Document:

{***}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.

    

    MASTER DEVELOPMENT AND
LICENSE AGREEMENT FOR {***} BETWEEN ELITE PHARMACEUTICALS, INC. AND MIKAH
PHARMA, LLC

    

    This
DEVELOPMENT AND LICENSE AGREEMENT (the “Agreement”), dated August 27, 2010 (the
“Effective Date”) between Elite Pharmaceuticals, Inc.and Elite Laboratories,
Inc. (a subsidiary of Elite Pharmaceuticals, Inc.), both corporations organized
under the laws of the State of Delaware, with offices at 165 Ludlow Avenue,
Northvale, New Jersey (“Elite”), and Mikah Pharma, LLC, a Delaware limited
liability company with its offices at 20 Kilmer Drive, Hillsborough, New Jersey
08844 (“Mikah”);

    

    A.          WHEREAS
Mikah desires that Elite (each a “Party” and collectively the “Parties”)
develop, formulate and manufacture finished dosage forms appropriate for NDA
filing, commercial sale, marketing and distribution in the Territory in
accordance with the requirements of this Agreement; and

     

    B.          WHEREAS,
Mikah has exclusive rights to certain Intellectual Property that is necessary or
useful for the development, regulatory approval and commercialization of the
pharmaceutical product known as {***} Tablets ({***}mg, {***}mg, and {***} mg)
collectively, “{***}” or “Product”; and

     

    C.          WHEREAS
Elite desires to perform such development, manufacture and production and Mikah
desires to market, sell and distribute the Product all upon the terms and
conditions of this Agreement and the agreements ancillary hereto;

     

    NOW,
THEREFORE in consideration of the mutual covenants and agreements contained
herein, the sufficiency, adequacy and satisfaction of which are hereby
acknowledged, Mikah and Elite hereby agree as follows:

     

    ARTICLE
1

     

    DEFINITIONS

     

    The
following terms shall have the meanings set forth in this
Agreement:

     

    
      	
              1.1

            	
              “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.

            

    

     

    
      	
              1.2

            	
              “Agreement”
      shall have the meaning set forth in the Preamble and shall include any
      exhibits and attachments hereto.

            

    

     

    
      	
              1.3

            	
              “NDA”
      shall mean any new drug application required to manufacture, market and
      sell finished dosage forms of the Products in the Territory (as defined
      herein) filed by Mikah with the FDA pursuant to the applicable part of 21
      CFR, and any supplements and amendments thereto which may be filed by
      Mikah from time to time.

            

    

     

    
      
        
          	
                   

                	 
      	
                  EXECUTION
      COPY

                

        

      

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    {***}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.

    

    
      	
              1.4

            	
              “ANDA”  means
      Abbreviated New Drug Application number 75-274 (Naltrexone Hydrochloride
      Tablets USP, 50mg) and all amendments thereto, that have to date been
      filed with the FDA seeking authorization and approval to manufacture,
      package, ship and sell, as more fully defined in 21 C.F.R Part 314 of the
      FD&C Act.

            

    

     

    
      	
              1.5

            	
              “API”
      shall mean the active pharmaceutical
ingredient.

            

    

     

    
      	
              1.6

            	
              “Applicable
      Laws” shall mean all laws, ordinances, codes, rules and regulations
      applicable to the manufacturing of the Product or any aspect thereof and
      the obligations of Elite or Mikah, as the context requires under this
      Agreement, including, without limitation: (i) all applicable federal,
      state and local laws and regulations of the Territory (including
      Environmental Laws); (ii) the U.S. Federal Food, Drug and Cosmetic Act,
      and (iii) the Regulations promulgated under the FD&C Act including
      without limitation those regarding the Good Manufacturing Practices
      (“cGMP”), each as amended from time to time and (iv) all laws ordinances,
      codes, rules and regulations of the Manufacturer as they apply to the
      Product.

            

    

     

    
      	
              1.7

            	
              “Competitive
      Product” shall mean a similar dosage form containing {***}or equivalent,
      that is {***}tablet.

            

    

     

    
      	
              1.8

            	
              “Data”
      shall refer to all data, materials, plans, reports, test results and other
      information developed solely by Elite in connection with the Elite
      Development Activities.

            

    

     

    
      	
              1.9

            	
              “Elite
      Development Activities” has the meaning set forth in Section
      2.1.

            

    

     

    
      	
              1.10

            	
              “Facility”
      shall mean Elite’s finished product manufacturing facility located at 165
      Ludlow Avenue, Northvale, New Jersey or any other Elite controlled
      facility approved by Mikah.

            

    

     

    
      	
              1.11

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

            

    

     

    
      	
              1.12

            	
              “FD&C
      Act” shall mean the United States Federal Food, Drug and Cosmetics Act,
      (21 U.S.C. 301, et seq.), as amended from time to time, and any regulation
      promulgated hereunder, including, without limitation, all current good
      manufacturing practices and current good laboratory practices as defined
      therein, in each case, as amended from time to
  time.

            

    

     

    
      	
              1.13

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

            

    

     

    
      	
              1.14

            	
              “Force
      Majeure” shall mean the occurrence of an event which materially interferes
      with the ability of a Party to perform its obligations or duties hereunder
      which is not within the reasonable control of the Party affected, not due
      to malfeasance, and which could not with the exercise of due diligence
      have been avoided, including, but not limited to, fire, accident, work
      stoppage, sabotage, strike, riot, civil commotion, terrorism, act of God
      or change in law.

            

    

     

    
      
        
          
            	
                     

                  	
                    2

                  	
                    EXECUTION
      COPY

                  

          

        

      

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    {***}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.

    

    
      	
              1.15

            	
              “GAAP”
      shall refer to United States generally accepted accounting principles,
      consistently applied.

            

    

     

    
      	
              1.16

            	
              “Good
      Manufacturing Practices” or “cGMP” shall mean the current good
      manufacturing practices for manufacturing finished products and active
      pharmaceutical ingredients as set forth in the FD&C Act, their
      attendant rules and regulations, and any other current good manufacturing
      practices which are applicable to the
Facility

            

    

     

    
      	
              1.17

            	
              “Know-How”
      means proprietary know-how, trademarks, inventions, data, technology and
      information relating to 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
    Product.

            

    

     

    
      	
              1.18

            	
              “Milestone
      Timetable” shall mean the mutually agreed dates upon which Elite is
      obligated to complete the specific components of the Elite Development
      Activities with respect to {***}, as evidenced in Exhibits A and B
      hereto.

            

    

     

    
      	
              1.19

            	
              “Naltrexone
      Product” means the following properties, assets and rights of whatever
      kind and nature, tangible or intangible, of Mikah, existing on the
      Effective Date that relate solely and exclusively to the ANDA and any
      testing, data, studies, and formulations created in connection therewith,
      including, without limitation: (i) the ANDA, (ii) any correspondence with
      the FDA in Mikah’s possession with respect to the ANDA, (iii) the right of
      reference to the Drug Master Files, as set forth in the ANDA; (iv) the
      ANDA Technology and Scientific Materials; and (v) a fully-paid, perpetual,
      royalty-free, exclusive license to use any Naltrexone Product technology
      which is associated with or incorporated in the Naltrexone Product, and to
      include the same in any other product of Mikah, but only for Elite’s use
      in connection with the manufacture in the Territory of the Naltrexone
      Product.

            

    

     

    
      	
              1.20

            	
              “Net
      Sales” means all proceeds received by Mikah and/or its Affiliates and/or
      from Mikah’s successors and/or from unaffiliated third parties from sales,
      of {***}in the Territories, less returns, samples, allowances, discounts
      and applicable taxes, as reflected on actual customer invoices, as may be
      applicable.

            

    

     

    
      	
              1.21

            	
              “Product”
      means {***}Tablets, strengths of {***}mg, {***} mg, and {***}
      mg.

            

    

     

    
      	
              1.22

            	
              “Regulatory
      Approvals” shall mean the approvals required under the FD&C Act to
      sell and market the Product in the
Territory.

            

    

     

    
      	
              1.23

            	
              “Regulatory
      Requirements” shall mean any requirements under or pursuant to the
      FD&C Act or other Applicable
Laws.

            

    

     

    
      
        
          
            	
                     

                  	
                    3

                  	
                    EXECUTION
      COPY

                  

          

        

      

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    {***}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.

    

    
      	
              1.24

            	
              “Regulatory
      Standards” shall mean (a) the Facility license requirements, including
      good laboratory practices, and the Good Manufacturing Practice regulations
      applicable to the Facility or Elite's research and development,
      production, packaging, storage or handling of Product at the Facility and
      (b) any standards of any governmental authority, including good laboratory
      practices, within the Territory, that apply to the Facility, Elite’s
      research and development facilities or Elite’s production, packaging,
      storage or handling of the Product.

            

    

     

    
      	
              1.25

            	
              “Specifications”
      with respect to the Product shall mean the development, manufacturing,
      quality control, packaging, labeling, shipping and storage specifications
      in the applicable USP/NF monograph, the DMF or other Regulatory Filing, in
      the form of specifications set forth as part of this Agreement, including
      without limitation, those set forth on Exhibit C hereto, and such
      specifications as may from time to time be established by applicable
      Regulatory Authorities and as mutually agreed upon by the
      Parties.

            

    

     

    
      	
              1.26

            	
              “Territory”
      means the United States of America, its territories, possessions,
      commonwealths.

            

    

     

    ARTICLE
2

     

    DEVELOPMENT
ACTIVITIES AND PRODUCT APPROVAL

     

    
      	
              2.1

            	
              Product
      Development and Development Activities for Elite.  Except as
      provided for in Section 2.2 of this Agreement, Elite, at its own cost and
      expense, shall undertake and perform all reasonably necessary development
      work to create a robust formulation, analytical development and perform
      all other developmental actions necessary or required to facilitate the
      preparation of a Regulatory Filing for {***}, as more fully set forth as
      Elite responsibilities on Exhibit A (the “Elite Development
      Activities”)  For purposes of further clarification, Elite
      Development Activities conducted by Elite shall include, without
      limitation, each of the following in accordance with applicable
      regulations and established
Specifications:

            

    

     

    
      	
               
      

            	
              a.

            	
              Tested
      and validated API, raw materials, packaging and components that are
      selected from an FDA approved
vendor.

            

    

     

    
      	
               
      

            	
              b.

            	
              Formulation
      development resulting in a formulation that will pass the USP and all
      other specifications required by FDA for {***}that leads to an approved
      NDA.

            

    

     

    
      	
               
      

            	
              c.

            	
              Analytically
      developed methods (such as content dissolution, related substances,
      etc.);

            

    

     

    
      	
               
      

            	
              d.

            	
              Manufacturing
      clinical supplies. exhibit batches and validation batches (three
      validation batches of each
strength);

            

    

     

    
      	
               
      

            	
              e.

            	
              Conducting
      stability studies in accordance with cGMP, applicable laws,including room
      temperature and accelerated stability for each
  lot;

            

    

     

    
      
        
          
            	
                     

                  	
                    4

                  	
                    EXECUTION
      COPY

                  

          

        

      

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    {***}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.

    

    
      	
               
      

            	
              f.

            	
              Writing
      the CMC section and compiling, the documents, data and dossier necessary
      for the filing of an NDA for the {***}that is adequate for Mikah to obtain
      final NDA approval.

            

    

     

    Elite has
sole responsibility for the Elite Development Activities, but shall consult with
Mikah and obtain Mikah’s approval for any formulation contemplated for use in
the exhibit batches.  Elite shall not use any information gained in
Elite’s Development Activities for Mikah to assist in the development of a
Competitive Product by any third party.

     

    
      	
              2.2

            	
              Product
      Development and Sales Activities for Mikah.  Mikah will be
      responsible for biostudies, regulatory filings and sales and distribution
      of the Product.

            

    

     

    
      	
               
      

            	
              a.

            	
              Mikah
      or its designees shall prepare all applications necessary to obtain any
      Product registration and permits required to file the Product in the
      Territories.  The NDA shall be owned by Mikah.  Elite,
      however, shall write the CMC section and prepare all completed data and
      information deemed necessary for the filing of a valid
  NDA.

            

    

     

    
      	
               
      

            	
              b.

            	
              Mikah
      will be responsible for any biostudies required for the
      Product.

            

    

     

    
      	
              2.3

            	
              Ownership
      of Regulatory Filings.  Mikah shall own and maintain the NDA,
      Regulatory Approvals and any other jurisdictionally required Regulatory
      Filings for the Product. Elite will offer any assistance as reasonably
      requested with maintenance of the Regulatory Filings, as Mikah or a
      Regulatory Authority may require.

            

    

     

    
      	
              2.4

            	
              Exclusive
      Rights.  Elite does not have any right, title or interest in or
      to the Data or any other information generated in connection with the
      Elite Development Activities other than as covered in Article 6 and shall
      not use the Data for any purpose other than as expressly provided
      herein.  Elite agrees that to violate this provision would cause
      Mikah significant and irreparable harm and accordingly, Mikah may seek an
      injunction against Elite in this
event.

            

    

     

    ARTICLE
3

     

    MANUFACTURING
AND SUPPLY OF PRODUCT

     

    
      
        	
                3.1

              	
                Manufacturing
      Agreement.  Elite and Mikah agree that, upon approval of the NDA
      for {***}, Elite will manufacture the Product and the Parties will
      negotiate in good faith a manufacturing and supply agreement for the
      Product.

              

      

    

     

    
      
        
          
            	
                     

                  	
                    5

                  	
                    EXECUTION
      COPY

                  

          

        

      

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    {***}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.

    

    ARTICLE
4

     

    ROYALTIES

     

    
      	
              4.1

            	
              Mikah,
      its Affiliates and/or its successors shall pay Elite on a quarterly basis
      a royalty payment as set forth in Exhibit B, item 4 (the “Royalty”), and
      provide a quarterly report of all Product
sales.

            

    

     

    
      	
              4.2

            	
              The
      Royalty shall be due and payable for the duration of the period beginning
      on the date of approval of the Product by the FDA and ending on the date
      of introduction into the market of a generic of {***} (such period being
      the “Royalty Period”).

            

    

     

    
      	
              4.3

            	
              Payment
      of the Royalty is contingent upon the Product being manufactured by Elite
      in a US-FDA approved facility, except as provided for in Article 11 of
      this Agreement.

            

    

     

    
      	
              4.4

            	
              All
      payments and quarterly sales reports shall be made within forty five (45)
      days after the end of each quarter starting with the end of the calendar
      quarter immediately following the commercial launch of the
      Product.

            

    

     

    
      	
              4.5

            	
              Audit
      rights for accounts. Upon ten days written notice, Elite shall have the
      right to designate a representative to inspect Mikah’s books of account,
      records, documents and instruments related to the sales of the Product of
      Mikah and any Affiliate and to make copies thereof, at any time during
      Mikah’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 in respect to calculation of
      royalty amounts. 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
      Mikah. In the event there is a dispute between Elite and Mikah regarding
      any discrepancy discovered by such audit, Mikah 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 Mikah shall pay the cost of the second
  audit.

            

    

     

    ARTICLE
5

    

    PAYMENTS

     

    
      	
              5.1

            	
              Payments
      for Development.  In consideration of Elite’s performance with
      the terms and conditions of this agreement, Mikah shall pay Elite for the
      development work according to the terms outlined in exhibit B, items 1,2
      and 3, of this agreement.

            

    

     

    
      	
              5.2

            	
              Grant
      of License.  Subject to the terms set forth herein, and in
      consideration for the payments set forth, Elite hereby grants to Mikah a
      royalty bearing license to market the Product within the Territory. The
      royalty amount is set forth in Exhibit B, item 4, and is contingent upon
      FDA approval of the Product and Article 4 of this
    Agreement.

            

    

     

    
      
        
          
            	
                     

                  	
                    6

                  	
                    EXECUTION
      COPY

                  

          

        

      

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    {***}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.

     

    ARTICLE
6

     

    REPRESENTATIONS,
WARRANTIES AND COVENANTS

     

    
      	
              6.1

            	
              Representations
      and warranties:

            

    

     

    
      	
               
      

            	
              (a)

            	
              Each
      Party represents and warrants to the other that it is authorized to enter
      into and to perform its obligations under this
  Agreement.

            

    

     

    
      	
               
      

            	
              (b)

            	
              Each
      Party represents and warrants to the other that its obligations created
      under this agreement do not conflict in any manner with any of its
      pre-existing obligations.

            

    

     

    
      	
               
      

            	
              (c)

            	
              Each
      Party represents and warrants to the other that it is the owner of any
      Know-How to be used or relied upon by such Party in performing its
      obligations under this Agreement.

            

    

     

    
      	
               
      

            	
              (d)

            	
              Mikah
      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 in
      the Territory; and

            

    

     

    
      	
               
      

            	
              (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 in the
Territory.

            

    

     

    
      	
               
      

            	
              (e)

            	
              Elite
      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
      in the Territory; and

            

    

     

    
      	
               
      

            	
              (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 in the
Territory.

            

    

     

    
      
        
          
            	
                     

                  	
                    7

                  	
                    EXECUTION
      COPY

                  

          

        

      

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    {***}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.

     

    ARTICLE
7

     

    INTELLECTUAL
PROPERTY RIGHTS

     

    
      	
              7.1

            	
              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 there from, for the
      term of this Agreement, with respect to Know-How owned by
      it.  With respect to any Product developed hereunder, the party
      developing the formulation shall be responsible for filing and prosecuting
      the patents.  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. Ownership of inventions shall be determined by US
      Patent Law.   Notwithstanding the foregoing, to the extent
      that a patent application includes claims applicable to a broader scope of
      products than the Product, such Know-How and rights related thereto shall
      be presumed to belong to Elite, provided that Mikah shall receive a fully
      paid up license for such patent with respect to the Product during the
      life of the patent.

            

    

     

    
      	
              7.2

            	
              For
      avoidance of doubt, Elite shall retain ownership of any Intellectual
      Property, which it owned prior to the execution of this Agreement and
      which has not been created or developed in connection with the provision
      of the activities contemplated hereunder. In such event, Elite shall grant
      Mikah a non-exclusive, royalty-free, sub-licensable, perpetual license to
      use Elite Intellectual Property solely in connection with the activities
      contemplated hereunder, and/or as is necessary or useful to the
      commercialization of the Product, including but not limited to making,
      having made, using, importing, exporting, and selling the
      Product.

            

    

     

    ARTICLE
8

     

    INDEMNIFICATION

     

    
      	
              8.1

            	
              Indemnification
      of Mikah. Elite shall indemnify and hold harmless Mikah and its officers,
      directors and employees 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 Mikah or such
      persons, or to which Mikah or such persons may otherwise become subject at
      any time, and that become payable or arise out of or by virtue of, or
      relate to:

            

    

     

    
      	
               
      

            	
              (a)

            	
              Any
      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

            

    

    

    
      	
               
      

            	
              (b)

            	
              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 employees or
      agents.

            

    

     

    
      	
              8.2

            	
              Indemnification
      of Elite. Mikah shall indemnify and hold harmless Elite and its officers,
      directors or employees 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 or such
      persons, or to which Elite or such persons may otherwise become subject at
      any time, and that become payable or arise out of or by virtue of, or
      relate to:

            

    

     

    
      
        
          
            
              	
                       

                    	
                      8

                    	
                      EXECUTION
      COPY

                    

            

          

        

      

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      {***}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.

    

     

    
      	
               
      

            	
              (a)

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

            

    

     

    
      	
               
      

            	
              (b)

            	
              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 Mikah or its employees or
      agents, or arising from the active ingredient of the
    Product.

            

    

     

    
      	
              8.3

            	
              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 7.1 and 7.2 hereof may apply, the Party seeking indemnification
      shall notify the indemnifying Party in writing 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.

            

    

     

    
      	
              8.4

            	
              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.

            

    

     

    ARTICLE
9

     

    TERM AND
TERMINATION AND DEFAULT

     

    
      	
              9.1

            	
              Term.  This
      Agreement shall be effective from the Effective Date and shall continue
      for a ten (10) year term after the initial marketing of the Product, or
      pursuant to Article 9 of this Agreement. For avoidance of doubt, the
      Royalty shall be due and owing only during the “Royalty Period” if the
      “Royalty Period” is less than ten years.  One year prior to the
      Termination Date, the Parties shall meet to discuss the commercial options
      regarding the supply and distribution of the Product subsequent to such
      Termination Date.

            

    

     

    
      
        
          
            	
                     

                  	
                    9

                  	
                    EXECUTION
      COPY

                  

          

        

      

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    {***}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.

    

    
      	
              9.2

            	
              Termination.  Either
      Party shall have the option to terminate this Agreement prior to the
      Termination Date upon the occurrence of a "Termination
      Event".  A "Termination Event" shall mean: (a) the voluntary or
      involuntary filing of a petition for bankruptcy, insolvency or placing in
      receivership of either Party; (b) a material breach of the terms of this
      Agreement by one Party followed by written notice of such breach by the
      non-breaching Party followed by the failure of the breaching Party to cure
      such breach within sixty (60) days of the date upon which written notice
      of breach was given as in Section 9.4; (c) adverse changes in the
      Intellectual Property environment wherein either Party, in its reasonable
      commercial judgment believes a third party patent may be infringed upon by
      a Product; (d) upon six (6) months written notice to the other Party, if
      in terminating Party’s reasonable judgment the Product ceases to be
      commercially viable. Otherwise, if Mikah is to terminate for any reason
      other than that which is set forth in Article 9.2, Mikah shall pay Royalty
      to Elite for the Royalty Period.  If Elite is to terminate for
      any reason other than that which is set forth in Article 9.2, the Royalty
      shall not be due and owing to Elite for the period subsequent to such
      termination.

            

    

     

    
      	
              9.3

            	
              Termination
      Prior to Regulatory Approvals.   Promptly upon termination
      of this Agreement as a result of Elite’s bankruptcy or breach of this
      Agreement prior to obtaining Regulatory Approvals, Mikah shall be entitled
      to a licensed copy of all of Elite’s Data or other materials reasonably
      necessary to enable Mikah to complete the process of obtaining Regulatory
      Approvals that have not yet been received, and in such case, the ownership
      rights of Elite and Mikah with respect to the Product shall remain in
      accordance with the provisions of this
  Agreement.

            

    

     

    
      	
              9.4

            	
              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 for a
      period of sixty (60) days after receipt of written notice of such
      nonperformance or noncompliance;

            

    

    

    
      	
               
      

            	
              (b)

            	
              Failure
      of Mikah 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.

            

    

    

    
      	
              9.5

            	
              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.

            

    

     

    
      
        
          
            	
                     

                  	
                    10

                  	
                    EXECUTION
      COPY

                  

          

        

      

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    {***}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.

     

    ARTICLE
10

     

    RESOLUTION
OF DISPUTES; ARBITRATION

     

    
      	
              10.1

            	
              The
      following dispute resolution process shall apply to all disputes that
      arise under this Agreement (the “Dispute Resolution
      Process”).  In the event of any dispute under this Agreement,
      the disputing Party shall provide written notice of the dispute to the
      other Parties detailing such dispute.  Within ten (10) business
      days from the date of the written notice, the Parties will meet at a
      mutually acceptable time and place or via phone or teleconference, and
      thereafter as often as they reasonably deem necessary, to exchange
      relevant information and to attempt to resolve the dispute.  If
      they are unable to resolve the dispute within fifteen (15) business days
      of their first meeting, the matter shall be referred to a senior board
      level manager of each of the
Parties.

            

    

     

    
      	
              10.2

            	
              If
      the senior board level managers of the Parties are unable to resolve the
      matter within three (3) business days after notification then, any Party
      to the dispute may initiate binding arbitration or pursue other legal
      proceedings to the extent Section 10.4 of the Agreement is not
      applicable.

            

    

     

    
      	
              10.3

            	
              Expenses.  Each
      Party shall be responsible for its own legal fees, travel and related
      expenses during the Parties’ attempt to resolve the
    dispute.

            

    

     

    
      	
              10.4

            	
              Other
      Rights.  Nothing in this Section 9 shall be deemed to waive the
      right of any Party to apply to a court of competent jurisdiction for a
      temporary restraining order, a preliminary injunction, or other equitable
      relief to preserve the status quo or prevent irreparable
    harm.

            

    

     

    
      	
               
      

            	
              ARTICLE
      11

            

    

     

    
      	
               
      

            	
              MISCELLANEOUS

            

    

     

    
      	
              11.1

            	
              Recitals.  The
      recitals are hereby incorporated by reference and made part of this
      Agreement.

            

    

     

    
      	
              11.2

            	
              Survival.  Except
      as expressly provided in this Agreement, expiration or termination of this
      Agreement will not relieve the Parties of any obligation that accrued
      prior to such expiration or termination. Upon expiration or early
      termination of this Agreement, all rights and obligations of the Parties
      shall cease, except as follows:

            

    

    

    
      
        	 	
                (a)

              	
                The
      obligations of Article 4 of this Agreement, specifically the payment of
      Royalties, shall survive termination of this Agreement up to and including
      the date that is ten (10) years after the initial marketing of the
      Product; or the last day of the Royalty Period, whichever is
      earlier.  In the event of Elite being willing and able to
      manufacture the Product in an Elite Facility and Mikah transferring such
      manufacturing to a non-Elite facility, the Parties agree that the Royalty
      shall continue to be due and payable to Elite regardless of the Product
      not being manufactured in an Elite facility.  For avoidance of
      doubt, Royalty will be paid as specified in Article 4.2 (the “Royalty
      Period”).

              

      

    

     

    
      
        
          
            	
                     

                  	
                    11

                  	
                    EXECUTION
      COPY

                  

          

        

      

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    {***}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.

    

    
      
        	 	
                (b)

              	
                The
      obligations of confidentiality set forth in Section 11.5 of Article 11
      shall survive;

              

      

    

     

    
      
        	 	
                (c)

              	
                The
      Parties obligations under Article 7 shall
  survive;

              

      

    

     

    
      
        	 	
                (d)

              	
                Any
      cause of action or claim of Mikah or Elite
      accrued or to accrue because of any breach or default by the other Party
      hereunder shall survive;
and

              

      

    

    

    
      	
              11.3

            	
              Entire
      Agreement; Amendment.  This Agreement, with all of the Exhibits,
      contain the entire understanding of the Parties with respect to the
      subject matter hereof and supersede all previous verbal and written
      agreements, representations and warranties.  This Agreement may
      be released, waived or modified only by written agreement signed by the
      Party against whom enforcement of any release, waiver, modification, or
      other change is sought.

            

    

     

    
      	
              11.4

            	
              Standard
      Forms.  In ordering and delivering the services or Product,
      Mikah and Elite may employ their standard forms, but nothing in those
      forms shall be construed to modify, amend or supplement the terms of this
      Agreement and, in the case of any conflict herewith, the terms of this
      Agreement shall govern and control.

            

    

     

    
      	
              11.5

            	
              Confidentiality.  Elite
      and Mikah shall not use, except in connection with this Agreement, nor
      disclose any information concerning the other Party's business or any
      proprietary information of the other Party, including but not limited to,
      technical or scientific data, unpublished findings, biological material,
      know-how, specifications, processes, techniques, patent, patent litigation
      strategies or tactics, trade secrets, algorithms, programs, designs,
      drawings, or formulae; and any engineering, manufacturing, marketing,
      financial, litigation, intellectual property or business plan,
      confidential knowledge, data or other similar information, whether
      received pursuant to this Agreement or otherwise ("Confidential
      Information") without the prior written consent of such other
      Party.  The obligation of non-disclosure referred to above shall
      not apply to:

            

    

     

    
      	
               
      

            	
              (i)

            	
              Information
      which is known to the receiving Party or one of its Affiliates or
      independently developed by the receiving Party or one of its Affiliates
      prior to the time of disclosure, in each case, to the extent evidenced by
      written records;

            

    

     

    
      	
               
      

            	
              (ii)

            	
              Information
      disclosed to the receiving Party by a third party, which has a right to
      make such disclosure;

            

    

     

    
      	
               
      

            	
              (iii)

            	
              Information
      which is or becomes patented, published or otherwise part of the public
      domain as a result of acts by the disclosing Party or a third person
      obtaining such information as a matter of right;
  or

            

    

     

    
      
        
          
            	
                     

                  	
                    12 

                  	
                    EXECUTION
      COPY

                  

          

        

      

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    {***}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.

    

    
      	
               
      

            	
              (iv)

            	
              Information
      which is required to be disclosed by order of the FDA or similar authority
      in other countries or a court of competent jurisdiction; provided that the
      Parties shall use their best efforts to obtain confidential treatment of
      such information by the court or
agency.

            

    

     

    
      	
              11.6

            	
              In
      addition to the provisions set forth in this agreement, the Mutual
      Confidentiality Agreement entered into by the Parties dated as of May
      18 ,
      2010 is hereby incorporated herein by reference in its
      entirety.

            

    

     

    
      	
              11.7

            	
              Force
      Majeure.  Failure of any Party to perform its obligations under
      this Agreement as a result of Force Majeure shall not subject such Party
      to any liability or place it in breach of any term or condition of this
      Agreement to the other Party if such failure is caused by any cause beyond
      the reasonable control of such non-performing Party. The Party prevented
      from performing its obligations or duties because of Force Majeure shall
      promptly notify the other Party hereto of the occurrence and particulars
      of such Force Majeure and shall provide the other Party, from time to
      time, with its best estimate of the duration of such Force Majeure and
      with notice of the termination thereof.  The Party so affected
      shall use its best efforts to avoid or remove such causes of
      nonperformance. Upon termination of Force Majeure, the performance of any
      suspended obligation or duty shall promptly recommence.  Neither
      Party shall be liable to the other Party for any direct, indirect,
      consequential, incidental, special, punitive or exemplary damages arising
      out of or relating to the suspension or termination of any of its
      obligations or duties under this Agreement by reason of the occurrence of
      Force Majeure.  In the event that Force Majeure has occurred and
      is continuing for a period of at least three (3) months, the other Party
      shall have the right to terminate this Agreement upon thirty (30) days
      notice.

            

    

     

    
      	
              11.8

            	
              Waiver.  The
      failure of a Party to enforce any breach or provision of this Agreement
      shall not constitute a continuing waiver of such breach or provision and
      such Party may at any time thereafter act upon or enforce such breach or
      provisions of this Agreement.  Any waiver of breach executed by
      either Party shall affect only the specific breach and shall not operate
      as a waiver of any subsequent or preceding
  breach.

            

    

     

    
      	
              11.9

            	
              No
      Assignment.  Elite may not delegate, subcontract, sublicense or
      otherwise transfer to a third party its rights or obligations under this
      Agreement, except to any Affiliate of Elite, without the consent of
      Mikah,  Mikah may transfer its rights or obligations under this
      Agreement to any Affiliate or to a successor of the portion of its
      business that is the subject matter hereof.  Subject to the
      foregoing, this Agreement shall inure to the benefit of and be binding
      upon the Parties and their respective permitted successors and
      assigns.

            

    

     

    
      	
              11.10

            	
              Severability.  If
      any clause or provision of this Agreement is declared invalid or
      unenforceable by a court of competent jurisdiction, such provision shall
      be severed and the remaining provisions of the Agreement shall continue in
      full force and effect.  The Parties shall use their best efforts
      to agree upon a valid and enforceable provision as a substitute for the
      severed provision, taking into account the intent of this
      Agreement.

            

    

     

    
      
        
          
            	
                     

                  	
                    13

                  	
                    EXECUTION
      COPY

                  

          

        

      

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    {***}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.

    

    
      	
              11.11

            	
              Notices.  Any
      notice, request or other communication required to be given pursuant to
      the provisions of this Agreement shall be in writing and shall be deemed
      to be given when delivered in person or by courier (return receipt
      requested) or five days after being deposited in the United States mail,
      postage prepaid, certified, return receipt requested to the Parties
      addressed as follows:

            

    

     

    
      	
               
      

            	
              If
      to Elite, to:

            

    

    

    
      	
               
      

            	
              Elite
      Laboratories, Inc.

            

    

    
      	
               
      

            	
              165
      Ludlow Avenue Northvale

            

    

    
      	
               
      

            	
              New
      Jersey 07647

            

    

    
      	
               
      

            	
              Attn:
      Chris Dick, President

            

    

    
      	
               
      

            	
              Fax:
      (201) 750-2755

            

    

    

    
      	
               
      

            	
              If
      to Mikah to:

            

    

    

    
      	
               
      

            	
              Mikah
      Pharma, LLC

            

    

    
      	
               
      

            	
              20
      Kilmer Drive

            

    

    
      	
               
      

            	
              Hillsborough,
      New Jersey 08844

            

    

    
      	
               
      

            	
              Attn:
      Nasrat Hakim, President

            

    

     

    
      
        	
                11.12

              	
                Governing
      Law.  This Agreement shall be governed by and construed in
      accordance with the laws of New Jersey, United States of America, without
      reference to conflicts of laws, rules or
  principles.

              

      

    

     

    
      
        	
                11.13

              	
                Independent
      Parties. The relationship of the Parties under this Agreement is that of
      independent contractors.  Neither Party shall be deemed to be
      the agent of the other, nor shall the Parties be deemed to be partners or
      joint venturers, and neither is authorized to take any action binding upon
      the other.  Elite expressly acknowledges for itself, its
      employees, agents and subcontractors, that none of them are employees of
      Mikah and that none of them are entitled to participate in any benefit
      plans of Mikah.  Elite further acknowledges that none of its
      employees, agents or subcontractors are eligible to participate in any
      benefit plans of Mikah, even if it is later determined that the status of
      any of them was that of an employee during the period of this engagement
      of Elite by Mikah.

              

      

    

     

    
      
        	
                11.14

              	
                Costs.  Except
      as otherwise provided in this agreement, each Party will pay its own costs
      and expenses in connection with the negotiation, preparation, execution,
      and performance of this
Agreement.

              

      

    

     

    
      	
              11.15

            	
              Currency.  Wherever
      a monetary currency is indicated throughout this Agreement, that currency
      shall be United States Dollars, unless otherwise clearly
      indicated.

            

    

     

    
      
        
          
            	
                     

                  	
                    14

                  	
                    EXECUTION
      COPY

                  

          

        

      

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    {***}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.

    

    
      	
              11.16

            	
              Days.  Wherever
      reference is made to days, working days or any measurement of time in
      days, calendar days shall be used regardless of weekends and
      holidays.

            

    

     

    
      	
              11.17

            	
              Sophisticated
      Parties.  Each Party to this Agreement is a sophisticated
      business party negotiating in good faith with the advice of legal
      counsel.  Each Party is hereby advised to seek the advice of
      legal counsel prior to executing this
Agreement.

            

    

     

    
      	
              11.18

            	
              English
      Language.  This Agreement has been negotiated and is written in
      the English language, and while some of the Parties may not speak English
      as their primary language, they have sought the use of translators, if
      necessary, and understand the meaning and implications of this entire
      Agreement.

            

    

     

    (The
remainder of this page has been intentionally left blank.)

     

    
      
        
          
            	
                     

                  	
                    15

                  	
                    EXECUTION
      COPY

                  

          

        

      

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    {***}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.

    

    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.

     

    
      
        
          
            
              
                
                  
                    
                      	
                              MIKAH
      PHARMA LLC

                            	 
      	
                              ELITE
      PHARMACEUTICALS, INC.

                            
	 
      	 
      	 
      	 
      	 
      
	
                              By:

                            	
                               
      

                            	 
      	
                              By:

                            	
                               
      

                            
	Name:
      Nasrat
      Hakim	 
      	Name:
      Chris
      C. Dick
	Title:  
      President
      and CEO	 
      	Title:  
      President

                    

                  

                

              

            

          

        

      

    

     

    
      
        
          
            	
                     

                  	
                    16

                  	
                    EXECUTION
      COPY

                  

          

        

      

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    

    {***}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.

    

    Exhibit
A

    

    {***}

    Development
Activities

     

    
      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      
                                        
                                          
                                            
                                              
                                                
                                                  
                                                    
                                                      
                                                        
                                                          
                                                            
                                                              
                                                                	 	 	 	 	
                                                                        Responsibility

                                                                      	 	 
	
                                                                        #

                                                                      	 	
                                                                        Activities

                                                                      	 	
                                                                        Elite

                                                                      	 	
                                                                        Mikah

                                                                      	 	
                                                                        Estimated Timing

                                                                      
	
                                                                        1

                                                                      	 	
                                                                        Formulation Development

                                                                        -  Preliminary
      batches

                                                                        -  API
      and Raw Material characterization

                                                                        -  Comparator
      product characterization

                                                                        -  In
      vitro dissolution

                                                                      	 	
                                                                        X

                                                                      	 	 	 	
                                                                        6
      months from signing of agreement

                                                                      
	
                                                                        2

                                                                      	 	
                                                                        Analytics

                                                                        -  Product
      specifications

                                                                        -  Methods
      development

                                                                        -  Validation
      package

                                                                      	 	
                                                                        X

                                                                      	 	 	 
	
                                                                        3

                                                                      	 	
                                                                        Manufacturing of Pivotal Batch

                                                                        -  Three
      batches each strength (150,000 tablets)

                                                                        -  Packaging
      in HDPE bottles

                                                                      	 	
                                                                        X

                                                                      	 	 	 	
                                                                        Immediately
      after completion of Step 2

                                                                      
	
                                                                        4

                                                                      	 	
                                                                        Shelf Stability Studies

                                                                        -
      Standard protocol for NDA

                                                                        - 3
      batches X 3 strengths

                                                                      	 	
                                                                        X

                                                                      	 	 	 	 
      
	
                                                                        5

                                                                      	 	
                                                                        Biostudies

                                                                      	 	 	 	
                                                                        X

                                                                      	 	
                                                                        At
      timing of Mikah

                                                                      
	
                                                                        6

                                                                      	 	
                                                                        Validation

                                                                      	 	
                                                                        X

                                                                      	 	 	 	 
      
	
                                                                        7

                                                                      	 	
                                                                        NDA:  Compile and
      submit

                                                                      	 	 	 	
                                                                        X

                                                                      	 	 
      

                                                              

                                                            

                                                          

                                                        

                                                      

                                                    

                                                  

                                                

                                              

                                            

                                          

                                        

                                      

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

     

    
      
        
          
            	
                    Exhibit
      A

                  	 
      	
                    CONFIDENTIAL

                  

          

        

      

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    

    {***}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.

    

    Exhibit
B

    

    Payments
for Development of

    {***}

    

    
      	
               
      

            	
              1.

            	
              For
      the full development of {***}as per this agreement and its exhibits, Elite
      shall receive all rights, title and interest held by Mikah in the
      Naltrexone Product.

            

    

     

    
      	
               
      

            	
              a.

            	
              The
      Parties agree to prepare and execute a separate asset purchase agreement
      for the transfer of such rights, title and interest held by Mikah in the
      Naltrexone Product within thirty days from the Effective
    Date.

            

    

     

    
      	
               
      

            	
              2.

            	
              The
      Parties agree that the value of the Naltrexone Product, estimated at
      $200,000, constitutes full and equitable consideration for the development
      services being performed by Elite under this
      Agreement.  Furthermore, the transfer of the Naltrexone Product
      represents payment of consideration in lieu of cash, with such payment
      being made by Mikah in advance of the performance of Elite Development
      Activities.

            

    

     

    
      	
               
      

            	
              3.

            	
              The
      Parties agree, that in the event of Elite not completing any of those
      Elite Development Activities listed as being the responsibility of Elite
      as per Exhibit A of this Agreement, Elite shall pay to Mikah amounts, as
      follows, with such amounts representing the value of consideration paid by
      Mikah by transfer of the Naltrexone Product, less the value of Elite
      Development Activities that were
completed:

            

    

     

    
      	
               
      

            	
              a.

            	
              If
      Elite does not complete item #6 of Exhibit A (Validation), Elite shall pay
      $25,000 to Mikah.

            

    

     

    
      	
               
      

            	
              b.

            	
              If
      Elite does not complete item #’s 3 and 4 of Exhibit A (Manufacturing of
      Pivotal Batch and Shelf Stability Studies, respectively), Elite shall pay
      $100,000 to Mikah

            

    

     

    
      	
               
      

            	
              c.

            	
              If
      Elite does not complete item #’s 1 & 2 of Exhibit A (Formulation
      Development and Analytics, respectively), Elite shall pay $75,000 to
      Mikah.

            

    

     

    
      	
               
      

            	
              4.

            	
              Royalties
      of amounts equal to {***}% of Net Sales of {***}shall be paid to Elite in
      accordance with the terms of this Agreement, including, without
      limitation, Article 4 and Article
11.

            

    

     

    
      
        
          
            	
                    Exhibit
      B

                  	 
      	
                    CONFIDENTIAL

                  

          

        

      

    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    

    {***}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.

    

    Exhibit
C

    

    {***}

    Product
Formulation Specifications

    

    The
desired Product consists of {***}mg, {***} mg, and {***}mg {***}

    

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

    

    For
avoidance of doubt, dissolution, content and related substance specification
profile shall meet all applicable regulatory standards for a NDA as set forth by
the CFR and USP.

     

    
      
        
          
            	
                    Exhibit
      C

                  	 
      	
                    EXECUTION
      COPY{***}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.

    

    PURCHASE
AGREEMENT

    

    between

    

    ELITE
PHARMACEUTICALS, INC.

    and

    

    EPIC
PHARMA, LLC

    

    Dated as
of September 10, 2010

    
      
         

      

      
        1

        
          

        

      

      
         

      

    

    {***}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.

    

    PURCHASE
AGREEMENT

    

    This
PURCHASE AGREEMENT (the
“Agreement”) is
entered into as of September 10, 2010, by and between ELITE PHARMACEUTICALS,
INC. and ELITE LABORATORIES, INC. (a subsidiary of Elite Pharmaceuticals, Inc.),
a Delaware corporations with offices at 165 Ludlow Avenue, Northvale, New Jersey
07430 (“Buyer”) and EPIC PHARMA, LLC, a Delaware limited liability corporation
with offices at 227-15 N. Conduit Ave., Laurelton, New York 11413 (“Seller”).
Seller and Buyer are sometimes hereafter referred to individually as a “Party”
and collectively as the “Parties”.

    

    RECITALS

    

    WHEREAS, Seller is engaged in
the business of developing, manufacturing, marketing and selling pharmaceutical
products and owns certain rights related to the product (the “Product”) and
Abbreviated New Drug Application (the “ANDA”) listed in Appendix 1 of this
Agreement.

    

    And,

    

    WHEREAS, the parties hereto
intend that Seller shall sell to Buyer, and Buyer shall purchase from Seller
certain assets related to the Product upon the terms and subject to the
conditions set forth in this Agreement.

    

    NOW, THEREFORE, in
consideration of the foregoing recitals and the mutual promises,
representations, warranties, covenants and agreements hereinafter set forth, and
intending to be legally bound, the parties do hereby agree as
follows:

    

    ARTICLE
1

    

    Purchase
and Sale of Assets

    

    1.1           Sale of Product.

    Pursuant
to the terms and conditions set forth in this Agreement, Seller agrees to sell,
convey, assign, grant, transfer and deliver to Buyer, and Buyer agrees to
purchase, acquire and receive from Seller on the Closing Date, Seller’s entire
interest in the Product for manufacture, sale and use in the United States
(including its territories and possessions, the (“Territory”),
including (i) all regulatory correspondence received from the FDA with respect
to the ANDA and (ii) all know-how and technical information embodied in the ANDA
and specifically relating to the development, manufacture, packaging, use or
sale of the Product in the Territory owned or possessed by Seller on the Closing
Date (the “Information”),
together with the Product, the “Assets”).    Seller
also hereby grants Buyer and its Affiliates the ANDA technology and scientific
materials for Buyer’s use in connection with the manufacture, registration or
sale of the Product outside of the Territory.

    
      
         

      

      
        2

        
          

        

      

      
         

      

    

    {***}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.

    

    1.2           Closing
Date.

    The
Closing Date of this Agreement shall be sixty (60) days from the date of this
Agreement or FDA approval of the ANDA, whichever is later.

    

    1.3           Delivery of
Assets.

    Upon
receipt of the payment of that portion of the Purchase Price set forth in
Section 2.1(a) (i), Seller shall deliver to Buyer a full and complete copy of
the following:

    

    
      	
               
      

            	
              (a)

            	
              Copy
      of the ANDA, together with a transfer letter to the FDA reflecting the
      change in ownership and the accompanying form
  356h;

            

    

    
      	
               
      

            	
              (b)

            	
              Development
      reports and analytical methods;

            

    

    
      	
               
      

            	
              (c)

            	
              Pre-approval
      inspection reports and responses;

            

    

    
      	
               
      

            	
              (d)

            	
              FDA
      communication letters during the approval process and through the date
      thereof;

            

    

    
      	
               
      

            	
              (e)

            	
              Bioequivalency
      report submitted to the FDA; and

            

    

    
      	
               
      

            	
              (f)

            	
              A
      duly executed Assignment and Bill of Sale, in the form annexed
      hereto.

            

    

    

    ARTICLE
2

    

    Consideration
for Transfer of Assets

    

    2.1           Purchase
Price.

    

    
      	
               
      

            	
              (a)

            	
              Subject
      to the terms and conditions of this Agreement, in consideration for the
      sale and transfer of the Assets, Buyer shall pay to Seller, and amount
      equal to {***} dollars (${***}) (the “Purchase
      Price”).  {***} dollars (${***}) will be paid at the
      closing of this Agreement and the remaining ${***} will be paid quarterly
      over the next three years with the first payment on the first full quarter
      after the closing.  The quarterly payments will be ${***} each
      quarter.

            

    

    

    
      	 	
              (b)

            	
              All
      payments under this Section shall be made by check, wire transfer or other
      immediately available funds to an account indicated by
    Seller.

            

    

    
      
         

      

      
        3

        
          

        

      

      
         

      

    

    {***}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.

    

    ARTICLE
3

    

    Representations
and Warranties

    

    3.1           Legal Authority.

    Each
party represents and warrants that it has the legal power, authority and right
to enter into this Agreement and to perform its respective obligations set forth
herein.

    

    3.2           Title to Assets.

    Seller
hereby represents and warrants that it or its Affiliates has good and marketable
title to the Assets, free and clear of all liens.

    

    3.3           Due
Diligence

    Buyer
hereby acknowledges that it has conducted its own due diligence on the subject
matter of this Agreement, and has not relied upon any of Seller’s
representations in entering this Agreement.

    

    3.4           Disclaimer of
Warranties.

    EXCEPT AS
EXPRESSLY PROVIDED HEREIN, SELLER DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR
IMPLIED, WITH REGARD TO THE PRODUCT, THE ANDA, AND THE ASSETS, INCLUDING THE
WARRANTY OF MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE.  WITHOUT LIMITING THE FOREGOING, BUYER ACKNOWLEDGES THAT
SELLER HAS MADE NO REPRESENTATION OR WARRANTY AS TO THE ABILITY TO OBTAIN
APPROVAL FROM THE FDA WITH RESPECT TO THE ANDA OR THE SITE TRANSFER OR THE
ABILITY TO MANUFACTURE OR SELL THE PRODUCT IN ACCORDANCE WITH APPLICABLE
LAW.  THE PARTIES ACKNOWLEDGE THAT THE SALE AND ASSUMPTION OF THE
ASSETS BY BUYER IS ON AN “AS IS” BASIS.  SELLER WILL NOT AND DOES NOT
WARRANT THAT OWNERS OF PRODUCT THAT ARE SUBSTANTIALLY SIMILAR TO OR IDENTICAL
WITH THE PRODUCT WILL NOT ATTEMPT TO REGISTER AND SELL SUCH PRODUCT IN THE
TERRITORY.  SELLER MAKES NO REPRESENTATION OR WARRANTY AS TO THE
PROSPECTS, FINANCIAL OR OTHERWISE, OF MARKETING THE PRODUCT IN THE
TERRITORY.

    

    ARTICLE
4

    

    Additional
Agreements

    

    4.1           Use of Seller Name.

    Buyer
shall not use the name of Seller or any Seller Affiliates or their respective
trademarks, logos or designs in any manner whatsoever in connection with the
manufacture, use, sale, promotion, advertising or distribution of the
Product.

    
      
         

      

      
        4

        
          

        

      

      
         

      

    

    {***}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           FDA Contacts.

    On and
after the Closing Date, Buyer shall be responsible for all contacts with the FDA
and any other applicable Governmental or Regulatory Authorities in the Territory
with respect to the Product, and all other responsibilities relating to its
registration.

    

    4.3           Payment of Transaction
Expenses.

    All sales
taxes, use taxes, transfer taxes, filing fees, and similar taxes, fees and
expenses (excluding any taxes arising from income or gains earned by Seller)
required to be paid in connection with the sale of the Assets to Buyer will be
borne and paid by Buyer.

    

    4.4           Site Transfer.

    Buyer
shall use its commercially reasonable efforts to obtain the approval from the
FDA for the site transfer of the Product to Buyer’s manufacturing facility as
expeditiously as is reasonably practicable.  Buyer is solely
responsible for preparing the necessary paperwork and conducting any testing
required to support the site transfer. Buyer is responsible for purchasing all
other materials and components necessary to manufacture the product for
testing.

    

    4.5           Limitation of
Transfer.

    Buyer
hereby agrees that until such time as Buyer has discharged its entire payment
obligation hereunder, it shall not convey, sell, assign, transfer, license or
otherwise dispose of any of the Assets without prior written consent of Seller,
which consent shall not be unreasonably withheld.

    

    4.6           Further
Assurances.

    Seller,
at any time after the Closing Date, at the reasonable request of Buyer and at
Buyer’s sole expense, shall execute, acknowledge and deliver further
assignments, and other assurances, documents and instruments of transfer that
may be reasonably necessary for the purpose of assigning and granting to Buyer
all Assets to be conveyed pursuant to this Agreement.

    

    4.7           Indemnification.

    

    
      
        	 	
                (a)

              	
                Buyer
      shall defend, indemnify and hold Seller and its employees, directors,
      officers, Affiliates and agents harmless from and against any and all
      claims, losses, damages, liabilities, judgments, awards and costs
      whatsoever, including reasonable attorneys’ fees and court costs, and
      including without limitation bodily injury, death or property damages
      arising out of or in connection with (i) any act or failure to act which
      is the responsibility of Buyer or its Affiliates under this Agreement,
      (ii) any and all liabilities arising from any Action relating to, directly
      or indirectly the Product or the Assets which are the responsibility of
      Buyer or its Affiliates at any time following the Closing Date, and (iii)
      any liabilities, obligations, commitments of whatever kind and nature,
      primary or secondary, direct or indirect, absolute or contingent, known or
      unknown, whether or not accrued, arising out of or relating to, directly
      or indirectly, the Product or the Assets which obligations relate to any
      conduct of Buyer or its Affiliates at any time following the Closing
      Date.  This provision shall survive the expiration or
      termination of this
Agreement.

              

      

    

    
      
         

      

      
        5

        
          

        

      

      
         

      

    

    {***}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.

    

    
      	
            	
              (b)

            	
              Seller
      shall defend, indemnify and hold Buyer and its employees, directors,
      officers, Affiliates and agents harmless from and against any and all
      claims, losses, damages, liabilities, judgments, awards and costs
      whatsoever, including reasonable attorneys’ fees and court costs, and
      including without limitation bodily injury, death or property damages
      arising out of or in connection with (i) any act or omission to act which
      is the responsibility of Seller or its Affiliates under this Agreement,
      (ii) any and all liabilities arising from any Action relating to, directly
      or indirectly the Product or the Assets which are the responsibility of
      Seller at any time prior to the Closing Date, and (iii) any liabilities,
      obligations, commitments of whatever kind and nature, primary or
      secondary, direct or indirect, absolute or contingent, known or unknown,
      whether or not accrued, arising out of or relating to, directly or
      indirectly, the Product or the Assets which obligations relate to any
      conduct of Seller at any time prior to the Closing Date.  This
      provision shall survive the expiration or termination of this
      Agreement.

            

    

    

    4.8           Confidentiality.

    For a
period of five (5) years from the date hereof, Seller shall hold in confidence
and use its best efforts to have its Affiliates and representatives hold in
confidence all information pertaining to the Assets and, except as contemplated
by this Agreement, shall not disclose, publish, use or permit others to use the
same; provided, however,
that the foregoing restriction shall not apply to any portion of the
foregoing which was or becomes available on a non-confidential basis to the
other party or when such disclosure is required by a Governmental or Regulatory
Authority or is otherwise required by law or is necessary in order to establish
rights under this Agreement or any other agreements related
hereto.  This provision shall survive the expiration or termination of
this Agreement.

    

    ARTICLE
5

    

    General

    

    5.1           Assignment.

    Until
such time as Buyer has discharged all its payment obligations hereunder, this
Agreement may not be assigned by Buyer without the prior written consent of
Seller as set for in Section 4.4.  This Agreement will be binding upon
and will inure to the benefit of permitted assigns and
successors.

    
      
         

      

      
        6

        
          

        

      

      
         

      

    

    {***}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.

    

    5.2           Notices.

    All
notices, requests, demands and other communications required or permitted under
this Agreement shall be in writing and shall be deemed to have been duly given,
made and received on the date when delivered by hand delivery with receipt
acknowledged, or upon the next Business Day following receipt of telex or
telecopy transmission, or upon the third day after deposit in the United States
mail, registered or certified with postage prepaid, return receipt requested,
addressed as set forth below:

    

    
      
        	 	
                (a)

              	
                If
      to Seller:

              
	 	 
      	 
      
	 	 
      	
                Epic
      Pharma, LLC

              
	 	 
      	
                227-15
      N, Conduit Avenue

              
	 	 
      	
                Laurelton,
      NY 11413

              
	 	 
      	
                Attn:

              	
                Ashok
      G. Nigalaye, President/CEO

              
	 	 
      	 
      	
                Ram
      Potti, Vice President

              
	 	 
      	
                Fax:

              	
                718-276-1735

              
	 	 
      	 
      	 
      
	 	 
      	 
      	 
      
	 	
                (b)

              	
                If
      to Buyer:

              
	 	 
      	 
      
	 	 
      	
                Elite
      Pharmaceuticals, Inc.

              
	 	 
      	
                165
      Ludlow Avenue

              
	 	 
      	
                Northvale,
      NJ 07647

              
	 	 
      	
                Attn:  Chris
      C. Dick, President/COO

              
	 	 
      	
                Fax:

              	
                201-367-7880

              

      

    

    

    Any party
may alter the addresses to which communications or copies are to be sent by
giving notice of such change of address in conformity with the provision of this
Section 5.2 for giving notice.

    

    5.3           Severability.

    If any
provision of this Agreement is held to be invalid or unenforceable for any
reason, the remaining provisions will continue in full force without being
impaired or invalidated in any way, and the parties agree to replace any invalid
provision with a valid provision that most closely approximates the intent and
economic effect of the invalid provision.

    

    5.4           Headings.

    Headings
used in this Agreement are for reference purposes only and in no way define,
limit, construe or describe the scope or extent of such paragraph, or in any way
affect this Agreement.

    

    5.5           No Waiver. 

    No term
or provisions hereof shall be deemed waived, and no breach excused, unless such
waiver or consent is in writing and signed by the party claimed to have waived
or consented.  The waiver by any party of any breach of any provision
of this Agreement will not operate or be interpreted as a waiver of any other
subsequent breach.

    
      
         

      

      
        7

        
          

        

      

      
         

      

    

    {***}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.

    

    5.6           Relationship of the
Parties.

    Nothing
in this Agreement should be construed to create a partnership, agency, joint
venture or employer-employee relationship.  None of the parties has
the authority to assume or create any obligation, express or implied, on behalf
of any other party.

    

    5.7           Governing Law.

    This
Agreement shall be governed and construed in accordance with the laws of the
State of New York (other than the provisions relating to conflicts of
law).  Each party hereby consents to the exclusive personal
jurisdiction of the state and federal courts located in the Borough of
Manhattan, City of New York, State of New York.

    

    5.8           Entire Agreement;
Amendment.

    This
Agreement and any additional documents required to be delivered on the Closing
Date, constitute the final, complete and exclusive agreement among the parties
with respect to the subject matter hereof and supersede any previous proposals,
negotiations, agreements, arrangements or warranties, whether verbal or written,
made among the parties with respect to such subject matter.  This
Agreement may be amended or modified only by mutual agreement in writing of the
authorized representatives of the parties.

    

    5.9           Counterparts.

    This
Agreement may be executed in two or more counterparts, each of which shall be
deemed an original and all of which shall together constitute one and the same
instrument.  This Agreement shall become binding when one or more
counterparts hereof shall bear the signatures of all parties indicated as
signatories hereto.

    

    5.10           No Third Party
Beneficiary.

    The terms
and provisions of this Agreement are intended solely for the benefit of each
party hereto and their respective successors or permitted assigns, and it is not
the intention of the parties to confer third-party beneficiary rights upon any
other person or entity.

    

    5.11           Definitions.

    As used
in this Agreement, the following defined terms shall have the meanings set forth
below:

    

    “Action” means any
action, suit, proceeding, arbitration or Governmental or Regulatory Authority
investigation or audit.

    

    “Affiliate” means any
Person that directly, or indirectly through one or more intermediaries,
controls, is controlled by, or is under common control with the Person
specified.  As used herein the term “control” means possession of the
power to direct, or cause the direction of, the management and policies of a
corporation or other entity whether through the ownership of voting securities,
by contract or otherwise.

    

    “Business Day” means a
day during which banks are generally open for business in New York.

     

    
      
         

      

      
        8

        
          

        

      

      
         

      

    

    {***}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.

    

     “FDA” means the
federal Food and Drug Administration.

    

    “Governmental or Regulatory
Authority” means any court, tribunal, arbitrator, agency, commission,
official or other instrumentality of any federal, state, county, city or other
political subdivision, domestic or foreign.

    

    “Person” means any
natural person, corporation, general partnership, limited partnership,
proprietorship, other business organization, trust, union, association or
Governmental or Regulatory Authority.

    

    IN WITNESS WHEREOF, the parties hereto
have executed this Agreement as of the date first above written.

    

    
      
        
          
            
              
                
                  	
                          EPIC
      PHARMA, LLC

                        
	 
      	 
      
	
                          By:

                        	
                              

                        
	
                          Name:

                        
	
                          Title:

                        
	 
      	 
      
	
                          ELITE
      PHARMACEUTICALS, INC.

                        
	 
      	 
      
	
                          By:

                        	
                              

                        
	
                          Name:

                        
	
                          Title:

                        

                

              

            

          

        

      

    

    
      
         

      

      
        9

        
          

        

      

      
         

      

    

    {***}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.

    

    APPENDIX  1

    

    Listing
of Product and ANDA

    

    
      
        	
                Product
      Description

              	
                ANDA
      #

              
	 
      	 
      
	
                {***}
      Tablets , {***} mg

              	
                {***}-{***}

              

      

    

     

    
      
         

      

      
        10

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00181-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00181-of-00352.parquet"}]]