants to Licensee under Article 2, as between the Parties,
      NovaDel shall own and retain all right, title and interest in and to the
      Licensed Process, including any and all Information and Inventions with respect
      to the Licensed Process (including any Improvements thereto) that are conceived,
      discovered, developed or otherwise made, by or on behalf of Licensee, its
      Affiliates or Sublicensees (other than NovaDel and its Affiliates), whether
      or
      not patented or patentable, and any and all Patent and other intellectual
      property rights with respect thereto. Licensee acknowledges and agrees that
      (a)
      the licenses granted to it pursuant to Section 2.1 permit Licensee to use the
      Licensed Process solely for the Exploitation of Licensed Product as provided
      in
      this Agreement, (b) Licensee has no right to use the Licensed Process or to
      discover, develop or otherwise make Improvements with respect to the Licensed
      Process under such grants, and (c) neither it, nor any of its Affiliates or
      Sublicensees, will engage, directly or indirectly, in activities designed to,
      or
      otherwise undertake or attempt, either on behalf of itself or another, to
      discover, develop or make any Information and Inventions that relate to the
      Licensed Process. Accordingly, Licensee shall promptly disclose to NovaDel
      in
      writing, the conception or reduction to practice, or the discovery, development
      or making of any such Information and Inventions that relate to the Licensed
      Process and shall, and does hereby, assign, and shall cause its Affiliates
      and
      Sublicensees to so assign, to NovaDel, without additional compensation, all
      of
      their respective rights, titles and interests in and to any such Information
      and
      Inventions. 

     

    
      
        
        

      

      
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    6.3 Disclosure
      and Assignment.
      Licensee
      or its Sublicensee, as applicable, shall promptly disclose to NovaDel in
      writing, the conception or reduction to practice, or the discovery, development
      or making of all intellectual property rights identified in Sections 6.1 and
      6.2, and shall, and does hereby, assign, and shall cause its respective
      Affiliates to so assign, to NovaDel, without additional compensation, all of
      their respective rights, titles and interests in and to any such intellectual
      property rights. To the extent necessary to assign any such intellectual
      property rights, Licensee or its Sublicensee, as applicable, shall enter into
      and execute all reasonable and appropriate assignments, transfers and other
      agreements, and enter into all agreements with its employees, contractors,
      and
      Affiliates, that are necessary or appropriate to ensure the assignment of such
      intellectual property rights to NovaDel. For the avoidance of doubt, all such
      intellectual property rights shall be included in the Licensed Technology,
      and
      Licensee or its Sublicensee, as applicable, shall be entitled to use such
      intellectual property rights in accordance with the licenses granted pursuant
      to
      Article 2.

     

    6.4 Non-Use
      of Trademarks.
      Except
      as set forth explicitly in this Agreement, neither Licensee or any of its
      Sublicensees or Affiliates nor NovaDel shall have the right to use the
      trademarks, trade names or logos of the other parties, nor any adaptation
      thereof, nor the names of any employees or consultants of any of the other
      parties, without the prior written consent of such other party in each instance,
      except that any party may use any other party’s name in its general list of
      collaborators and any party may use any other party’s name to the extent
      required by Applicable Law, including pursuant to the Securities Act of 1933
      and
      the Securities Exchange Act of 1934, each as amended, and the rules and
      regulations thereunder.

     

    6.5 United
      States Law. The
      determination of whether Information and Inventions are conceived, discovered,
      developed or otherwise made by a Party for the purpose of allocating proprietary
      rights (including Patent, copyright or other intellectual property rights)
      therein, shall, for purposes of this Agreement, be made in accordance with
      applicable United States law.

     

    6.6 Prosecution
      of Patents. Except
      as
      the Parties otherwise agree pursuant to the terms of an applicable
      sublicense:

     

    6.6.1 Prosecution
      of NovaDel Patents. As
      between the Parties, NovaDel shall have the sole right, at its cost and expense,
      to obtain, prosecute and maintain throughout the world the NovaDel Patents;
      provided, however, that Licensee shall reimburse NovaDel for [***]
      percent
      ([***]%)
      of the
      reasonable out-of-pocket costs incurred by NovaDel, as of the Effective Date,
      for filing, prosecuting and maintaining such NovaDel Patents to the extent
      that
      they claim or cover solely the Exploitation of the Licensed Product in the
      Territory.
      Licensee
      shall, and shall cause its Affiliates and Sublicensees, as applicable, to,
      cooperate fully with NovaDel in the preparation, filing, prosecution, and
      maintenance of NovaDel’s Patents. Such cooperation includes (a) promptly
      executing all papers and instruments and requiring employees to execute such
      papers and instruments as reasonable and appropriate so as to enable NovaDel
      to
      file, prosecute, and maintain its Patents in any country; and (b) promptly
      informing NovaDel of matters that may affect the preparation, filing,
      prosecution, or maintenance of any such Patents.
      NovaDel
      shall provide Licensee with drafts of all patent applications and other material
      submissions to and correspondence with any patent authorities to the extent
      such
      applications or submissions relate to the Licensed Technology (other than the
      Licensed Process), in sufficient time, but in any event not less than thirty
      (30) days prior to the date a reply is required by the relevant patent
      authorities, to allow for review and comment by Licensee. In addition, NovaDel
      shall provide Licensee with an opportunity to consult with NovaDel regarding
      the
      filing and contents of any such application, submission or correspondence.
      If
      Licensee provides to NovaDel comments with respect to any such application,
      submission or correspondence, to the extent such comments relate to any Licensed
      Technology (other than the Licensed Process), NovaDel agrees to reasonably
      consider such comments, it being understood that NovaDel retains the right
      to
      determine whether to comply with or incorporate such comments, if at all. If
      (x)
      NovaDel elects not to pursue the filing, prosecution or maintenance of a NovaDel
      Patent in a particular country, or to take any other action with respect to
      a
      NovaDel Patent in a particular country that is necessary or useful to establish
      or preserve rights with respect to the Licensed Product, and (y) such Patent
      does not claim or cover the Licensed Process, then NovaDel shall so notify
      Licensee promptly in writing and in good time to enable Licensee to meet any
      deadlines by which an action must be taken to establish or preserve any such
      rights in such NovaDel Patent in such country. Upon receipt of any such notice
      by NovaDel or if, at any time, NovaDel fails to initiate any such action within
      thirty (30) days after a request by Licensee that it do so (and thereafter
      diligently pursue such action), Licensee shall have the right, but not the
      obligation, to pursue the filing or registration, or support the continued
      prosecution or maintenance, of such NovaDel Patent at its expense in such
      country. If Licensee elects to pursue such filing or registration, as the case
      may be, or continue such support, then Licensee shall notify NovaDel of such
      election and NovaDel shall, and shall cause its Affiliates to, (x) reasonably
      cooperate with Licensee in this regard, and (y) promptly grant to Licensee,
      without additional consideration, an exclusive, perpetual, irrevocable,
      royalty-free license in such country under such NovaDel Patent.

     

    
      
        
        

      

      
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    6.7 Enforcement
      of NovaDel Patents. Except
      as
      the Parties otherwise agree pursuant to the terms of an applicable
      sublicense: 

     

    6.7.1 Technology
      of NovaDel. If
      either
      Party determines that any Technology or NovaDel or any joint Technology is
      being
      infringed by a Third Party’s activities and that such infringement could affect
      the exercise by the Parties of their respective rights and obligations under
      this
      Agreement, it shall promptly notify such other Party in writing and provide
      such
      other Party with any evidence of such infringement that is reasonably
      available.
      Promptly
      after the receipt of such written notice, the Parties shall meet and discuss
      in
      good faith the removal of such infringement. NovaDel shall consider in good
      faith any comments from Licensee and shall keep Licensee reasonably informed
      of
      any steps taken to remove such infringement. NovaDel shall have the first right,
      but not the obligation, to remove such infringement at its sole cost and
      expense; provided, however, that Licensee shall reimburse NovaDel for one
      hundred percent (100%) of the reasonable out-of-pocket costs incurred by NovaDel
      with respect to the removal of any such infringement to the extent that such
      infringement adversely affects the Exploitation of the Licensed Product in
      the
      Territory. In
      the
      event that NovaDel fails within ninety (90) days following notice of such
      infringement, or earlier notifies Licensee in writing of its intent not, to
      take
      commercially appropriate steps to remove any infringement of any NovaDel Patent
      that is likely to have a material adverse effect on the sale of a Licensed
      Product, Licensee shall have the right to do so at Licensee’s expense; provided,
      however, that if NovaDel has commenced negotiations with an alleged infringer
      for discontinuance of such infringement within such ninety (90) day period,
      NovaDel shall have an additional ninety (90) days to conclude its negotiations
      before Licensee may bring suit for such infringement, and provided further
      that
      Licensee shall not enter into any settlement or compromise with respect to
      any
      NovaDel Patent without NovaDel’s prior consent, which consent shall not be
      unreasonably withheld. Each Party shall provide reasonable assistance to the
      other Party, including providing access to relevant documents and other
      evidence, making its employees available
      at reasonable business hours, and joining the action to the extent necessary
      to
      allow the enforcing Party to maintain the action. Any
      amounts recovered by a Party pursuant to this Section, whether by settlement
      or
      judgment, shall be used to reimburse the Parties for their reasonable costs
      and
      expenses in making such recovery (which amounts shall be allocated pro rata
      if
      insufficient to cover the totality of such expenses), with any remainder being
      retained by the Party that brought the enforcement action; provided,
      however,
      that to
      the extent that any award is attributable to the loss of sales of Licensed
      Product, such amount shall be paid to Licensee and shall be treated as Net
      Sales
      on which royalties shall be due under Article 4. 

     

    
      
        
        

      

      
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    6.8 Potential
      Third Party Rights.
      Except
      as the Parties otherwise agree pursuant to the terms of an applicable
      sublicense:

     

    6.8.1 Third-Party
      Licenses. If
      (a) in
      the opinion of outside patent counsel to Licensee, Licensee, or any of its
      Affiliates or Sublicensees, cannot Exploit a Licensed Product in a country
      in
      the Territory without infringing one or more Patents that have issued to a
      Third
      Party in such country, or (b) as a result of any claim made against a Party,
      or
      any of its Affiliates or Sublicensees, alleging that the Exploitation of a
      Licensed Product infringes or misappropriates any Patent or any other
      intellectual property right of a Third Party in a country in the Territory,
      a
      judgment is entered by a court
      of
      competent jurisdiction from which no appeal is taken within the time permitted
      for appeal, such that Licensee cannot Exploit such Licensed Product in such
      country without infringing the Patent or other proprietary rights of such Third
      Party, then, in either case, Licensee shall have the first right, but not the
      obligation to negotiate and to obtain a license from such Third Party as
      necessary for the Exploitation of any Licensed Product hereunder in such
      country; provided, however, that NovaDel shall have the sole right to seek
      any
      such license with respect to the Licensed Process and shall use commercially
      reasonable efforts to obtain such a license in its own name from such Third
      Party in such country, under which NovaDel shall, to the extent permissible
      under such license, grant a sublicense to Licensee as necessary for Licensee,
      and any of its Affiliates and Sublicensees, to Exploit the Licensed Product
      as
      provided hereunder in such country. Licensee shall be solely responsible for
      [***]
      percent
      ([***]%)
      of all
      royalty and other obligations with respect to the Exploitation of the Licensed
      Product; provided, however, that Licensee shall have the right to credit
[***]
      percent
      ([***]%)
      any
      royalties paid by Licensee, its Affiliates or Sublicensees under such license
      with respect to such country against the royalty payments to be paid by Licensee
      to NovaDel with respect to the sale of the Licensed Product under Section 4.1;
      provided, however, that no royalty payment when due, regardless of the amount
      or
      number of credits available to Licensee in accordance with this Agreement,
      shall
      be reduced by more than [***]
      percent
      ([***]%)
      of the
      amounts otherwise owed pursuant to Section 4.1 in any calendar quarter. Credits
      not exhausted in any calendar quarter may be carried into future calendar
      quarters. 

     

    
      
        
        

      

      
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    6.8.2 Third
      Party Litigation. In
      the
      event that a Third Party institutes a patent or other infringement suit
      (including any suit alleging the invalidity or unenforceability of the Patents
      of a Party or its Affiliates) against either Party or its respective Affiliates,
      licensees or Sublicensees during the Term, alleging use of the Licensed
      Technology or any other activities hereunder, infringes one or more patent
      or
      other intellectual property rights held by such Third Party (an “Infringement
      Suit”),
      the
      Parties shall cooperate with one another in defending such suit. NovaDel shall
      have the first right to direct and control any Infringement Suit to the extent
      that it relates to the use of the Licensed Technology or the Licensed Process;
      provided
      that
      Licensee shall bear [***]
      percent
      ([***]%)
      of the
      costs and expenses associated with any such Infringement Suit to the extent
      that
      it relates to the Exploitation of the Licensed Product.

     

    6.8.3 Retained
      Rights. Nothing
      in this Section 6.8 shall prevent Licensee or its Sublicensee, as applicable,
      at
      its own expense, from obtaining any license or other rights from Third Parties
      it deems appropriate in order to permit the full and unhindered exercise of
      its
      rights under this Agreement.

     

    ARTICLE
      7

    TERM
      OF THE AGREEMENT

     

    7.1 Term.
      Unless
      otherwise terminated pursuant to Article 8, this Agreement shall enter into
      effect on the Effective Date and shall remain in full force and effect on a
      country-by-country basis until the later of (a) the expiration or invalidation
      in such country of the last NovaDel Patent that includes at least one Valid
      Claim covering the Licensed Product in such country and (b) the twentieth (20th)
      anniversary of the Execution Date (the “Term”).
      

     

    ARTICLE
      8

    TERMINATION

     

    8.1 Termination
      Upon Insolvency. If
      Licensee shall become bankrupt, or shall file a petition in bankruptcy or
      insolvency or for reorganization or for an arrangement or for the appointment
      of
      a receiver or trustee or of its assets, or if an involuntary petition for any
      of
      the foregoing shall be filed with respect to Licensee and not dismissed within
      sixty (60) days, or if the business of Licensee shall be placed in the hands
      of
      a receiver, assignee or trustee for the benefit of creditors, whether by the
      voluntary act of Licensee or otherwise, this Agreement shall automatically
      terminate.

     

    8.2 Termination
      for Payment Default. Should
      Licensee fail to make payment to NovaDel of royalties or other amounts due
      in
      accordance with the terms of this Agreement, NovaDel shall have the right to
      terminate this Agreement within ten (10) days after giving said notice of
      termination unless Licensee shall pay to NovaDel, within the 10-day period,
      all
      such amounts due and payable. Upon the expiration of the 10-day period, if
      Licensee shall not have paid all such amounts due and payable, the rights,
      privileges and licenses granted hereunder shall, at the option of NovaDel,
      immediately terminate. In the event a payment is the subject of a bona fide
      dispute between NovaDel and Licensee that is being pursued by a Party pursuant
      to the dispute resolution mechanism in Article 9, then Licensee shall make
      such
      payment, but shall provide NovaDel with written notice that such payment is
      being made subject to the outcome of such pending dispute resolution procedure
      and in the event such dispute is finally and conclusively resolved in favor
      of
      Licensee, NovaDel shall refund such payment to Licensee with interest calculated
      pursuant to Section 5.5 from the date of such payment.

     

    
      
        
        

      

      
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    8.3 Termination
      for Material Breach. Upon
      any
      material breach or default of this Agreement by either Party, other than as
      set
      forth in Section 8.2, and subject to Section 2.4.3, the other Party shall have
      the right to terminate this Agreement and the rights, privileges and licenses
      granted hereunder upon giving thirty (30) days notice to the breaching Party.
      Such termination shall become effective upon the expiration of such thirty
      (30)
      day period unless the breaching Party shall have cured any such breach or
      default prior to the expiration of such thirty (30) day period. 

     

    8.4 Termination
      By The Licensee. Licensee
      shall have the right at any time to terminate this Agreement in whole or as
      to
      any Licensed Product (i) by giving 90 days notice thereof in writing to NovaDel
      or (ii) if Licensee elects not to effect the Milestone Payment which is due
      and
      payable as provided in Section 4.5.2.

     

    8.5 Survival.
      Any
      expiration or termination of this Agreement shall not affect the rights and
      obligations of the Parties accrued prior to such expiration or termination.
      Without limiting the foregoing, Articles 4, 5, 6, 9, 10, 11, 14, 15 and 16
      and
      Sections 8.6, 8.7, 16.1, 16.7 and this Section 8.5 shall survive the termination
      or expiration of this Agreement for any reason. 

     

    8.6 Work-in-Progress.
      Licensee
      and/or any Sublicensee thereof may, however, after the effective date of such
      termination and continuing for a period not to exceed six (6) months thereafter,
      sell all completed Licensed Product, and any Licensed Product in the process
      of
      manufacture at the time of such termination, and sell the same, provided that
      Licensee shall pay or cause to be paid to NovaDel the royalties thereon as
      required by Article 4 of this Agreement and shall submit the reports required
      by
      Article 5 hereof on the sales of Licensed Product.

     

    8.7 Return
      of Information; Assignment and License. 

     

    8.7.1 Upon
      termination of this Agreement, Licensee shall, and shall cause its Affiliates
      and Sublicensees, as applicable, to return to NovaDel any and all data, files,
      records and other materials in its possession or control that relate to the
      Licensed Technology or contain or comprise NovaDel’s Information and Inventions
      or other Confidential Information (except one copy of each that may be retained
      for archival purposes). 

     

    8.7.2 Upon
      the
      termination of this Agreement, Licensee (a) shall, and shall cause its
      Affiliates and, subject to Section 8.7.3, Sublicensees to, promptly disclose
      to
      NovaDel, in whatever form NovaDel may request, all Regulatory Documentation
      and
      all other Information and Inventions in the possession or Control of Licensee,
      its Affiliates or Sublicensees that relate to the Exploitation of such Licensed
      Product, (b) shall, and does hereby, assign, and shall cause its Affiliates
      and,
      subject to Section 8.7.3, Sublicensees to assign, to NovaDel, without additional
      compensation, all of their respective rights, titles and interests in and to
      any
      and all (i) patent, trademark, copyright or other intellectual property rights,
      and (ii) Regulatory Documentation and all data included or referenced therein
      (the “Agreement-Related
      Assets”)
      and
      are permitted to be assigned, (c) to the extent that the Agreement-Related
      Assets may not be assigned, shall, and does hereby, grant, and shall cause
      its
      Affiliates and, subject to Section 8.7.3, Sublicensees to grant, to NovaDel,
      without additional compensation, a perpetual, irrevocable, royalty-free,
      exclusive, sublicenseable through multiple tiers of sublicensees, right and
      license to Exploit such Licensed Product in the Territory, and (d) shall, and
      does hereby, and shall cause its Affiliates and, subject to Section 8.7.3,
      Sublicensees to, assign to NovaDel, without additional compensation, all of
      their respective rights, titles and interests in and to any and all other
      Information and Inventions in the possession or control of Licensee and its
      Affiliates or any Sublicensee and its Affiliates in each case that relate to
      the
      Exploitation of such Licensed Product to the extent not already assigned to
      NovaDel pursuant to Sections 6.1 or 6.2.

     

    
      
        
        

      

      
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    8.7.3 Notwithstanding
      anything contained in Sections 8.7.1 and 8.7.2, in the event that any sublicense
      granted by Licensee survives pursuant to Section 2.4.3, the Sublicensee may
      retain (a) the information and materials identified in Section 8.7.1 that are
      rightfully in its possession and (b) Agreement-Related Assets, in each case
      until the termination of such sublicense, whereupon such Sublicensee shall
      return such materials to NovaDel. 

     

    8.8 Cumulative
      Remedies. The
      rights and remedies set forth in this Article 8 are cumulative and in addition
      to any other rights that may be available to the Parties.

     

    8.9 Non-Refundability
      of Milestones and Development Costs.
      Any and
      all Milestone Payments made to NovaDel by Licensee under Article 4 of this
      Agreement shall be non-refundable in the event of termination of this Agreement
      by either Party under any of the provisions of Article 8.

     

    ARTICLE
      9

    ARBITRATION

     

    9.1 Procedures.
      Any
      dispute arising from or relating to this Agreement shall be determined before
      a
      tribunal of three arbitrators in New York, New York in accordance with the
      Commercial Arbitration Rules of the American Arbitration Association (the
“AAA”).
      One
      arbitrator shall be selected by NovaDel, one arbitrator shall be selected by
      Licensee and the third arbitrator shall be selected by mutual agreement of
      the
      first two arbitrators or by the AAA, if the arbitrators appointed by the Parties
      are unable to select a third arbitrator within thirty (30) days.

     

    9.2 Patent
      Disputes. Any
      claim, dispute, or controversy concerning the validity, enforceability, or
      infringement of any patent contained in the NovaDel Patents licensed hereunder
      shall be resolved in any court having jurisdiction thereof. In the event that,
      in any arbitration proceeding, any issue shall arise concerning the validity,
      enforceability, or infringement of any patent contained in the NovaDel Patents
      licensed hereunder, the arbitrators shall, to the extent possible, resolve
      all
      issues other than validity, enforceability, and infringement; in any event,
      the
      arbitrators shall not delay the arbitration proceeding for the purpose of
      obtaining or permitting either Party to obtain judicial resolution of such
      issues, unless an order staying the arbitration proceeding shall be entered
      by a
      court of competent jurisdiction. Neither Party shall raise any issue concerning
      the validity, enforceability, or infringement of any patent contained in the
      NovaDel Patents licensed hereunder, in any proceeding to enforce any arbitration
      award hereunder, or in any proceeding otherwise arising out of any such
      arbitration award.

     

    
      
        
        

      

      
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    9.3 Costs.
      The
      costs
      of such arbitration shall be borne proportionate to the finding of fault as
      determined by the arbitration panel. Judgment on the arbitration award may
      be
      entered by any court of competent jurisdiction.

     

    ARTICLE
      10

    INDEMNIFICATION
      AND INSURANCE

     

    10.1 Indemnification
      of NovaDel. Subject
      to any Sublicensee’s first obligations to directly indemnify, defend and hold
      NovaDel harmless under an applicable sublicense agreement, Licensee shall
      defend, indemnify and hold NovaDel, its Affiliates, and their respective
      directors, officers, employees and agents harmless from and against all
      liability, demands, damages, including expenses or losses including death,
      personal injury, illness or property damage (collectively, “Losses”)
      arising directly or indirectly out of any: (a) breach of this Agreement by
      Licensee, its Affiliates, Sublicensees or permitted assigns or transferees;
      (b)
      actual or asserted violations of Applicable Law by Licensee, its Affiliates,
      Sublicensees or permitted assignees or transferees; (c) use by Licensee, its
      Affiliates, Sublicensees or permitted assignees or transferees of the Licensed
      Technology or (d) Exploitation of the Licensed Product by Licensee, its
      Affiliates, Sublicensees or permitted assignees or transferees, except for
      those
      Losses for which NovaDel has an obligation to indemnify Licensee and its
      Affiliates pursuant to Section 10.2, as to which Losses each Party shall
      indemnify the other to the extent of their respective liability for the Losses
      and other than as a result of NovaDel’s gross negligence, recklessness or
      willful misconduct.

     

    10.2 Indemnification
      of Licensee.
      Subject
      to any Sublicensee’s first obligations to directly indemnify, defend and hold
      Licensee harmless under an applicable sublicense agreement, NovaDel shall
      defend, indemnify and hold Licensee, its Affiliates, and their respective
      directors, officers, employees and agents harmless from and against all Losses
      arising directly or indirectly out of any: (a) breach of this Agreement by
      NovaDel or its Affiliates; or (b) actual or asserted violations of Applicable
      Law by NovaDel or its Affiliates, except for those Losses for which Licensee
      has
      an obligation to indemnify NovaDel and its Affiliates pursuant to Section 10.1,
      as to which Losses each Party shall indemnify the other to the extent of their
      respective liability for the Losses.

     

    10.3 Indemnification
      Procedure.

     

    10.3.1 Notice
      of Claim.
      The
      indemnified party shall give the indemnifying Party prompt written notice (an
      “Indemnification
      Claim Notice”)
      of any
      Losses or discovery of fact upon which such indemnified party intends to base
      a
      request for indemnification under Section 10.1 or Section 10.2, but in no event
      shall the indemnifying Party be liable for any Losses that result from any
      delay
      in providing such notice. Each Indemnification Claim Notice must contain a
      description of the claim and the nature and amount of such Loss (to the extent
      that the nature and amount of such Loss is known at such time). The indemnified
      party shall furnish promptly to the indemnifying Party copies of all papers
      and
      official documents received in respect of any Losses. All indemnification claims
      in respect of a Party, its Affiliates or their respective directors, officers,
      employees and agents shall be made solely by such party (the “Indemnified
      Party”).

     

    
      
        
        

      

      
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    10.3.2 Third
      Party Claims.
      The
      obligations of an indemnifying Party under this Article 10 with respect to
      Losses arising from claims of any Third Party that are subject to
      indemnification as provided for in Sections 10.1 or 10.2 (a “Third
      Party Claim”)
      shall
      be governed by and be contingent upon the following additional terms and
      conditions:

     

    (a) Control
      of Defense.
      At its
      option, the indemnifying Party may assume the defense of any Third Party Claim
      by giving written notice to the Indemnified Party within thirty (30) days after
      the indemnifying Party’s receipt of an Indemnification Claim Notice. The
      assumption of the defense of a Third Party Claim by the indemnifying Party
      shall
      not be construed as an acknowledgment that the indemnifying Party is liable
      to
      indemnify any Indemnified Party in respect of the Third Party Claim, nor shall
      it constitute a waiver by the indemnifying Party of any defenses it may assert
      against any Indemnified Party’s claim for indemnification. Upon assuming the
      defense of a Third Party Claim, the indemnifying Party may appoint as lead
      counsel in the defense of the Third Party Claim any legal counsel selected
      by
      the indemnifying Party. In the event the indemnifying Party assumes the defense
      of a Third Party Claim, the Indemnified Party shall immediately deliver to
      the
      indemnifying Party all original notices and documents (including court papers)
      received by any Indemnified Party in connection with the Third Party Claim.
      Should the indemnifying Party assume the defense of a Third Party Claim, the
      indemnifying Party shall not be liable to the Indemnified Party or any other
      Indemnified Party for any legal expenses subsequently incurred by such
      Indemnified Party in connection with the analysis, defense or settlement of
      the
      Third Party Claim. In the event that it is ultimately determined that the
      indemnifying Party is not obligated to indemnify, defend or hold harmless an
      Indemnified Party from and against the Third Party Claim, the Indemnified Party
      shall reimburse the indemnifying Party for any and all costs and expenses
      (including attorneys’ fees and costs of suit) and any Losses incurred by the
      indemnifying Party in its defense of the Third Party Claim with respect to
      such
      Indemnified Party. 

     

    (b) Right
      to Participate in Defense.
      Without
      limiting Section 10.3.2(a), any Indemnified Party shall be entitled to
      participate in, but not control, the defense of such Third Party Claim and
      to
      employ counsel of its choice for such purpose; provided, however, that such
      employment shall be at the Indemnified Party’s own expense unless (i) the
      employment thereof has been specifically authorized by the indemnifying Party
      in
      writing or (ii) the indemnifying Party has failed to assume the defense and
      employ counsel in accordance with Section 10.3.2(a) (in which case the
      Indemnified Party shall control the defense).

     

    (c) Settlement.
      With
      respect to any Losses relating solely to the payment of money damages in
      connection with a Third Party Claim and that will not result in the Indemnified
      Party’s becoming subject to injunctive or other relief or otherwise adversely
      affect the business of the Indemnified Party in any manner, and as to which
      the
      indemnifying Party shall have acknowledged in writing the obligation to
      indemnify the Indemnified Party hereunder, the indemnifying Party shall have
      the
      sole right to consent to the entry of any judgment, enter into any settlement
      or
      otherwise dispose of such Loss, on such terms as the indemnifying Party, in
      its
      sole discretion, shall deem appropriate. With respect to all other Losses in
      connection with Third Party Claims, where the indemnifying Party has assumed
      the
      defense of the Third Party Claim in accordance with Section 10.3.2(a), the
      indemnifying Party shall have authority to consent to the entry of any judgment,
      enter into any settlement or otherwise dispose of such Loss provided it obtains
      the prior written consent of the Indemnified Party (which consent shall not
      be
      unreasonably withheld or delayed). The indemnifying Party shall not be liable
      for any settlement or other disposition of a Loss by an Indemnified Party that
      is reached without the written consent of the indemnifying Party. Regardless
      of
      whether the indemnifying Party chooses to defend or prosecute any Third Party
      Claim, no Indemnified Party shall admit any liability with respect to, or
      settle, compromise or discharge, any Third Party Claim without the prior written
      consent of the indemnifying Party. 

     

    
      
        
        

      

      
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    (d) Cooperation.
      Regardless of whether the indemnifying Party chooses to defend or prosecute
      any
      Third Party Claim, the Indemnified Party shall, and shall cause each other
      Indemnified Party to, cooperate in the defense or prosecution thereof and shall
      furnish such records, information and testimony, provide such witnesses and
      attend such conferences, discovery proceedings, hearings, trials and appeals
      as
      may be reasonably requested in connection therewith. Such cooperation shall
      include access during normal business hours afforded to indemnifying Party
      to,
      and reasonable retention by the Indemnified Party of, records and information
      that are reasonably relevant to such Third Party Claim, and making Indemnified
      Parties and other employees and agents available on a mutually convenient basis
      to provide additional information and explanation of any material provided
      hereunder, and the indemnifying Party shall reimburse the Indemnified Party
      for
      all its reasonable out-of-pocket expenses in connection therewith. 

     

    (e) Expenses.
      Except
      as provided above, the costs and expenses, including fees and disbursements
      of
      counsel, incurred by the Indemnified Party in connection with any claim shall
      be
      reimbursed on a calendar quarter basis by the indemnifying Party, without
      prejudice to the indemnifying Party’s right to contest the Indemnified Party’s
      right to indemnification and subject to refund in the event the indemnifying
      Party is ultimately held not to be obligated to indemnify the Indemnified
      Party.

     

    10.4 Insurance. 

     

    10.4.1 At
      all
      times from and after the Effective Date, Licensee or its Sublicensee
      shall
      have and maintain such type and amounts of liability insurance covering the
      manufacture, supply, use and sale of the Licensed Product as is normal and
      customary in the pharmaceutical industry generally for parties similarly
      situated, and shall upon request provide NovaDel with a copy of its policies
      of
      insurance in that regard, along with any amendments and revisions
      thereto.

     

    10.4.2 At
      all
      times from and after the Effective Date, NovaDel shall
      have and maintain such type and amounts of liability insurance covering the
      manufacture, supply, use and sale of the Licensed Product as is normal and
      customary in the pharmaceutical industry generally for parties similarly
      situated, and shall upon request provide the Licensee with a copy of its
      policies of insurance in that regard, along with any amendments and revisions
      thereto. 

     

    10.4.3 
      Each of
      Licensee and NovaDel shall, starting 6 months prior to anticipated receipt
      of
      NDA approval of Licensed Product and extending through the remaining term of
      this Agreement and for a period of not less than 36 months following the
      termination of this Agreement, carry liability insurance (including blanket
      contractual liability) in an amount of not less than $[***]
      combined
      single limit, which insurance will be written on a “claims-made” policy basis
      with an insurance carrier reasonably acceptable to the other Party. Each Party
      shall provide the other Party with evidence of coverage contemplated hereby,
      in
      the form of certificates of insurance, as reasonably requested. Such
      certificates shall be provided by written notice to the other Party 15 days
      prior to any material change, cancellation or non-renewal of the policy. The
      said amount can vary if mutually agreed by both Parties.

     

    
      
        
        

      

      
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    ARTICLE
      11

    REPRESENTATIONS
      AND WARRANTIES;

    LIMITATION
      OF LIABILITY

     

    11.1 Representations,
      Warranties and Covenants. Each
      Party hereby represents and warrants to the other Party as of the Effective
      Date
      as follows:

     

    11.1.1 
      Duly Organized. Such
      Party is a corporation duly organized, validly existing and in good standing
      under the laws of the state 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 is
      contemplated to be conducted by this Agreement.

     

    11.1.2 Corporate
      Authority. Such
      Party (a) has the power and authority and the legal right to enter into this
      Agreement and perform its obligations hereunder, and (b) has taken all necessary
      action on its part required to authorize the execution and delivery of this
      Agreement and the performance of its obligations hereunder. The Agreement has
      been duly executed and delivered on behalf of such Party and is enforceable
      against it in accordance with its terms, subject to the effects of bankruptcy,
      insolvency or other laws of general application affecting the enforcement of
      creditor rights and judicial principles affecting the availability of specific
      performance and general principles of equity, whether enforceability is
      considered in a proceeding at law or in equity.

     

    11.1.3 Litigation.
      Such
      Party is not aware of any pending or threatened litigation (and has not received
      any communication) that alleges that such Party’s activities related to this
      Agreement have violated, or that by conducting the activities as contemplated
      herein such Party would violate, any of the intellectual property rights of
      any
      other Entity.

     

    11.1.4 Consents,
      Approvals, etc. All
      necessary consents, approvals and authorizations of all regulatory and
      governmental authorities and other Entities required to be obtained by such
      Party in connection with the execution and delivery of this Agreement and the
      performance of its obligations hereunder have been obtained.

     

    11.1.5 Conflicts.
      The
      execution and delivery of this Agreement and the performance of such Party’s
      obligations hereunder (a) do not conflict with or violate any requirement of
      Applicable Law or regulation or any provision of the articles of incorporation,
      bylaws, or any similar constitutive document of such Party, as applicable,
      in
      any material way, and (b) do not conflict with, violate, or breach or constitute
      a default or require any consent under, any contractual obligation or court
      or
      administrative order by which such Party is bound.

     

    
      
        
        

      

      
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    11.2 Additional
      Representations, Warranties and Covenants of NovaDel. NovaDel
      hereby represents and warrants and, on behalf of its Affiliates, agrees and
      covenants as follows: 

     

    11.2.1 NovaDel
      represents and warrants to Licensee that, to its Knowledge, as of the Effective
      Date, NovaDel is the owner or (sub)licensee (with the right to grant sublicenses
      to Licensee as contemplated under this Agreement) of the NovaDel Patents, and
      has
      all
      right, title, and interest in and to the NovaDel Patents, including exclusive,
      absolute, irrevocable right, title and interest thereto, free and clear of
      all
      liens, charges, encumbrances or other restrictions or limitations of any kind
      whatsoever and to the NovaDel’s knowledge and belief there are no licenses,
      options, restrictions, liens, rights of Third Parties, disputes, royalty
      obligations, proceedings or claims relating to, affecting, or limiting its
      rights or the rights of the Licensee under this Agreement with respect to,
      or
      which may lead to a claim of infringement or invalidity regarding, any part
      or
      all of the Licensed Technology and their use as contemplated in the underlying
      patent applications as presently drafted. The
      NovaDel Patents have not, as of the Effective Date, been held by a court of
      competent jurisdiction to be invalid or unenforceable, in whole or in
      part; 

     

    11.2.2 To
      NovaDel’s knowledge and belief there is no claim, pending or threatened, of
      infringement, interference or invalidity regarding, any part or all of the
      Licensed Technology and their use as contemplated in the underlying patent
      applications as presently drafted;

     

    11.3 Additional
      Representations, Warranties and Covenants of Licensee. Licensee
      hereby represents and warrants and,
      on
      behalf of itself and its Affiliates, agrees and covenants as
      follows:

     

    11.3.1 To
      the
      extent permitted by Applicable Law, in
      any
      country, region or jurisdiction in the Territory, Licensee, on behalf of its
      Affiliates, agrees and covenants never to institute or prosecute any claim,
      action or suit at law or in equity seeking to have any claim in a NovaDel Patent
      declared invalid or unenforceable; provided,
      however,
      that
      nothing contained herein shall prohibit Licensee and its Affiliates and
      Sublicensees from either (a) asserting any and all defenses available to it,
      including assertions relating to the validity or enforceability of the NovaDel
      Patents, in any suit or proceeding brought against them alleging the
      infringement of any of the NovaDel Patents, or (b) asserting any and all
      defenses, evidence and arguments, including lack of patentability of the subject
      matter of a count or claim and lack of support for a count or claim, in any
      interference involving a patent or patent application owned by Licensee or
      its
      Affiliates or Sublicensees and a patent or patent application included within
      the definition of the NovaDel Patents.

     

    11.3.2 Except
      as
      the Parties otherwise agree pursuant to the terms of an applicable sublicense,
      Licensee shall include covenants in its agreements with each of its Sublicensees
      materially identical to those Licensee is making in Sections 11.3.1 and 11.3.2
      on the part of the Sublicensee, and shall provide that NovaDel shall have
      march-in right to seek termination of such agreement in the event the
      Sublicensee breaches the covenant. NovaDel’s right to seek termination of such
      agreement with the Sublicensee shall be subject to notice, cure and dispute
      resolutions provisions materially identical to the provisions set forth in
      Article 9. Licensee and its Affiliates will take all reasonable action
      (including signing required documents) and offer full cooperation to allow
      NovaDel to exercise the march-in rights provided herein, to the extent permitted
      by law.

     

    
      
        
        

      

      
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    11.4 DISCLAIMER
      OF WARRANTY. EXCEPT
      FOR THE EXPRESS WARRANTIES SET FORTH IN SECTIONS 11.1, 11.2 AND 11.3, NEITHER
      NOVADEL NOR LICENSEE MAKE ANY REPRESENTATIONS AND GRANT NO WARRANTIES, EXPRESS
      OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE,
      UNDER THIS AGREEMENT, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER
      WARRANTIES, WHETHER WRITTEN
      OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY,
      MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY
      AS TO
      THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY
      RIGHTS OF THIRD PARTIES UNDER THIS AGREEMENT.

     

    11.5 LIMITATION
      OF LIABILITY. EXCEPT FOR EACH PARTY’S INDEMNIFICATION OBLIGATIONS IN RESPECT OF
      THIRD PARTY CLAIMS UNDER THIS AGREEMENT, NONE OF NOVADEL OR ANY OF ITS
      AFFILIATES OR LICENSEE OR ANY OF ITS AFFILIATES OR ANY SUBLICENSEE OR ANY OF
      ITS
      AFFILIATES SHALL BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL
      DAMAGES (INCLUDING FOR LOST PROFITS), WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE,
      TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT OF (A) THE USE OF THE LICENSED
      TECHNOLOGY OR (B) ANY BREACH OF OR FAILURE TO PERFORM ANY OF THE PROVISIONS
      OF
      THIS AGREEMENT.

     

    ARTICLE
      12

    ASSIGNMENT

     

    This
      Agreement and the rights and duties appertaining hereto may not be assigned
      by
      either Party without first obtaining the written consent of the other which
      consent shall not be unreasonably withheld. Any such purported assignment,
      without the written consent of the other Party, shall be null and of no effect.
      Notwithstanding the foregoing, Licensee may assign this Agreement (i) to a
      purchaser, merging or consolidating corporation, or acquiror of substantially
      all of Licensee’s assets or business and/or pursuant to any reorganization
      qualifying under section 368 of the Internal Revenue Code of 1986, as amended,
      and as may be in effect at such time, or (ii) to an Affiliate of Licensee
      subject to the consent of NovaDel which consent shall not be reasonably
      withheld.

    


    ARTICLE
      13

    USE
      OF NAMES AND PUBLICATION

     

    13.1 Publicity.
      No
      Party
      hereto shall originate any publicity, news release or other public announcement,
      written or oral, relating to this Agreement or the existence of a collaboration
      among the Parties, without the prior written approval of the other Parties
      except as otherwise permitted by this Agreement or required, in the reasonable
      judgment of the disclosing Party’s attorneys, by Applicable Law, including the
      Securities Act of 1933 and the Securities Exchange Act of 1934, each as amended,
      and the rules and regulations thereunder or as promulgated by an applicable
      securities exchange governing body.

     

    
      
        
        

      

      
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    13.2 Relationship
      of the Parties. Nothing
      herein shall be deemed to establish a relationship of principal and agent
      between NovaDel and Licensee, nor any of their agents or employees for any
      purpose whatsoever. This Agreement shall not be construed as creating a
      partnership between NovaDel and Licensee, or as creating any other form of
      legal
      association or arrangement which would impose liability upon one Party for
      the
      act or failure to act of the other Party.

     

    13.3 Publications.
      In
      the
      event that either Party desires to publish or disclose, by written, oral or
      other presentation, Licensed Technology or any material information related
      thereto, then such Party shall notify the other in writing of its intention
      at
      least sixty (60) days prior to any speech, lecture or other oral presentation
      and at least sixty (60) days before any written or other publication or
      disclosure, and shall include with such notice a description of any proposed
      oral presentation or, with respect to any proposed written or other disclosure,
      a current draft of such proposed disclosure or abstract. NovaDel may request
      that Licensee or its Sublicensee, no later than thirty (30) days following
      the
      receipt of such notice, delay such presentation, publication or disclosure
      in
      order to enable NovaDel to file, or have filed on its behalf or jointly, as
      applicable, a patent application, copyright or other appropriate form of
      intellectual property protection related to the information to be disclosed
      or
      request that Licensee or its Sublicensee do so. Upon receipt of such request
      to
      delay such presentation, publication or disclosure, Licensee or its Sublicensee
      shall arrange for a delay of such presentation, publication or disclosure until
      such time as Licensee or its Sublicensee or NovaDel has filed, or had filed
      on
      its behalf, such patent application, copyright or other appropriate form of
      intellectual property protection in form and in substance reasonably
      satisfactory to NovaDel. If Licensee or its Sublicensee does not receive any
      such request from NovaDel to delay such presentation, publication or disclosure,
      Licensee or its Sublicensee may submit such material for presentation,
      publication or other form of disclosure. Notwithstanding the foregoing, in
      no
      event shall Licensee or its Sublicensee have any right to publish or disclose
      the Licensed Process or any information or data related thereto without the
      prior written consent of NovaDel, which consent NovaDel may withhold in its
      sole
      discretion.

     

    ARTICLE
      14

    PAYMENTS,
      NOTICES AND OTHER COMMUNICATIONS

     

    All
      notices or other communications that are required or permitted hereunder shall
      be in writing and delivered personally, sent by telecopier (and promptly
      confirmed by personal delivery, registered or certified mail or overnight
      courier as provided herein), sent by nationally-recognized overnight courier
      or
      sent by registered or certified mail, postage prepaid, return receipt requested,
      addressed as follows:

     

    If
      to
      NovaDel to:

     

    NovaDel
      Pharma Inc.

    25
      Minneakoning Road

     

    
      
        
        

      

      
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    Flemington,
      NJ 08822

    Attention:
      President

    908.806.2445
      (fax)

     

    with
      a
      copy (not constituting notice) to:

     

    Morgan,
      Lewis & Bockius LLP

    502
      Carnegie Center

    Princeton,
      NJ 08540

    Attention:
      Randall B. Sunberg, Esq.

    Fax:
      (609) 919-6701

    


    If
      to
      Licensee to:

     

    Hana
      Biosciences, Inc.

    7000
      Shoreline Court, Suite 370

    South
      San
      Francisco, California 94080

    Attention:
      President

    Fax:
      (650) 588-2787

     

    with
      a
      copy (not constituting notice) to:

     

    Maslon
      Edelman Borman & Brand, LLP

    3300
      Wells Fargo Center

    90
      South
      Seventh Street

    Minneapolis,
      Minnesota 55402

    Attention:
      Christopher J. Melsha, Esq.

    Fax:
      (612) 642-8343

    


    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 (a) when delivered, if personally delivered
      or sent by telecopier on a business day, (b) on the business day after dispatch,
      if sent by nationally-recognized overnight courier, and (c) on the third
      business day following the date of mailing, if sent by mail. It is understood
      and agreed that this Article 14 is not intended to govern the day-to-day
      business communications necessary between the Parties in performing their
      duties, in due course, under the terms of this Agreement.

     

    ARTICLE
      15

    CONFIDENTIALITY

     

    15.1 Definition.
      “Confidential
      Information” of a Party shall mean all information and know-how and any tangible
      embodiments thereof provided by or on behalf of such Party to the other Party
      either in connection with the discussions and negotiations pertaining to, or
      in
      the course of performing, this Agreement, including the terms of this Agreement;
      the Designated Compound; data; knowledge; practices; processes; ideas; research
      plans; engineering designs and drawings; research data; manufacturing processes
      and techniques; scientific, manufacturing, marketing and business plans; and
      financial and personnel matters relating to the disclosing Party or to its
      present or future products, sales, suppliers, customers, employees, investors
      or
      business. For purposes of this Agreement, notwithstanding the Party that
      disclosed such information or know-how, all NovaDel Know-How and all Information
      and Inventions with respect to the Licensed Process shall be Confidential
      Information of NovaDel. 

     

    
      
        
        

      

      
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    15.2 Exclusions.
      Notwithstanding
      the foregoing, information or know-how of a Party shall not be deemed
      Confidential Information with respect to a receiving Party for purposes of
      this
      Agreement if such receiving Party can affirmatively demonstrate through the
      production of written documentation that such information or
      know-how:

     

    15.2.1 was
      already known to the receiving Party or its Affiliates, other than under an
      obligation of confidentiality or non-use, at the time of disclosure to such
      receiving Party;

     

    15.2.2 was
      generally available or known to parties reasonably skilled in the field to
      which
      such information or know-how pertains, or was otherwise part of the public
      domain, at the time of its disclosure to such receiving Party;

     

    15.2.3 became
      generally available or known to parties reasonably skilled in the field to
      which
      such information or know-how pertains, or otherwise became part of the public
      domain, after its disclosure to such receiving Party through no fault of a
      Party
      other than the Party that Controls such information and know-how;

     

    15.2.4 was
      disclosed to such receiving Party or its Affiliates, other than under an
      obligation of confidentiality or non-use, by a Third Party who had no obligation
      to the Party that Controls such information and know-how not to disclose such
      information or know-how to others; or

     

    15.2.5 was
      independently discovered or developed by such receiving Party or its Affiliates,
      as evidenced by their written records, without the use of Confidential
      Information belonging to the Party that Controls such information and know-how,
      except with respect to the NovaDel Know-How with respect to the Licensed
      Process, which shall be and remain Confidential Information of NovaDel.

     

    Specific
      aspects or details of Confidential Information shall not be deemed to be within
      the public domain or in the possession of a Party merely because the
      Confidential Information is embraced by more general information in the public
      domain or in the possession of such Party. Further, any combination of
      Confidential Information shall not be considered in the public domain or in
      the
      possession of a Party merely because individual elements of such Confidential
      Information are in the public domain or in the possession of such Party unless
      the combination and its principles are in the public domain or in the possession
      of such Party.

    


    15.3 Disclosure
      and Use Restriction. 
      Except
      as expressly provided herein, the Parties agree that during the Term of this
      Agreement, and for five (5) years thereafter, each Party and its Affiliates
      and sublicensees shall keep completely
      confidential and shall not publish or otherwise disclose and shall not use
      for
      any purpose except for the purposes contemplated by this Agreement any
      Confidential Information of the other Party, its Affiliates or
      Sublicensees.

     

    
      
        
        

      

      
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    15.4 Authorized
      Disclosure.
      Each
      Party may disclose Confidential Information of the other Party to the extent
      that such disclosure is:

     

    15.4.1 Required
      by Governmental Order.
      Made in
      response to a valid order of a court of competent jurisdiction or other
      supra-national, federal, national, regional, state, provincial or local
      governmental or regulatory body of competent jurisdiction; provided, however,
      that such Party shall first have given notice to such other Party and given
      such
      other Party a reasonable opportunity to quash such order and to obtain a
      protective order requiring that the Confidential Information and documents
      that
      are the subject of such order be held in confidence by such court or agency
      or,
      if disclosed, be used only for the purposes for which the order was issued;
      and
      provided further that if a disclosure order is not quashed or a protective
      order
      is not obtained, the Confidential Information disclosed in response to such
      court or governmental order shall be limited to that information which is
      legally required to be disclosed in response to such court or governmental
      order;

     

    15.4.2 Required
      by Law. Otherwise
      required by law; provided,
      however,
      that
      the disclosing Party shall (a) provide the other Party with reasonable advance
      notice of and an opportunity to comment on any such required disclosure, (b)
      if
      requested by such other Party, seek confidential treatment with respect to
      any
      such disclosure to the extent available, and (c) use good faith efforts to
      incorporate the comments of such other Party in any such disclosure or request
      for confidential treatment;

     

    15.4.3 Required
      by Regulatory Authority.
      Made by
      such Party to the Regulatory Authorities as required in connection with any
      filing, application or request for Regulatory Approval; provided, however,
      that
      reasonable measures shall be taken to assure confidential treatment of such
      information;
      or

     

    15.4.4 Required
      by Agreement.
      Made by
      such Party, in connection with the performance of this Agreement, to Affiliates,
      Sublicensees, research parties, employees, consultants, representatives or
      agents, each of whom prior to disclosure must be bound by obligations of
      confidentiality and non-use at least equivalent in scope to those set forth
      in
      this Article 15.

     

    15.5 Press
      Releases.
      Press
      releases or other similar public communication by either Party relating to
      this
      Agreement, shall be approved in advance by the other Party, which approval
      shall
      not be unreasonably withheld or delayed, except for those communications
      required by Applicable Law (which shall be provided to the other Party as soon
      as practicable after the release or communication thereof), disclosures of
      information for which consent has previously been obtained, and information
      of a
      similar nature to that which has been previously disclosed publicly with respect
      to this Agreement, each of which shall not require advance
      approval.

     

    ARTICLE
      16

    MISCELLANEOUS
      PROVISIONS

     

    16.1 Governing
      Law. This
      Agreement shall be governed by and construed in accordance with the laws of
      the
      State of New Jersey, excluding any conflicts or choice of law rule or principle
      that might otherwise refer construction or interpretation of this Agreement
      to
      the substantive law of another jurisdiction. 

     

    
      
        
        

      

      
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    16.2 Registration.
      If
      this
      Agreement or any associated transaction is required by the law of any nation
      to
      be either approved or registered with any governmental agency, Licensee or
      its
      Sublicensee, as applicable, shall assume all legal obligations to do so and
      the
      costs in connection therewith.

     

    16.3 Trade
      Regulations. Licensee
      or its Sublicensee and its Affiliates shall observe all applicable United States
      and foreign laws with respect to the transfer of Licensed Product and related
      technical data to foreign countries, including the International Traffic in
      Arms
      Regulations (ITAR) and the Export Administration Regulations.

     

    16.4 Entire
      Agreement. The
      Parties hereto acknowledge that this Agreement, including the Appendices and
      documents incorporated by reference, sets forth the entire agreement and
      understanding of the Parties hereto as to the subject matter hereof, and shall
      not be subject to any change of modification except by the execution of a
      written instrument subscribed to by the Parties hereto. This Agreement shall
      supersede all previous communications, representations or understandings, either
      oral or written, between the Parties relating to the subject matter hereof,
      including the Initial Agreement.

     

    16.5 Severability.
      If
      any
      provision of this Agreement is held to be illegal, invalid or unenforceable
      under any present or future law, and if the rights or obligations of either
      Party under this Agreement will not be materially and adversely affected
      thereby, (a) such provision shall be fully severable, (b) this Agreement shall
      be construed and enforced as if such illegal, invalid or unenforceable provision
      had never comprised a part hereof, (c) the remaining provisions of this
      Agreement shall remain in full force and effect and shall not be affected by
      the
      illegal, invalid or unenforceable provision or by its severance herefrom, and
      (d) in lieu of such illegal, invalid or unenforceable provision, there shall
      be
      added automatically as a part of this Agreement a legal, valid and enforceable
      provision as similar in terms to such illegal, invalid or unenforceable
      provision as may be possible and reasonably acceptable to the Parties herein.
      To
      the
      fullest extent permitted by Applicable Law, each Party hereby waives any
      provision of law that would render any provision prohibited or unenforceable
      in
      any respect.

     

    16.6 Waiver.
      The
      waiver by a Party of a breach or a default of any provision of this Agreement
      by
      the other Party shall not be construed as a waiver of any succeeding breach
      of
      the same or any other provision, nor shall any delay or omission on the part
      of
      a Party to exercise or avail itself of any right, power or privilege that it
      has
      or may have hereunder operate as a waiver of any right, power or privilege
      by
      such Party.

     

    16.7 Equitable
      Relief. Each
      Party acknowledges and agrees that the restrictions set forth in Articles 6
      and
      16 of this Agreement are reasonable and necessary to protect the legitimate
      interests of the other Party and that such other Party would not have entered
      into this Agreement in the absence of such restrictions, and that any violation
      or threatened violation of any provision of Article 6 and 16 may result in
      irreparable injury to such other Party. Each Party also acknowledges and agrees
      that in the event of a violation or threatened violation of any provision of
      Article 6 and 16, the other Party shall be entitled to seek preliminary and
      permanent injunctive relief, without the necessity of having to post a bond,
      as
      well as to an equitable accounting of all earnings, profits and other benefits
      arising from any such violation. The rights provided in the immediately
      preceding sentence shall be cumulative and in addition to any other rights
      or
      remedies that may be available to such other Party. Nothing in this Section
      16.7
      is intended, or should be construed, to limit such other Party’s right to
      preliminary and permanent injunctive relief or any other remedy for breach
      of
      any other provision of this Agreement.

     

    
      
        
        

      

      
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    16.8 Force
      Majeure. In
      the
      event that a Party fails to perform any of its obligations under this Agreement
      (other than an obligation to pay money) due to any act of God, fire, casualty,
      flood, war, strike, lockout, failure of public utilities, injunction, act of
      a
      governmental authority (including enactment of any governmental law, order
      or
      regulation permanently or temporarily prohibiting or reducing the level of
      research, development or production work hereunder or the manufacture, use
      or
      sale of the Licensed Product), epidemic, destruction of production facilities,
      riot, insurrection, inability to procure or use materials, labor, equipment,
      transportation or energy in quantities sufficient to meet experimentation or
      manufacturing needs, or any other cause beyond the reasonable control of the
      Party invoking this Section 16.8, provided, in each case, that such Party shall
      have used Commercially Reasonable Efforts to avoid such failure, then such
      Party
      shall promptly give written notice of such occurrence to the other Party, and
      thereupon the affected Party’s performance shall be excused and the time for
      performance shall be extended for the period of delay or inability to perform
      due to such occurrence.

     

    16.9 Construction.
      Except
      where the context otherwise requires, wherever used, the singular shall include
      the plural, the plural the singular, the use of any gender shall be applicable
      to all genders and the word “or” is used in the inclusive sense (and/or). The
      captions of this Agreement are for convenience of reference only and in no
      way
      define, describe, extend or limit the scope or intent of this Agreement or
      the
      intent of any provision contained in this Agreement. The term “including” as
      used herein shall mean including, without limiting the generality of any
      description preceding such term. The language of this Agreement shall be deemed
      to be the language mutually chosen by the Parties and no rule of strict
      construction shall be applied against either Party hereto.

     

    16.10 Further
      Assurance.
      Each
      Party shall duly execute and deliver, or cause to be duly executed and
      delivered, such further instruments and do and cause to be done such further
      acts and things, including the filing of such assignments, agreements, documents
      and instruments, as may be necessary or as the other Party may reasonably
      request in connection with this Agreement or to carry out more effectively
      the
      provisions and purposes, or to better assure and confirm unto such other Party
      its rights and remedies under this Agreement.

     

    16.11 Expenses.
      Each of
      Licensee and NovaDel shall be responsible for their own expenses relating to
      the
      negotiation, execution and performance of this Agreement.

     

    16.12 Export
      Controls.
      Each
      Party acknowledges that it is subject to United States laws and regulations
      controlling the export of technical data, computer software, laboratory
      prototypes and other commodities (including the Arms Export Control Act, as
      amended and the United States Department of Commerce Export Administrations
      Regulations). The transfer of such items may require a license from the
      cognizant agency of the United States Government and/or written assurances
      by
      NovaDel or Licensee or any Sublicensee and its Affiliates that it shall not
      export data or commodities to certain foreign countries without prior approval
      of such agency. No Party makes any representation as to whether any such license
      will be required or, if required, whether it will be issued.

     

    
      
        
        

      

      
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    16.13 Counterparts.
      This
      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.

     

    16.14 Binding.
      This
      Agreement shall not be binding upon the Parties until it has been signed below
      on behalf of each Party.

     

    [Signature
      Page Follows]

     

    
      
        
        

      

      
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    IN
      WITNESS WHEREOF,
      the duly
      authorized officers of the Parties have executed this Agreement as of the dates
      set forth below their respective signatures.

     

    
      
        	NOVADEL
                PHARMA INC.	 	HANA
                BIOSCIENCES, INC.
	 	 	 	 	 
	
                By:
                  

              	 /s/
                Steven Ratoff	 	
                By:
                  

              	 /s/
                Mark J. Ahn


      

       

      
        	
                Name:
                  

              	 Steven
                Ratoff	 	
                Name:
                  

              	 Mark
                J. Ahn
	 	 	 	 	 
	
                Title:
                  

              	 Chairman,
                President and CEO	 	
                Title:
                  

              	 President
                & CEO


      

       

      
        	
                Date:
                  

              	 July
                31, 2007	 	
                Date:
                  

              	 July
                31, 2007


      

    

    
       

    

    
      
        
        

      

      
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    EXHIBIT
      A


     

    PATENTS

     

    1. United
      States Patent No. 6,676,931 B2

     

    
      
        
        

      

      
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    EXHIBIT
      B

     

    Royalty
      Rate Structure

    

      
        	
                Net
                  Sales (U.S. Sales and Canadian Sales Converted to U.S.
                  Dollars)

              	
              	
                Royalty
                  Rate

              
	 	 	 
	
                $[***]
                  to $[***]

              	 	
                [***]%

              
	 	 	 
	
                Plus
                  

              	 	 
	 	 	 
	
                $[***]
                  to
                  $[***]

              	 	
                [***]%

              
	 	 	 
	
                Plus

              	 	 
	 	 	 
	
                $[***]
                  and
                  above

              	 	
                [***]%

              


      

    

     

    
      
        
        

      

      
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