Document:

LICENSE
AGREEMENT 

      
        

      

    

     

    Between

     

    Elite
Pharmaceuticals, Inc.

     

    And

     

    Precision
Dose, Inc.

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    {***}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.

     

    LICENSE
AGREEMENT

     

    This
License Agreement (“Agreement”) is entered into as of the 10th day of September,
2010 by and between PRECISION DOSE, INC., an Illinois corporation (“PRECISION
DOSE”), and ELITE PHARMACEUTICALS, INC. and ELITE LABORATORIES, INC. (a
subsidiary of Elite Pharmaceuticals, Inc.), both Delaware corporations
(collectively, “ELITE”).

     

    WHEREAS, ELITE has ownership rights to
products specified on Schedule A (the “Products”) as of September 10, 2010, and
PRECISION DOSE wishes to license from ELITE the right to purchase, market and
sell the Products on the terms and conditions set forth in this
Agreement;

     

    NOW, THEREFORE, in consideration of the
mutual covenants and agreements set forth in this Agreement, and for other good
and valuable consideration, the receipt of which is hereby acknowledged, the
parties hereto agree as follows:

     

    Article
1

    GRANT
OF LICENSE

     

    6.1.         License.  ELITE
hereby grants to PRECISION DOSE a license (“License” or “Licensing Rights”)
without the right to further sublicense, to market and sell the Products in
North America (including the United States, Canada and Puerto Rico), including
the right to reference the ANDA Number, where appropriate, for approval to
market the Product in North America.

     

    6.2.        
Exclusive Marketing Rights.  ELITE
hereby grants to PRECISION DOSE exclusive marketing rights (“Exclusive Marketing
Rights”) to market and sell the Products in the United States, and Puerto
Rico).  ELITE agrees that it shall not (and it shall not authorize,
permit or suffer any of its affiliates to), directly or indirectly, sell or
distribute a Product in North America at any time during the term of this
agreement unless specifically authorized under the terms of this Agreement.
ELITE hereby grants to PRECISION DOSE non-exclusive marketing rights to market
and sell the Products in Canada.

     

    6.3.         Trademarks.
PRECISION DOSE agrees and acknowledges that it shall not acquire by virtue of
this Agreement any interest in or to any trademarks or trade names of ELITE,
except that ELITE authorizes PRECISION DOSE to place the ELITE and PRECISION
DOSE trade names and trademarks on marketing and packaging materials of the
Products during the term of this Agreement. The labeling will incorporate the
following statement: “Manufactured by Elite Laboratories, Inc., 165 Ludlow
Avenue, Northvale, NJ 07647”.

     

    6.4.         Manufacturing. ELITE
will only manufacture the Products at the manufacturing site designated by
Product on Schedule A. The parties agree that, except for regulatory
prohibitions or mutual agreement of the parties that a Product is not
commercially viable, ELITE will be able to manufacture and ship all the Products
to PRECISION DOSE within two years of the date of this Agreement.

     

    6.5.         Licensed Trade
Secrets. The information exchanged between ELITE and PRECISION DOSE
pursuant to this Agreement is expressly subject to the Mutual Confidentiality
and Non-Disclosure Agreement entered into by the parties and dated June 25, 2010
(the “Confidentiality Agreement”) and whose term is hereby made coterminous with
this Agreement.

     

    PRECISION
DOSE-ELITE License Agreement

    09-10
-10

    
      
         

      

      
         

        
          

        

      

      
         

      

    

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

    

    6.6.         Improvements.  Any
new information, developments, or improvements relating to the Products subject
to this Agreement, and any patent or copyright rights arising from or related
thereto (collectively, “Improvements”) will be owned solely by ELITE but shall
be automatically included in the License, and if PRECISION DOSE develops an
Improvement that may be used beyond the Products which are the subject of this
Agreement, then ELITE does now automatically grant a worldwide, non-exclusive,
irrevocable, royalty-free right for PRECISION DOSE to use the
Improvement.

     

    Article
2

    COMPENSATION

     

    2.1.         License Fee and Milestone
Payments.  In return for the Licensing Rights described in this
Agreement, PRECISION DOSE shall pay to ELITE the milestone payments (“Milestone
Payments”) and a license fee (“License Fee”) compensation specified in Schedule
C.

     

    2.2.         Records.  PRECISION
DOSE shall keep complete and accurate records of all sales of the Products and
the calculation of net sales and gross profit of the Products. ELITE shall have
the right, at ELITE’s expense and after thirty (30) days’ prior written notice
to PRECISION DOSE, through an independent certified public accountant, on a
mutually agreeable date, to examine such records at any time within one (1) year
after the due date of the License Fee payments to which such records relate,
during regular business hours, during the life of this Agreement and for twelve
(12) months after expiration of ELITE’s last production lot of Product sold to
PRECISION DOSE, in order to verify the accuracy of the reports to be made under
this Agreement. If the accountant determines that PRECISION DOSE has
under-compensated ELITE, the findings shall be shared with PRECISION DOSE. If
PRECISION DOSE agrees that PRECISION DOSE has not paid ELITE all of the
compensation ELITE was entitled to receive, or it is later determined that
PRECISION DOSE did not pay all of the compensation due to ELITE, then PRECISION
DOSE shall pay the proper amount of compensation and all costs and expenses
incurred by ELITE to hire the accountant and all of the accountant’s expenses,
and all legal expenses, to obtain the appropriate compensation. If PRECISION
DOSE disputes in good faith the accuracy of the results of such examination, the
parties will retain a second independent certified public accountant whose
examination will be binding upon both parties. The losing party will pay all of
the expenses of both independent certified public accountant
examinations.

     

    2.3.         Reports. PRECISION
DOSE will provide Reports as stipulated in Schedule C.

     

    2.4.         Payments
by PRECISION DOSE.

     

    
      	
               
      

            	
              (a)

            	
              All
      Milestone Payments will be made by check and mailed to ELITE within ten
      (10) days after the payment becomes
due.

            

    

     

    
      	
               
      

            	
              (b)

            	
              The
      License Fee shall be paid to ELITE in monthly payments based upon the
      previous month’s Products that PRECISION DOSE shipped to its customers.
      All License Fee payments shall be made by check and mailed to ELITE within
      thirty (30) days after the end of each calendar month. A copy of the
      Report for the prior month will accompany the
  check.

            

    

     

    PRECISION
DOSE-ELITE License Agreement

    09-10 -10
Execution Version

    
      
         

      

      
        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.

    

    
      	
               
      

            	
               (c)

            	
              A
      late fee of 1% per month will be accrued for all payments which PRECISION
      DOSE fails to pay when due.

            

    

     

    Article
3

    ENFORCEABILITY

     

    3.1.         Manufacturing and Supply
Agreement. This Agreement shall not become enforceable until the parties
have executed a separate Manufacturing and Supply Agreement (the “Manufacturing
Agreement”). Inclusive in such Manufacturing and Supply Agreement shall be a
Quality Agreement.

     

    3.2.         Cost of Goods
Summary. ELITE shall provide a detailed summary of the Cost of Goods for
each product on Schedule B, and the parties shall further address the summary
and price adjustments in their Manufacturing and Supply Agreement.

     

    Article
4

    TERM
AND TERMINATION

     

    4.1.         Term.   This
Agreement shall become effective as of the date hereof and shall continue until
fifteen (15) years from such date (the “Initial Term”), unless terminated
earlier by mutual agreement of the parties or by one of the parties in
accordance with this Article 4; provided further that the parties shall have the
option, by mutual agreement, to extend the Initial Term of this Agreement for
three (3) successive terms of five (5) years each (each a “Renewal Term” and
collectively with the Initial Term, the “Term”) by the parties exchanging
written notice of such election not less than six (6) months prior to the
expiration of the Initial Term or then current Renewal Term.

     

    4.2.         Modification
for Lack of Licensing Fees and Minimum Unit Volumes.

     

    
      	
               
      

            	
              (a)

            	
              PRECISION
      DOSE hereby agrees to exert commercially reasonable efforts and shall
      devote the same efforts to marketing the Products that PRECISION DOSE
      exerts for its other major pharmaceutical products being marketed in the
      United States.

            

    

     

    
      	
               
      

            	
              (b)

            	
              If
      after twelve (12) months of a Product’s launch, the Gross Profit declines
      for any Product to the point that the License Fee paid to ELITE is less
      than {***} for a six (6) month period for that Product, other than through
      the fault of ELITE, then ELITE may terminate the Exclusive Marketing
      Rights granted hereunder to PRECISION DOSE as it relates to that
      individual Product.  If ELITE desires to terminate the Exclusive
      Marketing Rights granted hereunder, then ELITE shall give PRECISION DOSE
      ninety (90) days written notice that it will no longer have the Exclusive
      Marketing Rights to sell the particular
Product.

            

    

     

    
      	
               
      

            	
              (c)

            	
              If
      PRECISION DOSE’s unit volume sales of an API specific group of Products (“
      Product Group”), (initially defined as Hydromorphone, Naltrexone, or
      {***}Product Groups), does not meet its minimum annual unit volume
      forecast for that Product Group in the initial launch year, or does not
      meet its subsequent minimum annual unit volume forecast (as defined in
      Schedule D) for a Product Group, then PRECISION DOSE shall have the
      following six (6) months to achieve one-half of the prior year’s minimum
      annual unit volume forecast and if PRECISION DOSE still fails to meet such
      volume minimum during the six months described, then PRECISION DOSE shall
      lose its Exclusive Marketing Rights of such Product
  Group.

            

    

     

    PRECISION
DOSE-ELITE License Agreement

    09-10 -10
Execution Version

    
      
         

      

      
        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.

    

    
      	
               
      

            	
               (d)

            	
              If
      PRECISION DOSE loses its Exclusive Marketing Rights on any Product or
      Product Group, Precision Dose may at its option continue to market the
      Product or Product Group under the License according to the terms of this
      Agreement and other agreements between the parties, but without Exclusive
      Marketing Rights to such Product or Product
  Group.

            

    

     

    4.3.         Termination by Mutual
Agreement.  The parties may terminate this Agreement any time
by mutual written agreement.

     

    4.4.         Termination by
Breach.  Upon the breach or default in the performance or
observance of any of the material provisions of this Agreement by either Party,
when such breach or default is not cured by the responsible Party within sixty
(60) days after written notice by the other Party, the other Party may terminate
this Agreement upon an additional thirty (30) days written notice to the other
Party. Termination will be without prejudice to either Party to recover any and
all damages to which it may be entitled, or to exercise any other
remedies.

     

    4.5.         Termination by ELITE Upon
Bankruptcy or Reorganization of PRECISION DOSE. If PRECISION DOSE enters
into any proceeding (whether voluntary or otherwise) in bankruptcy,
reorganization or arrangement for the appointment of a receiver or trustee to
take possession of its assets, or any other proceeding under any law for the
relief of creditors or makes an arrangement for the benefit of its creditors,
and remains in such proceeding for 30 days, then ELITE shall retain its rights
to the Products and may terminate this Agreement without further payment to
PRECISION DOSE.

     

    4.6.         Licensing Rights upon
Termination.  Except as otherwise provided in this Agreement,
upon termination of this Agreement: all rights, privileges, and licenses will
terminate and revert to ELITE, and PRECISION DOSE must not thereafter make any
use whatsoever of any trade secrets, except that it is agreed that upon
termination notwithstanding any other terms of this Agreement, PRECISION DOSE
may retain one archival copy to have sufficient information solely to respond to
state and federal regulatory inquiries regarding the Products.

     

    4.7.         Accrued
Rights.  Expiration or termination of this Agreement shall be
without prejudice to the right of either Party to receive all payments accrued
and unpaid at the effective date of such expiration or termination, without
prejudice to the remedy of either Party in respect to any previous breach of the
representations, warranties or covenants herein contained, without prejudice to
any rights to indemnification set forth herein and without prejudice to any
other provision hereof which expressly or necessarily calls for performance
after such expiration or termination. PRECISION DOSE expressly retains the right
to sell Product on-hand after termination of this Agreement and shall remain
bound to pay ELITE the Licensing Fee as provided in this Agreement.

     

    PRECISION
DOSE-ELITE License Agreement

    09-10 -10
Execution Version

    
      
         

      

      
        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.
 

    Article
5

    REPRESENTATIONS,
WARRANTIES AND COMPETITION, COOPERATION UPON

    BANKRUPTCY
OF ELITE

     

    5.1.     PRECISION DOSE
Representations.  PRECISION DOSE hereby represents and warrants
to ELITE that (a) it has obtained all necessary licenses, authorizations and
approvals required by applicable Law, including those required by the FDA, DEA
or any other applicable regulatory agency to enter into this Agreement and
perform its obligations hereunder; (b) the execution, delivery and performance
of this Agreement by PRECISION DOSE does not conflict with or constitute a
breach of any order, judgment, agreement, or instrument to which it is a party;
(c) the execution, delivery and performance of this Agreement by PRECISION DOSE
does not require the consent of any person; and (d) none of its officers or
directors has ever been convicted of a felony under the laws of the United
States for conduct relating to the development or approval of a drug product or
relating to the marketing or sale of a drug product

     

    5.2.     ELITE
Representations. ELITE hereby represents and warrants to PRECISION DOSE
that (a) it has obtained all necessary licenses, authorizations and
approvals required by applicable Law, including those required by the FDA, DEA
or any other applicable regulatory agency to enter into this Agreement and
perform its obligations hereunder; (b) the execution, delivery and performance
of this Agreement by ELITE does not conflict with or constitute a breach of any
order, judgment, agreement, or instrument to which it is a party; (c) the
execution, delivery and performance of this Agreement by ELITE does not require
the consent of any person; and (d) none of its officers or directors has ever
been convicted of a felony under the laws of the United States for conduct
relating to the development or approval of a drug product or relating to the
marketing or sale of a drug product.

     

    5.3.     Non-competition by PRECISION
DOSE. PRECISION DOSE hereby covenants and agrees that without the prior
written consent of ELITE during the Term of this Agreement, and for 1 year after
the last shipment of Product by PRECISION DOSE if the agreement is terminated
due to breach of the Agreement by PRECISION DOSE, PRECISION DOSE will not
directly or indirectly market any of the Products Licensed to PRECISION DOSE by
ELITE pursuant to this Agreement. This section is not intended to prohibit
PRECISION DOSE from marketing and selling a product which addresses the same
therapeutic indication as a Product, as long as that other product does not
contain the same API as the Product(s) in this Agreement.

     

    5.4.     Cooperation Upon Bankruptcy
Event of ELITE. ELITE shall use, and cause its representatives and
affiliates to use, best efforts to make all necessary arrangements and take all
required actions to permit PRECISION DOSE to retain all rights licensed
hereunder with respect to the Products in the event that ELITE (i) is dissolved or liquidated, (ii) commences a voluntary
case or other proceeding seeking liquidation, reorganization or other relief with
respect to itself or its debts under any bankruptcy, insolvency or other similar law,
(iii) is subject to an involuntary case or
other proceeding seeking liquidation, reorganization or other relief with
respect to ELITE and an order for
relief entered or such proceeding has not be dismissed or discharged within
sixty (60) days of commencement, (v) has made an assignment for the
benefit of creditors, or (vi) otherwise
ceases to conduct business during the Term (each, an “Extraordinary
Event”). If ELITE breaches its obligations under the Manufacturing
Agreement as a result of an Extraordinary Event (a “Manufacturing Breach”), then
PRECISION DOSE will have the right to enter into a manufacturing arrangement
with a manufacturer other than ELITE in order to continue the manufacturing of
the Products. Without limitation of the foregoing, ELITE covenants and agrees
that:

     

    PRECISION
DOSE-ELITE License Agreement

    09-10 -10
Execution Version

    
      
         

      

      
        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.

    

    
      	
               
      

            	
               (a)

            	
              this
      Agreement involves intellectual property rights and PRECISION DOSE shall
      be entitled to all benefits and protections afforded by Section 365(n) of
      the United States Bankruptcy Code and any successor or similar statutes,
      including the right to elect to retain the rights under this Agreement
      and, upon a Manufacturing Breach, to receive, without additional cost, a
      licensed copy of all embodiments of the Products (but subject to any
      restrictions on ELITE’S right to disclose any such embodiments which are
      not proprietary to ELITE), including, without limitation, technical
      information necessary for the continued manufacture of the Products by a
      third party (collectively, the “Product
      Materials”);

            

    

     

    
      	
               
      

            	
              (b)

            	
              Product
      Materials received by PRECISION DOSE pursuant to subsection (a) above
      shall be used by PRECISION DOSE and its affiliates and contractors solely
      to enable the manufacture of the Products upon a Manufacturing Breach and
      to continue to market, enhance and improve the Products in accordance with
      this Agreement; and

            

    

     

    
      	
               
      

            	
              (c)

            	
              PRECISION
      DOSE shall hold any Product Materials in the strictest confidence and
      treat such Product Materials as proprietary and confidential information
      of ELITE in accordance with the Confidentiality
  Agreement.

            

    

     

    Article
6

    MISCELLANEOUS

     

    6.1.         Waiver; Remedies and
Amendment. Any waiver by any party hereto of a breach of any provisions
of this Agreement will not be implied and will not be valid unless such waiver
is recited in writing and signed by such party. Failure of any party to require,
in one or more instances, performance by the other party or parties in strict
accordance with the terms and conditions of this Agreement will not be deemed a
waiver or relinquishment of the future performance of any such terms or
conditions or of any other terms and conditions of this Agreement. A waiver by
any party of any term or condition of this Agreement, including this Section
6.1, shall be valid only if in writing and will not be deemed or construed to be
a waiver of such term or condition for any other term. All rights, remedies,
undertakings, obligations and agreements contained in this Agreement will be
cumulative and none of them will be a limitation of any other remedy, right,
undertaking, obligation or agreement of any party. This Agreement may not be
amended except in a writing signed by all parties.

     

    6.2.         Affiliates, Assignment, No
Inconsistent Agreements. The parties agree that PRECISION DOSE may
exercise its rights under this Agreement through its wholly owned subsidiary
TAGI PHARMA, INC. (“TAGI”), and references herein to PRECISION DOSE shall
include TAGI. PRECISION DOSE may not otherwise assign its rights and obligations
hereunder without the prior written consent of ELITE. Neither PRECISION DOSE nor
ELITE will enter into any agreement that is inconsistent with its obligations
hereunder.

     

    PRECISION
DOSE-ELITE License Agreement

    09-10 -10
Execution Version

    
      
         

      

      
        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.

    

    6.3.         Counterparts.  This
Agreement may be executed in any number of counterparts, each of which when so
executed will be deemed to be an original and all of which when taken together
will constitute this Agreement.

     

    6.4.         Governing Law; Dispute
Resolution; Venue.  This Agreement will be governed by and
construed in accordance with the laws of the state of New York without regard to
conflict of law or choice of law rules. Any controversy or claim pursuant to
this Agreement or the breach thereof shall be referred for decision forthwith to
a senior executive of each Party not directly involved in the dispute. If no
agreement is reached within thirty (30) days of the request by one Party to the
other to refer the same to such senior executive, then such controversy or claim
shall be settled by arbitration in accordance with the Commercial Arbitration
Rules of the American Arbitration Association; such arbitration to be held in
Rockford, Illinois on an expedited basis. Judgment upon the award rendered by
the Arbitrator(s) may be entered in any court having jurisdiction
thereof.

     

    6.5.         Headings.  The
headings set forth at the beginning of the various sections of this Agreement
are for convenience and form no part of the Agreement between the
parties.

     

    6.6.         Notices.  All
notices, requests, instructions, consents and other communications to be given
pursuant to this Agreement shall be in writing and shall be deemed received (a)
on the same day if delivered in person, by same-day courier or by facsimile,
electronic mail or other electronic transmission, (b) on the next day if
delivered by overnight mail or courier, or (c) on the date indicated on the
return receipt, or if there is no such receipt, on the third calendar day
(excluding Sundays) if delivered by certified or registered mail, postage
prepaid, to the party for whom intended to the following addresses:

     

    If to
PRECISION DOSE:

    

    PRECISION
DOSE

    722
Progressive Lane

    South
Beloit, IL  61080

    Attn:  President

    

    With a
copy to:

    Reilly
Law Offices

    6801
Spring Creek Rd., Ste 2D

    Rockford,
IL  61114

    Attn:
William A. Reilly II

    

    If to
ELITE:

    

    ELITE
PHARMACEUTICALS, Inc.

    165
Ludlow Avenue

    Northvale,
New Jersey 07647

    Attention:  President
and CEO

    

    With a
copy to:

    Richardson
& Patel

    Murdock
Plaza

     

    PRECISION
DOSE-ELITE License Agreement

    09-10 -10
Execution Version

    
      
         

      

      
        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.

    

    10900
Wilshire Boulevard

    Suite
500

    Los
Angeles, California  90024

    Attention:
Kevin Friedmann

     

    6.7.         Each
party may by written notice given to the other in accordance with this Agreement
change the address to which notices to such party are to be
delivered.

     

    6.8.         Severability.  If
any provision of this Agreement is held by a court of competent jurisdiction to
be invalid or unenforceable, it will be modified, if possible, to the minimum
extent necessary to make it valid and enforceable or, if such modification is
not possible, it will be stricken and the remaining provisions will remain in
full force and effect.

     

    6.9.         Survival.  The
rights and obligations which accrue to a party during the term of this agreement
shall survive the termination of this Agreement.

     

    6.10.       Force
Majeure.  No party to this Agreement will be liable for failure
or delay in the performance of any of its obligations hereunder, if such failure
or delay is due to causes beyond its reasonable control including, without
limitation, acts of God, earthquakes, fires, strikes, acts of war, or
intervention of any governmental authority, but any such delay or failure will
be remedied by such party as soon as possible after the removal of the cause of
such failure or delay.

     

    6.11.       Entire
Understanding.  This Agreement, including the schedules
attached hereto, contains the entire understanding relative to the matters
addressed herein, and supersedes all prior and collateral communications,
reports, and understandings, if any, between the parties regarding the matters
addressed herein.

     

    6.12.       Drafting.  The
parties have participated jointly in the negotiation and drafting of this
Agreement. In the event an ambiguity or question of intent or interpretation
arises, this Agreement shall be construed as if drafted jointly by the parties
and no presumption or burden of proof shall arise favoring or disfavoring any
party by virtue of the authorship of any of the provisions of this Agreement.
..

     

    6.13.       Not a Joint
Venture.  This Agreement does not constitute or create (and the
Parties do not intend to create hereby) a joint venture, pooling arrangement,
Partnership, or formal business organization of any kind between and among any
of the Parties, and the rights and obligations of the Parties shall be only
those expressly set forth herein. The relationship hereby established between
PRECISION DOSE and ELITE is solely that of licensee and licensor, each is an
independent contractor engaged in the operation of its own respective business.
Neither Party shall be considered to be an agent of the other for any purpose
whatsoever. Each Party shall be responsible for providing its own personnel and
workers compensation, medical coverage or similar benefits and shall be solely
responsible for the payment of social security benefits, unemployment insurance,
pension benefits, withholding any required amounts for income and other
employment-related taxes and benefits of its own employees, and shall make its
own arrangements for injury, illness or other insurance coverage to protect
itself, its Affiliates, its subcontractors and personnel from any damages, loss
and/or liability arising out of the performance of this Agreement. Neither Party
has the power or authority to act for, represent or bind the other (or its
Affiliates) in any manner.

     

    PRECISION
DOSE-ELITE License Agreement

    09-10 -10
Execution Version

    
      
         

      

      
        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.

    

    IN
WITNESS WHEREOF, the parties have executed this Agreement on the date first set
forth above.

     

    
      
        
          
            
              
                
                  
                    	
                            ELITE
      PHARMACEUTICALS, INC.

                          	 	
                            PRECISION
      DOSE, INC.

                          
	 
      	 	 
      
	
                            By:

                          	 
      	 	
                            By:

                          	 
      
	 	 	 	 	 
	
                            Name: 

                          	
                            Chris
      Dick

                          	 	
                            Name: 

                          	
                            Robert
      Koopman

                          
	 
      	 
      	 	 
      	 
      
	
                            Title:

                          	
                            President

                          	 	
                            Title:

                          	
                            President

                          
	 
      	 
      	 	 
      	 
      
	
                            Date:

                          	 
      	 	
                            Date:

                          	 
      

                  

                

              

            

          

        

      

    

    

    PRECISION
DOSE-ELITE License Agreement

    09-10 -10
Execution Version

    
      
         

      

      
        10

        
          

        

      

      
         

      

    

    {***}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.

    

    SCHEDULE
A

     

    Product
List

     

    Products
Manufactured by ELITE:

     

    
      
        
          
            
              	
                      Name

                    	 
      	
                      ANDA
      #

                    	 
      	
                      Approved  Manufacturing
      Site

                    
	 
      	 
      	 
      	 
      	 
      
	
                      Hydromorphone
      8mg, 4mg and 2mg Tablets, 100’s and 500’s

                    	 
      	
                      76-723
      (8 mg)

                    	 
      	
                      ELITE
      – 135 and 165 Ludlow Avenue, Northvale, NJ 07647

                    
	 
      	 
      	 
      	 
      	 
      
	
                      Naltrexone
      50mg Tablets, 30’s and 100’s

                    	 
      	
                      75-274

                    	 
      	
                      ELITE
      – 135 and 165 Ludlow Avenue, Northvale, NJ 07647

                    
	 
      	 
      	 
      	 
      	 
      
	
                      {***}Tablets, 100’s and
      1,000’s

                    	 
      	
                      {***}

                    	 
      	
                      ELITE
      – 135 and 165 Ludlow Avenue, Northvale, NJ 07647

                    
	 
      	 
      	 
      	 
      	 
      
	
                      {***}Capsules, 100,s and
      1000’s

                    	 
      	
                      Product
      not yet approved

                    	 
      	
                      ELITE
      – 135 and 165 Ludlow Avenue, Northvale, NJ
07647

                    

            

          

        

      

    

     

    Note: 
Temporary packaging (defined as less than twelve (12) months) of these products
may be done at the Epic Pharma, LLC facility located at 227-16 N. Conduit
Avenue, Laurelton, N.Y. 11413, unless Precision Dose consents to extend the
timeframe beyond twelve (12) months, with such consent not to be unreasonably
withheld.

     

    PRECISION
DOSE-ELITE License Agreement

    09-10-10

    
      
         

      

      
        11

        
          

        

      

      
         

      

    

    {***}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.

    

    SCHEDULE
B

     

    Standard
Manufacturing Costs (FOB, Northvale facility)

     

    
      
        
          	 
      	 
      	 
      	 
      	 
      	 
      	
                  Bottles

                	 
      	 
      	 
      	 
      
	 
      	 
      	
                  Batch

                	 
      	
                  Bottle

                	 
      	
                  Per

                	 
      	
                  Batch

                	 
      	
                  Cost/

                
	
                  ITEM

                	 
      	
                  Size

                	 
      	
                  Size

                	 
      	
                  Batch

                	 
      	
                  Cost

                	 
      	
                  Bottle 

                
	
                  Hydromorphone

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  8mg

                	 
      	
                  {***}

                	 
      	
                  100’s

                	 
      	
                  {***}

                	 
      	
                  {***}

                	 
      	
                  {***}

                
	 
      	 
      	 
      	 
      	
                  500’s

                	 
      	
                  {***}

                	 
      	
                  {***}

                	 
      	
                  {***}

                
	 	 	 	 	 	 	 	 	 	 	 
	
                  4mg

                	 
      	
                  {***}

                	 
      	
                  100’s

                	 
      	
                  {***}

                	 
      	
                  {***}

                	 
      	
                  {***}

                
	 
      	 
      	 
      	 
      	
                  500’s

                	 
      	
                  {***}

                	 
      	
                  {***}

                	 
      	
                  {***}

                
	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  2mg

                	 
      	
                  {***}

                	 
      	
                  100’s

                	 
      	
                  {***}

                	 
      	
                  {***}

                	 
      	
                  {***}

                
	 
      	 
      	 
      	 
      	
                  500’s

                	 
      	
                  {***}

                	 
      	
                  {***}

                	 
      	
                  {***}

                
	
                  Naltrexone

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  50mg

                	 
      	
                  {***}

                	 
      	
                  30’s

                	 
      	
                  {***}

                	 
      	
                  {***}

                	 
      	
                  {***}

                
	 
      	 
      	
                  {***}

                	 
      	
                  100’s

                	 
      	
                  {***}

                	 
      	
                  {***}

                	 
      	
                  {***}

                
	
                  {***}

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  {***}Tablets

                	 
      	
                  {***}

                	 
      	
                  100’s

                	 
      	
                  {***}

                	 
      	
                  {***}

                	 
      	
                  {***}

                
	 
      	 
      	
                  {***}

                	 
      	
                  1,000’s

                	 
      	
                  {***}

                	 
      	
                  {***}

                	 
      	
                  {***}

                
	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  {***} Capsules

                	 
      	
                  {***}

                	 
      	
                  100’s

                	 
      	
                  {***}

                	 
      	
                  {***}

                	 
      	
                  {***}

                
	 
      	 
      	
                  {***}

                	 
      	
                  1,000’s

                	 
      	
                  {***}

                	 
      	
                  {***}

                	 
      	
                  {***}

                
	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  {***}
Capsules

                	 
      	
                  {***}

                	 
      	
                  100’s

                	 
      	
                  {***}

                	 
      	
                  {***}

                	 
      	
                  {***}

                
	 
      	
                    

                	
                  {***}

                	
                    

                	
                  1,000’s

                	
                    

                	
                  {***}

                	
                    

                	
                  {***}

                	
                    

                	
                  {***}

                

        

      

    

     

    NOTE:
Includes all Product manufacturing and packaging costs, quality assurance and
batch quality control testing. Stability testing will be at an additional
cost.

    

    *
{***}

     

    PRECISION
DOSE-ELITE License Agreement

    09-10-10

    
      
         

      

      
        12

        
          

        

      

      
         

      

    

    {***}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.

    

    SCHEDULE
C

     

    Compensation
for Licensing Rights

    

    Milestone
Payments

    

    PRECISION
DOSE will pay to ELITE Milestone Payments totaling {***}, according to the
following schedule:

    
      	
               
      

            	
              ·

            	
              $200,000
      shall be paid to ELITE upon signing of this enforceable License
      Agreement

            

    

    
      	
               
      

            	
              ·

            	
              ${***}
      shall be paid to ELITE upon FDA approval and initial shipment of the
      “Products” to PRECISION DOSE according to the following
      schedule:

            

    

    
      	
               
      

            	
              §

            	
              Hydromorphone
      8mg — ${***}

            

    

    
      	
               
      

            	
              §

            	
              Hydromorphone
      4mg and 2mg — ${***}

            

    

    
      	
               
      

            	
              §

            	
              Naltrexone
      50mg — ${***}

            

    

    
      	
               
      

            	
              §

            	
              {***}tablet
      — ${***}

            

    

    
      	
               
      

            	
              §

            	
              {***}
      Capsules (All) — ${***}

            

    

    

    License
Fee

    

    PRECISION
DOSE will pay to ELITE a License Fee that is a percentage of the product gross
profit (“Product Gross Profit”) of PRECISION DOSE, as defined below, generated
on Products sold and shipped to its customers by PRECISION DOSE according to the
following schedule:

    

    
      	
               
      

            	
              ·

            	
              Hydromorphone
      8mg, 4mg, and 2mg Tablets — @ {***}% of Product Gross
    Profit

            

    

    
      	
               
      

            	
              ·

            	
              Naltrexone
      50mg Tablets — @ {***}% of Product Gross
Profit

            

    

    
      	
               
      

            	
              ·

            	
              {***}mg
      Tablets , {***}mg Capsules and {***}mg Capsules — @ {***}% of Product
      Gross Profit

            

    

    

    Product
Gross Profit is defined as:  Net Sales - Cost of Goods = Product Gross
Profit.

    

    
      	
               
      

            	
              §

            	
              Net Sales is defined
      as:  Net Invoice Price less the following: Charge backs, Buying
      Groups/Wholesaler Administrative Fees/Rebates, Allowances, Medicaid and
      Returns.

            

    

    

    
      	
               
      

            	
              §

            	
              Cost of Goods is defined
      as:  The total number of units sold and included in Net Sales
      multiplied by the Standard Manufacturing Cost ( “$/Bottle Cost”) set forth
      on Schedule B plus Quality Assurance and Quality Control (including
      Testing and Stability Costs) and Warehouse/Distribution (including inbound
      and outbound) of ELITE and PRECISION DOSE, also known as Unit Cost
      .

            

    

    

    The
calculation of Product Gross Profit and the Licensing Fee shall be performed by
Precision Dose and presented to Elite as a report (“Report”) which shall include
the following information:

    

    PRECISION
DOSE-ELITE License Agreement

    09-10 -10
Execution Version

    
      
         

      

      
        13

        
          

        

      

      
         

      

    

    {***}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.

    

    REPORT
ITEMS

       

    
      
        
          
            
              
                
                  	
                          Gross
      Invoice Sales

                        	
                          Total
      Sales for Month

                        
	
                          Cash
      Discount

                        	
                          Cash
      Discount

                        
	 
      	 
      
	
                          Net
      Invoice Sales

                        	
                          Total
      Sales - Cash Discount

                        
	 
      	 
      
	
                          Deductions

                        	
                          Allowances
      (including wholesale service fees; customer admin. fees; Medicaid rebate;
      state program rebates; administration fees)  price adjustments;
      returns; charge backs.

                        
	
                           

                          Net
      Sales

                        	
                          Net
      Invoice Sales – Deductions

                        
	 
      	 
      
	
                          Cost
      of Goods

                        	
                          Total
      Units x Unit Cost

                        
	 
      	 
      
	 
      	 
      
	
                          Gross
      Profit

                        	
                          Net
      Sales less Cost of Goods

                           

                        
	
                          Margin
      %

                        	
                          Margin
      Percentage (Gross Profit divided by Gross Invoice
Sales)

                        
	 
      	 
      
	
                          Amount
      Due

                        	Gross Profit $ 	
                          x
      {***}%:
      Hydromorphone

                        
	 
      	 	
                          x
      {***}%:
      Naltrexone

                        
	 
      	 	
                          x {***}%: {***}

                        

                

              

            

          

        

      

    

     

    Whenever
possible, the Report will be made using actual sales, charge backs,
administrative fees/rebates, price adjustments, and returns; however, in some
cases estimated numbers may be required because of timing of CBs, fees, returns,
etc. A true up Report will be completed and presented to ELITE within 60 days
after the end of each calendar year.

    

    PRECISION
DOSE-ELITE License Agreement

    09-10 -10
Execution Version

    
      
         

      

      
        14

        
          

        

      

      
         

      

    

    {***}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.

    

    SCHEDULE
D

     

    Minimum
Annual Unit Forecast for Each Product Group

    (As
of August 27, 2010)

    

    
      
        	 
      	 
      	
                Year 1

              	 
      	
                Year 2

              	 
      	
                Year 3

              	 
      	
                Year 4

              	 
      	
                Year 5

              
	
                (Units
      in 000 — Tablets)

              	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                Hydromorphone
      8mg

              	 
      	
                {***}

              	 
      	
                {***}

              	 
      	
                {***}

              	 
      	
                {***}

              	 
      	
                {***}

              
	
                Naltrexone
      50mg

              	 
      	
                {***}

              	 
      	
                {***}

              	 
      	
                {***}

              	 
      	
                {***}

              	 
      	
                {***}

              
	
                {***}
      {***}mg Tabs

              	
                  

              	
                {***}

              	
                  

              	
                {***}

              	
                  

              	
                {***}

              	
                  

              	
                {***}

              	
                  

              	
                {***}

              

      

    

    

    NOTE: The
above committed unit volumes are {***}% of the unit volumes in the Target
Financial Forecasts previously provided for Profit Split
calculations.

    

    For
purposes of this Provision, the minimum annual forecast will be reviewed
annually for any changes in the competitive environment, and revised by the
Parties as mutually agreed. As the additional products become available, the
combined Product Group minimum annual quantities will be reassessed according to
the then current market conditions.

    

    PRECISION
DOSE-ELITE License Agreement

    09-10 -10
Execution Version

    
      
         

      

      
        15Unassociated Document

     

    
      MANUFACTURING
AND SUPPLY AGREEMENT 

      
        

      

    

     

    Between

     

    Elite
Pharmaceuticals, Inc.

     

    And

     

    Precision
Dose, Inc.

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    MANUFACTURING AND SUPPLY
AGREEMENT

     

    This
Manufacturing and Supply Agreement (the "Agreement") is entered into as
of the 10th day of September, 2010 (the "Effective Date"), by and
between Precision Dose, Inc., an Illinois corporation ("PRECISION DOSE"), and
Elite Pharmaceuticals, Inc. and Elite Laboratories, Inc. (a subsidiary of Elite
Pharmaceuticals, Inc.), both Delaware corporations ("ELITE").

     

    RECITALS

     

    WHEREAS,
ELITE is engaged in the manufacture and commercialization of pharmaceutical
products;

     

    WHEREAS,
ELITE wishes to supply PRECISION DOSE with pharmaceutical products on the terms
and conditions set forth in this Agreement;

     

    WHEREAS,
PRECISION DOSE desires to have ELITE supply PRECISION DOSE and its wholly owned
subsidiary, TAGI Pharma, Inc., (“TAGI”),with pharmaceutical products as part of
a License Agreement (dated September 10, 2010) with Elite on the terms and
conditions set forth in this Agreement; and

     

    NOW,
THEREFORE, in consideration of the mutual covenants and agreements set forth in
this Agreement, and for other good and valuable consideration, the receipt of
which is hereby acknowledged, the parties hereto agree as follows:

     

    ARTICLE
1

    DEFINITIONS

     

    Capitalized
terms used in this Agreement shall have the meanings ascribed to them in this
Article 1 or as otherwise set forth herein.  Unless the context
indicates otherwise, the singular shall include the plural and the plural shall
include the singular.

     

    1.1.           "Act" means the United States
Food, Drug and Cosmetic Act, as amended from time to time, and the regulations
promulgated thereunder.

     

    1.2.           "Affiliates" means a
corporation or any other entity that directly, or indirectly through one or more
intermediaries, controls, is controlled by, or is under common control with, the
designated party, but only for so long as the relationship
exists.  "Control" shall mean ownership
of shares of stock having at least 50% of the voting power entitled to vote for
the election of directors in the case of a
corporation.  Notwithstanding the foregoing, the owners of preferred
stock (or common stock issued upon conversion thereof) of either party such as
financial institutions, venture capital funds and private equity investors shall
not be its "Affiliates" for purposes of this Agreement.

     

    1.3.           "ANDA" means a Abbreviated New
Drug Application pursuant to Section 505 of the Act (21 U.S.C. Section 355)
submitted to the FDA or any successor application or procedure or any foreign
counterpart of a United States New Drug Application for approval to market,
including where applicable, applications for pricing and reimbursement
approval.

     

    {***}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

        
          

        

      

      
         

      

    

    

    
      	
              ELITE
      and Precision Dose

            	 
      
	
              Manufacturing
      and Supply Agreement

            	
              Execution
      Version

            

    

    

    1.4.           “ELITE” shall mean Elite
Pharmaceuticals, Inc., and Elite Laboratories, Inc. (a subsidiary of Elite
Pharmaceuticals, Inc.), both Delaware corporations

     

    1.5.           “API” shall mean the active
pharmaceutical ingredient of a referenced Product.

     

    1.6.           "Batch" means a specific
quantity of Product as set forth on Exhibit A that is intended to have uniform
character and quality, within specified limits, and is produced according to a
single manufacturing order during the same cycle of manufacture.

     

    1.7.           "Certificate of Analysis" means
a certificate issued by the manufacturer of a lot or batch of a Product, which
certificate contains such information as provided in the Quality Agreement (as
defined below).

     

    1.8.           "cGMP" means the current
standards for the manufacture of pharmaceuticals, as set forth in the United
States Federal Food, Drug and Cosmetic Act, as amended, and applicable
regulations and guidance promulgated there under, including without limitation
the Code of Federal Regulations, as amended from time to time.

     

    1.9.           "Facility" means any ELITE
manufacturing and packaging facility.

     

    1.10.         "FDA" means the United States
Food and Drug Administration or any
successor United States governmental agency performing similar functions with
respect to pharmaceutical products.

     

    1.11.         "Laws" means any present and
future national, state, or local law (whether under statute, rule, regulation,
or otherwise); requirements under permits, orders, decrees, judgments, or
directives; and requirements of a Regulatory Agency and any other applicable
government authorities, including without limitation Good Manufacturing
Practices as promulgated by the United States Food and Drug Administration and
specified in the U.S. Code of Federal Regulations Parts 210 and 211, as amended
from time to time.  The determination of either party to this
Agreement that a Legal Requirement is necessary shall be dispositive for
purposes of this Agreement.

     

    1.12.         “License Agreement” means the
written agreement entered into by ELITE and PRECISION DOSE as of the 10th day of
September, 2010 titled “License Agreement”.

     

    1.13.         “PRECISION DOSE” shall mean
PRECISION DOSE, an Illinois corporation, and its wholly owned subsidiary, TAGI
Pharma, Inc., an Illinois corporation.

     

    1.14.         "Product" means the finished
pharmaceutical products identified in the attached Exhibit A and sold by ELITE
to Precision Dose in bottles to be distributed or packaged into unit
dose.

     

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

    
      
         

      

      
        2

        
          

        

      

      
         

      

    

    

    
      	
              ELITE
      and Precision Dose

            	 
      
	
              Manufacturing
      and Supply Agreement

            	
              Execution
      Version

            

    

      

    1.15.         "Product Specifications" means
the written specifications for the Product developed by ELITE, approved by the
FDA, and delivered to PRECISION DOSE thereafter as Exhibit B of this
Agreement.

     

    1.16.         “Production Report” means a
manufacturing and packaging report of production batches (at the Batch level and
consolidated Batches), providing actual production volumes and costs against
their associated standards.  The report shall include standard and
variance reporting cost notes.

     

    1.17.         "Quality Agreement" means the
agreement to be entered into by the parties hereto concurrently herewith,
setting out the quality assurance standards to be applicable to the
manufacturing services provided by ELITE.

     

    1.18.         "Regulatory Approval" means any
and all approvals (including supplements, amendments, label expansions, pre- and
post-approvals, pricing and reimbursement approvals), licenses, registrations or
authorizations of any national, regional, state, provincial or local regulatory
agency, department, bureau, commission, council or other governmental entity,
that are necessary for the manufacture, distribution, use or sale of a product
in a regulatory jurisdiction.

     

    1.19.         "Shipments" means all shipments
made hereunder of Product.

     

    1.20.         "Territory" means the United
States and Canada.

     

    1.21.         "United States" means the
United States of America and its states, territories, possessions and
protectorates thereof, the District of Columbia and the Commonwealth of Puerto
Rico.

     

    ARTICLE
2

    SUPPLY
OF PRODUCT

     

    2.1.         Supply.  During
the Term of this Agreement as defined below, and subject to the terms and
conditions set forth herein, PRECISION DOSE agrees to exclusively purchase
Products it requires from ELITE pursuant to this Agreement and ELITE agrees to
supply to PRECISION DOSE, from the Facility, such Product as is ordered by
PRECISION DOSE.

     

    
      	
               
      

            	
              (a)

            	
              Product
      supplied hereunder shall be supplied as specified in PRECISION DOSE's
      purchase orders made pursuant to this Article 2 and shall meet the
      Product Specifications.

            

    

     

    
      	
               
      

            	
              (b)

            	
              Each
      shipment shall be accompanied by a Certificate of Analysis in
      English.

            

    

     

    
      	
               
      

            	
              (c)

            	
              Product
      shall be manufactured in accordance with cGMP and all other applicable
      Laws and any procedures set forth in the Product Specifications and
      Quality Agreement, and such additional procedures as may be agreed upon in
      writing by the parties.

            

    

     

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

    
      
         

      

      
        3

        
          

        

      

      
         

      

    

    

    
      	
              ELITE
      and Precision Dose

            	 
      
	
              Manufacturing
      and Supply Agreement

            	
              Execution
      Version

            

    

     

    
      	
               
      

            	
               (d)

            	
              Product
      shall be purchased by PRECISION DOSE under this Agreement at the prices
      set forth on Exhibit A attached
      hereto.

            

    

     

    2.2.        Product
Orders.

     

    
      	
               
      

            	
              (a)

            	
              From
      time to time and subject to the other provisions of this Agreement,
      PRECISION DOSE shall place orders for Batch quantities of Product,
      specifying delivery dates.  Subject to the terms of this
      Agreement, ELITE shall meet specified delivery dates, provided the
      delivery dates specified in any such orders shall not be less than ninety
      (90) days from the date of such
orders.

            

    

     

    
      	
               
      

            	
              (b)

            	
              ELITE
      shall use commercially reasonable efforts to accommodate a PRECISION DOSE
      request for delivery of the Product sooner than as otherwise is required
      under this Agreement;  and, if PRECISION DOSE’s business
      conditions necessitate reduction of Product amount ordered or delay in
      purchase order shipment dates, then ELITE shall use commercially
      reasonable efforts to implement such requested changes, provided that, if
      such changes cause ELITE to incur additional expenses, ELITE shall specify
      such additional expenses in writing and provide such substantiating
      documentation reasonably requested by PRECISION DOSE, and PRECISION DOSE
      shall pay such additional expenses as and when
  incurred.

            

    

     

    2.3.        Acceptance.  ELITE
shall ensure that the Product ordered by PRECISION DOSE in accordance with this
Agreement is shipped in accordance with the delivery dates specified in
PRECISION DOSE's purchase order received by ELITE, and ELITE shall notify
PRECISION DOSE promptly of any anticipated delay.

     

    2.4.       
Forecasts and
Production Planning.

     

    
      	
               
      

            	
              (a)

            	
              Within
      fifteen days (15) business days of the Effective Date, PRECISION DOSE will
      provide ELITE with a written forecast of its requirements for the {***}
      {***}mg Tablet for the next twelve (12)
months.

            

    

     

    
      	
               
      

            	
              (b)

            	
              During
      each successive calendar quarter, on or about the first day of that
      quarter, PRECISION DOSE shall provide ELITE with a twelve (12) month
      rolling forecast of the quantity of Product required by PRECISION DOSE, by
      month, for the following twelve (12) months (each, a "Forecast").

            

    

     

    {***}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

        
          

        

      

      
         

      

    

    

    
      	
              ELITE
      and Precision Dose

            	 
      
	
              Manufacturing
      and Supply Agreement

            	
              Execution
      Version

            

    

     

    
      	
               
      

            	
              (c)

            	
              It
      is agreed by the parties that the first three (3) months of the twelve
      (12) month forecast are binding on PRECISION DOSE.  It is
      understood that such Forecasts for the remaining nine (9) months are
      intended to be good faith estimates only, and shall not be binding upon
      PRECISION DOSE.  PRECISION DOSE agrees that in the event this
      Agreement is terminated by PRECISION DOSE or through the fault of
      PRECISION DOSE, then PRECISION DOSE shall compensate ELITE for its cost
      for any pharmaceutical or packaging materials purchased by ELITE to meet
      any unused balance of the first three (3) months of the most recent twelve
      (12) month Forecast provided by PRECISION DOSE to
  ELITE.

            

    

     

    
      	
               
      

            	
              (d)

            	
              To
      the extent that Product orders specified for shipment in any quarter
      exceed the most recent PRECISION DOSE Forecast for such quarter by more
      than ten percent (10%) (any excess of ten percent (10%) or less
      shall, for this purpose, be deemed not to exceed forecast), ELITE shall
      use its commercially reasonable efforts to fulfill any such excess
      contained in PRECISION DOSE's Product orders, but ELITE shall not be
      liable to PRECISION DOSE for any inability, despite its reasonable
      efforts, to fill orders in excess of such
  forecast.

            

    

     

    2.5.        Initial Supply of API for
{***}Orders. PRECISION
DOSE agrees to purchase the required API for the initial validation batches of
the {***}{***}mg Tablet Product (estimated at ${***}).  Elite agrees
to credit Precision Dose for such amount against Precision Dose’s initial
purchases from ELITE of the finished Product from the validation
batches.

     

    2.6.        Delivery.

     

    
      	
               
      

            	
              (a)

            	
              Shipments
      of Product shall be made from ELITE's Facility unless otherwise mutually
      agreed to in writing by the parties.  Risk of loss or of damage
      to the Product shall remain with ELITE until such Product is loaded onto
      the carrier's vehicle in the United States by ELITE for shipment at the
      shipping point at which time risk of loss or damage shall transfer to
      PRECISION DOSE.  ELITE shall, in accordance with PRECISION
      DOSE's instructions and as agent for PRECISION DOSE, arrange for shipping
      to be paid by PRECISION DOSE.  PRECISION DOSE shall arrange for
      insurance and shall select the freight carrier used by ELITE to ship the
      Product and may monitor ELITE's shipping and freight practices as they
      pertain to this Agreement.  Product shall be transported in
      accordance with the Product Specifications and other applicable
      Laws.

            

    

     

    
      	
               
      

            	
              (b)

            	
              To
      accommodate production variances, a Batch quantity Product order shall be
      considered filled by Elite if the amount shipped is at least 97.5% of the
      quantity specified for a Batch in Exhibit
A.

            

    

     

    {***}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.

    
      
         

      

      
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    2.7.        Manufacturing
Changes.  All changes in the Product Specifications and
Manufacturing Processes by ELITE must be reviewed with PRECISION DOSE prior to
the change.  For changes to the Product Specifications or
manufacturing processes that are required by applicable Laws (collectively
"Required Manufacturing
Changes"), ELITE and PRECISION DOSE shall cooperate in making such
changes and use commercially reasonable efforts to implement such changes
promptly in a manner that minimizes any affect on the supply hereunder to
PRECISION DOSE of Product meeting the Product Specifications reflected in
Exhibit B. For changes to the Product Specifications or manufacturing processes
that are voluntary (collectively "Voluntary Manufacturing
Changes"), ELITE and PRECISION DOSE shall cooperate in making such
changes and use commercially reasonable efforts to accommodate an orderly
depletion of affected inventories.

     

    2.8.        Delays.  During
the Term of this Agreement, if ELITE is not able to timely meet Product orders
submitted by PRECISION DOSE pursuant to Section 2.2, ELITE shall promptly
notify PRECISION DOSE of the reason for the delay and the date shipment of
Product is expected to occur.

     

    2.9.        Late
Shipment.  In addition to other obligations and remedies under
this Agreement, whenever shipment of Product orders is delayed beyond the date
specified in this Agreement, Elite shall use commercially reasonable efforts to
expedite shipment of the Product to PRECISION DOSE, and shall exert at least equivalent
effort in resolving a Product shortage as compared to ELITE’s production
requirements for its other customers’ production requirements.

     

    ARTICLE
3

    PRICING
AND PAYMENT

     

    3.1.        Price.  Subject
to the remainder of this Article 3, the price to be paid by PRECISION DOSE
for Product from ELITE shall be as set forth on Exhibit A.

     

    3.2.        Price
Adjustment.  The price for Product under Section 3.1 may
be adjusted as follows:

     

    
      	
               
      

            	
              (a)

            	
              The
      price for Product may be increased by ELITE for any orders placed after
      the 12 month anniversary of the (1) first shipment of the Product subject
      to the price increase by ELITE to PRECISION DOSE or (2) the effective date
      of the previous price increase of such Product, whichever is later,
      hereinafter “Adjustment
      Date”.  In such an event, ELITE will propose an increase
      to be reviewed and discussed with PRECISION DOSE at least 90 days prior to
      the Adjustment Date. Any proposed increase shall not exceed the increase
      in the United States Producers' Price Index, Pharmaceuticals
      Preparations, NAICS
      325412, during the period since the last increase, under this
      Section 3.2 unless due to active pharmaceutical ingredient (API)
      increases documented by the supplier invoices.  PRECISION DOSE
      and ELITE recognize the competitive nature of the generic business and any
      proposed price increases will be discussed in the context of the current
      market environment at that time.

            

    

     

    
      	
               
      

            	
              (b)

            	
              The
      price for the Product may be decreased.  Just as increases in
      the material or component costs allow an increase in the Product cost, the
      parties agree that reductions in the material or component cost shall
      similarly reduce the price of the product charged by ELITE to PRECISION
      DOSE.  To monitor changes in production costs, ELITE shall
      deliver to PRECISION DOSE a Production Report on a quarterly
      basis.   ELITE shall reduce the Product price upon downward
      cost trends so that Product manufacturing cost savings are shared equally
      by ELITE and PRECISION DOSE.

            

    

     

    {***}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.

    
      
         

      

      
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              (c)

            	
              The
      parties acknowledge the highly competitive nature of generic drugs and
      that a situation might arise where ELITE cannot produce a Product at a
      cost low enough for PRECISION DOSE to profitably sell that
      Product.  In such event, at the discretion of ELITE and after
      consultation with PRECISION DOSE, ELITE will supply the Product from
      another supplier that is able to provide the Product to PRECISION DOSE for
      significantly less (defined as greater than 10 percent) than the amount
      which ELITE can provide the Product to PRECISION DOSE. PRECISION DOSE will
      support such a transfer, and ELITE will provide the necessary technical
      support for transfer of the Product manufacturing (including analytical
      methods transfer) to a 3rd
      party contract manufacturer.

            

    

     

    3.3.        Invoicing
and Payment.  Payment by PRECISION DOSE
for Product supplied by ELITE hereunder meeting Product Specifications shall be
in United States dollars and made within thirty-one (31) days after the
date of ELITE's invoice by check or wire transfer, and shall be made without
set-off and free and clear of, and without any deduction or withholding for or
on account of any taxes, duties, levies, fees or charges, except as otherwise
permitted under this Agreement.  Product shall be invoiced no sooner
than the date of shipment by ELITE.  If PRECISION DOSE disputes any
invoice, PRECISION DOSE shall notify ELITE that it disputes the accuracy of such
invoice and specify the particular respects in which such invoice is
inaccurate.  PRECISION DOSE and ELITE shall make good faith efforts to
resolve any disputes within thirty (30) days thereafter.  Any
amounts that are disputed shall be due upon the resolution of such
dispute.

     

    3.4.        Books and Records.
ELITE shall maintain production and accounting records according to
GAAP.   PRECISION DOSE shall have the right, at
PRECISION DOSE’s expense
and after thirty (30) days’ prior written notice to ELITE, through an
independent certified public accountant, on a mutually agreeable date, to
examine such records at any time within one (1) year after the due date of the
invoice for Product to which such records relate, during regular business hours,
during the term of this Agreement and for twelve (12) months after expiration of
ELITE’s last invoice to PRECISION DOSE for Product, in order to verify the
accuracy of the calculation of the price of the Product.  If the
accountant determines that ELITE has inaccurately invoiced PRECISION
DOSE, the findings shall be
shared with ELITE.  If ELITE agrees that it has improperly invoiced
PRECISION DOSE, then ELITE
shall correct the invoice, refund any amounts received in excess of the
proper  Product price, and pay for all costs and expenses incurred by
PRECISION DOSE to hire the
accountant and all of the accountant’s expenses, and all legal expenses, to
obtain the appropriate compensation. If ELITE disputes in good faith the
accuracy of the results of such examination, the parties will retain a second
independent certified public accountant whose examination will be binding upon
both parties.  The losing party will pay all of the expenses of both
independent certified public accountant examinations

     

    {***}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.

    
      
         

      

      
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    ARTICLE
4

    QUALITY
AND REGULATORY MATTERS

     

    In
conjunction with the execution of this Agreement, the parties shall execute a
Quality Agreement in the form of Exhibit C attached hereto.

     

    ARTICLE
5

    WARRANTIES

     

    5.1.        Compliance with
cGMP.  ELITE warrants that any Product supplied by it hereunder
shall be manufactured in accordance with cGMP.

     

    5.2.        Conformity with
Specifications. ELITE warrants that, at the time of shipment and for its
shelf life, any Product supplied by it hereunder shall meet the Product
Specifications except for any failure to meet Product Specifications arising
from the handling, packaging or other act or omission of PRECISION DOSE or
subsequent entity handling the Product.

     

    5.3.        ELITE
Representations. ELITE hereby represents and warrants to PRECISION DOSE
that (a) it has obtained all necessary licenses, authorizations and
approvals required by applicable Law, including those required by the FDA, DEA
or any other applicable regulatory agency to enter into this Agreement and
perform its obligations hereunder; (b) the execution, delivery and
performance of this Agreement by ELITE does not conflict with or constitute a
breach of any order, judgment, agreement, or instrument to which it is a party;
(c) the execution, delivery and performance of this Agreement by ELITE does
not require the consent of any person; and (d) none of its officers or
directors has ever been convicted of a felony under the laws of the United
States for conduct relating to the development or approval of a drug product or
relating to the marketing or sale of a drug product.

     

    5.4.        Certificate of
Analysis.  ELITE warrants that the Certificate of Analysis and
all other records and documents created by ELITE and provided to PRECISION DOSE
will be true and correct.

     

    5.5.        Nonconformance
and Procedures to Address.

     

    
      	
               
      

            	
              (a)

            	
              Nonconformance.
      If PRECISION DOSE discovers any nonconformance (“Nonconformance”) of
      Product under this Agreement, PRECISION DOSE shall give prompt written
      notice to ELITE specifying the
Nonconformance.

            

    

     

    {***}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.

    
      
         

      

      
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              (b)

            	
              Procedure for
      Nonconformance.  Upon notifying ELITE of any
      Nonconformance of Product PRECISION DOSE shall afford ELITE a reasonable
      opportunity to inspect the Product in question and make an appropriate
      adjustment or replacement.  The parties shall submit any dispute
      regarding quality of the Nonconformance of Product to a mutually selected
      independent laboratory, the determination of which shall be binding on the
      parties and the costs of which shall be borne by the party against whom
      such determination is rendered.  If such laboratory confirms a
      Nonconformance of the Product in question (or any part of it) at the time
      of delivery to the carrier, or if the parties agree that there is a
      Nonconformance, then, in addition to other remedies that may be available,
      ELITE shall promptly refund or provide a credit for any money paid by
      PRECISION DOSE (including shipping costs) with respect to such
      Nonconforming Product. ELITE may, at its sole option, either direct
      PRECISION DOSE to return nonconforming Product to ELITE or have it
      destroyed by PRECISION DOSE, and certify such destruction to ELITE, all at
      ELITE’s expense. 

            

    

     

    5.6.        PRECISION DOSE
Representations. PRECISION DOSE hereby represents and warrants to ELITE
that (a) it has obtained all necessary licenses, authorizations and
approvals required by applicable Law, including those required by the FDA, DEA
or any other applicable regulatory agency to enter into this Agreement and
perform its obligations hereunder; (b) the execution, delivery and
performance of this Agreement by PRECISION DOSE does not conflict with or
constitute a breach of any order, judgment, agreement, or instrument to which it
is a party; (c) the execution, delivery and performance of this Agreement
by PRECISION DOSE does not require the consent of any person; and (d) none
of its officers or directors has ever been convicted of a felony under the laws
of the United States for conduct relating to the development or approval of a
drug product or relating to the marketing or sale of a drug
product.

     

    ARTICLE
6

    INDEMNIFICATION
AND INSURANCE

     

    6.1.        ELITE
Indemnity.  Subject to Sections 6.2 and 6.4, ELITE shall
indemnify and hold harmless PRECISION DOSE and its Affiliates against all third
party claims, actions, costs, expenses, including court costs and legal fees or
other third party liabilities ("Third Party Liabilities")
whatsoever in respect of:

     

    
      	
               
      

            	
              (a)

            	
              ELITE's
      and/or its Affiliates', subcontractors' or suppliers' failure to comply
      with the Product Specifications, cGMP or applicable
  Laws;

            

    

     

    
      	
               
      

            	
              (b)

            	
              the
      storage, distribution or handling of the Product after the Effective Date
      by ELITE or any third party, other than a third party acting on behalf of
      PRECISION DOSE or its Affiliates, including, without limitation, any
      carrier delivering the Product;

            

    

     

    
      	
               
      

            	
              (c)

            	
              any
      breach of any representation, warranty, covenant or similar promise made
      under this Agreement or arising out of this
  Agreement;

            

    

     

    
      	
               
      

            	
              (d)

            	
              any
      negligence or willful misconduct by ELITE and/or any of its employees;
      and

            

    

     

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

    
      
         

      

      
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              (e)

            	
              for
      any Product that is recalled or withdrawn from the market by reason of
      ELITE’s breach of any warranty or other covenant under this Agreement or
      any other agreement with PRECISION DOSE, PRECISION DOSE will be entitled
      to reimbursement of all costs associated with a recall or withdrawal,
      including the cost of the Product, and reasonable costs associated with
      compliance with the recall or withdrawal (including
      penalties).  If it is determined that the recall or withdrawal
      should extend to the Product packaged into unit dose or distributed by
      PRECISION DOSE, then reimbursement to PRECISION DOSE will be extended to
      include all its expenses of compliance, including manufacturing and
      packaging costs and materials, return fees, distributor reimbursement,
      processing expense such as customer notification and returns, shipping,
      disposal and penalty costs associated with the product of the recalled or
      withdrawn lots only.

            

    

     

    6.2.        PRECISION DOSE
Indemnity.  Subject to Sections 6.1 and 6.4, PRECISION DOSE
shall indemnify and hold harmless ELITE and its Affiliates against all Third
Party Liabilities whatsoever in respect of:

     

    
      	
               
      

            	
              (a)

            	
              the
      use, marketing, storage, distribution, handling or sale of the Product
      after the Effective Date by PRECISION DOSE or any third party, other than
      a third party acting on behalf of ELITE or its
  Affiliates;

            

    

     

    
      	
               
      

            	
              (b)

            	
              any
      product liability in connection with the Products caused by PRECISION DOSE
      or any third party acting on behalf of PRECISION DOSE or its
      Affiliates;

            

    

     

    
      	
               
      

            	
              (c)

            	
              any
      liabilities arising out of the presence or actions of a PRECISION DOSE
      employee at the Facilities pursuant to this Agreement;
  and

            

    

     

    
      	
               
      

            	
              (d)

            	
              any
      negligent or wrongful act by PRECISION DOSE and any breach by PRECISION
      DOSE of any representation or warranty, covenant or similar promise made
      under this Agreement or arising out of this
  Agreement.

            

    

     

    6.3.        Procedures for
Indemnification.  In the event that a party (the "Indemnified Party") is seeking
indemnification under Sections 6.1 or 6.2, the Indemnified Party shall inform
the other party (the "Indemnifying Party") of a
claim as soon as reasonably practicable after the Indemnified Party receives
notice of the claim, shall permit the Indemnifying Party to assume direction and
control of the defense of the claim, and shall cooperate as requested by the
Indemnifying Party (at the expense of the Indemnifying Party) in the defense of
the claim; provided, however, if the defendants in any such action include both
the Indemnified Party and the Indemnifying Party and the Indemnified Party shall
have reasonably concluded that a conflict may arise between the positions of the
Indemnifying Party and the Indemnified Party in conducting the defense of any
such action or that there may be legal defenses available to it that are
different from or additional to those available to the Indemnifying Party, the
Indemnified Party shall have the right to select separate counsel to assume such
legal defenses and to otherwise participate in the defense of such action or on
behalf of the Indemnified Party.  No Indemnifying Party shall, without
the prior written consent of the Indemnified Party, settle or compromise or
consent to the entry of judgment with respect to any pending or threatened
action or claim whatsoever, in respect of which indemnification could be sought
under Sections 6.1 or 6.2 (whether or not the Indemnified Party is an actual or
potential party thereto), unless such settlement, compromise or consent (i)
includes an unconditional release of the Indemnified Party in form and substance
reasonably satisfactory to the Indemnified Party from all liability arising out
of such action or claim and (ii) does not include a statement as to or an
admission of fault, culpability or a failure to act by or on behalf of the
Indemnified Party.  The Indemnifying Party shall not be liable for
settlement of any pending or threatened action or any claim whatsoever that is
effected without its written consent (which consent shall not be unreasonably
withheld or delayed).

     

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

    
      
         

      

      
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    6.4.        Mitigation.  In
the event of any occurrence which may result in either party becoming liable
under Section 6.1 or Section 6.2, each party shall use its best efforts to
take such actions as may be reasonably necessary to mitigate the damages payable
by the other party under Section 6.1 or Section 6.2, as the case may
be.

     

    6.5.        Limitation of
Liability.  NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED
HEREIN, IN NO EVENT SHALL ANY PARTY, ITS DIRECTORS, OFFICERS, EMPLOYEES, AGENTS
OR AFFILIATES BE LIABLE TO THE OTHER PARTIES FOR ANY CLAIMS RELATED TO LOST
PROFITS AND GOODWILL, WHETHER BASED UPON A CLAIM OR ACTION OF CONTRACT,
WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER TORT, OR OTHERWISE, ARISING OUT
OF THIS AGREEMENT.

     

    6.6.        Insurance.  Each
party shall maintain commercial general liability insurance through the term of
this Agreement upon launch of the first Product, which insurance shall afford
limits of not less than $5,000,000 for each occurrence for personal injury or
property damage liability.  Furthermore, each party shall maintain
product liability insurance, through the term of this Agreement upon launch of
the first Product and for a period of three (3) years thereafter, which
insurance shall afford limits of not less than $5,000,000 in the aggregate per
annum with respect to product and completed operations
liability.  This insurance shall be written to cover claims incurred,
discovered, manifested, or made during or after the expiration of this
Agreement.  Each party shall provide the other with a certificate of
insurance evidencing the above and showing the name of the issuing company, the
policy number, the effective date, the expiration date and the limits of
liability.  The insurance certificate shall further provide for a
minimum of thirty (30) days' written notice to the insured of a
cancellation of, or material change in, the insurance.  If a party is
unable to maintain the insurance policies required under this Agreement through
no fault on the part of such party, then such party shall forthwith notify the
other party in writing and the parties shall in good faith negotiate appropriate
amendments to the insurance provision of this Agreement in order to provide
adequate assurances. In the event that either a customer or an insurer of either
party requires such party to increase its insurance limits above the $5,000,000
described above for any policy, then the other party to this Agreement must also
match the required insurance increase, so that the parties to this Agreement are
carrying the same insurance policy limits. It is the express intention of the
parties that the parties shall endeavor to avoid insurance policy limits above
$10,000,000.

     

    {***}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.

    
      
         

      

      
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    ARTICLE
7

    TERM
AND TERMINATION

     

    7.1.        Term.  The
term of this Agreement is equal to the “Term” of the License Agreement as it is
described in the License Agreement, and expressly includes the Initial Term and
the Renewal Term, as described therein.

     

    7.2.        Rights on
Termination.  Termination of this Agreement for any reason
shall not affect the accrued rights and obligations of either PRECISION DOSE or
ELITE arising under or out of this Agreement.

     

    7.3.        Additional Responsibilities
Post Termination. In addition to the ongoing obligations of the parties
previously outlined in the License Agreement and Manufacturing & Supply
Agreement, any PRECISION DOSE Product orders previously accepted by ELITE prior
to termination will be manufactured by ELITE and shipped to PRECISION DOSE as
described in this Agreement. Additionally, under 2.4(c) PRECISION DOSE agrees to
pay ELITE under the circumstances described therein for ELITE’s cost for any
pharmaceutical or packaging materials purchased by ELITE to meet any unused
balance of the first 3 months of the most recent 12 month Forecast provided by
PRECISION DOSE to ELITE, and under such circumstances, at the option of
PRECISION DOSE, the materials may be used by ELITE for the manufacture
of  finished Product or shipped to a location designated my PRECISION
DOSE.

     

    7.4.        Transfer
Assistance.  Upon termination by ELITE as a result
of  its inability to manufacture the Product(s) due to (1) compliance
issues with Regulatory Agencies (including FDA and DEA), (2) commercial factors
or (3) bankruptcy, ELITE will use commercially reasonable efforts to
transfer  the Product(s) to a third party manufacturing
site.

     

    ARTICLE
8

    CONFIDENTIALITY

     

    8.1.        The
information exchanged between ELITE and PRECISION DOSE pursuant to this
Agreement is expressly subject to the Mutual Confidentiality and Non-Disclosure
Agreement entered into by the parties and dated June 25, 2010 (the
“Confidentiality Agreement”) and whose term is hereby made coterminous with this
Agreement.

     

    {***}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.

    
      
         

      

      
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    ARTICLE
9

    MISCELLANEOUS

     

    9.1.        Force
Majeure.  If any party is prevented from complying, either
totally or in part, with any of the terms or provisions of this Agreement, by
reason of force majeure, including, but not limited to fire, flood, earthquake,
explosion, storm, strike, lockout or other labor trouble, riot, war, rebellion,
accidents, acts of God and/or any other cause or externally induced casualty
beyond its reasonable control, whether similar to the foregoing matters or not,
then, upon written notice by the party liable to perform to the other party, the
requirements of this Agreement or such of its provisions as may be affected, and
to the extent so affected, shall be suspended during the period of such
disability; provided that the party asserting force majeure shall bear the
burden of establishing the existence of such force majeure by clear and
convincing evidence; and provided further, that the party prevented from
complying shall use its best efforts to remove such disability within
thirty (30) days, and shall continue performance with the utmost dispatch
whenever such causes are removed, and shall notify the other party of the force
majeure event not more than five (5) working days from the time of the
event.  When such circumstances arise, the parties shall discuss what,
if any, modification of the terms of this Agreement may be required in order to
arrive at an equitable solution.

     

    9.2.        Trademarks.  Each
party agrees and acknowledges that it shall not acquire by virtue of this
Agreement any interest (other than such non-exclusive license as may be
necessary for the party to perform its duties hereunder) in or to any trademarks
or trade names of the other party; provided, however, that PRECISION DOSE shall
have the right to identify ELITE as the manufacturer of the
Product.  All Products shall bear a label that incorporates the
following statement:  “Manufactured by Elite Laboratories, Inc., 165
Ludlow Avenue, Northvale, NJ  07647”.

     

    9.3.        Notices.  Except
as otherwise specifically provided, any notice or other documents to be given
under this Agreement shall be in writing and shall be deemed to have been duly
given if sent by registered mail, nationally recognized overnight delivery
service or facsimile transmission to a party or delivered in person to a party
at the address or facsimile number set out below for such party or such other
address as the party may from time to time designate by written notice to the
other:

     

    
      	
              If
      to ELITE:

            	
              Elite
      Pharmaceuticals, Inc.

            
	 
      	
              165
      Ludlow Avenue

            
	 
      	
              Northvale,
      NJ 07647

            
	 
      	
              Attention:  President

            
	 
      	
              Facsimile:
      201-750-2755

            
	 
      	 
      
	
              with
      a copy to:

            	
              Richardson
      & Patel

            
	 
      	 
      
	 
      	
              Murdock
      Plaza

            
	 
      	
              10900
      Wilshire Boulevard, Suite 500

            

    

    

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

    
      
         

      

      
        13

        
          

        

      

      
         

      

    

    

    
      	
              ELITE
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              Manufacturing
      and Supply Agreement

            	
              Execution
      Version

            

    

     

    
      	 
      	
              Los
      Angeles, California 90024

            
	 
      	
              Attention:
      Kevin Friedmann

            
	 
      	
              Facsimile:
      310-208-1154

            
	 
      	 
      
	
              If
      to PRECISION DOSE:

            	
              Precision
      Dose, Inc.

            
	 
      	
              722
      Progressive Lane

            
	 
      	
              South
      Beloit, IL  61080

            
	 
      	
              Attention:  President

            
	 
      	
              Facsimile:
      815-624-8245

            
	 
      	 
      
	
              with
      a copy to:

            	
              Reilly
      Law Offices

            
	 
      	
              6801
      Spring Creek Rd., Suite 2D

            
	 
      	
              Rockford,
      IL 61114

            
	 
      	
              Attention:  William
      A. Reilly II, Esq.

            
	 
      	
              Facsimile:
      815-316-8545

            

    

     

    Any such
notice provided pursuant to this Section 9.3 shall be deemed to have been
received by the addressee five business days following the date of dispatch of
the notice or other document by mail or, where the notice or other document is
sent by overnight delivery service, by hand or is given by facsimile,
simultaneously with the transmission or delivery.  To prove the giving
of a notice or other document it shall be sufficient to show that it was
dispatched. Either party
may change its address at which notice is to be received by written notice
provided pursuant to this Section 9.3.

     

    9.4.        Waiver and
Amendment.  A waiver by either party of any term or condition
of this Agreement in any one instance shall not be deemed or construed to be a
waiver of such term or condition for any other time.  All rights,
remedies, undertakings, obligations and agreements contained in this Agreement
shall be cumulative and none of them shall be a limitation of any other remedy,
right, undertaking, obligation or agreement of either party.  This
Agreement may not be amended or modified, except in a writing signed by an
officer of each party hereto.

     

    9.5.        Severability.  If
any one or more of the provisions of this Agreement shall be held to be invalid,
illegal or unenforceable in any respect, the validity, legality or
enforceability of the remaining provisions hereof shall not in any way be
affected or impaired thereby.  In the event any provisions shall be
held invalid, illegal or unenforceable, the parties shall use their best efforts
to substitute a valid, legal and enforceable provision which, insofar as
practical, implements the purposes hereof.

     

    9.6.        Headings.  The
headings contained in this Agreement are included herein for reference and
convenience and shall not affect the meaning of the provisions of this
Agreement.

     

    {***}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.

    
      
         

      

      
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    9.7.        Assignment and
Successors.  This Agreement may not be assigned by either
party, except by operation of law, to any third party without the prior written
consent of the other party, which consent shall not be unreasonably withheld,
delayed or conditioned.  In the event of any such assignment, the
assignee shall expressly assume in writing the performance of all the terms and
conditions of this Agreement and all of the obligations to be performed by the
assignor.  Any assignment not in accordance with this Agreement shall
be void. It is understood and agreed that in the event ELITE intends to sell all
or substantially all of its assets and the proposed assignment required in
connection therewith is not consented to by PRECISION DOSE, then ELITE and
PRECISION DOSE shall work together to qualify a replacement supplier and
transition the manufacturing, packaging and supply of the Products to such
replacement supplier.

     

    9.8.        Governing Law; Dispute
Resolution; Venue.  This Agreement shall be construed, and the
rights of the parties determined, in accordance with the laws of the State of
New York without regard to conflict of law or choice of law rules. Any
controversy or claim pursuant to this Agreement or the breach thereof shall be
referred for decision forthwith to a senior executive of each Party not directly
involved in the dispute.  If no agreement is reached within thirty
(30) days of the request by one Party to the other to refer the same to such
senior executive, then such controversy or claim shall be settled by arbitration
in accordance with the Commercial Arbitration Rules of the American Arbitration
Association; such arbitration to be held in Rockford, Illinois on an expedited
basis.  Judgment upon the award rendered by the Arbitrator(s) may be
entered in any court having jurisdiction thereof.

     

    9.9.        Independent
Parties.  This Agreement shall not be deemed to create any
partnership, joint venture, amalgamation or agency relationship between the
parties.  Each party shall act hereunder as an independent
contractor.  Neither party shall at any time enter into, incur, or
hold itself out to third parties as having authority to enter into or incur, on
behalf of the other party, any commitment, expense, or liability
whatsoever.

     

    9.10.      Survival of
Provisions.  All accrued rights and obligations of the parties,
expressly including the provisions of Articles 4, 6, 7 and 8, shall survive
the termination for any reason of this Agreement.

     

    9.11.      Publicity.  Neither
party shall make any public announcement concerning, or otherwise publicly
disclose, any information with respect to the transactions contemplated by this
Agreement or any of the terms and conditions hereof without the prior written
consent of the other party hereto.  Notwithstanding the foregoing,
either party may make any public disclosure concerning the transactions
contemplated hereby that in the opinion of such party's counsel may be required
by law or the rules of any stock exchange on which such party's or its
Affiliates' securities trade; provided, however, the party
making such disclosure shall provide the non-disclosing party with a copy of the
intended disclosure reasonably, and to the extent practicable, prior to public
dissemination, and the parties hereto shall coordinate with one another
regarding the timing, form and content of such disclosure.

     

    9.12.      Entire
Agreement.  This Agreement, together with the Quality
Agreement, constitutes the full, complete, final and integrated agreement
between the parties hereto relating to the subject matter hereof and supersedes
all previous written or oral negotiations, commitments, agreements, transactions
or understandings with respect to the subject matter hereof.  Any
modification, amendment or supplement to this Agreement must be in writing and
signed by authorized representatives of both parties.  In case of a
conflict between the agreements, this Agreement shall prevail.

     

    {***}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.

    
      
         

      

      
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      Version

            

    

      

    9.13.      No Third Party
Beneficiaries.  No person or entity not a party to this
Agreement, including any employee of any party to this Agreement, shall have or
acquire any rights by reason of this Agreement, nor shall either party have any
obligations or liabilities to such other person or entity by reason of this
Agreement.

     

    9.14.      Remedies
Cumulative.  Except as otherwise provided herein, any and all
remedies herein expressly conferred upon a party shall be deemed cumulative with
and not exclusive of any other remedy conferred hereby, or by law or equity upon
such party, and the exercise by a party of any one remedy shall not preclude the
exercise of any other remedy.  If any action at law or in equity is
necessary to enforce or interpret the terms of this Agreement, the prevailing
party shall be entitled to reasonable attorney's fees, costs and necessary
disbursements in addition to any other relief to which such party may be
entitled.

     

    9.15.      Further
Assurances.  Each party shall execute and deliver such
additional instruments and other documents and use commercially reasonable
efforts to take or cause to be taken, all actions and to do, or cause to be
done, all things necessary under applicable law to consummate the transactions
contemplated hereby.

     

    9.16.      Counterparts; Facsimile
Signatures.  This Agreement may be executed in counterparts,
each of which shall be deemed an original, and all of which together shall
constitute a single agreement.  This Agreement may be executed by
facsimile signatures, which signatures shall have the same force and effect as
original signatures.

     

    9.17.      Drafting.  The
parties have participated jointly in the negotiation and drafting of this
Agreement.  In the event an ambiguity or question of intent or
interpretation arises, this Agreement shall be construed as if drafted jointly
by the parties and no presumption or burden of proof shall arise favoring or
disfavoring any party by virtue of the authorship of any of the provisions of
this Agreement.

     

    Signature
Page Follows

     

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

    
      
         

      

      
        16

        
          

        

      

      
         

      

    

    
      

      
        	
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      Version

              

      

      
      

    

     

    IN WITNESS WHEREOF, the
parties hereto have caused this Agreement to be executed, as of the date first
above written, by their duly authorized representatives.

     

    
      
        
          	
                  ELITE
      PHARMACEUTICALS, INC.

                	 
      	
                  PRECISION
      DOSE INC.

                
	 
      	 
      	 
      	 
      	 
      
	
                  By:

                	
                    

                	 
      	
                  By:

                	 
      
	
                  Name: 

                	
                  Chris
      Dick

                	 
      	
                  Name: 

                	
                  Robert
      Koopman

                
	
                  Title:

                	
                  President

                	 
      	
                  Title:

                	
                  President

                

        

      

    

    

    Execution Version
9/10/10

     

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

    
      
         

      

      
        17

        
          

        

      

      
         

      

    

       

    
      
        	
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      EXHIBIT
A

    

     

     Products and Purchase
Price

    
      
        
          
            
              
                
                  
                    
                      
                        	
                                Product

                              	 
      	
                                Mg

                              	 
      	
                                Bottle

                                Size

                              	 
      	
                                Batch

                                Size

                              	 
      	
                                Bottles

                                Per

                                Batch

                              	 
      	
                                Batch

                                Cost

                              	 
      	
                                Cost Per

                                Bottle

                              	 
      	
                                Label

                              
	
                                Hydromorphone
      Tablets

                              	 
      	
                                8mg

                              	 
      	
                                100's

                              	 
      	
                                {***}

                              	 
      	
                                {***}

                              	 
      	
                                ${***}*

                              	 
      	
                                ${***}*

                              	 
      	
                                TAGI
      Pharma

                              
	
                                Hydromorphone
      Tablets

                              	 
      	
                                4mg

                              	 
      	
                                100's

                              	 
      	
                                {***}

                              	 
      	
                                {***}

                              	 
      	
                                ${***}*

                              	 
      	
                                ${***}*

                              	 
      	
                                TAGI
      Pharma

                              
	
                                Hydromorphone
      Tablets

                              	 
      	
                                2mg

                              	 
      	
                                100's

                              	 
      	
                                {***}

                              	 
      	
                                {***}

                              	 
      	
                                ${***}*

                              	 
      	
                                ${***}*

                              	 
      	
                                TAGI
      Pharma

                              
	
                                Hydromorphone
      Tablets

                              	 
      	
                                8mg

                              	 
      	
                                500’s

                              	 
      	
                                {***}

                              	 
      	
                                {***}

                              	 
      	
                                ${***}*

                              	 
      	
                                ${***}*

                              	 
      	
                                TAGI
      Pharma

                              
	
                                Hydromorphone
      Tablets

                              	 
      	
                                4mg

                              	 
      	
                                500’s

                              	 
      	
                                {***}

                              	 
      	
                                {***}

                              	 
      	
                                ${***}*

                              	 
      	
                                ${***}*

                              	 
      	
                                TAGI
      Pharma

                              
	
                                Hydromorphone
      Tablets

                              	 
      	
                                2mg

                              	 
      	
                                500’s

                              	 
      	
                                {***}

                              	 
      	
                                {***}

                              	 
      	
                                ${***}*

                              	 
      	
                                ${***}*

                              	 
      	
                                TAGI
      Pharma

                              
	
                                Naltrexone
      Tablets

                              	 
      	
                                50mg

                              	 
      	
                                30's

                              	 
      	
                                {***}

                              	 
      	
                                {***}

                              	 
      	
                                ${***}

                              	 
      	
                                ${***}

                              	 
      	
                                TAGI
      Pharma

                              
	
                                Naltrexone
      Tablets

                              	 
      	
                                50mg

                              	 
      	
                                100's

                              	 
      	
                                {***}

                              	 
      	
                                {***}

                              	 
      	
                                ${***}

                              	 
      	
                                ${***}

                              	 
      	
                                TAGI
      Pharma

                              
	
                                {***}Tablets

                              	 
      	
                                {***}mg

                              	 
      	
                                100's

                              	 
      	
                                {***}

                              	 
      	
                                {***}

                              	 
      	
                                ${***}

                              	 
      	
                                ${***}

                              	 
      	
                                TAGI
      Pharma

                              
	
                                {***}Tablets

                              	 
      	
                                {***}mg

                              	 
      	
                                1,000's

                              	 
      	
                                {***}

                              	 
      	
                                {***}

                              	 
      	
                                ${***}

                              	 
      	
                                ${***}

                              	 
      	
                                TAGI
      Pharma

                              
	
                                {***}Capsules

                              	 
      	
                                {***}mg

                              	 
      	
                                100's

                              	 
      	
                                {***}

                              	 
      	
                                {***}

                              	 
      	
                                ${***}

                              	 
      	
                                ${***}

                              	 
      	
                                TAGI
      Pharma

                              
	
                                {***}Capsules

                              	 
      	
                                {***}mg

                              	 
      	
                                1,000's

                              	 
      	
                                {***}

                              	 
      	
                                {***}

                              	 
      	
                                ${***}

                              	 
      	
                                ${***}

                              	 
      	
                                TAGI
      Pharma

                              
	
                                {***}Capsules

                              	 
      	
                                {***}mg

                              	 
      	
                                100's

                              	 
      	
                                {***}

                              	 
      	
                                {***}

                              	 
      	
                                ${***}

                              	 
      	
                                ${***}

                              	 
      	
                                TAGI
      Pharma

                              
	
                                {***}Capsules

                              	
                                  

                              	
                                {***}mg

                              	
                                  

                              	
                                1,000's

                              	
                                  

                              	
                                {***}

                              	
                                  

                              	
                                {***}

                              	
                                  

                              	
                                ${***}

                              	
                                  

                              	
                                ${***}

                              	
                                  

                              	
                                TAGI
      Pharma

                              

                      

                    

                  

                

              

            

          

        

      

    

     

    
      NOTE:
Includes all Product manufacturing and packaging costs, quality assurance and
batch quality control testing.

      Stability
testing wil be at an additional cost.

    

     

    
      * {***}

    

    
      
         

      

      
        
        

        
          

        

      

      
         

      

    

    

    
      	
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    EXHIBIT
B

     

    Product and Packaging
Specifications

     

    The
written specifications for the Product will be developed by ELITE, approved by
the FDA, and delivered to PRECISION DOSE thereafter as Exhibit B of this
Agreement.

    
      
         

      

      
        
        

        
          

        

      

      
         

      

    

    

    
      	
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      Execution
Copy

       

      

       

      

       

      EXHIBIT
C

       

       QUALITY
AGREEMENT

       

      Dated:
September 10, 2010

       

      

       

      Between

       

      Precision
Dose, Inc.

       

      And

       

      ELITE
Pharmaceuticals, Inc.

       

      

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

       

      EXHIBIT
C

      TO THE MANUFACTURING AND
SUPPLY AGREEMENT

       

      
         

        
          	
                  This
      Exhibit C to the Manufacturing and Supply Agreement (the “Supply
      Agreement”) defines the responsibilities for all current Good
      Manufacturing Practice (cGMP) activity relating to manufacturing,
      packaging, storing, and testing the
      identified  Product(s).    The above
      mentioned parties hereto mutually agree to the following
      requirements.

                

        

         

        
          
            
              	
                      1.

                    	
                      SCOPE

                       

                    
	 
      	
                      This
      Exhibit C defines the requirements related to the manufacturing,
      packaging, quality control, release and stability testing for Products
      manufactured by ELITE.  These requirements are intended to
      ensure compliance with current cGMP guidelines and other regulatory
      requirements.

                    

            

          

        

         

      

      
        
          	
                  2.

                	
                  DEFINITIONS
      AND ABBREVIATIONS

                

        

      

       

      
        	
                 
      

              	
                ANDA

              	
                Abbreviated
      New Drug Application

              

      

       

      
        	
                 
      

              	
                APR

              	
                Annual
      Product Review

              

      

       

      
        	
                 
      

              	
                C
      of A

              	
                Certificate
      of Analysis

              

      

       

      
        	
                 
      

              	
                C
      of C

              	
                Certificate
      of Conformance

              

      

       

      
        	
                 
      

              	
                CFR

              	
                Code
      of Federal Regulations

              

      

       

      
        	
                 
      

              	
                cGMP

              	
                Current
      Good Manufacturing Practice

              

      

       

      
        	
                 
      

              	
                DEA

              	
                Drug
      Enforcement Agency

              

      

       

      
        	
                 
      

              	
                DMF

              	
                Drug
      Master File

              

      

       

      
        	
                 
      

              	
                FDA

              	
                Food
      & Drug Administration

              

      

       

      
        	
                 
      

              	
                HS&E

              	
                Health,
      Safety & Environment

              

      

       

      
        	
                 
      

              	
                HVAC

              	
                Heating,
      Ventilation, and Air Conditioning

              

      

       

      
        	
                 
      

              	
                IND

              	
                Investigational
      New Drug

              

      

       

      
        	
                 
      

              	
                May

              	
                Indicates
      that a provision is optional and is used for conditional
      issues

              

      

       

      
        	
                 
      

              	
                MSDS

              	
                Material
      Safety Data Sheets

              

      

       

      
        	
                 
      

              	
                Must

              	
                Indicates
      a provision that is compulsory, such as
  regulations

              

      

       

      
        	
                 
      

              	
                NDA

              	
                New
      Drug Application

              

      

       

      
        	
                 
      

              	
                OOS

              	
                Out
      of Specification

              

      

       

      
        	
                 
      

              	
                Shall

              	
                Indicates
      a provision that is binding

              

      

       

      
        	
                 
      

              	
                Will

              	
                Indicates
      a provision of intent, but not necessarily an
  obligation

              

      

       

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

       

      
        
          
            
              
                
                  
                    	
                            3.

                          	
                            PRODUCT

                             

                          
	 
      	
                            The
      Product that is covered by this Exhibit C is included in Appendix
      2.  A separate Appendix is or will be provided for each
      additional Product.  As drugs and services are added or removed,
      Appendices may be added or deleted with the written approval of ELITE and PRECISION
      DOSE.

                             

                          
	
                            4.

                          	
                            MANUFACTURE

                             

                          
	
                            4.1

                          	
                            Premises

                             

                          
	 
      	
                            4.1.1   
      Operations

                             

                          
	 
      	
                            ELITE will manufacture
      the Product at its Northvale, New Jersey Plant as specified by this
      Exhibit C and will not use or transfer at a later date any of the
      manufacturing or testing operations for the Product to an alternate site
      without the prior written notification to PRECISION
      DOSE.

                             

                          
	 
      	
                            4.1.2   
      Compliance

                             

                          
	 
      	
                            The
      premises and equipment used for manufacture must be in compliance with
      Product Specifications and approved aNDA, cGMPs,  and current
      regulatory requirements.

                          
	 
      	
                            4.1.3    Security

                             

                          
	 
      	
                            ELITE will maintain
      controlled access to the premises.  For example, additional
      security measures may be required for DEA products, per current
      regulations.  All visitors must sign in and be escorted during
      any visit to the areas of the premise used to manufacture, test, and store
      the Product.

                          
	 
      	
                               
      4.1.4    Confidentiality

                             

                          
	 
      	
                            ELITE and PRECISION DOSE
      will protect the confidentiality of the processes and documents
      related to the Product.  The obligations of confidentiality
      shall be continuing and shall survive the expiration or termination of the
      Agreement and this Exhibit C and/or any attachments hereto for a period of
      five years.

                          
	 
      	
                            4.1.5   
      Personnel

                             

                          
	 
      	
                            ELITE shall employ an
      adequate number of trained personnel to support the manufacture of
      Product(s) according to cGMP requirements.  Each person engaged
      in the manufacture, processing, packaging, or holding of a drug product
      shall have education, training, and experience, or a combination thereof,
      to enable that person to perform the assigned functions in a competent and
      efficient manner.  (CFR 21 Sec. 211.25)

                          
	 
      	 
      

                  

                

              

            

          

        

         

         

        
          
            
            

          

          
            
            

            
              

            

          

          
            
            

          

        

      

       

      
        
          
            
              
                
                  
                    
                      	
                               

                            	
                              
                                4.1.6   
      Health, Safety, and Environment

                                 

                              

                            
	
                               

                            	
                              ELITE commits to operate
      within all current HS&E legislation at sites that manufacture
      products.  

                               

                            
	
                              4.2 
       GMP
      Guidelines

                               

                            
	
                               

                            	
                              The
      cGMP guidelines to be applied are the United States cGMPs listed in 21
      Code of Federal Regulations (CFR) Parts 11 Electronic Records, 200, 210,
      and 211 and associated Compliance Guidances.

                               

                            
	
                              4.3   
      IND/NDA/ANDA/OTC/

                               

                            
	
                               

                            	
                              The
      Product(s) must be manufactured as specified in the manufacturing formula
      within the approved Investigational New Drug/New Drug
      Application/Abbreviated New Drug Application (IND/NDA/ANDA) or approved
      internal documents. If ELITE makes any changes
      to these methods, that require a supplement to the application, written
      notification will be given to PRECISION
      DOSE.

                               

                            
	
                              4.4   
      Specifications

                               

                            
	
                               

                            	
                              Manufacturing
      Batch Records and Testing Protocols will be prepared according to
      Specifications as defined in the Supply Agreement.

                               

                            
	
                              4.5   
      Subcontractors
       

                               

                            
	
                               

                            	
                              ELITE is responsible for
      auditing the quality systems of a potential subcontractor and agrees to
      demonstrate due diligence during the audit process. PRECISION DOSE retains
      the right to audit such contractors. Subcontractors approved for a portion
      of the manufacturing and packaging tasks shall be audited by either party
      on an annual basis, with such audits alternating between the parties each
      year. If critical deficiencies are found, the parties (PRECISION DOSE, ELITE
      and subcontractor) shall meet promptly to discuss and resolve them and
      PRECISION DOSE
      shall be entitled to make reasonable follow up inspections (as much as
      semi-annual) to monitor the correction of the deficiencies. All other
      subcontractors will be audited on a bi-annual basis. ELITE must not
      subcontract any aspects of the Manufacture of the Product to a third party
      without prior notification and approval of PRECISION DOSE. ELITE shall be
      responsible for complete supervision and control over every
      subcontractor.  All subcontractors shall be directly responsible
      to ELITE and shall
      be subject in all respects to the provisions of the Agreement and all
      attachments including this Exhibit C. Nothing contained in the Supply
      Agreement and this Exhibit C or any attachment shall create any
      contractual relationship between any subcontractor and PRECISION DOSE. Further,
      any subcontractor of services shall not relieve ELITE from full
      responsibility for the work or for the fulfillment of all obligations
      under the Supply Agreement or this Exhibit C or any attachment
      hereto.

                            

                    

                  

                

              

            

          

        

      

       

      

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

       

       

      
        
          
            
              	
                      4.6   
      Materials

                       

                    
	 
      	
                      4.6.1   
      Materials
      Procured by ELITE 

                       

                    
	
                       

                    	
                      ELITE
      is responsible for ensuring that all materials procured by and for use in
      the Product(s) are in full compliance with the approved
      specifications.  Each incoming batch of components shall be
      assigned a unique identity or control number and inspected according to
      incoming testing protocols.

                       

                    
	 
      	
                      4.6.2   
      Potential
      Contaminants

                       

                    
	
                       

                    	
                      ELITE must inform PRECISION DOSE of any
      highly sensitizing material, infectious agents, high pharmacological
      activity or toxicity materials (e.g., penicillin, hormones, and
      cephalosporin), herbicides, or pesticides that are handled by ELITE at the same
      site.

                       

                    
	
                      4.7   
      Labeling

                       

                    
	 
      	
                      4.7.1   
      Content

                       

                    
	
                       

                    	
                      PRECISION
      DOSE is responsible for
      all accuracy of the information contained in all PRECISION
      DOSE labeling and will
      comply with all regulatory standards. PRECISION DOSE is responsible for providing
      ELITE with all
      related artwork/mock-ups for the Products. ELITE is responsible for the
      submission of the labeling, in Structured Product Labeling format to the
      application.

                       

                    
	 
      	
                      4.7.2   
      Procurement

                       

                    
	
                       

                    	
                      ELITE will procure all required
      labeling that must be created according to the labeling specifications
      of PRECISION DOSE
      labeled product.

                       

                    
	 
      	
                      4.7.3. 
        Label
      Development / Changes 

                       

                    
	
                       

                    	
                      ELITE is responsible for
      maintaining the labeling as current to the approved
      application.  ELITE shall notify PRECISION DOSE of any
      proposed changes to the labeling in sufficient time to allow PRECISION DOSE to make
      the necessary changes.

                       

                    
	
                      4.8   
      Manufacturing/Packaging
      Documentation

                       

                    
	 
      	
                      4.8.1
         Licenses

                       

                    
	
                       

                    	
                      ELITE shall maintain a
      current Manufacturing License and DEA License as required to manufacture
      and package the Product(s).

                       

                    
	 
      	
                      4.8.2   
      Master
      Documents

                       

                    
	
                       

                    	
                      ELITE shall develop and
      control all master documentation relative to the manufacture, packaging,
      and testing of the Product(s).  Any changes to the master
      documentation that require a supplement to the application will require
      PRECISION DOSE’s
      written approval.

                    

            

          

        

      

       

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          	 
      	
                                  4.8.3   
      Executed
      Batch Records

                                   

                                
	
                                   

                                	
                                  ELITE shall keep records
      of the manufacture, testing and shipping of the Product, to comply with
      the Product Specifications and all manufacturing regulatory requirements
      and Laws applicable to ELITE, as well as to
      assist with resolving Product complaints and other similar
      investigations.  Copies of such records and samples shall be
      retained according to a record retention procedure and for a period of
      five (5) years following the date of Product(s) expiry or longer if
      required by applicable Law, after which ELITE may destroy such
      records.

                                   

                                
	
                                  4.9   
      Sterile
      Product  

                                   

                                
	
                                	
                                  Not
      Applicable.

                                   

                                
	
                                  4.10
      Batch
      Numbering  

                                   

                                
	
                                   

                                	
                                  ELITE batch numbering
      system will be used to uniquely number each batch of
      Product(s).  This number will appear on all documents relating
      to a particular batch of Product(s).

                                   

                                
	
                                  4.11
      Date
      of Manufacture  

                                   

                                
	
                                	
                                  ELITE shall assign the
      Date of Manufacture as the first day the active ingredient is added to the
      process.

                                   

                                
	
                                  4.12
      Expiration
      Dating  

                                   

                                
	
                                   

                                	
                                  ELITE shall assign the
      expiration date according to ELITE standard
      procedures, which calculate the expiry date from the Date of Manufacture,
      or date of filling, plus the Shelf life.  The expiration date
      shall be formatted as month/year.

                                   

                                
	
                                  4.13
      Manufacturing
      and Equipment Data  

                                   

                                
	 
      	
                                  4.13.1   
      Equipment
      Data 

                                     

                                  

                                
	
                                   

                                	
                                  ELITE is responsible for
      maintaining records of equipment usage, cleaning, service and maintenance,
      raw material batch numbers and certification, in process results and
      parameters, and previous Product(s) used in machinery, if non-dedicated
      machinery is used.  Only equipment that has been validated,
      calibrated, or qualified shall be used.

                                   

                                
	 
      	
                                  4.123.2   
      Specifications

                                   

                                
	
                                   

                                	
                                  ELITE must produce and
      package the Product(s) as specified in the
      approved  manufacturing process, using the equipment and
      procedures specified in the ANDA,  approved internal document
      and/or
DMF.

                                

                        

                      

                    

                  

                

              

            

          

        

      

       

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

       

      
        
          
            
              
                	
                        5.0   
       QUALITY
      ASSURANCE

                         

                      
	
                        5.1   
      Laboratories

                         

                      
	 
      	
                        5.1.1 
        Compliance
      and Equipment

                         

                      
	
                         

                      	
                        ELITE shall be
      responsible for ensuring that all laboratories are compliant with relevant
      cGMPs and GLP’s, and personnel and test methods are properly validated
      and/or qualified for all of the methodology associated with
      Product(s).

                         

                      
	
                         

                      	
                        ELITE shall be
      responsible for ensuring that all test equipment is properly maintained
      and calibrated and that appropriate qualification has been
      conducted.
 
	 
      	
                        5.1.2   
      Laboratory
      Methods

                         

                      
	
                         

                      	
                        ELITE will ensure that
      all components and in-process release testing used to manufacture the
      Product(s) meets the specifications.  At least one test (ID) to
      verify the identity of each batch of incoming material will be
      conducted.  A supplier C of A or C of C may be referenced
      instead of performing other tests, provided that a supplier evaluation
      program is in force.  ELITE’s internal Quality
      unit will approve all test results.

                         

                      
	 
      	
                        5.1.3   
      Out
      of Specification (OOS) Procedure

                         

                      
	
                         

                      	
                        ELITE is responsible for
      investigating any test result or in-process test that fails to meet
      specification, in accordance with the current ELITE approved OOS
      Procedures. ELITE
      must notify PRECISION
      DOSE of any confirmed OOS for its Product(s) within 24 hours of the
      OOS identification, and ELITE will provide PRECISION DOSE with a
      report of all OOS instances on a quarterly basis.

                         

                      
	
                        5.2   
      Release
      Procedures

                         

                      
	 
      	
                        5.2.1
         Release
      for Distribution

                         

                      
	
                         

                      	
                        ELITE is responsible for
      bottled product release for distribution - however, at the time of
      shipment ELITE
      must provide PRECISION
      DOSE with the Certificate of Analysis used in the release of the
      Product(s).

                         

                      

              

            

             

             

            
              
                
                

              

              
                
                

                
                  

                

              

              
                
                

              

            

             

             

            
              
                
                  
                    	
                             

                          	
                            5.2.2       Product
      Rejection Upon Receipt

                             

                          
	
                             

                          	
                            PRECISION
      DOSE shall notify ELITE in writing of any claim relating to any Product(s)
      that fails to meet the Product specifications no later than fifteen (15)
      days of receipt of the Product(s) except where such failure to meet the
      Product specification could not be reasonably known at the time of
      receipt; in which case a fifteen (15) day period
      commences.  PRECISION DOSE  shall be deemed to have
      accepted the Product if it does not provide ELITE written notice of such
      failure.  Both
      parties may share information and agree on action plans including further
      testing/analysis to resolve the situation.  PRECISION
      DOSE and ELITE shall
      mutually work together on final disposition and payment of any rejected
      Product.

                             

                          
	
                            5.3
          Documentation

                             

                          
	 
      	
                            5.3.1   
      Certificate
      of Analysis/Certificate of Conformance

                             

                          
	
                             

                          	
                            All
      deliveries of the Product(s) to PRECISION DOSE shall be
      accompanied by the full C of A with the results of the analytical testing
      by ELITE’s quality
      control department and the confirmation that the Product(s) has/have been
      manufactured and tested in accordance with cGMP requirements and complies
      with the requirements of the Governmental Approval(s) and with the
      Specifications, as set forth in Exhibit  C of the Supply
      Agreement.  [However, such C of A and Confirmation shall be
      pre-shipped before delivery of the Product(s).]

                             

                          
	
                            5.4    
      Retained
      Samples

                             

                          
	 
      	
                            5.4.1   
      Sample
      Types

                             

                          
	
                             

                          	
                            ELITE shall retain
      adequate representative samples of each batch or lot of the Product(s), of
      raw material, and of components used in the Manufacture of the Product(s).
      (21 CFR Part 211.170a)

                             

                          
	 
      	
                            5.4.2    Annual
      Retain Reviews

                             

                          
	
                             

                          	
                            On
      an annual basis, representative samples of retained lots will be inspected
      visually according to ELITE’s
      procedures.

                             

                          
	
                            5.5   
      Stability
      Protocols and Testing

                             

                          
	
                             

                          	
                            ELITE shall maintain a
      stability program. Analysis of stability samples that do not meet
      specification are subject to the process outlined in section 5.1.3 Out of
      Specification (OOS) Procedures.  In the event that any batch of
      Product fails stability testing, ELITE shall notify PRECSISION DOSE within
      24 hours of the confirmed failure.

                             

                          

                  

                

              

            

             

             

            
              
                
                

              

              
                
                

                
                  

                

              

              
                
                

              

            

             

             

            
              
                
                  	
                          5.6   
      Audits

                           

                        
	 
      	
                          5.6.1   
      Facility
      Audit

                           

                        
	
                           

                        	
                          Upon
      prior notification to ELITE and within normal
      working hours, PRECISION
      DOSE is entitled to perform an annual quality inspection of the
      facilities connected with the manufacture of the
      Product(s).  Such representatives will be allowed to access all
      relevant premises and facilities and to witness the manufacture of the
      Product(s) in all its aspects to satisfy itself of the compliance of ELITE to the
      Governmental Approval(s) with respect to the manufacture of the Product(s)
      and compliance with cGMP regulations.  If deficiencies are
      found, the parties shall meet promptly to discuss and resolve them and
      PRECISION DOSE
      shall be entitled to make reasonable follow up inspections (as often as
      quarterly) to monitor the correction of the deficiencies

                           

                        
	 
      	
                          5.6.2    Regulatory
      Audit/Inspection

                           

                        
	
                           

                        	
                          ELITE shall permit any necessary
      inspection by the competent Authorities at the premises of manufacture,
      including subcontractor sites.  Any such inspection by the
      competent authorities which has potential to impact any Product(s) will be
      promptly notified to PRECISION DOSE in
      writing, and ELITE
      shall immediately inform PRECISION DOSE in
      writing of general and specific findings of the Authorities related to the
      manufacture or testing of the Product(s) and or quality
      systems.

                           

                        
	
                          5.7   
      Recall/Field
      Alert/Complaints

                           

                        
	 
      	
                          5.7.1
         Recalls

                           

                        
	
                           

                        	
                          ELITE is responsible for
      the initiation, execution and follow-up for any Product
      recall.  ELITE
      must communicate and issue the recall in accordance with federal
      regulations.  ELITE must notify PRECISION DOSE within 24
      hours of a decision to recall

                           

                        
	
                           

                        	
                          5.7.1.1  
       PRECISION DOSE is obligated to report any potential problems
      or issues with the Product to ELITE within 24 hours
      from the time such information is known.  

                           

                        
	 
      	
                          5.7.2   
      Field
      Alerts

                           

                        
	
                           

                        	
                          ELITE shall notify PRECISION DOSE
      immediately of any failure that meets Field Alert Report criteria.
      ELITE shall notify
      the District Office within three (3) working days of the failure for ELITE
      labeled Product.  PRECISION DOSE is
      obligated to report any potential problems or issues with the Product to
      ELITE within 24
      hours from the time such information is known.

                           

                        

                

              

            

             

             

            
              
                
                

              

              
                
                

                
                  

                

              

              
                
                

              

            

             

             

            
              
                
                  
                    
                      	 
      	 
      
	 
      	
                              5.7.3   
      Complaints
      

                                 

                              

                            
	
                               

                            	
                              In
      the event that a customer complaint is received by PRECISION DOSE, written
      notification shall be provided to ELITE within 48 hours of
      receipt. ELITE is
      responsible for the handling, administration, investigation, corrective
      actions and response to customers for all complaints.

                               

                            
	
                               

                            	
                              5.7.3.1 In the event an
      adverse experience is reported to or received by PRECISION DOSE, written
      notification including all known patient and product information shall be
      provided to ELITE
      within 24 hours of receipt by PRECISION
      DOSE.  ELITE is responsible for maintaining the
      pharmacovigillence program including adverse experience reporting,
      regulatory reporting and follow-up reports within the established
      timelines of the federal regulations.

                               

                            
	
                              5.8   
      Change
      Control and Deviations

                               

                            
	 
      	
                              5.8.1   
      Change
      Control 

                                 

                              

                            
	
                               

                            	
                              ELITE shall maintain a change contorl program and
      provide PRECISION DOSE notification of their intention to make
      changes to the formulation, components, manufacturing processes, test
      methods or specifications, or labeling.

                               

                            
	 
      	
                              5.8.2   
      Deviations
      

                                 

                              

                            
	
                               

                            	
                              ELITE shall record any deviations from
      the manufacturing process and/or testing of the Product(s) in the
      batch/testing records and clearly document any such deviations related to
      finished goods specifications.

                               

                            
	 
      	
                              5.8.3    Validation
      

                                 

                              

                            
	
                               

                            	
                              Any
      changes to validated equipment, systems, processes or test methods shall
      be assessed and evaluated as to the impact on the Product and the approved
      application. ELITE
      shall communicate changes that affect the approved application to
      PRECISION
      DOSE.  ELITE is responsible for maintaining all
      equipment, systems, processes and test methods in a validated
      state.

                               

                            
	
                              5.9   
      Annual
      Product Review

                               

                            
	
                                  

                            	
                              ELITE is responsible for
      performing and providing an Annual Product Review (APR) on the anniversary
      date for each manufactured Product.

                               

                            
	
                              6.0    Miscellaneous

                               

                            
	
                              6.1   
      Communications

                               

                            
	
                               

                            	
                              All
      notices and communications concerning this Exhibit  C, or any of
      the provisions contained herein, shall be addressed to the responsible
      functionaries of the Parties respectively assigned designated Appendix
      1.

                               

                            

                    

                  

                

              

            

          

        

      

       

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

       

       

      
        
          
            	
                    IN WITNESS WHEREOF, the
      parties hereto have caused this Agreement to be executed, as of the date
      first above written, by their duly authorized
    representatives

                  

          

        

      

       

      

      
        	
                ELITE
      PHARMACEUTICALS, INC.

                 

              	 
      	
                PRECISION
      DOSE INC.

              
	
                By:                                                                        
      

              	 
      	
                By:                                                                
      

              
	
                Name:
      Chris Dick

              	 
      	
                Name:
      Robert Koopman

                 

              
	
                Title:   President

              	 
      	
                Title:   President

              

      

       

      

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

       

      
      

       

      
        	
                APPENDIX
      1

              

      

       

       

      PRECISION DOSE AND ELITE
CONTACT INFORMATION

       

      
        
          
            
              	
                      ELITE
      Pharmaceuticals, Inc.

                       

                    
	
                      Primary
      Contact

                    	 
      	
                      QA
      Contact

                    	 
      	
                      Regulatory
      Contact

                    
	
                       

                      Name
      Chris Dick

                    	 
      	
                       

                      Name
      Mimi Park  

                    	 
      	
                       

                      Name  Mimi
      Park

                    
	
                       

                      Title  President

                    	 
      	
                       

                      Title  Head
      of Quality Assurance & Compliance

                    	 
      	
                       

                      Title   Head
      of Quality Assurance & Compliance

                    
	
                       

                      Telephone
      Number  201-367-7860

                    	 
      	
                       

                      Telephone
      Number  201-367-7854

                    	 
      	
                       

                      Telephone
      Number  201-367-7854

                    

            

          

        

      

      

       

      
        
          
            
              	
                      PRECISION
      DOSE, Inc

                       

                    
	
                      Primary
      Contact

                    	 
      	
                      QA
      Contact

                    	 
      	
                      Regulatory
      Contact

                    
	
                      Name:  Melissa
      Edge

                    	 
      	
                      Name:  Mark
      Franzen

                    	 
      	
                      Name:  Mary
      Zieker

                    
	
                       

                      Title
      Vice President of Procurement

                    	 
      	
                       

                      Title  Director,
      Quality Assurance

                    	 
      	
                       

                      Title
      Vice President of Quality and Regulatory

                    
	
                       

                      Telephone
      Number  815-624-8523 ext. 218

                    	 
      	
                       

                      Telephone
      Number  815-624-8523 ext. 226

                    	 
      	
                       

                      Telephone
      Number  815-624-8523 ext.
208

                    

            

          

        

      

       

      

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

       

      

       

       

      

       

       

      
         

        
          	
                  APPENDIX
      2

                

        

         

      

      PRODUCT
LISTING

       

      RX

       

      
        	
                ·  

              	
                Hydromorphone
      8 mg, 4 mg and 2mg Tablets – 100’s and
500’s

              

      

       

      

       

      
        	
                ·  

              	
                Naltrexone
      50 mg Tablets – 30’s and 100’s

              

      

       

      

       

      
        	
                ·  

              	
                {***} {***}
      mg Tablets – 100’s and 1000’s

              

      

       

      

       

      
        	
                ·  

              	
                {***} {***}
      mg and {***} mg Capsules – 100’s and
1000’s

              

      

       

      

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

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"}]]