Unassociated Document


    Exhibit
      10.1

    


    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.

    
      


    

    PRODUCT
      DEVELOPMENT AND

    COMMERCIALIZATION
      SUBLICENSE AGREEMENT

     

    This
      Development and Commercialization Sublicense Agreement (this “Agreement”)
      is
      made and entered into this 31st day of July, 2007 (the “Effective
      Date”),
      by
      and among HANA Biosciences, Inc., a Delaware corporation (“HANA”),
      PAR
      Pharmaceutical, Inc., a Delaware corporation (“PAR”),
      and
      NovaDel Pharma, Inc., a Delaware corporation (“NovaDel”).

     

    WHEREAS,
      HANA has exclusive, restricted sublicensable rights under a license from NovaDel
      , the owner of certain patents, intellectual property and know-how relating
      to
      lingual sprays for the metered delivery of pharmaceutical products to
      humans;

     

    WHEREAS,
      HANA has commenced the development of a pharmaceutical product containing
      ondansetron as an active ingredient that will be administered to humans using
      the Licensed Technology (as defined below) on terms and conditions set forth
      herein;

     

    WHEREAS,
      HANA
      desires to sublicense to PAR the Licensed Technology, and PAR desires to accept
      such sublicense on the terms and conditions set forth herein; and

     

    WHEREAS, simultaneously
      with the execution of this Agreement, the Parties are entering into that certain
      Subscription Agreement that provides, on the terms and subject to the conditions
      set forth therein, for a purchase by PAR of the common stock of HANA in an
      amount up to $5,000,000.

     

    NOW,
      THEREFORE, in consideration of the mutual covenants and promises contained
      in
      this Agreement and other good and valuable consideration, the receipt and
      sufficiency of which are hereby acknowledged, HANA, PAR and NovaDel agree as
      follows:

     

    ARTICLE
      1

    DEFINITIONS

     

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

     

    1.1 AAA has
      the
      meaning set forth in Section 15.2.1.

     

    1.2 Affiliate shall
      mean, with respect to any Person, any other Person that directly or indirectly
      through one or more intermediaries, controls, is controlled by or is under
      common control with such Person. For purposes of this Section 1.1 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 Person, 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 a Person

     


    
      
        
        

      

      
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    1.3 Agreement has
      the
      meaning set forth in the preamble.

     

    1.4 Agreement
      Related Assets has
      the
      meaning set forth in Section 11.3.2.

     

    1.5 Anticipated
      Filing Date has
      the
      meaning set forth in Section 4.2.2.

     

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

     

    1.7 CGMP means
      the
      regulatory requirements for current good manufacturing practices promulgated
      by
      the FDA under the U.S. Food, Drug and Cosmetic Act and the regulations
      promulgated thereunder, particularly 21 C.F.R. Section 210 et seq., and 21
      C.F.R. Sections 600-610, as the same may be amended from time to
      time.

     

    1.8 Commercialization means
      the
      marketing, promotion, advertising, selling and/or distribution of the Licensed
      Product in the Territory after Regulatory Approval therefor has been obtained;
      and the term “Commercialize”
has
      a
      corresponding meaning.

     

    1.9 Commercially
      Reasonable Efforts shall
      mean, with respect to the development or commercialization of the 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 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.

     

    1.11 Confidential
      Information has
      the
      meaning set forth in Section 9.1.

     

    1.12 Control shall
      mean, with respect to any item of Information and Inventions, Patent Rights
      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 Development
      Committee has
      the
      meaning set forth in Section 4.1.2.

     

    1.14 Designated
      Compound
      means
      ondansetron.

     

    1.15 Development
      Plan
      has the
      meaning set forth in Section 4.1.1.


    
      
        
        

      

      
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    1.16 Effective
      Date
      has the
      meaning set forth in the preamble.

     

    1.17 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.

     

    1.18 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.

     

    1.19 FDA
      means
      The Food and Drug Administration of the United States Department of Health
      and
      Human Services, or any successor agency(ies) thereof performing similar
      functions.

     

    1.20 GAAP
      shall
      have the meaning set forth in Section 6.8.

     

    1.21 HANA has
      the
      meaning set forth in the preamble.

     

    1.22 HANA
      Indemnified Parties
      has
      meaning set forth in Section 12.1.

     

    1.23 HANA
      Know-How
      shall
      mean all Information and Inventions Controlled by HANA or an Affiliate of HANA
      at any time during the Term that (a) are necessary for the use of the Licensed
      Process to Exploit the Licensed Product, and (b) are not generally
      known.

     

    1.24 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. 

     

    1.25 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.

     

    1.26 Indemnification
      Claim Notice
      shall
      have the meaning set forth in Section 12.4.1.

     

    1.27 Indemnified
      Party
      has
      meaning set forth in Section 12.4.1.


    
      
        
        

      

      
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    1.28 Information
      And Invention
      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.

     

    1.29 Infringement
      Suit
      has
      meaning set forth in Section 10.3.

     

    1.30 Initial
      Commercial Sale
      means
      the first sale for use or consumption by the general public of the Licensed
      Product by PAR or its Affiliates 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 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 of the NovaDel-Hana License and any Improvements thereto that are conceived
      and reduced to practice by NovaDel in the course of performing its obligations
      under the NovaDel-Hana License.

     

    1.32 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 active ingredient,
      the Designated Compound delivered by means of the Licensed Process.

     

    1.33 Licensed
      Technology
      shall
      mean the NovaDel Patent Rights, the NovaDel Know-How and Improvements thereof,
      and the Drug Master File, collectively, but only with respect to the
      Exploitation of the Licensed Product.

     

    1.34 Licensed
      Trademark
      shall
      mean “ZENSANA” owned by HANA as evidenced by U.S. Trademark Application Serial
      No. 78,710,181.

     

    1.35 Lock-Up
      Period
      has
      meaning set forth in Section 6.1.

     

    1.36 Losses
      has the
      meaning set forth in Section 12.1.

     

    1.37 NDA
      means a
      New Drug Application as defined in the United States Federal Food, Drug and
      Cosmetic Act and applicable regulations promulgated thereunder as amended from
      time to time 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.


    
      
        
        

      

      
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    1.38 Net
      Sales
      means
      [***] 

     

    1.39 NovaDel has
      the
      meaning set forth in the preamble.

     

    1.40 NovaDel-Hana
      License
      means
      that certain License and Development Agreement originally dated October 26,
      2004, by and between NovaDel and HANA, as amended and restated effective as
      of
      July 31, 2007.


    
      
        
        

      

      
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    1.41 NovaDel
      Indemnified Parties
      has
      meaning set forth in Section 12.1.

     

    1.42 NovaDel
      Know-How
      shall
      mean all Information and Inventions Controlled by NovaDel or an Affiliate of
      NovaDel as of the effective date of the NovaDel-Hana License 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 License Process,
      and (b) are not generally known, but excluding any Information and Inventions
      to
      the extent claimed by any NovaDel Patents.

     

    1.43 NovaDel
      Patents
      shall
      mean the Patent Rights that NovaDel Controls (a) as of the effective date of
      the
      NovaDel-Hana License that are listed on Exhibit A hereto and (b) from time
      to
      time during the Term that claim (i) the Licensed Process, (ii) the Licensed
      Product, (iii) NovaDel Know-How, or (iv) any Improvements that are conceived
      and/or reduced to practice in the course of Exploiting the Licensed Product
      or
      License Process.

     

    1.44 Par has
      the
      meaning set forth in the preamble.

     

    1.45 PAR
      Indemnified Parties
      has
      meaning set forth in Section 12.2. 

     

    1.46 Party
      or Parties
      means
      HANA, NovaDel and/or PAR, as applicable.

     

    1.47 Patent
      Rights
      means
      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.

     

    1.48 Person
      means an
      individual, partnership, joint venture, association, corporation, limited
      liability company and any other form of business organization, government,
      regulatory or governmental agency, commission, department or
      instrumentality.

     

    1.49 Product
      Liability Claim
      means a
      Third Party’s assertion of a strict liability claim of actual personal injury or
      death as a result of the use of the Licensed Product during the
      Term.

     

    1.50 Product
      Trademarks
      has
      meaning set forth in Section 5.4.


    
      
        
        

      

      
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    1.51 Regulatory
      Approval
      means
      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.

     

    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 the
      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 Subscription
      Agreement
      has the
      meaning set forth in Section 6.1.

     

    1.55 Term
      has the
      meaning set forth in Section 11.1.

     

    1.56 Territory
      means
      the United States of America and Canada.

     

    1.57 Third
      Party
      means
      any Person other than PAR, NovaDel, HANA and their respective
      Affiliates.

     

    1.58 Third
      Party Claim
      shall
      have the meaning set forth in Section 12.5.2.

     

    1.59 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.

     

    1.60 Valid
      Claim
      shall
      mean, with respect to a particular country, a claim of a Patent Right 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

    SCOPE
      OF THE COLLABORATION

     

    2.1 Objectives.
      The
      Parties agree, pursuant and subject to the terms of this Agreement, that HANA
      intends to assign to PAR, and PAR intends to assume, all of HANA’s rights and
      obligations to develop and obtain Regulatory Approval for the Licensed Product
      in the Territory and to commercialize the Licensed Product in the
      Territory.

     

    
      
        
        

      

      
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    2.2 Diligence
      Obligations.
      PAR
      shall use Commercially Reasonable Efforts in accordance with the terms and
      conditions of this Agreement, including the Development Plan, to (a) develop
      and
      commercialize the Licensed Product in the entire Territory; (b) file the NDA
      with the FDA in PAR’s name and obtain Regulatory Approval(s) with respect to the
      Licensed Product in the Territory; and (c) Exploit the Licensed Product in
      the
      Territory.

     

    2.3 Outsourcing
      of MARQIBO Development.
      HANA
      holds the exclusive license and patent rights for the commercialization of
      Sphingosomal Vincristine sulfate liposome for the therapeutic treatment of
      patients with leukemia, lymphoma and solid tumors currently being developed
      under the trade name “MARQIBO.” In the event that HANA in its sole discretion,
      elects to grant a Third Party a right to manufacture and sell such product,
      HANA
      will inform PAR and, if PAR so requests, HANA will allow PAR to submit a
      proposal for HANA’s consideration prior to entering into negotiations with any
      other Third Party to manufacture and sell the product. 

     

    2.4 Co-Promotion
      of ZENSANA.
      Within
      ninety (90) days following PAR’s submission of an NDA for the Licensed Product,
      HANA may submit a proposal for PAR’s consideration with respect to the Parties’
joint promotion and commercialization of such Licensed Product; provided,
      however,
      that
      any determination whether to jointly promote and commercialize the Licensed
      Product with HANA will be in PAR’s sole discretion and if PAR determines to
      jointly promote with HANA, then PAR and HANA will negotiate in good faith an
      agreement that provides for the rights and obligations in respect
      thereof.

     

    ARTICLE
      3

    GRANT
      OF RIGHTS

     

    3.1 License
      Grant.
      Subject
      to Section 3.3 and the other terms and conditions of this Agreement, HANA hereby
      grants to PAR and its Affiliates and PAR accepts:

     

    3.1.1 A
      non-transferable (except as provided in Section 11.3.2), nonsublicenseable
      (except as set forth in this Section 3.1 and Section 3.2), royalty-bearing,
      exclusive sublicense 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;
      provided, however, that PAR shall have the right to (i) utilize Third Parties
      to
      manufacture the Licensed Product in the Territory, and (ii) use, have used,
      manufacture or have manufactured the Licensed Product outside of the Territory
      solely for purposes of the distribution and sale of the Licensed Product inside
      the Territory. PAR shall be entitled to use a Third Party contract sales
      organization to market the Licensed Product in the Territory; provided, that
      the
      employees of such Third Party contract sales organization that are utilized
      to
      market the Licensed Product are trained and managed by PAR and carry only PAR’s
      products.


    
      
        
        

      

      
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    3.1.2 In
      the
      event that PAR elects to use the Licensed Trademark in connection with the
      Exploitation of the Licensed Product in the Territory pursuant to Section
0,
      then a
      non-transferable (except as provided in Article 12), nonsublicenseable,
      royalty-bearing, non-exclusive right and license under the Licensed Trademark
      will be granted for the sole purpose of using the Licensed Trademark to market,
      distribute and sell the Licensed Product in the Territory, to the full end
      of
      the Term for which the Licensed Product is licensed, unless sooner terminated
      as
      herein after provided.

     

    3.1.3 PAR
      shall
      not sell, distribute or transfer the Licensed Product to any Person that, to
      PAR’s knowledge or should reasonably know, is using or intends to use the
      Licensed Product outside of the Territory or is selling or transferring, or
      intends to sell or transfer, the Licensed Product to a Person who is using
      or
      intends to use such Licensed Product outside of the Territory.

     

    3.1.4 PAR
      agrees that during the Term it will use the Licensed Technology only as
      explicitly provided and in accordance with the term and conditions of this
      Agreement. PAR expressly acknowledges and agrees that the only licenses granted
      under this Agreement are the licenses expressly granted under this Agreement
      and
      that there shall be no implied license or license by estoppel.

     

    3.2 License
      Grant to NovaDel.
      In the
      event that NovaDel and PAR agree pursuant to Section 0
      that
      NovaDel is to perform certain development activities under the Development
      Plan,
      PAR hereby grants to NovaDel a limited, royalty-free, co-exclusive right and
      license in the Territory in and to the Licensed Technology to the extent
      necessary to perform such development activities.

     

    3.3 Retained
      Rights.
      PAR
      acknowledges that NovaDel retains all right, title and interest, including
      the
      right to grant licenses to Third Parties, in and to the Licensed Technology.
      PAR
      shall have no rights, express or implied, with respect to the Licensed
      Technology except as expressly set forth in Section 3.1, and PAR covenants
      to
      HANA and NovaDel that none of PAR or its Affiliates 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, PAR acknowledges that NovaDel retains, without any duty of accounting
      or otherwise to PAR:

     

    3.3.1 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 

     

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

     

    3.3.3 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

     

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


    
      
        
        

      

      
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    3.4 Additional
      Covenants and Agreements.
      

     

    3.4.1 HANA
      covenants and agrees that, from and after the Effective Date until the
      termination of this Agreement, neither it nor any of its Affiliates shall seek
      to develop (directly or indirectly) any lingual spray technology for the
      delivery of anti-emetic pharmaceutical compounds.

     

    3.4.2 Promptly
      after the Effective Date, each of NovaDel and HANA shall at its cost and
      expense, use good faith reasonable efforts to disclose to PAR in writing, or
      via
      mutually acceptable electronic media, copies or reproductions of all HANA
      Know-How and NovaDel Know-How, not previously disclosed to PAR, reasonably
      necessary in order to enable PAR to exploit its rights granted under this
      Article 3. In addition, during the Term, each of HANA and NovaDel shall promptly
      disclose to PAR in writing, or via mutually acceptable electronic media, on
      an
      ongoing basis, copies or reproductions of all new HANA Know-How and NovaDel
      Know-How that is reasonably necessary to market, sell or have sold the Licensed
      Product. Such HANA Know-How and NovaDel Know-How and other information shall
      be
      automatically deemed to be within the scope of the licenses granted herein
      without payment of any additional compensation.

     

    3.5 Manufacturing.
      

     

    3.5.1 Subject
      to the other provisions of this Section 3.5.1, PAR 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
      PAR may contract with a Third Party to perform such manufacturing services.
      PAR
      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; provided, however, that PAR shall have the ultimate
      decision making authority in the event of any dispute between NovaDel and PAR
      relating to the terms of any such manufacturing agreement (or the choice of
      such
      Third Party manufacturer). NovaDel and its Extraterritorial Licensees (as
      defined in the NovaDel-Hana License) retain the right to purchase product from
      said Third Party, if applicable, at the same costs as PAR with the exception
      of
      an increase of cost due to a modification to the packaging/labeling by NovaDel
      or any Extraterritorial Licensee. 

     

    3.5.2 PAR
      agrees that, at all times during the performance of the development activities,
      it, or its designee, will act in accordance with all Applicable
      Laws.

     

    3.5.3 To
      the
      extent PAR 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 9 of this Agreement.

        

    3.5.4 PAR
      shall
      not object to permitting any Third Party manufacturer from selling NovaDel
      and
      its Extraterritorial Licensees Licensed Product under Section 3.5.1 in the
      identical packaging and labeling as PAR 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 PAR.


    
      
        
        

      

      
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    3.5.5 PAR
      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 PAR for obtaining such licenses or permissions within thirty (30)
      days of an Extraterritorial Licensee’s receipt of an invoice from PAR itemizing
      such expenses

     

    3.5.6 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 PAR 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
      PAR; provided, however, that in no event shall the scope of the indemnification
      to PAR be any less than the scope of the Extraterritorial Licensee’s
      indemnification obligations to NovaDel. 

     

    ARTICLE
      4

    DEVELOPMENT
      PROGRAM

     

    4.1 Development
      Plan; Responsibility and Control.
      

     

    4.1.1 Within
      sixty (60) days after the Effective Date, PAR will adopt a development plan,
      and
      provide such development plan to NovaDel, describing its strategy and principal
      activities in seeking Regulatory Approval for the Licensed Product and
      commercializing the Licensed Product in accordance with the terms of this
      Agreement (the “Development
      Plan”),
      which
      may be amended by PAR in its commercially reasonable discretion. PAR will use
      its Commercially Reasonable Efforts to execute the Development Plan. Subject
      to
      the Development Plan and the other terms and conditions contained in this
      Agreement, PAR shall have control over and responsibility for executing all
      aspects of the Development Plan, including planning, strategy, administrative
      management, and fiscal control; provided, however, that PAR shall include the
      Development Committee in such efforts in a consultative capacity. In the event
      that PAR desires, PAR may request NovaDel to conduct certain development
      activities, and, if NovaDel agrees, NovaDel and PAR shall negotiate in good
      faith the scope of such development activities to be undertaken by NovaDel,
      appropriate amendments to the Development Plan and the amounts to be paid to
      NovaDel for the provision of such development activities; provided that it
      is
      understood that PAR shall not be entitled to amend the Development Plan to
      include the performance of any activities by NovaDel without the prior written
      consent of NovaDel.

     


    
      
        
        

      

      
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    4.1.2 PAR
      and NovaDel
      shall establish a development committee (the “Development
      Committee”),
      which
      shall confer at least on an annual basis to coordinate PAR’s and NovaDel’s
      performance of their respective responsibilities under this Agreement. PAR
      and NovaDel
      each shall appoint an equal number of representatives with the requisite
      experience and seniority to enable them to make decisions on behalf of the
      Parties. From time to time, PAR and NovaDel
      each may substitute its representatives on written notice to the
      other.
      The
      Development Committee shall not have the power to amend or modify the
      Development Plan, which may only be amended or modified as provided in Section
      4.1.1.

     

    4.1.3 By
      no
      later than November 1 of each calendar year during the Term, PAR shall prepare
      and deliver to NovaDel an updated Development Plan for the following calendar
      year. NovaDel shall have the right to comment on the Development Plan (including
      the initial Development Plan delivered pursuant to Section 4.1.1), and PAR
      shall
      consider such comments in good faith; provided that nothing contained herein
      is
      intended to limit PAR’s sole discretion with respect to the development of the
      Licensed Product in the Territory.

     

    4.2 Clinical
      and Regulatory Approval.

     

    4.2.1 Subject
      to the terms of the Development Plan, in the Territory, PAR shall (a) use its
      Commercially Reasonable Efforts to conduct required clinical trials of the
      Licensed Product and obtain Regulatory Approval, and (b) be responsible for
      all
      activities related to the toxicology, formulation, process development, quality
      assurance/quality control, and regulatory affairs for the Licensed Product
      and
      (c) include HANA and NovaDel in such efforts in a consultative capacity;
      provided, however, that, as and to the extent requested by PAR and agreed to
      by
      NovaDel pursuant to Section 4.1.1, NovaDel may collaborate with PAR in executing
      the Development Plan; provided further, however, for purposes of clarity,
      neither HANA nor NovaDel shall have the right to direct or control PAR’s conduct
      of such activities.

     

    4.2.2 Subject
      to the terms of the Development Plan, PAR shall use its Commercially Reasonable
      Efforts to prepare any required application(s) for Regulatory Approval,
      including the filing of the NDA with the FDA in PAR’s name, and shall have
      responsibility for: (a) all clinical data and reports related to Licensed
      Product studies, including clinical trials for the Licensed Product; and (b)
      all
      NDAs and other Regulatory Approvals for the Licensed Product in the Territory.
      PAR shall inform HANA and NovaDel of all communications with the FDA, and shall
      provide copies of all FDA submissions and other written communication with
      the
      FDA as soon as reasonably practicable. The Parties shall cooperate in good
      faith
      with respect to all such submissions and meetings with the FDA relating to
      regulatory approval of the Licensed Product. In addition, and without limiting
      PAR’s obligations under Section 0
      or this
      Section 0,
      PAR
      shall file the NDA with the FDA on or before the last day of the thirty-second
      (32nd) month after the Effective Date (the “Anticipated
      Filing Date”);
      provided, however, that PAR may extend the Anticipated Filing Date by four
      (4)
      months by delivering, at any time after the second (2nd) anniversary of the
      Effective Date, written notice of such extension to NovaDel. The Anticipated
      Filing Date, as extended, may thereafter be extended only upon the mutual
      agreement of PAR and NovaDel.

     


    
      
        
        

      

      
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    4.2.3 PAR
      shall, and shall cause its Affiliates to, promptly disclose to NovaDel all
      Regulatory Documentation and all other Information and Inventions in the
      possession or Control of PAR or its Affiliates that relate to the Exploitation
      of the Licensed Product. NovaDel and NovaDel’s Extraterritorial Licensees shall
      have a perpetual, royalty-free, irrevocable, worldwide right to use and
      reference the Regulatory Documentation and any data included or referenced
      therein for all purposes. PAR 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 Licensees outside of the
      Territory.

     

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

     

    4.2.5 PAR
      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 9.

     

    4.3 Development
      Program Reporting.
      PAR
      shall provide HANA and NovaDel at least quarterly with updates regarding the
      progress of the Development Program and Regulatory Approval process, including
      all planned and ongoing clinical trials for the Licensed Product, planned and
      ongoing formulation and stability studies, interaction with Regulatory
      Authorities, planned and ongoing promotional advertising and other marketing
      efforts, rolling forecasts of projected sales of each Licensed Product for
      the
      upcoming twelve (12) months, and also shall advise HANA and NovaDel of any
      unforeseen material problems or delays encountered since the date of its last
      such report and any other information reasonably requested by HANA or NovaDel
      with respect to the development activities related to the Licensed Product
      undertaken by PAR in such calendar quarter.

     

    4.4 Development
      Costs.
      PAR
      shall be solely responsible for all costs and expenses incurred by it after
      the
      Effective Date relating to the development of the Licensed Products for
      Exploitation in the Territory, including costs and expenses, if any, incurred
      by
      NovaDel at in accordance with Section 4.1.1.

     

    4.5 Regulatory
      Records.
      PAR
      shall
      maintain records of its 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 development activities, and which
      shall be retained by PAR for at least five (5) years after the termination
      of
      this Agreement, or for such longer period as may be required by Applicable
      Law.
      NovaDel shall have the right, during normal business hours and upon reasonable
      notice, to inspect and copy any such records; provided,
      however, that NovaDel shall not have the right to conduct more than one such
      inspection in any twelve (12)-month period.


    
      
        
        

      

      
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    ARTICLE
      5

    COMMERCIALIZATION
      OBLIGATIONS

     

    5.1 Regulatory
      Compliance.
      All
      Commercialization activities in respect of the Licensed Product in the Territory
      shall be conducted by PAR in compliance with Applicable Laws and the Regulatory
      Approval in the country of sale.

     

    5.2 Labeling
      and Patent Marking.
      The
      Licensed Product shall be packaged by PAR and labeled in a manner consistent
      with the requirements of the Regulatory Authorities and all Applicable Laws
      in
      the country in which it will be sold, and where legally permissible, shall
      identify any applicable Patent Rights consistent with any patent marking
      requirements.

     

    5.3 Commercialization
      Efforts.
      Following receipt of Regulatory Approval of the Licensed Product by the FDA,
      PAR
      shall use Commercially Reasonable Efforts to Exploit the Licensed Product in
      the
      United States. PAR shall have the right to Exploit the Licensed Product in
      Canada; provided, however, that if PAR does not use Commercially Reasonable
      Efforts to Commercialize the Licensed Product in Canada within one hundred
      eighty (180) days following Regulatory Approval by Health Canada, then HANA
      may
      Commercialize the Licensed Product in Canada, provided further, that, in such
      case, PAR shall be entitled to a royalty of [***]
      percent
      ([***]%)
      of the
      Net Sales in Canada. In addition, and without limiting PAR’s obligations under
      Section 0
      or this
      Section 0,
      PAR
      shall 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. PAR 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. PAR shall, at all times during the Term after receipt of
      Regulatory Approval, 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 for those formulations
      and
      indications for which PAR is commercializing the Licensed Product. Should PAR
      fail to meet the above 'standard', the NovaDel and PAR will discuss PAR’s
      continued commitment to commercialize the Licensed Product and the termination
      of this Agreement.

     

    5.4 Trademarks.
      PAR
      shall have the right and obligation to determine the trademark and any other
      related logos, trade names, and similar source identifiers that are created
      or
      selected for use to be used on and with the Licensed Product, including the
      whether to use the Licensed Trademark (collectively, the “Product
      Trademarks”).
      With
      the exception of the Licensed Trademark, the Product Trademarks shall not
      include any trademarks, logos, trade names or similar source identifiers that
      are owned or licensed by HANA or NovaDel as of the Effective
      Date.


    
      
        
        

      

      
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    ARTICLE
      6

    ROYALTIES
      AND OTHER CONSIDERATIONS

     

    6.1 License
      Fee and Equity.
      Simultaneously with the execution of this Agreement, PAR shall purchase Five
      Million Dollars ($5,000,000) worth of shares of newly issued HANA common stock
      at a price per share that reflects a twenty-five percent premium to the then
      current market price of HANA’s common stock pursuant to the terms and conditions
      of that certain Stock Purchase Agreement between the Parties of even date
      herewith (the “Subscription
      Agreement”).
      The
      number of shares of HANA’s common stock issued to PAR will be determined by
      dividing the sum of Five Million Dollars ($5,000,000) by one hundred twenty-five
      percent (125%) of the weighted average closing price per share of HANA’s common
      stock on the NASDAQ Global Market during the ten (10) business days prior to
      the
      Effective Date. PAR represents that it is acquiring the shares of common stock
      of HANA for investment purposes only and covenants that it will not sell,
      transfer or otherwise dispose of any such shares until the earliest of: (a)
      the one (1) year anniversary of the Effective Date, (b) the filing of an NDA
      for
      the Licensed Product, and (c) the termination of this Agreement. PAR shall
      pay HANA for such shares by wire transfer of immediately available funds upon
      execution and delivery of this Agreement (the “Lock-Up
      Period”).
      Following the expiration of the Lock-Up Period, the Investor further agrees
      that, without the prior written consent of the Company, it will not sell more
      than fifty percent (50%) of the aggregate number of Shares purchased hereunder
      in any ninety (90) day period until the first anniversary of the end of the
      Lock-Up Period, at which time this further restriction shall no longer be
      applicable.

     

    6.2 Milestone
      Payments.
      In
      addition to the preceding amounts, PAR shall also pay milestone payments to
      HANA
      as follows: 

     

    6.2.1 [***]
      Dollars
      ($[***])
      within
      ten (10) days following PAR’s receipt of Regulatory Approval from the FDA of the
      NDA for the Licensed Product; plus 

     

    6.2.2 If
      Net
      Sales during a specified fiscal year equal at least $[***]
      in the
      Territory, then PAR will pay to HANA [***]
      Dollars
      ($[***])
      within
      60 days following the end of such year; plus

     

    6.2.3 If
      Net
      Sales during a specified fiscal year equal at least $[***]
      in the
      Territory, then PAR will pay to HANA [***]
      Dollars
      ($[***])
      within
      60 days following the end of such year; plus

     

    6.2.4 If
      cumulative Net Sales of the Licensed Product reaches [***]
      Dollars
      ($[***])
      within
      five (5) years following Regulatory Approval by the FDA of the NDA, then PAR
      will pay to HANA [***]
      Dollars
      ($[***])
      within
      60 days after obtaining such Net Sales threshold; plus

     

    6.2.5 If
      cumulative Net Sales of the Licensed Product reaches [***]
      Dollars
      ($[***])
      within
      five (5) years following Regulatory Approval by the FDA of the NDA, then PAR
      will pay to HANA [***]
      Dollars
      ($[***])
      within
      60 days after obtaining such Net Sales threshold. 

     

    6.3 Royalty
      Payments.
      In
      addition to the milestone payments described above, PAR shall pay to HANA
      royalty payments based on Net Sales of the Licensed Product as follows:


     

    6.3.1 PAR
      shall
      pay to HANA amounts due to NovaDel as royalties under the NovaDel-Hana License
      as follows:


    
      
        
        

      

      
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    6.3.1.1 [***]
      percent
      ([***]%)
      of up
      to the first $[***]
      of Net
      Sales by PAR or any Affiliate during each fiscal year in the Territory;
      plus

     

    6.3.1.2 [***]
      percent
      ([***]%)
      of Net
      Sales greater than $[***]
      and up
      to $[***]
      by PAR
      or any Affiliate during each fiscal year in the Territory; plus

     

    6.3.1.3 [***]
      percent
      ([***]%)
      of Net
      Sales greater than $[***]
      by PAR
      or any Affiliate during each fiscal year in the Territory.

     

    6.3.2 After
      cumulative Net Sales exceed [***]
      Dollars
      ($[***])
      within
      five (5) years following Regulatory Approval by the FDA of the NDA, PAR shall
      pay to HANA royalty payments based on Net Sales equal to [***]
      percent
      ([***]%)
      of Net
      Sales in excess of [***]
      Dollars
      ($[***])
      per
      Contract Year (in addition to the [***]
      percent
      ([***]%)
      royalty provided in Section 6.3.1.3). 

     

    6.3.3 All
      royalties shall be payable to HANA on a calendar quarterly basis, within
      forty-five (45) days after the end of each calendar quarter. The conversion
      rate
      for payments under this section, 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 this section will
      apply.

     

    6.3.4 Notwithstanding
      anything to the contrary contained herein, any and all amounts to be received
      by
HANA
      from
      PAR
      pursuant to Section 6.3.1 shall be paid to a lock-box account. Accordingly,
      the
      Parties agree that, within thirty (30) days after the Effective Date, the
      Parties 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 HANA’s right, title and interest
      under this Agreement (including without limitation its right to receive payments
      of the sublicense fees and other amounts payable by PAR hereunder) and in and
      to
      any lockbox account(s) to which 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 the NovaDel-Hana License
      and (iii) irrevocably instruct PAR to make all payments under this Agreement
      directly to such lockbox account(s); provided, however, that any payment
      obligation owed by PAR to HANA pursuant to Section 6.3.1 shall be deemed paid
      immediately upon delivery of such amount to the agreed-to lock box
      account.

     

    6.4 Royalty
      Term.
      PAR’s
      royalty obligations under Section 6.3 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 Effective 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 Effective Date and (ii) 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 6.3 in such country shall be reduced
      in
      accordance with the terms of Section 6.7. 


    
      
        
        

      

      
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    6.5 Mode
      of Payment.
      All
      payments to HANA under this Agreement shall be paid in United States Dollars
      by
      wire transfer of immediately available funds to a bank account in the United
      States as HANA may reasonably designate. 

     

    6.6 Non-Refundable,
      Non-Creditable.
      Subject
      to Sections 6.8 and
      8.2,
      the amounts paid or payable under this Article 6 shall be non-refundable
      and non-creditable against any other amounts due NovaDel or HANA under this
      Agreement.

     

    6.7 Reduction
      of Royalty.
      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 in the Territory 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 payment set forth in Section 6.3 with respect to the
      Licensed Product in such country shall be reduced by [***]
      percent
      ([***]%).
      In
      addition, if at any time during the Term the royalties owed by HANA to NovaDel
      pursuant to the NovaDel-Hana License are reduced, then (i) HANA shall promptly
      provide PAR with written notice of such reduction and (ii) HANA and PAR shall
      amend this Article 6 to reduce the royalties owed by PAR to HANA in the
      identical manner.

     

    6.8 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
      Generally Accepted Accounting Principles (“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, PAR shall pay HANA the amount of such underpayment
      on
      the next date payment is due to HANA hereunder. To the extent that the
      difference between such accruals and the actual results has led to an
      overpayment to HANA, PAR may set-off such overpayments against subsequent
      payments to be made to HANA; additionally, if any overpayments remain upon
      the
      expiration or termination of this Agreement, HANA shall refund such overpayments
      to PAR within thirty (30) days of receiving an invoice for such overpayment
      together with applicable supporting documentation.

     

    ARTICLE
      7

    INTELLECTUAL
      PROPERTY RIGHTS AND LICENSES

     

    7.1 Ownership
      of Intellectual Property.
      Subject
      to Sections 3.1 and 7.2, PAR hereby acknowledges and agrees that NovaDel owns
      and shall continue at all times to own all right, title and interest in and
      to:
      (a) the NovaDel Patent Rights and NovaDel Know-How, including all intellectual
      property rights appurtenant thereto; (b) the Licensed Technology and
      Improvements; and (c) other Information and Inventions that are conceived,
      discovered, developed or otherwise made by or on behalf of any Party (or its
      Affiliates or its sublicensees), whether or not patented or patentable, and
      any
      and all Patent Rights and other intellectual property rights with respect
      thereto.

     

    
      
        
        

      

      
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    7.2 Ownership
      of the Licensed Process.
      Subject
      to the license grants to PAR under Article 3, 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 PAR or its Affiliates, whether or not patented or
      patentable, and any and all Patent Rights and other intellectual property rights
      with respect thereto. PAR acknowledges and agrees that (a) the licenses granted
      to it pursuant to Section 3.1 permit PAR to use the Licensed Process solely
      for
      the Exploitation of Licensed Product as provided in this Agreement, (b) PAR
      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 outside
      the
      scope of this Agreement, and (c) neither it, nor any of its Affiliates 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. 

     

    7.3 Disclosure
      and Assignment.
      PAR
      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 7.1 and 7.2, and shall, and does hereby, assign,
      and shall cause its 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, PAR 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 PAR shall be entitled to use such
      intellectual property rights in accordance with the licenses granted pursuant
      to
      Article 3.

     

    7.4 Non-Use
      of Trademarks.
      Except
      as set forth explicitly in this Agreement, no Party shall have the right to
      use
      the trademarks, trade names or logos of any other Parties, nor any adaptation
      thereof, nor the names of any employees or consultants of any other Party,
      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,
      as
      amended, and the rules and regulations thereunder. 

     

    7.5 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 Right, copyright or other intellectual property rights)
      therein, shall, for purposes of this Agreement, be made in accordance with
      applicable United States law.

     

    ARTICLE
      8

    REPORTS
      AND RECORDS

     

    8.1 Record
      Retention.
      PAR
      shall maintain (and shall ensure that 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 PAR 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.


    
      
        
        

      

      
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    8.2 Audit.
      HANA
      shall have the right, on behalf of itself and NovaDel, to have an independent
      certified public accounting firm of nationally recognized standing, reasonably
      acceptable to PAR, to have access during normal business hours, and upon
      reasonable prior written notice, to such of the records of PAR (and its
      Affiliates) as may be reasonably necessary to verify the accuracy of all sales
      and payments due to HANA for any calendar quarter ending not more than
      thirty-six (36) months prior to the date of such request; provided, however,
      that neither HANA 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 only whether such sales or payments are correct or incorrect and the
      specific details concerning any discrepancies. HANA shall bear the cost of
      such
      audit unless the audit reveals an under-reporting or underpayment in excess
      of
      the greater of one hundred thousand dollars ($100,000) or two percent (2%)
      of
      royalties or milestone payments payable for such period, in which case PAR
      shall
      bear the cost of the audit, rectify such underpayment and pay HANA applicable
      interest as required by Section 8.5. Any overpayment shall be promptly repaid
      by
      HANA. All payments required under this Section 8.2 shall be due within thirty
      (30) days of the date that notice of the payment due. The results of such
      accounting firm shall be final, absent manifest error. PAR acknowledges that
      the
      results of any such audit may be shared by HANA with NovaDel and such results
      shall be treated as “Confidential Information” subject to the terms of Article
      9.

     

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

     

    8.3.1 All
      Licensed Product used, leased or sold, by or for PAR or its
      Affiliates.

     

    8.3.2 Total
      amounts invoiced for Licensed Product used, leased or sold, by or for PAR or
      its
      Affiliates.

     

    8.3.3 Total
      milestone payments due based on achievement of milestones.

     

    8.3.4 Total
      Net
      Sales and the royalties due by or for PAR and its Affiliates.

     

    8.3.5 Names
      and
      addresses of all Affiliates of PAR.

     

    8.4 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 an annual rate equal
      to
      the then prevailing prime rate of Citibank, N.A., plus six percent (6%), but
      in
      no event exceeding the amount permitted by applicable law.

     

    8.5 Confidentiality.
      Each
      report received by HANA and NovaDel shall be treated by HANA and NovaDel as
      if
      it were “Confidential Information” subject to the terms of Article
      9.


    
      
        
        

      

      
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    ARTICLE
      9

    CONFIDENTIALITY

     

    9.1 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
      another 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. 

     

    9.2 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:

     

    9.2.1 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;

     

    9.2.2 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;

     

    9.2.3 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;

     

    9.2.4 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

     

    9.2.5 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.

     

    9.3 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 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 another
      Party or its Affiliates.

     

    
      
        
        

      

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

     

    9.4.1 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 the owning Party and given
      the
      owning 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;

     

    9.4.2 Required
      by Law.
      Otherwise required by law; provided, however, that the disclosing Party shall
      (a) provide the owning Party with reasonable advance notice of and an
      opportunity to comment on any such required disclosure, (b) if requested by
      the
      owning 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 the owning Party in any such disclosure or request for confidential
      treatment;

     

    9.4.3 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

     

    9.4.4 Required
      by Agreement.
      Made by
      such Party, in connection with the performance of this Agreement, to Affiliates,
      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
      9.

     

    9.5 Injunctive
      Relief.
      The
      Parties acknowledge that any breach of this Article 9 will constitute
      irreparable harm, and that the non-breaching Party shall be entitled to specific
      performance or injunctive relief to enforce this Article 9 in addition to
      whatever remedies such Party may otherwise be entitled to at law or in
      equity.

     

    ARTICLE
      10

    PATENT
      PROSECUTION AND INFRINGEMENT

     

    10.1 Prosecution
      of NovaDel Patent Rights.
      

     

    10.1.1 NovaDel
      shall have the sole right, at its cost and expense, to obtain, prosecute and
      maintain throughout the world the NovaDel Patent Rights. PAR shall, and shall
      cause its Affiliates to, cooperate fully with NovaDel in the preparation,
      filing, prosecution, enforcement and maintenance of the NovaDel 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, enforce and maintain
      the
      NovaDel Patents in any country; (b) promptly informing NovaDel in reasonable
      detail of any Improvements by PAR or any of its Affiliates or agents; and (c)
      promptly informing NovaDel of any matters of which PAR may be aware that may
      affect the preparation, filing, prosecution or maintenance of any such NovaDel
      Patent.

     

    
      
        
        

      

      
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    10.1.2 NovaDel
      shall provide PAR with drafts of all patent applications and other material
      submissions to and correspondence with any patent authorities in the Territory
      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 in the Territory, to allow for review and comment by PAR.
      In
      addition, NovaDel shall provide PAR with an opportunity to consult with NovaDel
      regarding the filing and contents of any such application, submission or
      correspondence in the Territory. If PAR 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) in the Territory, 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, in the Territory or to take any other action with respect
      to
      a NovaDel Patent in a particular country in the Territory that is necessary
      or
      useful to establish or preserve rights with respect to the Licensed Product,
      and
      (y) such NovaDel Patent does not claim or cover the Licensed Process, then
      NovaDel shall so notify PAR promptly in writing and in good time to enable
      PAR
      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 in the Territory. 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 PAR that
      it
      do so (and thereafter diligently pursue such action), PAR 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 in the Territory. If PAR elects to pursue such filing or
      registration, as the case may be, or continue such support, then PAR shall
      notify NovaDel of such election and NovaDel shall, and shall cause its
      Affiliates to, (x) reasonably cooperate with PAR in this regard, and (y)
      promptly grant to PAR, without additional consideration, an exclusive,
      perpetual, irrevocable, royalty-free license in such country in the Territory
      under such NovaDel Patent in order to Exploit the Licensed Product in accordance
      with the terms of this Agreement.

     

    10.2 Infringement
      of NovaDel Patent Rights.
      

     

    10.2.1 PAR
      and
      HANA shall inform each other and NovaDel promptly in writing of any alleged
      or
      suspected infringement by a Third Party of any Licensed Technology, and of
      any
      available evidence thereof. Each Party shall provide reasonable assistance
      to
      other Parties, including providing access to relevant records, papers,
      information, samples, specimens and other evidence, making its employees
      available at reasonable business hours, and joining the action to the extent
      necessary to maintain the action.

     

    
      
        
        

      

      
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    10.2.2 In
      respect of any alleged or suspected actual or constructive infringement by
      a
      Third Party of any NovaDel Patent, NovaDel Know-How or Improvements, in each
      case related solely to the Licensed Process and Licensed Product, most
      particularly where a Third Party files an ANDA or a 505(b)(2) application
      containing a Paragraph IV certification with the FDA targeting or referencing
      the Licensed Product, as the NDA holder, PAR shall have the right to institute
      a
      suit and control the prosecution, settlement negotiation, settlement or
      compromise thereof or defend against any suit alleging the invalidity or
      noninfringement or unenforceability of the Patent Rights of a Party or its
      Affiliates to the extent related solely to the Licensed Product; provided that
      PAR shall not enter into any settlement or compromise with respect to any
      NovaDel Patent, NovaDel Know-How or Improvement without NovaDel’s prior written
      consent, such consent not to be unreasonably withheld, unless such settlement
      or
      compromise does not include any statements as to or otherwise affect the
      validity or enforceability of the NovaDel Patents, NovaDel Know-How or
      Improvements and the only form of consideration paid by the Third Party is
      monetary that has not been reduced or offset by any consideration by PAR.
 PAR shall bear all the costs of such a suit.  At PAR’s request,
      NovaDel shall be named as a party in such litigation, and NovaDel shall execute
      all papers and perform such acts as may be reasonably required, in respect
      thereof; provided, however, that NovaDel’s joining of such action shall not
      affect PAR’s control thereof.  NovaDel and HANA shall, at the request and
      sole expense of PAR, provide reasonable cooperation and, to the extent possible,
      each of NovaDel and HANA shall have its employees testify when requested and
      make available relevant records, papers, information, samples, specimens and
      the
      like regardless of whether NovaDel has joined such suit.  NovaDel shall
      have the right to select, at NovaDel’s expense, separate counsel to participate
      in such suits on NovaDel’s behalf.  In the event that PAR fails within
      ninety (90) days following notice of such infringement, or earlier notifies
      NovaDel in writing of its intent not to take commercially appropriate steps
      to
      remove any infringement of any NovaDel Patent, NovaDel Know-How or Improvement,
      NovaDel shall have the right, but not the obligation, to do so at its own
      expense; provided, however, that if PAR has commenced negotiations with an
      alleged infringer for discontinuance of such infringement within such ninety
      (90) day period, PAR shall have an additional ninety (90) days to conclude
      its
      negotiations before NovaDel may bring suit for such infringement.  Each of
      PAR, HANA, and NovaDel shall provide reasonable assistance to the Person
      controlling such litigation, 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, with all reasonable expenses incurred by HANA in providing
      such assistance to such Person to be paid in full by PAR.  Any amounts,
      royalties, payments, damages, expenses, fees or other awards received by or
      recovered by NovaDel or PAR, as applicable, pursuant to this Section 10.2.2,
      whether by settlement or by judgment, shall be used to reimburse such Person
      for
      their reasonable costs and expenses in making such recovery, with any remainder
      to be shared [***]
      percent
      ([***]%)
      to
      NovaDel and [***]
      percent
      ([***]%)
      to
      PAR.  For all other NovaDel Patents, NovaDel Know-How or Improvements,
      NovaDel shall have the sole right to institute a suit and control prosecution,
      settlement negotiation, settlement or compromise thereof and defend against;
      provided that NovaDel shall consult with PAR and NovaDel shall use reasonable
      business judgment to determine whether to consent to instituting a suit, such
      reasonable business judgment to include consideration of any other existing
      or
      contemplated products covered by the NovaDel Patents, NovaDel Know-How or
      Improvements.

     

    
      
        
        

      

      
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    10.3 Third
      Party Litigation.
      In the
      event that a Third Party institutes a patent or other infringement suit against
      any of NovaDel, PAR or HANA or any of its respective Affiliates during the
      Term,
      alleging manufacture, use or sale of a Licensed Product in the Territory,
      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.  PAR, as
      the NDA holder, shall have the first right to direct and control, at its
      expense, any Infringement Suit (including settlement negotiations, settlement
      or
      compromise thereof) to the extent that it relates to the manufacture, use or
      sale of a Licensed Product but does not implicate the Licensed Technology or
      Licensed Process.  In the event that the Infringement Suit relates to the
      use of the Licensed Technology or Licensed Process, NovaDel shall have the
      first
      right to direct and control, at its expense, any such Infringement Suit
      (including settlement negotiations, settlement or compromise thereof).  To
      the extent that any amounts become payable to any Third Party as a result of
      such action, whether through judgment or settlement, then PAR shall, unless
      HANA
      is jointly promoting and commercializing the Licensed Product pursuant to
      Section 2.4 and subject to Section 12.2, bear [***]
      percent
      ([***]%)
      of
      such amounts with respect to the Exploitation of the Licensed Product; provided,
      however, that PAR shall have the right to credit [***]
      percent
      ([***]%)
      of any
      amounts paid by PAR through judgment or settlement with respect to such country
      against the royalty payments to be paid by PAR to HANA with respect to the
      sale
      of the Licensed Product under Section 6.3; provided further, however, that
      no
      royalty payment when due, regardless of the amount or number of credits
      available to PAR shall be reduced by more than [***]
      percent
      ([***]%)
      of the
      amounts otherwise owed pursuant to Section 6.3 in any calendar quarter.
 Credits not exhausted in any calendar quarter may be carried into future
      calendar quarters. Notwithstanding the foregoing, in the event that no payments
      are due or owing, or contemplated to be due or owing, by PAR to HANA under
      Article 6 with respect to the sale of the Licensed Product, then NovaDel shall
      pay to PAR such amount owed to a Third Party up to a cap of [***]%
      of such
      amount owed to such Third Party, less any amount already credited to PAR under
      this Section 10.3. Notwithstanding the foregoing, NovaDel shall have no
      obligation under this Section 10.3 for any costs, expenses or damages that
      are
      paid or payable to a Third Party as a result of an actual or alleged
      infringement by PAR or HANA to the extent such costs, expenses or damages result
      from the use of a Product Trademark.

     

    10.4 Retained
      Rights.
      Nothing
      in this Section 10 shall prevent PAR, 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
      11

    TERMINATION

     

    11.1 Term.
      Unless
      otherwise terminated pursuant to this Article 11, 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) expiration date of the last
      to
      expire of any issued NovaDel patent that includes at least one Valid Claim
      and
      (b) the twentieth (20th) anniversary of the Effective Date (the “Term”).
      

     

    11.2 Termination
      Events.
      This
      Agreement may be terminated prior to expiration of the Term as
      follows:

    
       

      
        
          
          

        

        
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    11.2.1 Termination
      Upon Insolvency.
      

     

    11.2.1.1 If
      HANA
      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 HANA and not dismissed within sixty (60) days,
      or
      if the business of HANA shall be placed in the hands of a receiver, assignee
      or
      trustee for the benefit of creditors, whether by the voluntary act of HANA
      or
      otherwise, PAR or NovaDel (subject to Section 11.6.3) shall have the right
      to
      terminate this Agreement.

     

    11.2.1.2 If
      PAR
      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 PAR and not dismissed within sixty (60) days,
      or
      if the business of PAR shall be placed in the hands of a receiver, assignee
      or
      trustee for the benefit of creditors, whether by the voluntary act of PAR or
      otherwise, HANA or NovaDel shall have the right to terminate this
      Agreement.

     

    11.2.2 Termination
      for Payment Default.
      Should
      PAR fail to make payment to HANA of royalties or other amounts due in accordance
      with the terms of this Agreement, HANA or NovaDel shall have the right to
      terminate this Agreement within ten (10) days after giving said notice of
      termination unless PAR shall pay to HANA, within the 10-day period, all such
      amounts due and payable. Upon the expiration of the 10-day period, if PAR shall
      not have paid all such amounts due and payable, the rights, privileges and
      licenses granted hereunder shall, at the option of HANA or NovaDel, immediately
      terminate. In the event a payment is the subject of a bona fide dispute between
      HANA and PAR that is being pursued by a Party pursuant to the dispute resolution
      mechanism in Article 15, then PAR shall make such payment, but shall provide
      HANA 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 PAR, HANA shall refund such
      payment to PAR with interest calculated pursuant to Section 8.5 from the date
      of
      such payment.

     

    11.2.3 Termination
      for Material Breach.
      

     

    11.2.3.1 Upon
      any
      material breach or default of this Agreement by either HANA or PAR, other than
      as set forth in Section 11.2.2, NovaDel shall, subject to Section 11.6.3, have
      the right to terminate this Agreement and the rights, privileges and licenses
      granted hereunder upon giving thirty (30) days notice to HANA and PAR. 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.

     

    11.2.3.2 Upon
      any
      material breach or default of this Agreement by HANA, other than as set forth
      in
      Section 11.2.2, PAR shall have the right to terminate this Agreement and the
      rights, privileges and licenses granted hereunder upon giving thirty (30) days
      notice to the HANA and NovaDel. Such termination shall become effective upon
      the
      expiration of such thirty (30)-day period unless HANA shall have cured any
      such
      breach or default prior to the expiration of such thirty (30) day
      period.

     

    11.2.3.3 Upon
      any
      material breach or default of this Agreement by PAR, other than as set forth
      in
      Section 11.2.2, HANA shall have the right to terminate this Agreement and the
      rights, privileges and licenses granted hereunder upon giving thirty (30) days
      notice to the PAR and NovaDel. Such termination shall become effective upon
      the
      expiration of such thirty (30)-day period unless PAR shall have cured any such
      breach or default prior to the expiration of such thirty (30) day
      period.

     

    
      
        
        

      

      
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    11.2.4 Termination
      By PAR.
      PAR
      shall have the right at any time to terminate this Agreement in whole or as
      to
      any Licensed Product by giving ninety (90) days notice thereof in writing to
      HANA and NovaDel.

     

    11.3 Return
      of Information; Assignment and License.
      

     

    11.3.1 Upon
      termination of this Agreement as a result of PAR’s material breach hereof
      pursuant to Section 11.2.2, 11.2.3.1 or 11.2.3.3, or as a result of PAR’s
      insolvency pursuant to Section 11.2.1.2 or by PAR pursuant to Section 11.2.4,
      PAR shall, and shall cause its Affiliates to return to HANA and 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 Information and
      Inventions or other Confidential Information (except one copy of each that
      may
      be retained for archival purposes). 

     

    11.3.2 Upon
      termination of this Agreement as a result of PAR’s material breach hereof
      pursuant to Section 11.2.2, 11.2.3.1 or 11.2.3.3, or as a result of PAR’s
      insolvency pursuant to Section 11.2.1.2, or by PAR pursuant to Section 11.2.4,
      PAR: (a) shall, and shall cause its Affiliates to, promptly disclose to HANA
      and
      NovaDel, in whatever form HANA may request, all Regulatory Documentation and
      all
      other Information and Inventions in the possession or Control of PAR or its
      Affiliates that relate to the Exploitation of such Licensed Product, (b) shall,
      and does hereby, assign, and shall cause its Affiliates to assign, to HANA,
      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 to grant, to HANA, without additional compensation, a perpetual,
      irrevocable, royalty-free, exclusive, sublicenseable through multiple tiers
      of
      sublicenses, right and license to Exploit such Licensed Product in the Territory
      and (d) shall, and does hereby, assign, and shall cause its Affiliates 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 PAR or its Affiliates in each case
      that relate to the Exploitation of such Licensed Product to the extent not
      already assigned to NovaDel pursuant to Section 7.1 or Section 7.2.

     

    11.4 Cumulative
      Remedies.
      The
      rights and remedies set forth in this Article 11 are cumulative and in addition
      to any other rights that may be available to the Parties.

     

    11.5 Non-Refundability
      of Payments.
      Any and
      all license fees, royalties and milestone payments made to HANA by PAR under
      Article 6 of this Agreement shall be non-refundable, notwithstanding the
      termination of this Agreement under any provision of this
      Agreement.

     

    
      
        
        

      

      
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    11.6 Effect
      of Termination.
      

     

    11.6.1 The
      termination or expiration of this Agreement for any reason shall be without
      prejudice to any rights which shall have accrued to the benefit of any Party
      prior to such termination or expiration. Such termination or expiration shall
      not relieve any Party from obligations which are expressly indicated to survive
      termination or expiration of this Agreement.

     

    11.6.2 Upon
      the
      termination of the Agreement pursuant to Section 11.2.1.2 or by HANA in
      accordance with Section 11.2.2 or 11.2.3.3 or by NovaDel pursuant to Section
      11.2.2 or 11.2.3.1, all rights and licenses granted to PAR pursuant to this
      Agreement shall automatically and immediately terminate and PAR immediately
      shall discontinue Commercialization of the Licensed Product.

     

    11.6.3 Upon
      the
      termination of the Agreement pursuant to Section 11.2.1.1 or by PAR or NovaDel
      as a result of HANA’s material breach pursuant to Section 11.2.2 or 11.2.3.2,
      then, in such event, HANA shall, contemporaneously with the termination of
      this
      Agreement and in exchange for the good and valuable consideration set forth
      herein (the sufficiency of which is hereby acknowledged by HANA), assign all
      of
      its rights and interests in, under and to, the NovaDel-Hana License (without
      regard to any termination thereunder) and PAR shall assume the obligations
      of
      HANA thereunder (and NovaDel hereby consents to such assignment and assumption);
      provided, however, that NovaDel acknowledges that in no event shall PAR have
      any
      greater obligations (economically or otherwise) to NovaDel than it has to HANA
      under the terms of this Agreement; provided further, that if there are any
      operational obligations of HANA that are not covered by the terms of this
      Agreement, then NovaDel and PAR shall, at the time of such assignment, in good
      faith negotiate commercially reasonable terms in respect of such operational
      obligations.

     

    11.7 Disposition
      of Product.
      Upon
      any termination of this Agreement pursuant to other than for which Section
      11.6.2 would be applicable, PAR shall within thirty (30) days after the
      effective date of such termination notify HANA in writing of the amount of
      each
      Licensed Product which PAR and its Affiliates then have completed on hand,
      the
      sale of which would, but for the termination, be subject to royalty. At HANA’s
      sole election, evidenced by written consent, HANA may grant PAR and/or its
      Affiliates written permission during the one (1) year following such termination
      to sell that amount of Licensed Product, provided that PAR shall pay royalties
      owing thereon in accordance with the provisions of this Agreement. 

     

    11.8 Survival.
      In
      addition to all rights that have accrued as of the date of termination, the
      following provisions shall survive the termination of this Agreement for
      whatever reason: Articles 7, 8, 9, 12, 14 and 15, and Sections 4.5, 10.3, 11.3,
      11.4, 11.5, 11.6. 11.7, 11.8, 13.6, 16.4, 16.7, 16.9, 16.10, 16.11, 16.12,
      16.13, 16.14 and 16.15. In addition, any other provision required to interpret
      and enforce the Parties’ rights and obligations under this Agreement shall also
      survive, but only to the extent required for the observation and performance
      of
      the aforementioned surviving rights or portions of this Agreement.

     

    
      
        
        

      

      
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    ARTICLE
      12

    INDEMNIFICATION

     

    12.1 Indemnification
      By PAR.
      PAR
      shall at all times during the term of this Agreement and thereafter, indemnify,
      defend and hold HANA and its Affiliates and their respective officers,
      directors, employees and agents, and the successors and assigns of the foregoing
      (“Hana
      Indemnified Parties”)
      and
      NovaDel and its Affiliates and their respective officers, directors, employees
      and agents, and the successors and assigns of the foregoing (“NovaDel
      Indemnified Parties”),
      harmless from and against all liability, demands, damages, including expenses
      or
      loses including death, personal injury, illness or property damage of any kind
      whatsoever, including legal expenses and reasonable attorneys’ fees
      (collectively, “Losses”)
      arising directly or indirectly out of (a) any breach of this Agreement by PAR
      or
      its Affiliates or permitted Third Party manufacturers, including the failure
      of
      PAR or its Affiliates or permitted Third Party manufacturers to manufacture,
      test or release Licensed Product in accordance with Applicable Law, agreed-to
      specifications or CGMP, (b) the negligence or willful misconduct or willful
      omissions by PAR or its Affiliates or permitted Third Party manufacturers,
      (c)
      actual or asserted violations of Applicable Law by PAR or its Affiliates or
      permitted Third Party manufacturers, (d) the Exploitation of the Licensed
      Product in the Territory (subject to Section 12.4 and intellectual property
      infringement claims, which shall be governed by Article 10), and (e) the use
      of
      the Product Trademark, except to the extent of those Losses for which, as
      applicable, HANA has an obligation to indemnify the PAR Indemnified Parties
      pursuant to Section 12.2 or to the extent caused by a breach of this Agreement
      by NovaDel or the negligence or willful misconduct or willful omissions of
      NovaDel.

     

    12.2 Indemnification
      By HANA.
      HANA
      shall defend, indemnify and hold PAR and its Affiliates and their respective
      officers, directors, employees and agents (“PAR
      Indemnified Parties”)
      and
      the NovaDel Indemnified Parties harmless from and against all Losses arising
      directly or indirectly out of (a) any breach of this Agreement or the
      NovaDel-Hana License by HANA or Affiliates, (b) the negligence or willful
      misconduct or willful omissions by HANA or its Affiliates, and (c) actual or
      asserted violations of Applicable Law by HANA or its Affiliates, except to
      the
      extent of those Losses for which PAR has an obligation to indemnify the HANA
      Indemnified Parties pursuant to Section 12.1.

     

    12.3 Indemnification
      By NovaDel.
      NovaDel
      shall defend, indemnify and hold the Indemnified Parties harmless from and
      against all Losses arising directly or indirectly out of (a) any breach of
      this
      Agreement or the NovaDel-Hana License by NovaDel or Affiliates, (b) the
      negligence or willful misconduct or willful omissions by NovaDel or its
      Affiliates and (c) actual or asserted violations of Applicable Law by NovaDel
      or
      its Affiliates, except to the extent of those Losses for which PAR has an
      obligation to indemnify the NovaDel Indemnified Parties pursuant to Section
      12.1.

     

    
      
        
        

      

      
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    12.4 Product
      Liability Claims.
      If any
      Party becomes aware of a Product Liability Claim solely with respect to Licensed
      Product sold by PAR or its Affiliates during the Term that is not otherwise
      subject to indemnification by a Party under Section 12.1, 12.2 or 12.3, it
      shall promptly notify the other Parties in writing of any such Product Liability
      Claim. PAR shall have the first option to control the defense of such Product
      Liability Claim with counsel of its choice and PAR will fund the litigation
      expenses with respect to such Product Liability Claim; provided that NovaDel
      shall reimburse PAR for [***]%
      of such
      expenses within forty-five (45) days of receiving an invoice setting forth
      such expenses and NovaDel’s share of the same. NovaDel will have the option of
      joining in any action related to such Product Liability Claim, and upon so
      joining, if NovaDel shall be represented in such action by its own counsel,
      such
      representation shall be at its own expense. In the event that PAR does not
      so
      elect to defend against such Product Liability Claim within ninety (90)
      days of becoming aware of the same, NovaDel shall be free to proceed and solely
      control such defense and NovaDel shall fund the litigation expenses with respect
      to such Product Liability Claim; provided that PAR shall reimburse NovaDel
      for
[***]%
      of such
      expenses within forty-five (45) days of receiving an invoice setting forth
      such expenses and PAR’s share of the same. Each Party, and its employees and
      agents, shall provide to the other Party and its legal representatives
      reasonable assistance and cooperation with respect to such Product Liability
      Claim, including entering into any joint defense and/or joint privilege
      agreement that may be reasonably requested by such Party, to the extent
      possible, having its employees testify when requested and making available
      relevant records, papers, information, samples, specimens and the like. To
      the
      extent either Party incurs any Losses arising from or in connection with any
      such Product Liability Claim with respect to the Licensed Product that is not
      otherwise subject to indemnification by a Party under Section 12.1, 12.2 or
      12.3 of this Agreement, such Losses shall be shared [***]%
      by
      NovaDel and [***]%
      by
      PAR.

     

    12.5 Indemnification
      Procedure.

     

    12.5.1 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, 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 to this Agreement (the “Indemnified
      Party”).

     

    12.5.2 Third
      Party Claims.
      The
      obligations of an indemnifying Party under this Article 12 with respect to
      Losses arising from claims of any Third Party that are subject to
      indemnification as provided for in Section 12.1, 12.2 or 12.3 (a “Third
      Party Claim”)
      shall
      be governed by and be contingent upon the following additional terms and
      conditions:

     


    
      
        
        

      

      
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    12.5.2.1 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. 

     

    12.5.2.2 Right
      to Participate in Defense.
      Without
      limiting Section 12.5.2.1, 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 12.5.2.1 (in which case the
      Indemnified Party shall control the defense).

     

    12.5.2.3 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 12.5.2.1, 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. 

     

    12.5.2.4 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. 

     

    
      
        
        

      

      
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    12.5.2.5 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.

     

    12.6 Insurance.
      

     

    12.6.1 At
      all
      times from and after the Effective Date, PAR 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 and HANA with a copy of its policies of insurance in that
      regard, along with any amendments and revisions thereto.

     

    12.6.2 PAR
      shall, starting 6 months prior to anticipated receipt of NDA approval of the
      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 NovaDel and HANA. PAR shall
      provide NovaDel and HANA 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 each of NovaDel and HANA thirty (30)
      days
      prior to any material change, cancellation or non-renewal of the policy. The
      said amount can vary if mutually agreed by both parties.

     

    12.7 Indemnification
      for Infringement Claims.
      The
      provisions of this Article 12 shall supplement the terms of Section 10.3 with
      respect to Third Party patent infringement claims. In the event of a conflict
      between this Article 12 and Section 10.3, the terms of Section 10.3 shall
      control (except as expressly made subject to Section 12.2 therein).

     

    ARTICLE
      13

    REPRESENTATIONS
      AND WARRANTIES

     

    13.1 Legal
      Authority.
      Each of
      HANA and PAR represents and warrants as follows: (a) 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; (b) such Party has the legal power, authority and right
      to
      enter into this Agreement and to perform its respective obligations set forth
      herein; and (c) this Agreement has been duly executed and delivered by such
      Party and constitutes the valid and binding obligation of such Party,
      enforceable against such Party in accordance with its terms, except as
      enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency,
      reorganization, moratorium and other laws relating to or affecting creditors’
rights generally and by general equitable principles.

     

    
      
        
        

      

      
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    13.2 No
      Conflicts.
      Each of
      HANA and PAR represents or warrants that as of the date of this Agreement it
      is
      not a party to any agreement or arrangement with any Third Party or under any
      obligation or restriction, including pursuant to its corporate charter, bylaws
      or comparable governing documents, which in any way limits or conflicts with
      its
      entering into this Agreement or its ability to fulfill any of its obligations
      under this Agreement. 

     

    13.3 Litigation.
      Each of
      HANA and PAR represents or warrants that it 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 Person.

     

    13.4 Additional
      Covenants of PAR.
      PAR on
      behalf of itself and its Affiliates, agrees and covenants to the extent
      permitted by Applicable Law, never, in any country, region or jurisdiction
      in
      the Territory, to institute or prosecute any claim, action or suit at law or
      in
      equity seeking to have any claim in a NovaDel Patent Right declared invalid
      or
      unenforceable; provided, however, that nothing contained herein shall prohibit
      PAR and its Affiliates from either (a) asserting any and all defenses available
      to it, including assertions relating to the validity or enforceability of the
      NovaDel Patent Rights, in any suit or proceeding brought against them alleging
      the infringement of any of the NovaDel Patent Rights, 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 PAR or its
      Affiliates and a patent or patent application included within the definition
      of
      the NovaDel Patent Rights. PAR 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; provided, however, that such rights shall be subject to PAR’s
      right to notice and cure and shall be subject to the dispute resolutions
      provided herein.

     

    13.5 Additional
      Representations and Warranties of HANA.
      HANA
      hereby represents, warrants and covenants to PAR as follows:

     

    (i) Neither
      HANA nor any of its Affiliates has received any written notice from any Person,
      or has knowledge, of any actual or threatened claim or assertion that the
      development of the Licensed Product infringes (or would infringe) or
      misappropriates any intellectual property rights of any Third Party;


     

    (ii) There
      is
      no action or proceeding pending or, to HANA’s knowledge, threatened that
      questions the validity of this Agreement or any action taken by HANA in
      connection with the effectiveness of this Agreement;

     


    
      
        
        

      

      
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    (iii) HANA
      has
      no knowledge of any pending patent application, which if issued, would similarly
      be infringed by the use of the Licensed Technology as contemplated by this
      Agreement;

     

    (iv) HANA
      has
      not violated the trade secrets or misappropriated the confidential information
      or intellectual property of any Third Party in connection with the development
      of the Licensed Technology;

     

    (v) HANA
      has
      the right to grant the sublicense granted to PAR herein; 

     

    (vi) To
      HANA’s
      knowledge, as of the Effective Date, there is no unauthorized use, infringement
      or misappropriation of any of the Licensed Technology by any Third Party,
      including any current or former employee or consultant of HANA and its
      Affiliates; and

     

    (vii) HANA
      has
      made available to or provided PAR with copies of all information in HANA’s
      Control regarding the Licensed Technology, which could reasonably be expected
      to
      be material to assessing the commercial potential for the Licensed Product,
      or
      the ability to timely gain Regulatory Approval of the Licensed
      Product.

     

    13.6 DISCLAIMER
      OF WARRANTY.
      EXCEPT
      FOR THE EXPRESS WARRANTIES SET FORTH IN SECTIONS 13.1, 13.2, 13.3 AND 13.5,
      NEITHER HANA, PAR NOR NOVADEL MAKES ANY REPRESENTATIONS OR GRANTS ANY
      WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY
      STATUTE OR OTHERWISE, UNDER THIS AGREEMENT, AND HANA AND NOVADEL EACH
      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 PATENT
      RIGHTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD
      PARTIES UNDER THIS AGREEMENT.

     

    ARTICLE
      14

    LIMITATION
      OF LIABILITY

     

    14.1 LIMITATION
      OF LIABILITY.
      EXCEPT
      FOR EACH PARTY’S INDEMNIFICATION OBLIGATIONS IN RESPECT OF THIRD PARTY CLAIMS
      UNDER THIS AGREEMENT, NONE OF HANA, PAR, NOVADEL OR ANY OF THEIR RESPECTIVE
      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 LICENSED TRADEMARKS OR (B) ANY BREACH OF OR FAILURE TO PERFORM
      ANY
      OF THE PROVISIONS OF THIS AGREEMENT.

     

    
      
        
        

      

      
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    ARTICLE
      15

    DISPUTE
      RESOLUTION

     

    15.1 Good
      Faith Negotiations.
      In the
      event of any dispute or disagreement among the Parties as to the interpretation
      of any provision of this Agreement or the performance of obligations hereunder,
      the matter, upon written request of any Party, shall first be referred to the
      chief executive officers of the Parties for decision. Such chief executive
      officers shall promptly meet in a good faith effort to resolve the
      dispute.

     

    15.2 Arbitration.

     

    15.2.1 Procedures.
      Any
      dispute arising from or relating to this Agreement that is not resolved by
      the
      Parties chief executive officers pursuant to Section 0
      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
      PAR
      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.

     

    15.2.2 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 ether Party to obtain judicial resolution of such
      issues, unless an order staying the arbitration proceeding shall be entered
      by a
      court of competent jurisdiction. No Party hereto 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.

     

    15.2.3 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
      16

    MISCELLANEOUS

     

    16.1 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, as amended, and the rules and regulations
      thereunder or as promulgated by an applicable securities exchange governing
      body.

     

    
      
        
        

      

      
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    16.2 Publications.
      In the
      event that any Party desires to publish or disclose, by written, oral or other
      presentation, Licensed Technology or any material information relating 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 PAR, 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 PAR do so. Upon receipt
      of
      such request to delay such presentation, publication or disclosure, PAR shall
      arrange for a delay of such presentation, publication or disclosure until such
      time as PAR 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
      PAR
      does not receive any such request from NovaDel to delay such presentation,
      publication or disclosure, PAR may submit such material for presentation,
      publication or other form of disclosure. Notwithstanding the foregoing, in
      no
      event shall PAR 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.

     

    16.3 Assignment.
      During
      the Term, neither this Agreement nor any of the rights or obligations hereunder
      may be assigned by without the prior written consent of the other Parties
      hereto, which consent shall not be unreasonably withheld. 

     

    16.4 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. 

     

    16.5 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, PAR shall assume
      all legal obligations to do so and the costs in connection
      therewith.

     

    16.6 Trade
      Regulations.
      PAR
      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.

     

    16.7 Equitable
      Relief.
      Each
      Party acknowledges and agrees that the restrictions set forth in Article 9
      of
      this Agreement are reasonable and necessary to protect the legitimate interest
      of the other Parties and that such other Parties would not have entered into
      this Agreement in the absence of such restrictions, and that any violations
      or
      threatened violation of any provision of Article 9 may result in irreparable
      injury to such other Parties. Each Party also acknowledges and agrees that
      in
      the event of a violation or threatened violation of any provision of Article
      9,
      the affected 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.

     

    
      
        
        

      

      
        35

        
          

        

      

      
        
        

      

    

     

    16.8 Force
      Majeure.
      In the
      event that any 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 Waiver.
      The
      waiver by any Party of a breach or a default of any provision of this Agreement
      by another 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
      any 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.

     

    16.10 Notices.
      Any and
      all notices or other communications made or given pursuant to this Agreement
      shall be in writing and shall be delivered (i) by express overnight or two-day
      international courier service, (ii) by certified or registered mail, return
      receipt requested, or (iii) by confirmed facsimile or other electronic
      transmission (with confirming copy to follow by express overnight courier
      service):

     

    
      	 	
              If
                to HANA 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

              Attention:
                Christopher J. Melsha Esq.

              3300
                Wells Fargo Center

              90
                South Seventh Street

              Minneapolis,
                Minnesota 55402

               

            


    

     

    
      
        
        

      

      
        36

        
          

        

      

      
        
        

      

    

     

    
      	 	
              In
                the case of PAR:

               

            	
              Par
                Pharmaceutical, Inc.

              300
                Tice Boulevard

              Woodcliff
                Lake, NJ 07677

              Attn:
                John MacPhee, President, Branded Division and

              General
                Counsel’s Office

              Fax:
                (201) 802-4223

               

            
	 	
              with
                a copy (not constituting notice) to:

            	
              Orrick,
                Herrington & Sutcliffe LLP

              666
                Fifth Avenue

              New
                York, NY 10103-0001

              Attn:
                R. King Milling, Jr., Esq.

              Fax:
                (212) 506-5151

               

            
	 	
              In
                the case of NovaDel

            	
              NovaDel
                Pharma, Inc.

              25
                Minneakoning Road

              Flemington,
                NJ 08822

              Attn:
                President

              Fax:
                (908) 806-2445

               

            
	 	
              with
                a copy (not constituting notice) to:

            	
              Morgan,
                Lewis & Bockius LLP

              502
                Carnegie Center

              Princeton,
                NJ 08540

              Attn:
                Randall B. Sunberg, Esq.

              Fax:
                (609) 919-6701

            


    

     

    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 Section 16.10 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. Notices provided
      in
      accordance with this Section 16.10 shall be deemed delivered upon receipt of
      the
      notice by the Party being sent the notice.

     

    16.11 No
      Agency.
      Nothing
      herein shall be deemed to constitute any Party as the agent or representative
      of
      any other Party, or the Parties hereto as joint venturers or partners for any
      purpose. HANA shall be an independent contractor, not an employee or partner
      of
      PAR or NovaDel, and the manner in which HANA performs its obligations under
      this
      Agreement shall be within HANA’s sole discretion. PAR shall be an independent
      contractor, not an employee or partner of HANA or NovaDel, and the manner in
      which PAR performs its obligations under this Agreement shall be within PAR’s
      sole discretion (subject to PAR’s compliance with its obligations under this
      Agreement). No Party hereto shall be responsible for the acts or omissions
      of
      any other Party, and no Party shall have authority to speak for, represent
      or
      bind any other Party in any way without prior written authority from such other
      Party.

     

    
      
        
        

      

      
        37

        
          

        

      

      
        
        

      

    

     

    16.12 Entire
      Agreement.
      This
      Agreement and the Exhibits and Schedules attached hereto (which Exhibits and
      Schedules are deemed to be a part of this Agreement for all purposes) contain
      the full understanding of the Parties with respect to the subject matter hereof
      and supersede all prior understandings and writings relating thereto. No waiver,
      alteration or modification of any of the provisions hereof shall be binding
      unless made in writing and signed on behalf of the Parties by their respective
      officers thereunto duly authorized.

     

    16.13 Headings;
      Interpretation.
      The
      section headings contained in this Agreement are for convenience of reference
      only, do not form a part of this Agreement and shall not affect in any way
      the
      meaning or interpretation of this Agreement. Whenever the context may require,
      any pronoun shall include the corresponding masculine, feminine and neuter
      forms. The words “include,” “includes” and “including” shall be deemed to be
      followed by the phrase “but not limited to.” All references herein to Articles,
      Sections and Exhibits shall be deemed references to Articles and Sections of,
      and Exhibits to, this Agreement unless the context shall otherwise require.
      All
      Exhibits and Schedules attached to this Agreement shall be deemed incorporated
      herein by reference as if fully set forth herein. Words such as “herein,”
“hereof,” “hereto,” “hereby” and “hereunder” refer to this Agreement and to the
      Exhibits, taken as a whole. Except as otherwise expressly provided herein:
      (a)
      any reference in this Agreement to any agreement shall mean such agreement
      as
      amended, restated, supplemented or otherwise modified from time to time; and
      (b)
      any reference in this Agreement to any law shall include corresponding
      provisions of any successor law and any regulations and rules promulgated
      pursuant to such law or such successor law.

     

    16.14 Severability.
      In the
      event that any provision of this Agreement is held by a court of competent
      jurisdiction to be unenforceable because it is invalid or in conflict with
      any
      law of any relevant jurisdiction, the validity of the remaining provisions
      shall
      not be affected, and the rights and obligations of the Parties shall be
      construed and enforced as if the Agreement did not contain the particular
      provisions held to be unenforceable.

     

    16.15 Successors
      and Assigns.
      This
      Agreement shall be binding upon and inure to the benefit of the Parties hereto
      and their permitted successors and assigns.

     

    16.16 Counterparts.
      This
      Agreement may be executed in any number of counterparts (including signature
      by
      facsimile), each of which shall be deemed an original but all of which together
      shall constitute one and the same instrument.

     

    16.17 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
      PAR or HANA 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.

     

    
      
        
        

      

      
        38

        
          

        

      

      
        
        

      

    

     

    16.18 Further
      Assurances.
      Each
      Party hereby agrees, without further consideration, to execute and deliver
      such
      documents and take such other actions as the other Party may reasonably request
      to carry out the provisions hereof and further the intent of this
      Agreement.

    


    16.19 Consent
      to Sublicense.
      NovaDel
      hereby consents to the terms of this Agreement and the sublicense granted
      hereunder.

     

    [Signature
      Page Follows]


    
      
        
        

      

      
        39

        
          

        

      

      
        
        

      

    

    


    IN
      WITNESS WHEREOF, the Parties hereto have caused this Development and
      Commercialization Sublicense Agreement to be executed as a sealed instrument
      in
      their names by their properly and duly authorized officers or representatives
      as
      of the date first above written.

     

    
      	 HANA
              BIOSCIENCES, INC.	 	PAR PHARMACEUTICAL, INC. 
	 	 	 
	
              By:

            	
                 /s/ Mark J. Ahn

            	 	
              By:

            	
                 /s/ John MacPhee

            
	 	
              Name:  Mark J. Ahn

            	 	 	
              Name:  John MacPhee

            
	 	
              Title:  President and CEO

            	 	 	
              Title:  President, Branded Division

            


    

     

     

    NOVADEL PHARMA, INC.

     

     

    
      	
              By:

            	
                 /s/ Steven Ratoff

            	 
	 	
              Name: Steven Ratoff

            	 
	 	
              Title: Chairman, President and CEO

            	 


    

     

    
      
        
        

      

      
        40

        
          

        

      

      
        
        

      

    


    EXHIBIT
      A

     

    NOVADEL
      PATENTS

     

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

     

    
      
        
        

      

      
        41