Exhibit 10.23


    
      

    

    Exhibit
      10.23

     

    CONFIDENTIAL
      TREATMENT

    


    “Subject
      to a request for confidential treatment, certain provisions of this agreement
      have been intentionally omitted. The omitted portions subject to the
      confidential treatment are designated by three asterisks (***). A complete
      version of this agreement has been separately filed with the Securities and
      Exchange Commission.”

    


    


    


    Manufacturing
      Services Agreement

    


    


    Between

    


    


    Patheon
      Pharmaceuticals Inc.

    


    


    And

    


    


    New
      River Pharmaceuticals Inc.

    


    


    August
      18, 2006


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    Table
      of Contents

    


    
      	
              ARTICLE
                1 INTERPRETATION

            	
              1

            
	 	 	 
	
              1.1

            	
              Definitions

            	
              1

            
	 	 	 
	
              1.2

            	
              Currency

            	
              4

            
	 	 	 
	
              1.3

            	
              Sections
                and Heading

            	
              4

            
	 	 	 
	
              1.4

            	
              Singular
                Terms

            	
              5

            
	 	 	 
	
              1.5

            	
              Schedules

            	
              5

            
	 	 	 
	
              ARTICLE
                2 PATHEON’S MANUFACTURING RESPONSIBILITIES

            	
              6

            
	 	 	 
	
              2.1

            	
              Manufacturing
                Services

            	
              6

            
	 	 	 
	
              2.2

            	
              Standard
                of Performance

            	
              7

            
	 	 	 
	
              2.3

            	
              Failure
                to Supply

            	
              7

            
	 	 	 
	
              2.4

            	
              Active
                Material Yield

            	
              7

            
	 	 	 
	
              ARTICLE
                3 NEW RIVER’S OBLIGATIONS

            	
              9

            
	 	 	 
	
              3.1

            	
              Payment

            	
              9

            
	 	 	 
	
              3.2

            	
              Active
                Materials

            	
              9

            
	 	 	 
	
              ARTICLE
                4 CONVERSION FEES AND COMPONENT COSTS

            	
              10

            
	 	 	 
	
              4.1

            	
              First
                Year Pricing

            	
              10

            
	 	 	 
	
              4.2

            	
              Subsequent
                Years’ Pricing

            	
              10

            
	 	 	 
	
              4.3

            	
              Adjustments
                to Pricing

            	
              11

            
	 	 	 
	
              4.4

            	
              Adjustments
                Due to Technical Changes

            	
              12

            
	 	 	 
	
              ARTICLE
                5 ORDERS, SHIPMENT, INVOICING. PAYMENT

            	
              13

            
	 	 	 
	
              5.1

            	
              Orders
                and Forecasts

            	
              13

            
	 	 	 
	
              5.2

            	
              Reliance
                by Patheon

            	
              14

            
	 	 	 
	
              5.3

            	
              Minimum
                Orders

            	
              15

            


    


    
      
        
        

      

      
        i

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

     

    
      	
              5.4

            	
              Patheon
                Forecast for Active Ingredient

            	
              15

            
	 	 	 
	
              5.5

            	
              Shipments

            	
              15

            
	 	 	 
	
              5.6

            	
              Invoices
                and Payment

            	
              15

            
	 	 	 
	
              ARTICLE
                6 PRODUCT CLAIMS AND RECALLS

            	
              16

            
	 	 	 
	
              6.1

            	
              Product
                Claims

            	
              16

            
	 	 	 
	
              6.2

            	
              Product
                Recalls and Returns

            	
              17

            
	 	 	 
	
              6.3

            	
              Disposition
                of Defective or Recalled Products

            	
              18

            
	 	 	 
	
              6.4

            	
              Customer
                Questions and Complaints

            	
              18

            
	 	 	 
	
              ARTICLE
                7 CO-OPERATION

            	
              18

            
	 	 	 
	
              7.1

            	
              Quarterly
                Review

            	
              18

            
	 	 	 
	
              7.2

            	
              Governmental
                Agencies

            	
              19

            
	 	 	 
	
              7.3

            	
              Records
                and Accounting by Patheon

            	
              19

            
	 	 	 
	
              7.4

            	
              Inspection

            	
              19

            
	 	 	 
	
              7.5

            	
              Access

            	
              19

            
	 	 	 
	
              7.6

            	
              Reports

            	
              20

            
	 	 	 
	
              7.7

            	
              FDA
                Filings

            	
              20

            
	 	 	 
	
              ARTICLE
                8 TERM AND TERMINATION

            	
              21

            
	 	 	 
	
              8.1

            	
              Initial
                Term

            	
              21

            
	 	 	 
	
              8.2

            	
              Termination
                for Cause

            	
              21

            
	 	 	 
	
              8.3

            	
              Product
                Discontinuation

            	
              22

            
	 	 	 
	
              8.4

            	
              Termination
                upon Regulatory Refusal

            	
              22

            
	 	 	 
	
              8.5

            	
              Obligations
                on Termination

            	
              22

            
	 	 	 
	
              ARTICLE
                9 REPRESENTATIONS, WARRANTIES AND COVENANTS

            	
              23

            
	 	 	 
	
              9.1

            	
              Authority

            	
              23

            
	 	 	 
	
              9.2

            	
              New
                River Warranties

            	
              23

            


    


    
      
        
        

      

      
        ii

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

     

    
      	
              9.3

            	
              Patheon
                Warranties

            	
              23

            
	 	 	 
	
              9.4

            	
              Debarred
                Persons

            	
              24

            
	 	 	 
	
              9.5

            	
              Permits

            	
              24

            
	 	 	 
	
              9.6

            	
              Compliance
                with Laws

            	
              24

            
	 	 	 
	
              9.7

            	
              No
                Warranty

            	
              24

            
	 	 	 
	
              ARTICLE
                10 REMEDIES AND INDEMNITIES

            	
              25

            
	 	 	 
	
              10.1

            	
              Consequential
                Damages

            	
              25

            
	 	 	 
	
              10.2

            	
              Limitation
                of Liability

            	
              25

            
	 	 	 
	
              10.3

            	
              Patheon

            	
              26

            
	 	 	 
	
              10.4

            	
              New
                River

            	
              26

            
	 	 	 
	
              ARTICLE
                11 CONFIDENTIALITY

            	
              27

            
	 	 	 
	
              11.1

            	
              Confidentiality

            	
              27

            
	 	 	 
	
              ARTICLE
                12 DISPUTE RESOLUTION

            	
              27

            
	 	 	 
	
              12.1

            	
              Commercial
                Disputes

            	
              27

            
	 	 	 
	
              12.2

            	
              Technical
                Dispute Resolution

            	
              28

            
	 	 	 
	
              ARTICLE
                13 MISCELLANEOUS

            	
              28

            
	 	 	 
	
              13.1

            	
              Inventions

            	
              28

            
	 	 	 
	
              13.2

            	
              Intellectual
                Properly

            	
              29

            
	 	 	 
	
              13.3

            	
              Insurance

            	
              29

            
	 	 	 
	
              13.4

            	
              Independent
                Contractors

            	
              29

            
	 	 	 
	
              13.5

            	
              No
                Waiver

            	
              30

            
	 	 	 
	
              13.6

            	
              Assignment

            	
              30

            
	 	 	 
	
              13.7

            	
              Force
                Majeure

            	
              30

            
	 	 	 
	
              13.8

            	
              Additional
                Product

            	
              31

            
	 	 	 
	
              13.9

            	
              Notices

            	
              31

            


    


    
      
        
        

      

      
        iii

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

     

    
      	
              13.10

            	
              Severability

            	
              32

            
	 	 	 
	
              13.11

            	
              Entire
                Agreement

            	
              32

            
	 	 	 
	
              13.12

            	
              Other
                Terms

            	
              32

            
	 	 	 
	
              13.13

            	
              No
                Third Party Benefit or Right

            	
              32

            
	 	 	 
	
              13.14

            	
              Execution
                in Counterparts

            	
              32

            
	 	 	 
	
              13.15

            	
              Governing
                Law

            	
              32

            


    


    
      
        
        

      

      
        iv

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    MANUFACTURING
      SERVICES AGREEMENT

     

    THIS
      MANUFACTURING SERVICES AGREEMENT (the “Agreement’)
      made as
      of the 18th day of August, 2006 (the “Effective
      Date”)

    


    B
      E T W E
      E N:

    


    
      	 	
              PATHEON
                PHARMACEUTICALS INC.,

            


    

    
      	 	
              a
                corporation existing under the laws of the State of
                Delaware,

            


    

    


    
      	 	
              (hereinafter
                referred to as “Patheon”),

            


    

    


    
      	 	
              -
                and -

            


    

    


    
      	 	
              NEW
                RIVER PHARMACEUTICALS
                INC.,

            


    

    
      	 	
              a
                corporation existing under the laws of the Commonwealth of
                Virginia,

            


    

    


    
      	 	
              (hereinafter
                referred to as “New
                River”).

            


    

    


    THIS
      AGREEMENT WITNESSES THAT in consideration of the rights conferred and the
      obligations assumed herein, and for other good and valuable consideration (the
      receipt and sufficiency of which are acknowledged by each party), and intending
      to be legally bound the parties agree as follows:

    


    ARTICLE
      1

    INTERPRETATION

    


    
      	
              1.1

            	
              Definitions.

            


    

    


    The
      following terms shall, unless the context otherwise requires, have the
      respective meanings set out below and grammatical variations of such terms
      shall
      have corresponding meanings:

    


    “Active
      Materials”
      means
      the materials listed on Schedule D hereto;

    


    “Active
      Materials Credit Value”
      means
      the value to be attributed to the Active Materials for the purposes of Section
      2.4 of this Agreement, as set forth in Schedule D hereto;

    


    “Affiliate”
      means:

    


    
      	 	
              (a)

            	
              a
                business entity which owns, directly or indirectly, a controlling
                interest
                in a party to this Agreement, by stock ownership or otherwise;
                or

            


    


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              (b)

            	
              a
                business entity which is controlled by a party to this Agreement,
                either
                directly or indirectly, by stock ownership or otherwise;
                or

            


    

    


    
      	 	
              (c)

            	
              a
                business entity, the controlling interest of which is directly or
                indirectly common to the majority ownership of a party to this
                Agreement;

            


    

    


    For
      the
      purposes of this definition, “control” means the ownership of shares carrying at
      least a majority of the votes in respect of the election of the directors of
      a
      corporation.

    


    “Annual
      Product Review Report”
      means
      the annual product review report as described in Title 21 of the United States
      Code of Federal Regulations, Section 211.180(e);

    


    “Annual
      Report”
      means
      the annual report as described in Title 21 of the United States Code of Federal
      Regulations, Section 314.8 1(b)(2);

    


    “Annual
      Requirement of Product”
      means
      all of New River’s annual requirement of solid dosage form(s) of the Product in
      the Territory, including all Product manufactured under the United States
      Collaboration Agreement dated as of March 31, 2005 between New River, Shire
      LLC
      and Shire Pharmaceuticals Group PLC as identified in New River’s Form 10-K
      filing with the Securities Exchange Commission dated April 1, 2005 or any
      amendment thereto.

    


    “Annual
      Volume”
      means
      the volume of Product to be manufactured in any Year of this Agreement as set
      forth in Schedule B hereto.

    


    “Applicable
      Laws”
      means
      all federal laws, the Laws of the State of Ohio being the jurisdiction where
      the
      Manufacturing Site is located, and the Laws of all jurisdictions where the
      Products are manufactured, distributed or marketed;

    


    “Authority”
      means
      any governmental or regulatory authority, department, body or agency or any
      court, tribunal, bureau, commission or other similar body, whether federal,
      state, provincial, county or municipal having proper jurisdiction over the
      parties and/or the Products, as the context requires;

    


    “Breach
      Notice”
      shall
      have the meaning ascribed thereto in Section 8

    


    “Business
      Day”
      means a
      day other than a Saturday, Sunday or a day that is a statutory holiday in the
      Commonwealth of Virginia or in the State of Ohio;

    


    “cGMPs”
      means
      current good manufacturing practices as described in Parts 210 and 211 of Title
      21 of the United States Code of Federal Regulations, together with the latest
      FDA guidance documents pertaining to manufacturing and quality control practice,
      all as updated, amended and revised from time to time, or the foreign equivalent
      in those foreign jurisdictions where Patheon has agreed to supply
      Product;

    


    “Components”
      means,
      collectively, all packaging components, raw materials and ingredients (including
      labels, product inserts and other labeling for the Products), required to be
      used in order to produce the Products in accordance with the Specifications,
      other than the Active Materials;


    
      
        
        

      

      
        2

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    “Confidentiality
      Agreement”
      means
      the agreement relating to the non-disclosure of confidential information between
      Patheon and New River dated May 31, 2003, as amended August 25,
      2005;

    


    “Deficiency
      Notice”
      shall
      have the meaning ascribed thereto in Section 6.1(a); “Delivery Date” shall have
      the meaning ascribed thereto in Section 5.1;

    


    “FDA”
      means
      the United States government department known as the Food and Drug
      Administration, or any successor entity thereto, or the foreign equivalent
      in
      those foreign jurisdictions where Patheon has agreed to supply
      Product;

    


    “Failure
      Period”
      has the
      meaning specified in Section 2.3(a);

    


    “Firm
      Orders”
      has the
      meaning specified in Section 5.1(b);

    


    “Intellectual
      Property” includes, without limitation, rights in patents, patent applications,
      formulae, trade-marks, trade-mark applications, trade-names, Inventions,
      copyright and industrial designs;

    


    “Invention”
      means
      information relating to any data, innovation, improvement, development,
      discovery, computer program, device, trade secret, method, know-how, process,
      technique or the like, whether or not written or otherwise fixed in any form
      or
      medium, regardless of the media on which it is contained and whether or not
      patentable or copyrightable;

    


    “Inventory”
      means
      all inventories of Components and work-in-process produced or held by Patheon
      in
      connection with the manufacture of the Products but, for greater certainty,
      does
      not include the Active Materials;

    


    “Laws”
      means
      all applicable laws, statutes, ordinances, regulations, rules, by-laws,
      judgments, decrees or orders of any Authority;

    


    “Manufacturing
      Services”
      means
      the manufacturing, quality control, quality assurance and stability testing,
      packaging, storage, and related services, as contemplated in this Agreement,
      and
      the Quality Agreement, required to produce Products from Active Materials and
      Components;

    


    “Manufacturing
      Site”
      means
      the facility owned and operated by Patheon that is located at 2110 East
      Galbraith Road, Cincinnati, Ohio 45237-1625; 

    


    “Patheon
      Manufacturing Responsibilities”
      means
      Patheon’s responsibilities and obligations with respect to the provision of
      Manufacturing Services as set forth in this Agreement and the Quality
      Agreement;


    
      
        
        

      

      
        3

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    “Permits”
      shall
      have the meaning ascribed thereto in Section 9.3(d); “Products” means the
      products listed on Schedule A hereto;

    


    “Quality
      Agreement”
      means
      the agreement to be entered into between the parties hereto setting forth,
      among
      other things, the quality assurance standards to be applicable to the
      Manufacturing Services provided by Patheon, which agreement shall be
      substantially in the form attached hereto as Schedule 0;

    


    “Recall”
      shall
      have the meaning ascribed thereto in Section 6.2;

    


    “Run
      Quantity”
      means
      the number of batches of a Product to be produced during the same cycle of
      manufacturing as set forth in Schedule B hereto;

    


    “Specifications”
      means
      the applicable quality control provisions in the Quality Agreement, along with
      the file for each Product which is provided by New River to Patheon in
      accordance with the procedures listed in Schedule A, which contains documents
      relating to such Product, including, without limitation:

    


    
      	 	
              (a)

            	
              [***];

            


    

    
      	 	
              (b)

            	
              [***];

            


    

    
      	 	
              (c)

            	
              [***];

            


    

    
      	 	
              (d)

            	
              [***];

            


    

    
      	 	
              (e)

            	
              [***];
                and

            


    

    
      	 	
              (f)

            	
              [***].

            


    

    


    all
      as
      updated, amended and revised from time to time by New River in accordance with
      the terms of this Agreement;

    


    “Technical
      Dispute”
      has the
      meaning specified in Section 12.2;

    


    “Territory”
      means
      the United States of America, its territories and possessions;

    


    “Third
      Party Rights”
      means
      the Intellectual Property of any third party other than (i) Patheon,
      (ii) New River, or (iii) an Affiliate; and

    


    “Year”
      means in
      the first year of this Agreement, the period from the Effective Date up to
      and
      including December 31 of the same calendar year, and thereafter shall mean
      a
      calendar year.

    


    
      	
              1.2

            	
              Currency.

            


    

    


    Unless
      otherwise indicated, all monetary amounts are expressed in this Agreement in
      the
      lawful currency of the United States of America.

    


    
      	
              1.3

            	
              Sections
                and Heading.

            


    

    


    The
      division of this Agreement into Articles, sections, subsections and Schedules
      and the insertion of headings are for convenience of reference only and shall
      not affect the interpretation of this Agreement. Unless otherwise indicated,
      any
      reference in this Agreement to a Section or Schedule refers to the specified
      Section or Schedule to this Agreement. In this Agreement, the terms “this
      Agreement”,
      “hereof”,
      “herein”, “hereunder”
      and
      similar expressions refer to this Agreement and not to any particular part,
      Section, Schedule or the provision hereof.


    
      
        
        

      

      
        4

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	
              1.4

            	
              Singular
                Terms.

            


    

    


    Except
      as
      otherwise expressly provided herein or unless the context otherwise requires,
      all references to the singular shall include the plural and vice
      versa.

    


    
      	
              1.5

            	
              Schedules

            


    

    


    The
      following Schedules are attached to, incorporated in and form part of this
      Agreement:

    


    
      	 	
              Schedule
                A

            	
              -

            	
              Product
                Formula and Specifications

            


    

    
      	 	
              Schedule
                B

            	
              -

            	
              Run
                Quantity, Annual Volume & Fees

            


    

    
      	 	
              Schedule
                C

            	
              -

            	
              Stability
                Testing

            


    

    
      	 	
              Schedule
                D

            	
              -

            	
              Active
                Materials & Active Materials Credit
                Value

            


    

    
      	 	
              Schedule
                E

            	
              -

            	
              Batch
                Numbering & Expiration Dates

            


    

    
      	 	
              Schedule
                F

            	
              -

            	
              Technical
                Dispute Resolution

            


    

    
      	 	
              Schedule
                0

            	
              -

            	
              Quality
                Agreement

            


    

    
      	 	
              Schedule
                H

            	
              -

            	
              Quarterly
                Active Materials Inventory Report

            


    

    
      	 	
              Schedule
                I

            	 	
              Report
                of Annual Active Material Inventory Reconciliation and Calculation
                of
                Actual Annual Yield

            


    


    
      
        
        

      

      
        5

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    ARTICLE
      2

    


    PATHEON’S
      MANUFACTURING RESPONSIBILITIES

    


    
      	
              2.1

            	
              Manufacturing
                Services

            


    

    


    Patheon
      shall provide the Manufacturing Services to New River on a non- exclusive basis.
      Patheon shall manufacture and supply a [***] of New River’s Annual Requirement
      of Product in the Territory and for the fees specified in Schedules B and C.
      Patheon may change the Manufacturing Site for the Products only with the prior
      written consent of New River, such consent not to be unreasonably withheld.
      The
      parties acknowledge and agree that it would be reasonable for New River to
      withhold such consent if Patheon proposes to change the Manufacturing Site
      to a
      location outside the 48 contiguous U.S. states or to a facility that, in New
      River’s reasonable judgment, has a poor quality or safety record. The cost of
      any such change in Manufacturing Site shall be bone solely by Patheon. If
      Manufacturing Services have not commenced within 12 months of the date of
      execution of this Agreement due to no fault of Patheon, Patheon reserves the
      right to amend the fees set out in Schedules B and C, but in no event shall
      any
      increase in fees exceed the fee adjustment contemplated in Section 4.2. In
      providing the Manufacturing Services, Patheon shall perform each of the
      following services:

    


    
      	 	
              (a)

            	
              Conversion
                of Active Materials and Components.
                Patheon shall convert Active Materials and Components into Products
                in
                accordance with the Specifications and
                cGMPs.

            


    

    


    
      	 	
              (b)

            	
              Quality
                Control and Quality Assurance.
                Patheon shall comply with the obligations set forth in the Quality
                Agreement. Each time Patheon ships Products to New River, it shall
                provide
                New River with a certificate of analysis and certificate of compliance
                (as
                defined in the Quality Agreement) and other documentation as reasonably
                required by New River for such
                Products.

            


    

    


    
      	 	
              (c)

            	
              Components.
                Patheon shall purchase and test all Components at Patheon’s expense, as
                specified by the Specifications.

            


    

    


    
      	 	
              (d)

            	
              Stability
                Testing.
                Patheon shall conduct stability testing on the Products in accordance
                with
                the protocols set out in the Specifications. Patheon shall not make
                any
                changes to these testing protocols [***]. New River shall pay the
                fees
                specified in Schedule C for all stability testing that is necessary
                for
                compliance with FDA requirements or is requested by New River. In
                the
                event that any batch of Products fails stability testing, Patheon
                and New
                River shall jointly determine the proceedings and methods to be undertaken
                to investigate the causes of such failure, including which party
                shall
                bear the cost of such investigation, provided that Patheon shall
                not be
                liable for any such costs unless there has been a failure by it to
                provide
                the Manufacturing Services in accordance with the Patheon Manufacturing
                Responsibilities. Patheon will provide any and all data and results
                relating to the stability testing to New River promptly following
                any
                request by New River.

            


    


    
      
        
        

      

      
        6

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              (e)

            	
              Packaging.
                Patheon shall package the Products with labels, product inserts and
                other
                packaging as set out in the Specifications. [***]. In addition, Patheon
                shall make arrangements for and implement the imprinting of batch
                numbers
                and expiration dates on the packaging of each Product in compliance
                with
                all Laws. Such batch numbers and expiration dates shall be affixed
                on the
                Products and on the shipping carton of each Product as outlined in
                the
                Specifications and as required by cGMPs. The system used by Patheon
                for
                batch numbering and expiration dates is detailed in Schedule E hereto.
                New
                River may, in its sole discretion, make changes to labels, product
                inserts
                and other packaging for the Products, which changes shall be submitted
                by
                New River to all applicable governmental agencies and other third
                parties
                responsible for the approval of the Products. New River shall be
                responsible for any additional costs related to such labeling changes
                when
                such changes occur. Patheon’s name shall not appear on the label or
                anywhere else on the Products unless: (i) required by any Laws; or
                (ii)
                Patheon expressly consents to such use of its name in
                writing.

            


    

    


    
      	
              2.2

            	
              Standard
                of Performance

            


    

    


    Patheon
      shall provide the Manufacturing Services in accordance with the Specifications,
      cGMPs, the Quality Agreement, and all Laws associated with the manufacture
      and
      supply of human pharmaceutical products.

    


    
      	
              2.3

            	
              Failure
                to Supply

            


    

    


    In
      the
      event that Patheon is unable to provide Manufacturing Services for the Product
      in accordance with the Specifications, the terms of this Agreement, the Quality
      Agreement or cGMPs, and such inability is or is likely to subsist on a [***]
      (“Failure
      Period”),
      the
      parties agree to work together in good faith during the Failure Period to
      resolve the event causing Patheon’s failure to provide the Manufacturing
      Services for the Product and to procure the continued Manufacturing Services
      for
      the Product from Patheon as soon as reasonably practicable following the
      resolution of the event causing the Failure Period.

    


    
      	
              2.4

            	
              Active
                Material Yield

            


    

    


    
      	 	
              (a)

            	
              Reporting.
                Patheon shall provide New River with a quarterly inventory report
                of the
                Active Materials held by Patheon in accordance with the inventory
                report
                form annexed hereto as Schedule H which shall contain the following
                information for such quarter:

            


    

    


    Quantity
      Received:
      The
      total quantity of Active Materials that complies with the Specifications and
      is
      received at a Manufacturing Site during the applicable period.

    


    Quantity
      Dispensed:
      The
      total quantity of Active Materials dispensed at a Manufacturing Site during
      the
      applicable period. The Quantity Dispensed is calculated by adding the Quantity
      Received to the inventory of Active Materials that complies with the
      Specifications and is held at the beginning of the applicable period, less
      the
      inventory of Active Materials that complies with the Specifications and is
      held
      at the end of such period. The Quantity Dispensed shall only include (a) Active
      Materials received and dispensed in connection with commercial manufacturing
      of
      Products and (b) Active Materials that are lost, damaged, or destroyed after
      receipt at a Manufacturing Site, and, for certainty, shall not include any
      Active Materials received or dispensed in connection with technical transfer
      activities or development activities during the applicable period, including,
      without limitation, any regulatory, stability, validation or test batches
      manufactured during the applicable period.


    
      
        
        

      

      
        7

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    Quantity
      Converted:
      The
      total amount of Active Materials contained in the Products produced with the
      Quantity Dispensed (including lab samples and any additional Products produced
      in accordance with Section 6.1 or 6.2), delivered by Patheon, and not rejected,
      recalled or returned in accordance with Section 6.1 or 6.2 as a result of a
      failure by Patheon to provide Manufacturing Services in accordance with Patheon
      Manufacturing Responsibilities.

    


    [***]
      after the end of each Year, Patheon shall prepare an annual reconciliation
      of
      Active Materials in accordance with the reconciliation report form annexed
      hereto as Schedule I including the calculation of the “Actual Annual Yield”
or “ for the Product at the Manufacturing Site during the Year, which AAY is the
      percentage of the Quantity Dispensed that was converted to Products and is
      calculated as follows:

    


    [***]

    


    After
      Patheon has produced a minimum of ten (10) commercial production batches of
      Product without significant losses and has produced commercial production
      batches for at least six (6) months at a Manufacturing Site (collectively,
      the
“Target
      Yield Determination Batches”)
      pursuant to this Agreement, the Parties will mutually agree on the target yield
      in respect of such Product at such Manufacturing Site (each, a “Target
      Yield”).
      Thereafter, Patheon shall strive to maintain Actual Annual Yield levels for
      each
      Product above the applicable Target Yield. Notwithstanding the foregoing, the
      Target Yield will be adjusted Yearly through good faith negotiations, which
      negotiations will take in account the Actual Annual Yield for the Product over
      the preceding Year.

    


    
      	 	
              (b)

            	
              Shortfall
                Calculation.
                If the Actual Annual Yield [***], then the shortfall for such Year
                (the
                “Shortfall”) shall be determined based on the following
                calculation:

            


    

    


    [***]

    


    The
      Shortfall shall be disclosed by Patheon on the reconciliation report prepared
      in
      the form annexed hereto as Schedule I.

    


    
      	 	
              (c)

            	
              Credit.
                If the Actual Annual Yield for a Product [***], then Patheon shall
                reimburse New River the amount of the applicable Shortfall [***].
                Each
                credit under this Section 2.4 shall be summarized on the reconciliation
                report prepared in the form annexed hereto as Schedule I and shall
                be made
                in accordance with Section 5.6. If the Actual Annual Yield for a
                Product
                [***] (as set forth in Section 2.1) of such Product that will be
                manufactured by Patheon for the remainder of the term of the Agreement,
                at
                New River’s sole discretion. In addition, if any point during a Year, it
                is likely, in the reasonable opinion of New River management, that
                the
                Actual Annual Yield for a Product for such Year will [***], then
                [***] (as
                set forth in Section 2.1) of such Product that will be manufactured
                by
                Patheon during the [***]. In any event, the parties shall make all
                reasonable efforts to correct through amicable negotiations any failure
                of
                the Actual Annul Yield to meet the respective Target Yield in a
                Year.

            


    


    
      
        
        

      

      
        8

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              (d)

            	
              Maximum
                Credit.
                Notwithstanding the foregoing provisions of this Section 2.4, Patheon’s
                liability for Active Materials calculated in accordance with this
                Section
                2.4 for any Product in a Year shall not exceed, in the aggregate,
                the
                maximum credit value set forth in Schedule D
                hereto.

            


    

    


    
      	 	
              (e)

            	
              No
                Material Breach.
                It shall not constitute a material breach of this Agreement by Patheon,
                for the purposes of Section 8.2(a), if the Actual Annual Yield is
                less
                that the Target Yield.

            


    

    


    
      	 	
              (f)

            	
              Significant
                Losses Not with anything to the contrary in this Agreement, Patheon
                shall
                notify New River of any significant loss of Active Material [***].
                Such
                notification shall not in any way limit New River’s rights or Patheon’s
                obligations under this Section 2.4 with respect to
                Shortfalls.

            


    

    


    ARTICLE
      3

    


    NEW
      RIVER’S OBLIGATIONS

    


    
      	
              3.1

            	
              Payment

            


    

    


    Pursuant
      to the terms of this Agreement, New River shall pay Patheon for the provision
      of
      the Manufacturing Services according to the fees specified in Schedules 8 and
      C
      hereto (such fees being subject to adjustment in accordance with the terms
      hereof).

    


    
      	
              3.2

            	
              Active
                Materials

            


    

    


    New
      River
      shall at its sole cost and expense, deliver the Active Materials to Patheon
      in
      sufficient quantities and at such times to facilitate the provision of the
      Manufacturing Services by Patheon, which Active Materials shall be held by
      Patheon on behalf of New River on the terms and subject to the conditions herein
      contained. New River shall pay Patheon [***], [***], for storing Active
      Materials [***]. If the Active Material is determined to be a DEA Schedule
      2
      drug or requires refrigeration, [***] per pallet, per month. The parties
      acknowledge and agree that all right, title and interest in and to the Active
      Materials shall at all times belong to and remain with New River. Patheon agrees
      that any Active Materials received by it shall only be used by Patheon to
      provide the Manufacturing Services.


    
      
        
        

      

      
        9

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    ARTICLE
      4

    


    CONVERSION
      FEES AND COMPONENT COSTS

    


    
      	
              4.1

            	
              First
                Year Pricing.

            


    

    


    The
      fees
      for the Manufacturing Services (which fees include Component costs) through
      December 31, 2006, are set forth in pricing schedule as listed in Schedules
      B
      and C and are subject to the adjustments set forth in Section 4.3. Fees are
      also
      subject to adjustments for any changes in the process or equipment, including,
      but not limited to, inclusion of individual capsule weight
      checking.

    


    
      	
              4.2

            	
              Subsequent
                Years’ Pricing.

            


    

    


    The
      fees
      for the Manufacturing Services provided pursuant to the terms of this Agreement
      during any period following December 31, 2006, shall be determined in accordance
      with the following:

    


    
      	 	
              (a)

            	
              Manufacturing
                and Component Costs.
                On each Yearly anniversary of this Agreement, either party shall
                be
                entitled to an adjustment to the fees (i) for Manufacturing Services
                in
                respect of the Products to reflect inflation or deflation, which
                adjustment shall be based on the increase or decrease in the United
                States
                - Consumer Price Index for All Urban Consumers (CPI-U), published
                by the
                United States Department of Labor, Bureau of Labor Statistics in
                September
                of the then current Year compared to the same month of the preceding
                Year,
                unless the parties otherwise agree in writing; and (ii) for Component
                costs to pass on the actual amount of any increase o; as set forth
                in
                Section 4.4(c), the decrease in such
                costs.

            


    

    


    
      	 	
              (b)

            	
              Annual
                Forecast.
                To the extent that the parties agree that the projections contained
                in the
                rolling forecast provided pursuant to Section 5.1(a) necessitate
                that an
                appropriate adjustment be made to the Manufacturing Services fees
                in
                respect of any Product for such Year, then such fees shall be either
                increased or decreased accordingly.

            


    

    


    
      	 	
              (c)

            	
              Pricing
                Basis.
                New River acknowledges that the fee for Manufacturing Services in
                respect
                of a Product in any Year, following December 31, 2006, is quoted
                based
                [***] specified in Schedule B or thereafter specified in the forecast
                provided pursuant to clause (b) of this Section 4.2 for such Year
                and is
                subject to change if the [***]. For greater certainty, if Patheon
                and New
                River agree that the Run Quantity in respect of a Product shall be
                reduced, whether as a result of a decrease in estimated Annual Volume
                or
                otherwise, and as a result of such reduction, Patheon’s fees for
                Manufacturing Services relating to such Product increase on a per
                unit
                basis, then Patheon shall be entitled to an increase in the fee for
                Manufacturing Services in respect of such Product by an amount sufficient
                to absorb such increase solely for any third party costs related
                to
                Components. Likewise, if Patheon and New River agree that the Run
                Quantity
                in respect of a Product shall be increased, whether as a result of
                an
                increase in estimated Annual Volume or otherwise, and as a result
                of such
                increase, Patheon’s fees for Manufacturing Services relating to such
                Product decrease on a per unit basis, then New River shall be entitled
                to
                a decrease in the fee for Manufacturing Services in respect of such
                Product by an amount sufficient to reflect such
                decrease.

            


    


    
      
        
        

      

      
        10

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    In
      connection with a fee adjustment pursuant to clause (a) of this Section 4.2,
      Patheon shall deliver to New River by [***] of each Year following December
      31,
      2006 a revised Schedule B and a statement outlining the percentage increase
      or
      decrease, as applicable, in the Consumer Price Index, upon which such fee
      adjustment is based. In connection with all fee adjustments pursuant to clauses
      (b) and (c) of this Section 4.2, Patheon shall deliver to New River by [***]
      of
      each Yea; including [***], a revised Schedule B and such budgetary pricing
      information or other documentation reasonably sufficient to demonstrate that
      a
      fee adjustment is justified, provided that Patheon shall have no obligation
      to
      provide any supporting documents to the extent such documents are subject to
      obligations of confidentiality between Patheon and its suppliers. Such revised
      fee shall be effective with respect to any Product manufactured or delivered
      after the end of the then current Year.

    


    
      	
              4.3

            	
              Adjustments
                to Pricing.

            


    

    


    During
      any Year of this Agreement the fees set out in Schedule B shall be subject
      to
      adjustment in accordance with the following:

    


    
      	 	
              (a)

            	
              Campaign
                Pricing.
                The fees for the Manufacturing Services listed in Schedule B reflect
                campaign sizes based upon Annual Volume for each Product. The most
                recent
                annual New River forecast available on October l of the preceding
                year
                will be used to determine the monthly campaign sizes, and therefore,
                the
                corresponding fees applicable for the following year, subject to
                the
                documentation requirement set forth in the paragraph immediately
                following
                Section 4.3(b). Campaign sizes are not subject to monthly changes,
                but the
                frequency may be adjusted to match
                demand.

            


    

    


    
      	 	
              (b)

            	
              Extraordinary
                Changes in Component Costs.
                If at any time after December 31, 2006 market conditions result in
                Patheon’s cost of Components being materially greater than normal
                forecasted increases or materially lower than normal forecasted decreases,
                then Patheon shall adjust the fee for Manufacturing Services accordingly
                to reflect such an increase or decrease with respect to any affected
                Products to compensate for such material change in Component costs.
                For
                the purposes of this clause (b), changes materially greater than
                normal
                forecasted increases or materially lower than normal forecasted decreases
                (as the case may be) shall be considered to have occurred if: (i)
                the cost
                of a Component increases or decreases by [***] of the cost for that
                Component upon which the most recent fee quote was based; or (ii)
                the
                aggregate cost for all Components required to manufacture a Product
                increases or decreases by [***] of the total Component costs for
                such
                Product upon which the most recent fee quote was based. To the extent
                that
                Component costs have been previously adjusted pursuant to clause
                (a) of
                Section 4.2 or this clause (b) to reflect an increase or decrease
                in the
                cost of one or more Components, the adjustments provided for in (i)
                and
                (ii) above shall operate based on the costs attributed to such Component
                (or Components) at the time the last of such adjustments were
                made.

            


    


    
      
        
        

      

      
        11

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    In
      connection with a fee adjustment pursuant to Section 4.3(a) or 4.3(b), Patheon
      shall deliver to New River a revised Schedule B and such budgetary pricing
      information, adjusted Component costs or other documentation reasonably
      sufficient to demonstrate that a fee adjustment is justified, provided that
      Patheon shall have no obligation to provide any supporting documents to the
      extent such documents are subject to obligations of confidentiality between
      Patheon and its suppliers. Such revised fee shall be effective with respect
      to
      any Product delivered or manufactured after the end of the then current
      Year.

    


    
      	
              4.4

            	
              Adjustments
                Due to Technical
                Changes.

            


    

    


    
      	 	
              (a)

            	
              In
                the event that New River requests an amendment to the Specifications
                or
                the Quality Agreement, Patheon shall conduct a technical and cost
                review
                of the proposed amendment. If requested by Patheon, Patheon and New
                River
                shall negotiate in good faith an equitable revision to the fees specified
                in Schedule B or C to reflect changes in costs that would result
                from such
                amendment. Any cost increases asserted by Patheon shall be consistent
                with
                then-prevailing market standards, and Patheon will provide New River
                with
                documentation reasonably sufficient to demonstrate that a fee adjustment
                is justified, provided that Patheon shall have no obligation to provide
                any supporting documents to the extent such documents are subject
                to
                obligations of confidentiality between Patheon and its suppliers.
                If the
                Parties agree on a proposed fee change, the proposed change in the
                Specifications and/or Quality Agreement shall be implemented, and
                the fee
                change shall become effective only with respect to those orders of
                Products that are manufactured in accordance with the revised
                Specifications and/or revised Quality Agreement. In addition [***],
                all
                Inventory utilized under the “old” Specifications and purchased or
                maintained by Patheon necessary to fill Firm Orders or in accordance
                with
                Section 5.2, to the extent that such Inventory can no longer be utilized
                under the revised Specifications. Open purchase orders for Components
                no
                longer required under any revised Specifications that were placed
                by
                Patheon with suppliers in order to fill Firm Orders or in accordance
                with
                Section 5.2 shall be cancelled where possible, and where such orders
                are
                not subject to cancellation without penalty, shall be assigned to
                and
                satisfied by New River.

            


    

    


    
      	 	
              (b)

            	
              Amendments
                to the Specifications, the Quality Agreement or the Manufacturing
                Site
                requested by Patheon will only be implemented following the prior
                approval
                of New River, including a technical and cost review by the parties
                and are
                subject to New River and Patheon reaching agreement as to revisions,
                if
                any, to the fees specified in Schedules B or C necessitated by any
                such
                amendment.

            


    

    


    
      	 	
              (c)

            	
              Patheon
                and New River may collaborate to identify, target and implement all
                potential areas of cost reduction relating to the performance of
                their
                obligations under this Agreement, including the cost of Components
                and
                improvements in processing and Manufacturing Services. Such areas
                of
                jointly developed cost reduction shall be discussed at the quarterly
                meetings of the relationship managers as set forth in Section 7.1.
                Any
                benefits of such jointly developed cost reductions or improved
                efficiencies achieved shall be shared equally between Patheon and
                New
                River after the party who incurred any costs associated therewith,
                if any,
                has recovered its costs.

            


    


    
      
        
        

      

      
        12

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    ARTICLE
      5

    


    ORDERS,
      SHIPMENT, INVOICING. PAYMENT

    


    
      	
              5.1

            	
              Orders
                and Forecasts

            


    

    


    
      	 	
              (a)

            	
              Rolling
                Forecasts.
                Concurrent with the execution of this Agreement, New River shall
                provide
                Patheon with a written, non-binding, [***] of the volume of each
                Product
                that New River then anticipates will be required to be produced and
                delivered to New River or its designee during each month of that
                [***].
                Such forecast will be updated by New River monthly on or before the
                [***]
                day of each calendar month [***] and updated forthwith upon New River
                determining that the volumes contemplated in the most recent of such
                forecasts has changed by more than [***]. The most recent [***] forecast
                shall prevail. Patheon shall accept each written forecast by signing
                and
                returning such forecast to New River. The first three months of rolling
                forecast for supply of Product shall be
                binding.

            


    

    


    
      	 	
              (b)

            	
              Firm
                Orders.
                On or before the [***], New River shall issue firm written orders
                (“Firm
                Orders”)
                for the Products to be produced and delivered to New River on a date
                specified in each Firm Order (the “Delivery
                Date”),
                such Delivery Date to be [***] from the first day of the calendar
                month
                immediately following the date that the Firm Order is submitted.
                Such Firm
                Orders shall further specify New River’s purchase order number, quantities
                by Product type, monthly delivery schedule and any other elements
                necessary to ensure the timely production and shipment of the Products.
                The quantities of Products ordered in such written orders shall be
                firm
                and binding on New River and shall not be subject to reduction by
                New
                River. If New River requests an increase in a Firm Order, Patheon
                shall
                use [***] to comply with such increase,
                [***].

            


    

    


    
      	 	
              (c)

            	
              [***]
                Forecast.
                On or before the [***] of [***] in each Year, New River shall provide
                Patheon with a [***] forecast (broken down by [***] for the [***]
                and
                [***] of the forecast) of the volume of each Product New River then
                anticipates will be required to be produced and delivered to New
                River
                during the [***].

            


    

    


    
      	 	
              (d)

            	
              Delivery.
                Patheon shall use [***] to deliver 100% of the Products ordered in
                Firm
                Orders on the applicable Delivery Date. If Patheon has learned that
                any
                delivery of Products may be expected to be delivered any time after
                the
                Delivery Date, Patheon shall (0 as soon as practical notify New River
                or
                its designee, (ii) ensure that its own senior management is advised
                of
                this issue, and (iii) develop and implement a remedial plan reasonably
                calculated to prevent future late deliveries. In the event that Patheon
                either (i) delivers to New River [***] of the Product specified in
                the
                Firm Orders for any given [***]; (ii) delivers to New River [***]
                of the
                Product specified in the Firm Orders for any [***]; or (iii) delivers
                to
                New River [***] of the Product specified in the Firm Orders for any
                given
                Year, including the first Year, [***], then New River shall have
                the right
                to reduce the Annual Requirement (as set forth in Section 2.1) of
                such
                Product that will be manufactured by Patheon for the remainder of
                the term
                of the Agreement by [***].

            


    


    
      
        
        

      

      
        13

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              (e)

            	
              Regulatory
                Approval.
                Except for launch quantities of Product as provided in Section 5.2(a),
                New
                River shall be under no obligation to issue Firm Orders for Products
                unless and until New River receives regulatory approval for marketing
                of
                the Product.

            


    

    


    
      	
              5.2

            	
              Reliance
                by Patheon

            


    

    


    
      	 	
              (a)

            	
              New
                River understands and acknowledges that Patheon will rely on the
                rolling
                forecasts and Firm Orders submitted pursuant to Sections 5.1(a) and
                (b) in
                ordering the Components required to meet such Firm Orders. In addition,
                New River understands that to ensure an orderly supply of such Components,
                it may be desirable for Patheon to purchase such Components in sufficient
                volumes to meet the production requirements for Products during part
                or
                all of the forecasted periods referred to in Section 5.1(a) or to
                meet the
                production requirements of any longer period agreed to by Patheon
                and New
                River. Accordingly, New River authorizes Patheon to purchase Components
                in
                order to satisfy the production requirements for Products for the
                [***]
                contemplated in the most recent forecast provided by New River pursuant
                to
                Section 5.1(a) and agrees that Patheon may make such other purchases
                of
                Components to meet production requirements during such longer periods
                as
                may be agreed to in writing from time to time by New River at the
                request
                of Patheon or New River. New River shall provide Patheon with its
                written
                authorization to order Components in respect of any launch quantities
                of
                Product requested by New River, which upon acceptance by Patheon
                shall
                constitute a Firm Order. If Components ordered by Patheon pursuant
                to Firm
                Orders or this Section 5.2 are not included in finished Products
                purchased
                by New River after the forecasted month in respect of which such
                purchases
                have been made (or such longer period as the parties may agree) or
                if such
                Components have expired during such period, then New River shall
                pay to
                Patheon its costs therefor (including all costs incurred by Patheon
                in
                connection with the purchase and handling of such Components) within
                reason; provided, however, that in the event such Components are
                incorporated into Products subsequently purchased by New River or
                into
                third party products manufactured by Patheon and subsequently purchased
                by
                a third party, New River will receive credit for any costs of such
                Components previously paid to Patheon by New
                River.

            


    

    


    
      	 	
              (b)

            	
              If
                New River fails to dispose of Components [***] or Product [***].
                If the
                Product contains an Active Material that is determined to be a DEA
                Schedule 2 drug or requires refrigeration, [***]. Patheon shall have
                the
                option to ship Product held longer than three months to New River
                at New
                River’s expense upon two weeks written notice to New
                River.

            


    


    
      
        
        

      

      
        14

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	
              5.3

            	
              Minimum
                Orders

            


    

    


    New
      River
      may only order batches of Products equal to or greater than the Minimum Run
      Quantities set out in Schedule B.

    


    
      	
              5.4

            	
              Patheon
                Forecast for Active Ingredient.

            


    

    


    [***]
      of
      receiving New River’s first written forecast, pursuant to Section 5.1(a), of its
      anticipated requirements for the Product for the next succeeding Year and
      thereafter [***] from receipt of each additional New River forecast, Patheon
      shall submit to New River its written forecast of its anticipated requirements
      of the Active Ingredient for the next succeeding Year. The parties acknowledge
      that the Active Material is scheduled under the Federal Controlled Substances
      Act and that Patheon is required to obtain a quota from the DEA before
      manufacturing Products. Patheon shall submit in a timely matter all necessary
      documents to request a quota sufficient to meet New River’s forecast needs.
      Additional requests shall be submitted by Patheon to DEA in a timely matter
      as
      necessary to reflect changes in New River’s forecast requirements of
      Products.

    


    
      	
              5.5

            	
              Shipments.

            


    

    


    Shipments
      of Products shall be made EXW (as such term is defined in INCOTERMS 2000)
      Patheon’s shipping point unless otherwise mutually agreed. Risk of loss or of
      damage to Products shall remain with Patheon until Patheon loads the Products
      onto the carrier’s vehicle for shipment at the shipping point at which time risk
      of loss or damage shall transfer to New River. Patheon shall, in accordance
      with
      New River’s instructions and as agent for New River, (i) arrange for shipping to
      be paid by New River and (ii) at New River’s risk and expense, obtain any export
      license or other official authorization necessary to export the Products. New
      River shall arrange for insurance and shall select the freight carrier used
      by
      Patheon to ship Products and may monitor Patheon’s shipping and freight
      practices as they pertain to this Agreement. Products shall be transported
      in
      accordance with the Specifications.

    


    
      	
              5.6

            	
              Invoices
                and Payment.

            


    

    


    Invoices
      shall be sent by fax or email to such fax number or email address as may be
      provided by New River in writing from time to time. Patheon shall also submit
      to
      New River with each shipment of Products, a duplicate copy of the invoice
      covering such shipment. Patheon shall also provide New River with an invoice
      covering any Inventory which is to be purchased by Patheon pursuant to the
      terms
      of this Agreement. Each such invoice shall, to the extent applicable, identify
      New River’s purchase order number, Product numbers, names and quantities, unit
      price, freight charges and the total amount to be remitted by New River. New
      River shall pay all such invoices [***] of the date thereof. In the event that
      New River disputes any portion of such invoices in good faith, payment for
      such
      invoices shall not be due until the parties resolve such
      dispute.


    
      
        
        

      

      
        15

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    ARTICLE
      6

    


    PRODUCT
      CLAIMS AND RECALLS

    


    
      	
              6.1

            	
              Product
                Claims.

            


    

    


    
      	 	
              (a)

            	
              Product
                Claims.
                New River has the right to reject any portion of any shipment of
                Products
                that deviates from the Specifications, cGMPs or the Quality Agreement,
                without invalidating any remainder of such shipment. New River shall
                inspect the Products manufactured by Patheon upon receipt thereof
                and
                shall give Patheon written notice (a “Deficiency Notice”) of all claims
                for Products that deviate from the Specifications or cGMPs [***]
                after New
                River’s receipt thereof (or, in the case of any defects not reasonably
                susceptible to discovery upon receipt of the Product, [***] after
                discovery thereof by New River, but in no event after the expiration
                date
                of the Product). Should New River fail to provide Patheon with the
                Deficiency Notice [***], then the delivery shall be deemed to have
                been
                accepted by New River [***], as applicable. Except as set out in
                Section
                6.2 or Section 10.3, Patheon shall have no liability for any
                deviations for which it has not received notice
                [***].

            


    

    


    
      	 	
              (b)

            	
              Determination
                of Deficiency.
                Upon receipt of a Deficiency Notice, Patheon shall have [***] to
                advise
                New River by notice in writing that it disagrees with the contents
                of such
                Deficiency Notice. If New River and Patheon fail to agree [***] after
                Patheon’s notice to New River as to whether any Products identified in the
                Deficiency Notice deviate from the Specifications or cGMPs, then
                the
                parties shall mutually select an independent laboratory to evaluate
                if the
                Products deviate from the Specifications or cGMPs. Such evaluation
                shall
                be binding on the parties, and if such evaluation certifies that
                any
                Products deviate from the Specifications or cGMPs, New River may
                reject
                those Products in the manner contemplated in Section 6.1(a). If such
                evaluation does not so certify that a Product-deviates the Specifications
                or cGMP, then New River shall be deemed to have accepted delivery
                of such
                Product on the date such evaluation was completed, but in no event
                after
                the expiration date of the Product. The party to whom such third
                party
                laboratory certification is adverse shall bear any out-of- pocket
                and/or
                actual costs that the parties incur in connection with such
                evaluation.

            


    

    


    
      	 	
              (c)

            	
              Patheon
                Responsibility.
                In the event New River rejects Products in accordance with this Section
                6.1, and the deviation is determined to arise from Patheon’s failure to
                provide the Manufacturing Services in accordance with the Patheon
                Manufacturing Responsibilities, Patheon will credit New River’s account
                for Patheon’s invoice price to New River for such defective Products. If
                New River shall have previously paid for such defective Products,
                Patheon
                shall promptly, at New River’s election, either: (i) refund the invoice
                price for such defective Products; (ii) offset such amount against
                other
                amounts due to Patheon hereunder; or (iii) replace such Products
                with
                conforming Products [***] without New River being liable for payment
                therefor under Section 3.1, contingent upon the receipt from New
                River of
                all Active Materials and subject to the availability of Components
                required for the manufacture of such replacement Products. In any
                case in
                which New River rejects Products in accordance with this Section
                6.1,
                Patheon shall, subject to the provisions of Section 2.4, reimburse
                New
                River for all costs incurred by New River with respect to Active
                Materials
                used in such non-compliant
                Products.

            


    


    
      
        
        

      

      
        16

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              (d)

            	
              Shortages.
                Subject to Section 5.1(b), claims for shortages in the amount of
                Products
                shipped by Patheon shall be dealt with as may reasonably be agreed
                to by
                the parties.

            


    

    


    
      	
              6.2

            	
              Product
                Recalls and Returns

            


    

    


    
      	 	
              (a)

            	
              Records
                and Notice.
                Patheon and New River shall each maintain such records as may be
                necessary
                to permit a Recall of any Products delivered to New River or customers
                of
                New River. Each party shall promptly notify the other by telephone
                (to be
                confirmed in writing) of any information which might affect the
                marketability, safety or effectiveness of the Products and/or which
                might
                result in the Recall or seizure of the Products. Upon receiving any
                such
                notice or upon any such discovery, each party shall cease and desist
                from
                further shipments of such Products in its possession or control until
                a
                decision has been made whether a Recall or some other corrective
                action is
                necessary. The decision to initiate a Recall or to take some other
                corrective action, if any, shall be made and implemented by New River
                or
                its designee. “Recall”
                shall mean any action (i) by New River or its designee to recover
                title to
                or possession of quantities of the Products sold or shipped to third
                parties (including, without limitation, the voluntary withdrawal
                of
                Products from the market); or (ii) by any regulatory authorities
                to detain
                or destroy any of the Products. Recall shall also include any action
                by
                either party to refrain from selling or shipping quantities of the
                Products to third parties which would have been subject to a Recall
                if
                sold or shipped.

            


    

    


    
      	 	
              (b)

            	
              Recalls.
                In the event (i) any governmental or regulatory authority issues
                a
                directive, order or, following the issuance of a safety warning or
                alert
                with respect to a Product, a written request that any Product be
                recalled,
                (ii) a court of competent jurisdiction orders such a Recall, or (iii)
                New
                River determines that any Product should be Recalled or that a “dear
                doctor” letter is required relating the restrictions on the use of any
                Product, Patheon will co-operate as reasonably required by New River
                or
                its designee, having regard to all applicable laws and
                regulations.

            


    

    


    
      	 	
              (c)

            	
              Product
                Returns.
                New River shall have the responsibility for handling customer returns
                of
                the Products. To the extent Products are inadvertently sent to Patheon
                by
                New River’s customers, Patheon shall notify New River and follow New
                River’s instruction for handling such returned Products, such instruction
                to be provided by New River upon notice from Patheon, at New River’s
                costs.

            


    


    
      
        
        

      

      
        17

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              (d)

            	
              Patheon’s
                Responsibility.
                To the extent that a Recall or return results from, or arises out
                of, a
                failure by Patheon to provide the Manufacturing Services in accordance
                with the Patheon Manufacturing Responsibilities, Patheon shall be
                responsible to New River for New River’s documented out of pocket expenses
                of such Recall or return. Patheon shall promptly, at New River’s election,
                either: (i) refund the invoice price for such Recalled or returned
                Products; (ii) offset such amount against other amounts due to Patheon
                hereunder or (iii) use [***] to replace the Recalled or returned
                Products
                with new Products [***], contingent upon the receipt from New River
                of all
                Active Materials and subject to the availability of Components required
                for the manufacture of such replacement Products. Subject to the
                limitations set out in Section 10.2, [***]. In all other circumstances,
                [***].

            


    

    


    
      	
              6.3

            	
              Disposition
                of Defective or Recalled Products.

            


    

    


    Neither
      party (“Complaining
      Party”)
      shall
      dispose of any damaged, defective, returned, or Recalled Products in relation
      to
      which it intends to assert a claim against the other party without such other
      party’s prior written authorization to do so. Alternatively, the Complaining
      Party may instruct the other party to return such Products to Complaining Party
      at such party’s cost. Complaining Party shall bear the cost of disposition with
      respect to any damaged, defective, returned, or Recalled Products in relation
      to
      which such party bears responsibility under Section 6.1 or 6.2 hereof. In all
      other circumstances, [***].

    


    
      	
              6.4

            	
              Customer
                Questions and Complaints.

            


    

    


    New
      River
      shall have the sole responsibility for responding to questions and complaints
      from New River’s customers. Questions or complaints received by Patheon from New
      River’s customers shall be promptly referred to New River. Patheon shall
      co-operate as reasonably required to allow New River to determine the cause
      of
      and resolve any customer questions and complaints. Such assistance shall include
      follow-up investigations, including testing. In addition Patheon shall provide
      New River with all mutually agreed upon information that will enable New River
      to respond properly to questions or complaints relating to the Products as
      provided in the Quality Agreement. Unless it is determined that the cause of
      any
      customer complaint resulted from a failure by Patheon to provide the
      Manufacturing Services in accordance with the Patheon Manufacturing
      Responsibilities, all costs incurred in respect of this Section 6.4 shall be
      borne by New River.

    


    ARTICLE
      7

    


    CO-OPERATION

    


    
      	
              7.1

            	
              Quarterly
                Review.

            


    

    


    Each
      party shall forthwith upon execution of this Agreement appoint one of its
      employees to be a relationship manager responsible for liaison between the
      parties. The relationship managers shall meet not less than quarterly to review
      the current status of the business relationship and manage any issues that
      have
      arisen, including any ways to improve efficiency or reduce costs associated
      with
      the Manufacturing Services. Patheon’s relationship manager shall take minutes at
      such meetings and deliver such minutes to the relationship manager for New
      River
      within a reasonable amount of time following such meetings.


    
      
        
        

      

      
        18

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	
              7.2

            	
              Governmental
                Agencies.

            


    

    


    Subject
      to Section 7.7, each party may communicate with any governmental agency,
      including but not limited to governmental agencies responsible for granting
      regulatory approval for the Products, regarding such Products if in the opinion
      of that party’s counsel, such communication is necessary to comply with the
      terms of this Agreement or the requirements of any law, governmental order
      or
      regulation; provided, however, that unless in the reasonable opinion of its
      counsel there is a legal prohibition against doing so, such party shall permit
      the other party to accompany and take part in any communications with the
      agency, and to receive copies of all such communications from the
      agency.

    


    
      	
              7.3

            	
              Records
                and Accounting by
                Patheon.

            


    

    


    In
      conformance with the Quality Agreement, Patheon shall keep records of the
      Manufacturing Services and shipping of the Products, and retain samples of
      such
      Products as are necessary to comply with manufacturing regulatory requirements
      applicable to Patheon, as well as to assist with resolving Product complaints
      and other similar investigations. Copies of such records and samples shall
      be
      retained for a [***] following the date of Product expiry, or longer if required
      by law after which Patheon may destroy such records or samples. New River is
      responsible for retaining samples of the Products necessary to comply with
      the
      legal and/or regulatory requirements applicable to New River.

    


    
      	
              7.4

            	
              Inspection.

            


    

    


    New
      River
      or its designee may inspect Patheon reports and records relating to this
      Agreement during normal business hours and with reasonable advance notice,
      provided a Patheon representative is present during any such
      inspection.

    


    
      	
              7.5

            	
              Access.

            


    

    


    Patheon
      shall provide New River or its designee with reasonable access at mutually
      agreeable times to its Manufacturing Site in which the Products are
      manufactured, stored, handled or shipped in order to permit New River’s
      verification of Patheon’s compliance with the Patheon Manufacturing
      Responsibilities and with all Laws. For greater certainty, the right of access
      provided in this Section 7.5 shall not include a right to access or inspect
      Patheon’s financial records. Patheon shall notify New River of any inspections
      by any governmental agency specifically involving the Products. New River or
      its
      designee reserves the right to be present during any such inspection by any
      governmental agency, to review any findings by such governmental agency that
      are
      communicated to Patheon, and to have a reasonable period in which to comment
      on
      any response before such response is sent to the governmental agency. All
      audited data shall be treated as Confidential Information of Patheon and New
      River or its designee shall not be permitted to remove or copy data without
      Patheon’s prior written consent. Any investigation conducted in connection with
      an invoice dispute shall not be considered a financial audit under this Section
      7.5.


    
      
        
        

      

      
        19

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	
              7.6

            	
              Reports.

            


    

    


    Patheon
      will supply on an annual basis, and upon lesser intervals as may be reasonably
      requested by New River, all Product data, including release test results,
      complaint test results, and all investigations (in manufacturing, testing and
      storage), that New River reasonably requires in order to complete any filing
      under any applicable regulatory regime, including any annual product report
      that
      New River is required to file with the FDA. At New River’s request, Patheon
      shall provide a copy of the Annual Product Review Report to New River at no
      additional cost. Any additional report requested by New River beyond the scope
      of cGMPs and customary FDA requirements may be subject to an additional fee
      to
      be agreed upon between Patheon and New River.

    


    
      	
              7.7

            	
              FDA
                Filings.

            


    

    


    
      	 	
              (a)

            	
              FDA
                Filings.
                New River shall have the sole responsibility for filing all documents
                with
                the FDA and taking any other actions that may be required for the
                receipt
                of FDA Approval for the commercial manufacture of all of the Products.
                Patheon shall assist New River, to the extent consistent with Patheon’s
                obligations under this Agreement, to obtain FDA Approval for the
                commercial manufacture of all Products as quickly as reasonably possible.
                New River shall provide Patheon with copies of all FDA filings at
                the time
                of submission which contain chemistry, manufacturing and controls
                (“CMC”)
                data regarding the Product.

            


    

    


    
      	 	
              (b)

            	
              Verification
                of CMC.
                [***] with the FDA, or a timeframe mutually agreed to by the parties,
                the
                CMC of the New Drug Application (“NDA”) or the Abbreviated New Drug
                Application (“ANDA”) filing, as the case may be, New River shall provide
                Patheon with a draft copy of the CMC portion of such application,
                as well
                as all supporting documents which have been relied upon to prepare
                the CMC
                portion, so as to permit Patheon to verify that the CMC portion accurately
                describes the work that Patheon has performed and the manufacturing
                processes that Patheon will perform pursuant to this
                Agreement.

            


    

    


    
      	 	
              (c)

            	
              Pre-Approval
                Inspection.
                If New River does not provide Patheon with the documentation requested
                under paragraph (b) above within the time stipulated in that paragraph
                and
                if Patheon reasonably believes that Patheon’s standing with the FDA may be
                jeopardized, Patheon may, in its sole discretion, delay or postpone
                the
                FDA pre-approval inspection ( until such time Patheon has reviewed
                the
                requested documentation and is satisfied that its contents accurately
                describe the Manufacturing Services Patheon has performed and will
                perform
                under this Agreement.

            


    

    


    
      	 	
              (d)

            	
              Deficiencies.
                If in Patheon’s reasonable discretion, Patheon determines that any of the
                information provided by New River in accordance with paragraph (b)
                above
                is inaccurate or deficient in any manner whatsoever (the “Deficiencies”),
                Patheon shall notify New River in writing of such Deficiencies [***],
                and
                cooperate in good faith with New River to resolve any
                Deficiencies.

            


    


    
      
        
        

      

      
        20

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              (e)

            	
              New
                River Responsibility.
                For clarity, the parties agree that in reviewing the documents referred
                to
                in paragraph (b) above, Patheon’s role will be limited to verifying the
                accuracy of the description of the Manufacturing Services undertaken
                or to
                be undertaken by Patheon. As such, Patheon shall not assume any
                responsibility for the accuracy of the NDA or the ANDA, as the case
                may
                be. The sole responsibility of the preparation and filing of the
                NDA shall
                be borne by New River.

            


    

    


    ARTICLE
      8

    


    TERM
      AND TERMINATION

    


    
      	
              8.1

            	
              Initial
                Term.

            


    

    


    This
      Agreement shall become effective as of the Effective Date and shall continue
      until December 31, 2011 (the “Initial
      Term”),
      unless
      terminated earlier by one of the parties in accordance herewith. This Agreement
      shall automatically continue after the Initial Term for successive terms of
      two
      (2) years each unless either party gives written notice to the other party
      of
      its intention to terminate this Agreement at least twelve (12) months prior
      to
      the end of the then current term.

    


    
      	
              8.2

            	
              Termination
                for Cause.

            


    

    


    
      	 	
              (a)

            	
              Either
                party at its sole option may terminate this Agreement upon written
                notice
                in circumstances where the other party has failed to remedy a material
                breach of any of its representations, warranties or other obligations
                under this Agreement [***] of said breach that expressly states that
                it is
                a notice under this Section 8.2(a) and sets forth in reasonable detail
                the
                nature of such breach.

            


    

    


    
      	 	
              (b)

            	
              Either
                party at its sole option may immediately terminate this Agreement
                upon
                written notice, but without prior advance notice, to the other party
                in
                the event that: (i) the other party is declared insolvent or bankrupt
                by a
                court of competent jurisdiction; (ii) a voluntary petition of bankruptcy
                is filed in any court of competent jurisdiction by such other party;
                or
                (iii) this Agreement is assigned by such other party for the benefit
                of
                creditors.

            


    

    


    
      	 	
              (c)

            	
              New
                River may terminate this Agreement as to any Product at any time
                [***] in
                the event that any governmental agency takes any action, or raises
                any
                objection, that prevents New River from importing, exporting, purchasing
                or selling such Product.

            


    

    


    
      	 	
              (d)

            	
              In
                the event that New River assigns pursuant to Section 13.6 any of
                its
                rights under this Agreement, Patheon may terminate this Agreement
                [***]
                if, in the opinion of Patheon acting reasonably, such assignee is
                not a
                credit worthy substitute for New River. In addition, Patheon or the
                permitted assignee may terminate this Agreement [***] to the other
                party
                if Patheon and the assignee (i) are commercial competitors; or (ii)
                have
                had prior unsatisfactory business
                relations.

            


    


    
      
        
        

      

      
        21

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	
              8.3

            	
              Product
                Discontinuation.

            


    

    


    New
      River
      shall provide [***] if it intends to no longer order a Product due to that
      Product’s discontinuance in the market.

    


    
      	
              8.4

            	
              Termination
                upon Regulatory
                Refusal.

            


    

    


    New
      River
      may terminate this Agreement as to any Product or in its entirety with immediate
      effect, in the event that any applicable Authority, state or local regulatory
      approvals, laws, ordinances, or regulations, present or future, including but
      not limited to any conditions, amendments, or variations state that the
      Manufacturing Site is not suitable or ceases to be suitable for the manufacture
      of the Product or suspends, or refuses to grant any approval, license, permit,
      or other authorization to manufacture the Product.

    


    
      	
              8.5

            	
              Obligations
                on Termination.

            


    

    


    If
      this
      Agreement expires or is terminated, with the exception of Failure to Supply,
      in
      whole or in part for any reason other than for termination by New River under
      Section 8.2(a) or (b), then (in addition to any other remedies Patheon may
      have
      in the event of default by New River):

    


    
      	 	
              (a)

            	
              [***]

            


    

    


    
      	 	
              (b)

            	
              [***]

            


    

    


    
      	 	
              (c)

            	
              [***].

            


    

    


    If
      this
      Agreement expires or is terminated for any reason, then Patheon shall return
      to
      New River all unused Active Materials ([***]). Following termination of this
      Agreement by New River pursuant to Section 8.2(a), 8.2(b), or 8.4, should New
      River desire to manufacture Product at a non-Patheon facility, Patheon shall
      assist New River in transferring manufacturing of the Product by providing
      support for the transfer of the manufacturing process to New River or an
      organization named by New River, pursuant to a plan to be negotiated in good
      faith and agreed upon by the parties (the “Process
      Transfer Plan”).
      Such
      Process Transfer Plan [***] and shall also include, without limitation, all
      documentation relating to process development, manufacturing procedures, and
      product-specific procedures referenced in such manufacturing procedures, test
      records and technical documents including testing and characterization of Active
      Materials, and any regulatory documents prepared by Patheon to support the
      Products. Patheon shall provide New River or its designee with reasonable
      assistance and co-operation in the transfer of any know-how or technology
      required for the manufacture or validation of the Manufacturing Services by
      such
      third party in a timely manner. In the event New River terminates this Agreement
      pursuant to Section 8.2(a) or (b), Patheon shall grant and hereby does grant
      New
      River [***] of any Patheon Intellectual Property necessary for performance
      of
      the Manufacturing Services and New River and Patheon shall share the costs
      specified in the Process Transfer Plan for manufacturing transfer activities,
      including, without limitation, document duplication and shipping, and associated
      time for Patheon personnel.


    
      
        
        

      

      
        22

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    Any
      termination or expiration of this Agreement shall not affect any outstanding
      obligations or payments due hereunder prior to such termination or expiration,
      nor shall it prejudice any other remedies that the parties may have under this
      Agreement. For greater certainty, termination of this Agreement for any reason
      shall not affect the obligations and responsibilities of the parties pursuant
      to
      Articles 10, 11 and 12, and Sections 13.1, 13.2, 13.3 and 13.15, all of which
      survive any termination.

    


    ARTICLE
      9

    


    REPRESENTATIONS,
      WARRANTIES AND COVENANTS

    


    
      	
              9.1

            	
              Authority.

            


    

    


    Each
      party covenants, represents and warrants that it has the full right and
      authority to enter into this Agreement, and that it is not aware of any
      impediment that would inhibit its ability to perform its obligations
      hereunder.

    


    
      	
              9.2

            	
              New
                River Warranties

            


    

    


    New
      River
      covenants, represents and warrants that:

    


    
      	 	
              (a)

            	
              New
                River or its Affiliates have the right to use the Specifications
                for each
                of the Products as contemplated in this Agreement, and that New River
                may
                lawfully disclose the Specifications to
                Patheon;

            


    

    


    
      	 	
              (b)

            	
              to
                the best of its knowledge, any Intellectual Property, other than
                Patheon
                Intellectual Property, utilized by Patheon in connection with the
                provision of the Manufacturing Services (i) may be lawfully used
                as set
                out in this Agreement and the Quality Agreement, and (ii) such use
                does
                not infringe any Third Party
                Rights;

            


    

    


    
      	 	
              (c)

            	
              to
                the best of its knowledge, there are no actions or other legal
                proceedings, the subject of which is the infringement of Third Party
                Rights related to the Products;

            


    

    


    
      	 	
              (d)

            	
              the
                Specifications for all Products conform to all applicable cGMPs,
                laws and
                regulations; and,

            


    

    


    
      	 	
              (e)

            	
              the
                Products, if labeled and manufactured in accordance with the
                Specifications and in compliance with applicable cGMPs, may be lawfully
                sold and distributed in the
                Territory.

            


    

    


    
      	
              9.3

            	
              Patheon
                Warranties

            


    

    


    Patheon
      covenants, represents and warrants that:

    


    
      	 	
              (a)

            	
              it
                shall perform the Manufacturing Services in compliance with the terms
                of
                this Agreement, the Quality Agreement, the Specifications and
                cGMPs;

            


    


    
      
        
        

      

      
        23

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              (b)

            	
              it
                has the necessary facilities, plant, equipment, know-how, procedures,
                and
                personnel at its Manufacturing Site to perform the Manufacturing
                Services
                in compliance with the terms of this Agreement and the Quality
                Agreement;

            


    

    


    
      	 	
              (c)

            	
              each
                batch of the Product supplied under this Agreement shall be of
                satisfactory quality, free from any defects and manufactured strictly
                in
                compliance with the Specifications, the terms of this Agreement and
                the
                Quality Agreement;

            


    

    


    
      	 	
              (d)

            	
              it
                has obtained (or will obtain prior to producing Product), and will
                maintain and remain in compliance with, all permits, consents, approvals,
                licenses and other authorizations or waivers (the “Permits”) during the
                term of this Agreement which are required under federal, state and
                local
                laws, rules, guidelines and regulations generally applicable to the
                production of the Product at the Manufacturing Site (including without
                limitation Permits required to manufacture the Products to fill
                [***]);

            


    

    


    
      	 	
              (e)

            	
              to
                the best of its knowledge, the Intellectual Property rights used
                to
                perform the Manufacturing Services do not infringe any Third Party
                Rights;
                and

            


    

    


    
      	 	
              (f)

            	
              it
                shall convey good title in any Product delivered to New River or
                its
                designee under this Agreement, and that all such Product will be
                delivered
                to New River or its designee free from any security interest, lien,
                or
                other encumbrance.

            


    

    


    
      	
              9.4

            	
              Debarred
                Persons.

            


    

    


    Patheon
      covenants that it will not in the performance of its obligations under this
      Agreement use the services of any person debarred or suspended under 21 U.S.C.
      §335(a) or (b). Patheon represents that it does not currently have, and
      covenants that it will not hire, as an officer or an employee any person who
      has
      been convicted of a felony under the laws of the United States for conduct
      relating to the regulation of any drug product under the Federal Food, Drug,
      and
      Cosmetic Act.

    


    
      	
              9.5

            	
              Permits.

            


    

    


    New
      River
      shall be solely responsible for obtaining or maintaining, on a timely basis,
      any
      permits or other regulatory approvals (other than those required under Section
      9.3(d)) in respect of the Products or the Specifications, including, without
      limitation, all marketing and post-marketing approvals.

    


    
      	
              9.6

            	
              Compliance
                with Laws.

            


    

    


    Each
      party, in connection with its performance of its obligations under this
      Agreement and the Quality Agreement, shall comply with all Laws.

    


    
      	
              9.7

            	
              No
                Warranty

            


    

    


    THE
      WARRANTIES CONTAINED IN THIS ARTICLE 9 ARE THE SOLE WARRANTIES GWEN BY THE
      PARTIES HEREUNDER. PATHEON MAKES NO WARRANTY OF ANY KIND, EITHER EXPRESSED
      OR
      IMPLIED, BY FACT OR LAW, OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS AGREEMENT.
      PATHEON MAKES NO WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR WARRANTY OF
      MERCHANTABILITY WITH RESPECT TO THE PRODUCTS.


    
      
        
        

      

      
        24

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    ARTICLE
      10

    


    REMEDIES
      AND INDEMNITIES

    


    
      	
              10.1

            	
              Consequential
                Damages

            


    

    


    Except
      for a breach of Article 11, under no circumstances whatsoever shall either
      party
      be liable to the other in contract, tort, negligence, breach of statutory duty
      or otherwise (direct or indirect) for any loss of profits, of production, of
      anticipated savings, of business or goodwill or for any liability, damage,
      costs
      or expense of any kind incurred by the other party of an indirect or
      consequential nature. The foregoing provision shall not be construed to limit
      a
      party’s indemnification obligation under Section 10.3 or 10.4 of this Agreement
      for third party claims which may include consequential, punitive or other types
      of damages.

    


    
      	
              10.2

            	
              Limitation
                of Liability.

            


    

    


    
      	 	
              (a)

            	
              Active
                Materials.
                Except as expressly set forth in Section 2.4 hereof, under no
                circumstances whatsoever shall Patheon be responsible for any loss
                or
                damage to the Active Materials. Patheon’s maximum liability for loss or
                damage to the Active Materials in a Year
                [***].

            


    

    


    
      	 	
              (b)

            	
              Products.
                Except to the extent that Patheon has failed to provide the Manufacturing
                Services in accordance with the terms of this Agreement or the Quality
                Agreement, or has breached its warranties as set forth in Article
                9,
                Patheon shall not be liable nor have any responsibility for any
                deficiencies in, or other liabilities associated with, any Product
                manufactured by it, including, without limitation, the costs and
                expenses
                of any Recall (collectively, “Product
                Claims”).
                For greater certainty, Patheon shall have no obligation for any Product
                Claims, to the extent such Product Claim (i) is caused by deficiencies
                with respect to the Specifications themselves and not Patheon’s
                implementation of Specifications, the safety, efficacy or marketability
                of
                the Products or any distribution thereof, (ii) results from a defect
                in a
                Component that is not reasonably discoverable by Patheon using the
                test
                methods set forth in the Specifications, (iii) results from a defect
                in
                the Active Materials or Components supplied by New River that is
                not
                reasonably discoverable by Patheon using the test methods set forth
                in the
                Specifications, (iv) is caused by actions of third parties occurring
                after
                such Product is shipped by Patheon, (iv) is due to packaging or labeling
                defects or omissions for which Patheon has no responsibility, or
                (v) is
                solely due to a breach by New River of its obligations under this
                Agreement.

            


    

    


    
      	 	
              (c)

            	
              Maximum
                Liability.
                Except for any liability arising under Section 10.3, Patheon’s maximum
                liability under this Agreement for any reason whatsoever, including,
                without limitation, any liability arising under Article 6 hereof
                or
                resulting from a breach of its representations, warranties or other
                obligations under this Agreement
                [***].

            


    


    
      
        
        

      

      
        25

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	
              10.3

            	
              Patheon.

            


    

    


    Subject
      to Sections 10.1 and 10.2, Patheon agrees to defend, indemnify and hold New
      River, its Affiliates, and its or their officers, employees, consultants, and
      agents harmless against any and all losses, damages, costs or expenses ([***]),
      claims, demands, judgments and liability to, from or in favour of third parties
      resulting from, or relating to any claim of personal injury or property damage
      to the extent that such injury or damage is the result of or due to the
      negligence or wrongful act(s) of Patheon, breach of this Agreement or the
      Quality Agreement by Patheon, or a failure by Patheon to provide the
      Manufacturing Services in accordance with this Agreement, except to the extent
      that any such losses, damages, costs, claims, demands, judgments and liability
      are due to the negligence or wrongful act(s) of New River, its officers,
      employees or agents or Affiliates.

    


    In
      the
      event of a claim, New River shall: (a) promptly notify Patheon of any such
      claim; (b) use [***] to mitigate the effects of such claim; (c) reasonably
      cooperate with Patheon in the defense of such claim; (d) permit Patheon to
      control the defense and settlement of such claim, all at Patheon’s cost and
      expense; and (e) not make any payment or incur any expenses in connection with
      any such claim or make any admission or do anything that may compromise or
      prejudice the defense of the claim without the prior written consent of Patheon,
      such consent not to be unreasonably withheld or delayed.

    


    
      	
              10.4

            	
              New
                River.

            


    

    


    Subject
      to Sections 10.1 and 10.2, New River agrees to defend, indemnify and hold
      Patheon, its Affiliates, and its or their officers, employees, consultants,
      and
      agents harmless against any and all losses, damages, costs or expenses ([***]),
      claims, demands, judgments and liability to, from and in favour of third parties
      resulting from, or relating to (i) any claim of infringement or alleged
      infringement of any Third Party Rights in respect of the Products, and (ii)
      any
      claim of personal injury or property damage to the extent that such injury
      or
      damage is the result of a breach of this Agreement or the Quality Agreement
      by
      New River, including, without limitation, any representation or warranty
      contained herein, except to the extent that any such losses, damages, costs,
      claims, demands, judgments and liability are due to the negligence or wrongful
      act(s) of Patheon, its officers, employees or agents.

    


    In
      the
      event of a claim, Patheon shall: (a) promptly notify New River of any such
      claims; (b) [***] to mitigate the effects of such claim; (c) reasonably
      cooperate with New River in the defense of such claim; (d) permit New River
      to
      control the defense and settlement of such claim, all at New River’s cost and
      expense; and (e) not make any payment or incur any expenses in connection with
      any such claim or make any admission or do anything that may compromise or
      prejudice the defense of the claim without the prior written consent of New
      River, such consent not to be unreasonably withheld or delayed.


    
      
        
        

      

      
        26

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    ARTICLE
      11

    


    CONFIDENTIALITY

    


    
      	
              11.1

            	
              Confidentiality

            


    

    


    The
      parties agree that the provisions of the Confidentiality Agreement shall apply
      to all confidential information disclosed by the parties under this Agreement,
      and that the activities contemplated and carried out under this Agreement shall
      be deemed to be included within the “Business Purpose” as such term is defined
      in the Confidentiality Agreement, which agreement remains in effect in
      accordance with its terms; provided, however, that in the event the
      Confidentiality Agreement expires or is terminated prior to the expiration
      or
      termination of this Agreement, the terms of the Confidentiality Agreement shall
      continue to govern the parties’ obligations of confidentiality with respect to
      any confidential or proprietary information disclosed by the parties hereunder,
      for the term of this Agreement and [***], as though such agreement remained
      in
      full force and effect. The parties agree that any confidential or proprietary
      information that satisfies the requirements of Section 5(e) or 5(1) of the
      Confidentiality Agreement shall, subject to the remainder of the Confidentiality
      Agreement, continue to be considered Confidential Information (as defined
      therein) for all purposes other than the disclosures specifically contemplated
      by such sections. In addition, in the event a party desires to make a disclosure
      pursuant to Section 5(e) of the Confidentiality Agreement (including, without
      limitation, any disclosure deemed necessary under applicable federal or state
      securities laws or any rule or regulation of a nationally recognized securities
      exchange), it shall, except where impracticable, give reasonable advance notice
      to the other party of such disclosure, use reasonable efforts to secure
      confidential treatment of such information, and provide the other party the
      opportunity to comment on any confidential treatment requested prior to the
      submission.

    


    ARTICLE
      12

    


    DISPUTE
      RESOLUTION

    


    
      	
              12.1

            	
              Commercial
                Disputes.

            


    

    


    In
      the
      event of any dispute arising out of or in connection with this Agreement (other
      than a dispute determined in accordance with Section 6.1(b) or a Technical
      Dispute), the parties shall first try to solve it amicably. In this regard,
      any
      party may send a notice of dispute to the other, and each party shall appoint,
      [***] from receipt of such notice of dispute, a single representative having
      full power and authority to solve the dispute. The representatives so designated
      shall meet as necessary in order to solve such dispute. If these representatives
      fail to solve the matter within one month from their appointment, or if a party
      fails to appoint a representative [***] set forth above, such dispute shall
      immediately be referred to the Chief Operating Officer or Executive Vice
      President, Operations (or such other officer as such representative may
      designate) of each party who will meet and discuss as necessary in order to
      try
      to solve the dispute amicably. Should the parties fail to reach a resolution
      under this Section 12.1, their dispute will be referred to a court of competent
      jurisdiction in accordance with Section 13.15.


    
      
        
        

      

      
        27

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	
              12.2

            	
              Technical
                Dispute Resolution.

            


    

    


    In
      the
      event of a dispute (other than disputes in relation to the matters set out
      in
      Sections 6.1(b) and 12.1) between the parties that is exclusively related to
      technical aspects of the manufacturing, packaging, labeling, quality control
      testing, handling, storage or other activities under this Agreement (a
“Technical
      Dispute”),
      the
      parties shall make all reasonable efforts to resolve the dispute by amicable
      negotiations. In this regard, senior representatives of each party shall, as
      soon as practicable and in any event no later than [***] after a written request
      from either party to the other party, meet in good faith to resolve any
      Technical Dispute. If, despite such meeting, the parties are unable to resolve
      a
      Technical Dispute within a reasonable time, and in any event [***] of such
      written request, the Technical Dispute shall, at the request of either party,
      be
      referred for determination to an expert in accordance with the provisions of
      Schedule F. In the event that the parties cannot agree whether a dispute is
      a
      Technical Dispute, Section 12.1 shall prevail. For greater certainty, the
      parties agree that the release of the Products for sale or distribution pursuant
      to the applicable marketing approval for such Products shall not by itself
      indicate compliance by Patheon with its obligations in respect of the
      Manufacturing Services and further that nothing in this Agreement (including
      Schedule F) shall remove or limit the authority of the relevant qualified person
      (as specified by the Quality Agreement) to determine whether the Products are
      to
      be released for sale or distribution.

    


    ARTICLE
      13

    


    MISCELLANEOUS

    


    
      	
              13.1

            	
              Inventions.

            


    

    


    
      	 	
              (a)

            	
              For
                the term of this Agreement, New River hereby grants to Patheon a
                [***] to
                New River’s Intellectual Property which Patheon must use in order to
                perform the Manufacturing Services under this
                Agreement.

            


    

    


    
      	 	
              (b)

            	
              All
                Intellectual Property generated or derived by Patheon in the course
                of
                performing the Manufacturing Services, to the extent it is specific
                to the
                development, manufacture, use and sale of the Product that is the
                subject
                of the Manufacturing Services, shall be the exclusive property of
                New
                River.

            


    

    


    
      	 	
              (c)

            	
              All
                Intellectual Property generated or derived by Patheon in the course
                of
                performing the Manufacturing Services which are not specific, or
                dependent
                upon, New River’s Product and which have application to manufacturing
                processes or formulation development of drug products or drug delivery
                systems shall be the exclusive property of Patheon (the “Broader
                Intellectual Property Rights”).
                Patheon hereby grants to New River, [***] to Patheon’s Broader
                Intellectual Property Rights to make, have made, use and sell New
                River’s
                Product.

            


    

    


    
      	 	
              (d)

            	
              Each
                party shall be solely responsible for the costs of filing, prosecution
                and
                maintenance of patents and patent applications on its own
                Inventions.

            


    


    
      
        
        

      

      
        28

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              (e)

            	
              Either
                party shall give the other party written notice, as promptly as
                practicable, of all Inventions which can reasonably be deemed to
                constitute improvements or other modifications of the Products or
                processes or technology owned or otherwise controlled by such other
                party.

            


    

    


    
      	 	
              (f)

            	
              Patheon
                shall cooperate with New River, and at New River’s request and expense,
                shall execute any instrument or do such act or thing as may be necessary
                or desirable to ensure that any such Intellectual Property referred
                to in
                clause 13.1(b) above vest in New River, including without limitation,
                obtaining the assignment to such Intellectual Property from its employees
                by requiring each such employee to execute a written assignment to
                Patheon
                prior to performance of Patheon’s obligations
                hereunder.

            


    

    


    
      	
              13.2

            	
              Intellectual
                Properly.

            


    

    


    Subject
      to Section 13.1, all Intellectual Property of New River shall be owned by New
      River and all Intellectual Property of Patheon shall be owned by Patheon. Except
      as otherwise expressly provided herein, New River and Patheon hereby acknowledge
      that neither party has, nor shall it acquire, any interest in any of the other
      party’s Intellectual Property unless otherwise expressly agreed to in this
      Agreement or subsequently in writing. Each party agrees not to use any
      Intellectual Property of the other party, except (i) as specifically authorized
      by the other party, (ii) as allowed under Section 13.1, or (iii) as required
      for
      the performance of its obligations under this Agreement. Except as otherwise
      expressly provided herein, nothing contained in this Agreement shall be
      construed or interpreted, either expressly or by implication, estoppel or
      otherwise, as a grant, transfer or other conveyance by either party to the
      other
      of any right, title, license or other interest of any kind in any of its
      Intellectual Property.

    


    
      	
              13.3

            	
              Insurance.

            


    

    


    Each
      party shall maintain commercial general liability insurance, including blanket
      contractual liability insurance covering the obligations of that party under
      this Agreement through the term of this Agreement and for [***] beyond the
      expiration date of any Product, which insurance shall afford limits [***] for
      each occurrence for personal injury or property damage liability; and (ii)
      [***]
      with respect to product and completed operations liability. If requested each
      party will 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 [***] 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.

    


    
      	
              13.4

            	
              Independent
                Contractors.

            


    

    


    The
      parties are independent contractors and this Agreement shall not be construed
      to
      create between Patheon and New River any other relationship such as, by way
      of
      example only, that of employer-employee, principal agent, joint-venturer,
      co-partners or any similar relationship, the existence of which is expressly
      denied by the parties hereto.


    
      
        
        

      

      
        29

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	
              13.5

            	
              No
                Waiver.

            


    

    


    Either
      party’s failure to require the other party to comply with any provision of this
      Agreement shall not be deemed a waiver of such provision or any other provision
      of this Agreement.

    

      
        	
                13.6

              	
                Assignment.

              


      

    

    


    
      	 	
              (a)

            	
              Patheon
                may not assign this Agreement or any of its rights or obligations
                hereunder except with the written consent of New River, such consent
                not
                to be unreasonably withheld; provided, however, that Patheon may
                arrange
                for subcontractors to perform specific testing services arising under
                this
                Agreement without the consent of New
                River.

            


    

    


    
      	 	
              (b)

            	
              Subject
                to Section 8.2(d), New River may assign this Agreement or any of
                its
                rights or obligations hereunder without approval from Patheon; provided,
                however, that New River shall give prior written notice of any assignment
                to Patheon, any assignee shall covenant in writing with Patheon to
                be
                bound by the terms of this Agreement and New River shall remain liable
                hereunder. Any assignment or partial assignment will be subject to
                a cost
                review of the assigned Products by Patheon and is subject to assignee
                and
                Patheon reaching agreement as to revisions, if any, to the fees,
                failing
                such agreement, Patheon or the permitted assignee may terminate this
                Agreement [***] to the other party.

            


    

    


    
      	 	
              (c)

            	
              Notwithstanding
                the foregoing provisions of this Section 13.6, either party may assign
                this Agreement to any of its Affiliates or to a successor to or purchaser
                of all or substantially all of its business, provided that such assignee
                executes an agreement with the non-assigning party hereto whereby
                it
                agrees to be bound hereunder.

            


    

    


    
      	
              13.7

            	
              Force
                Majeure.

            


    

    


    Neither
      party shall be liable for the failure to perform its obligations under this
      Agreement if such failure is occasioned by a cause or contingency beyond such
      party’s reasonable control, including, but not limited to, strikes or other
      labor disturbances, lockouts, riots, public health quarantines, communicable
      disease outbreaks, wars, acts of terrorism, fires, floods, storms, interruption
      of or delay in transportation, defective equipment (solely to the extent that
      such defects in equipment are not due to Patheon’s negligence and are outside
      Patheon’s control), lack of or inability to obtain fuel, power or components
      (solely to the extent that the procurement of such components is the
      responsibility of New River), or compliance with any order or regulation of
      any
      government entity acting within color of right (a “Force
      Majeure Event”).
      A
      party claiming a right to excused performance under this Section 13.7 shall
      immediately notify the other party in writing of the extent of its inability
      to
      perform, which notice shall specify the occurrence beyond its reasonable control
      that prevents such performance. Neither party shall be entitled to rely on
      a
      Force Majeure Event to relieve it from an obligation to pay money (including
      any
      interest for delayed payment) which would otherwise be due and payable under
      this Agreement.


    
      
        
        

      

      
        30

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	
              13.8

            	
              Additional
                Product.

            


    

    


    Additional
      products may be added to this Agreement and such additional products shall
      be
      governed by the general conditions hereof with any special terms (including,
      without limitation, price) governed by an addendum hereto.

    


    
      	
              13.9

            	
              Notices.

            


    

    


    Any
      notice, approval, instruction or other written communication required or
      permitted hereunder shall be sufficient if made or given to the other party
      by
      personal delivery, by telecopier or facsimile communication or by sending the
      same by first class mail, postage prepaid to the mailing address, or telecopier
      or facsimile number set forth below:

    


    If
      to
      New River

    


    New
      River
      Pharmaceuticals Inc.

    1881
      Grove Avenue

    Radford,
      Virginia 24141

    Attention:
      Chief Executive Officer

    


    with
      a
      copy to: New River Legal Department

    Telecopier
      No.: 540-633-7979

    


    If
      to
      Patheon:

    


    Patheon
      Inc.

    7070
      Mississauga Road,

    Suite
      350, Mississauga, Ontario

    LSN
      7J8

    Attention:
      President, Patheon U.S.A.

    Telecopier
      No.: 905-812-6705

    


    with
      a
      copy to:

    


    Patheon
      Pharmaceuticals Inc.

    2110
      East
      (Galbraith Road

    Cincinnati,
      Ohio 45237-1625

    Attention:
      Director of Legal Services

    Telecopier
      No.: 513-948-6927

    


    or
      to
      such other addresses or telecopier or facsimile numbers provided to the other
      party in accordance with the terms of this Section 13.9. Notices or written
      communications made or given by personal delivery or by telecopier or facsimile
      shall be deemed to have been sufficiently made or given when sent (receipt
      acknowledged), or if mailed, five days after being deposited in the United
      States mail, postage prepaid or upon receipt, whichever is
      sooner.


    
      
        
        

      

      
        31

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	
              13.10

            	
              Severability.

            


    

    


    If
      any
      provision of this Agreement is determined by a court of competent jurisdiction
      to be invalid, illegal or unenforceable in any respect, such determination
      shall
      not impair or affect the validity, legality or enforceability of the remaining
      provisions hereof, and each provision is hereby declared to be separate,
      severable and distinct.

    


    
      	
              13.11

            	
              Entire
                Agreement.

            


    

    


    This
      Agreement, together with the Quality Agreement and the Confidentiality
      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 conflict, the prevailing
      order of documents shall be this Agreement, the Quality Agreement and the
      Confidentiality Agreement.

    


    
      	
              13.12

            	
              Other
                Terms.

            


    

    


    The
      parties agree that no terms, provisions or conditions of any purchase order
      or
      other business form or written authorization used by New River or Patheon will
      have any effect on the rights, duties or obligations of the parties under or
      otherwise modify this Agreement, regardless of any failure of New River or
      Patheon to object to such terms, provisions, or conditions unless such document
      specifically refers to this Agreement and is signed by both
      parties.

    


    
      	
              13.13

            	
              No
                Third Party Benefit or
                Right.

            


    

    


    For
      greater certainty, nothing in this Agreement shall confer or be construed as
      conferring on any third party, except an Affiliate of the parties, any benefit
      or the right to enforce any express or implied term of this
      Agreement.

    


    
      	
              13.14

            	
              Execution
                in Counterparts.

            


    

    


    This
      Agreement may be executed in two counterparts, by original or facsimile
      signature, each of which shall be deemed an original, but all of which together
      shall constitute one and the same instrument.

    


    
      	
              13.15

            	
              Governing
                Law.

            


    

    


    This
      Agreement shall be construed and enforced in accordance with the laws of the
      State of Delaware. The parties expressly agree that the UN Convention on
      Contracts for the International Sale of Goods shall not apply to this
      Agreement.


    
      
        
        

      

      
        32

        
          

        

      

      
        
        

      

    

     

    CONFIDENTIAL
      TREATMENT

     

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

    


    
      	 	
              PATHEON
                PHARMACEUTICALS INC.

            
	 	 	 	 
	 	
              By:

            	/s/
              Ronald R. Schallick	 
	 	 	 	 
	 	
              Date:

            	10/3/06	 
	 	 	 	 
	 	 	 	 
	 	 	 	 
	 	
              NEW
                RIVER PHARMACEUTICALS, INC.

            
	 	 	 	 
	 	
              By:

            	/s/
              Krish S. Krishnan	 
	 	 	 	 
	 	
              Date:

            	9/26/06	 


    

    

      
        
          
          

        

        
          33

          
            

          

        

        
          
          

        

      

    


    CONFIDENTIAL
      TREATMENT

    


    SCHEDULE
      A

    


    PRODUCT
      FORMULA AND SPECIFICATIONS

    


    Prior
      to
      the commencement of commercial manufacturing of Product under this Agreement
      New
      River shall provide Patheon with originally executed copies of the FDA approved
      Specifications. If the Specifications provided are subsequently amended, then
      New River shall provide Patheon with revised and originally executed copies
      of
      such revised Specifications. Upon acceptance of the revised Specifications,
      Patheon shall provide New River with a signed and dated receipt evidencing
      such
      acceptance of the revised Specifications by Patheon.


    
      
        
        

      

      
        34

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    SCHEDULE
      B

    


    RUN
      QUANTITY, ANNUAL VOLUME AND FEES

    

      
        	 	
                ·

              	
                Annual
                  Volume in all tables represents the sum total capsules for all
                  [***].

              


      

      


      
        	 	
                ·

              	
                This
                  proposal is based on an Annual Volume of [***]
                  capsules.

              


      

    

    
      

        
          	
                  [***]

                
	
                  V-Blender/

                  Batch
                    Size

                	
                  [***]

                	
                  [***]

                
	
                  Annual

                  Volume

                  (million
                    caps)

                	
                  [***]

                	
                  [***]

                
	
                  DEA
                    Schedule

                	
                  II

                	
                  III+

                	
                  II

                	
                  III+

                
	
                  Run
                    Quality

                  (batches)

                	
                  1

                	
                  2

                	
                  3

                	
                  1

                	
                  2

                	
                  3

                	
                  5

                	
                  1

                	
                  3

                	
                  2

                	
                  3

                	
                  5

                
	
                  Run
                    Quantity

                  (bottles)

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                
	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                
	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                
	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                
	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                
	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                
	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                


        

      

    

    [***]


    
      
        
        

      

      
        35

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

     

    
      
        	
                [***]

              
	
                V-Blender/

                Batch
                  Size

              	
                [***]

              	
                [***]

              
	
                Annual

                Volume

                (million
                  caps)

              	
                [***]

              	
                [***]

              
	
                DEA
                  Schedule

              	
                II

              	
                III+

              	
                II

              	
                III+

              
	
                Run
                  Quality

                (batches)

              	
                1

              	
                2

              	
                3

              	
                1

              	
                2

              	
                3

              	
                5

              	
                1

              	
                3

              	
                2

              	
                3

              	
                5

              
	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              	
                [***]

              


      

    

    


    [***].


    
      
        
        

      

      
        36

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    
      

        
          	
                  [***]

                
	
                  V-Blender/

                  Batch
                    Size

                	
                  [***]

                	
                  [***]

                
	
                  Annual

                  Volume

                  (million
                    caps)

                	
                  [***]

                	
                  [***]

                
	
                  DEA
                    Schedule

                	
                  II

                	
                  III+

                	
                  II

                	
                  III+

                
	
                  Run
                    Quality

                  (batches)

                	
                  1

                	
                  2

                	
                  3

                	
                  1

                	
                  2

                	
                  3

                	
                  5

                	
                  1

                	
                  3

                	
                  2

                	
                  3

                	
                  5

                
	
                  Run
                    Quantity

                  (bottles)

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                
	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                
	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                
	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                
	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                
	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                
	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                	
                  [***]

                


        

      

    

    


    [***]


    
      
        
        

      

      
        37

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    Manufacturing
      Assumptions

    


    
      	 	
              1.

            	
              The
                manufacturing process at Patheon will closely follow the process
                information provided by NRP and year-to-date experience with this
                product
                at the site.

            


    

    


    
      	 	
              2.

            	
              [***].

            


    

    


    
      	 	
              3.

            	
              Final
                blending of granulation will utilize the [***], for the [***],
                respectively.

            


    

    


    
      	 	
              4.

            	
              The
                [***] and [***] will also used in
                processing.

            


    

    


    
      	 	
              5.

            	
              Encapsulation
                will be run using an [***].

            


    

    


    
      	 	
              6.

            	
              Capsules
                for all strengths are size #3, at the following target fill
                weights:

            


    

    


    
      	 	
              •

            	
              [***]

            


    

    


    
      	 	
              •

            	
              [***]

            


    

    


    
      	 	
              •

            	
              [***]

            


    

    


    
      	 	
              7.

            	
              Depending
                on the total capsule volume mix at the time, a second encapsulator
                will be
                required for the higher volume tiers. Another GKF 1500 encapsulator
                is
                available, but needs to be rebuilt. In addition, a new booth will
                be
                required to house this second
                machine.

            


    

    


    
      	 	
              8.

            	
              It
                is assumed that capsule checkweighing is not required. If NRP requires
                capsules to be checkweighed then evaluation on labor input and yield
                assumptions will be necessary.

            


    

    


    
      	 	
              9.

            	
              Batch
                sizes and various campaign runs are proposed against each volume
                tier and
                DEA Schedule options, in the Pricing Tables. It is assumed that each
                campaign can be a composite of different strengths, and can be sequenced
                to minimize additional cleanup.

            


    

    


    
      	 	
              10.

            	
              [***]
                to be required on all processing steps, if the product is a DEA Schedule
                II drug.

            


    

    


    Packaging
      Assumptions

    


    
      	 	
              1.

            	
              The
                packaging equipment train for bottles of [***] will consist of the
                following equipment:

            


    

    


    
      	 	
              •
                

            	
              [***]

            


    

    


    
      	 	
              •

            	
              [***]

            


    

    


    
      	 	
              •
                

            	
              [***]

            


    


    
      
        
        

      

      
        38

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              •
                

            	
              [***]

            


    

    


    
      	 	
              •
                

            	
              [***]

            


    

    


    
      	 	
              •

            	
              [***]

            


    

    


    
      	 	
              •

            	
              [***]

            


    

    


    
      	 	
              •

            	
              [***]

            


    

    


    
      	 	
              2.

            	
              No
                carton is assumed.

            


    

    


    
      	 	
              3.

            	
              An
                outsert will be applied to each
                bottle.

            


    

    


    
      	 	
              4.

            	
              The
                same bottle and cap will be used for all
                strengths.

            


    

    


    
      	 	
              5.

            	
              [***]
                will be placed into each shipper.

            


    

    


    
      	 	
              6.

            	
              As
                per request, a bulk price option is also presented. Bulk capsules
                will be
                packed into lined and sealed fiber drums ([***]), in quantity of
                about
                [***] capsules each.

            


    

    


    Testing
      Assumptions

    


    
      	 	
              1.

            	
              Raw
                material and finished product testing are based on available
                specifications and Patheon’s best
                estimates.

            


    

    


    
      	 	
              2.

            	
              Standard
                product testing such as identity, assay, content uniformity, related
                substances is assumed.

            


    

    


    
      	 	
              3.

            	
              It
                  is assumed that [***].

            


    

    


    
      	 	
              4.

            	
              Testing
                labor may be subject to change after the final agreement on testing
                specifications and requirements.

            


    

    


    General
      Assumptions, Terms and Conditions

    


    Pricing
      for various campaign runs as listed are provided. However, at the beginning
      of
      each year, the batch size and campaign size selected for the year will be agreed
      upon by both parties, based on forecast.


    
      
        
        

      

      
        39

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    SCHEDULE
      C

    


    STABILITY
      TESTING

    


    Patheon
      and New River shall agree in writing on any stability testing to be performed
      by
      Patheon in connection with the Products. Such agreement shall specify the
      commercial and Product stability protocols applicable to the stability testing
      and the fees payable by New River in connection with such
      testing.


    
      
        
        

      

      
        40

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    SCHEDULE
      D

    


    ACTIVE
      MATERIALS

     

    
      	
              Active
                Materials

            	
              Supplier

            
	
              [***]

            	
              Approved contract
                manufacturers as outlined in the NDA submitted by
                [***]

            


    

     

    ACTIVE
      MATERIALS CREDIT VALUE

    


    For
      the
      purposes of the Agreement, the parties agree that the Active Materials Credit
      Value shall be as follows:

     

    
      	
              Product

               

            	
              Active
                Materials

               

            	
              Active
                Materials Credit Value

               

            
	
              [***]

            	
              [***]

            	
              The
                actual cost to New River of Active Materials
                [***]

            


    

     

    MAXIMUM
      CREDIT VALUE

    


    Patheon’s
      liability for Active Materials calculated in accordance with Section 2.4 of
      the
      Agreement for any Product in a Year shall not exceed, in the aggregate, the
      maximum credit value set forth below:

     

    
      	
              Product

            	
              Maximum
                Credit Value

            
	
              [***]

            	
              (a)
                [***];

               

              (b)
                [***];

               

              (c)
                [***]

            


    

     

    
      
        
        

      

      
        41

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    SCHEDULE
      E

    


    BATCH
      NUMBERING AND EXPIRATION DATES

    


    Each
      batch of the Product manufactured by Patheon will bear a unique batch number
      using the Patheon batch numbering system. This number will appear on all
      documents relating to the particular batch of Product.

    


    Patheon
      will calculate the expiration date for the product for each batch by adding
      the
      expiration period of the Product supplied by New River to the date of
      Manufacture of each batch.


    
      
        
        

      

      
        42

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    SCHEDULE
      F

    


    TECHNICAL
      DISPUTE RESOLUTION

    


    Technical
      Disputes which cannot be resolved by negotiation as provided in Section 12.2
      shall be resolved in the following manner:

    


    1.     Appointment
      of Expert.
      [***]
      after a party requests pursuant to Section 12.2 that an expert be appointed
      to
      resolve a Technical Dispute, the parties shall jointly appoint a mutually
      acceptable expert with experience and expertise in the subject matter of the
      dispute. If the parties are unable to so agree within such [***], or in the
      event of disclosure of a conflict by an expert pursuant to paragraph 2 hereof
      which results in the parties not confirming the appointment of such expert,
      then
      an expert (willing to act in that capacity hereunder) shall be appointed by
      an
      experienced arbitrator on the roster of the American Arbitration
      Association.

    


    2.     Conflicts
      of Interest.
      Any
      person appointed as an expert shall be entitled to act and continue to act
      as
      such, notwithstanding that at the time of his appointment or at any time before
      he gives his determination, he has or may have some interest or duty which
      conflicts or may conflict with his appointment, provided that before accepting
      such appointment (or as soon as practicable after he becomes aware of the
      conflict or potential conflict) he fully discloses any such interest or duty
      and
      the parties shall after such disclosure have confirmed his
      appointment.

    


    
      	 	
              3.

            	
              Procedure.
                Where an expert is appointed:

            


    

    


    
      	 	
              (a)

            	
              Timing
                The expert shall be so appointed on condition that (i) he promptly
                fixes a
                reasonable time and place for receiving representations, submissions
                or
                information from the parties and that he issues such authorizations
                to the
                parties and any relevant third party for the proper conduct of his
                determination and any hearing and (ii) he renders his decision (with
                full
                reasons) [***] (or such other date as the parties and the expert
                may
                agree) after receipt of all information requested by him pursuant
                to
                paragraph 3(b) hereof.

            


    

    


    
      	 	
              (b)

            	
              Disclosure
                of Evidence The parties undertake one to the other to provide to
                any
                expert all such evidence and information within theft respective
                possession or control as the expert may reasonably consider necessary
                for
                determining the matter before him which they shall disclose promptly
                and
                in any event [***] of a written request from the relevant expert
                to do
                so.

            


    

    


    
      	 	
              (c)

            	
              Advisors
                Each party may appoint such counsel, consultants and advisors as
                it feels
                appropriate to assist the expert in his determination and so as to
                present
                theft respective cases so that at all times the parties shall co-operate
                and seek to narrow and limit the issues to be
                determined.

            


    

    


    
      	 	
              (d)

            	
              Appointment
                of New Expert.
                If
                within the time specified in paragraph 3(a) above the expert shall
                not have rendered a decision in accordance with his appointment,
                a new
                expert may (at the request of either party) be appointed and the
                appointment of the existing expert shall thereupon cease for the
                purposes
                of determining the matter at issue between the parties save that
                if the
                existing expert renders his decision with 11111 reasons prior to
                the
                appointment of the new expert, then such a decision shall have effect
                and
                the proposed appointment of the new expert shall be
                withdrawn.

            


    


    
      
        
        

      

      
        43

        
          

        

      

      
        
        

      

    


    
      	 	
              (e)

            	
              Final
                and Binding The determination of the expert shall, save in the event
                of
                fraud or manifest error, be final and binding upon the
                parties.

            


    

    


    
      	 	
              (f)

            	
              Costs
                Each party shall bear its own costs in connection with any matter
                referred
                to an expert hereunder and, in the absence of express provision in
                the
                Agreement to the contrary, the costs and expenses of the expert shall
                be
                shared equally by the parties.

            


    

    


    For
      greater certainty, the parties agree that the release of the Products for sale
      or distribution pursuant to the applicable marketing approval for such Products
      shall not by itself indicate compliance by Patheon with its obligations in
      respect of the Manufacturing Services and further that nothing in this Agreement
      (including this Schedule F) shall remove or limit the authority of the relevant
      qualified person (as specified by the Quality Agreement) to determine whether
      the Products are to be released for sale or distribution.


    
      
        
        

      

      
        44

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    SCHEDULE
      G

    


    QUALITY
      AGREEMENT


    
      
        
        

      

      
        45

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    QUALITY
      AGREEMENT

    


    BETWEEN

    


    NEW
      R PHARMACEUTICALS INC

    


    AND

    


    PATHEON
      PHARMACEUTICALS INC


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    Table
      of Contents

    


    QUALITY
      AGREEMENT

     

    
      	
              1.

            	
              PARTIES

            	
              5

            
	 	 	 	 
	
              2.

            	
              QUALITY
                AGREEMENT

            	
              5

            
	 	 	 	 
	
              3.

            	
              ADMINISTRATIVE
                INFORMATION

            	
              5

            
	 	 	 	 
	
              4.

            	
              PRODUCTS

            	
              5

            
	 	 	 	 
	
              5.

            	
              DURATION
                OP AGREEMENT

            	
              5

            
	 	 	 	 
	
              6.

            	
              CONFIDENTIALITY

            	
              6

            
	 	 	 	 
	
              7.

            	
              SECURITY

            	
              6

            
	 	 	 	 
	
              8.

            	
              SUPPLY

            	
              6

            
	 	 	 	 
	 	
              8.1.

            	
              Premises

            	
              6

            
	 	 	 	 
	 	
              8.2.

            	
              Product
                Specification and Master Production Records

            	
              6

            
	 	 	 	 
	 	
              8.3.

            	
              GMP
                Guidelines

            	
              7

            
	 	 	 	 
	 	
              8.4.

            	
              Materials

            	
              7

            
	 	 	 	 
	 	
              8.5.

            	
              Master
                Production Record Approval

            	
              8

            
	 	 	 	 
	 	
              8.6.

            	
              Production

            	
              8

            
	 	 	 	 
	 	
              8.7.

            	
              Methodology

            	
              8

            
	 	 	 	 
	 	
              8.8.

            	
              Standard
                Operating Procedures

            	
              8

            
	 	 	 	 
	 	
              8.9.

            	
              Dates
                of Manufacture and Expiration

            	
              8

            
	 	 	 	 
	 	
              8.10.

            	
              Manufacturing
                and Equipment Data

            	
              9

            
	 	 	 	 
	
              9.

            	
              QUALITY
                ASSURANCE AND CONTROL

            	
              9

            
	 	 	 	 
	 	
              9.1.

            	
              Laboratory
                Control of Materials

            	
              9

            
	 	 	 	 
	 	
              9.2.

            	
              In-Process
                and Finished Product Testing

            	
              9

            
	 	 	 	 
	 	
              9.3.

            	
              Release
                Procedures

            	
              10

            
	 	 	 	 
	 	
              9.4.

            	
              Documentation

            	
              10

            


    

     

    
      
        
        

      

      
        2

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

     

    
      	 	
              9.5.

            	
              Retain
                Sampling

            	
              11

            
	 	 	 	 
	 	
              9.6.

            	
              Stability

            	
              11

            
	 	 	 	 
	 	
              9.7.

            	
              Deviations
                and Investigations

            	
              12

            
	 	 	 	 
	 	
              9.8.

            	
              Rejection
                of Product

            	
              13

            
	 	 	 	 
	 	
              9.9.

            	
              Dispute
                Resolution

            	
              13

            
	 	 	 	 
	 	
              9.10.

            	
              Regulatory
                Inspections

            	
              13

            
	 	 	 	 
	 	
              9.11.

            	
              Regulatory
                Actions at New River

            	
              14

            
	 	 	 	 
	 	
              9.12.

            	
              Regulatory
                Investigations

            	
              14

            
	 	 	 	 
	 	
              9.13.

            	
              Manufacturing
                Audits (MA)

            	
              14

            
	 	 	 	 
	 	
              9.14.

            	
              Correspondence:

            	
              15

            
	 	 	 	 
	 	
              9.15.

            	
              Product
                Complaints

            	
              16

            
	 	 	 	 
	 	
              9.16.

            	
              Product
                Recalls

            	
              16

            
	 	 	 	 
	 	
              9.17.

            	
              Compliance
                Deficiencies

            	
              16

            
	 	 	 	 
	 	
              9.18.

            	
              NDA
                Field Alerts

            	
              16

            
	 	 	 	 
	
              10.

            	
              CHANGE
                MANAGEMENT

            	
              16

            
	 	 	 	 
	
              11.

            	
              PRODUCT
                AND PROCESS VALIDATION

            	
              17

            
	 	 	 	 
	 	
              11.1.

            	
              Process

            	
              17

            
	 	 	 	 
	 	
              11.2.

            	
              Cleaning
                Validation

            	
              17

            
	 	 	 	 
	 	
              11.3.

            	
              Equipment,
                Computer, Facility, and Utilities Qualification

            	
              18

            
	 	 	 	 
	 	
              11.4.

            	
              Laboratory
                Qualifications

            	
              18

            
	 	 	 	 
	
              12.

            	
              ANNUAL
                PRODUCT REVIEW, DRUG LISTING, AND ANNUAL REPORTS

            	
              18

            
	 	 	 	 
	 	
              12.1.

            	
              Annual
                Product Review

            	
              18

            
	 	 	 	 
	 	
              12.2.

            	
              Drug
                Listing

            	
              19

            
	 	 	 	 
	 	
              12.3.

            	
              Annual
                Reports, IND Updates or Other Regulatory Filings

            	
              19

            
	 	 	 	 
	
              13.

            	
              STORAGE
                AND SHIPPING

            	
              19

            


    

     

    
      
        
        

      

      
        3

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

     

    
      	 	
              13.1.

            	
              Storage

            	
              19

            
	 	 	 	 
	 	
              13.2.

            	
              Packing
                and Labeling for Transit

            	
              19

            
	 	 	 	 
	 	
              13.3.

            	
              Mixing
                of Product

            	
              19

            
	 	 	 	 
	 	
              13.4.

            	
              Shipment
                of Product to New River

            	
              20

            
	 	 	 	 
	
              14.

            	
              CONTRACTUAL
                AGREEMENT

            	
              20

            


    

    

      
        	
                APPENDIX
                  I

              	
                -

              	
                RESPONSIBILITIES
                  MATRIX

              


      

      
        	
                APPENDIX
                  II

              	
                -

              	
                DEFINITIONS

              


      

      
        	
                APPENDIX
                  III

              	
                -

              	
                LIST
                  OF CONTACTS

              


      

      
        	
                APPENDIX
                  IV

              	
                -

              	
                BATCH
                  DOCUMENT AUDIT SCHEDULE

              


      

      
        	
                APPENDIX
                  V

              	
                -

              	
                LIST
                  OF PRODUCTS

              


      

      
        	
                APPENDIX
                  VI

              	
                -

              	
                RELEASE
                  DOCUMENTATION

              


      

      
        	
                APPENDIX
                  VII

              	
                -

              	
                NEW
                  RIVER APPROVED SUPPLIER LIST

              


      

      
        	
                APPENDIX
                  VIII

              	
                -

              	
                PATHEON
                  APPROVED SUPPLIER LIST

              


      

    

     

    
      
        
        

      

      
        4

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	
              1.

            	
              PARTIES

            


    

    


    This
      Quality Agreement is effective as of __________, 2006, by and between New River
      Pharmaceuticals Inc., a Virginia Corporation having it’s corporate offices at
      1881 Grove Avenue, Radford Virginia 24141 (hereinafter referred to as “New
      River”) and Patheon Pharmaceuticals Inc., a Delaware Corporation having a place
      of business at 2110 East Galbraith Road, Cincinnati, Ohio 45237 (hereinafter
      referred to as “Patheon”).

    


    
      	
              2.

            	
              QUALITY
                AGREEMENT

            


    

    


    This
      agreement defines the roles and responsibilities of Patheon for services or
      materials supplied to New River or affiliates, for commercial distribution
      or
      clinical trial use to ensure compliance with applicable cGMPs. This agreement
      is
      supplemental to and constitutes a part of the Manufacturing Agreement entered
      into between New River and Patheon on the same date as noted in Section 1 above
      (the “Manufacturing Agreement”). The provisions of this Agreement are intended
      to be supplemental to and not in derogation from the terms of the Manufacturing
      Agreement and provisions contained herein shall be treated as supplemental
      to
      the Manufacturing Agreement and in particular but without limitation in relation
      to the application,, compliance, verification and implementation of cGMP. To
      the
      extent any terms set forth in this Agreement conflict with the terms of the
      Manufacturing Agreement, the tents of the Manufacturing Agreement shall control
      unless otherwise specified in this Agreement. A responsibilities matrix can
      be
      found in Appendix I it is intended to support the terms of this agreement.
      The
      terms of this agreement take jurisdiction over the information in the
      responsibilities matrix should a conflict be noted. Capitalized terms used
      in
      this Agreement shall have the same meaning as set forth in the Manufacturing
      Agreement, unless defined in Appendix II or otherwise defined
      herein.

    


    
      	
              3.

            	
              ADMINISTRATIVE
                INFORMATION

            


    

    


    Contact
      names will be provided from both sites for key functional areas. Contact names
      are provided in Appendix III and may be updated as needed upon written notice
      of
      a Party.

    


    
      	
              4.

            	
              PRODUCTS

            


    

    


    A
      product
      list is provided in Appendix V and may be updated as needed and authorized
      by
      both parties. In this Agreement, all products in the Appendix will be referred
      to as “Products”.

    


    
      	
              5.

            	
              DURATION
                OP AGREEMENT

            


    

    


    This
      Agreement shall commence on execution by both Parties and subject to the
      following provisions of this clause shall expire or terminate on the expiry
      or
      termination of the Manufacturing Agreement. Any section of this Agreement which
      has a predefined retention, survival or maintenance period, for example raw
      data
      storage, product complaints and sample retention, shall survive the termination
      of this Agreement upon termination of the Manufacturing Agreement for the period
      defined in the appropriate section. This Agreement cannot be modified except
      with the written approval of both Parties. Specifications and Master Batch
      Records may be modified with written authorization font designated Quality
      Assurance representatives of both companies.


    
      
        
        

      

      
        5

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	
              6.

            	
              CONFIDENTIALITY

            


    

    


    Confidential
      Information shall be governed by the terms of the applicable Manufacturing
      Agreement. Both Parties will treat as confidential all data supplied by the
      other in connection with the manufacture of the Products.

    


    
      	
              7.

            	
              SECURITY

            


    

    


    Patheon
      has and will maintain controlled access to the Plant through a security card
      key
      or similar system. All visitors will be required by Patheon to sign-in and
      be
      escorted during any site visit. All Third Party visitors will be required to
      enter into a confidentiality agreement prior to entering areas being used to
      manufacture the New River Products.

    


    
      	
              8.

            	
              SUPPLY

            


    

    


    
      	 	
              8.1

            	
              Premises

            


    

    


    
      	 	
              8.1.1

            	
              Patheon
                will manufacture, package, and/or test the Products at the Plant
                and will
                not use or transfer at a later date any of the manufacturing, packaging
                or
                testing operations for the Product(s) to Third Parties or other sites
                without the prior written agreement of New
                River.

            


    

    


    
      	 	
              8.1.2

            	
              Patheon
                will ensure at all times that the premises and equipment comprising
                the
                Plant used to manufacture/supply the Products comply at all times
                with
                current regulatory requirements and are in accordance with the
                documentation approved by New
                River.

            


    

    


    
      	 	
              8.2

            	
              Product
                Specification and Master Production
                Records

            


    

    


    
      	 	
              8.2.1

            	
              Patheon
                will manufacture, package, and test the Product(s) in accordance
                with the
                most recent version of the Specifications and Master Batch Record
                (formula, in-process and release specs, methods, shelf life, and
                regulatory requirements) as supplied or approved by New River. All
                such
                documentation must be approved by New River (see section
                11).

            


    

    


    
      	 	
              8.2.2

            	
              New
                River will select the API supplier - quality assurance and purchasing
                evaluations, which verify compliance by the supply company with cGMP
                and
                Specifications. Patheon will select approved excipient suppliers
                according
                to Patheon Procedures and SOPs, which verify compliance by the supply
                company with cGMP and Specifications. New River must approve suppliers.
                When suppliers are identified in the NDA or compendial documentation,
                Patheon will be limited to those suppliers. Any change from these
                suppliers must be first approved through New River’s change control
                system.

            


    


    
      
        
        

      

      
        6

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              8.2.2.1

            	
              Raw
                Material Specification

            


    

    


    Patheon
      will obtain excipient from approved suppliers as defined in the appropriate
      Regulatory documentation. Patheon will test Raw Materials to the full
      Specification unless a supplier Certificate of Analysis (“COA”) is available
      from a certified supplier, in which case, complete testing may not be required
      upon mutual agreement and written approval by both Patheon and New
      River.

    


    
      	 	
              8.2.2.2

            	
              Label
                Component Specifications

            


    

    


    Patheon
      will use only labels and labeling approved in compliance with Specifications
      provided or approved by New River.

    


    
      	 	
              8.2.2.3

            	
              Packaging
                Component Specifications

            


    

    


    Patheon
      will obtain primary packaging components from approved suppliers as defined
      in
      the appropriate Regulatory documentation and test packaging components to the
      full Specification unless a validated supplier COA is available from a certified
      supplier. If a COA is available complete testing may not be necessary upon
      written approval by New River. Packaging Specifications must be provided or
      approved by New River.

    


    
      	 	
              8.3

            	
              GMP
                Guidelines

            


    

    


    Any
      applicable product license or pharmacopoeia or formulatory requirements
      applicable to the manufacture of Product(s) shall be complied with in addition
      to cGMP and Specifications.

    


    
      	 	
              8.4

            	
              Materials

            


    

    


    
      	 	
              8.4.1

            	
              Materials
                Procured by Patheon

            


    

    


    Patheon
      is responsible for ensuring that all Raw Materials procured for use in the
      Product(s) are in fill compliance with the Specifications in accordance with
      8.2. Raw Materials shall be given a recontrol date upon the satisfactory
      completion of all-initial testing. Recontrol testing will be performed at
      defined time intervals to ensure the chemical and physical stability of the
      Raw
      Materials. New River may audit any Patheon program that allows retesting or
      recontrol of Raw Materials.


    
      
        
        

      

      
        7

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              8.4.2

            	
              Materials
                Provided by New River

            


    

    


    Active
      Materials provided by New River require acceptance testing by Patheon to confirm
      that the Active Materials are in full compliance with the Specifications.
      Patheon is responsible for ensuring that all Active Materials are used
      correctly, have the correct identity by testing identity on receipt, and have
      met the relevant analytical testing requirements for the Batch.

    


    
      	 	
              8.5

            	
              Master
                Production Record Approval

            


    

    


    Patheon
      may transcribe the information (i.e. formulation, filling work order, packaging
      work order) into its own format and must obtain written approval from New River
      US Corporate Quality Assurance for each document version before
      Manufacturing.

    


    
      	 	
              8.6

            	
              Production

            


    

    


    The
      Products will be Manufactured in accordance with the manufacturing and packaging
      procedures set forth in the Specifications and Master Batch Records and
      additional internal Patheon site procedures. Such procedures must be made
      available for scrutiny during audits by authorized personnel of New
      River.

    


    
      	 	
              8.7

            	
              Methodology

            


    

    


    Patheon
      will test Raw Materials and Products using the approved methodology listed
      in
      the appropriate Specification.

    


    
      	 	
              8.8

            	
              Standard
                Operating Procedures

            


    

    


    Patheon
      is responsible for maintaining any Standard Operating Procedures (SOPs) required
      to make the Product in accordance with cGMPs and as described in the NDA or
      compendial documentation as well as any other regulatory
      requirements.

    


    
      	 	
              8.9

            	
              Dates
                of Manufacture and Expiration

            


    

    


    
      	 	
              8.9.1

            	
              Date
                of Manufacture

            


    

    


    Patheon
      will determine the date of manufacture based on site SOPs that identify the
      date
      as the date that the Active Material is mixed or added to the batch
      materials.

    


    
      	 	
              8.9.2

            	
              Expiration
                Date

            


    

    


    New
      River
      will provide the appropriate approved expiry period so Patheon can calculate
      expiration dates for Batches to be manufactured.


    
      
        
        

      

      
        8

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              8.10

            	
              Manufacturing
                and Equipment Data

            


    

    


    Patheon
      is responsible for safe keeping and retention of records of machine usage
      (previous product produced in non-dedicated machinery), cleaning, any
      maintenance(calibration performed, Raw Material batch numbers and certification,
      in-process results and parameters, and test results in accordance with and
      shall
      perform all functions in accordance with legal and regulatory requirements
      and
      all Applicable Laws.

    


    
      	
              9.

            	
              QUALITY
                ASSURANCE AND CONTROL

            


    

    


    
      	 	
              9.1

            	
              Laboratory
                Control of Materials

            


    

    


    
      	 	
              9.1.1

            	
              Any
                Specifications, sampling plans, and test procedures, including changes
                to
                these, should be drafted by Patheon and reviewed and approved by
                New
                River.

            


    

    


    
      	 	
              9.1.2

            	
              Quality
                control of Raw Materials supplied by Patheon or by suppliers to Patheon
                will be undertaken by Patheon in accordance with the Specifications
                and
                methods approved by New River.

            


    

    


    
      	 	
              9.1.2.1

            	
              Patheon
                is responsible for investigating any laboratory out of specification
                (005)
                results per Patheon’s internal procedures. Each 005 investigation must be
                reviewed and approved by Patheon’s designated quality assurance person and
                must evaluate if the failure has jeopardized the safety, efficacy
                or
                quality of the Product.

            


    

    


    
      	 	
              9.1.2.2

            	
              New
                River must be notified [***] of the start of a significant “un-planned”
                batch or testing deviation. Patheon will forward the completed package
                upon conclusion of the
                investigation.

            


    

    


    
      	 	
              9.1.3

            	
              New
                River must be notified in writing prior to the testing or processing
                of a
                “planned” batch or testing deviation. Approval of such planned deviation
                must be given by New River. Patheon will forward the completed package
                upon conclusion of the
                investigation.

            


    

    


    
      	 	
              9.1.4

            	
              Any
                reference standards that are supplied by New River or New River’s
                Affiliates must be accompanied by a COA listing the expiration date
                and
                any correction factors that need to be
                applied.

            


    

    


    
      	 	
              9.2

            	
              In-Process
                and Finished Product Testing

            


    

    


    
      	 	
              9.2.1

            	
              Raw
                Materials and packaging components

            


    

     

    Patheon
      will ensure that all materials used are in compliance with the compendial and/or
      approved Methods and Specifications.


    
      
        
        

      

      
        9

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              9.2.2

            	
              Patheon
                will perform all in-process and finished Product testing using the
                Specifications, and Methods of analysis listed in the release
                documentation list provided and approved by New River’s Quality Assurance
                and other applicable licenses.

            


    

    


    
      	 	
              9.3

            	
              Release
                Procedures

            


    

    


    
      	 	
              9.3.1

            	
              Product

            


    

    


    Patheon
      is responsible for ensuring and certifying that the Product has been made
      according to cGMPs, the Specifications and procedures documented in the Master
      Batch Record. This includes a complete and thorough review of the executed
      batch
      records. Executed batch records will be requested by New River for periodic
      review independent of batch investigations conducted for batch or testing
      difficulties. The planned frequency of New River full review of batch records
      will be outlined in Appendix IV. Patheon will supply requested documents within
      5 days of completion of batch manufacturing and/or packaging and closure of
      all
      related deviations.

    


    
      	 	
              9.3.2

            	
              Certificate
                of Compliance/Analysis

            


    

    


    Prior
      to
      release, a Patheon Quality Assurance Representative will sign a Certificate
      of
      Compliance/Analysis confirming that the Product has been Manufactured, packaged
      and tested in. accordance with cGMP and Applicable Laws and meets the
      requirements of the Master Batch Record and Specifications. These documents
      will
      also include the packaging lot numbers, associated batch expiry dates, and
      quantifies in each shipment. The specific lot number will be the lot number
      identified on the executed batch record for the finished product being released.
      Routine release documentation is identified in Appendix VI.

    


    
      	 	
              9.3.3

            	
              New
                River Receipts

            


    

    


    Release
      of Products to the market or for use in clinical studies will be undertaken
      by
      New River based on New River’s internal procedures and the documentation
      provided by Patheon. Patheon may not release Product to market.

    


    
      	 	
              9.3.4

            	
              New
                River Confirmatory Testing

            


    

    


    New
      River
      or its affiliates may perform confirmatory testing to validate Patheon’s
      data.

    


    
      	 	
              9.4

            	
              Documentation

            


    

    


    
      	 	
              9.4.1

            	
              Requests
                for Full Documentation

            


    


    
      
        
        

      

      
        10

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    Patheon
      agrees to supply New River or its Affiliates with any completed Manufacturing,
      packaging, testing, or stability data [***] of request.

    


    
      	 	
              9.4.2

            	
              Patheon
                will retain, at minimum, batch production records, quality control
                testing
                records, all records of shipments of the Product from Patheon, all
                validation data and other documentation relating to the Product for
                the
                time periods required by Applicable Laws with respect to the Product
                according to Patheon site
                procedures.

            


    

    


    
      	 	
              9.4.2.1

            	
              Patheon
                shall make such records and data available for review by New River
                at
                Patheon’s Plant upon [***] prior written notice from New River to Patheon
                and at a time mutually agreeable to both New River and
                Patheon.

            


    

    


    
      	 	
              9.4.3

            	
              Patheon
                shall, upon New River’s request, supply to New River a copy of its
                document retention policy. Upon termination or expiration of this
                Agreement or prior to destruction of any records, whichever occurs
                first,
                Patheon will upon New River’s written request and at New River’s expense,
                make copies of such records and data for New
                River.

            


    

    


    
      	 	
              9.5

            	
              Retain
                Sampling

            


    

    


    
      	 	
              9.5.1

            	
              Retain
                Samples - Raw Materials

            


    

    


    Patheon
      will retain samples of Active Materials for at least one year beyond the expiry
      period of the Products in which such Active Materials were used. The amount
      of
      sample retained will be [***] required to carry out all of the tests required
      to
      determine if the material meets its Specifications.

    


    
      	 	
              9.5.2

            	
              Retain
                Samples - Products

            


    

    


    Patheon
      will retain samples of the Products for at least one year beyond the expiry
      period. The amount of sample retained will be [***] required to early out all
      of
      the tests required to determine if the material meets its
      Specifications.

    


    
      	 	
              9.6

            	
              Stability

            


    

    


    
      	 	
              9.6.1

            	
              Routine/Commercial
                Stability Program

            


    

    


    
      	 	
              9.6.1.1

            	
              Patheon
                is responsible for maintaining a routine stability testing program
                for the
                Products, and it will be performed per Patheon site SOPs. Patheon
                will
                provide stability data [***] to New River or more frequently if requested
                by New River.

            


    

    


    
      	 	
              9.6.1.2

            	
              The
                stability program will be in compliance with any license commitments
                as
                notified by New River. At a minimum one lot of each product, of each
                strength and in each package type (largest to smallest) will be placed
                on
                stability each year unless otherwise agreed to in writing by Patheon
                and
                New River. The stability program must comply with ICH and FDA guidelines.
                The stability protocol or any changes must be approved by New
                River.

            


    


    
      
        
        

      

      
        11

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              9.6.2

            	
              Development
                (Clinical, Registration, R&D) Stability
                Program

            


    

    


    Patheon
      will be responsible for performing any development stability required to support
      the Products. If that development stability is to support projects initiated
      by
      Patheon, then Patheon will develop, execute and write reports for the program.
      All protocols for and reports from such work must be approved by New
      River.

    


    
      	 	
              9.6.3

            	
              Stability
                Failures

            


    

    


    Any
      confirmed problems or out of specification (OOS) results which arise as a result
      of or during any of the stability programs will be communicated by Patheon
      to
      New River [***].

    


    
      	 	
              9.6.4

            	
              Patheon
                will supply New River’s Quality Assurance department with completed
                stability results [***] of receiving a written
                request.

            


    

    


    
      	 	
              9.7

            	
              Deviations
                and Investigations

            


    

    


    
      	 	
              9.7.1

            	
              Deviations

            


    

    


    Any
      deviation from the process during Manufacture must be fully investigated
      according to Patheon’s procedures and will be carefully explained and documented
      in the batch records, justified and approved by Patheon’s Quality Assurance
      Department, and included in the documentation package.

    


    
      	 	
              9.7.1.1

            	
              Any
                significant “un-planned” process deviations that may impact the quality,
                compliance or regulatory status of a batch will be forwarded to New
                River
                via notification [***] from the discovery of the
                occurrence.

            


    

    


    
      	 	
              9.7.1.2

            	
              Any
                “planned” process deviation will be presented for approval to New River
                Quality Assurance before proceeding with
                processing.

            


    

    


    NOTE:
      A
“deviation” is defined, for purposes of this Section 9.7, as any anomalous event
      that may occur during the processing of a Batch that is a departure from filed
      specifications, approved procedures or validated processes. Planned deviations
      are considered those that occur before a process step is executed and when
      a
      batch can be interrupted to consider the ramifications of the proposed process
      or batch instruction deviation.


    
      
        
        

      

      
        12

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    All
      deviations will be provided to New River in a list format with the batch release
      documentation as outline in Appendix VI.

    


    
      	 	
              9.7.2

            	
              Failure
                Investigations and Out Of Specification (OOS)
                Results

            


    

    


    Patheon
      is responsible for fully investigating any test result or in-process test that
      fails to meet Specification per their internal procedures. Each investigation
      will be reviewed and approved by Patheon’s designated Quality Assurance person.
      The investigation must evaluate if the failure has jeopardized the safety,
      efficacy or quality of the product. New River must be notified [***] of the
      discovery of a confirmed 005 result.

    


    
      	 	
              9.7.3

            	
              Patheon
                will notify New River forthwith if any problems are discovered that
                may
                impact products batch(s) previously shipped to New River or its Affiliates
                identifying the Batches in
                question.

            


    

    


    
      	 	
              9.7.4

            	
              Some
                deviations/failures may require that additional testing, stability,
                or
                validation be conducted. This work will be performed by Patheon as
                agreed
                by both Parties.

            


    

    


    
      	 	
              9.8

            	
              Rejection
                of Product

            


    

    


    
      	 	
              9.8.1

            	
              Patheon
                will notify New River in writing of any Batch rejected by Patheon.
                This
                communication should be accompanied by a completed investigation
                with
                regard to the failure and include evaluation of effect of failure
                on other
                Batches.

            


    

    


    
      	 	
              9.8.2

            	
              New
                River or its affiliates will notify Patheon of any problems thought
                to be
                due to Manufacture or stability which are found during the distribution
                of
                the Product. When requested by New River, Patheon will promptly perform
                investigations for these problems. Investigation reports will be
                forwarded
                to New River as required.

            


    

    


    
      	 	
              9.9

            	
              Dispute
                Resolution

            


    

    


    In
      the
      event that a dispute arises between Patheon and New River or its Affiliates
      in
      the analysis of the Products, the resolution will proceed according to the
      procedures set forth in the Manufacturing Agreement.

    


    
      	 	
              9.10

            	
              Regulatory
                Inspections

            


    

    


    New
      River’s Director or designate of Quality
      Assurance will be notified within 1 business day of any inspections by FDA,
      DEA
      or similar foreign regulatory authorities regarding New River Products and
      Patheon will permit a representative from New River on-sit; if requested by
      New
      River.


    
      
        
        

      

      
        13

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    Patheon
      will notify New River [***] of receipt of any FDA Form 483 observations, warning
      letters or the like from regulatory agencies relating to: (i) the Product(s);
      (ii) the supply of Product(s) or (iii) the facilities used to produce, test
      or
      package the Product(s). New River will review and approve responses that relate
      to the Product(s) before submission to the regulatory agency. Patheon reserves
      the right to respond to such regulatory agencies without approval, if, in the
      reasonable opinion of Patheon’s counsel, it is required to do so.

    


    
      	 	
              9.11

            	
              Regulatory
                Actions at New River

            


    

    


    New
      River
      or its affiliates will notify Patheon of any regulatory actions on the Products
      that may impact Patheon. Additionally, New River will immediately forward any
      regulatory correspondence on the Products to Patheon.

    


    
      	 	
              9.12

            	
              Regulatory
                Investigations

            


    

    


    Patheon
      is responsible for supporting all Batch record investigations associated with
      regulatory actions. New River must be notified of any such events
      [***].

    


    
      	 	
              9.13

            	
              Manufacturing
                Audits (MA)

            


    

    


    
      	 	
              9.13.1

            	
              Annual
                MA: New River shall have the right to conduct one Manufacturing Audit
                (as
                defined in section 9.13.3) per year. (Such annual Manufacturing Audit
                to
                be hereinafter referred to as an “Annual
                MA”).

            


    

    


    
      	 	
              9.13.2

            	
              Event
                MA: In addition to the Annual MA, in the event that (i) Patheon receives
                483 Observations or a “Warning Letter” from the FDA or any foreign
                equivalent outside the USA relating to the Manufacture, packaging
                testing
                or labeling of the New River Product by Patheon, (ii) Patheon has
                received
                a DEA “Letter of Admonishment” or similar notice alleging non-compliance
                (iii) New River has rejected a Batch of Product where it has been
                agreed
                or determined that such Product failed to meet Specifications or
                cGMP or
                (iv) for circumstances where New River and Patheon reasonably believe
                and
                agree that significant quality and/or compliance issues exist or
                have been
                discovered, New River shall have the right to conduct additional
                Manufacturing Audits according to the terms specified in Section
                9.13.3
                below (such Event Manufacturing Audit or Audits to be hereinafter
                referred
                to as an “Event MA’).

            


    


    
      
        
        

      

      
        14

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              9.13.3

            	
              Manufacturing
                Audit: For purposes of this Agreement, the term “Manufacturing Audit”
                shall mean an audit of Patheon’s Plant for the Product by employees and/or
                agents of New River for purposes of reviewing Patheon’s procedures and
                processes used in manufacturing the New River Products. Any such
                agents
                shall be qualified to conduct manufacturing audits, shall comply
                with all
                Patheon’s facility rules regarding safety and security notified by Patheon
                to New River and its employees and agents and shall execute a written
                agreement to maintain in confidence all information obtained during
                the
                count of any such audit except for disclosure to New River subject
                to the
                terms hereof. Each Manufacturing Audit shall be conducted during
                Patheon’s
                normal business hours and [***] to Patheon in the case of an Annual
                MA, or
                with at least 3 working days notice to Patheon in the case of an
                Event MA.
                The dates of the audit will be mutually agreed upon by the Parties.
                In all
                cases New River shall ensure that its employees or agents will conduct
                each Manufacturing Audit so as not, insofar as is reasonably practicable
                to interfere with the normal and ordinary operation of Patheon’s Plant.
                During a Manufacturing Audit, upon New River’s request, Patheon shall make
                available for New River’s review and inspection all equipment and
                facilities used in or in relation to the Manufacture of a Product,
                records
                and support documents (i.e. manufacturing and analytical) with respect
                to
                each Batch of the Product and other Raw Materials and packaging components
                used in the Manufacture or packaging of the Product hereunder. At
                any such
                audit, New River shall have the right to obtain copies of such batch
                records with respect to New River product(s), provided however, that
                New
                River pays Patheon for its reasonable costs associated with making
                such
                copies. All costs of an Event MA shall be borne by New River unless
                the
                requirement for audit arises as a result of the negligence of Patheon
                or
                the breach of the terms of this Agreement or the Manufacturing Agreement
                by Patheon, in which case Patheon shall absorb all costs associated
                with
                the audit.

            


    

    


    
      	 	
              9.13.4

            	
              New
                River or its affiliates or representatives will be escorted at all
                times
                by Patheon personnel.

            


    

    


    
      	 	
              9.13.5

            	
              Audit
                Procedures

            


    

    


    
      	 	
              9.13.5.1

            	
              An
                exit meeting will be held with representatives from Patheon and New
                River
                to discuss significant audit
                observations.

            


    

    


    
      	 	
              9.13.5.2

            	
              New
                River will provide a written report of all observations [***] to
                Patheon.
                [***] of audit report receipt, Patheon will provide a written response
                to
                all findings that details corrective action to be implemented. Patheon
                will follow up to ensure that all corrective actions are implemented.
                New
                River may confirm follow-up action by performing a follow-up audit
                separate from the Annual MA

            


    

    


    
      	 	
              9.14

            	
              Correspondence:

            


    

    


    Each
      Party shall promptly notify the other Party of; and shall provide the other
      Party with copies of, any correspondence and other documentation received or
      prepared by the notifying Party in connection with any of the following
      events:

    


    
      	 	
              9.14.1

            	
              Receipt
                of a 483 Observation Letter or “Warning Letter” from the FDA or any other
                Regulatory Authority or any relevant foreign equivalent outside the
                USA in
                connection with the Manufacture, packaging, testing, storage or security
                of the Product;

            


    


    
      
        
        

      

      
        15

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              9.14.2

            	
              Any
                field alert, recall, market withdrawal or correction of any Batch
                of the
                Product; or

            


    

    


    
      	 	
              9.14.3

            	
              Any
                regulatory comments relating to the Manufacture of New River Product(s)
                requiring a response or action by the notifying
                Party.

            


    

    


    
      	 	
              9.15

            	
              Product
                Complaints

            


    

    


    New
      River
      or its affiliates shall maintain complaint files with respect to the Product(s)
      in accordance with cGMP’s. New River or its affiliates are responsible for
      receiving and initially investigating any complaints and will notify Patheon
      of
      any complaint that may impact the Product quality Patheon will investigate
      Product complaints supplied by New River and provide a report to New River
      promptly but [***] from receipt. The investigation shall be completed in
      accordance with all cGMP regulations and any other Applicable Laws. New River
      shall have responsibility for reporting all complaints relating to the Product
      to the FDA and any other Regulatory Authority including, but not limited to,
      complaints relating to the Manufacture of the Product as well as adverse thug
      experience (ADE) reports.

    


    
      	 	
              9.16

            	
              Product
                Recalls

            


    

    


    New
      River
      or its affiliates are responsible for instituting a product recall due to any
      defect considered sufficiently serious. New River will notify Patheon of any
      recall that may be due to Patheon. Patheon will work with New River and its
      affiliates to investigate the recall. Patheon will provide a rapid initial
      response and a full report [***].

    


    
      	 	
              9.17

            	
              Compliance
                Deficiencies

            


    

    


    Should
      Patheon become aware of any issues that could affect the quality, safety,
      identity or efficacy of any New River Product produced at their facility,
      Patheon will notify New River in writing [***].

    


    
      	 	
              9.18

            	
              NDA
                Field Alerts

            


    

    


    Patheon
      will notify New River (likewise, New River will notify Patheon) [***] of receipt
      of information meeting NDA Field Alert criteria as defined in 21 CFR
      314.81(b)(l). New River is responsible for initiating and submitting NDA Field
      Alert reports.

    


    
      	
              10.

            	
              CHANGE
                MANAGEMENT

            


    

    


    Product
      specific Master Batch Records, Raw Material Methods and Specifications, process
      control Specifications of intermediates and testing methods and Specifications
      and testing methods will be approved by both New River’s Quality Assurance
      Department and Patheon’s Quality Assurance Department. No changes to the above
      documents may be implemented without the signed authorization from an authorized
      member of the New River Quality Assurance Department. All required regulatory
      approvals will be obtained prior to implementation. Variations to established
      production procedures may be initiated by either Party, but must be agreed
      to in
      writing by the authorized members of the Quality Assurance Departments of both
      Parties before implementation. The release status of the Product produced under
      a variation will be decided as part of the variation approval process. Quality
      Assurance Departments of Patheon or New River will have the right to assign
      a
      final disposition of “rejected” to the batch should they conclude that such
      action is appropriate.


    
      
        
        

      

      
        16

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	
              11.

            	
              PRODUCT
                AND PROCESS VALIDATION

            


    

    


    
      	 	
              11.1

            	
              Process

            


    

    


    New
      River
      is responsible for ensuring that the process for Manufacture is validated.
      The
      validation should ensure that the process is capable of consistently achieving
      the Product’s acceptance Specifications. Patheon will generate, internally
      approve and execute approved validation protocol(s) and may not use any
      validation protocol or issue a report unless New River technical personnel
      and
      New River Quality Assurance have first approved. Patheon will provide all
      protocols and reports in a timely manner to allow sufficient tune for review,
      prior to process requirements. New River will review all protocols and
      validation reports promptly, but [***] of receipt.

    


    
      	 	
              11.2

            	
              Cleaning
                Validation

            


    

    


    
      	 	
              11.2.1

            	
              Patheon
                is responsible for ensuring that adequate cleaning is carried out
                between
                batches of different products to prevent contamination. This is achieved
                and verified with the overall cleaning validation program on
                site.

            


    

    


    
      	 	
              11.2.2

            	
              New
                River will provide available information to establish cleaning limits
                for
                New River Product(s) within 7 business days of the request- The cleaning
                procedure and analytical methodology may be reviewed by New River
                upon
                request.

            


    

    


    
      	 	
              11.2.3

            	
              Patheon
                is responsible for having appropriate cleaning procedures for all
                products
                manufactured on non-dedicated equipment used to Manufacture New River
                Product(s).

            


    

    


    
      	 	
              11.2.4

            	
              Patheon
                is responsible for having appropriate cleaning procedures for New
                River
                product(s) manufactured on dedicated equipment. The cleaning procedure
                and
                analytical methodology must be reviewed and approved by New River
                prior to
                use by Patheon.

            


    


    
      
        
        

      

      
        17

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              11.3

            	
              Equipment,
                Computer, Facility, and Utilities
                Qualification

            


    

    


    Patheon
      is responsible for the safe, compliant and efficient working of all equipment,
      computer, utility and facility qualification activities associated with the
      products, including maintenance. Patheon is also responsible for the validation
      and qualification of all equipment, computer, and utilities associated with
      the
      Products. As deemed appropriate, equipment shall be qualified prior to use
      by
      performing Installation Qualification, Operation Qualification and Performance
      Qualification (as applicable) using protocols in accordance with all applicable
      laws, rules and regulations. Should an issue become evident that has or could
      affect the Products, Patheon will notify New River [***]. Patheon must make
      available Equipment, Computer, Facility, and Utilities Qualification data during
      an Annual or Event MA.

    


    
      	 	
              11.4

            	
              Laboratory
                Qualifications

            


    

    


    
      	 	
              11.4.1

            	
              Patheon
                is responsible for ensuring that all laboratories are compliant with
                cGMPs
                with regard to systems and equipment
                qualifications.

            


    

    


    
      	 	
              11.4.2

            	
              Patheon
                is responsible for maintaining appropriate cGMP documentation procedures
                in the laboratories (i.e. notebooks, logbooks, sample receipt, sample
                tracking, SOPs, etc)

            


    

    


    
      	 	
              11.4.3

            	
              Patheon
                is responsible for ensuring all methodology associated with the Product(s)
                is appropriately qualified and/or validated, If analytical work is
                performed at Patheon, then New River will also provide any existing
                analytical documentation to assist in Methods transfer or Methods
                validation. Patheon will not use any validation protocol or issue
                a report
                unless New River technical personnel and New River Quality Assurance
                have
                first approved. New River will review all protocols and reports promptly,
                but [***].

            


    

    


    
      	 	
              11.4.4

            	
              If
                analytical work is not performed at Patheon’s site, Patheon may elect to
                perform an audit on vendors to be used for analytical testing. Should
                Patheon decide to sub-contract out any quality control work, or approval
                from New River will be required.

            


    

    


    
      	
              12.

            	
              ANNUAL
                PRODUCT REVIEW, DRUG LISTING, AND ANNUAL
                REPORTS

            


    

    


    
      	 	
              12.1

            	
              Annual
                Product Review

            


    

    


    Patheon
      will perform an annual product review on the Products and will issue a report
      to
      New River [***] after the conclusion of an annual manufacturing cycle. New
      River
      and Patheon will jointly determine the annual reporting cycle.
      This report will be a review of any changes in the manufacturing packaging,
      testing or validation of the Product in the previous year; a summary of lots
      made, released, and rejected; a stability summary. Also, control charting or
      trend analysis of key Finished Product parameters will be performed on an annual
      basis per Patheon written procedures. Any abnormalities will be explained in
      the
      annual review. This review will be conducted in accordance with 21CFR211.180(e)
      and any other Applicable Laws.


    
      
        
        

      

      
        18

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              12.2

            	
              Drug
                Listing

            


    

    


    Patheon
      is responsible for drug listing as the Manufacturer of the Product(s) while
      New
      River and its affiliates are responsible for drug listing as the distributor
      of
      the Product(s). New River will provide Patheon copies of all product labeling
      including package insert, NBA number, name and address of NBA holder, and NBC
      code which includes labeler code, product code, and packaging code. New River
      will notify Patheon of the scheduled product launch.

    


    
      	 	
              12.3

            	
              Annual
                Reports, IND Updates or Other Regulatory
                Filings

            


    

    


    New
      River
      is responsible for preparing any Annual Report, IN]) update or other regulatory
      filing as required by Applicable Laws, including 21 CFR. 314.7(g)(3),
      314.81(b)(2), and/or 601.12 (d), (f)(3). For a routine Annual Report, New River
      shall request in writing, [***] prior to the due date, the chemistry,
      manufacturing and controls data required for the submission, Patheon will
      provide the requested information [***] before the due date. For other
      regulatory filings New River will request CMC data from Patheon with appropriate
      advance notice. The standard notice period is [***], however, other time periods
      shall be satisfactory upon agreement of the parties.

    


    
      	
              13.

            	
              STORAGE
                AND SHIPPING

            


    

    


    
      	 	
              13.1

            	
              Storage

            


    

    


    Patheon
      will ensure that during storage of the Product(s) that procedures are in place
      to protect the Products from deterioration, interference, theft, Product
      contamination or admixture with any other materials. New River will provide
      details of any labeling requirements and container sealing and integrity
      requirements.

    


    
      	 	
              13.2

            	
              Packing
                and Labeling for Transit

            


    

    


    The
      Product(s) will be suitably packed for transit, each pallet or outer container
      being labeled in accordance with the approved Specifications and Applicable
      Laws.

    


    
      	 	
              13.3

            	
              Mixing
                of Product

            


    

    


    Different
      lots of a single Product or different types of Products
      will not
      be mixed on a pallet.


    
      
        
        

      

      
        19

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              13.4

            	
              Shipment
                of Product to New River

            


    

    


    Only
      approved, finished (unless required by New River), labeled Products will be
      shipped by Patheon to New River or Affiliates Distribution Center. Any shipment
      of Product from Patheon, which is unapproved, or under quarantine requires
      prior
      written consent by New River’s Quality Assurance. This authorization will be on
      a lot by lot basis.

    


    
      	
              14.

            	
              CONTRACTUAL
                AGREEMENT

            


    

    


    Established
      at New River Pharmaceuticals Inc., 1881 Grove Avenue, Radford, Virginia 24141
      

    


    For
      and
      on behalf of NEW RIVER PHARMACEUTICALS INC.:

    


    
      	 	 	 	 	 	 
	
              NAME

            	 	
              TITLE

            	 	
              SIGNATURE

            	 


    

    


    For
      and
      on behalf of PATHEON PHARMACEUTICALS INC.:

    


    
      	 	 	 	 	 	 
	
              NAME

            	 	
              TITLE

            	 	
              SIGNATURE

            	 


    


    
      
        
        

      

      
        20

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    APPENDIX
      I

    


    Responsibilities
      Matrix

    


    Patheon
      is responsible for all the operations that are marked with “X” in the column
      titled “Patheon” and New River is responsible for all the operations that are
      marked with C” in the column titled “New River.” If marked with “(X)”, the
      designated party will cooperate.

    


    
      	 	
              (a)

            	
              Administrative
                or Overall

            


    

    


    
      	 	 	
              New
                River

               

            	
              Patheon

               

            
	
              1.   
                

            	
              Provide
                Product Specifications. (Schedule A of MSA)

               

            	
              X

            	 
	
              2.   
                

            	
              Manufacture
                and package Product(s) according to the Specifications. (Appendix
                V)

               

            	 	
              X

            
	
              3.   
                

            	
              Permit
                GMP audits of all relevant premises, procedures and documentation
                by New
                River and permit inspection by regulatory authorities.

               

            	 	
              X

            
	
              4.   
                

            	
              Will
                not subcontract any of the work to a third party without prior written
                consent of New River.

               

            	 	
              X

            
	
              5.   
                

            	
              Provide
                copies of Annual Product Review reports.

               

            	 	
              X

            
	
              6.   
                

            	
              Provide
                copies of information and correspondence necessary to support the
                Annual
                Report when requested by New River.

               

            	 	
              X

            
	
              7.   
                

            	
              Notify
                and obtain approval from New River before initiating any proposed
                changes
                to the process, materials, testing, equipment or premises that may
                affect
                the Product(s). New River approval will not be unreasonably
                withheld.

               

            	 	
              X

            
	
              8.   
                

            	
              Notify
                New River within [***]
                of
                receipt of any FDA Form 483’s, warning letters or the like from regulatory
                agencies relating to: (i) the Product(s); (ii) the supply of Product(s)
                or
                (iii) the facilities used to produce, test or package the Product(s).
                New
                River will review and approve responses that relate to the Product(s)
                before submitting to the regulatory agency. Patheon reserves the
                right to
                respond to such regulatory agencies without approval, if, in the
                reasonable opinion of Patheon’s counsel, it is required to do
                so.

               

            	 	
              X

            
	
              9.   
                

            	
              Notify
                New River within [***]
                of
                any regulatory authority requests for samples, batch documentation,
                or
                other information related to the Product(s).

               

            	 	
              X

            
	
              10.   
                

            	
              Conduct
                operations in compliance with applicable environmental, occupational
                health and safety laws, and cGMP regulations.

               

            	 	
              X

            
	
              11.   
                

            	
              Investigate
                all medical and non-medical product complaints related to the
                manufacturing of the Product(s).

               

            	
              X

            	
              (X)

            


    


    
      
        
        

      

      
        21

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

     

    
      	
              12.   
                

            	
              Investigate
                all manufacturing Product complaints at New River’s request.

               

            	 	
              X

            
	
              13.   
                

            	
              Notify
                other party within [***]
                of
                receipt of information meeting NDA Field Alert criteria as defined
                in 21
                CFR 314.81(b)(l).

               

            	
              X

            	
              X

            
	
              14.   
                

            	
              Initiate
                and submit NDA Field Alert reports.

               

            	
              X

            	 
	
              15.   
                

            	
              Initiate
                and manage Product recalls.

               

            	
              X

            	
              (X)

            
	
              16.   
                

            	
              Timely
                liaise with Regulatory Authorities for approval, maintenance and
                updating
                of marketing approval.

               

            	
              X

            	 


    

    


    
      	 	
              (b)

            	
              Validation
                and Process Testing Activities

            


    

    


    
      	 	 	
              New
                River

               

            	
              Patheon

               

            
	
              1.   
                

            	
              Establish
                applicable validation plans and maintain a validation program for
                the
                Product(s).

               

            	
              X

            	
              X

            
	
              2.   
                

            	
              Qualify
                (IQ/OQ) facilities, utilities, laboratory equipment and process
                equipment.

               

            	 	
              X

            
	
              3.   
                

            	
              Calibrate
                instrumentation and qualify computer systems used in the manufacture
                and
                testing of the Product(s).

               

            	 	
              X

            
	
              4.   
                

            	
              Prepare
                all validation protocols and reports, for manufacturing and packaging
                operations.

               

            	
              (X)

            	
              X

            
	
              5.   
                

            	
              Review
                and approve master validation plan, and validation protocols and
                reports
                for manufacturing and packaging of the Product(s).

               

            	
              X

            	
              X

            
	
              6.   
                

            	
              Maintain
                appropriate equipment cleaning procedures and cleaning validation
                program.

               

            	 	
              X

            
	
              7.   
                

            	
              Provide
                toxicological information to be used in the development of a cleaning
                program.

               

            	
              X

            	 
	
              8.   
                

            	
              Validate
                analytical test methods for finished Product(s).

               

            	
              (X)

            	
              X

            


    


    
      
        
        

      

      
        22

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              (c)

            	
              Raw
                Materials

            


    

    


    
      	 	 	
              New
                River

            	
              Patheon

            
	
              1.   
                

            	
              Provide
                the master formula including Bill of Materials.

               

            	
              X

            	 
	
              2.   
                

            	
              Provide
                approved supplier list. New River to audit and approve API suppliers
                and
                ensure cGMP compliance where New River stipulates the supplier. New
                River
                stipulated suppliers will be included on New River’s approved supplier
                list (attached hereto as APPENDIX VII)

               

            	
              X

            	 
	
              3.   
                

            	
              New
                River to qualify and approve product specific excipient suppliers
                and
                ensure cGMP compliance where New River stipulates the supplier. New
                River
                stipulated suppliers will be included on New River’s approved supplier
                list (APPENDIX VII).

               

            	
              X

            	 
	
              4.   
                

            	
              Patheon
                to qualify and approve excipient suppliers and ensure cGMP compliance
                where Patheon stipulates the suppliers. Patheon stipulated suppliers
                will
                be included on the Patheon approved supplier list (APPENDIX
                VII).

               

            	 	
              X

            
	
              5.   
                

            	
              Provide
                API specifications.

               

            	
              X

            	 
	
              6.   
                

            	
              Procure
                API (including Certificates of Analysis and Certificates of
                Compliance).

               

            	
              X

            	 
	
              7.   
                

            	
              Provide
                test methods for API (if non-Compendial).

               

            	
              X

            	 
	
              8.   
                

            	
              Validate
                non-Compendial testing methods for API.

               

            	 	
              X

            
	
              9.   
                

            	
              Analyze
                and release API.

               

            	 	
              X

            
	
              10.   
                

            	
              Retain
                reference sample of API for [***]
                of
                the last batch of Product(s) manufactured with that material in the
                Product(s) or such longer period required by law.

               

            	 	
              X

            
	
              11.   
                

            	
              Procure
                inactive ingredients (including Certificates of Analysis and Certificates
                of Compliance)

               

            	 	
              X

            
	
              12.   
                

            	
              Provide
                test methods and method validation for inactive ingredients (if
                non-Compendial).

               

            	
              X

            	 
	
              13.   
                

            	
              Analyze
                and release inactive ingredients.

               

            	 	
              X

            
	
              14.   
                

            	
              Retain
                reference samples of inactive ingredients [***]
                or
                such longer period as required by law.

               

            	 	
              X

            
	
              15.   
                

            	
              Maintain
                records and evidence on the testing of raw materials [***]
                after the materials were last used in the manufacture of the
                Product(s).

               

            	 	
              X

            
	
              16.   
                

            	
              At
                New River’s request, confirm that [***]
                raw materials purchased by Patheon for the manufacture of Product(s)
                have
                a BSE/TSE certificate of compliance from the raw material
                vendor.

               

            	 	
              X

            


    


    
      
        
        

      

      
        23

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              (d)

            	
              Bulk
                Manufacture

            


    

    


    
      	 	 	
              New
                River

            	
              Patheon

            
	
              1.   
                

            	
              Create,
                control, issue and execute master batch record.

               

            	 	
              X

            
	
              2.   
                

            	
              Approve
                master batch record.

               

            	
              X

            	
              X

            
	
              3.   
                

            	
              Document,
                investigate and resolve deviations from approved manufacturing
                instructions or specifications.

               

            	
              (X)

            	
              X

            


    

    


    
      	 	
              (e)

            	
              Packaging

            


    

    


    
      	 	 	
              New
                River

            	
              Patheon

            
	
              1.   
                

            	
              Provide
                specifications for packaging components. 

               

            	
              X

            	
              (X)

            
	
              2.   
                

            	
              Review
                and approve labeling proofs.

               

            	
              X

            	 
	
              3.   
                

            	
              Provide
                artwork and labeling text (blister, carton, leaflet, label etc.)
                specifications.

               

            	
              X

            	 
	
              4.   
                

            	
              Create
                control, issue and execute master packaging record.

               

            	 	
              X

            
	
              5.   
                

            	
              Approve
                master packaging record.

               

            	
              X

            	
              X

            
	
              6.   
                

            	
              Qualify
                and approve packaging component suppliers. New River to qualify and
                approve packaging component suppliers and ensure cGMP compliance
                where New
                River stipulates the supplier. New River stipulated suppliers will
                be
                included on its approved supplier list (APPENDIX VII). 

               

            	
              X

            	
              (X)

            
	
              7.   
                

            	
              Patheon
                to qualify and approve packaging component suppliers and ensure cGMP
                compliance when Patheon stipulates the supplier. Patheon stipulated
                suppliers will be included on its approved supplier list (APPENDIX
                VIII).
                

               

            	 	
              X

            
	
              8.   
                

            	
              Provide
                test methods for packaging components. 

               

            	
              (X)

            	
              X

            
	
              9.   
                

            	
              Procure
                packaging components.

               

            	 	
              X

            
	
              10.   
                

            	
              Analyze
                and release packaging components.

               

            	 	
              X

            
	
              11.   
                

            	
              Maintain
                records and evidence on the testing of packaging/labeling materials
                [***]
                after the materials were last used in the packaging/labeling of the
                Product(s).

               

            	 	
              X

            
	
              12.   
                

            	
              Document,
                investigate and resolve any deviation from approved packaging instructions
                or specifications.

               

            	 	
              X

            


    

     

    
      
        
        

      

      
        24

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    
      	 	
              (f)

            	
              Testing
                & Release of Finished Product

            


    

    


    
      	 	 	
              New
                River

            	
              Patheon

            
	
              1.   
                

            	
              Provide
                finished product specifications. (Schedule A of MSA)

               

            	
              X

            	 
	
              2.   
                

            	
              Supply/develop
                analytical test methods for finished product.

               

            	
              (X)

            	
              X

            
	
              3.   
                

            	
              Test
                finished product. Issue CoA/ CoC (Appendix VI)

               

            	 	
              X

            
	
              4.   
                

            	
              Maintain
                all batch records for a minimum of [***]
                past Product(s) expiry date and supply copies of all such records
                to New
                River upon request.

               

            	 	
              X

            
	
              5.   
                

            	
              Notify
                New River QA of confirmed Out-Of-Specification results within [***].

               

            	 	
              X

            
	
              6.   
                

            	
              Resolve
                Out-Of-Specifications results and Issue Quality Observation Report
                prior
                to product release.

               

            	 	
              X

            
	
              7.   
                

            	
              Retain
                reference samples of finished product for [***]
                past expiration date.

               

            	 	
              X

            
	
              8.   
                

            	
              Retain
                reserve sample of finished product as required by 21 CFR
                211.l70(b)(1)

               

            	 	
              X

            


    

    


    
      	 	
              (g)

            	
              Stability
                Testing

            


    

    


    
      	 	 	
              New
                River

            	
              Patheon

            
	
              1.   
                

            	
              Provide
                stability testing protocol for finished Product(s).

               

            	
              X

            	
              (X)

            
	
              2.   
                

            	
              Store
                stability samples.

               

            	 	
              X

            
	
              3.   
                

            	
              Develop
                and validate stability indicating assay.

               

            	
              (X)

            	
              X

            
	
              4.   
                

            	
              Complete
                stability testing including data review [***]
                of
                stability pull, or earlier as dictated by site SOPs.

               

            	 	
              X

            
	
              5.   
                

            	
              Report
                stability data annually or more frequently if requested.

               

            	 	
              X

            
	
              6.   
                

            	
              Notify
                New River of any confirmed stability failure for Product(s) supplied
                to
                New River [***]
                and [***].

               

            	 	
              X

            


    

     

    
      
        
        

      

      
        25

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    APPENDIX
      II

    DEFINITIONS

    


    “ANDA”
      means Abbreviated New Drug Application.

    


    “API”
      means Active Pharmaceutical Ingredient

    


    “APR”
      means Annual Product Review as defined in 21 CPR 2

    


    “AR
      or
      Annual Report means a regulatory update to a New Drug Application (NDA) or
      Abbreviated New Drug Application (ANDA) submitted to the FDA (or other such
      equivalent agency). Typically minor changes to such applications are submitted
      pursuant to 21 CFR 314.70(4

    


    “BSE”
      means Bovine Spongiform Encephalopathy.

    


    “CofA”
      means Certificate of Analysis

    


    “Cot”
      means Certificate of Compliance

    


    “CFR”
      means the United States Code of Federal Regulations

    


    “cGMP”
      means Current Good Manufacturing Practice as described in 21 CFR 210 and 211,
      or
      its equivalent foreign counterpart.

    


    “DEA”
      means Drug Enforcement Administration, or its equivalent foreign
      counterpart

    


    “Event
      means an audit initiated by a quality or process event, which warrants Thither
      investigation by New River. “FDA” means Food & Drug Administration, or its
      equivalent foreign counterpart

    


    “ICH”
      means the International Committee on Harmonization.

    


    “IQ’
      means Installation Qualification.

    


    “MA”
      means routine or annual Manufacturing Audit 

    


    “MSA”
      means Manufacturing Services Agreement

    


    “Master
      Batch Record(s)” mean the approved formulation, manufacturing/packaging
      instructions, and controls whereby a Batch of Product is manufactured. Master
      Batch Records must be written per cGMPs for all clinical, registration,
      stability, and commercial manufacturing processes and may be issued repeatedly
      of the manufacture of the same Batch of Product

    


    “Methods”
      means approved analytical testing procedures for Raw Materials, intermediates
      and final Product.


    
      
        
        

      

      
        26

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    “NDA”
      means New Drug Application or non-US equivalent thereof applicable to or
      referencing of the API to be supplied hereunder relating to the New River
      formulation of the finished dose product and owned by New River, and any
      supplements to such NDA as may be filed during the term hereof

    


    “NDC”
      means National Drug Code.

    


    “OOS”
      means Out of Specification.

    


    “OQ”
      means Operational Qualification.

    


    “Primary
      Packaging Component” means a component that is or maybe in direct contact with
      the dosage form and labeling.

    


    “TSE”
      means Transmissible Spongiform Encephalopathy.


    
      
        
        

      

      
        27

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    APPENDIX
      III


    LIST
      OF CONTACTS


    (NAME,
      PHONE, FAX, E-MAIL)

     

    
      	
              ISSUE

            	
              NEW
                RIVER

              PHARMACEUTICALS,
                INC. or 

              AFFILIATES

            	
              PATHEON

              PHARMACEUTICALS
                INC.

            
	
              Product
                Release

            	
              Andy
                Romano

              [***]

               

            	
              Chuck
                Venable

              [***]

               

            
	
              Investigations

            	
              Cheryl
                Zwirgzdas 

              [***]

               

            	
              Chuck
                Venable

              [***]

               

            
	
              Regulatory
                Inspections

            	
              Andy
                Romano

              [***]

               

            	
              David
                Leuck

              [***]

               

            
	
              Stability

            	
              Andy
                Romano

              [***]

               

            	
              Chuck
                Venable

              [***]

               

            
	
              Validation

            	
              Andy
                Romano

              [***]

               

            	
              Chuck
                Venable

              [***]

               

            
	
              Complaints

            	
              Andy
                Romano

              [***]

               

            	
              Phil
                Bates

              [***]

               

            
	
              Change
                Management

            	
              Andy
                Romano

              [***]

               

            	
              Greg
                Hammer

              [***]

               

            
	
              Audits

            	
              Andy
                Romano

              [***]

               

            	
              David
                Leuck

              [***]

               

            
	
              Regulatory
                Affairs

            	
              Andy
                Romano

              [***]

              or

              Suma
                Krishnan

              [***]

               

            	
              Greg
                Hammer

              [***]

               

            
	
              Emergency

            	
              Cheryl
                Zwirgzdas 

              [***]

               

            	
              Chuck
                Venable

              [***]

               

            


    


    
      
        
        

      

      
        28

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    APPENDIX
      IV

    Batch
      Document Audit Schedule

    


    The
      primary responsibility for batch document review resides with Patheon
      Pharmaceuticals. New River Pharmaceuticals will conduct a graduated plan for
      auditing batch documentation. This will supplement the annual cGMP audit, or
      any
      other investigations related to quality or batch incidents.

    


    The
      following table outlines the plans for New River or its affiliates review of
      batch documentation:

     

    
      	 	
              [***]

            	
              [***]

            	
              [***]

            
	
              [***]

            	
              [***]

            	
              [***]

            	
              [***]

            
	
              [***]

            	
              [***]

            	
              [***]

            	
              [***]

            
	
              [***]

            	
              [***]

            	
              [***]

            	
              [***]

            
	
              [***]

            	
              [***]

            	
              [***]

            	
              [***]

            
	
              [***]

            	
              [***]

            	
              [***]

            	
              [***]

            


    

     

    
      
        
        

      

      
        29

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    APPENDIX
      V

    List
      of Products

     

    
      	
              Product
                Name and Strength

            	
              Package
                Configuration

            	
              Finished
                Product

              Identification
                Number

               

            
	
              [***]

            	
              Bulk

            	 
	
              [***]

            	
              Bulk

            	 
	
              [***]

            	
              Bulk

            	 


    

     

    
      
        
        

      

      
        30

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    APPENDIX
      VI


    Release
      Documentation

    


    The
      release documentation for all batches will include a Certificate of Analysis
      (COA), a Certificate of Conformance (COC), and a list of all process or testing
      deviations for this batch.

    


    A
      Certificate of Analysis

    This
      document will list the following:

    
      	 	
              •

            	
              The
                Product Name

            


    

    
      	 	
              •

            	
              The
                Batch Number

            


    

    
      	 	
              •

            	
              The
                Date of Manufacture

            


    

    
      	 	
              •

            	
              All
                Analytical Test Results and
                Specifications

            


    

    
      	 	
              •

            	
              All
                Microbiological Test Results

            


    

    
      	 	
              •

            	
              Certification
                that all Specifications have been
                met.

            


    

    


    A
      Certificate of Conformance (

    This
      document will attest to the fact that the batch of products was made in
      accordance with all applicable regulations, product licenses, and company
      policies. This document will include:

    
      	 	
              •

            	
              Product
                name

            


    

    
      	 	
              •

            	
              Lot
                number

            


    

    
      	 	
              •

            	
              Batch
                quantity approved

            


    

    
      	 	
              •

            	
              Expiry
                date

            


    

    
      	
              •

            	
              A
                statement confirming that the batch record conforms to cGMP requirements
                and has been reviewed and approved by Patheon’s Quality
                Assurance.

            


    

    


    Patheon’s
      authorized Quality Assurance personnel will sign the above
      certificates.


    
      
        
        

      

      
        31

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    APPENDIX
      VII

    New
      River Approved Supplier List

    


    NOTE:
      Approval of these API suppliers in pending approval of NRP1O4 NDA by
      FDA.

    


    
      	 	
              1.

            	
              [***]

            


    

    


    
      	 	
              2.

            	
              [***]

            


    


    
      
        
        

      

      
        32

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    APPENDIX
      VIII


    Patheon
      Approved Supplier List

    


    


    
      	
              Material

            	
              Approved
                Supplies(s)

            
	
              [***]

            	
              [***]

            
	
              [***]

            	
              [***]

            
	
              [***]

            	
              [***]

            
	
              [***]

            	
              [***]

            
	
              [***]

            	
              [***]

            
	
              [***]

            	
              [***]

            


    


    
      
        
        

      

      
        33

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    SCHEDULE
      H

    


    QUARTERLY
      ACTIVE MATERIAL INVENTORY REPORT

    


    
      	
              TO:

            	
              NEW
                RIVER PHARMACEUTICALS INC.

            


    

    


    
      	
              FROM:

            	
              PATHEON
                PHARMACEUTICALS INC.

            


    

    


    
      	
              RE:

            	
              Active
                Materials quarterly inventory report pursuant to Section 2.4(a) of
                the
                Manufacturing Services Agreement dated (the
                “Agreement”)

            


    

     

    
      
        

      

    

     

    
      	
              Reporting
                quarter:

            	 	 	 
	 	 	 	 
	
              Active
                Materials on hand at beginning of quarter:

            	 	
              kg

            	
              (A)

            
	 	 	 	 
	
              Active
                Materials on hand at end of quarter:

            	 	
              kg

            	
              (B)

            
	 	 	 	 
	
              Quantity
                Received during quarter:

            	 	
              kg

            	
              (C)

            
	 	 	 	 
	
              Quantity
                Dispensed
                during quarter:

            	 	
              kg

            	 
	
              (A
                + C - B)

            	 	 	 
	 	 	 	 
	
              Quantity
                Converted during quarter:

            	 	
              kg

            	 
	
              (total
                Active Materials in Products produced and not rejected, recalled
                or
                returned)

            	 	 	 


    

    


    Capitalized
      terms used in this report have the meanings given to such terms in the
      Agreement.

    


    
      	
              DATE:

            	 	 
	 	 	 
	
              PATHEON
                PHARMACEUTICALS NC.

            
	 	 	 
	
              Per:

            	 	 
	 	 	 
	
              Name:

            	 	 
	 	 	 
	
              Title:

            	 	 


    

     

        ______________________________________

     

    1   
      Excludes any Active Materials received or dispensed in connection with
      technical transfer activities or development activities, including, without
      limitation, any regulatory, stability, validation or test batches manufactured
      during the quarter.

     

    
      
        
        

      

      
        34

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    EXECUTION
      VERSION

    


    SCHEDULE
      I

    


    REPORT
      OF ANNUAL ACTIVE MATERIAL INVENTORY RECONCILIATION

    AND

    CALCULATION
      OF ACTUAL ANNUAL YIELD.

    


    
      	
              TO:

            	
              NEW
                RIVER PHARMACEUTICALS NC.

            


    

    


    
      	
              FROM:

            	
              PATHEON
                PHARMACEUTICALS NC.

            


    

    


    
      	
              RE:

            	
              Active
                Materials annual inventory reconciliation report and calculation
                of Actual
                Annual Yield pursuant to Section 2.4(a) of the Manufacturing Services
                Agreement dated’ (the “Agreement

            


    

     

    
      	
              Reporting
                Year Ending:

            	 	 	 
	 	 	 	 
	
              Active
                Materials on hand at beginning of Year:

            	 	
              kg

            	
              (A)

            
	 	 	 	 
	
              Active
                Materials on hand at end of Year:

            	 	
              kg

            	
              (B)

            
	 	 	 	 
	
              Quantity
                Received during Year:

            	 	
              kg

            	
              (C)

            


    

     

    
      
        
        

      

      
        35

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

     

    
      	
              Quantity during
                Year:

            	 	
              kg

            	
              (D)

            
	
              (A
                +C - B)

            	 	 	 
	 	 	 	 
	
              Quantity
                Converted during Year:

            	 	
              kg

            	
              (E)

            
	
              (total
                Active Materials in Products produced and not rejected, recalled
                or
                returned)

            	 	 	 
	 	 	 	 
	
              Active
                Materials Cost:

            	
              $

            	
              kg

            	
              (F)

            
	 	 	 	 
	
              Target
                Yield:

            	 	
              kg

            	
              (G)

            
	 	 	 	 
	
              Actual
                Annual Yield:

            	 	
              kg

            	
              (H)

            
	
              ((E/D)
                * 100)

            	 	 	 


    

    
       

          ______________________________________

      

        2   
          Excludes any Active Materials received or dispensed in connection
          with
          technical transfer activities or development activities, including, without
          limitation, any regulatory, stability, validation or test batches manufactured
          during the quarter.

         

      

    

    
      
        
        

      

      
        36

        
          

        

      

      
        
        

      

    


    CONFIDENTIAL
      TREATMENT

    


    EXECUTION
      VERSION

    


    Shortfall:         $___________________________  (I)


    (((H
      --3%
      - I)/100) * * D) (if
      a
      negative number, insert zero)

    


    Based
      on
      the foregoing reimbursement calculation ______________________ will reimburse
      __________________the amount of $__________________

    


    Capitalized
      terms used in this report have the meanings given to such terms in the
      Agreement.

    


    


    
      	
              DATE:

            	 	 
	 	 	 
	
              PATHEON
                PHARMACEUTICALS NC.

            
	 	 	 
	
              Per:

            	 	 
	
              Name:

            	 	 
	
              Title:

            	 	 


    

     

     37