Unassociated Document


    DEVELOPMENT AND SUPPLY
AGREEMENT

    FOR GENERIC
{***}

    BETWEEN ELITE
PHARMACEUTICALS AND

    HI-TECH PHARMACAL CO.
INC.

     

    This
DEVELOPMENT AND SUPPLY AGREEMENT (the “Agreement”), dated as of January 4, 2011
between Elite Pharmaceuticals, Inc., a corporation organized under the laws of
the State of Delaware, with its offices at 165 Ludlow Avenue, Northvale, New
Jersey (“Elite”), and Hi-Tech Pharmacal Co., Inc., a corporation organized under
the laws of the State of Delaware with its offices at 369 Bayview Avenue,
Amityville, NY  11701 (“Hi-Tech”).  Elite and Hi-Tech may
sometimes hereinafter be referred to as a “Party” or collectively as the
“Parties”.

    


    WITNESSETH
THAT:

    


    WHEREAS, Elite is the owner of
original processes and know-how for the development and manufacture of specialty
oral solid dosage pharmaceutical products;

    


    WHEREAS, Elite and Hi-Tech
entered into a Mutual Non-Disclosure Agreement, dated August 1, 2010, pursuant
to which the Parties exchanged confidential information relating to this
proposed cooperative effort;

    


    WHEREAS,  Hi-Tech
desires that Elite undertake a developmental program directed towards producing
an Intermediate Product that will be used by Hi-Tech to formulate a Product that
is a generic equivalent to {***} having the specifications agreed upon between
Hi-Tech and Elite;

    


    WHEREAS, Elite is willing to
undertake such a development program on the terms and conditions set forth
hereinafter;

    


    WHEREAS,  Hi-Tech
also desires to market and sell products utilizing Elite’s know-how and Elite is
willing to permit Hi-Tech to utilize its know-how on the terms and conditions
set forth herein;

    


    NOW, THEREFORE, in
consideration of the agreements and covenants hereinafter set forth and
intending to be legally bound hereby, the Parties hereto covenant and agree as
follows:

    


    1.           DEFINITIONS

    


    
      	
               
      

            	
              1.1

            	
              “Act”
      shall mean the United States Food, Drug and Cosmetic Act, as amended from
      time to time and corresponding laws and regulations in other
      countries.

            


    

    


    
      
        	
              	
                1.2

              	
                “Affiliate”
      shall mean any person or entity which, directly or indirectly, controls,
      is controlled by, or is under common control with, a Party or its
      assignee. Control shall
      be determined based upon either their legal right to control or de facto
      control of the entity.

              


      

    

    


    {***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    


    
      
        
        

      

      
        1

        
          

        

      

      
        
        

      

    

     

    
      	
               
      

            	
              1.3

            	
              “ANDA”
      means an Abbreviated New Drug Application (or successor or similar
      application) for the Product filed with the FDA in the name of
      Hi-Tech.

            


    

    


    
      	
               
      

            	
              1.4

            	
              “Applicable
      Laws” means all laws, statutes, and regulations of any governmental
      authority, including the FDA having jurisdiction over the development,
      manufacture, use, marking or sale of the Product, as same may be amended
      from time to time.

            


    

    


    
      	
               
      

            	
              1.5

            	
              ”cGMP”
      shall mean current Good Manufacturing Practices as defined in regulations
      promulgated by the FDA under the Act, as may be amended from time to time,
      and corresponding regulations in the other
  countries.

            


    

    


    
      	
               
      

            	
              1.6

            	
              “Competitive
      Product” shall mean a product that is the generic equivalent to {***}, as
      marketed by {***}.

            


    

    


    
      	
               
      

            	
              1.7

            	
              “Cost
      of Goods Sold” means the costs of supplying Product calculated in
      accordance with a Party's accounting methods consistently applied which
      methodology shall be calculated in compliance with
  GAAP.

            


    

    


    
      	
               
      

            	
              1.8

            	
              “Development
      Program” shall mean Elite’s program to develop an Intermediate Product
      meeting the Specifications.

            


    

    


    
      	
               
      

            	
              1.9

            	
              “FDA”
      shall mean the Food and Drug Administration in the United States and
      corresponding governmental regulatory agencies in other
      countries.

            


    

    


    
      	
               
      

            	
              1.10

            	
              “Finished
      Goods” means the Intermediate Product or Product in its final commercial
      package.

            


    

     

    
      	
               
      

            	
              1.11

            	
              “Force
      Majeure” means any cause or causes which wholly or partially prevent or
      delay the performance of obligations arising under this Agreement and
      which are not reasonably within the control of the non-performing Party,
      including, but not limited to, acts of God, government regulations, labor
      disputes, floods, fires, civil commotion, embargoes, quotas, shortage of
      labor or materials or any delays in transportation or detention by
      customs, health or other government
authorities.

            


    

    


    
      	
               
      

            	
              1.12

            	
              “Governmental
      Authority” means any governmental department, commission, board, bureau,
      agency, court or other instrumentality of the United States or any other
      supranational organization of sovereign states, including without
      limitation, the European Union.

            


    

     

    {***}Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to
a confidential treatment request in accordance with Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

     

    
      
        
        

      

      
        2

        
          

        

      

      
        
        

      

    

     

    
      	
               
      

            	
              1.13

            	
              “Intermediate
      Product” means formulation made by Elite meeting the Specifications that
      will be used by Hi-Tech to formulate a Product that will be the generic
      equivalent to {***}as manufactured by
{***}

            


    

    


    
      	
               
      

            	
              1.14

            	
              “Know-How”
      means proprietary know-how, trademarks, inventions, data, technology and
      information relating to Intermediate Product or the Product, which either
      Party hereto has the lawful right to disclose to the other Party.
      “Know-How” shall include, without limitation, processes and analytical
      methodology used in development, testing, analysis and manufacture and
      medical, clinical, toxicological testing as well as other scientific data
      relating to Intermediate Product or the Product. With respect to Elite,
      “Know How” shall also include, without limitation, proprietary know-how,
      trademarks, data, technology and information relating to the manufacture
      of the Intermediate Product.

            


    

    


    
      	
               
      

            	
              1.15

            	
              “Net
      Profit” means Net Sales minus (a) Cost of Goods Sold for the Product and
      (b) Sales and Distribution Costs.  Sales and Distribution Costs
      shall not exceed five percent (5%) percent of Net
  Sales.

            


    

    


    
      	
               
      

            	
              1.16

            	
              “Net
      Sales” means all proceeds received by Hi-Tech and/or its Affiliates from
      sales, licensing or other transaction pertaining to the Product or from
      unaffiliated third parties , less the following as accrued  and
      adjusted for amounts actually taken: (a) any and all credits for Product
      returns during such calendar quarter, including, but not limited to,
      credits for short-dated, returned or unsold Products, and any and all
      credits, rebates, allowances actually granted or included in the invoice,
      cash discounts or other discounts, shelf-stock or other adjustments and
      rebates issued with respect to the Product incurred during such calendar
      quarter, including but not limited to, any and all Medicaid and other
      state rebates, chargeback and similar items, all net of sales and similar
      taxes thereon, provided, however, that some or all such items may be
      estimated and subsequently adjusted on GAAP basis; (b) any sales and
      excise taxes, other consumption taxes, duty or other governmental charges
      to the extent actually included in Net Sales; (c) any receivables on the
      books of Hi-Tech that are deemed to be uncollectible according to
      Hi-Tech’s internal accounting principles and GAAP consistently
      applied.  Such bad debt deduction shall be applied to Net Sales
      in the period in which such receivables are written off and shall be
      exclusive of any bad debt or uncollectible receivables of Hi-Tech
      unrelated to the Product; (d) any costs incurred by Hi-Tech in connection
      with any recalls of the Product; and (e) freight and
      insurance;

            


    

    


    
      	
               
      

            	
              1.17

            	
              “Person”
      means any individual, partnership, association, joint venture, limited
      liability company or corporation.

            


    

    


    
      	
               
      

            	
              1.18

            	
              “Product”
      means the drug product that is the generic equivalent to {***} as
      manufactured by {***}

            


    

     

    {***}Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to
a confidential treatment request in accordance with Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

     

    
      
        
        

      

      
        3

        
          

        

      

      
        
        

      

    

    
 

    
      	
               
      

            	
              1.19

            	
              “Registration”
      shall mean approval (including, but not limited to, any ANDA Approval) of
      a Registration Application for the Product filed by Hi-Tech relating to
      the manufacturing, use, marketing and sale, and/or pricing and
      reimbursement when applicable, of the
Product.

            


    

    


    
      	
               
      

            	
              1.20

            	
              “Registration
      Application” shall mean any filing(s) (including, but not limited to, any
      ANDA) made by Hi-Tech under this Agreement with a Governmental Authority
      for regulatory approval of the manufacture, use, marketing and/or sale,
      and/or pricing and reimbursement when applicable, of the Product
      including, without limitation, any amendments or supplements
      thereto.

            


    

    


    
      	
               
      

            	
              1.21

            	
              “Specifications”
      means the specifications for Product agreed upon in writing by the
      Parties, as set forth in Schedule
A.

            


    

    


    
      	
               
      

            	
              1.22

            	
              “Sales
      and Distribution Costs” means costs of selling and distributing the
      Product calculated in accordance with Hi-Tech’s accounting methods
      consistently applied which methodology shall be calculated in compliance
      with GAAP.

            


    

    


    2.           DEVELOPMENT PROGRAM AND
MANUFACTURING AGREEMENT

    


    
      	
               
      

            	
              2.1

            	
              The Development
      Program.

            


    

    


    
      	
               
      

            	
              (a)

            	
              Hi-Tech
      hereby engages Elite, and Elite hereby agrees to use commercially
      reasonable efforts to develop and manufacture an Intermediate Product
      which meets FDA requirements and according to the
      Specifications.

            


    

    


    
      	
               
      

            	
              (b)

            	
              Elite
      shall have completed the Development Program when it provides an
      Intermediate Product meeting the Specifications outlined in Schedule A of
      this Agreement.

            


    

    


    
      	
               
      

            	
              (c)

            	
              In
      the event the Development Program materially deviates from the Development
      Program outlined in Schedule B attached hereto, the Parties will meet to
      discuss the changes and will use commercially reasonable efforts to
      resolve any issues in connection
therewith.

            


    

    


    
      	
               
      

            	
              2.2

            	
              Manufacturing and
      Quality Agreement.  Elite agrees to manufacture the
      Intermediate Product pursuant to a separate manufacturing agreement and
      quality assurance agreement to be executed by Elite and Hi-Tech. The
      Parties agree to negotiate the terms and provisions of the manufacturing
      agreement and quality assurance agreement within ninety (90) days from the
      date hereof.

            


    

     

    {***}Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to
a confidential treatment request in accordance with Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

     

    
      
        
        

      

      
        4

        
          

        

      

      
        
        

      

    

     

    
      	
               
      

            	
              2.3

            	
              Regulatory
      Filings.  Hi-Tech, or its designees, shall prepare all
      applications necessary to obtain any product Registrations required to
      market the Product. Elite shall write the CMC section for the Intermediate
      Product. All such Registrations shall be solely owned by Hi-Tech including
      any ANDA filing for the Product.  Elite shall use all
      commercially reasonable efforts to provide Hi-Tech with all
      pharmaceutical, technical, and clinical data and information in support of
      the ANDA application by Hi-Tech for the approval of the Product. Elite
      shall assist Hi-Tech as necessary in the preparation of any applications
      required to obtain any such permits. Elite shall use commercially
      reasonable efforts to file a Drug Master File for {***} upon Hi-Tech’s
      request therefor.

            


    

    


    
      	
               
      

            	
              2.4

            	
              Payments for
      Development.

            


    

    


    
      	
               
      

            	
              (a)

            	
              In
      consideration of Elite’s performance in accordance with the terms and
      conditions of the Agreement, Hi-Tech shall pay Elite’s fees for the
      Development Program according to the terms outlined in Schedule B of this
      agreement.  The payments described in Schedule B shall be made
      in advance, following completion of each phase, and prior to commencing
      work on the next phase.  Elite shall provide written notice of
      its intent to commence each phase, and Hi-Tech shall pay Elite’s fee for
      such phase within fifteen (15) days after receipt of such notice, unless
      Hi-Tech elects to terminate the Agreement pursuant to Section
      9.4.  The initial payment shall be made when Elite notifies
      Hi-Tech that it intends to commence the Development
      Program.  Any costs in excess of the amount outlined in Schedule
      B must be approved in writing in advance by Hi-Tech.  Any
      out-of-pocket-expenses including raw material costs will be paid for by
      Hi-Tech.  Costs for filing of the DMF per Section 2.3 and any
      additional work mutually agreed upon by the Parties, but not covered in
      Schedule B shall be paid for at cost.  Elite will invoice
      Hi-Tech for these costs and provide details of the work completed and
      suppliers’ invoices as documentation of the costs.  Costs over
      $1,000 will be pre-approved in writing by Hi-Tech.  Hi-Tech
      shall pay within 30 days any invoice from Elite with respect to any
      approved expenses incurred in developing the Intermediate
      Product.

            


    

    


    
      	
               
      

            	
              (b)

            	
              In
      addition to the developmental work outlined, Hi-Tech will pay the cost of
      stability studies and any bio-studies and any analyses associated with
      such bio-studies which are performed in conjunction with the Development
      Program.

            


    

    


    
      	
               
      

            	
              (c)

            	
              Any
      payments earned in accordance with Schedule B shall not be
      refundable.

            


    

    


    3.           TRADEMARKS

    


    Use of Trademark by
Hi-Tech.  Hi-Tech shall own and market the Product under its
own Trademark.

     

    {***}Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to
a confidential treatment request in accordance with Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

     

    
      
        
        

      

      
        5

        
          

        

      

      
        
        

      

       

    

    4.           REGISTRATION OBLIGATIONS;
NONCOMPETITION

    


    
      	
               
      

            	
              4.1

            	
              Registration
      Obligations of Hi-Tech.  Hi-Tech shall exercise
      commercially reasonable efforts to apply for Registration of the Product
      within one year following completion of the Development Program. In
      addition, Hi-Tech shall begin marketing the Product within one year
      following receipt of any required approvals, or Registration, whichever is
      later and shall use its commercially reasonable efforts to market and sell
      the Product.  Hi-Tech and Elite hereby agree that exertion of
      “commercially reasonable efforts” shall mean the same efforts that such
      Party devotes to its other pharmaceutical products and shall include,
      without limitation, the cooperation for submission by Hi-Tech of any
      additional documentation on the Product required under any Applicable
      Laws.

            


    

    


    
      	
               
      

            	
              4.2

            	
              Competing Dosage
      Forms.  During the term of this Agreement, neither Party
      shall produce, develop or market, any Competitive Product with the
      Specifications noted in Schedule A of this Agreement without the prior
      written approval of the other Party. For a period of five (5) years
      following the termination of this Agreement, regardless of the reason for
      such termination (except for termination by Elite due to default of
      Hi-Tech as provided in Section 10), Elite shall not produce, develop or
      market, any Competitive Product without the prior written approval of
      Hi-Tech.

            


    

    


    
      	
               
      

            	
              4.3

            	
              CGMP.  Elite
      shall be responsible for the manufacture of the Intermediate Product and
      Hi-Tech shall be responsible for the manufacture of the
      Product.  All Finished Goods shall be manufactured and packaged
      under cGMP, in accordance with the Specifications, and in compliance with
      all applicable laws and
regulations.

            


    

    


    
      	
              5.

            	
              PATENTS AND
      KNOW-HOW

            


    

    


    Each
Party shall be responsible, at its own expense, for filing and prosecuting
patent applications relating to its Know-How, as it deems appropriate, and for
paying maintenance fees on any patents issuing therefrom, for the term of this
Agreement, with respect to Know-How owned by it.  Each Party shall
promptly render all necessary assistance reasonably requested by the other Party
in applying for and prosecuting patent applications relating to such Party’s
Know-How under this Agreement.  Hi-Tech shall also have the right to
have Elite file and prosecute patent applications in Hi-Tech’s name for Elite
Know-How for the Intermediate Product, at Hi-Tech’s cost, for any Know-How that
Elite chooses not to file on its own.

    


    Ownership
of inventions shall be determined by US Patent Law.  Subject to the
terms set forth herein and in consideration for the payments set forth, Elite
hereby grants to Hi-Tech an exclusive fully paid up, royalty-free, perpetual
license to use the Know-How for the Intermediate Product and the
Product.  Elite also grants to Hi-Tech an exclusive fully paid up
royalty-free, perpetual license to use the Know-How for the Intermediate Product
for other {***} for pharmaceutical products.

     

    {***}Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to
a confidential treatment request in accordance with Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

     

    
      
        
        

      

      
        6

        
          

        

      

      
        
        

      

       

    

    All
Hi-Tech Know-How used in connection with the manufacture and formulation of the
Product shall be exclusively owned by Hi-Tech.

    


    6.           REPRESENTATIONS AND
WARRANTIES

    


    
      	
               
      

            	
              6.1

            	
              Each
      Party hereby represents and warrants that such Party is duly organized and
      validly existing under the laws of the country of its organization or
      state of incorporation, as applicable, and has full corporate power and
      authority to enter into this Agreement and to carry out the provisions
      hereof.

            


    

    


    
      	
               
      

            	
              6.2

            	
              Each
      Party hereby represents and warrants that such Party is duly authorized to
      execute and deliver this Agreement and to perform its obligations
      hereunder.

            


    

    


    
      	
               
      

            	
              6.3

            	
              Each
      Party hereby represents and warrants that this Agreement is a legal and
      valid obligation binding upon it and is enforceable in accordance with its
      terms.  The execution, delivery and performance of this
      Agreement by such Party does not conflict with any agreement, contract,
      instrument or understanding, oral or written, to which it is a Party or by
      which it may be bound nor violate any law or regulation of any court,
      governmental body or administrative or other agency having authority over
      it.

            


    

    


    
      	
               
      

            	
              6.4

            	
              Each
      Party hereby represents and warrants that there is no action, suit,
      proceeding or investigation pending or threatened, against such Party (or
      any of its Affiliates) that questions the validity of this Agreement or
      the right of such Party to enter into this Agreement or consummate the
      transactions contemplated hereby, nor does such Party have knowledge that
      there is any basis for the
foregoing.

            


    

    


    
      	
               
      

            	
              6.5

            	
              Each
      Party hereby represents and warrants that it is not in violation of any
      law or regulation, nor is it aware of any violation of any law or
      regulation by any other Person, which violation could reasonably be
      expected to adversely affect its performance of its obligations hereunder,
      and except as otherwise contemplated hereby, such Party holds each of the
      licenses, permits, approvals or authorizations necessary with respect to
      its current business and operations (and its rights and obligations
      contemplated hereby) in compliance with all laws and
      regulations.

            


    

     

    {***}Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to
a confidential treatment request in accordance with Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

     

    
      
        
        

      

      
        7

        
          

        

      

      
        
        

      

    

     

    
      	
               
      

            	
              6.6

            	
              Each
      Party hereby represents and warrants that neither it nor any of its
      officers, directors or Affiliates is prohibited by any law, rule or
      regulation or by any order, directive or policy from selling the
      Intermediate Product or Product or other pharmaceutical products and that
      neither such Party nor any of its officers, directors or Affiliates is a
      Person that is listed by a United States federal agency as debarred,
      suspended or otherwise ineligible for federal programs in the United
      States, its territories and protectors or proposed for such debarment or
      suspension.

            


    

    


    
      	
               
      

            	
              6.7

            	
              Each
      Party hereby represents and warrants that it is the owner of the
      Intellectual Property to be used or relied upon by the other
      Party.

            


    

    


    
      	
               
      

            	
              6.8

            	
              Elite
      hereby represents and warrants that is has full right, power and authority
      to the Intellectual Property in connection with the formulation, including
      all discoveries and improvements thereto, of the Intermediate Product and
      that its employees or agents shall be the sole inventors and creators of
      such Intellectual Property.

            


    

    


    
      	
               
      

            	
              6.9

            	
              Each
      Party hereby covenants and agrees to provide the other Party with prompt
      written notice of any facts or circumstances (whether occurring prior to
      or after the date hereof) which cause or may cause any of the
      representations and warranties contained in this Article 6 not to be true,
      accurate or complete as of the date hereof or as of any date during the
      term of this Agreement.

            


    

    


    
      	
               
      

            	
              6.10

            	
              Except
      as set forth in this Agreement, neither Party makes any warranties with
      respect to the Product or Intermediate Product.  Without
      limiting the generality of the foregoing, neither Party makes any
      warranties, express or implied, including, without limitations, as to
      merchantability, fitness for a particular purpose, or any other matter
      concerning the commercial utility of the
  Product.

            


    

    


    
      	
               
      

            	
              6.11

            	
              Hi-Tech
      represents and warrants that:

            


    

    


    
      	
               
      

            	
              (i)

            	
              it
      has not received any notice or claim that the use of its Know-How
      infringes any patent or intellectual property rights of any third
      party.

            


    

    


    
      	
               
      

            	
              (ii)

            	
              to
      its actual knowledge, without any independent investigation, the use of
      its Know-How will not infringe any patent or intellectual property rights
      of any third party.

            


    

    


    
      	
               
      

            	
              6.12

            	
              Elite
      represents and warrants that:

            


    

    


    
      	
               
      

            	
              (i)

            	
              the
      Intermediate Product manufactured pursuant to this Agreement shall meet
      the Specifications and shall not be adulterated or misbranded within the
      meaning of the Act;

            


    

    


    
      	
               
      

            	
              (ii)

            	
              it
      has not received any written notice or claim that the use of its Know-How
      infringes any patent, , or other intellectual property rights of any third
      party; and

            


    

     

    {***}Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to
a confidential treatment request in accordance with Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

     

    
      
        
        

      

      
        8

        
          

        

      

      
        
        

      

    

     

    
      	
               
      

            	
              (iii)

            	
              to
      its actual knowledge, without any independent investigation, the use of
      its Know-How will not infringe any patent or intellectual property rights
      of any third party.

            


    

    


    7.           NET
PROFIT

    


    
      	
               
      

            	
              7.1

            	
              Net
      Profit.

            


    

    


    
      	
               
      

            	
              (a)

            	
              Hi-Tech
      shall pay Elite {***} of the Net Profit earned from the
      Product.

            


    

    


    
      	
               
      

            	
              (b)

            	
              Hi-Tech
      shall provide quarterly reports of all sales of Product sold. All
      quarterly reports shall be on a quarterly calendar schedule starting with
      the end of the calendar quarter immediately following the commercial
      launch of the Product. In the event there are no sales to report in any
      particular quarter, the quarterly report shall so
  state.

            


    

    


    
      	
               
      

            	
              (c)

            	
              All
      payments and quarterly sales reports hereunder shall be made within
      forty-five (45) days after the end of each calendar
    quarter.

            


    

    


    
      	
               
      

            	
              7.2

            	
              Audit
      Rights.  Upon twenty (20) days written notice, Elite or
      its designated representative shall have the right to inspect Hi-Tech’s
      books of account, records, documents and instruments related to the sales
      of the Product of Hi-Tech and any Affiliate and to make copies thereof, at
      any time during Hi-Tech’s regular business hours during the term of this
      Agreement and for a period of two (2) years immediately after termination
      of this Agreement to ascertain the accuracy of such records provided, however, that
      such audits may not be performed by Elite more than once per calendar year
      and that Elite shall not be permitted to audit the same period of time
      more than once.  Such accountants, prior to any review
      hereunder, shall have entered into an appropriate confidentiality
      agreement with Hi-Tech on mutually acceptable terms and shall have been
      instructed not to reveal to Elite the details of its review, except for
      (i) such information as is required to be disclosed under this Agreement,
      and (ii) such information presented in a summary fashion as is necessary
      to report the accountants’ conclusions to Elite.  If Elite fails
      to invoke its audit rights pursuant to this Section 7.2 with respect to a
      Calendar Year within two (2) years following the end of such year, the
      calculation of all amounts with respect to such year shall be binding and
      conclusive upon Elite and Hi-Tech, and each Party and its Affiliates shall
      be released from any liability or accountability with respect to
      distributions of Net Profits for such period.  The expense of
      such audit shall be Elite’s unless the audit shall demonstrate a
      discrepancy greater than five percent (5%) between royalties reported and
      paid and those which were actually incurred, in which event the expenses
      of such audit shall be borne by Hi-Tech. In the event there is a dispute
      between Elite and Hi-Tech regarding any discrepancy discovered by such
      audit, Hi-Tech and Elite shall together designate a qualified third party
      certified public accountant to perform a second audit, the results of
      which shall be binding. In the event the second audit reveals that the
      discrepancy was less than five percent (5%), then Elite shall pay the
      costs of the second audit. In the event that the second audit reveals that
      the discrepancy was more than five percent (5%), then Hi-Tech shall pay
      the cost of the second audit.

            


    

     

    {***}Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to
a confidential treatment request in accordance with Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

     

    
      
        
        

      

      
        9

        
          

        

      

      
        
        

      

    

     

    
      	
               
      

            	
              7.3

            	
              Taxes.  All
      taxes, assessments, fees and other charges, if any, levied under the laws
      or regulations with respect to payments due to Elite hereunder shall be
      for the account of Elite, and if required to be withheld from payments to
      Elite, shall be deducted by Hi-Tech from such payments to Elite. Receipts,
      if available, for all such withholdings shall be provided to
      Elite.  Hi-Tech shall be responsible for establishing its right
      to claim any exemption to such charges or to its withholding, and shall
      keep Elite advised in writing of the basis and status of all such
      exemption claims.

            


    

    


    
      	
               
      

            	
              7.4

            	
              Currency. All
      payments to Elite hereunder shall be computed and made in United States
      Dollars. For the purpose of computing payments for Product sold in a
      currency other than United States Dollars, such currency shall be
      converted into United States Dollars using the rate of exchange prevailing
      at the Citibank, New York, NY (or such other bank as the Parties may agree
      upon from time to time) for the last day of the applicable
      period.

            


    

    


    8.           PRICES

    


    
      	
               
      

            	
              8.1

            	
              Prices and Price
      Changes.

            


    

    


    
      	
               
      

            	
              (a)

            	
              Elite
      shall sell, and Hi-Tech shall buy, the Intermediate Product for a price
      equal to Elite’s manufacturing costs, plus {***} at Elite’s facility in
      Northvale, New Jersey, or at another mutually agreeable location of Elite,
      or at a subcontractor’s facility; provided,
      Hi-Tech has approved such subcontractor in
      advance.  Manufacturing costs shall be calculated in accordance
      with a Party's accounting methods consistently applied which methodology
      shall be calculated in compliance with
GAAP.

            


    

    


    
      	
               
      

            	
              (b)

            	
              Elite
      shall be entitled to adjust the price set forth in Section 8.1 (a) above
      to reflect the actual changes in its manufacturing costs; provided,
      however, that such adjustments may be made no more than once each calendar
      year and shall become effective July 1 of the calendar year. Elite shall
      notify Hi-Tech of the revised price of the Intermediate Product during the
      second quarter of each calendar year during the term of the Agreement and
      shall deliver to Hi-Tech evidence of any increases of 4% or more to such
      manufacturing costs incurred by Elite. The revised price shall be applied
      to any delivery of Product made after July 1 of the calendar year. In
      addition, the price applicable during any calendar year may be adjusted by
      Elite as soon as is practicable after thirty (30) days written notice to
      Hi-Tech, to cover one hundred percent (100%) of any additional cost or
      expense of manufacturing Intermediate Product, in the event that a change
      in manufacturing technique is (i) requested by Hi-Tech or (ii) required by
      a change in Applicable Laws (including a change in cGMP), or (iii) caused
      by an increase in the cost of raw materials, or (iv) is caused. by any
      other factor beyond Elite’s control which materially affects Elite’s
      ability to perform its obligations
hereunder.

            


    

     

    {***}Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to
a confidential treatment request in accordance with Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

     

    
      
        
        

      

      
        10

        
          

        

      

      
        
        

      

    

     

    
      	
               
      

            	
              8.2

            	
              Payment and
      Terms.  Elite shall send to Hi-Tech an invoice showing
      the amount due under Section 8.1 following each shipment Hi-Tech shall pay
      Elite the amount due by check within thirty (30) days of the date of the
      invoice.

            


    

    


    
      	
               
      

            	
              8.3

            	
              Audit
      Rights.  Upon twenty (20) days written notice, Hi-Tech or
      its designated representative shall have the right to inspect Elite’s
      records in regard to price changes of the Intermediate Product and to make
      copies thereof, at any time during Elite’s regular business hours during
      the term of this Agreement and for a period of two (2) years immediately
      after termination of this Agreement to ascertain the accuracy of such
      records; provided, however, that
      such audits may not be performed by Hi-Tech more than once per calendar
      year and that Hi-Tech shall not be permitted to audit the same period of
      time more than once.  Such accountants, prior to any review
      hereunder, shall have entered into an appropriate confidentiality
      agreement with Elite on mutually acceptable terms and shall have been
      instructed not to reveal to Hi-Tech the details of its review, except for
      (i) such information as is required to be disclosed under this Agreement,
      and (ii) such information presented in a summary fashion as is necessary
      to report the accountants’ conclusions to Hi-Tech.  If Hi-Tech
      fails to invoke its audit rights pursuant to this Section 8.3 with respect
      to a price change within two (2) years following the price change, the
      calculation of all amounts with respect to such year shall be binding and
      conclusive upon Elite and Hi-Tech, and each Party and its Affiliates shall
      be released from any liability or accountability with respect to payments
      for such period.  The expense of such audit shall be Hi-Tech’s
      unless the audit shall demonstrate a discrepancy greater than five percent
      (5%) between the manufacturing costs reported and paid and those which
      were actually incurred, in which event the expenses of such audit shall be
      borne by Elite. In the event there is a dispute between Elite and Hi-Tech
      regarding any discrepancy discovered by such audit, Hi-Tech and Elite
      shall collectively designate a qualified third party certified public
      accountant to perform a second audit, the results of which shall be
      binding. In the event the second audit reveals that the discrepancy was
      less than five percent (5%), then Hi-Tech shall pay the costs of the
      second audit. In the event that the second audit reveals that the
      discrepancy was more than five percent (5%), then Elite shall pay the cost
      of the second audit.

            


    

     

    {***}Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to
a confidential treatment request in accordance with Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

    
    

    
      
        
        

      

      
        11

        
          

        

      

      
        
        

      

    

     

    9.           TERM

    


    
      	
               
      

            	
              9.1

            	
              Basic Term.
      This Agreement shall be effective from the date consummated and shall
      continue for a ten (10) year term after the initial marketing of the
      Product or pursuant to Section 9. Upon the expiration of the initial term
      or any renewal term, this Agreement will automatically renew for an
      additional five (5) year term, unless one Party gives at least six (6)
      months notice in writing in advance of its intent not to
    renew

            


    

    


    
      	
               
      

            	
              9.2

            	
              Early Termination by
      Reason of Patent Litigation. In the event that either Party to this
      Agreement is named in third-party patent litigation related to the subject
      matter of this Agreement and seeking an award of damages or an injunction,
      either Party shall have the right at any time following the entry of an
      adverse, nonappealable judgment in such case to terminate this Agreement
      immediately on 10 days written notice without further obligation to the
      other except for obligations incurred prior to the time of such
      notice.

            


    

    


    
      	
               
      

            	
              9.3

            	
              Early Termination by
      Reason of Failure to Develop Product. In the event Elite has not
      completed the Development Program within twelve (12) months of execution
      of this Agreement, Hi-Tech may terminate this Agreement upon ten (10) days
      written notice.  In such event, Elite shall not produce, develop
      or market a Competitive Product without the prior written approval of
      Hi-Tech for a period of five (5) years following such termination unless
      Elite first offers such Product to Hi-Tech on the identical terms
      contained in this Agreement, and Hi-Tech chooses not to accept such offer
      within 30 days.

            


    

    


    
      	
               
      

            	
              9.4

            	
              Earlv Termination by
      Reason of Market Conditions. At any time prior to commencement of
      any phase of the Development Program, Hi-Tech may terminate this Agreement
      on 10 days written notice in the event Hi-Tech, in its sole discretion,
      determines that the Product is no longer commercially reasonable or the
      Product is not compatible with Hi-Tech’s business strategy. In such event,
      Hi-Tech shall have no further obligation to Elite, and Elite shall be
      under no obligation to reimburse Hi-Tech for any payments made. In the
      event Hi-Tech terminates the Agreement pursuant to this Section 9.4, the
      covenant not to compete described in Section 4.2 shall not
      apply.

            


    

     

    {***}Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to
a confidential treatment request in accordance with Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

     

    
      
         


      

      
        12

        
          

        

      

      
         


      

    


    
      	
              10.

            	
              EVENTS OF DEFAULT,
      REMEDIES AND EFFECTS OF
DEFAULT

            


    

    


    
      	
               
      

            	
              10.1

            	
              Events of
      Default. An event of default under this Agreement shall be deemed
      to exist upon the occurrence of anyone or more of the following
      events:

            


    

    


    
      	
               
      

            	
              (a)

            	
              Failure
      by either Party hereto to perform fully, or comply fully, with, any
      material provision of this Agreement and such failure continues (i) for a
      period of sixty (60) days after receipt of written notice of such
      nonperformance or noncompliance, or (ii) if the non-performing or
      noncomplying Party shall commence within such sixty (60) days and shall
      thereafter proceed with all due diligence to cure such failure, such
      failure is not cured within such longer period (not to exceed sixty (60)
      days) as shall be reasonably necessary for such Party to cure the same
      with all due diligence; or

            


    

    


    
      	
               
      

            	
              (b)

            	
              Failure
      of Hi-Tech to pay any amount due to Elite, which failure continues for a
      period of sixty (60) days after written notice of such non-payment unless,
      and to the extent such non-payment is due to a good faith dispute
      concerning the amount owed.

            


    

    


    
      	
               
      

            	
              10.2

            	
              Remedies. Upon
      the occurrence and during the continuation of any event of default
      hereunder, the Party not in default may terminate this Agreement in whole
      or only with regard to the provision which has given rise to the event of
      default, and pursue any other remedies provided under this Agreement or
      available at law.

            


    

    


    
      	
               
      

            	
              10.3

            	
              Survival. In
      the event of a termination of this Agreement the provisions of Articles 4,
      5, 6, 9, 10, 11, 12 and 13 shall survive such
  termination.

            


    

    


    
      	
               
      

            	
              10.4

            	
              WARRANTY
      LIMITATION. EXCEPT AS EXPRESSLY SET FORTH IN SECTION 6, THE PARTIES
      MAKE NO WARRANTIES, EXPRESSED OR IMPLIED, CONCERNING TECHNOLOGY, GOODS,
      SERVICES, RIGHTS OR THE MANUFACTURE AND SALE OF PRODUCTS, AND HEREBY
      DISCLAIM: ANY OTHER WARRANTIES, INCLUDING WITHOUT LIMITATION ANY WARRANTY
      OF MERCHANTABILITY, FITNESS FOR A PARTICULAR USE OR PURPOSE OR
      NONINFRINGEMENT WITH RESPECT TO ANY AND ALL OF THE
    FOREGOING.

            


    

    


    
      	
              11.

            	
              INDEMNIFICATION

            


    

    


    
      	
               
      

            	
              11.1

            	
              Indemnification of
      Hi-Tech. Elite shall indemnify and hold harmless Hi-Tech, its
      Affiliates and its officers, directors and employees (“Hi-Tech Indemnified
      Parties”) against and from any losses, damages, injuries, liabilities,
      exposure, claims, demands, settlement, judgments, awards, fines,
      penalties, taxes, fees (including attorneys’ fees), charges or expenses
      that are suffered or incurred at any time by Hi-Tech Indemnified Parties,
      or to which Hi-Tech Indemnified Parties may otherwise become subject at
      any time, and that become payable or arise out of or by virtue of, or
      relate to:

            


    

    


    
      	
               
      

            	
              (a)

            	
              Any
      injury, claim or damage resulting from Elite’s manufacture and/or
      development activities relating to the Intermediate
    Product;

            


    

    


    
      	
               
      

            	
              (b)

            	
              The
      failure of Elite, its officers, directors, agents, and employees to comply
      with Applicable Laws;

            


    

    


    {***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    
      
         


      

      
        13

        
          

        

      

      
         


      

    

    


    
      	
               
      

            	
              (c)

            	
              Any
      material breach by Elite or default by Elite in the performance of, or any
      failure on the part of Elite to observe, perform or abide by, any
      restriction, covenant, obligation, representation, warranty or other
      provision contained in this Agreement
or

            


    

    


    
      	
               
      

            	
              (d)

            	
              Any
      injury or alleged injury to any person (including death) or to the
      property of any person not a Party hereto arising out of or alleging the
      negligence or intentional act or omission of Elite or its officers,
      directors, agents and employees.

            


    

    


    
      	
               
      

            	
              11.2

            	
              Indemnification of
      Elite.  Hi-Tech shall indemnify and hold harmless Elite,
      its Affiliates, and its officers, directors or employees (“Elite
      Indemnified Parties”) against and from any losses, damages, injuries,
      liabilities, exposure, claims, demands, settlement, judgments, awards,
      fines, penalties, taxes, fees (including attorneys’ fees), charges or
      expenses that are suffered or incurred at any time by Elite Indemnified
      Parties, or to which Elite Indemnified Parties may otherwise become
      subject at any time, and that become payable or arise out of or by virtue
      of, or relate to:

            


    

    


    
      	
               
      

            	
              (a)

            	
              Any
      injury, claim or damages resulting from Hi-Tech’s development activities,
      manufacture, marketing and/or sale of the
  Product;

            


    

    


    
      	
               
      

            	
              (b)

            	
              The
      failure by Hi-Tech, its officers, directors, agents, and employees to
      comply with Applicable Laws;

            


    

    


    
      	
               
      

            	
              (c)

            	
              Any
      material breach by Hi-Tech or default by Hi-Tech in the performance of, or
      any failure on the part of Hi-Tech to observe, perform or abide by, any
      restriction, covenant, obligation, representation, warranty or other
      provision contained in this Agreement
or

            


    

    


    
      	
               
      

            	
              (d)

            	
              Any
      injury or alleged injury to any person (including death) or to the
      property of any person not a Party hereto arising out of or alleging the
      negligence or intentional act or omission of Hi-Tech or its officers,
      directors, agents and employees or
agents.

            


    

    


    
      	
               
      

            	
              11.3

            	
              Notice and Legal
      Defense. Promptly after receipt by a Party hereunder of any claim
      or notice of the commencement of any action, administrative or legal
      proceeding, or investigation as to which the indemnity provided for in
      Section 11.1 and 11.2 hereof may apply, the Party seeking indemnification
      shall notify the indemnifying Party in writing within 10 days of such fact
      The indemnifying Party shall assume the defense thereof; provided,
      however, that if the defendants in any such action include both the Party
      seeking indemnification and the indemnifying Party and the Party seeking
      indemnification shall reasonably conclude that there may be legal defenses
      available to it which are different from or additional to, or inconsistent
      with, those available to the indemnifying Party, the Party seeking
      indemnification shall have the right to select separate counsel to
      participate in the defense of such action on behalf of such Party seeking
      indemnification, at the indemnifying Party’s
  expense.

            


    

     

    {***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    
      
         


      

      
        14

        
          

        

      

      
         


      

    

    


    
      	
               
      

            	
              11.4

            	
              LIMITATION OF
      DAMAGES. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER
      PARTY FOR LOST PROFITS (OTHER THAN AS ARE ORDINARILY ENCOMPASSED BY
      CONTRACT DAMAGES), LOSS OF GOODWILL, OR ANY SPECIAL, INDIRECT,
      CONSEQUENTIAL OR INCIDENTAL DAMAGES, HOWEVER CAUSED, ARISING UNDER ANY
      THEORY OF LIABILITY. THIS LIMITATION SHALL APPLY EVEN IF A PARTY HAS BEEN
      ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, AND NOTWITHSTANDING ANY
      FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED
  REMEDY.

            


    

    


    
      	
              12.

            	
              CLAIMS AND LEGAL
      PROCEEDINGS; INSURANCE

            


    

    


    
      	
               
      

            	
              12.1

            	
              Claims Against Hi-Tech
      or Elite. If any claim is asserted or any legal proceedings
      commenced against Hi-Tech or Elite during the term of this Agreement, and
      such claim or legal proceeding involves any allegation that (i) the use of
      either Party’s Know-How in connection with the Product or the marketing or
      sale of the Product infringes or has infringed on any patent or other
      proprietary right of any person or entity; or (ii) any of such Know-How,
      or any patent or other portion thereof, is invalid or unenforceable, then
      the Party against whom such proceeding has been commenced shall provide
      the other Party with written notice of the assertion of such claim or the
      commencement of such legal proceeding within 10 days, and shall furnish to
      the other Party copies of all correspondence, pleadings and other
      materials relating to such claim or legal proceeding within 10 days; and
      in any event

            


    

    


    
      	
               
      

            	
              (a)

            	
              Hi-Tech
      shall have the right to control the defense of any such claim or legal
      proceeding with counsel of its own
choosing;

            


    

    


    
      	
               
      

            	
              (b)

            	
              Elite
      shall provide Hi-Tech with such information and reasonable assistance as
      Hi-Tech may request regarding such claim or legal proceeding at Elite’s
      expense, provided that Hi-Tech shall reimburse Elite for all out-of-pocket
      costs occurred;

            


    

    


    
      	
               
      

            	
              (c)

            	
              Hi-Tech
      shall not enter into any settlement with regard to such claim or legal
      proceeding without the consent of Elite (which shall not be unreasonably
      withheld or delayed);

            


    

     

    {***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    
      
         


      

      
        15

        
          

        

      

      
         


      

    

    


    
      	
               
      

            	
              (d)

            	
              In
      the event there is a negative outcome to any such claim or legal
      proceeding, any amount payable to the complaining Party in connection with
      any settlement of such claim or legal proceeding, or the amount of any
      damages or costs awarded to the complaining Party by any court,
      arbitrator, or other trier of fact, shall be borne and paid by Elite if
      related to the Know-How provided by Elite, or by Hi-Tech if the
      infringement is attributable to Know-How provided by
    Hi-Tech.

            


    

    


    
      	
               
      

            	
              12.2

            	
              Infringement by Third
      Parties. If either Party becomes aware of any actual or possible
      infringement of any aspect of either Party’s Know-How, including any
      patent or part thereof, by any person or entity, then such Party shall
      provide the other Party with written notice of such actual or possible
      infringement within 10 days and shall furnish to the other Party any
      available evidence of such actual or possible infringement within 10 days.
      Regardless of which Party first becomes aware of the possible infringement
      of any of the Know-How, the Party who is the owner of such Know-How shall
      have the exclusive right, in its discretion, to assert any infringement
      claim against such third party, and to commence and control any related
      proceedings, and neither Party shall assert any infringement claim or
      commence any proceeding without the prior written consent of the Party who
      owns the Know-How in question. In the event that the owner of such
      Know-How elects not to assert the infringement claim the other Party may
      assert the infringement claim at its own expense. If either Party elects
      to assert an infringement claim, the other Party shall make available such
      information and assistance as the prosecuting Party may request for the
      purposes of enabling such Party to pursue the infringement
      claim.

            


    

    


    
      	
               
      

            	
              12.3

            	
              Insurance.  Each
      Party shall maintain during the term and any renewal terms insurance in
      such amounts and against such risks as is customary by companies engaged
      in the same or similar business and similarly located, and shall, upon
      request, furnish evidence of such
insurance.

            


    

    


    
      	
               
      

            	
              12.4

            	
              Coverage
      Amounts.  Without prejudice to any rights or remedies
      either Party may have under this Agreement or otherwise at law generally,
      Elite and Hi-Tech shall each maintain in full force and effect adequate
      product liability insurance with annual coverage of at least US$3,000,000
      per occurrence and US$10,000,000 in the aggregate, during the period of
      manufacture by Hi-Tech and for a period of seven (7) years
      thereafter.  Each Party will provide the other with evidence of
      such insurance and such insurance shall name the other Party as an
      additional insured.

            


    

     

    {***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    
      
         


      

      
        16

        
          

        

      

      
         


      

    

    


    
      	
              13.

            	
              RECALL OR
      WITHDRAWAL

            


    

    


    
      	
               
      

            	
              13.1

            	
              Recall or
      Withdrawal.

            


    

    


    
      	
               
      

            	
              (a)

            	
              If
      any governmental authority having jurisdiction requires or reasonably
      requests Hi-Tech to recall any Product that have been distributed due to a
      defect in the design of the package or manufacture, processing, packaging
      or labeling of the Product or for any other reason whatsoever or Hi-Tech
      decides to withdraw or recall the Product in it sole discretion, Hi-Tech
      shall notify Elite, in writing within 2 days of Hi-Tech receiving the
      notice for a recall or withdrawal or deciding to initiate a recall or
      withdrawal.

            


    

    


    
      	
               
      

            	
              (b)

            	
              Elite
      hereby agrees to follow any reasonable direction of Hi-Tech as to the
      manner of completing the recall or withdrawal, provided the responsible
      governmental authority does not disagree with any such action. Elite shall
      assist Hi-Tech in the recall or withdrawal in the manner agreed upon in as
      expeditious a manner as possible and in such a way as to cause the least
      disruption to business, and to preserve the goodwill and reputation of
      their respective customers.

            


    

    


    
      	
               
      

            	
              (c)

            	
              With
      respect to any recall or withdrawal caused by the negligence, mistake,
      fault, error or omission of Elite, Elite
shall:

            


    

    


    
      	
               
      

            	
              (i)

            	
              reimburse
      Hi-Tech for any and all losses, costs and expenses reasonably incurred by
      Hi-Tech in connection with the recall;
and

            


    

    


    
      	
               
      

            	
              (ii)

            	
              indemnify
      and save Hi-Tech harmless from and against any and all damages to or
      claims by third parties associated with or resulting from any such recall
      or withdrawal.

            


    

    


    
      	
               
      

            	
              (d)

            	
              With
      respect to any recall or withdrawal caused by the negligence, mistake,
      fault, error or omission of Hi-Tech,  Hi-Tech
    shall:

            


    

    


    
      	
               
      

            	
              (i)

            	
              reimburse
      Elite for any and all losses, costs and expenses reasonably incurred by
      Elite in connection with the recall or withdrawal;
  and

            


    

    


    
      	
               
      

            	
              (ii)

            	
              indemnify
      and save Elite harmless from and against any and all damages to or claims
      by third parties associated with or resulting from any such recall or
      withdrawal.

            


    

     

    
      {***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with
Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

    

    
      
         


      

      
        17

        
          

        

      

      
         


      

    


    
      	
              14.

            	
              MISCELLANEOUS

            


    

    


    
      	
               
      

            	
              14.1

            	
              Neither
      this Agreement nor any interest herein may be assigned, in whole or in
      part, by either Party hereto without the prior written consent of the
      other Party hereto, provided, that either Party shall have the right to
      assign all or part of its rights, interest and obligations to an affiliate
      of such Party, a Purchaser of a majority of the outstanding shares of such
      Party, or to a Purchaser of substantially all the assets of the business
      to which this Agreement relates. Subject to the foregoing, this Agreement
      shall be binding upon and inure to the benefit of the Parties hereto and
      their respective permitted successors and
  assigns.

            


    

    


    
      	
               
      

            	
              14.2

            	
              Confidentiality.

            


    

    


    
      	
               
      

            	
              (a)

            	
              Any
      and all information provided by one Party to the other pursuant to this
      Agreement or the Mutual Non-Disclosure Agreement by and between the
      Parties made as of August 1, 2010 (“Mutual Non-Disclosure Agreement”)
      shall be deemed to be confidential information (“Proprietary
      Information”).  Proprietary Information means all
      communications, documents, materials, and other information, whether in
      written, oral, electronic or other form, that either disclosing Party
      provides, causes to be provided, or otherwise discloses to a receiving
      Party, or which a receiving Party otherwise learns in connection with the
      Agreement.  Proprietary Information includes, but is not limited
      to, the existence and terms of this Agreement, prospect information and
      lists, techniques, methodologies, patents, market research and analysis,
      costs, pricing, accounting and financial information, projections,
      regulatory information and data, customer and supplier information,
      strategies, forecasts, all information (in all forms) related to Elite’s
      and Hi-Tech’s business strategies, specific products, technical data and
      Know-How.  The obligations of confidentiality present in this
      Agreement supersede those contained in the Mutual Non-Disclosure
      Agreement.  Each Party will hold Proprietary Information of the
      other Party in complete confidence and will not, without the prior written
      consent of the other, use or disclose it in whole or in part to any person
      other than for the purposes set forth in this Agreement for a period
      ending five (5) years following expiration of this Agreement. Each Party
      will be entitled to disclose any such Proprietary Information to such of
      its professional advisers, directors, officers and senior employees who
      are directly concerned with this Agreement and its implementation and
      whose knowledge of such information is necessary for these purposes. Each
      Party will use its reasonable efforts to ensure that each individual to
      whom such a disclosure is made adheres to the terms of this undertaking as
      if he or she were a Party hereto, including without limitation, having
      such individuals execute similar
agreements.

            


    

    


    
      	
               
      

            	
              (b)

            	
              As
      used herein, the term Proprietary Information shall not include
      information:

            


    

     

    {***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    
      
         


      

      
        18

        
          

        

      

      
         


      

    

    


    
      	
               
      

            	
              (i)

            	
              which
      at the time of disclosure to the other Party is in the public domain or is
      otherwise available to the receiving Party other than on a confidential
      basis;

            


    

    


    
      	
               
      

            	
              (ii)

            	
              which,
      after disclosure, becomes generally available to third parties from a
      source other than the discloser; provided that such source is not bound by
      a confidentiality or other similar agreement with the disclosing Party or
      by any other legal, contractual or fiduciary obligation which prohibits
      the disclosure of such Proprietary
Information;

            


    

    


    
      	
               
      

            	
              (iii)

            	
              which
      was lawfully in possession of the receiving Party prior to disclosure, as
      evidenced by written records and which was not acquired directly or
      indirectly from the disclosing Party;
or

            


    

    


    
      	
               
      

            	
              (iv)

            	
              which
      the receiving Party is required to disclose to the extent required under
      the laws or regulations of any governmental agency lawfully requesting the
      same, or to any court of competent jurisdiction acting pursuant to its
      powers; provided, that in such event the receiving Party shall provide the
      disclosing Party with advance notice of any such required
      disclosure.

            


    

    


    
      	
               
      

            	
              (c)

            	
              Each
      Party acknowledges that monetary damages may not be sufficient remedy for
      unauthorized disclosure of confidential information or materials and that
      the non-disclosing Party shall be entitled, without waiving any other
      rights or remedies, to such injunctive or equitable relief as may be
      deemed proper by a court of competent
  jurisdiction.

            


    

    


    
      	
               
      

            	
              14.3

            	
              Force Majeure.
      Each of the Parties shall be excused from the performance or delay in
      performance of its obligations under this Agreement in the event such
      performance is prevented by Force Majeure and such performance shall be
      excused as long as the condition constituting such Force Majeure continues
      plus an additional thirty (30) days after termination of such condition;
      provided that the non-performing Party shall provide prompt notice to the
      other Party of the particulars of the occurrence constituting Force
      Majeure and of its cessation and shall make diligent efforts to mitigate
      the adverse consequences of such nonperformance or delays in
      performance.

            


    

    


    
      	
               
      

            	
              14.4

            	
              Amendments.
      Amendments to the Agreement shall not be binding on either Party unless
      reduced to writing and signed by both
Parties.

            


    

     

    {***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    
      
         


      

      
        19

        
          

        

      

      
         


      

    

    


    
      	
               
      

            	
              14.5

            	
              Waiver. Failure
      by either Party hereto on one or more occasions to avail itself of a right
      conferred by this Agreement shall in no event be construed as a waiver of
      such Party’s right to enforce said right in the
  future.

            


    

    


    
      	
               
      

            	
              14.6

            	
              Forum. The
      Parties agree that any action brought by either Party to enforce its
      rights hereunder shall be brought in the State of New York and both
      Parties consent to the jurisdiction of New
York.

            


    

    


    
      	
               
      

            	
              14.7

            	
              Enforcement. In
      the event that it is necessary for a Party to incur any costs and expenses
      in the enforcement of any of the terms and provisions of this Agreement in
      a court of law or equity, the Party substantially prevailing shall be
      entitled to reimbursement from the other Party for all costs and expenses
      incurred including, but not limited to, reasonable counsel fees and court
      costs.

            


    

    


    
      	
               
      

            	
              14.8

            	
              Mediation. All
      controversies arising out of or concerning the alleged breach of this
      Agreement shall first be submitted to non-binding mediation. In connection
      therewith, the parties hereby agree to attempt in good faith to resolve
      any such controversies through the mediation process. Notwithstanding the
      provisions of this paragraph, either Party may seek appropriate injunctive
      relief for any threatened conduct.

            


    

    


    
      	
               
      

            	
              14.9

            	
              Notices. Any
      notice or other communication required or permitted to be given hereunder
      shall be in writing and shall be deemed given when delivered personally,
      telecopied, received by registered mail, return receipt
      requested,  or by overnight special service guaranteeing next
      day or second day delivery, to the Parties at the following
      addresses:

            


    

    


    
      	
              If
      to Elite, to:

            	
              With
      a copy to:

            
	 
      	 
      
	
              Elite
      Pharmaceuticals, Inc.

            	
              William
      P. Ruffa

            
	
              165
      Ludlow Avenue

            	
              Ruffa
      & Ruffa, P.C.

            
	
              Northvale,
      New Jersey 07647

            	
              110
      East 59th Street

            
	
              Attn:
      President

            	
              New
      York, NY 10022

            
	
              Fax:
      (201) 750-2755

            	
              Tel.
      (212) 355-0606

            
	 
      	
              Fax.
      (1-877) Fax -Ruffa

            
	 
      	
              Lawruffa@gmail.com

            


    

    


    
      	
              If
      to Hi-Tech to:

            	
              With
      a copy to:

            
	 
      	 
      
	
              Hi-Tech
      Pharmacal Co., Inc.

            	
              Tashlik,
      Kreutzer, Goldwyn & Crandell P.C.

            
	
              369
      Bayview Avenue

            	
              40
      Cuttermill Road, Suite 200

            
	
              Amityville,
      NY  11701

            	
              Great
      Neck NY  11021

            
	
              Attn:
      President

            	
              Attn:
      Martin M. Goldwyn

            
	
              Fax:
      (631) 789-1884

            	
              Fax:
      (516) 829-6509

            


    

     

    {***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

     

    
      
         


      

      
        20

        
          

        

      

      
         


      

    

    


    
      	
            	
              14.10

            	
              Execution of
      Additional Documents. Each Party hereto agrees to execute such
      further papers or agreements as may be reasonably necessary or desirable
      to effect the purpose of this Agreement and carry out its
      provisions.

            


    

    


    
      	
            	
              14.11

            	
              Severability.
      In the event that any provision of this Agreement shall be held invalid or
      unenforceable by any court of competent jurisdiction, such holding shall
      not invalidate or render unenforceable any other provision
      hereof.

            


    

    


    
      	
            	
              14.12

            	
              Captions. The
      article and section captions in this Agreement have been inserted as a
      matter of convenience and are not part of this
  Agreement.

            


    

    


    
      	
            	
              14.13

            	
              Counterparts.
      This Agreement may be executed in any number of counterparts, each of
      which shall be deemed an original of this Agreement and all of which
      together shall constitute one and the same
  instrument

            


    

    


    
      	
            	
              14.14

            	
              Waiver of Jury
      Trial. Each Party hereto hereby waives to the fullest extent
      permitted by applicable law, any right it may have to a trial by jury in
      respect to any litigation directly or indirectly arising out of, under or
      in connection with this Agreement or any related
      instrument.  Each Party hereto (a) certifies that no
      representative, agent or attorney of any other Party has represented,
      expressly or otherwise, that such other Party would not, in the event of
      litigation, seek to enforce that foregoing waiver; and (b) acknowledges
      that it and the other Party hereto have been induced to enter into this
      Agreement and the related agreements, as applicable, by, among other
      things, the mutual waivers and certifications in this section
      14.14.

            


    

    


    
      	
            	
              14.15

            	
              Publicity.  No
      press release, publicity or other form of public written disclosure
      related to this Agreement or any Party’s name, trade name, trademark,
      symbol or logo, shall be permitted by either Party to be published or
      otherwise disclosed unless the other Party has indicated its consent to
      the form of the release in writing, except for any disclosure as is deemed
      necessary, in the reasonable judgment of the responsible Party, to comply
      with Applicable Laws with respect to regulatory reporting or disclosure
      obligations.

            


    

    


    
      	
            	
              14.16

            	
              Independent
      Contractor.  Each Party is acting under this Agreement as
      an independent contractor and not as the agent or employee of the
      other.  Each Party understands and agrees that it has no
      authority to assume any obligation on behalf of the other Party and that
      it shall not hold out to third parties that it has any authority to act on
      the other Party’s behalf except as expressly permitted herein. Unless
      otherwise expressly stated herein, each Party shall be responsible for its
      own expenses relating to its performance under this Agreement and shall
      not incur expenses for the other Party’s account unless expressly
      authorized herein or by subsequent written
  agreements.

            


    

     

    {***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    
      
         


      

      
        21

        
          

        

      

      
         


      

    

    


    
      	
            	
              14.17

            	
              Entire
      Agreement.  This Agreement, including any Exhibits and
      Schedules attached hereto and referenced herein, constitutes the full
      understanding of the Parties and a complete and exclusive statement of the
      terms of their agreement with respect to the subject matter hereof, and no
      terms, conditions or understandings or agreements purporting to modify or
      vary the terms thereof shall be binding unless it is hereafter made in
      writing and signed by each of the Parties.  No modification to
      this Agreement shall be effected by the acknowledgement or acceptance of
      any purchase order or shipping instructions forms or similar documents
      containing terms or conditions at variance with or in addition to those
      set forth herein.  In the event of a conflict between this
      Agreement and the Exhibits and Schedules hereto, the terms of this
      Agreement shall control.  This Agreement may be amended and
      supplemented only by a written instrument signed by each of the
      Parties.  An email intending to modify or amend this Agreement
      shall not be binding on the
Parties.

            


    

    


    IN WITNESS WHEREOF, the
Parties have caused this Agreement to be executed by their duly authorized
representatives as of the day and year first above written.

    


    
      
        	
                HI-TECH PHARMACAL CO., INC.

              	 
      	
                ELITE PHARMACEUTICALS, INC.

              
	 
      	 
      	 
      
	
                By:

              	
                /s/ David Seltzer

              	 
      	
                By:

              	
                /s/
  Chris C. Dick

              
	
                Name:  David Seltzer

              	 
      	
                Name: Chris C. Dick

              
	
                Title:    President and CEO

              	 
      	
                Title: President

              


      

    

     

    {***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    
      
         


      

      
        22

        
          

        

      

      
         


      

    

     

    SCHEDULE
A

      


    Intermediate
Product Formulation Specifications

     

    The
desired Intermediate Product will consist of {***}  products will be
formulated with {***}.

     

    An
acceptable release profile based on dissolution and bioavailability parameters
will be determined in detail by mutual agreement between Hi-Tech and
Elite.

     

    ADD
SPECIFICATIONS HERE

     

    {***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    
      
         


      

      
        23

        
          

        

      

      
         


      

    

     

    SCHEDULE
B

     

    Developmental
Program Outline and Schedule of Payments

    


    {***}
Generic

    ({***})

    


    
      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    	
                                            #

                                          	 
      	
                                            Activities

                                          	 
      	
                                            Responsibility

                                          	 
      	
                                            Cost

                                          
	 	 	 	 	 	 	 
	
                                            1

                                          	 
      	
                                            Formulation Development

                                            -  Preliminary
      {***} batches – ({***}

                                            -  Comparator
      product characterization

                                            -  In
      vitro dissolution

                                          	 
      	
                                            Elite

                                          	 
      	
                                            ${***}

                                          
	 	 	 	 	 	 	 
	
                                            2

                                          	 
      	
                                            Analytics

                                            -  API
      and Raw Material characterization

                                            -  Intermediate
      Product specifications and methods for assay and
    dissolution

                                          	 
      	
                                            Elite

                                          	 
      	
                                            ${***}

                                          
	 	 	  	 	 	 	 
	
                                            3

                                          	 
      	
                                            Solution compounding

                                          	 
      	
                                            Hi-Tech

                                          	 
      	
                                            Hi-Tech

                                          
	 	 	   	 	 	 	 
	
                                            4

                                          	 
      	
                                            Manufacturing of GMP Batches (Clinical and
      Validation)

                                            -  3
      batches {***}and 3 batches {***} (50 kg)

                                            -  Packaging
      in HDPE bottles

                                          	 
      	
                                            Elite

                                          	 
      	
                                            ${***}
      per batch

                                          
	 	 	 	 	 	 	 
	
                                            5

                                          	 
      	
                                            Shelf Stability Studies

                                            -
      Standard protocol for ANDA

                                            - 3
      batches X 3 strengths

                                          	 
      	
                                            Hi-Tech

                                          	 
      	
                                            Hi-Tech

                                          
	 	 	  	 	 	 	 
	
                                            6

                                          	 
      	
                                            Biostudies

                                          	 
      	
                                            Hi-Tech

                                          	 
      	
                                            Hi-Tech

                                          
	 	 	  	 	 	 	 
	
                                            7

                                          	
                                              

                                          	
                                            ANDA:  Compile and
      submit

                                          	
                                              

                                          	
                                            Hi-Tech

                                          	
                                              

                                          	
                                            Hi-Tech

                                          


                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

     

    {***}Confidential
portions of this exhibit have been redacted and filed separately with the
Commission pursuant to a confidential treatment request in accordance with
Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    
      
         


      

      
        24