----

**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 |

----

**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     |

----

**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     |

----

**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     |

----

**CONFIDENTIAL      TREATMENT**

**MANUFACTURING      SERVICES AGREEMENT**

**THIS      MANUFACTURING SERVICES AGREEMENT (the “Agreement’)**
**“Effective      Date”**

|   | **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”**). |
|--------|-----------------------------------------------------------------------------------------|

**ARTICLE      1**

**INTERPRETATION**

| **1.1** | **Definitions.** |
|---------|------------------|

**“Active      Materials”**

**“Active      Materials Credit Value”**

**“Affiliate”**

|   | (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; |
|--------|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

**“Annual      Product Review Report”**

**“Annual      Report”**

**“Annual      Requirement of Product”**

**“Annual      Volume”**

**“Applicable      Laws”**

**“Authority”**

**“Breach      Notice”**

**“Business      Day”**

**“cGMPs”**

**“Components”**

----

**CONFIDENTIAL      TREATMENT**

**“Confidentiality      Agreement”**

**“Deficiency      Notice”**

**“FDA”**

**“Failure      Period”**

**“Firm      Orders”**

**“Invention”**

**“Inventory”**

**“Laws”**

**“Manufacturing      Services”**

**“Manufacturing      Site”**

**“Patheon      Manufacturing Responsibilities”**

----

**CONFIDENTIAL      TREATMENT**

**“Permits”**

**“Quality      Agreement”**

**“Recall”**

**“Run      Quantity”**

**“Specifications”**

|   | (a) | [***]; |
|--------|-----|--------|

|   | (b) | [***]; |
|--------|-----|--------|

|   | (c) | [***]; |
|--------|-----|--------|

|   | (d) | [***]; |
|--------|-----|--------|

|   | (e) | [***];                and |
|--------|-----|---------------------------|

|   | (f) | [***]. |
|--------|-----|--------|

**“Technical      Dispute”**

**“Territory”**

**“Third      Party Rights”**

**“Year”**

| **1.2** | **Currency.** |
|---------|---------------|

| **1.3** | **Sections                and Heading.** |
|---------|------------------------------------------|

**“this      Agreement”**
**“hereof”,      “herein”, “hereunder”**

----

**CONFIDENTIAL      TREATMENT**

| **1.4** | **Singular                Terms.** |
|---------|------------------------------------|

| **1.5** | **Schedules** |
|---------|---------------|

|   | 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 |
|--------|---------------------------|--------|-----------------------------------------------------------------------------------------------------------------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

**ARTICLE      2**

**PATHEON’S      MANUFACTURING RESPONSIBILITIES**

| **2.1** | **Manufacturing                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. |
|--------|-----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**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** |
|---------|--------------------------------------------|

| **2.3** | **Failure                to Supply** |
|---------|--------------------------------------|

**“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:**

**Quantity      Dispensed:**

----

**CONFIDENTIAL      TREATMENT**

**Quantity      Converted:**

**“Target      Yield Determination Batches”**
**“Target      Yield”**

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

|   | (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. |
|--------|-----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**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** |
|---------|-------------|

| **3.2** | **Active                Materials** |
|---------|-------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

**ARTICLE      4**

**CONVERSION      FEES AND COMPONENT COSTS**

| **4.1** | **First                Year Pricing.** |
|---------|----------------------------------------|

| **4.2** | **Subsequent                Years’ Pricing.** |
|---------|-----------------------------------------------------|

|   | (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. |
|--------|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

| **4.3** | **Adjustments                to Pricing.** |
|---------|--------------------------------------------|

|   | (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. |
|--------|-----|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

| **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. |
|--------|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**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 [***]. |
|--------|-----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**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. |
|--------|-----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

| **5.3** | **Minimum                Orders** |
|---------|-----------------------------------|

| **5.4** | **Patheon                Forecast for Active Ingredient****.** |
|---------|----------------------------------------------------------------|

| **5.5** | **Shipments****.** |
|---------|--------------------|

| **5.6** | **Invoices                and Payment****.** |
|---------|----------------------------------------------|

----

**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. |
|--------|-----|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**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. |
|--------|-----|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**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****.** |
|---------|-----------------------------------------------------------------------|

**“Complaining      Party”**

| **6.4** | **Customer                Questions and Complaints****.** |
|---------|-----------------------------------------------------------|

**ARTICLE      7**

**CO-OPERATION**

| **7.1** | **Quarterly                Review.** |
|---------|--------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

| **7.2** | **Governmental                Agencies.** |
|---------|-------------------------------------------|

| **7.3** | **Records                and Accounting by                Patheon.** |
|---------|----------------------------------------------------------------------|

| **7.4** | **Inspection.** |
|---------|-----------------|

| **7.5** | **Access.** |
|---------|-------------|

----

**CONFIDENTIAL      TREATMENT**

| **7.6** | **Reports.** |
|---------|--------------|

| **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. |
|--------|-----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**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.** |
|---------|----------------------------------|

**“Initial      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. |
|--------|-----|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

| **8.3** | **Product                Discontinuation.** |
|---------|---------------------------------------------|

| **8.4** | **Termination                upon Regulatory                Refusal.** |
|---------|------------------------------------------------------------------------|

| **8.5** | **Obligations                on Termination.** |
|---------|------------------------------------------------|

|   | (a) | [***] |
|--------|-----|-------|

|   | (b) | [***] |
|--------|-----|-------|

|   | (c) | [***]. |
|--------|-----|--------|

**“Process      Transfer Plan”**

----

**CONFIDENTIAL      TREATMENT**

**ARTICLE      9**

**REPRESENTATIONS,      WARRANTIES AND COVENANTS**

| **9.1** | **Authority.** |
|---------|----------------|

| **9.2** | **New                River Warranties** |
|---------|-----------------------------------------|

|   | (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** |
|---------|---------------------------------------|

|   | (a) | it                shall perform the Manufacturing Services in compliance with the terms                of                this Agreement, the Quality Agreement, the Specifications and                cGMPs; |
|--------|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**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.** |
|---------|--------------------------------------|

| **9.5** | **Permits.** |
|---------|--------------|

| **9.6** | **Compliance                with 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.**

----

**CONFIDENTIAL      TREATMENT**

**ARTICLE      10**

**REMEDIES      AND INDEMNITIES**

| **10.1** | **Consequential                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                [***]. |
|--------|-----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

| **10.3** | **Patheon.** |
|----------|--------------|

| **10.4** | **New                River.** |
|----------|-------------------------------|

----

**CONFIDENTIAL      TREATMENT**

**ARTICLE      11**

**CONFIDENTIALITY**

| **11.1** | **Confidentiality** |
|----------|---------------------|

**ARTICLE      12**

**DISPUTE      RESOLUTION**

| **12.1** | **Commercial                Disputes.** |
|----------|-----------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

| **12.2** | **Technical                Dispute Resolution.** |
|----------|--------------------------------------------------|

**“Technical      Dispute”**

**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. |
|--------|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**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.** |
|----------|-------------------------------------------|

| **13.3** | **Insurance.** |
|----------|----------------|

| **13.4** | **Independent                Contractors.** |
|----------|---------------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

| **13.5** | **No                Waiver.** |
|----------|-------------------------------|

| **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.** |
|----------|-----------------------------------|

**“Force      Majeure Event”**

----

**CONFIDENTIAL      TREATMENT**

| **13.8** | **Additional                Product.** |
|----------|----------------------------------------|

| **13.9** | **Notices.** |
|----------|--------------|

----

**CONFIDENTIAL      TREATMENT**

| **13.10** | **Severability.** |
|-----------|-------------------|

| **13.11** | **Entire                Agreement.** |
|-----------|--------------------------------------|

| **13.12** | **Other                Terms.** |
|-----------|---------------------------------|

| **13.13** | **No                Third Party Benefit or                Right.** |
|-----------|--------------------------------------------------------------------|

| **13.14** | **Execution                in Counterparts.** |
|-----------|-----------------------------------------------|

| **13.15** | **Governing                Law.** |
|-----------|-----------------------------------|

----

**CONFIDENTIAL      TREATMENT**

|   | **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 |   |

----

**CONFIDENTIAL      TREATMENT**

**SCHEDULE      A**

**PRODUCT      FORMULA AND SPECIFICATIONS**

----

**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       | [***] | [***] |
| AnnualVolume(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)      | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
| [***]                                         | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
| [***]                                         | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
| [***]                                         | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
| [***]                                         | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
| [***]                                         | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
| [***]                                         | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |

----

**CONFIDENTIAL      TREATMENT**

| [***]                                       |
|---------------------------------------------|
| V-Blender/Batch                  Size       | [***] | [***] |
| AnnualVolume(million                  caps) | [***] | [***] |
| DEA                  Schedule               | II | III+ | II | III+ |
| Run                  Quality(batches)       | 1 | 2 | 3 | 1 | 2 | 3 | 5 | 1 | 3 | 2 | 3 | 5 |
| [***]                                       | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
| [***]                                       | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
| [***]                                       | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
| [***]                                       | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
| [***]                                       | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
| [***]                                       | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
| [***]                                       | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |

----

**CONFIDENTIAL      TREATMENT**

| [***]                                         |
|-----------------------------------------------|
| V-Blender/Batch                    Size       | [***] | [***] |
| AnnualVolume(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)      | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
| [***]                                         | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
| [***]                                         | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
| [***]                                         | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
| [***]                                         | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
| [***]                                         | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
| [***]                                         | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |

----

**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: |
|--------|----|---------------------------------------------------------------------------------------------------------------------------|

|   | • | [***] |
|--------|---------|-------|

|   | • | [***] |
|--------|---------|-------|

|   | • | [***] |
|--------|---------|-------|

----

**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**

----

**CONFIDENTIAL      TREATMENT**

**SCHEDULE      C**

**STABILITY      TESTING**

----

**CONFIDENTIAL      TREATMENT**

**SCHEDULE      D**

**ACTIVE      MATERIALS**

| Active                Materials | Supplier                                                                                                     |
|---------------------------------|--------------------------------------------------------------------------------------------------------------|
| [***]                           | Approved contract                manufacturers as outlined in the NDA submitted by                [***] |

**ACTIVE      MATERIALS CREDIT VALUE**

| Product  | Active                Materials  | Active                Materials Credit Value                                    |
|---------------|---------------------------------------|--------------------------------------------------------------------------------------|
| [***]         | [***]                                 | The                actual cost to New River of Active Materials                [***] |

**MAXIMUM      CREDIT VALUE**

| Product | Maximum                Credit Value                                                    |
|---------|----------------------------------------------------------------------------------------|
| [***]   | (a)                [***]; (b)                [***]; (c)                [***] |

----

**CONFIDENTIAL      TREATMENT**

**SCHEDULE      E**

**BATCH      NUMBERING AND EXPIRATION DATES**

----

**CONFIDENTIAL      TREATMENT**

**SCHEDULE      F**

**TECHNICAL      DISPUTE RESOLUTION**

**Appointment      of Expert**
**.**

**Conflicts      of Interest**
**.**

|   | 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. |
|--------|-----|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

|   | (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. |
|--------|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

**SCHEDULE      G**

**QUALITY      AGREEMENT**

----

**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 |

----

**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                                                                        |

----

**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 |
|--------------------------------|---|-------------------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

| **1.** | **PARTIES** |
|--------|-------------|

| **2.** | **QUALITY                AGREEMENT** |
|--------|--------------------------------------|

| **3.** | **ADMINISTRATIVE                INFORMATION** |
|--------|-----------------------------------------------|

| **4.** | **PRODUCTS** |
|--------|--------------|

| **5.** | **DURATION                OP AGREEMENT** |
|--------|------------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

| **6.** | **CONFIDENTIALITY** |
|--------|---------------------|

| **7.** | **SECURITY** |
|--------|--------------|

| **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. |
|--------|-------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

|   | 8.2.2.1 | Raw                Material Specification |
|--------|---------|-------------------------------------------|

|   | 8.2.2.2 | Label                Component Specifications |
|--------|---------|-----------------------------------------------|

|   | 8.2.2.3 | Packaging                Component Specifications |
|--------|---------|---------------------------------------------------|

|   | 8.3 | GMP                Guidelines |
|--------|-----|-------------------------------|

|   | 8.4 | Materials |
|--------|-----|-----------|

|   | 8.4.1 | Materials                Procured by Patheon |
|--------|-------|----------------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

|   | 8.4.2 | Materials                Provided by New River |
|--------|-------|------------------------------------------------|

|   | 8.5 | Master                Production Record Approval |
|--------|-----|--------------------------------------------------|

|   | 8.6 | Production |
|--------|-----|------------|

|   | 8.7 | Methodology |
|--------|-----|-------------|

|   | 8.8 | Standard                Operating Procedures |
|--------|-----|----------------------------------------------|

|   | 8.9 | Dates                of Manufacture and Expiration |
|--------|-----|----------------------------------------------------|

|   | 8.9.1 | Date                of Manufacture |
|--------|-------|------------------------------------|

|   | 8.9.2 | Expiration                Date |
|--------|-------|--------------------------------|

----

**CONFIDENTIAL      TREATMENT**

|   | 8.10 | Manufacturing                and Equipment Data |
|--------|------|-------------------------------------------------|

| **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 |
|--------|-------|-------------------------------------------------------|

----

**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 |
|--------|-------|---------|

|   | 9.3.2 | Certificate                of Compliance/Analysis |
|--------|-------|---------------------------------------------------|

|   | 9.3.3 | New                River Receipts |
|--------|-------|-----------------------------------|

|   | 9.3.4 | New                River Confirmatory Testing |
|--------|-------|-----------------------------------------------|

|   | 9.4 | Documentation |
|--------|-----|---------------|

|   | 9.4.1 | Requests                for Full Documentation |
|--------|-------|------------------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

|   | 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 |
|--------|-------|-----------------------------------------------|

|   | 9.5.2 | Retain                Samples - Products |
|--------|-------|------------------------------------------|

|   | 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. |
|--------|---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

|   | 9.6.2 | Development                (Clinical, Registration, R&D) Stability                Program |
|--------|-------|-----------------------------------------------------------------------------------------------|

|   | 9.6.3 | Stability                Failures |
|--------|-------|-----------------------------------|

|   | 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 |
|--------|-------|------------|

|   | 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. |
|--------|---------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

|   | 9.7.2 | Failure                Investigations and Out Of Specification (OOS)                Results |
|--------|-------|---------------------------------------------------------------------------------------------|

|   | 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 |
|--------|-----|-----------------------------------|

|   | 9.10 | Regulatory                Inspections |
|--------|------|---------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

|   | 9.11 | Regulatory                Actions at New River |
|--------|------|------------------------------------------------|

|   | 9.12 | Regulatory                Investigations |
|--------|------|------------------------------------------|

|   | 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’). |
|--------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**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: |
|--------|------|-----------------|

|   | 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; |
|--------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**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 |
|--------|------|-----------------------------------|

|   | 9.16 | Product                Recalls |
|--------|------|--------------------------------|

|   | 9.17 | Compliance                Deficiencies |
|--------|------|----------------------------------------|

|   | 9.18 | NDA                Field Alerts |
|--------|------|---------------------------------|

| **10.** | **CHANGE                MANAGEMENT** |
|---------|--------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

| **11.** | **PRODUCT                AND PROCESS VALIDATION** |
|---------|---------------------------------------------------|

|   | 11.1 | Process |
|--------|------|---------|

|   | 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. |
|--------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

|   | 11.3 | Equipment,                Computer, Facility, and Utilities                Qualification |
|--------|------|------------------------------------------------------------------------------------------|

|   | 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 |
|--------|------|--------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

|   | 12.2 | Drug                Listing |
|--------|------|-----------------------------|

|   | 12.3 | Annual                Reports, IND Updates or Other Regulatory                Filings |
|--------|------|---------------------------------------------------------------------------------------|

| **13.** | **STORAGE                AND SHIPPING** |
|---------|-----------------------------------------|

|   | 13.1 | Storage |
|--------|------|---------|

|   | 13.2 | Packing                and Labeling for Transit |
|--------|------|-------------------------------------------------|

|   | 13.3 | Mixing                of Product |
|--------|------|----------------------------------|

----

**CONFIDENTIAL      TREATMENT**

|   | 13.4 | Shipment                of Product to New River |
|--------|------|-------------------------------------------------|

| **14.** | **CONTRACTUAL                AGREEMENT** |
|---------|------------------------------------------|

|   |   |   |   |      |   |
|--------|--------|--------|--------|-----------|--------|
| NAME   |   | TITLE  |   | SIGNATURE |   |

|   |   |   |   |      |   |
|--------|--------|--------|--------|-----------|--------|
| NAME   |   | TITLE  |   | SIGNATURE |   |

----

**CONFIDENTIAL      TREATMENT**

**APPENDIX      I**

**Responsibilities      Matrix**

|   | (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)               |

----

**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                 |

----

**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           |

----

**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           |

----

**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           |

----

**CONFIDENTIAL      TREATMENT**

**APPENDIX      II**

**DEFINITIONS**

----

**CONFIDENTIAL      TREATMENT**

----

**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[***]orSuma                Krishnan[***]               | Greg                Hammer[***]               |
| Emergency                             | Cheryl                Zwirgzdas [***]                                            | Chuck                Venable[***]             |

----

**CONFIDENTIAL      TREATMENT**

**APPENDIX      IV**

**Batch      Document Audit Schedule**

|   | [***] | [***] | [***] |
|--------|-------|-------|-------|
| [***]  | [***] | [***] | [***] |
| [***]  | [***] | [***] | [***] |
| [***]  | [***] | [***] | [***] |
| [***]  | [***] | [***] | [***] |
| [***]  | [***] | [***] | [***] |

----

**CONFIDENTIAL      TREATMENT**

**APPENDIX      V**

**List      of Products**

| **Product                Name and Strength** | **Package                Configuration** | **Finished                Product****Identification                Number**  |
|----------------------------------------------|------------------------------------------|-----------------------------------------------------------------------------------|
| [***]                                        | Bulk                                     |                                                                              |
| [***]                                        | Bulk                                     |                                                                              |
| [***]                                        | Bulk                                     |                                                                              |

----

**CONFIDENTIAL      TREATMENT**

**APPENDIX      VI**

**Release      Documentation**

|   | • | 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. |
|--------|---------|------------------------------------------------------------------------------------|

|   | • | 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. |
|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

**CONFIDENTIAL      TREATMENT**

**APPENDIX      VII**

**New      River Approved Supplier List**

|   | 1. | [***] |
|--------|----|-------|

|   | 2. | [***] |
|--------|----|-------|

----

**CONFIDENTIAL      TREATMENT**

**APPENDIX      VIII**

**Patheon      Approved Supplier List**

| Material | Approved                Supplies(s) |
|----------|-------------------------------------|
| [***]    | [***]                               |
| [***]    | [***]                               |
| [***]    | [***]                               |
| [***]    | [***]                               |
| [***]    | [***]                               |
| [***]    | [***]                               |

----

**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) |   |   |   |

| DATE:                                      |   |   |
|--------------------------------------------|--------|--------|
|                                       |   |   |
| PATHEON                PHARMACEUTICALS NC. |
|                                       |   |   |
| Per:                                       |   |   |
|                                       |   |   |
| Name:                                      |   |   |
|                                       |   |   |
| Title:                                     |   |   |

----

**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)    |

----

**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)                                                                                                      |   |   |   |

----

**CONFIDENTIAL      TREATMENT**

| DATE:                                      |   |   |
|--------------------------------------------|--------|--------|
|                                       |   |   |
| PATHEON                PHARMACEUTICALS NC. |
|                                       |   |   |
| Per:                                       |   |   |
| Name:                                      |   |   |
| Title:                                     |   |   |

----